chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash erythematous, Vaccination site pain
Clinical narrative: her arm hurt more and she could feel a lump/nodule and the muscle feels hard; her arm hurt more and she could feel a lump/nodule and the muscle feels hard; low grade fever of 100.5 degrees Fahrenheit; red rash; flu like symptoms; Extra dose administered; the injection site became tender; malaise; injection site soreness in right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Aug2021 08:30 (age at vaccination:50 Years) as DOSE 3, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination. Medical history included renal transplant from 1998 to an unknown date. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2(BNT162B2, solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on 30Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced the injection site became tender on 17Aug2021, malaise on 17Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, her arm hurt more and she could feel a lump/nodule and the muscle feels hard on 18Aug2021, low grade fever of 100.5 degrees fahrenheit on 18Aug2021, red rash on 18Aug2021, flu like symptoms on 18Aug2021, injection site soreness in right arm on 17Aug2021 , extra dose administered on 17Aug2021 08:30. No relevant tests were reported. The outcome of the events vaccination site pain recovering, the outcome of the event malaise was recovered, the outcome of the events vaccination site pain, pain in extremity, nodule, pyrexia, rash erythematous, Influenza like illness, Extra dose administered was unknown.  Agency Communication: She declined report number and phone number prior to attempted transfer to unit. Caller agreed to be placed in the queue to hold for next available agent.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden sensorineural hearing loss
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness neurosensory, Sudden hearing loss
Clinical narrative: Sudden sensorineural hearing loss
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness
Clinical narrative: Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; This is a spontaneous report from a contactable nurse (patient). A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0176), via an unspecified route of administration on 23Aug2021 at 15:45 (at the age of 25-years-old) at dose number unknown, single for COVID-19 immunization. Medical history included known allergies to shellfish and COVID. Concomitant medications were reported as none. There were no other vaccines in four weeks. Vaccination facility type was reported as hospital. She was not tested for COVID post vaccination. On 23Aug2021 at 16:45, 1 hour after vaccination, the patient experienced tinnitus and hearing loss in both ears which felt like a pressure but couldn't clear (as reported). She did not receive any treatment in response to the events. The outcome of the events was not recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event deafness bilateral and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness bilateral, Ear discomfort, Tinnitus
Clinical narrative: Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; This is a spontaneous report from a contactable nurse (patient). A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0176), via an unspecified route of administration on 23Aug2021 at 15:45 (at the age of 25-years-old) at dose number unknown, single for COVID-19 immunization. Medical history included known allergies to shellfish and COVID. Concomitant medications were reported as none. There were no other vaccines in four weeks. Vaccination facility type was reported as hospital. She was not tested for COVID post vaccination. On 23Aug2021 at 16:45, 1 hour after vaccination, the patient experienced tinnitus and hearing loss in both ears which felt like a pressure but couldn't clear (as reported). She did not receive any treatment in response to the events. The outcome of the events was not recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event deafness bilateral and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Skin warm, Swelling, Swelling face
Clinical narrative: she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); fast heartbeat lasted approximately 3 minutes; dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), via an unspecified route of administration, administered in right deltoid on 30Jul2021 as single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes on an unspecified date in 1994 and Hashimoto's disease on an unspecified date in 1997. The patient's concomitant medications were not reported. The vaccination facility type was pharmacy/drug store. Prior to vaccinations (within 4 weeks), the patient did not received any other vaccinations. The patient reported that she received her first dose of the vaccine 30Jul2021, and had a reaction within 15 minutes. She is concerned about getting the second dose, which is coming up. The patient reported that she had a severe allergic reaction, which included swelling of face and throat (could still breathe), fast heartbeat, dizziness and weakness, all on 30Jul2021. The patient confirmed her reaction was pretty much exactly 15 minutes after she got the injection on 30Jul2021. She stated it was relatively short lived but came on very quickly and all at once. She stated that the swelling of her face and throat lasted probably 6 hours. She could breathe just fine, she just looked in mirror and was like whoa. The fast heartbeat lasted approximately 3 minutes, it was not very long. She stated that the pharmacist did come out and confirmed she had an elevated heartbeat. The dizziness and weakness was worse for the first hour after she had the vaccine. She experienced dizziness the duration of the rest of the day, so she would say probably 12 hours. The patient underwent lab tests and procedures which included heartbeat: elevated on 30Jul2021. The outcome of the events allergic reaction, swelling of face, throat swelling and heartbeats increased was recovered on 30Jul2021; and the outcome of the events dizziness and weakness was recovered on Jul2021.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Hypersensitivity
