chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Erythema, Eye irritation, Head discomfort
Clinical narrative: she had covid after the 2 doses and before the booster dose; she had covid after the 2 doses and before the booster dose; hot in the area; redness from flu shout and covid; burring eyes; She was sick in June and July; intermittent pressure at the back of the head; stuffiness; weakness; fever; nausea; could not taste anything; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).  A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 07Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history included autoimmune disease but no transplant. The concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced covid after the 2 doses (4 weeks later) and before the booster dose, weakness, fever, stuffiness (with different food something her heard gets like this), intermittent pressure at the back of the head, headache, nausea, burring eyes, she was sick in June and July, could not taste anything, redness from flu shout and covid, hot in the area (full blown symptoms like when she received the shots) on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 97 on an unspecified date, blood immunoglobulin g: positive on 09Sep2021, Quantitative test (investigation): 459.1 on 07Oct2021 (and 11Oct2021 result value 459.1- antibodies were detected) and antibody test: unknown, sars-cov-2 test (covid): positive result, serology test: 400 (in the last 3 to 6months) on 11Oct2021. she will be seeing her rheumatology. Patient was also interested in plasma donation. she did not specifically ask for the lab test that was ordered but is now wishing to have a better understanding of the lab results. She wanted to know if that meant she potentially had a breakthrough case, like her friend's parents and friend's husband. She reported she attempted to reach Lab, but they are not answer; her primary doctor is out for the weekend. She wanted to know if taking booster too soon could have caused the symptoms as she did test positive to covid after the 2 doses. The patient was administered with booster received on 26Oct2021 at 13:30. She wanted to know should she even gotten the booster dose since she had covid and with high antibodies. The clinical outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Investigation, Nasal congestion, Nausea
Clinical narrative: she had covid after the 2 doses and before the booster dose; she had covid after the 2 doses and before the booster dose; hot in the area; redness from flu shout and covid; burring eyes; She was sick in June and July; intermittent pressure at the back of the head; stuffiness; weakness; fever; nausea; could not taste anything; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).  A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 07Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history included autoimmune disease but no transplant. The concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced covid after the 2 doses (4 weeks later) and before the booster dose, weakness, fever, stuffiness (with different food something her heard gets like this), intermittent pressure at the back of the head, headache, nausea, burring eyes, she was sick in June and July, could not taste anything, redness from flu shout and covid, hot in the area (full blown symptoms like when she received the shots) on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 97 on an unspecified date, blood immunoglobulin g: positive on 09Sep2021, Quantitative test (investigation): 459.1 on 07Oct2021 (and 11Oct2021 result value 459.1- antibodies were detected) and antibody test: unknown, sars-cov-2 test (covid): positive result, serology test: 400 (in the last 3 to 6months) on 11Oct2021. she will be seeing her rheumatology. Patient was also interested in plasma donation. she did not specifically ask for the lab test that was ordered but is now wishing to have a better understanding of the lab results. She wanted to know if that meant she potentially had a breakthrough case, like her friend's parents and friend's husband. She reported she attempted to reach Lab, but they are not answer; her primary doctor is out for the weekend. She wanted to know if taking booster too soon could have caused the symptoms as she did test positive to covid after the 2 doses. The patient was administered with booster received on 26Oct2021 at 13:30. She wanted to know should she even gotten the booster dose since she had covid and with high antibodies. The clinical outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Serology test, Vaccination site warmth
