chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Lip swelling, Pruritus
Clinical narrative: anaphylaxis; lip swelling; Eyes swelling; blood pressure dropped; Heart palpitations; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 11Aug2021 15:38 (Batch/Lot Number: EW0187) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation.  Medical history included allergies: Alpha Gal, all mammal products, shrimp, adhesives and dermatitis contact. There were no concomitant medications.  The patient previously took ALEVE and magnesium stearate, multivitamins and experienced allergies.  Nine minutes after injection (11Aug2021): itching on hands, arms, legs. At 15 min: lip swelling, eyes swelling, blood pressure dropped. It was in anaphylaxis and admitted to ER. Treatment: Epinephrine, Steroids, albuterol breathing treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19.  The event was reported as life-threatening except for palpitations. The outcome of palpitation was unknown and other events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to the reported events.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Eye swelling, Lip swelling
Clinical narrative: anaphylaxis; lip swelling; Eyes swelling; blood pressure dropped; Heart palpitations; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 11Aug2021 15:38 (Batch/Lot Number: EW0187) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation.  Medical history included allergies: Alpha Gal, all mammal products, shrimp, adhesives and dermatitis contact. There were no concomitant medications.  The patient previously took ALEVE and magnesium stearate, multivitamins and experienced allergies.  Nine minutes after injection (11Aug2021): itching on hands, arms, legs. At 15 min: lip swelling, eyes swelling, blood pressure dropped. It was in anaphylaxis and admitted to ER. Treatment: Epinephrine, Steroids, albuterol breathing treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19.  The event was reported as life-threatening except for palpitations. The outcome of palpitation was unknown and other events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to the reported events.  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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: anaphylaxis; lip swelling; Eyes swelling; blood pressure dropped; Heart palpitations; This is a spontaneous report from a contactable healthcare professional.  A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 11Aug2021 15:38 (Batch/Lot Number: EW0187) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation.  Medical history included allergies: Alpha Gal, all mammal products, shrimp, adhesives and dermatitis contact. There were no concomitant medications.  The patient previously took ALEVE and magnesium stearate, multivitamins and experienced allergies.  Nine minutes after injection (11Aug2021): itching on hands, arms, legs. At 15 min: lip swelling, eyes swelling, blood pressure dropped. It was in anaphylaxis and admitted to ER. Treatment: Epinephrine, Steroids, albuterol breathing treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19.  The event was reported as life-threatening except for palpitations. The outcome of palpitation was unknown and other events was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination  and  the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Underlying hypertension could be contributory to the reported events.  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: 73.0
Sex: F
Vaccine: FLUA3, UNK
Symptoms: Erythema, Product administered at inappropriate site, Skin irritation, Swelling
Clinical narrative: Red, swollen, irritated area; Red, swollen, irritated area; Red, swollen, irritated area; Vaccine was administered about 2 inches below ideal site; This spontaneous case was retrieved on 06-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1558272-1), reported by other health professional and concerned a 73-year-old female patient.  The patient's concurrent condition included chronic kidney disease stage two (S2CKD). The patient's concomitant medications were not reported.   On 13-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as '1', route of administration: intramuscular, anatomical location: left arm and indication: not reported) about two inches below ideal site (explicitly coded as 'Vaccine administered at inappropriate site'). The batch number reported was 312832.  On 14-Aug-2021, one day after receiving Fluad Quadrivalent, the patient experienced red, swollen, irritated area.   The outcome of the events of 'localized erythema', 'local swelling' and 'skin irritation' was unknown.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Case updated on 14-Sep-2021: Correction made to information received on 06-Sep-2021: Regulatory authority removed from the intermediary field and Report Sent to Regulatory Authority by Reporter changed from 'yes' to 'unk' in the general tab as the case should be re-submitted to FDA since the suspect product was recoded from Fluad (TIV) to Fluad Quadrivalent upon batch number mapping. No changes in the narrative.  Company comment: A 73-year-old patient was administered Fluad Quadrivalent, about two inches below ideal site. One day after receiving Fluad Quadrivalent, the patient experienced red, swollen, irritated area (location unspecified). Causal role of the vaccine is assessed as possibly related. Product administered at inappropriate site is assessed as unrelated per company's conventions.; Sender's Comments: A 73-year-old patient was administered Fluad Quadrivalent, about two inches below ideal site. One day after receiving Fluad Quadrivalent, the patient experienced red, swollen, irritated area (location unspecified). Causal role of the vaccine is assessed as possibly related. Product administered at inappropriate site is assessed as unrelated per company's conventions.