chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: I felt like the whole room and bed were spinning and moving like in an earthquake.; a little lightheaded; This is a spontaneous report from a non-contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), via an unspecified route of administration on 26Jan2021 13:15 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at the Clinic facility. Patient age at vaccination was 88 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included high blood pressure, and Hashimoto's Disease. Concomitant medications included levothyroxine sodium (SYNTHYROID), fenofibrate, lisinopril, colecalciferol (VITAMIN D). On 27Jan2021 at 06:00 AM upon waking up the morning after the shot, before getting out of bed, the patient felt like the whole room and bed were spinning and moving like in an earthquake. She stayed in bed for about 15 minutes, then sat up on the edge of the bed. She was still a little lightheaded so waited a few more minutes and then the feeling went away. The patient reported this has never happened to her before. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The outcome of the events was reported as resolving.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable Pharmacist.  A male patient of an unspecified age (Age: 38; Unit: Unknown) receive 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. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid after the first dose of the covid 19. Caller wanted to know if the patient needed to wait to get the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  However, no complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer reported for himself  A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea in Jan2021 with outcome of unknown. The action taken in was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Inflammation of previous knee injury; This is a spontaneous report from a contactable other HCP (patient). A 26-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration in right deltoid on 27Jan2021 around 15:20 at SINGLE DOSE for covid-19 immunisation. Medical history included Prediabetic from Feb2019 and ongoing, obesity from 2021 and ongoing (thought he just turned the corner to obesity this year), previous knee injury. Family history included diabetes only. There were no concomitant medications. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as 'None'.  The patient experienced inflammation of previous knee injury on 27Jan2021. He reported onset of inflammation of previous knee injury around 15:35-15:40 which was ongoing. He called to ask if this event was known to be associated with the vaccine; if it was normal, just an inflammatory response of old injuries that was expected or not. Inflammation of previous knee injury: Described as knee was probably about 25% bigger than normal, swollen and painful, ballooned up a bit with swelling. Noted when he started walking back to the vehicle and knee just started hurting real bad to bend the knee; Described as a bad knee, previous knee injury was an old high school injury where he tore the meniscus and a few other things in the knee. The bad knee normally did not hurt or bothered him, but flared up if he got sick. The swelling was only in his knee, not in his throat or anything else. The event did not require a visit to Emergency Room and Physician office. The outcome of the event was not recovered (reported as worsened).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Somnolence
Clinical narrative: Her joints hurt terribly on her right side; Fatigue 'slept all day and all night'; Fatigue 'slept all day and all night'; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing osteoporosis (she is known for osteoporosis in her knee) and ongoing allergy. Concomitant medications included denosumab (PROLIA) and allergy shots. The patient received the Pfizer Covid shot on 25Jan2021 and her regular allergy shots 2 days prior. She was told by that facility that it was okay to receive the allergy shot. However, she was told by the Physician where she gets Prolia infusions to wait 2 weeks after the vaccine. In Jan2021 she felt post-vaccine side effects of fatigue 'slept all day and all night' and her joints hurt terribly on her right side, although she is known for osteoporosis in her knee. She is 'fully active'. She took a Motrin for the pain and it eased up. The event join hurt was resolving, while outcome of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose but tested positive for covid 2 days after; The Patient received the Pfizer-BioNTech COVID-19 Vaccine first dose but tested positive for covid 2 days after; This is a spontaneous report from a contactable consumer. This consumer reported for her 76-year-old mother who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Relevant history and concomitant drugs were unknown. The patient was tested positive for COVID 2 days after the vaccination. Outcome of the event was unknown.   The information on the LOT/Batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Pain
Clinical narrative: dizziness; diarrhea; generalized aches; This is a spontaneous report from a contactable consumer A 91-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 dose 1 at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Nursing Home. Medical history included cardiac assistance device user, hyperthyroidism, hypertension, blood cholesterol increased, macular degeneration, glaucoma, osteoporosis. Concomitant medication included calcium (CALCIUM), flecainide (FLECAINIDE), chondroitin sulfate, glucosamine sulfate (OSTEOFLEX [CHONDROITIN SULFATE;GLUCOSAMINE SULFATE]), vitamin d (VITAMIN D) , meclizine [meclozine] (MECLIZINE [MECLOZINE]). The patient experienced dizziness on 16Jan2021 20:00 with outcome of not recovered, diarrhea on 16Jan2021 20:00 with outcome of not recovered, generalized aches on 16Jan2021 20:00 with outcome of not recovered. The action taken was not applicable. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient resulted positive to COVID-19 after vaccination; patient resulted positive to COVID-19 after vaccination; This is a spontaneous report from a contactable other hcp (patient).   This 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 27Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient resulted positive to Covid-19 after vaccination on 27Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Jan2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Malaise, Pruritus, Rash papular