Clinical narrative: she had covid after the 2 doses and before the booster dose; she had covid after the 2 doses and before the booster dose; hot in the area; redness from flu shout and covid; burring eyes; She was sick in June and July; intermittent pressure at the back of the head; stuffiness; weakness; fever; nausea; could not taste anything; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself).  A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 07Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history included autoimmune disease but no transplant. The concomitant medications were not reported. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. The patient experienced covid after the 2 doses (4 weeks later) and before the booster dose, weakness, fever, stuffiness (with different food something her heard gets like this), intermittent pressure at the back of the head, headache, nausea, burring eyes, she was sick in June and July, could not taste anything, redness from flu shout and covid, hot in the area (full blown symptoms like when she received the shots) on an unspecified date in 2021. The patient underwent lab tests and procedures which included body temperature: 97 on an unspecified date, blood immunoglobulin g: positive on 09Sep2021, Quantitative test (investigation): 459.1 on 07Oct2021 (and 11Oct2021 result value 459.1- antibodies were detected) and antibody test: unknown, sars-cov-2 test (covid): positive result, serology test: 400 (in the last 3 to 6months) on 11Oct2021. she will be seeing her rheumatology. Patient was also interested in plasma donation. she did not specifically ask for the lab test that was ordered but is now wishing to have a better understanding of the lab results. She wanted to know if that meant she potentially had a breakthrough case, like her friend's parents and friend's husband. She reported she attempted to reach Lab, but they are not answer; her primary doctor is out for the weekend. She wanted to know if taking booster too soon could have caused the symptoms as she did test positive to covid after the 2 doses. The patient was administered with booster received on 26Oct2021 at 13:30. She wanted to know should she even gotten the booster dose since she had covid and with high antibodies. The clinical outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma attack; This is a spontaneous report from a contactable consumer(patient).   A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on 02May2021 (At the age 57-year-old) as dose 1, single for COVID-19 immunization. Medical history included neuropathy peripheral (Neuropathy), nerve injury. The patient's concomitant medications were not reported. The patient experienced asthma attack on an unspecified date. The patient stated, she have several underline autoimmune conditions (history) and her Neurologist said that she personally needed to get the Covid Shot. The patient first dose shot administered on May 2nd and she had adverse effect which she did not report. Patient took the prednisolone shot for the asthma attack, patient waited 3 hours in the rain and did not get the appointment at 11:30, so she cancelled, and she tried to reschedule. she went for an appointment on 23Sep, and she was told by someone that she have to receive his second dose shot and she received that, within 20 minutes and she had breathing difficulty and she couldn't breath, so she used albuterol inhaler (treatment) and went to the Pharmacist about what was going on, breaking up hives on his body, so Pharmacist told to go home and take Benadryl. She have Neuropathy, nerve damage (history). his fingertips were annoying, she was having electrical impulse in feet. she also had severe Migraine, so this Sunday this was the first time she was not able to walk. she didn't have fever but she had just cold, she didn't have the neurological symptoms, so she just did see his Neurologist she take Gabapentin 1800 mg now Doctor increased it to 2400 mg a day and she have to receive Sumatriptan injection for Migraine (treatment) so that's the one until today so far and however she still have the neurological issue of the fingertips pain, numbness and the electrical impulse. Therapeutic measures were taken as a result of asthma attack. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Frequent bowel movements, Immunisation
