chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Disease recurrence, Dizziness, Fatigue
Clinical narrative: felt dizzy; felt weak; face felt weird; couldn't walk in a straight line; felt drunk and on drugs; felt shaky; bruise/bruised; couldn't use her arm for a day (couldn't move for a few days); headache; fatigue; arm had agonizing pain; felt a tight band around my thyroid; felt a tight band around my thyroid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included allergies such as penicillin, sulfa (have a lot of allergies), and accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. The patient's concomitant medications were not reported. The patient previously received a tetanus shot (arm was sore for 4-6 days). It was reported that patient was due to receive her second dose of the Pfizer vaccine next Wednesday (also reported as COVID-19 vaccine). Patient stated that weird stuff happened to her after she got the vaccine and was not sure if she could get her second dose. It was stated that immediately after getting the vaccine she walked out to the waiting room, after her first dose patient experienced that she instantly felt dizzy and needed help to sit in a chair but it didn't last too long. Patient was weak (just felt weak) and stated she waited 1.5 hours before leaving the hospital (also reported waited 1 hour and half in the waiting room) and felt a tight band around her thyroid but no difficulty breathing. It was further stated that the vaccine must have impacted her thyroid. It lasted for an hour and went way. She never felt it again. She reported that she had an accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. Further reported that face felt weird didn't had trouble breathing, fuzzy headed and felt drunk. Patient just felt drunk and on drugs. She couldn't walk in a straight line and just felt shaky. She informed that she received a tetanus shot, her arm was sore for 4-6 days but the Pfizer vaccine was far worse. It didn't swell but she had a big bruise. Stated arm had agonizing pain, agonizing for the first 1-2 days and on third day it was gone. Patient couldn't use her arm for a day (also reported couldn't move for a few days and was bruised). Secondary felt fatigue and headache (after she got home). It was questioned if she should receive second dose. The outcome of the events felt dizzy was recovered on unspecified date (didn't last too long), felt a tight band around my thyroid was recovered on unspecified date (lasted for an hour) and arm had agonizing pain was recovered on unspecified date (third day it was gone), while unknown for the other events.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling drunk, Gait disturbance, Headache, Mobility decreased
Clinical narrative: felt dizzy; felt weak; face felt weird; couldn't walk in a straight line; felt drunk and on drugs; felt shaky; bruise/bruised; couldn't use her arm for a day (couldn't move for a few days); headache; fatigue; arm had agonizing pain; felt a tight band around my thyroid; felt a tight band around my thyroid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included allergies such as penicillin, sulfa (have a lot of allergies), and accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. The patient's concomitant medications were not reported. The patient previously received a tetanus shot (arm was sore for 4-6 days). It was reported that patient was due to receive her second dose of the Pfizer vaccine next Wednesday (also reported as COVID-19 vaccine). Patient stated that weird stuff happened to her after she got the vaccine and was not sure if she could get her second dose. It was stated that immediately after getting the vaccine she walked out to the waiting room, after her first dose patient experienced that she instantly felt dizzy and needed help to sit in a chair but it didn't last too long. Patient was weak (just felt weak) and stated she waited 1.5 hours before leaving the hospital (also reported waited 1 hour and half in the waiting room) and felt a tight band around her thyroid but no difficulty breathing. It was further stated that the vaccine must have impacted her thyroid. It lasted for an hour and went way. She never felt it again. She reported that she had an accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. Further reported that face felt weird didn't had trouble breathing, fuzzy headed and felt drunk. Patient just felt drunk and on drugs. She couldn't walk in a straight line and just felt shaky. She informed that she received a tetanus shot, her arm was sore for 4-6 days but the Pfizer vaccine was far worse. It didn't swell but she had a big bruise. Stated arm had agonizing pain, agonizing for the first 1-2 days and on third day it was gone. Patient couldn't use her arm for a day (also reported couldn't move for a few days and was bruised). Secondary felt fatigue and headache (after she got home). It was questioned if she should receive second dose. The outcome of the events felt dizzy was recovered on unspecified date (didn't last too long), felt a tight band around my thyroid was recovered on unspecified date (lasted for an hour) and arm had agonizing pain was recovered on unspecified date (third day it was gone), while unknown for the other events.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain in extremity, Thyroid disorder
