chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dysmenorrhoea
Clinical narrative: I got on my periods and I usually have really bad pain but this time it is like 10 times worse than really bad that I usually have; I have really bad abdominal pain; This is a spontaneous report from a contactable consumer (patient).  A 27-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization, at the age at vaccination of 27 years old.  The patient's medical history and concomitant medications were not reported. The patient experienced she had really bad abdominal pain (non-serious) on 20Apr2021 with outcome of unknown, she got on her periods and she usually had really bad pain but this time it was like 10 times worse than really bad that she usually have (non-serious) on an unspecified date with outcome of unknown.  Consumer stated, "On Monday I got the Pfizer covid vaccine and I got it like yesterday and situation was pretty bad but it likes lot worse and it is like has been stopped being like really bad. I don't know if this is like something, that was adverse side effect or what?" It was the 1st shot." Consumer stated, "Yes but that's not the concern about it is the fact that I got on my periods and I usually have really bad pain but this time it is like 10 times worse than really bad that I usually have. I don't know if I be concerned or not. I have really bad abdominal pain. It is worse than usual that I have in my period."  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: severe impotence; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration at arm left on 29Mar2021 09:00 AM at age of 56-year-old for COVID-19 immunization. Medical history and concomitant medications were not reported. There was no known allergies. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, patient wasn't tested for COVID-19. After taking the first shot two weeks later (as reported), patient started experiencing severe impotence and he was still going through this he had never been this way before. Onset date of the event was reported as 29Mar2021. Event was reported as non-serious. No treatment was received for the event. Outcome of the event was not recovered.  Information about lot/batch number was available. Further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; I had symptoms; This is a spontaneous report from a Pfizer.  This is a report from a contactable consumer (self).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot Number: ER8732) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced tested positive for COVID, fever is gone 'and everything' (not clear nor clarified) but still have a cough and little bit of headache on 09Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash pruritic, Skin irritation
Clinical narrative: itching type of rash; Right below her neck she is have itching, irritation; Right below her neck she is have itching, irritation; This is a spontaneous report from a contactable consumer (patient's husband) reported for patient. A female patient of an unspecified age received dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced itching type of rash (non-serious) on an unspecified date with outcome of unknown, right below her neck she is have itching, irritation (non-serious) on an unspecified date with outcome of unknown. Reporter stated, "My wife had like a reaction, like itching type of rash or something few weeks after the first Covid shot and I wanted to know what she can use to get rid of that itching? She had the shot on her left arm and right below her neck she is have itching, irritation."  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Glossitis, Glossodynia, Tongue erythema
Clinical narrative: whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed; tongue is hurting everywhere; whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed; tongue is hurting everywhere; whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed; tongue is hurting everywhere; This is a spontaneous report from a contactable consumer (patient).   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that "four hours after I took the vaccine the whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed. It is like you drink a hot drink and you burn you tongue but I did not even realized when I was speaking and I was like my tongue is hurting everywhere." Outcome for events was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Heart rate, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient).   The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization.  Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration.  After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pulse abnormal
Clinical narrative: Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; Pulse continued body aches especially in legs making her almost immobile; bitter taste; This is a spontaneous report from a contactable consumer(patient).   The 51-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 25Apr2021 14:30 (Batch/Lot number was not reported) as second dose, single for covid-19 immunization.  Medical history included hashimoto. Concomitant medication included collagen, peptide powder, multi vitamins. She previously received sulfur based antibiotics. Historical vaccine included first dose of BNT162B2 on 03Apr2021 09:30 AM for COVID-19 immunization and experienced bitter taste in back of throat for half day on date of administration.  After second dose, the patient experienced same bitter taste for 24 hours from time of administration. Pulse continued body aches especially in legs making her almost immobile, all on 26Apr2021 06:00 with outcome of recovering. Treatment included alternated taking ibuprofen(ADVIL) and paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID 19, Since the vaccination, the patient had not been tested for COVID 19.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466738 Same patient/drug, similar AEs, different dose
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy from his trunk down to his arms; This is a spontaneous report from a contactable pharmacist.  A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, as single dose on an unknown date (Lot number: not provided) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient became well itchy from his trunk down to his arms and lasted about a day or so after he received his first shot. Event outcome was recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: Rash on my hand; My lip was swollen; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, as single dose on an unknown date (Lot number: not provided) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient asked that if he/she did have the rash on hand after the first dose and his/her lip was swollen, should he/she take the other one. Event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Deafness, Magnetic resonance imaging head, Tinnitus
Clinical narrative: I developed tinnitus in my left ear and some loss of hearing in my left ear.; I developed tinnitus in my left ear and some loss of hearing in my left ear.; This is a spontaneous report from a contactable consumer reporting for self.   A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 10Mar2021 (Batch/Lot Number: EN6205) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure increased from 2001 ("for 20 years") and cancer (first time was in 2004 and then in 2008).  The patient was receiving unspecified concomitant medications ("I am taking a lot of different medication").  The patient previously received first dose of BNT162B2 (Batch/lot number: EN6205) on 09Feb2021. On 17Mar2021, the patient developed tinnitus in her left ear and some loss of hearing in her left ear. The patient underwent lab tests including blood work on 14Apr2021 with normal results and MRI brain 15Apr2021 with normal result. The patient had not yet received any treatment for the events at the time of reporting. The patient states she doesn't know for sure, but she believed she had a side effect from receiving the Pfizer vaccine. The outcome of the events tinnitus in her left ear and some loss of hearing in her left ear was unknown.