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: Hair fell out in clumps/ bald; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 22Jul2021 at 01:00 as a single dose for COVID-19 immunisation. On 23Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 01Sep2021 at 15:00, the patient's hair fell out in clumps. The patient had become bald at the time of this report, she had beautiful hair till she received this vaccine. The patient had a picture taken before and after had a video it looked like a 3-year-old cut hair while sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event hair fell out in clumps/ bald was not resolved at the time of report.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Hair fell out in clumps/ bald; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the left arm on 22Jul2021 at 01:00 as a single dose for COVID-19 immunisation. On 23Aug2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 01Sep2021 at 15:00, the patient's hair fell out in clumps. The patient had become bald at the time of this report, she had beautiful hair till she received this vaccine. The patient had a picture taken before and after had a video it looked like a 3-year-old cut hair while sleeping. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event hair fell out in clumps/ bald was not resolved at the time of report.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Herpes zoster, Influenza like illness, Pyrexia
Clinical narrative: Shingle diagnosis 1 week after 1st shot.; Shingles rash on lower back/ buttocks; Fatigue; flue like symptoms; This is a spontaneous report from a contactable Consumer (Patient) or other non HCP.   A 32-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 12Jun2021 at 11:00 (Age at Vaccination 32-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included Bariatric surgery and Penicillin allergy. There were no concomitant medications reported. It was reported that she was not a pregnant at the time of vaccination. She did not take any other medications in two weeks and other vaccine in four weeks of COVID vaccination. patient was not diagnosed with COVID prior to vaccination and not tested with COVID post vaccination. On 14Jun2021, 2 days after first dose the patient experienced shingle diagnosis 1 week after 1st shot, shingles rash on lower back/ buttocks, fatigue, flue like symptoms. Patient had visited the physician's office as a result of events. Therapeutic measures were taken as a result of events includes anti-viral therapy. The seriousness of the events was considered as non-serious. The outcome of the events was recovered on an unspecified date in 2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Herpes zoster, Influenza like illness, Rash
Clinical narrative: Shingle diagnosis 1 week after 1st shot.; Shingles rash on lower back/ buttocks; Fatigue; flue like symptoms; This is a spontaneous report from a contactable Consumer (Patient) or other non HCP.   A 32-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 12Jun2021 at 11:00 (Age at Vaccination 32-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included Bariatric surgery and Penicillin allergy. There were no concomitant medications reported. It was reported that she was not a pregnant at the time of vaccination. She did not take any other medications in two weeks and other vaccine in four weeks of COVID vaccination. patient was not diagnosed with COVID prior to vaccination and not tested with COVID post vaccination. On 14Jun2021, 2 days after first dose the patient experienced shingle diagnosis 1 week after 1st shot, shingles rash on lower back/ buttocks, fatigue, flue like symptoms. Patient had visited the physician's office as a result of events. Therapeutic measures were taken as a result of events includes anti-viral therapy. The seriousness of the events was considered as non-serious. The outcome of the events was recovered on an unspecified date in 2021.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Feeling abnormal, Feeling hot, Malaise
Clinical narrative: fluttering of her heart; blood pressure has been up and down, highest about 154/78; blood pressure has been up and down; heart palpitations; constant ringing in her ears; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Aug2021 12:00 (63-year-old at time of vacciantion) as single dose for COVID-19 immunisation. Medical history included "Rhuematic fever age 11 no long term affect" and "hip replacement needed". Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously took codeine and experienced drug allergy. There was no other vaccine in four weeks. Adverse events started from 16Aug2021 15:00: The patient made a previous report but since then her blood pressure has been up and down, highest about 154/78, heart palpitations and fluttering of her heart, constant ringing in her ears even when blood pressure is normal. She saw her cardiologist, she is wearing a heart monitor and will have an echocardiagram tomorrow. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the events and included heart monitor (as reported). The outcome of the events was not recovered.  Information on the Lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Cardiac flutter, Hypertension, Palpitations