Clinical narrative: felt dizzy; felt weak; face felt weird; couldn't walk in a straight line; felt drunk and on drugs; felt shaky; bruise/bruised; couldn't use her arm for a day (couldn't move for a few days); headache; fatigue; arm had agonizing pain; felt a tight band around my thyroid; felt a tight band around my thyroid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included allergies such as penicillin, sulfa (have a lot of allergies), and accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. The patient's concomitant medications were not reported. The patient previously received a tetanus shot (arm was sore for 4-6 days). It was reported that patient was due to receive her second dose of the Pfizer vaccine next Wednesday (also reported as COVID-19 vaccine). Patient stated that weird stuff happened to her after she got the vaccine and was not sure if she could get her second dose. It was stated that immediately after getting the vaccine she walked out to the waiting room, after her first dose patient experienced that she instantly felt dizzy and needed help to sit in a chair but it didn't last too long. Patient was weak (just felt weak) and stated she waited 1.5 hours before leaving the hospital (also reported waited 1 hour and half in the waiting room) and felt a tight band around her thyroid but no difficulty breathing. It was further stated that the vaccine must have impacted her thyroid. It lasted for an hour and went way. She never felt it again. She reported that she had an accidental radiation leak which damage the thyroid and sometimes it created a tight band around her throat. Further reported that face felt weird didn't had trouble breathing, fuzzy headed and felt drunk. Patient just felt drunk and on drugs. She couldn't walk in a straight line and just felt shaky. She informed that she received a tetanus shot, her arm was sore for 4-6 days but the Pfizer vaccine was far worse. It didn't swell but she had a big bruise. Stated arm had agonizing pain, agonizing for the first 1-2 days and on third day it was gone. Patient couldn't use her arm for a day (also reported couldn't move for a few days and was bruised). Secondary felt fatigue and headache (after she got home). It was questioned if she should receive second dose. The outcome of the events felt dizzy was recovered on unspecified date (didn't last too long), felt a tight band around my thyroid was recovered on unspecified date (lasted for an hour) and arm had agonizing pain was recovered on unspecified date (third day it was gone), while unknown for the other events.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: I may have had an unusual abdominal reaction; This is a spontaneous report received from Pfizer . A contactable consumer of unspecified age and gender reported to have received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient may have had an unusual abdominal reaction to the second Pfizer Covid vaccine shot. Outcome of event was unknown. The patient was directed to the appropriate site to share this information. Forwarded as an Adverse Event by the  team on 29Mar2021. Reporter provided verification of contact address on 27Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Migraine
Clinical narrative: I got sick for a week; Migraines; This is a spontaneous report from a Pfizer.  A 89-years-old contactable female consumer (patient) reported for herself she received BNT16B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included blindness, rheumatoid arthritis, fibromyalgia, osteoporosis, scoliosis, intervertebral disc protrusion, arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced sick for a week, migraines on an unspecified date. The patient stated that the patient got sick for a week. Her rheumatoid arthritis was so bad that she can't open anything. Patient then mentioned having migraines. Patient then stated she was a nurse and hurt herself, my back. She had arthritis, fibromyalgia, osteoporosis and went to a surgeon for scoliosis. She had 9 docs with no cartilage. She had herniated bulging discs and was cut down my left side. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Headache, Hypotension, Maternal exposure during pregnancy
Clinical narrative: Nausea; Pain in legs, back and arms; Pain in legs, back and arms; Headache; Low blood pressure; pregnant at the time of vaccination; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 at 14:30 at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. The patient experienced nausea, pain in legs, back and arms, headache, low blood pressure on an unspecified date. The patient was pregnant at the time of vaccination. The patient last menstrual period was 15Nov2020. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Nausea; Pain in legs, back and arms; Pain in legs, back and arms; Headache; Low blood pressure; pregnant at the time of vaccination; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 at 14:30 at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. The patient experienced nausea, pain in legs, back and arms, headache, low blood pressure on an unspecified date. The patient was pregnant at the time of vaccination. The patient last menstrual period was 15Nov2020. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: Patient mentioned that her son tested positive last Friday and so they were exposed; This is a spontaneous report received from a Pfizer Sponsored Program . A contactable consumer (patient herself) reported that an unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient mentioned that her son tested positive last Friday and so they were exposed. So she wants to know if it's okay to take the 2nd dose today, or do they need to delay the schedule. The outcome of the event was unknown.  No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: pain at injection site; arm is heavy and it is painful to lift; arm is heavy and it is painful to lift; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via unspecified route of administration on 27Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date in Mar2021 patient stated that he had a little pain at injection site for 2 days. Now his arm was heavy, and it was painful to lift. The outcome of the events was unknown.  