Clinical narrative: he has had a flare up since then; multiple bowel movements daily (3-4 per day); received a booster vaccine for coronavirus; received a booster vaccine for coronavirus; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Sep2021 (at the age of 36-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included tofacitinib citrate (XELJANZ XR) takes 22 mg by mouth once daily for ulcerative colitis from Nov2020 and ongoing. The patient previously received dose 1 and dose 2 of COVID-19 Vaccine for immunisation. The patient reported he had been having 1 bowel movement daily for the past few months. He received a booster vaccine for coronavirus, and he has had a flare up since then. He was having multiple bowel movements daily (3-4 per day). The outcome of events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: woke up the next morning with shingles on my right breast, arm pit, and shoulder blade.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FE3590), dose 2 via an unspecified route of administration in arm left on 07Oct2021 at 18:30 (age at vaccination 43-year-old) as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had allergies with darvocet. Medical history included methylenetetrahydrofolate reductase gene and prothrombin level abnormal from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received any other medications included gabapentin and fluoxetine hcl taken for an unspecified indication, start and stop date were not reported the patient received within 2 weeks of vaccination. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: 301308A), dose 1 via an unspecified route of administration in arm left on 16Sep2021 at 12:00 pm as dose 1, single for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced woke up the next morning with shingles on right breast, arm pit, and shoulder blade on 08Oct2021 at 06:30 am. The adverse event resulted to visit emergency room. Therapeutic measures included methylprednisolone tablets and valacyclovir HCL were taken for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity
Clinical narrative: worse headache; complaints of dizziness to the point/had to hold onto furniture because she was so dizzy; sore arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 91-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included dizziness (medical history of dizziness). The patient's concomitant medications were not reported. The patient experienced sore arm on an unknown date in 2021, worse headache on 06Sep2021, complaints of dizziness to the point/had to hold onto furniture because she was so dizzy on an unknown date in 2021. Therapeutic measures were taken as a result of worse headache, complaints of dizziness to the point/had to hold onto furniture because she was so dizzy (Caller stated that she took Tylenol for the headache and the medication that she is prescribed for dizziness but it did not help with her complaints of dizziness). Outcome of the events sore arm, worse headache, complaints of dizziness to the point/had to hold onto furniture because she was so dizzy was recovering.  Follow-up (19Oct2021): This is a follow-up spontaneous report from a contactable consumer which included vaccine start date and event start date.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Immunisation
Clinical narrative: Had the booster on 15-OCT-2021; Had the booster last Friday and 2-3 days later the eczema just erupted; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [03Nov2021], this case now contains serious adverse reaction.  This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received bnt162b2 (BNT162B2), dose 3 intramuscular, administered in Arm Left on 15Oct2021 15:00 (Lot Number: 301358A) as dose 3 (booster), single for COVID-19 immunization. The patient previously received the first dose of BNT162B2 via intramuscular, administered in left arm on 21Jan2021 3:22 PM (at the age of 84-year-old) as dose 1, single and the second dose of BNT162B2 (lot number: EL9266) intramuscular, administered in left arm on 16Feb2021 3:40 PM (at the age of 84-year-old) as dose 2, single for Covid-19 immunization. He got the 2nd Pfizer shot on 16Feb2021 and about 3 weeks after that he developed eczema, also he experienced red bumps, patches of dry skin with the second dose. Medical history included mild case of asthma and maybe allergies to cats. Family medical history included father had a psoriasis and mother had asthma. Concomitant medications included unspecified statin.  The patient had the booster last Friday and 2-3 days later (on unspecified date in Oct2021), the eczema just erupted. He got the booster and it's better to not get Covid than not get the booster. He is going crazy and is up at 1-3am. His wife told him to call Pfizer and see if there's a connection for the rash or skin outbreak. He is going crazy with what to eat or not and some doctors say it has nothing to do with it and some say it's a drug reaction. The latest thing is to stop his statin which will make his cholesterol increase. The caller states there seem to be a correlation between the vaccine and the emergence of a bout with eczema as he has never had any kind of skin problem ever, bottom line. On 29Oct2021 the patient still has eczema- head to toe, he had seen 4 dermatologists, an allergy doctor and his primary. The last dermatologist will start him on phototherapy on 04Nov2021. Also, he just got a steroid injection and new stronger ointment- Halobetasol propionate .05% The reporter assessed the event as seriousness (Persistent/Significant disability/Incapacity). Eczema was treated with Ointments, Steroid shots, lotions. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysphonia
Clinical narrative: Dysphonia; COVID-19; This is a spontaneous report based on the information received by Pfizer (MFR Control No. 2021BHV000459(0)). A pharmacist (company representative) reported for a female patient. A female patient of an unspecified age received bnt162b2 BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via unknown route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced covid-19 and dysphonia after taking Pfizer covid-19 Vaccine. Causality as per reporter was not reported for covid-19 and dysphonia. Outcome of the event covid-19 was recovering and outcome of the event dysphonia was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Hypertension, Hypoaesthesia, Overdose
Clinical narrative: male patient that was inadvertently administered by a nurse with an undiluted vial; Received six times the dose; undiluted; left foot went numb; chest pain; BP was high; This is a spontaneous report from a contactable pharmacist.     A 41-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 22Oct2021 (Batch/Lot Number: UJ711AB) as single dose for covid-19 immunisation (Age at vaccination 41 years) .  The patient medical history was not reported. Concomitant medications included influenza vaccine inact sag 3v (FLUCELVAX) taken for an unspecified indication from 22Oct2021 to 25Oct2021.  The patient experienced left foot went numb (medically significant) on 27Oct2021 with outcome of not recovered , chest pain  (medically significant) on 27Oct2021 with outcome of not recovered , BP was high  (medically significant) on 27Oct2021 with outcome of unknown , male patient  was inadvertently administered by a nurse with an undiluted vial  (non-serious) on 22Oct2021 with outcome of unknown , received six times the dose; undiluted  (non-serious) on 22Oct2021 with outcome of unknown.  The patient underwent lab tests and procedures which included electrocardiogram: WNL  on 28Oct2021 Comment: Normal.  The patient visited the ER because of the event.  Course of the event. The patient was administered an undiluted vial of Pfizer Covid-19 vaccine on 22Oct2021. No ADE reported on day of event. Flu was done on 23Oct, 24Oct and on 25Oct and no ADEs were reported. He was kept for observation for an hour on 22Oct before he was released. On 27Oct2021 patient stated his left foot went numb while in the shower that night. He also started having chest pains that radiated down his left arm. He reports his BP was high. He awoke on 28Oct2021 and still had some numbness in the left foot and pain down his arm so he went to our clinic for follow up. He had an EKG and it was normal. He had not gone to pick up his BP meds that was sent at his last visit. He was going to pick up when he left the clinic. We will follow up with patient in a week.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events hypoaesthesia, chest pain and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: male patient that was inadvertently administered by a nurse with an undiluted vial; Received six times the dose; undiluted; left foot went numb; chest pain; BP was high; This is a spontaneous report from a contactable pharmacist.     A 41-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 22Oct2021 (Batch/Lot Number: UJ711AB) as single dose for covid-19 immunisation (Age at vaccination 41 years) .  The patient medical history was not reported. Concomitant medications included influenza vaccine inact sag 3v (FLUCELVAX) taken for an unspecified indication from 22Oct2021 to 25Oct2021.  The patient experienced left foot went numb (medically significant) on 27Oct2021 with outcome of not recovered , chest pain  (medically significant) on 27Oct2021 with outcome of not recovered , BP was high  (medically significant) on 27Oct2021 with outcome of unknown , male patient  was inadvertently administered by a nurse with an undiluted vial  (non-serious) on 22Oct2021 with outcome of unknown , received six times the dose; undiluted  (non-serious) on 22Oct2021 with outcome of unknown.  The patient underwent lab tests and procedures which included electrocardiogram: WNL  on 28Oct2021 Comment: Normal.  The patient visited the ER because of the event.  