Clinical narrative: fluttering of her heart; blood pressure has been up and down, highest about 154/78; blood pressure has been up and down; heart palpitations; constant ringing in her ears; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Aug2021 12:00 (63-year-old at time of vacciantion) as single dose for COVID-19 immunisation. Medical history included "Rhuematic fever age 11 no long term affect" and "hip replacement needed". Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously took codeine and experienced drug allergy. There was no other vaccine in four weeks. Adverse events started from 16Aug2021 15:00: The patient made a previous report but since then her blood pressure has been up and down, highest about 154/78, heart palpitations and fluttering of her heart, constant ringing in her ears even when blood pressure is normal. She saw her cardiologist, she is wearing a heart monitor and will have an echocardiagram tomorrow. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the events and included heart monitor (as reported). The outcome of the events was not recovered.  Information on the Lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: fluttering of her heart; blood pressure has been up and down, highest about 154/78; blood pressure has been up and down; heart palpitations; constant ringing in her ears; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 16Aug2021 12:00 (63-year-old at time of vacciantion) as single dose for COVID-19 immunisation. Medical history included "Rhuematic fever age 11 no long term affect" and "hip replacement needed". Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously took codeine and experienced drug allergy. There was no other vaccine in four weeks. Adverse events started from 16Aug2021 15:00: The patient made a previous report but since then her blood pressure has been up and down, highest about 154/78, heart palpitations and fluttering of her heart, constant ringing in her ears even when blood pressure is normal. She saw her cardiologist, she is wearing a heart monitor and will have an echocardiagram tomorrow. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient had no COVID-19 prior vaccination. COVID-19 was not tested post vaccination. Therapeutic measures were taken as a result of the events and included heart monitor (as reported). The outcome of the events was not recovered.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Rash, Scan with contrast, X-ray
Clinical narrative: acute pericarditis; pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy; pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy; bubble in her chest and was in pain so went to the ER; Covid arm/rash; This is a spontaneous report from a non-contactable consumer (patient). A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced acute pericarditis, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, bubble in her chest and was in pain so went to the er, covid arm/rash. The patient received the first dose on 06Aug2021 and was wondering if she should receive the second dose due to side effects. The patient was required to receive the vaccine for her job or she will be terminated. A few days after the first dose she developed Covid arm/rash, then she felt a bubble in her chest and was in pain so went to the emergency room (ER). She was diagnosed with acute pericarditis and was told it would go away in a couple of days and it did. She then developed pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy. It just started going away a week and a half ago but was still having tingling in the right had from time to time. She actually was waiting to receive the second dose but wanted to call and see if she should. Her doctor did give her a note that she shouldn't receive the vaccine until further notice but she had to get the vaccine or she will be terminated. Her doctor recommended her to see a neurologist. They prescribed gabapentin, toradol and another medication but it didn't help her. The events resulted in visit to the emergency room. The patient was hospitalized due the events acute pericarditis, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy, bubble in her chest and was in pain so went to the er. The outcome of acute pericarditis was recovered and outcome of the event pain in the arm and up through her neck and she went to the hospital again and was diagnosed with cervical radiculopathy (cervical radiculopathy) was not recovered while outcome of rest of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: FLUA3, FLUA4
Symptoms: Chest discomfort, Dyspnoea, Swollen tongue
Clinical narrative: Chest tightness; Tongue swelling; Shortness of breath/difficulty breathing; This spontaneous case was retrieved on 13-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1602866-1), reported by other health professional and concerned a 75-year-old female patient.   The patient's medical history and concomitant medications were not reported.  On 20-Aug-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as '1', anatomical location: left arm (LA), route of administration: intramuscular and indication: not reported). The batch number reported was 312840.  On the same day, after receiving Fluad Quadrivalent vaccine, the patient experienced chest tightness, tongue swelling and shortness of breath/difficulty breathing.  On an unspecified day in Aug-2021, the patient visited emergency room.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.    The evens of chest tightness, tongue swelling and 'dyspnoea' were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 75-year-old patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent vaccine, the patient experienced chest tightness, tongue swelling and shortness of breath/difficulty breathing. Chronology is plausible. Causality is assessed as possibly related. Brighton Collaboration criteria could not be assessed due to insufficient information.; Sender's Comments: A 75-year-old patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent vaccine, the patient experienced chest tightness, tongue swelling and shortness of breath/difficulty breathing. Chronology is plausible. Causality is assessed as possibly related. Brighton Collaboration criteria could not be assessed due to insufficient information.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted; received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted; Headache; Sore throat; Blood pressure high; really tired; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 1 via an unspecified route of administration, administered in the left arm on 22Aug2021 as a single dose for COVID-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. No other vaccines received prior to or on same date.  