No follow-up is required. No further information expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Severe fatigue; Vaccination site pain; This is a spontaneous report received a contactable consumer, the patient. A 62-year-old adult male received the second dose of intramuscular BNT162b2 (solution for injection; Lot EL3248 expiry information not reported) as a single dose in the right arm on 05Janr2021 (at 62-years-old), for COVID-19 immunisation.  Relevant medical history included ongoing Hypertension (HTN; 2013), and ongoing Coronary Artery Disease (CAD; Aug2020) with coronary stent. Concomitant medications included sans indications and posology included ticagrelor (BRILINTA) ongoing rom 30Aug2020; lisinopril; acetylsalicylic acid (ASA) ongoing rom 30Aug2020; ergocalciferol (VIT D); and magnesium ongoing from 01Apr2020. The patient previously received COVID-19 immunisation with the first dose of intramuscular BNT162b2 (Lot EK5730) in the left arm on 16Dec2020. The patient reported that on 05Jan2021 he experienced injection site pain and that same day at 13:00 he developed severe fatigue. Treatment for the events included oral paracetamol (ACETAMINOPHEN) 1000mg from 05Jan2021 through 06Jan2021. The outcome of the events injection site pain, and severe fatigue was recovered on an unspecified date in 2021.  No follow-up attempts are possible; No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site left arm soreness; This is a spontaneous report received from a contactable consumer reporting on behalf of the patient.   A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6202, Expiration date: Unknown), via an unspecified route of administration in left arm on 10Mar2021 at 10:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient medical history included, allergies to medications, food, or other products:sulpha drugs, azithromycin (not had either in a very long time, many years) also allergies to animal dander, sun exposure.The patient concomitant medications received within 2 weeks of vaccination included: Vitamins supplements (one a day Vita Craves, Nature Made B-12, Flaxseed & Tumeric supplements) Osteobi-flex supplement, daily and fluticasone propionate (FLONASE) (MANUFACTURER UNKNOWN) daily. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient was not tested post for COVID.  On 10Mar2021, the patient experienced Injection site left arm soreness which was gone by 12Mar2021. The patient did not take any treatment medication for the event. The outcome of the events was resolved.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Wednesday Positive; cough; mild fever; arm was sore; This is a spontaneous report from a contactable consumer or other non hcp.  A 60-years-old female patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 03Apr2021 as single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that, on saturday received first dose of vaccine. Monday PCR was done and it was negative PCR. Rapid test was done on Tuesday it was negative again the patient done test on Wednesday it was positive. She asked the vaccine could give the False Positive test. On Saturday after shot mild fever, arm was sore and on Monday had cough. The outcome of the events reported as unknown.  The action taken in response to the events  for bnt162b2 was not applicable.  Follow-up recived on 09Apr2021: New information added, New events added (mild fever, arm was sore and cough). Lab tests were added.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: asthma; shortness of breath; This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself that a 52-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that he had asthma and got shortness of breath, wanted to know if he can take his inhaler when he takes the second dose. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Heart rate, SARS-CoV-1 test
Clinical narrative: tested positive today; tested positive today; This is a spontaneous report from a contactable consumer (Patient herself) or other non-HCP. A female patient (Age: 64 unit : Unknown) of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Not reported, Expiration Date: Not reported) via an unspecified route of administration on 30Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced tested positive today, fever, cough, elevated pulse, persistence dry cough. The patient stated first Pfizer covid vaccine on Tuesday and thinks she might have been exposed to covid in the weekend before that. she tested positive today, after vaccine she had fever (fever is gone now), cough, blood pressure is normal, elevated pulse, persistence dry cough, used inhaler for it, she takes aspirin and stated she is on lockdown till April 11. The patient wanted to know if vaccine will moderate symptoms from covid.  The outcome of events was Unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid sensory disorder, Hypoaesthesia, Hypoaesthesia oral, Magnetic resonance imaging head