Course of the event. The patient was administered an undiluted vial of Pfizer Covid-19 vaccine on 22Oct2021. No ADE reported on day of event. Flu was done on 23Oct, 24Oct and on 25Oct and no ADEs were reported. He was kept for observation for an hour on 22Oct before he was released. On 27Oct2021 patient stated his left foot went numb while in the shower that night. He also started having chest pains that radiated down his left arm. He reports his BP was high. He awoke on 28Oct2021 and still had some numbness in the left foot and pain down his arm so he went to our clinic for follow up. He had an EKG and it was normal. He had not gone to pick up his BP meds that was sent at his last visit. He was going to pick up when he left the clinic. We will follow up with patient in a week.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events hypoaesthesia, chest pain and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test, Vaccination failure
Clinical narrative: breakthrough COVID; breakthrough COVID; was sick; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age (reported as under 40 years old) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, then dose 2 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient who had Pfizer COVID-19 vaccine in Feb2021 and then got another dose in Mar2021, 21 days after the first dose, had breakthrough COVID and was sick but not hospitalized in Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test reported as breakthrough COVID positive in Jul2021. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Inflammation, Migraine, Mobility decreased
Clinical narrative: Severe migraine which lasted for 4 weeks; unable to move around; heart rate increase quickly; inflammatory response to the vaccine; Pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0175), via an unspecified route of administration, administered in the left arm on 17May2021 10:15 (at the age of 40 years old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroid, migraine, celiac, gluten allergy, dairy allergy, nickel allergy and phenylephrine allergy, all from an unknown date and unknown if ongoing. The patient is not pregnant. The patient was taking unspecified concomitant medications in two weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0175), via an unspecified route of administration, administered in the left arm on 25Apr2021 (at the age of 40 years old) as dose 1, single for COVID-19 immunization. The patient experienced severe migraine which lasted for 4 weeks, unable to move around, heart rate increase quickly, inflammatory response to the vaccine and pain on 22May2021. It was reported that 5 days after 2nd shot, the patient experienced severe migraine which lasted for 4 weeks and not reactive to treatment. During this time, the patient was unable to move around as it would make her heart rate increase quickly. Saw doctor, was assessed for stroke risk, and was told she was having an inflammatory response to the vaccine. Took large doses of ibuprofen for the last 2 weeks which helped reduce the pain. The events resulted in physician office visit. The patient has not had COVID prior vaccination and not COVID tested post vaccination. The patient underwent lab tests and procedures which included heart rate: increase on 22May2021. The outcome of all events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe migraine which lasted for 4 weeks; unable to move around; heart rate increase quickly; inflammatory response to the vaccine; Pain; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0175), via an unspecified route of administration, administered in the left arm on 17May2021 10:15 (at the age of 40 years old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroid, migraine, celiac, gluten allergy, dairy allergy, nickel allergy and phenylephrine allergy, all from an unknown date and unknown if ongoing. The patient is not pregnant. The patient was taking unspecified concomitant medications in two weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0175), via an unspecified route of administration, administered in the left arm on 25Apr2021 (at the age of 40 years old) as dose 1, single for COVID-19 immunization. The patient experienced severe migraine which lasted for 4 weeks, unable to move around, heart rate increase quickly, inflammatory response to the vaccine and pain on 22May2021. It was reported that 5 days after 2nd shot, the patient experienced severe migraine which lasted for 4 weeks and not reactive to treatment. During this time, the patient was unable to move around as it would make her heart rate increase quickly. Saw doctor, was assessed for stroke risk, and was told she was having an inflammatory response to the vaccine. Took large doses of ibuprofen for the last 2 weeks which helped reduce the pain. The events resulted in physician office visit. The patient has not had COVID prior vaccination and not COVID tested post vaccination. The patient underwent lab tests and procedures which included heart rate: increase on 22May2021. The outcome of all events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Neuropathy peripheral