Clinical narrative: she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); fast heartbeat lasted approximately 3 minutes; dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), via an unspecified route of administration, administered in right deltoid on 30Jul2021 as single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes on an unspecified date in 1994 and Hashimoto's disease on an unspecified date in 1997. The patient's concomitant medications were not reported. The vaccination facility type was pharmacy/drug store. Prior to vaccinations (within 4 weeks), the patient did not received any other vaccinations. The patient reported that she received her first dose of the vaccine 30Jul2021, and had a reaction within 15 minutes. She is concerned about getting the second dose, which is coming up. The patient reported that she had a severe allergic reaction, which included swelling of face and throat (could still breathe), fast heartbeat, dizziness and weakness, all on 30Jul2021. The patient confirmed her reaction was pretty much exactly 15 minutes after she got the injection on 30Jul2021. She stated it was relatively short lived but came on very quickly and all at once. She stated that the swelling of her face and throat lasted probably 6 hours. She could breathe just fine, she just looked in mirror and was like whoa. The fast heartbeat lasted approximately 3 minutes, it was not very long. She stated that the pharmacist did come out and confirmed she had an elevated heartbeat. The dizziness and weakness was worse for the first hour after she had the vaccine. She experienced dizziness the duration of the rest of the day, so she would say probably 12 hours. The patient underwent lab tests and procedures which included heartbeat: elevated on 30Jul2021. The outcome of the events allergic reaction, swelling of face, throat swelling and heartbeats increased was recovered on 30Jul2021; and the outcome of the events dizziness and weakness was recovered on Jul2021.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); fast heartbeat lasted approximately 3 minutes; dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), via an unspecified route of administration, administered in right deltoid on 30Jul2021 as single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes on an unspecified date in 1994 and Hashimoto's disease on an unspecified date in 1997. The patient's concomitant medications were not reported. The vaccination facility type was pharmacy/drug store. Prior to vaccinations (within 4 weeks), the patient did not received any other vaccinations. The patient reported that she received her first dose of the vaccine 30Jul2021, and had a reaction within 15 minutes. She is concerned about getting the second dose, which is coming up. The patient reported that she had a severe allergic reaction, which included swelling of face and throat (could still breathe), fast heartbeat, dizziness and weakness, all on 30Jul2021. The patient confirmed her reaction was pretty much exactly 15 minutes after she got the injection on 30Jul2021. She stated it was relatively short lived but came on very quickly and all at once. She stated that the swelling of her face and throat lasted probably 6 hours. She could breathe just fine, she just looked in mirror and was like whoa. The fast heartbeat lasted approximately 3 minutes, it was not very long. She stated that the pharmacist did come out and confirmed she had an elevated heartbeat. The dizziness and weakness was worse for the first hour after she had the vaccine. She experienced dizziness the duration of the rest of the day, so she would say probably 12 hours. The patient underwent lab tests and procedures which included heartbeat: elevated on 30Jul2021. The outcome of the events allergic reaction, swelling of face, throat swelling and heartbeats increased was recovered on 30Jul2021; and the outcome of the events dizziness and weakness was recovered on Jul2021.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Feeling abnormal, Syncope, Tremor
Clinical narrative: Patient went into anaphylaxis.  Immediately after the shot the patient started to convulse and then passed out briefly.   The patient was advised to wait until the color came back into his lips and then asked to wait 15 minutes after the shot to watch for adverse effects.  After waiting the 15 minutes the patient left with his mother.  Approximately 10 minutes later the patient began experiencing his throat closing.  He has having problems swallowing and breathing.  911 was called and epinephrine was administered.  Patient was taken to Hospital via ambulance.  Patient was seen by ER doctor and administered Dexamethasone and a Pediatric EKG was performed.  After four (4) hours after the epinephrine was administered, patient was released from the hospital and advised to follow up with his pediatrician.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Electrocardiogram, Immediate post-injection reaction