Clinical narrative: numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; numbing on the left side of face - eye, cheek, mouth and left fingers, thumb to pinky; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (lot number: ER8727), via unspecified route of administration in left arm on 26Mar2021 11:45 AM at single dose for COVID-19 immunisation. The patient's medical history included primary central nervous system lymphoma and seizure. The patient had allergies to tree nuts. The patient's concomitant medications included vitamins, fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously received levetiracetam (KEPPRA) (anti-seizure medication) that she had stopped in end of Jan2021. Approximately 21 hours after injection of vaccine, the patient experienced numbing on the left side of face - eye, cheek, mouth - and left fingers, thumb to pinky. Lasted about 10 minutes and feeling came back. Same thing happened 15 minutes later and then stopped. Events onset date reported as 27Mar2021 09:15 AM. The event resulted in doctor or other healthcare professional office/clinic visit. The patient contacted her oncologist, she resumed taking levetiracetam and will continue until 2 weeks after next shot (if decide to get it). The patient had routine brain MRI and all clear. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: severe rash on left leg  and hip 4 days after shot.  Immediately after shot, pain in left hand.; severe rash on left leg  and hip 4 days after shot.  Immediately after shot, pain in left hand.; Shingles Variant; This is a spontaneous report received from a contactable consumer. This 47-year-old female consumer (Patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot_number=EN6207) at single dose for COVID-19 immunization on 25Mar2021 at 08:30 AM. Relevant history included high blood pressure and Bi-Polar II. Relevant concomitant drug received within 2 weeks of vaccination included Ambien, Linsilpril, Seroquel, Paxil. The patient experienced severe rash on left leg and hip 4 days after shot (on 29Mar2021 at 08:00 AM).  She was still diagnosing, but thinking a Shingles Variant which was  Very Painful.  She was awaiting dermatologist review. Treatment therapy included Triamcinolone, Gabapentin, Valacyclovir, prednisone. Outcome of events was not resolved. The event was assessed as non-serious. Due to the events the patient visited Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID prior vaccination. The patient had not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: joint pain; tiredness; headaches; muscle pain; chills; fever; felt bad; migraine; This is spontaneous report from a contactable consumer reported for female patient (reporter's wife). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Apr2021 at 3:08 PM EST via voicemail verbatim, patient queried how long these shot effects last, the tiredness, the headaches, muscle pain, chills, joint pain, fever. Reporter stated his wife received the Pfizer COVID-19 vaccine on Wednesday (he did not specify if it was the first or second dose). Reporter was very rushed during the phone call and stated, they just need to know how long these side effects were going to last. This agent clarified what was said on the voicemail and he confirmed, then his wife spoke up in the background and said, she got the shot on Wednesday, felt bad on Thursday and Friday but today she had a migraine because of all of this. Reporter stated that they were really busy and had to get off the phone. Unable to offer transfer to speak with a different department. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pyrexia
Clinical narrative: joint pain; tiredness; headaches; muscle pain; chills; fever; felt bad; migraine; This is spontaneous report from a contactable consumer reported for female patient (reporter's wife). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 03Apr2021 at 3:08 PM EST via voicemail verbatim, patient queried how long these shot effects last, the tiredness, the headaches, muscle pain, chills, joint pain, fever. Reporter stated his wife received the Pfizer COVID-19 vaccine on Wednesday (he did not specify if it was the first or second dose). Reporter was very rushed during the phone call and stated, they just need to know how long these side effects were going to last. This agent clarified what was said on the voicemail and he confirmed, then his wife spoke up in the background and said, she got the shot on Wednesday, felt bad on Thursday and Friday but today she had a migraine because of all of this. Reporter stated that they were really busy and had to get off the phone. Unable to offer transfer to speak with a different department. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Investigation, Polymerase chain reaction, Vaccination failure
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report from a contactable pharmacist (patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EH9899) intramuscularly into the left arm on 29Dec2020 08:30 am and second dose (Lot Number: EL1283) intramuscularly into the left arm on 21Jan2021 08:30 am (at the age of 34-years-old) and both at single dose for Covid-19 immunization. No other medical history was reported. The patient had no known allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included zinc and MVI (MVI-ADULT). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 30Mar2021, the patient tested positive for Covid test. No treatments received for the adverse events. On 04Mar2021, laboratory tests showed positive COVID test and on 02Apr2021, polymerase chain reaction (PCR) showed Covid test result positive. No other vaccines were taken in four weeks. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and COVID 19 and the suspect drug.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Cold sweat, Feeling abnormal, Muscle spasms
Clinical narrative: muscle cramp; tightness in chest; shoulders cold sweat with no fever; body weakness; 7days brain fog; This is a spontaneous report from a contactable consumer reported for himself that a 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733, expiry date: Jul2021) at the age of 61-years, via an unspecified route of administration in right arm on 29Mar2021 11:30 at single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient experienced 7days brain fog, muscle cramp, tightness in chest, shoulders cold sweat with no fever and body weakness. These events started since unknown date (reported as 28Mar2021, pending clarification). No treatment received for the adverse events. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Pain in extremity