Clinical narrative: Neuropathy of both arms lasting one week after vaccination; Dizziness; severe headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Right, on 16Oct2021 12:00, at the age of 25-year-old, as DOSE 1, SINGLE, for covid-19 immunisation. Medical history included covid-19. The patient had no allergies. The patient is not pregnant at the time of vaccination. There were no concomitant medications.  The patient had no other vaccines in four weeks and had no other medication in two weeks. On 17Oct2021 at 04:00, the patient experienced neuropathy of both arms lasting one week after vaccination; dizziness, severe headache, and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for COVID post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event neuropathy peripheral and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arrhythmia, Blood pressure measurement, Cardiac disorder, Cardiac flutter
Clinical narrative: chest pain; rib /lung pain; rib /lung pain; tachycardia; high pulse; high blood pressure; heart lbs were high; echo cardio was abnormal; pleurisy; heart rhythm was completely off; rapid heart beat; chest tightness and had difficulty breathing/noticed fluttering and almost like an anxiety; chest tightness; difficulty breathing; anxiety; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 02Mar2021 at 12:30 (Lot Number: EN6203) as dose 1, single, then on 23Mar2021 at 12:30 (Lot Number: EP7534) as dose 2, single, then on 01Sep2021 at 15:30 (Lot Number: FC31837) as dose 3 (BOOSTER), single for COVID-19 immunization (at the age of 37 years old). Medical history included asthma, systemic lupus erythematosus (SLE), hypergammaglobulinaemia benign monoclonal (MGUS), known allergies; all from an unknown date. No other vaccine in four weeks. The patient had other medications in two weeks. No COVID prior vaccination and was not tested post vaccination. On 05Mar2021, after the first injection patient noticed chest tightness and had difficulty breathing. Patient noticed fluttering and almost like an anxiety. By 06Mar2021, she had a rapid heart beat and her heart rhythm was completely off, she was admitted to ER on 15Mar2021 with extreme chest pain, difficulty breathing and rib / lung pain. She had tachycardia, high pulse, high blood pressure, her heart lbs were high, echo cardio was abnormal but was eventually discharged and stated that everyone felt it was pluerisy (ct scan and X-ray clear). However, after every shot after, this has happened (she had 3). She has avoided the hospital, because she took BENADRYL but now with the third shot it was really bad again. Events lasted 10- 14 days. The patient was hospitalized for the events for 1 day. The patient underwent lab tests and procedures which included heart beat: rapid on 06Mar2021; then on 15Mar2021, blood pressure: high, computerised tomogram (CT scan): clear, echo cardio: abnormal, pulse: high and X-ray: clear. Therapeutic measures were taken as a result of the events, treatment included prednisone, TORADOL, SOLU-MEDROL. The outcome of the events was recovered on unspecified date in Mar2021.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Computerised tomogram, Dyspnoea, Echocardiogram
Clinical narrative: chest pain; rib /lung pain; rib /lung pain; tachycardia; high pulse; high blood pressure; heart lbs were high; echo cardio was abnormal; pleurisy; heart rhythm was completely off; rapid heart beat; chest tightness and had difficulty breathing/noticed fluttering and almost like an anxiety; chest tightness; difficulty breathing; anxiety; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 02Mar2021 at 12:30 (Lot Number: EN6203) as dose 1, single, then on 23Mar2021 at 12:30 (Lot Number: EP7534) as dose 2, single, then on 01Sep2021 at 15:30 (Lot Number: FC31837) as dose 3 (BOOSTER), single for COVID-19 immunization (at the age of 37 years old). Medical history included asthma, systemic lupus erythematosus (SLE), hypergammaglobulinaemia benign monoclonal (MGUS), known allergies; all from an unknown date. No other vaccine in four weeks. The patient had other medications in two weeks. No COVID prior vaccination and was not tested post vaccination. On 05Mar2021, after the first injection patient noticed chest tightness and had difficulty breathing. Patient noticed fluttering and almost like an anxiety. By 06Mar2021, she had a rapid heart beat and her heart rhythm was completely off, she was admitted to ER on 15Mar2021 with extreme chest pain, difficulty breathing and rib / lung pain. She