Clinical narrative: Patient went into anaphylaxis.  Immediately after the shot the patient started to convulse and then passed out briefly.   The patient was advised to wait until the color came back into his lips and then asked to wait 15 minutes after the shot to watch for adverse effects.  After waiting the 15 minutes the patient left with his mother.  Approximately 10 minutes later the patient began experiencing his throat closing.  He has having problems swallowing and breathing.  911 was called and epinephrine was administered.  Patient was taken to Hospital via ambulance.  Patient was seen by ER doctor and administered Dexamethasone and a Pediatric EKG was performed.  After four (4) hours after the epinephrine was administered, patient was released from the hospital and advised to follow up with his pediatrician.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Pallor, Seizure, Throat tightness
Clinical narrative: Patient went into anaphylaxis.  Immediately after the shot the patient started to convulse and then passed out briefly.   The patient was advised to wait until the color came back into his lips and then asked to wait 15 minutes after the shot to watch for adverse effects.  After waiting the 15 minutes the patient left with his mother.  Approximately 10 minutes later the patient began experiencing his throat closing.  He has having problems swallowing and breathing.  911 was called and epinephrine was administered.  Patient was taken to Hospital via ambulance.  Patient was seen by ER doctor and administered Dexamethasone and a Pediatric EKG was performed.  After four (4) hours after the epinephrine was administered, patient was released from the hospital and advised to follow up with his pediatrician.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I am still having numbness. It has gone into the chest numbness. I don't have chest pain just numbness.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blindness, Chest pain, Dyspnoea, Immediate post-injection reaction
Clinical narrative: loss of vision 15 minutes; experienced severe allergic reaction after the first dose of the Pfizer BioNTech Covid-19 Vaccine.; elbow pain; shortness of breath; chest pain; This is a spontaneous report from a contactable other hcp via medical information team. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 07Aug2021 (age at vaccination was 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination was not administered at military facility. Medical history included diabetes mellitus from Jan2020 to an unknown date, chronic obstructive pulmonary disease (COPD) from Feb2019 to an unknown date and hypertension from 15Jan2015 to an unknown date. Concomitant medication was not reported. On 07Aug2021, 15 minutes after the getting the shot, the patient experienced severe allergic reaction after first dose of bnt162b2 vaccine, elbow pain, shortness of breath, chest pain and loss of vision. It all lasted 35-40 minutes. All were simultaneous after the injection. The patient underwent lab tests and procedures which included blood test: unknown, but it is not back yet on an unspecified date in 2021. The event of elbow pain and shortness of breath was related to bnt162b2. No additional vaccines were administered on same date of bnt162b2 vaccine. Prior vaccination, no other vaccines were received within four weeks prior to the administration of bnt162b2. The symptoms subsided and was sent home with no medical treatment. Outcome of the events was resolved on 07Aug2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - blindness, hypersensitivity, arthralgia, dyspnoea, chest pain, and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test
Clinical narrative: loss of vision 15 minutes; experienced severe allergic reaction after the first dose of the Pfizer BioNTech Covid-19 Vaccine.; elbow pain; shortness of breath; chest pain; This is a spontaneous report from a contactable other hcp via medical information team. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 07Aug2021 (age at vaccination was 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination was not administered at military facility. Medical history included diabetes mellitus from Jan2020 to an unknown date, chronic obstructive pulmonary disease (COPD) from Feb2019 to an unknown date and hypertension from 15Jan2015 to an unknown date. Concomitant medication was not reported. On 07Aug2021, 15 minutes after the getting the shot, the patient experienced severe allergic reaction after first dose of bnt162b2 vaccine, elbow pain, shortness of breath, chest pain and loss of vision. It all lasted 35-40 minutes. All were simultaneous after the injection. The patient underwent lab tests and procedures which included blood test: unknown, but it is not back yet on an unspecified date in 2021. The event of elbow pain and shortness of breath was related to bnt162b2. No additional vaccines were administered on same date of bnt162b2 vaccine. Prior vaccination, no other vaccines were received within four weeks prior to the administration of bnt162b2. The symptoms subsided and was sent home with no medical treatment. Outcome of the events was resolved on 07Aug2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - blindness, hypersensitivity, arthralgia, dyspnoea, chest pain, and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blindness, Blood test, Chest pain, Dyspnoea