Clinical narrative: Tightness in chest; shortness of breath; headache; sore arm; This is a spontaneous report from a contactable consumer. This consumer(patient) reported for herself that a 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at the age of 58-years, via an unspecified route of administration in left arm on 03Apr2021 09:15 AM at single dose for COVID-19 immunization. Medical history included hypertrophic cardiomyopathy, asthma, hypothyroidism. Patient was not pregnant at the time of vaccination. 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. Concomitant medications included metoprolol; bupropion hydrochloride (WELLBUTRIN); desvenlafaxine succinate (PRISTIQ); loratadine and synth (as reported). The patient historically received first single dose of BNT162B2 (lot number: EN6199) via an unspecified route of administration in left arm on 06Mar2021 09:30 AM for COVID-19 immunization. The patient previously took Compazine and experienced allergy to it. On 03Apr2021 22:00 (10:00 PM), the patient experienced tightness in chest, shortness of breath, headache, sore arm. The events resulted in emergency room/department or urgent care. Patient received nebulizer treatment for the adverse events. Outcome of the events were not recovered. Since the vaccination, the patient been has not tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Feeling jittery
Clinical narrative: About 8 hours later, I feel like someone gave me a big shot of epinephrine. Jittery and revved.; About 8 hours later, I feel like someone gave me a big shot of epinephrine. Jittery and revved.; This is a spontaneous report from a contactable consumer. This 36-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 11:30 AM (Lot Number: ER8734) as SINGLE DOSE for covid-19 immunisation.  Medical history included asthma, migraine, obese, allergies. Patient had allergies to Albuterol. Concomitant medication(s) included cannabidiol and ibuprofen.  Historical vaccine included the first dose of BNT162B2 on 13Mar2021 at 11:30 AM (age at vaccination: 36 Years), vaccine location: Left arm, lot number: EN6204 for covid-19 immunization. On 03Apr2021 at 08:00 PM (about 8 hours later), patient felt like someone gave her a big shot of epinephrine. Jittery and revved with outcome of unknown. No treatment received for the adverse event. No pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Influenza like illness, Insomnia
Clinical narrative: Mild flu-like symptoms; beginning with sleeplessness; headache; fatigue; waves of mild nausea; muscle/joint aches; muscle/joint aches; waves of muscle spasm in right groin area; This is a spontaneous report from a contactable Other Health Professional reported for herself that a 63-year-old Female (no pregnant) patient received 2nd dose of Pfizer COVID-19 vaccine BNT162B2 (lot/batch number: EN6201) at Left arm on 02Mar2021 at single dose for covid-19 immunization. Medical history was Fibromyalgia, Arthritis, Lumbar disc bulge. Allergies to medications, food, or other products: PCN, codeine, ephedra, gluten. Concomitant drug included Progesterone, estradiol (ESTROGEN), minerals nos/quercetin/thioctic acid/vitamins nos (EMERGEN-C), ergocalciferol (VIT D), zinc. No other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine was 1st dose of BNT162B2 on 09Feb2021 (lot/batch number: EL9269) at Left arm for covid-19 immunization. Patient experienced Mild flu-like symptoms: beginning with sleeplessness, headache, fatigue, waves of mild nausea, muscle/joint aches and waves of muscle spasm in right groin area. All lasted less than 24 hours from 03Mar2021 02:00 am with outcome was Recovered. No treatment. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea
Clinical narrative: Mild flu-like symptoms; beginning with sleeplessness; headache; fatigue; waves of mild nausea; muscle/joint aches; muscle/joint aches; waves of muscle spasm in right groin area; This is a spontaneous report from a contactable Other Health Professional reported for herself that a 63-year-old Female (no pregnant) patient received 2nd dose of Pfizer COVID-19 vaccine BNT162B2 (lot/batch number: EN6201) at Left arm on 02Mar2021 at single dose for covid-19 immunization. Medical history was Fibromyalgia, Arthritis, Lumbar disc bulge. Allergies to medications, food, or other products: PCN, codeine, ephedra, gluten. Concomitant drug included Progesterone, estradiol (ESTROGEN), minerals nos/quercetin/thioctic acid/vitamins nos (EMERGEN-C), ergocalciferol (VIT D), zinc. No other vaccines within 4 weeks prior to the COVID vaccine. Historical Vaccine was 1st dose of BNT162B2 on 09Feb2021 (lot/batch number: EL9269) at Left arm for covid-19 immunization. Patient experienced Mild flu-like symptoms: beginning with sleeplessness, headache, fatigue, waves of mild nausea, muscle/joint aches and waves of muscle spasm in right groin area. All lasted less than 24 hours from 03Mar2021 02:00 am with outcome was Recovered. No treatment. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Thirst
Clinical narrative: Sensation that my brain was on fire or oddly fevered even though my body's temperature did not elivate; severe joint pain; very thirsty; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Patient Program COVAES. A 59-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Mar2021 at 11:30 (Lot number: ER8730) on the left arm as single dose for COVID-19 immunization. Medical history included allergy to cats, asthma from allergy. Concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 at 09:30 (Lot number: EN6205) on the left arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient reported that sensation that his brain was on fire or oddle fevered even though his body's temperature did not elevate, not a headache on 24Mar2021 at 22:00. On 24Mar2021 at 22:00, patient also had severe joint pain and very thirsty; lasted about 36 hours. There was no treatment received for the adverse events. The outcome of events was recovered on unspecified date.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Fatigue, Palpitations, X-ray