had tachycardia, high pulse, high blood pressure, her heart lbs were high, echo cardio was abnormal but was eventually discharged and stated that everyone felt it was pluerisy (ct scan and X-ray clear). However, after every shot after, this has happened (she had 3). She has avoided the hospital, because she took BENADRYL but now with the third shot it was really bad again. Events lasted 10- 14 days. The patient was hospitalized for the events for 1 day. The patient underwent lab tests and procedures which included heart beat: rapid on 06Mar2021; then on 15Mar2021, blood pressure: high, computerised tomogram (CT scan): clear, echo cardio: abnormal, pulse: high and X-ray: clear. Therapeutic measures were taken as a result of the events, treatment included prednisone, TORADOL, SOLU-MEDROL. The outcome of the events was recovered on unspecified date in Mar2021.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Heart rate, Heart rate increased, Hypertension, Musculoskeletal chest pain
Clinical narrative: chest pain; rib /lung pain; rib /lung pain; tachycardia; high pulse; high blood pressure; heart lbs were high; echo cardio was abnormal; pleurisy; heart rhythm was completely off; rapid heart beat; chest tightness and had difficulty breathing/noticed fluttering and almost like an anxiety; chest tightness; difficulty breathing; anxiety; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 02Mar2021 at 12:30 (Lot Number: EN6203) as dose 1, single, then on 23Mar2021 at 12:30 (Lot Number: EP7534) as dose 2, single, then on 01Sep2021 at 15:30 (Lot Number: FC31837) as dose 3 (BOOSTER), single for COVID-19 immunization (at the age of 37 years old). Medical history included asthma, systemic lupus erythematosus (SLE), hypergammaglobulinaemia benign monoclonal (MGUS), known allergies; all from an unknown date. No other vaccine in four weeks. The patient had other medications in two weeks. No COVID prior vaccination and was not tested post vaccination. On 05Mar2021, after the first injection patient noticed chest tightness and had difficulty breathing. Patient noticed fluttering and almost like an anxiety. By 06Mar2021, she had a rapid heart beat and her heart rhythm was completely off, she was admitted to ER on 15Mar2021 with extreme chest pain, difficulty breathing and rib / lung pain. She had tachycardia, high pulse, high blood pressure, her heart lbs were high, echo cardio was abnormal but was eventually discharged and stated that everyone felt it was pluerisy (ct scan and X-ray clear). However, after every shot after, this has happened (she had 3). She has avoided the hospital, because she took BENADRYL but now with the third shot it was really bad again. Events lasted 10- 14 days. The patient was hospitalized for the events for 1 day. The patient underwent lab tests and procedures which included heart beat: rapid on 06Mar2021; then on 15Mar2021, blood pressure: high, computerised tomogram (CT scan): clear, echo cardio: abnormal, pulse: high and X-ray: clear. Therapeutic measures were taken as a result of the events, treatment included prednisone, TORADOL, SOLU-MEDROL. The outcome of the events was recovered on unspecified date in Mar2021.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pleurisy, Pulmonary pain, Tachycardia, X-ray
Clinical narrative: chest pain; rib /lung pain; rib /lung pain; tachycardia; high pulse; high blood pressure; heart lbs were high; echo cardio was abnormal; pleurisy; heart rhythm was completely off; rapid heart beat; chest tightness and had difficulty breathing/noticed fluttering and almost like an anxiety; chest tightness; difficulty breathing; anxiety; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 02Mar2021 at 12:30 (Lot Number: EN6203) as dose 1, single, then on 23Mar2021 at 12:30 (Lot Number: EP7534) as dose 2, single, then on 01Sep2021 at 15:30 (Lot Number: FC31837) as dose 3 (BOOSTER), single for COVID-19 immunization (at the age of 37 years old). Medical history included asthma, systemic lupus erythematosus (SLE), hypergammaglobulinaemia benign monoclonal (MGUS), known allergies; all from an unknown date. No other vaccine in four weeks. The patient had other medications in two weeks. No COVID prior vaccination and was not tested post vaccination. On 05Mar2021, after the first injection patient noticed chest tightness and had difficulty breathing. Patient noticed fluttering and almost like an anxiety. By 06Mar2021, she had a rapid heart beat and her heart rhythm was completely off, she was admitted to ER on 15Mar2021 with extreme chest pain, difficulty breathing and rib / lung pain. She had tachycardia, high pulse, high blood pressure, her heart lbs were high, echo cardio was abnormal but was eventually discharged and stated that everyone felt it was pluerisy (ct scan and X-ray clear). However, after every shot after, this has happened (she had 3). She has avoided the hospital, because she took BENADRYL but now with the third shot it was really bad again. Events lasted 10- 14 days. The patient was hospitalized for the events for 1 day. The patient underwent lab tests and procedures which included heart beat: rapid on 06Mar2021; then on 15Mar2021, blood pressure: high, computerised tomogram (CT scan): clear, echo cardio: abnormal, pulse: high and X-ray: clear. Therapeutic measures were taken as a result of the events, treatment included prednisone, TORADOL, SOLU-MEDROL. The outcome of the events was recovered on unspecified date in Mar2021.