On 22Aug2021, the patient experienced received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted, medically significant events for which the patient was hospitalized. In Aug2021, the patient experienced headache, sore throat, blood pressure high, and really tired; all medically significant events for which the patient was hospitalized. The patient was hospitalized for the events from 22Aug2021 to 23Aug2021 (2 days, 1 night). Her son went and got the Pfizer shot. This was her son's first shot. He waited the 15 minutes and while they were waiting, they called him back to the pharmacy. The pharmacy manager who administered the vaccine notified her son that they accidentally gave him 6x amount of the Pfizer shot he was supposed to receive and did not dilute the vaccine. The pharmacy manager advised them to take him to the Emergency Room where he was admitted into the hospital and they ran all these different tests. Her son did have side effects. Headaches, which has lasted for a week. She states her son still has the headaches, they are not gone. When probed for the outcome, she explains they told him to take Tylenol, which he has been taking Ibuprofen and he will take one if the headache is unbearable. Sore throat, she states she asks her son every day about his symptoms and he states his sore throat is staying the same. He was told numerous times while in the hospital that his blood pressure was high. When probed for the outcome, the caller states no, he doesn't have high blood pressure. Her son is also tired, like really tired. When probed for the outcome, she makes the comment her is always playing the game so he's always tired. The patient has been released from the hospital. Outcome of the events, received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted was unknown. The patient recovered from the event, blood pressure high in Aug2021. The patient had not recovered from the other events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Fatigue, Headache, Hypertension, Investigation
Clinical narrative: received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted; received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted; Headache; Sore throat; Blood pressure high; really tired; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 1 via an unspecified route of administration, administered in the left arm on 22Aug2021 as a single dose for COVID-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. No other vaccines received prior to or on same date.  On 22Aug2021, the patient experienced received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted, medically significant events for which the patient was hospitalized. In Aug2021, the patient experienced headache, sore throat, blood pressure high, and really tired; all medically significant events for which the patient was hospitalized. The patient was hospitalized for the events from 22Aug2021 to 23Aug2021 (2 days, 1 night). Her son went and got the Pfizer shot. This was her son's first shot. He waited the 15 minutes and while they were waiting, they called him back to the pharmacy. The pharmacy manager who administered the vaccine notified her son that they accidentally gave him 6x amount of the Pfizer shot he was supposed to receive and did not dilute the vaccine. The pharmacy manager advised them to take him to the Emergency Room where he was admitted into the hospital and they ran all these different tests. Her son did have side effects. Headaches, which has lasted for a week. She states her son still has the headaches, they are not gone. When probed for the outcome, she explains they told him to take Tylenol, which he has been taking Ibuprofen and he will take one if the headache is unbearable. Sore throat, she states she asks her son every day about his symptoms and he states his sore throat is staying the same. He was told numerous times while in the hospital that his blood pressure was high. When probed for the outcome, the caller states no, he doesn't have high blood pressure. Her son is also tired, like really tired. When probed for the outcome, she makes the comment her is always playing the game so he's always tired. The patient has been released from the hospital. Outcome of the events, received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted was unknown. The patient recovered from the event, blood pressure high in Aug2021. The patient had not recovered from the other events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Overdose, Product preparation error
Clinical narrative: received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted; received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted; Headache; Sore throat; Blood pressure high; really tired; This is a spontaneous report from a contactable consumer (parent). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) Dose 1 via an unspecified route of administration, administered in the left arm on 22Aug2021 as a single dose for COVID-19 immunisation.  Medical history was none. The patient's concomitant medications were not reported. No other vaccines received prior to or on same date.  