Clinical narrative: she had bumps all over her body and below her eyes which appeared swollen.; itchiness; At 10:30 she started feeling sick; raised humps on her hands and arms/ throughout the evening the bumps went to different places on her body; This is a spontaneous report from a contactable consumer who reported for herself.  An 82-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on 21Jan2021 for Covid-19 immunization. Medical history was not reported. Concomitant medications included gabapentin and paracetamol (TYLENOL). On 25Jan2021 around 5:30-6 p.m, the patient noticed raised bumps on her hands and arms, and throughout the evening the bumps went to different places on her body. At 10:30 she started feeling sick and noticed that she had bumps all over her body and below her eyes which appeared swollen. She went to the ER because the itchiness was unbearable. In the ER, they gave her Prednisone and a Benadryl, in which she broke out again after taking the medication. The ER sent her home with a prescription for Prednisone and Claritin. She slept all the following day and she normally only takes Gabapentin and Tylenol for her medication. Patient wanted to know that if these reactions have been reported, If she should take the second injection and have the reactions been reported days later. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Has been in pain since he got the vaccine because he is used to taking Tylenol, and now he is not.; This is a spontaneous report from a non-contactable consumer (patient).  This male patient (age not provided) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Past drug history included paracetamol (TYLENOL). He has been in pain since he got vaccine because he is used to taking paracetamol (TYLENOL), and now he is not (as reported). The outcome of the event was unknown.  No follow-up attempts are possible. No further information expected. Information about batch/lot number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Nausea; tiredness; chills; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at arm left on 26Jan2021 at 09:45 single dose for COVID-19 immunization. The patient medical history included allergy to wasps from an unknown date and unknown if ongoing.  The patient concomitant medication included fluticasone. On 27Jan2021 at 11:00, the patient experienced nausea, tiredness and chills. No therapeutic measures were taken in response to the events. The patient outcome of the events was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: swelling of the tongue; This is a spontaneous report from a contactable physician via Pfizer sales representative. A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history included a very similar event (unspecified) following a presumed COVID-19 infection about 6 weeks prior. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced swelling of the tongue on an unspecified date a few days following the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on an unspecified date. It was reported that the patient needed to take monoclonal antibodies (bamlanivimab (MANUFACTURER UNKNOWN)) before the second dose. However, the patient tested positive after the first dose and so the pharmacist was questioning if it is okay for the patient to take the antibodies before the second dose. The patient underwent lab tests and procedures, which included COVID-19 test: positive on an unspecified date. The clinical outcome of tested positive for COVID-19 was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: Limited information precludes a medically meaningful assessment of the case.  Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia, Presyncope, Vital signs measurement
Clinical narrative: felt like she was going to pass out; face started to tingle/tingling returned but this time it was down her chest; lips started going numb; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration, in the right arm, on 27Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took amoxicillin and experienced allergies. The patient is not pregnant. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 27Jan2021, after getting the vaccine, the patient experienced face started to tingle and felt like she was going to pass out. On 27Jan2021, vitals were taken and showed normal. The patient reported that on her way home on 27Jan2021, lips started going numb and the tingling returned but this time it was down her chest. Therapeutic measures were taken as a result of all the events which included diphenhydramine (BENADRYL). Outcome of all the events was recovered on unspecified date in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Headache, Heart rate, Heart rate increased
Clinical narrative: anaphylaxis; she didn't feel well; she felt weak; felt like throat was closing; Her heartrate was 113; low grade headache; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was not sure if patient made her symptoms worse with her attitude, but in the first 5 minutes (27Jan2021), patient reported she didn't feel well, she felt weak, and felt like throat was closing. She was referred to the ED (emergency department) for anaphylaxis and given 1 dose of epinephrine. The ED said they do not know if it was an anaphylactic reaction.  Her heart rate was 113 (27Jan2021). After that, she rested for the rest of the day and now has a low grade headache and some of the typical side effects (unspecified). Reporter asked for the recommendation for the second dose. The events were not serious as per reporter. Therapeutic measures taken as a result of the event anaphylaxis. The outcome of the event anaphylaxis, didn't feel well, felt weak, felt like throat was closing, heart rate was 113, and low grade headache was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug.. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Throat tightness