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Blood test, SARS-CoV-2 test
Clinical narrative: hair loss on head and other parts of body; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153) via an unspecified route of administration, administered on the left arm on 13Apr2021 11:30 (at the age of 58-year-old) as dose 2, single for COVID-19 immunization. The patient had no medical history. The patient had other medications in two weeks (unspecified). The patient previously received first dose of Comirnaty (Lot number: EP6965) on 23Mar2021 11:30 AM at Left arm for COVID-19 immunisation. For the last few months experiencing extensive hair loss on head and other parts of body. Have seen doctors and had blood work done and there is no explanation, other than the vaccine. The event resulted to a Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of the events which included Finasteride, minoxidil. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included PCR Nasal Swab: Negative in Oct2021. Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Type 1 diabetes mellitus, Vision blurred
Clinical narrative: Type I diabetes; higher baseline heart rates; Blurry vision; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient (43-year-old female at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously administered with the first dose of bnt162b2 (lot: not reported (Misplaced/discarded)) via an unspecified route of administration, administered in Arm Right on 13Mar2021 as DOSE 1 single for covid-19 immunisation. The patient also previously took pseudoephedrine and experienced drug hypersensitivity (Allergy_Pseudoephedrine). It was reported that the patient experienced Type I diabetes diagnosis and higher baseline heart rates. Blurry vision took place in May (as reported), diagnosis at the end of June (29Jun2021). The events resulted in Doctor or other healthcare professional office/clinic visit. The treatment includes: Insulin. The outcome of the events was recovered with sequel (also reported as patient recovered: Recovered with lasting effects). The reporter considered the events as non-serious.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: extremely itchy; Had a very sore left arm for about 3 days; the site was very red, hot, & swollen; the site was very red, hot, & swollen; the site was very red, hot, & swollen; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Lot Number: AA16607), dose 2 via an unspecified route of administration, administered in left arm on 04Oct2021 15:00 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number: FF2587) administered in left arm on 11Sep2021 13:30 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization and had a very sore left arm for about 3 days. Medical history included penicillin allergy, fibromyalgia, high blood pressure, GERD, depression, anxiety, painful periods. Concomitant medications included gabapentin, duloxetine, zolpidem tartrate (AMBIEN), topiramate, and bupropion hydrochloride (WELLBUTRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Oct2021 18:00, the patient experienced extremely itchy, had a very sore left arm for about 3 days, and the site was very red, hot, & swollen. Course of events: The patient had a very sore left arm for about 3 days after dose 1 & 2. After dose 2, about 3 hours after the injection, the site was very red, hot, & swollen. It was bigger than the size of a half dollar. It became extremely itchy, she tried hydrocortisone cream but that didn't help. It continued to stay like that the rest of the night. At bedtime, she washed the injection site with soap & took one benadryl pill. Woke up in the morning & no more problems except arm still being sore. Therapeutic measure was taken as a result of extremely itchy and the site was very red, hot, & swollen. The patient received no treatment for the event very sore left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from sore left arm on 08Oct2021 and from the remaining events on unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.