Clinical narrative: loss of vision 15 minutes; experienced severe allergic reaction after the first dose of the Pfizer BioNTech Covid-19 Vaccine.; elbow pain; shortness of breath; chest pain; This is a spontaneous report from a contactable other hcp via medical information team. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 07Aug2021 (age at vaccination was 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination was not administered at military facility. Medical history included diabetes mellitus from Jan2020 to an unknown date, chronic obstructive pulmonary disease (COPD) from Feb2019 to an unknown date and hypertension from 15Jan2015 to an unknown date. Concomitant medication was not reported. On 07Aug2021, 15 minutes after the getting the shot, the patient experienced severe allergic reaction after first dose of bnt162b2 vaccine, elbow pain, shortness of breath, chest pain and loss of vision. It all lasted 35-40 minutes. All were simultaneous after the injection. The patient underwent lab tests and procedures which included blood test: unknown, but it is not back yet on an unspecified date in 2021. The event of elbow pain and shortness of breath was related to bnt162b2. No additional vaccines were administered on same date of bnt162b2 vaccine. Prior vaccination, no other vaccines were received within four weeks prior to the administration of bnt162b2. The symptoms subsided and was sent home with no medical treatment. Outcome of the events was resolved on 07Aug2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - blindness, hypersensitivity, arthralgia, dyspnoea, chest pain, and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: loss of vision 15 minutes; experienced severe allergic reaction after the first dose of the Pfizer BioNTech Covid-19 Vaccine.; elbow pain; shortness of breath; chest pain; This is a spontaneous report from a contactable other hcp via medical information team. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number, Expiration date and NDC number: Unknown), via an unspecified route of administration on 07Aug2021 (age at vaccination was 66-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Vaccination was not administered at military facility. Medical history included diabetes mellitus from Jan2020 to an unknown date, chronic obstructive pulmonary disease (COPD) from Feb2019 to an unknown date and hypertension from 15Jan2015 to an unknown date. Concomitant medication was not reported. On 07Aug2021, 15 minutes after the getting the shot, the patient experienced severe allergic reaction after first dose of bnt162b2 vaccine, elbow pain, shortness of breath, chest pain and loss of vision. It all lasted 35-40 minutes. All were simultaneous after the injection. The patient underwent lab tests and procedures which included blood test: unknown, but it is not back yet on an unspecified date in 2021. The event of elbow pain and shortness of breath was related to bnt162b2. No additional vaccines were administered on same date of bnt162b2 vaccine. Prior vaccination, no other vaccines were received within four weeks prior to the administration of bnt162b2. The symptoms subsided and was sent home with no medical treatment. Outcome of the events was resolved on 07Aug2021.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the events - blindness, hypersensitivity, arthralgia, dyspnoea, chest pain, and the suspect drug "BNT162B2" cannot be completely excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Chest pain, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Patient stated that she started to have chest pain and feeling of dizziness shortly after the shot.  She soon said her throat was closing and could not talk or breathe.  She came toward the pharmacy from the waiting room to alert  the staff but could not talk.  The pharmacist said to call 911, sat the patient down and administered an EpiPen.  After the EpiPen she said she could breath better, shortly after that the paramedics came to take her to the Hospital.  She was observed for 2 hours then released with steroidal medication.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Patient stated that she started to have chest pain and feeling of dizziness shortly after the shot.  She soon said her throat was closing and could not talk or breathe.  She came toward the pharmacy from the waiting room to alert  the staff but could not talk.  The pharmacist said to call 911, sat the patient down and administered an EpiPen.  After the EpiPen she said she could breath better, shortly after that the paramedics came to take her to the Hospital.  She was observed for 2 hours then released with steroidal medication.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Chest pain, Depersonalisation/derealisation disorder, Dizziness, Dyspnoea
Clinical narrative: Patient stated that she started to have chest pain and feeling of dizziness shortly after the shot.  She soon said her throat was closing and could not talk or breathe.  She came toward the pharmacy from the waiting room to alert  the staff but could not talk.  The pharmacist said to call 911, sat the patient down and administered an EpiPen.  After the EpiPen she said she could breath better, shortly after that the paramedics came to take her to the Hospital.  She was observed for 2 hours then released with steroidal medication.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Throat tightness
Clinical narrative: Patient stated that she started to have chest pain and feeling of dizziness shortly after the shot.  She soon said her throat was closing and could not talk or breathe.  She came toward the pharmacy from the waiting room to alert  the staff but could not talk.  The pharmacist said to call 911, sat the patient down and administered an EpiPen.  After the EpiPen she said she could breath better, shortly after that the paramedics came to take her to the Hospital.  She was observed for 2 hours then released with steroidal medication.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: tingling that started to her toes in both feet and went up to her arms; rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date in Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced reaction within two minutes which would include rapid heartbeat, some dizziness, tingling that started to her toes in both feet and went up to her arms, which was more in the left arm where she got the shot. The reporter stated that CDC recommended her not to get the second dose of the same vaccine but she also mentioned that according to the CDC in receiving the booster dose, it should be the same vaccine. The reporter said that she did not need it now but might need in Dec2021. The reporter wanted to known if she should take another shot and if she should stick with another vaccine or if it is possible for her to get a "child dose" of the Pfizer COVID19 vaccine. The Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Nervousness, Paraesthesia