Clinical narrative: anaphylaxis; she didn't feel well; she felt weak; felt like throat was closing; Her heartrate was 113; low grade headache; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was not sure if patient made her symptoms worse with her attitude, but in the first 5 minutes (27Jan2021), patient reported she didn't feel well, she felt weak, and felt like throat was closing. She was referred to the ED (emergency department) for anaphylaxis and given 1 dose of epinephrine. The ED said they do not know if it was an anaphylactic reaction.  Her heart rate was 113 (27Jan2021). After that, she rested for the rest of the day and now has a low grade headache and some of the typical side effects (unspecified). Reporter asked for the recommendation for the second dose. The events were not serious as per reporter. Therapeutic measures taken as a result of the event anaphylaxis. The outcome of the event anaphylaxis, didn't feel well, felt weak, felt like throat was closing, heart rate was 113, and low grade headache was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug.. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Feeling abnormal, Gastrointestinal disorder
Clinical narrative: low grade head ache; GI c/o; anaphylaxis; Difficulty breathing; Lightheaded; throat felt like swollen/Throat getting narrower; did not feel well; hr 112; nausea; Didn't feel right; This is a spontaneous report from a contactable Physician who reported for a patient (staff member). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and during 15 min observation window did not feel well. It was later reported by the same reporter that within 3-5 minutes after injection the patient didn't feel right. Felt lightheaded, wasn't there. Having difficulty breathing and felt throat was getting narrower. Stated throat felt like swollen and heart rate was 112. Went up to people at vaccine center, was given Benadryl and sent to the Emergency Room (ER). Told she was having anaphylaxis. ER was not convinced of anaphylaxis, but was given epinephrine. Ultimately was given epinephrine although they stated that unclear if anaphylaxis or not. Was given 50mg of Benadryl. Was given Zofran for nausea. 'Today' (28Jan2021) had low grade head ache and GI c/o (gastrointestinal complaints of). Had no previous issues with vaccine or drug reaction. Has comorbidities. The reporter was seeking recommendations for the second COVID-19 Vaccine. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Malaise, Nausea
Clinical narrative: low grade head ache; GI c/o; anaphylaxis; Difficulty breathing; Lightheaded; throat felt like swollen/Throat getting narrower; did not feel well; hr 112; nausea; Didn't feel right; This is a spontaneous report from a contactable Physician who reported for a patient (staff member). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and during 15 min observation window did not feel well. It was later reported by the same reporter that within 3-5 minutes after injection the patient didn't feel right. Felt lightheaded, wasn't there. Having difficulty breathing and felt throat was getting narrower. Stated throat felt like swollen and heart rate was 112. Went up to people at vaccine center, was given Benadryl and sent to the Emergency Room (ER). Told she was having anaphylaxis. ER was not convinced of anaphylaxis, but was given epinephrine. Ultimately was given epinephrine although they stated that unclear if anaphylaxis or not. Was given 50mg of Benadryl. Was given Zofran for nausea. 'Today' (28Jan2021) had low grade head ache and GI c/o (gastrointestinal complaints of). Had no previous issues with vaccine or drug reaction. Has comorbidities. The reporter was seeking recommendations for the second COVID-19 Vaccine. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: low grade head ache; GI c/o; anaphylaxis; Difficulty breathing; Lightheaded; throat felt like swollen/Throat getting narrower; did not feel well; hr 112; nausea; Didn't feel right; This is a spontaneous report from a contactable Physician who reported for a patient (staff member). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and during 15 min observation window did not feel well. It was later reported by the same reporter that within 3-5 minutes after injection the patient didn't feel right. Felt lightheaded, wasn't there. Having difficulty breathing and felt throat was getting narrower. Stated throat felt like swollen and heart rate was 112. Went up to people at vaccine center, was given Benadryl and sent to the Emergency Room (ER). Told she was having anaphylaxis. ER was not convinced of anaphylaxis, but was given epinephrine. Ultimately was given epinephrine although they stated that unclear if anaphylaxis or not. Was given 50mg of Benadryl. Was given Zofran for nausea. 'Today' (28Jan2021) had low grade head ache and GI c/o (gastrointestinal complaints of). Had no previous issues with vaccine or drug reaction. Has comorbidities. The reporter was seeking recommendations for the second COVID-19 Vaccine. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Weight decreased
Clinical narrative: runny, loose stool specified as diarrhea; weight loss; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration in the right arm on 25Jan2021 15:30 at a single dose for covid-19 immunisation. The patient's medical history included rotator cuff surgery from 2019 and hysterectomy from 2020. The patient have no known allergies to medications, food, or other products. The 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 but received any other unspecified medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced runny, loose stool specified as diarrhea on 26Jan2021. It was also reported that she did not know this would be a weight loss drug on 26Jan2021. "UGH" (pending clarification). No treatment was received for the adverse events. Outcome of the events was recovering. The events were considered non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Headache, Pain