Age: 19.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Axillary mass, Chills, Pyrexia
Clinical narrative: lump under his armpit; Fever; Chills; This is a spontaneous report from a contactable consumer or other non hcp.    A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection,Batch/Lot Number: EW0157), dose 2 via an unspecified route of administration, administered in Arm Right on 21Apr2021 10:30 as single dose for covid-19 immunisation; ibuprofen (IBUPROFEN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication.History: She says he took ibuprofen and that they all started to have fever and chills.He took ibuprofen. She things the dose was 300mg or 400mg and he took a total of 3 doses .Prior Vaccinations within 4 weeks (List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s)): no. The patient medical history, concomitant medications were not reported. On 21Apr2021 The patient experienced fever, chills, and on 23APr2021 lump under his armpit. The outcome of events was recovered ,On 23Apr2021 and lump under his armpit (axillary mass) was not recovered.  Follow-up (23Apr2021): No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Excruciating headaches; Dizziness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Apr2021 (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received dose 1 for COVID-19 immunization. The patient experienced excruciating headaches, had the headache and dizziness, have all the possible symptoms. The patient did the neuro exam and got some migraine medications (Unspecified medication). The event outcome of excruciating headaches was not recovered, dizziness was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Drug intolerance, Malaise, Nausea
Clinical narrative: She couldn't take anymore I had to take her to hospital; Pain; she hasn't felt like this ever before but this is like you know, very unusual; She is not well; Swelling in her stomach and just very like gut thing; Back pain; Nausea; She was throwing up; This is a spontaneous report from a contactable consumer (patient's son). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was calling because his mom had getting some very strange (Incomplete sentence). 2 weeks before 25Apr2021 (in Apr2021) patient got the Pfizer vaccine and the following week which was last week in Apr2021 she started feeling like kind like swelling in her stomach and just very like gut thing, back pain, Nausea, she was throwing up. So, yesterday (24Apr2021) she couldn't take anymore reporter had to take her to hospital. Reporter was just told they need to go to the emergency room. They gave her pain killers and that was yesterday and she felt better after the pain medications (Unspecified medications) but then the pain returned today (25Apr2021) and she said she hadn't felt like this ever before but this was like very unusual. A week after she got the Pfizer vaccine. So, they were just had trying to figure out what they could do because she was not well in Apr2021. Therapeutic measures were taken as a result of back pain included pain killers. The outcome of the event Pain was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: She couldn't take anymore I had to take her to hospital; Pain; she hasn't felt like this ever before but this is like you know, very unusual; She is not well; Swelling in her stomach and just very like gut thing; Back pain; Nausea; She was throwing up; This is a spontaneous report from a contactable consumer (patient's son). A female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter was calling because his mom had getting some very strange (Incomplete sentence). 2 weeks before 25Apr2021 (in Apr2021) patient got the Pfizer vaccine and the following week which was last week in Apr2021 she started feeling like kind like swelling in her stomach and just very like gut thing, back pain, Nausea, she was throwing up. So, yesterday (24Apr2021) she couldn't take anymore reporter had to take her to hospital. Reporter was just told they need to go to the emergency room. They gave her pain killers and that was yesterday and she felt better after the pain medications (Unspecified medications) but then the pain returned today (25Apr2021) and she said she hadn't felt like this ever before but this was like very unusual. A week after she got the Pfizer vaccine. So, they were just had trying to figure out what they could do because she was not well in Apr2021. Therapeutic measures were taken as a result of back pain included pain killers. The outcome of the event Pain was not recovered, outcome of the other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Memory impairment, Pain, Suicidal ideation
Clinical narrative: Acute suicidal ideation with strong intent to hang herself; Severe body aches; Severe chills; Had cognitive side effects where she was forgetting basic facts including her date of birth; This is a spontaneous report from a contactable physician. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8729), intramuscularly in left arm on 13Apr2021 at 09:00 (at the age of 38-years-old) at single dose for COVID-19 immunization. Medical history included post-traumatic stress disorder (PSTD), obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), premature ventricular tachycardia, hashimoto's disease, migraine, celiac disease, hysterectomy and was diagnosed with COVID-19 prior vaccination. Concomitant medications included trazodone, lisdexamfetamine mesilate (VYVANSE), venlafaxine hydrochloride (EFEXOR XR), and metoprolol (METOPROLOL XR). The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER2613) intramuscularly in left arm on 23Mar2021 at 09:00 (at the age of 38-years-old) at single dose for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19, did not receive any other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 13Apr2021 at 17:00, the patient experienced acute suicidal ideation with strong intent to hang herself and at the same time she developed severe body aches and chills. The patient also had cognitive side effects where she was forgetting basic facts including her date of birth. It was reported that, all the side effects resolved after 1.5 days. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovered on 15Apr2021.; Sender's Comments: Based on the information currently available, the event Suicidal ideation is considered most likely associated with intercurrent or underlying medical conditions, appear unrelated to the suspect drug.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a non-contactable consumer (patient). This 70-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in right arm on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were 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. Since the vaccination, the patient had not been tested for COVID-19. Covid-19 test was negative. The patient had a heart attack four days after first vaccination. The adverse event result in emergency room/department or urgent care and received treatment. Seriousness criteria was caused/prolonged hospitalization for 4 days, not results in death, not life threatening, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual, Pyrexia, Sensory loss
Clinical narrative: visual hallucinations lasting 18 hrs; 102º-104º fever lasting 36 hrs; loss of sensation from waist down for 12 hrs; This is a spontaneous report from a non-contactable other hcp (patient). A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170), intramuscular on 21Apr2021 12:45 PM as single dose for covid-19 immunisation. Medical history not reported. Patient not pregnant at the time of vaccination and not diagnosed with COVID-19 prior to vaccination, not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient intramuscular received first dose of bnt162b2 (Lot number= EW0150) on 31Mar2021 12:45 PM. On 22Apr2021 patient experienced 102º-104º fever lasting 36 hrs, visual hallucinations lasting 18 hrs, loss of sensation from waist down for 12 hrs. The outcome of events was recovered. Patient has not been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event visual hallucinations cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Syncope, Vomiting
Clinical narrative: Felt like was going to pass out; Diarrhea; Vomited; This is a spontaneous report from a contactable consumer report for self. A female patient of an unspecified age received first doe of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 3:00PM as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had the first dose of the covid vaccine on 13Apr2021 around 3:00PM. The next day, 14Apr2021 around 3:00PM, she started to have symptoms. She had diarrhea, vomited, and felt like she was going to pass out. She was supposed to get her second dose of the covid vaccine on 04May2021 (second dose of the covid vaccine is scheduled on 04May2021). She was wondering if she will have the same reaction for the second dose. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
Clinical narrative: She tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced she tested positive for covid on an unspecified date. Reporter stated his wife got (first) shot on 07Apr2021 that was like 3 weeks ago and she was supposed to get second shot on 28Apr2021 which is Wednesday. She tested positive for covid. Now she has Covid. Reported asked if she should go and get the shot or not go and get the shot. The event outcome for events was unknown
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Arm pain at jab site (couldn't sleep on right side); Very tired; This is a spontaneous report received from a contactable consumer (patient herself). A 55-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; lot number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccination included first dose of BNT162B2 for COVID-19 Immunization. On an unspecified date, the patient experienced arm pain at jab site (couldn't sleep on right side) and very tired. Outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parosmia
Clinical narrative: she had just a slight smell but it was so horrible; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Right Deltoid on 22Jan2021 (Lot Number: EK9231) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first one 22Jan2021 and after that (22Jan2021) she had just a slight smell but it was so horrible. She thought that it was the blanket on the bed and she had passed it off a little bit. When she had her first shot she had mild side effects and then the next morning she could eat a little bit. After her first COVID vaccine she only had the horrible smell. That episode was short and by the next morning she didn't have the smell anymore. The event was reported as medically significant. The outcome of the event was recovered on 23Jan2021. The reporter considered the causality was related.; Sender's Comments: As there is limited information in the case provided, the causal association between the event parosmia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Chills, Diarrhoea, Dysarthria