Clinical narrative: tingling that started to her toes in both feet and went up to her arms; rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date in Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced reaction within two minutes which would include rapid heartbeat, some dizziness, tingling that started to her toes in both feet and went up to her arms, which was more in the left arm where she got the shot. The reporter stated that CDC recommended her not to get the second dose of the same vaccine but she also mentioned that according to the CDC in receiving the booster dose, it should be the same vaccine. The reporter said that she did not need it now but might need in Dec2021. The reporter wanted to known if she should take another shot and if she should stick with another vaccine or if it is possible for her to get a "child dose" of the Pfizer COVID19 vaccine. The Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Paraesthesia
Clinical narrative: tingling that started to her toes in both feet and went up to her arms; rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date in Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced reaction within two minutes which would include rapid heartbeat, some dizziness, tingling that started to her toes in both feet and went up to her arms, which was more in the left arm where she got the shot. The reporter stated that CDC recommended her not to get the second dose of the same vaccine but she also mentioned that according to the CDC in receiving the booster dose, it should be the same vaccine. The reporter said that she did not need it now but might need in Dec2021. The reporter wanted to known if she should take another shot and if she should stick with another vaccine or if it is possible for her to get a "child dose" of the Pfizer COVID19 vaccine. The Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: diagnosed with a delayed local reaction/allergic reaction; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was 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. Patient reported I had an adverse reaction to the COVID vaccine, and I know that you can tell I had gone to an urgent care because there was the delayed reaction on an unspecified date in 2021. Patient stated, I had gone to urgent care to have a (Incomplete Sentence) and he diagnosed me with a delayed local reaction. And so, that physician said that I needed to go to whoever had administered the shot to me whatever you know like clinic or whatever and so, I had gotten at a withheld so, I was back to them and spoke with them with the pharmacist and just kind of told them document on my symptoms and everything (Further clarification unknown) and then I notified them that my symptoms had subsided and so, they told me that they have filed with you guys like an adverse reaction and then Pfizer would be reach to me because now that I had what they had categorized as an allergic reaction they don't want to (Incomplete Sentence) They won't sure, they wanted to be speak with the Pfizer about if I was a candidate for the second shot or not. Patient stated she got the first dose of the Pfizer COVID 19 vaccine and a week later she had a reaction. She did go to urgent care who told her it was a reaction to the COVID 19 vaccine. The outcome of the event was reported as recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: diagnosed with a delayed local reaction/allergic reaction; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was 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. Patient reported I had an adverse reaction to the COVID vaccine, and I know that you can tell I had gone to an urgent care because there was the delayed reaction on an unspecified date in 2021. Patient stated, I had gone to urgent care to have a (Incomplete Sentence) and he diagnosed me with a delayed local reaction. And so, that physician said that I needed to go to whoever had administered the shot to me whatever you know like clinic or whatever and so, I had gotten at a withheld so, I was back to them and spoke with them with the pharmacist and just kind of told them document on my symptoms and everything (Further clarification unknown) and then I notified them that my symptoms had subsided and so, they told me that they have filed with you guys like an adverse reaction and then Pfizer would be reach to me because now that I had what they had categorized as an allergic reaction they don't want to (Incomplete Sentence) They won't sure, they wanted to be speak with the Pfizer about if I was a candidate for the second shot or not. Patient stated she got the first dose of the Pfizer COVID 19 vaccine and a week later she had a reaction. She did go to urgent care who told her it was a reaction to the COVID 19 vaccine. The outcome of the event was reported as recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Blister, Pemphigoid, Pruritus, Rash macular
