More than 15,000 report  side-effects from Covid-19 vaccines

Allergic reactions to the four approved vaccines remain low, with 12 cases of anaphylaxis reported by people who received an mRNA vaccine – Pfizer/BioNTech and Moderna – while a small number were reported in relation to the adenoviral vector vaccines. File picture

There have been 15,424 reports of suspected side-effects in association with the Covid-19 vaccines, according to the latest data.

The suspected side-effects range from tiredness and nausea to – in some cases – heart inflammation and low platelet counts.

Data supplied in the Health Products Regulatory Authority (HPRA) safety update, covers the period to September 28 when just over 7.2m doses of vaccine had been administered.

Allergic reactions to the four approved vaccines remain low, with 12 cases of anaphylaxis reported by people who received an mRNA vaccine – Pfizer/BioNTech and Moderna – while a small number were reported in relation to the adenoviral vector vaccines.

The HPRA is closely monitoring side-effects reported by adolescents since the vaccine rollout was extended to those over the age of 12. There were a total of 168 reports of suspected side-effects by September 28.

Reports from those aged between 12 and 17 "are consistent with the types of reports received for adults, with most being mild to moderate in nature", the report says.

Heart inflammation

The medicines watchdog recorded 80 reports of people suffering heart inflammation, with most cases occurring within two weeks of vaccination.

There were 25 reports of myocarditis, an inflammation of the heart muscle, and 33 reports of pericarditis, inflammation of the heart lining, while 22 people described a combination of both.

Of these, 70 were following the Pfizer vaccine and 10 after getting the Moderna jab.

Heart inflammation was more commonly reported in men, who account for 57 cases while 23 women experienced similar-side effects. In five of the 70 cases, the report concerned a child between the ages of 12 and 17.

The HPRA said there were possible alternative explanations other than vaccination in a number of cases and all cases notified are carefully reviewed.

The European Medicines Agency (EMA) has added a number of new potential side effects for the Pfizer vaccine including:

• Paraesthesia (tingling/pins and needles) 
• Hypoaesthesia (numbness/reduced sensations in the skin) 
• Asthenia (weakness/lack of energy or strength) 
• Lethargy (tiredness) 
• Decreased appetite 
• Nocturnal hyperhidrosis (sweating, especially at nighttime) 

In terms of the viral vector vaccines – AstraZeneca and Johnson & Johnson – there have been some reports of low platelet counts or blood clots.

The report confirms five cases of immune thrombocytopenia (ITP) reported following the AstraZeneca jab and none associated with J&J.

In some cases, the person had a history of ITP, a bleeding disorder caused by the body mistakenly attacking platelets. In all five cases, ITP occurred within one to three weeks post-vaccination and all were treated in hospital.

There have been 12 cases describing a blood-clotting event following the J&J jab.

A condition known as venous thromboembolism (VTE) typically begins by a clot forming in a vein of a leg, arm or groin, which then travels to the lungs and blocks the blood supply there. It can have potential life-threatening consequences.

The HPRA said the majority of the cases reported describe clots typically seen in the general population.

The average age of people affected was 40 years old but cases were seen in those as young as 19 years.

In rare cases, a person can experience thrombosis, with thrombocytopenia syndrome (TTS). There have been nine such cases notified to the HPRA.

Typically, symptoms occur between one and five weeks of vaccination and include: shortness of breath, severe and/or persistent headache, unusual skin bruising, abdominal pain, leg pain and leg swelling.

Cases reported were individuals between the ages of 21 and 63. At the time of reporting, all cases have either been discharged or are recovering in hospital after receiving specialist medical care.

Menstrual disturbances

A commonly reported side-effect from those who get their periods is a disturbance in their menstrual cycle.

Some have reported their period arriving earlier or later than expected, or of a heavier nature than normal.

There have been a small number of reports of post-menopausal women experiencing a bleeding event.

The EMA is reviewing the reports in relation to all Covid vaccines authorised in the EU but to date have found no specific pattern of menstrual disturbances and no evidence of a causal association or link between menstrual disturbances and vaccination.

In half of cases reviewed, the EMA said the patient's medical history or other medication being used provided a possible explanation for the symptom.

Menstrual disturbances can occur due to a wide range of reasons, including stress or conditions such as endometriosis.

Anyone concerned about prolonged or severe menstrual disturbances should seek medical advice, particularly if unexpected vaginal bleeding, for example, in a postmenopausal patient, is experienced.