Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Immediate post-injection reaction, Magnetic resonance imaging head
Clinical narrative: pressure on frontal lobes; experiencing severe migraine, 8 weeks after getting the first dose; pressure in the head; severe headache after the first dose/Stabbing pain in the head; Tingling; Her left foot went numb and felt like her foot was asleep; brain fog; This is a spontaneous report from a contactable consumer (patient, self-reported). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0158 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 13May2021 at 10:45 (age at vaccination: 32 years), as a single dose for COVID-19 immunization. The patient's medical history included Covid (she had Covid in January). There was no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any vaccine within 4 weeks prior vaccinations and did not have any adverse effect prior vaccinations. Concomitant medication included doxycycline (Face was peeling from wearing masks and for breakout in face). Caller interested to know if the Doxycycline she took before the first dose of the Pfizer BioNTech Covid-19 Vaccine would have a potential effect on her body. Advised caller that the PI did not have information specifically on the interaction between Doxycycline and the Pfizer BioNTech Covid-19 Vaccine. Spoke from attached antivirals/antibiotics CONS doc. The patient stated that she had her first dose of the Pfizer BioNTech Covid-19 Vaccine on 13May2021 and did not get the second dose per HCP's advice due to severe headache after the first dose on 18May2021. She stated that she felt a lot of pressure on her head. She also stated that she took Doxycycline for 10 days but stopped a day before she got the first dose of the vaccine. Also mentioned to her that we normally stick to the normal dosing schedule specified in the PI to maximize the 95% efficacy rate 7 days after the 2nd dose. She has been having headaches since about 5 days after the vaccine and has had a lot of pressure on her head. It doesn't matter what the neurologist has recommended, nothing has touched it and asked had we seen something similar with other patients. It will be 8 weeks, tomorrow. The pain only stops when she was asleep. It was a constant head pressure and stabbing pain and tingling, which was constant. She went to a walk-in clinic. They wouldn't have any information about that. There were days where it was worse and actually didn't improve. She had tried migraine medications, over the counter medications and it didn't do anything. Some days were worse than others. The pressure on her frontal lobes did not go away at all and was a lot of pressure. If you were to wear a headband, right where it lands, it felt like she had a headband on all day long. It was so much pressure on the brain. She had stabbing pain in the head since she had Covid. It has been on and off. The pressure is all day, no matter what. The stabbing occurs throughout the day. She has tried Tylenol and Excedrin, which didn't touch it and, also tried Ibuprofen and tried migraine medications Nurtec and Ubrelvy. Tried these all and nothing worked. She honestly didn't want it. She already had Covid. She does work with a lot of patients. Her husband had Covid and has Long haulers, still dealing with problems from that. She wouldn't try getting it again. Doxycycline was stopped this the day before having the vaccine and did not continue after the vaccine. She had checked with her dermatologist who said it wouldn't counteract it and was on it for 10 days. Had to have started on 02May2021. It was a very low dose. Thinks it was like 50mg, once a day. A brain MRI was done on 26May2021, which showed up negative. Think it was 2 weeks after the symptoms started, so maybe 22 or 23 May, or no, it was 26May2021, which was the day she went to the walk in clinic. Caller laughed and said, Brain fog is real. Her left foot went numb and felt like her foot was asleep on 13May2021 at 10:45 AM. It was right after the shot and lasted a couple of hours, then went away. The adverse events did not require a visit to emergency room and physician office She went into a walk in clinic 26May2021, about 5 or 6 days after the headaches started and nothing was treating it. Caller reported and patient confirmed that they are experiencing severe migraine, 8 weeks after getting the first dose of the PFIZER-BIONTECH COVID-19 VACCINE and that they (physician) were already able to give the patient the medication, Neurtec but proves ineffective for the patient's migraine. Also, patient was not able to get the second dose of the vaccine due to this side effect. Outcome of the event her left foot went numb and felt like her foot was asleep was recovered on 13May2021 at 12:45, brain fog was unknown and for all other events, it was not recovered.   Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Caller has been having headaches since receiving the first dose of the Covid 19 vaccine, 13May2021. Has tried Tylenol, Excedrin, Ibuprofen, Nurtec and Ubrelvy. Nothing has helped.  Product strength and count size dispensed: unknown Additional lot numbers: Unknown, she does not have these with her. What they gave her were samples and she has thrown away the boxes.  Is a sample of the product available to be returned, if requested (Y/N): No Packaging sealed and intact? not provided