Clinical narrative: bullous pemphigoid; She could not walk she had blisters on her feet; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PEMPHIGOID (bullous pemphigoid) (seriousness criteria disability and medically significant) and GAIT INABILITY (She could not walk she had blisters on her feet) (seriousness criterion disability). The patient was treated with PREDNISONE for Bullous pemphigoid, at an unspecified dose and frequency. At the time of the report, PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) outcome was unknown.            The events were treated with steroids, Diuretic, Antibiotic unspecified and was successfully treated but recently had come back again.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: bullous pemphigoid; She could not walk she had blisters on her feet; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PEMPHIGOID (bullous pemphigoid) (seriousness criteria disability and medically significant) and GAIT INABILITY (She could not walk she had blisters on her feet) (seriousness criterion disability). The patient was treated with PREDNISONE for Bullous pemphigoid, at an unspecified dose and frequency. At the time of the report, PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) outcome was unknown.            The events were treated with steroids, Diuretic, Antibiotic unspecified and was successfully treated but recently had come back again.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait inability, Pemphigoid
Clinical narrative: bullous pemphigoid; She could not walk she had blisters on her feet; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PEMPHIGOID (bullous pemphigoid) (seriousness criteria disability and medically significant) and GAIT INABILITY (She could not walk she had blisters on her feet) (seriousness criterion disability). The patient was treated with PREDNISONE for Bullous pemphigoid, at an unspecified dose and frequency. At the time of the report, PEMPHIGOID (bullous pemphigoid) and GAIT INABILITY (She could not walk she had blisters on her feet) outcome was unknown.            The events were treated with steroids, Diuretic, Antibiotic unspecified and was successfully treated but recently had come back again.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pruritus, Urticaria
Clinical narrative: I started having Fever and chills, by Sunday morning I was mess I was over hydrating. The first place I notice when I'm having allergic reaction is my inner arms, started pink, then went to a rash to hives, and it spread like wildfire went to both arms, my stomach, my back just progressively started going all over my body. I went to Well Now Urgent Care, they gave me  benadryl sent you home. I was worried about my airway so I went to my doctor 2 days later, High prednisone for 14 days. It helped, every once in a while the pink comes back on my arms. Dr. recommended to get the booster.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Pyrexia, Rash, Urticaria
Clinical narrative: I started having Fever and chills, by Sunday morning I was mess I was over hydrating. The first place I notice when I'm having allergic reaction is my inner arms, started pink, then went to a rash to hives, and it spread like wildfire went to both arms, my stomach, my back just progressively started going all over my body. I went to Well Now Urgent Care, they gave me  benadryl sent you home. I was worried about my airway so I went to my doctor 2 days later, High prednisone for 14 days. It helped, every once in a while the pink comes back on my arms. Dr. recommended to get the booster.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Joint stiffness, Magnetic resonance imaging neck, Magnetic resonance imaging thoracic
Clinical narrative: Lower back pain, shooting pain through back, extreme neck and shoulder pains. Neuro issues with hands and arm. Heavy left arm. Swollen lymph nodes under left arm, night sweats, abnormal cycle.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Muscular weakness, Nerve injury, SARS-CoV-2 RNA, SARS-CoV-2 test
Clinical narrative: Lower back pain, shooting pain through back, extreme neck and shoulder pains. Neuro issues with hands and arm. Heavy left arm. Swollen lymph nodes under left arm, night sweats, abnormal cycle.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: Lower back pain, shooting pain through back, extreme neck and shoulder pains. Neuro issues with hands and arm. Heavy left arm. Swollen lymph nodes under left arm, night sweats, abnormal cycle.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Blood test, Lymphadenopathy, Magnetic resonance imaging
Clinical narrative: Lower back pain, shooting pain through back, extreme neck and shoulder pains. Neuro issues with hands and arm. Heavy left arm. Swollen lymph nodes under left arm, night sweats, abnormal cycle.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Neck pain, Neurological symptom, Night sweats, Pain
Clinical narrative: Lower back pain, shooting pain through back, extreme neck and shoulder pains. Neuro issues with hands and arm. Heavy left arm. Swollen lymph nodes under left arm, night sweats, abnormal cycle.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Lower back pain, shooting pain through back, extreme neck and shoulder pains. Neuro issues with hands and arm. Heavy left arm. Swollen lymph nodes under left arm, night sweats, abnormal cycle.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Nausea, Paraesthesia
Clinical narrative: Full body and dizziness
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Full body and dizziness
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Full body and dizziness
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Joint range of motion decreased, Pain, Product administered at inappropriate site
Clinical narrative: I now have great pain and loss of range of motion in my left shoulder. Both the first shot and the second were given at the tip of my shoulder. I had to take my shirt off to give the persons giving the shots the access they wanted. When I asked why so high up the arm both ladies told me this was "per CDC guidelines" like it was a rehearsed response.  My doctor and everyone I talked to said the shots should have been in the muscle lower down the arm from the shoulder. Pharmacy has bad information as to how to correctly give the shot.