Clinical narrative: off breathing patterns; Headache; Chills/shivering; body aches; extreme thirst; weak; high temperature; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ez3249), intramuscular at the left arm on 25Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Type 1 diabetes and hypothyroidism. Concomitant medication included insulin. The patient previously took the first dose of BNT162B2 on 04Jan2021 intramuscular on the left arm for COVID-19 immunization. The patient experienced off breathing patterns, headache, chills/shivering, body aches, extreme thirst, weak, and high temperature on 26Jan2021 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiration abnormal, Thirst
Clinical narrative: off breathing patterns; Headache; Chills/shivering; body aches; extreme thirst; weak; high temperature; This is a spontaneous report from a contactable healthcare professional (patient). A 19-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ez3249), intramuscular at the left arm on 25Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included Type 1 diabetes and hypothyroidism. Concomitant medication included insulin. The patient previously took the first dose of BNT162B2 on 04Jan2021 intramuscular on the left arm for COVID-19 immunization. The patient experienced off breathing patterns, headache, chills/shivering, body aches, extreme thirst, weak, and high temperature on 26Jan2021 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered with sequel.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Pharyngitis streptococcal, Pruritus, Vaccination site pain
Clinical narrative: a bad itch all over her body; allergic reaction; arm became sore; strep throat; This is a spontaneous report from a contactable consumer (patient's husband).  A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1284) via an unspecified route of administration (arm), on 06Jan2021, single dose, for covid-19 immunisation.  The patient medical history was not reported.  Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), blood pressure medicine (unspecified) and a couple of pills (the reporter does not know what they are).  The patient had no other vaccines on the same day as the COVID vaccine. It was reported that the patient was having some kind of allergic reaction in Jan2021. The patient received the first dose on 6Jan2021 then her arm became sore for a couple of days. On 09Jan2021, the third day after the first dose of the vaccine, the patient got a real sore throat, the patient had to keep clearing her throat, and she had pus bags on the side of her throat in the back. The patient went to urgent care, and they did not check her for strep throat but they prescribed her Amoxicillin for strep throat and the patient took that. Later that same day, the patient started itching all over her body, her back especially. The doctor thought that the patient might be allergic to Amoxicillin, so they told her to quit taking that and to take Benadryl and Zyrtec however the antihistamine did help the itching. The patient never had a rash, just itching. The patient  went back to the doctor, about the sore throat, and they are sending her to an ENT doctor. Her appointment with the ENT is scheduled on the 10Jan2021, and while they are waiting for that, the patient went back and got their second COVID shots. The patient has not recently been itching because she was taking the Zyrtec and Benadryl. Outcome of the events was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Intermittent Fever; feeling tired; This is a spontaneous report from a contactable 74-year-old male consumer reported for himself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:1140/ELI284) at single dose for COVID-19 immunisation on 10Jan2021 at 15:00. Relevant history was unknown. Relevant concomitant drugs which the patient received within 2 weeks of vaccination included: metropol tart, fluoxetine, vitamin d, allopurinol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intermittent fever, feeling tired since 13Jan2021. Relevant lab test included COVID test (Nasal Swab) on 26Jan2021 with Negative result. The patient had no Covid antibodies detected after 3 weeks of first vaccine dose. Outcome of event was not resolved. Doctor or other healthcare professional office/clinic was visited. No treatment was received. Prior to vaccination,  the patient was not diagnosed with COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient was positive with covid-19 after the first dose; patient was positive with covid-19 after the first dose; This is a spontaneous report from a Pfizer-sponsored program by a contactable consumer (patient).  This 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1284), via an unspecified route of administration at single dose on 06Jan2021 for Covid-19 immunisation. The patient medical history and concomitant medications were not reported.   The patient was positive with Covid-19 after the first dose in Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Jan2021. The event was described as follows: She received the first dose of Covid-19 vaccine on 06Jan2021. She had mild symptoms after receiving the vaccine. Since receiving the first dose she contracted Covid. She has completed her quarantine period. She was due to receive the second dose last Monday. The county health department does not recommend that she receive the second dose since she has the natural antibodies and she will have to wait 90 days to get the second dose. Her doctor says she needs to get the second dose. What is Pfizer's position as far as waiting since she tested positive for Covid? She barely experienced symptoms.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills
Clinical narrative: chills; a low temperature; This is a spontaneous report from a contactable consumer (patient's son) from a Pfizer-sponsored program, Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that his father (patient) had the first shot yesterday (25Jan2021) at 2:30 and ran some chills and has a low temperature on Jan2021. The outcome of the events was unknown.  Information on batch/lot number was requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a non-contactable healthcare professional (patient himself). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylaxis in Jan2021. The outcome of the event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin haemorrhage