On 22Aug2021, the patient experienced received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted, medically significant events for which the patient was hospitalized. In Aug2021, the patient experienced headache, sore throat, blood pressure high, and really tired; all medically significant events for which the patient was hospitalized. The patient was hospitalized for the events from 22Aug2021 to 23Aug2021 (2 days, 1 night). Her son went and got the Pfizer shot. This was her son's first shot. He waited the 15 minutes and while they were waiting, they called him back to the pharmacy. The pharmacy manager who administered the vaccine notified her son that they accidentally gave him 6x amount of the Pfizer shot he was supposed to receive and did not dilute the vaccine. The pharmacy manager advised them to take him to the Emergency Room where he was admitted into the hospital and they ran all these different tests. Her son did have side effects. Headaches, which has lasted for a week. She states her son still has the headaches, they are not gone. When probed for the outcome, she explains they told him to take Tylenol, which he has been taking Ibuprofen and he will take one if the headache is unbearable. Sore throat, she states she asks her son every day about his symptoms and he states his sore throat is staying the same. He was told numerous times while in the hospital that his blood pressure was high. When probed for the outcome, the caller states no, he doesn't have high blood pressure. Her son is also tired, like really tired. When probed for the outcome, she makes the comment her is always playing the game so he's always tired. The patient has been released from the hospital. Outcome of the events, received 6x amount of the Pfizer shot he was supposed to receive, the dose was not diluted was unknown. The patient recovered from the event, blood pressure high in Aug2021. The patient had not recovered from the other events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blister, Pain in extremity, Pruritus, Rash
Clinical narrative: He's developed a rash on his left foot and leg; Its like raised blistered bumps; Itches really bad; His left foot and ankle was hurting really bad like he twisted it; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old male patient (reporter's son) .A male patient of 12 years had received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number FA7485 was reported), dose 1 via an unspecified route of administration on 13 Aug2021 in left arm as DOSE 1, SINGLE for covid-19 immunization (at the age of 12-Years-old).The patient medical history had included ADHD and concomitant medications were not reported. The patient did not take any vaccination within 4 weeks of Covid vaccine. On an 27Aug2021 the patient had experienced a rash on his left foot and leg. Its like raised blistered bumps and itches really bad. .The rash was on the left leg around his ankle and shin, really itchy raised blistered bumps. Patient's left foot and ankle was hurting really bad like he twisted it and then he got the rash. It was reported that patient did not remember doing anything to twist it but it feels like he had. The patient had been hobbling on it for the last two days. It was also reported that reporter didn't know if it was a side effect of the injection, if she should be concerned or what it is. The reporter had a question should his soon took second dose which would be scheduled on 09Sep2021.It was reported that the patient took Covid Vaccine so that he Back in school and its going around like crazy in school system age group and wanted him protected. but stated would like to wait until he is 16 or 20, but it was up to them. Caller states they decided to get him vaccinated since he is back in school and Covid is running withheld through the school. Caller states there are 2-3 spots on the top of his foot and a line of them across the shin area and they kind of look like blisters. Caller states she sent him on to school and he is still in school now so she doesn't know what it looks like right now and told that she knows rash is common in the arm he gets it in, but this is on the same side but not the arm.Caller states her first thought was hand foot and mouth but the rash is no where near his mouth or hands. The patient had received anti -itching cream as an treatment . The outcome of the event was unknown.  Indication Continued: Caller states they wear their masks adamantly, she has had Covid twice and her mother and her both have compromised immune systems and he was the only one in the household not protected or vaccinated  Follow-up (27Aug2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old male patient (reporter's son) .Clinical information has been amended.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Rash vesicular
Clinical narrative: He's developed a rash on his left foot and leg; Its like raised blistered bumps; Itches really bad; His left foot and ankle was hurting really bad like he twisted it; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old male patient (reporter's son) .A male patient of 12 years had received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number FA7485 was reported), dose 1 via an unspecified route of administration on 13 Aug2021 in left arm as DOSE 1, SINGLE for covid-19 immunization (at the age of 12-Years-old).The patient medical history had included ADHD and concomitant medications were not reported. The patient did not take any vaccination within 4 weeks of Covid vaccine. On an 27Aug2021 the patient had experienced a rash on his left foot and leg. Its like raised blistered bumps and itches really bad. .The rash was on the left leg around his ankle and shin, really itchy raised blistered bumps. Patient's left foot and ankle was hurting really bad like he twisted it and then he got the rash. It was reported that patient did not remember doing anything to twist it but it feels like he had. The patient had been hobbling on it for the last two days. It was also reported that reporter didn't know if it was a side effect of the injection, if she should be concerned or what it is. The reporter had a question should his soon took second dose which would be scheduled on 09Sep2021.It was reported that the patient took Covid Vaccine so that he Back in school and its going around like crazy in school system age group and wanted him protected. but stated would like to wait until he is 16 or 20, but it was up to them. Caller states they decided to get him vaccinated since he is back in school and Covid is running withheld through the school. Caller states there are 2-3 spots on the top of his foot and a line of them across the shin area and they kind of look like blisters. Caller states she sent him on to school and he is still in school now so she doesn't know what it looks like right now and told that she knows rash is common in the arm he gets it in, but this is on the same side but not the arm.Caller states her first thought was hand foot and mouth but the rash is no where near his mouth or hands. The patient had received anti -itching cream as an treatment . The outcome of the event was unknown.  