Clinical narrative: she had just a slight smell but it was so horrible; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Right Deltoid on 22Jan2021 (Lot Number: EK9231) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first one 22Jan2021 and after that (22Jan2021) she had just a slight smell but it was so horrible. She thought that it was the blanket on the bed and she had passed it off a little bit. When she had her first shot she had mild side effects and then the next morning she could eat a little bit. After her first COVID vaccine she only had the horrible smell. That episode was short and by the next morning she didn't have the smell anymore. The event was reported as medically significant. The outcome of the event was recovered on 23Jan2021. The reporter considered the causality was related.; Sender's Comments: As there is limited information in the case provided, the causal association between the event parosmia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Nausea, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: she had just a slight smell but it was so horrible; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Right Deltoid on 22Jan2021 (Lot Number: EK9231) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first one 22Jan2021 and after that (22Jan2021) she had just a slight smell but it was so horrible. She thought that it was the blanket on the bed and she had passed it off a little bit. When she had her first shot she had mild side effects and then the next morning she could eat a little bit. After her first COVID vaccine she only had the horrible smell. That episode was short and by the next morning she didn't have the smell anymore. The event was reported as medically significant. The outcome of the event was recovered on 23Jan2021. The reporter considered the causality was related.; Sender's Comments: As there is limited information in the case provided, the causal association between the event parosmia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Scan, Sneezing, Taste disorder, Thinking abnormal
Clinical narrative: she had just a slight smell but it was so horrible; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Right Deltoid on 22Jan2021 (Lot Number: EK9231) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first one 22Jan2021 and after that (22Jan2021) she had just a slight smell but it was so horrible. She thought that it was the blanket on the bed and she had passed it off a little bit. When she had her first shot she had mild side effects and then the next morning she could eat a little bit. After her first COVID vaccine she only had the horrible smell. That episode was short and by the next morning she didn't have the smell anymore. The event was reported as medically significant. The outcome of the event was recovered on 23Jan2021. The reporter considered the causality was related.; Sender's Comments: As there is limited information in the case provided, the causal association between the event parosmia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fevers; chills; This is a spontaneous report from a contactable consumer (patient) via sales representative. A patient of unspecified age and gender received 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. The patient experienced fevers and chills on an unspecified date after vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: body aches; headache; nausea; chills; sore arm; swelled lymph node under the arm; This is a spontaneous report from a contactable other health care professional. A 46-year-old female patient 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 15Apr2021(at the age of 46-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient experienced body aches, headache, nausea, chills, sore arm and swelled lymph node under the arm the evening after receiving the second dose on 15Apr2021. The outcome of the events (body aches, headache, nausea, chills, sore arm) was recovered on 17Apr2021 and swelled lymph node under the arm was recovered on 22Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: body aches; headache; nausea; chills; sore arm; swelled lymph node under the arm; This is a spontaneous report from a contactable other health care professional. A 46-year-old female patient 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 15Apr2021(at the age of 46-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient experienced body aches, headache, nausea, chills, sore arm and swelled lymph node under the arm the evening after receiving the second dose on 15Apr2021. The outcome of the events (body aches, headache, nausea, chills, sore arm) was recovered on 17Apr2021 and swelled lymph node under the arm was recovered on 22Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid infection after the first dose.14 days from the second dose; got covid infection after the first dose.14 days from the second dose; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose 0n an unspecified date for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient had 21 days recommendation inquiry for covid. Patient got covid infection after the first dose. 14 days from the second dose (as reported). Patient was inquiring timeline for second dose. Covid test was positive. The outcome of events was unknown.  The information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: infection; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The caller wanted to reschedule their second dose appointment because his wife got hospitalized due to infection. They missed the second dose last 24Apr2021. They received the first dose last 30Mar2021(More than 3 weeks). The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid after both Covid vaccines; Tested positive for Covid after both Covid vaccines; had a Covid exposure in another country; This is a spontaneous report received from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, first dose on an unspecified date (Lot Number: Not Provided), second dose on an unspecified date (Lot Number: Not Provided), both at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Physician stated she had a question about whether Pfizer was interested in tracking people who tested positive for the Covid virus after having the Covid vaccine. Physician stated she was calling on behalf of her Nephew. Patient tested positive for Covid twice, after both Covid vaccines. Patient travelled and had a Covid exposure in another country. Patient had two positive Covid tests. Outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Drug ineffective, COVID-19, exposure to SARS-CoV-2 and the suspect drug BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient went to work afterwards, and was only tired after the administration on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin reaction, Swelling