Clinical narrative: palpitations; fatigue; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) at the age of 41-years, via an unspecified route of administration in left arm on 09Mar2021 15:15 at single dose for COVID-19 immunisation. Medical history was not reported. 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. Patient was not pregnant at the time of vaccination. No allergies to medications, food, or other products. Concomitant medications were not reported. The patient experienced palpitations and fatigue on 19Mar2021. The events result in emergency room/department or urgent care. Treatment was received for the adverse events. The patient underwent lab tests and procedures, which included X-Ray, Cat scan and Blood work, all with unknown results on unspecified date. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered/not resolved.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021371063 same patient/SD, different AE/dose
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation.  Medical history included osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) and finasteride (PROSCAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left arm (Vax site) migrated down to elbow & forearm on 27Mar2021 with outcome of recovered. The patient received treatment: ibuprofen. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Palpitations
Clinical narrative: After her second dose palpitations came back; After her second dose palpitations came back; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 31Mar2021 15:15 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included was not reported. No pregnant at the time of vaccination. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 immunization (Dose number: 1, administration_time=03:15 PM, Batch/lot number; EN6204, Anatomical location: Arm Left). Prior to vaccination, the patient was not diagnosed with COVID-19. The consumer reported few days after she received first she started having palpitations and fatigue on 19Mar2021 03:45 PM. Event resulted in: [Emergency room/department or urgent care]. Went to the ER did cat scan, X-Ray and blood but nothing was found, and treatment received. After her second dose palpitations came back in 2021. The event was reported as non-serious. No covid tested post vaccination. The event outcome was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021370209 same patient/SD, different AE/dose
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: Colds; Congestion; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 04Apr2021, this case now contains all required information to be considered valid.   This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 31Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunization. The patient experienced colds and congestion on an unspecified date in Mar2021. Treatment included pseudoephedrine. It was reported that the patient had his 2nd dose last 31Mar2021 then he took pseudoephedrine for his colds and congestion. The patient would like to know if it's fine to take pseudoephedrine or if there was any issue taking pseudoephedrine after the second dose of the vaccine. The patient hung up abruptly/transfer was incomplete. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection
Clinical narrative: she developed an infection in the leg 2 weeks later; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported.     The patient's concomitant medications were not reported. The patient reported she could not get the second dose as she developed an infection in the leg 2 weeks later on Mar2021 with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: she developed a sinus infection and was started on short term antibiotics/; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 11MAR2021 and that following that, she developed a sinus infection and was started on short term antibiotics. She t received her second dose of the Pfizer BioNTech COVID-19 vaccine on 01ARP2021 and now her doctor wanted to start her on additional antibiotics as well as Prednisone. The event outcome was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: swollen lymph node and painful to touch; hives; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A female patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE ; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization, after which patient experienced some fatigue and headache for 24 hours. Patient had a swollen lymph node on side she received second shot. She was 6 days out and the swelling was down however it was still painful to touch. She also had hives 48 hours after 2nd dose that self-resolved on an unspecified date. She does take an immunosuppressant agent. The outcome of the event swollen lymph node and painful to touch was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372009 same patient, different event/dose
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea
Clinical narrative: Shortness of breath; wheezing cough; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Mar2021 11:30 as single dose for covid-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medication included etanercept (ENBREL). After the 3rd day (31Mar2021 06:00 PM), patient developed increasing shortness of breath accompanied with a wheezing cough. The treatment was not received. No covid prior vaccination nor covid test post vaccination. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No allergies to medications, food, or other products. The outcomes of events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.