Clinical narrative: she had all these red dots on her shin, they were itchy and she scratched them and they bled; she had all these red dots on her shin, they were itchy and she scratched them and they bled; She had all these red dots on her shin, they were itchy and she scratched them and they bled; This is a spontaneous report from a contactable consumer, reporting for herself. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number), via an unspecified route of administration at the left arm on 26Jan2021 12:00 at a single dose for COVID-19 immunization. Vaccination was done in a nursing home. Vaccine was not administered at military facility. Medical history included inflammation post-surgery for cataract and detached retina, from an unknown date and unknown if ongoing.  Concomitant medication included ketorolac tromethamine for inflammation post-surgery for cataract and detached retina. The patient previously received a flu shot on 29Dec2020 for immunization. The patient had the vaccine on Tuesday, 26Jan2021 and didn't look yesterday but today, 28Jan2021, she noticed capillaries at the surface of her skin, red dots, itchy and when she scratched them, they bled. She was asking if this was a side effect and should she be concerned about getting the second dose? It was reported that when she got out of the shower today 28Jan2021, she had all these red dots on her shin, they were itchy, and she scratched them and they bled. The area was about five or six inches long and inch to two inches wide. After she blotted it with her towel, it stopped bleeding and it has scabbed up pretty quickly. She mentioned she has pictures to provide. The patient was scheduled to receive the second dose of the vaccine on 16Feb2021. No hospitalization.No additional vaccines administered on same date of the Pfizer suspect. The outcome of the even itchy was recovered on 28Jan2021 while the outcome of all other events was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: both arms ache; back itching; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced both arms ache and back itching. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on 10Jan2021. Outcome of the event was unknown.  The following information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Pallor
Clinical narrative: Lightheaded; Skin color pale; Dry mouth; This is a spontaneous report from a contactable consumer (patient himself).  This 59-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 27Jan2021 (at 09:30) at a single dose on the left arm for COVID-19 immunisation. The vaccine was administered at Clinic. No relevant medical history was provided. No known allergies. Relevant concomitant medications included atorvastatin and tamsulosin. On 27Jan2021 (at 09:45), the patient was lightheaded, she had skin color pale and dry mouth. The events were assessed as non-serious and lasted approximately 1.5 hours. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed.  No treatments were given for the events. The events resolved on 27Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Limb discomfort, Tremor
Clinical narrative: chills; shaking; limb heaviness; cold feeling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. After the second Covid vaccine about 12 hrs later the patient experienced chills, shaking, limb heaviness and was extremely cold feeling. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood creatine phosphokinase, Hepatic pain, Renal pain
Clinical narrative: pain in Kidney-liver area; pain in Kidney-liver area and into right shoulder blade; pain in Kidney-liver area; This is a spontaneous report received from a contactable consumer (herself) reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EN5318) via an unspecified route of administration in the right arm on 29Jan2021 17:15 at single dose for COVID-19 immunization. Medical history included Lymes, undiagnosed illness and CK levels doubled into the 550 level in November (unknown year). Concomitant medication was not reported. Patient was not pregnant at the time of vaccination. On 30Jan2021 07:00 patient experienced pain in Kidney-liver area and into right shoulder blade concern as her CK levels just doubled into the 550 level in November (unknown year). No treatment was received for the adverse events. Seriousness was reported as non-serious. Outcome of events was not recovered.  No follow-up attempts are possible. No further information was provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Soreness and weakness of the left arm.; Soreness and weakness of the left arm.; This is a spontaneous report from a contactable other health professional (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9245, Expiration date: unknown) intramuscular on left arm on 30Jan2021 at 07:45 AM at a single dose for covid-19 immunisation. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medication which the patient received within 2 weeks of vaccination included acetaminophen and ibuprofen. The patient experienced soreness and weakness of the left arm on 30Jan2021 at 12:00 PM. The most recent COVID-19 vaccine was administered in hospital. 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 and since the vaccination, the patient was not been tested for COVID-19. The patient did not received treatment for the adverse events. The patient has not recovered from soreness and weakness of the left arm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Sore arm neck; Sore arm neck; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on left arm on 30Jan2021 at 10:30 AM at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced sore arm neck on 30Jan2021 at 20:00. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was unknown.  The information on the Batch/Lot number has been requested.