Clinical narrative: swelled up; had a knot, was red; had a knot, was red; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history included auto-immune disease and psoriatic arthritis. Concomitant medications included guselkumab (TREMFYA). Patient stated that with the first shot that she had a delayed reaction to her right arm and it did not pop up until week later. Stated that it swelled up, had a knot, was red and then went away. There was no product complaint to report. There was request for medical information. Patient wanted to know if this is from the vaccine or if she should go to doctor. Wanted to know if others had reported it. The outcome for the event was recovered.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson syndrome; allergic reaction; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as an unspecified dose for covid-19 immunisation. The patient medical history included sulfa allergies. The patient's concomitant medications were not reported. The patient stated that 'I had an allergic reaction to the Covid vaccine. Stevens-Johnson syndrome. Due to my past experiences with it, I knew what was going on and got treatment. Doing some googling I learned that those with sulfa allergies shouldn't get the shot. I told the pharmacy about the allergies. Please educate the pharmacies. I'm not taking this anywhere, because people should get the shot if they can'.  Outcome of events was unknown.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Mass, Pain
Clinical narrative: a lump in between my shoulder blade and my collar bone. The lump it is like size of a small grape like a very small grape; little sore right there; This is a spontaneous report from a contactable consumer (patient). A 39-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 15Apr2021 (Lot Number: EW0162; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. Patient previously received first dose of vaccine on 25Mar2021 (lot number: EN6207) administered in left arm for COVID-19 immunization. Patient had COVID vaccine second shot on last Thursday on 15Apr2021 and on Sunday this past Sunday on 18Apr2021, patient noticed had a lump in between shoulder blade and collar bone and patient noticed it was little sore right there and started rubbing it and a little lump there. Patient stated that the lump it is like size of a small grape like a very small grape. Patient stated the lump is there and still a little sore, the soreness has improved but the lump is still there. Patient stated no treatment. No investigation assessment. The event outcome for a lump in between my shoulder blade and my collar bone. The lump it is like size of a small grape like a very small grape was not recovered, for little sore right there was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID; Got COVID; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Feb2021 08:00 (Batch/Lot Number: EL9262) as single dose, dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 08:00 (Batch/Lot Number: EL9269) as single dose, both vaccinated at the age of 52 years old for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient got covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Apr2021.  patient visited Doctor or other healthcare professional office/clinic visit. Outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation, Skin disorder
Clinical narrative: I broke out whit little bumps; I am itchy all over; Last night it was so bad it was burning; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. Medical history included covid-19, patient had Covid back in December at Christmas time. Concomitant medication was not reported. On an unspecified date the patient experienced broke out with little bumps and experienced itchy all over, and last night it was so bad it was burning. Second dose was scheduled on 15, patient stated it is not contraindicated to receive the second dose based on his reaction. Therapeutic measures were taken by taking Benadryl which helping a little bit. The 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: Pain in extremity
Clinical narrative: Tiny bit of arm hurting; This is a spontaneous report from a contactable patient.   A 69-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  Medical history included diabetes from 2004 and ongoing she has had diabetes since 2004.     The patient's concomitant medications were not reported.  The patient experienced tiny bit of arm hurting on an unspecified date with outcome of unknown.  She received the first dose of the vaccine on 09Mar2021 and had no symptoms, just a tiny bit of arm hurting for a couple of days.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dysstasia, Headache, Myalgia
Clinical narrative: fever; headache; muscle pain; chills; he can't stand up very well because he feels weak; he can't stand up very well because he feels weak; This is a spontaneous report from a Pfizer received from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. On an unspecified date of Apr2021, the patient experienced fever, headache, muscle pain, chills and also reported that he could not stand up very well because he felt weak. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about batch number cannot be obtained.