Indication Continued: Caller states they wear their masks adamantly, she has had Covid twice and her mother and her both have compromised immune systems and he was the only one in the household not protected or vaccinated  Follow-up (27Aug2021): This is a Follow-up spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old male patient (reporter's son) .Clinical information has been amended.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This consumer reported similar events for two patients. This is the first of two reports. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172) via unspecified route in the right arm on 26Aug2021 at about 1:30 -1:40pm (at the age of 52-years-old) as a single dose for COVID-19 immunization. Patient had no medical history and no concomitant medications. No additional vaccines were administered on the same date as the COVID vaccine and no other prior vaccinations (within 4 weeks) of the COVID vaccine were received. The patient and her husband received the first dose of the vaccine from employer on Thursday, 26Aug2021 and before they got home, the lab called and said the company they hired to administered it, instead of giving them the 0.3ml they got 2.1ml which is over 6 times the amount they should have gotten. She also said 7 other patients were involved with incorrect dosing of the vaccine. Patient reported they (she and her husband) haven't had any crazy side effects, just sore (Aug2021) and the 'expected things' (as reported). When she ask the director of the site about the second shot, she was told to go ahead and take the shot. She is going to wait and hear from her primary care doctor but wanted some more information regarding this. The normal things mentioned were described as headache which started that evening (26Aug2021) and is better now, seasonal allergies with runny nose which started on 29Aug2021 and is better today, her arm swelled at the injection site on 26Aug2021 but this has gone down now and this has subsided, body aches including leg cramps (Aug2021) and her neck hurting (the leg hurting started 29Aug2021 and is about the same and the neck hurting started a few days ago (Aug2021) and is about the same). She also reported that the biggest thing has been fatigue which started right away on 26Aug2016, that evening and it is about the same. The reported events did not require ER visit or physician office visit. There were no relevant tests. Treatment for the events included ibuprofen. The outcome of headaches and seasonal allergies with runny nose  was recovering; arm swelled at the injection site was recovered in Aug2021; while body aches including leg cramps, leg hurting, fatigue and neck hurting were not recovered. Follow-up (06Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101132573 same reporter/events/product, different patient.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Immediate post-injection reaction, Incorrect dose administered, Myalgia, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. This consumer reported similar events for two patients. This is the first of two reports. A 52-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0172) via unspecified route in the right arm on 26Aug2021 at about 1:30 -1:40pm (at the age of 52-years-old) as a single dose for COVID-19 immunization. Patient had no medical history and no concomitant medications. No additional vaccines were administered on the same date as the COVID vaccine and no other prior vaccinations (within 4 weeks) of the COVID vaccine were received. The patient and her husband received the first dose of the vaccine from employer on Thursday, 26Aug2021 and before they got home, the lab called and said the company they hired to administered it, instead of giving them the 0.3ml they got 2.1ml which is over 6 times the amount they should have gotten. She also said 7 other patients were involved with incorrect dosing of the vaccine. Patient reported they (she and her husband) haven't had any crazy side effects, just sore (Aug2021) and the 'expected things' (as reported). When she ask the director of the site about the second shot, she was told to go ahead and take the shot. She is going to wait and hear from her primary care doctor but wanted some more information regarding this. The normal things mentioned were described as headache which started that evening (26Aug2021) and is better now, seasonal allergies with runny nose which started on 29Aug2021 and is better today, her arm swelled at the injection site on 26Aug2021 but this has gone down now and this has subsided, body aches including leg cramps (Aug2021) and her neck hurting (the leg hurting started 29Aug2021 and is about the same and the neck hurting started a few days ago (Aug2021) and is about the same). She also reported that the biggest thing has been fatigue which started right away on 26Aug2016, that evening and it is about the same. The reported events did not require ER visit or physician office visit. There were no relevant tests. Treatment for the events included ibuprofen. The outcome of headaches and seasonal allergies with runny nose  was recovering; arm swelled at the injection site was recovered in Aug2021; while body aches including leg cramps, leg hurting, fatigue and neck hurting were not recovered. Follow-up (06Sep2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101132573 same reporter/events/product, different patient.