chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Paraesthesia, Rash, Tachycardia
Clinical narrative: elevated BP : 193/113; Tachycardia 134 BPM; bad headache; numbness and tingling in both hands; numbness and tingling in both hands; nausea; rash across the top of my chest; sore muscles in legs; This is a spontaneous report from a contactable nurse.  A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, via intramuscular route of administration in the left arm, on 12Jan2021 10:30 at SINGLE DOSE for covid-19 immunization. Medical history included asthma, sinusitis and migraine.  Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), albuterol, estradiol, norethisterone acetate (ESTRADIOL AND NORETHINDRONE), vitamin d3, zinc, paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took erythromycin, levaquin, biaxin and cefzil (on unspecified dates) and experienced allergy.  The patient started having reactions after 20 mins (12Jan2021, 10:45am): a bad headache, elevated BP: 193/113 (no history of hypertension), tachycardia 134 BPM, numbness and tingling in both hands, nausea, and a rash across the top of the chest. Since it was administered in a workplace drive-thru clinic, there was a 15-30 mins post vaccine monitoring. She was taken inside for further evaluation and monitoring with no changes after 30 mins. EMS was called for transport to the closet hospital that wasn't on diversion. Her allergist was consulted by the treating ER physician and was later discharged with prescriptions for the following: Epipen, prednisone for 5 days, and pepcid. Follow-up with allergist in 3-5 days and PCP. Patient was still recovering however headache was and sore muscles in legs were still present. The outcome of events headache was and sore muscles in legs was not recovered whereas patient was recovering from all other events. Therapeutic measures taken as result of the events included Benadryl, Pepcid, Zofran, Tylenol, 1L Saline bolus, EKG, lab work, monitoring on a pulse ox, frequent BP.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.; Sender's Comments: Based on the compatible time association, the reported events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dysphonia, Pruritus, Rash
Clinical narrative: rash and itchiness on face and chest; rash and itchiness on face and chest; anxiety; feeling restless/shakiness; insomnia; difficulty concentrating; feeling restless/shakiness; she developed sudden chest tightness; throat hoarseness; scratchiness; lightheadedness; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 10:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Approximately 5 minutes later on 31Dec2020 10:50, she developed sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness. Staff responded with AED and rescue meds, called  for EMS transport to ED. Employee reported that at ED , the patient was treated with rescue medications including Benadryl, Pepcid, solumedrol, but symptoms continued to worsen, therefore epi was given which improved symptoms. The patient was observed in ED for approximately 6 hours before being discharged home with oral antihistamines, steroid pack, and an epi-pen. Once home, employee experienced a rash and itchiness on face and chest which has now resolved. Patient was still experiencing side effects from medications including insomnia, anxiety, difficulty concentrating, and feeling restless/shakiness. The outcome of the events sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness was recovering; the outcome of the events rash and itching was recovered on an unknown date; while the outcome of the remaining events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between events chest tightness, throat hoarseness and scratchiness, and lightheadedness occurred approx. 5 minutes after vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 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.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: rash and itchiness on face and chest; rash and itchiness on face and chest; anxiety; feeling restless/shakiness; insomnia; difficulty concentrating; feeling restless/shakiness; she developed sudden chest tightness; throat hoarseness; scratchiness; lightheadedness; This is a spontaneous report from a contactable pharmacist. An adult female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 31Dec2020 10:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Approximately 5 minutes later on 31Dec2020 10:50, she developed sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness. Staff responded with AED and rescue meds, called  for EMS transport to ED. Employee reported that at ED , the patient was treated with rescue medications including Benadryl, Pepcid, solumedrol, but symptoms continued to worsen, therefore epi was given which improved symptoms. The patient was observed in ED for approximately 6 hours before being discharged home with oral antihistamines, steroid pack, and an epi-pen. Once home, employee experienced a rash and itchiness on face and chest which has now resolved. Patient was still experiencing side effects from medications including insomnia, anxiety, difficulty concentrating, and feeling restless/shakiness. The outcome of the events sudden chest tightness, throat hoarseness and scratchiness, and lightheadedness was recovering; the outcome of the events rash and itching was recovered on an unknown date; while the outcome of the remaining events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between events chest tightness, throat hoarseness and scratchiness, and lightheadedness occurred approx. 5 minutes after vaccination and BNT162B2 (PFIZER-BIONTECH COVID-19 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, and it was 89 to 90; achy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration right deltoid on 09Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 21Dec2020 via injection in left deltoid for COVID-19 immunization.  The patient reported that she feels fine today (13Jan2021), but she received her second dose of the COVID vaccine on Saturday, 09Jan2021. She experienced side effects including headache, feeling tired, and joint aches on 11Jan2021. She also experienced shortness of breath on 12Jan2021. The shortness of breath started early Tuesday morning in the middle of the night. She would say that it was like her chest was hurting. She measured her oxygen at the time, and it was 89 to 90 (Jan2021). It gradually went up from there. This lasted about 3 hours.  She is fine now.  She would say these are all not serious as she knew it could be from the vaccine and she was keeping an eye on it.  She could get up and do things she was just achy (Jan2021). It took her by surprise. She does not know if this is a known side effect or if it should be expected or if she should report this. The patient recovered from the events "oxygen at the time, and it was 89 to 90" on unspecified date; headache and joint aches on 11Jan2021; shortness of breath and "chest was hurting" on 12Jan2021; feeling tired on 13Jan2021; while unknown outcome for the remaining events.   The events shortness of breath, joint aches, feeling tired, and headache were assessed as related to COVID vaccine by the reporter. The event shortness of breath, feeling tired, joint aches, and headache was assessed as non-serious   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Pain
Clinical narrative: Shortness of breath; chest was hurting; Headache; Feeling tired; Joint aches; oxygen at the time, and it was 89 to 90; achy; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration right deltoid on 09Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration) on 21Dec2020 via injection in left deltoid for COVID-19 immunization.  The patient reported that she feels fine today (13Jan2021), but she received her second dose of the COVID vaccine on Saturday, 09Jan2021. She experienced side effects including headache, feeling tired, and joint aches on 11Jan2021. She also experienced shortness of breath on 12Jan2021. The shortness of breath started early Tuesday morning in the middle of the night. She would say that it was like her chest was hurting. She measured her oxygen at the time, and it was 89 to 90 (Jan2021). It gradually went up from there. This lasted about 3 hours.  She is fine now.  She would say these are all not serious as she knew it could be from the vaccine and she was keeping an eye on it.  She could get up and do things she was just achy (Jan2021). It took her by surprise. She does not know if this is a known side effect or if it should be expected or if she should report this. The patient recovered from the events "oxygen at the time, and it was 89 to 90" on unspecified date; headache and joint aches on 11Jan2021; shortness of breath and "chest was hurting" on 12Jan2021; feeling tired on 13Jan2021; while unknown outcome for the remaining events.   The events shortness of breath, joint aches, feeling tired, and headache were assessed as related to COVID vaccine by the reporter. The event shortness of breath, feeling tired, joint aches, and headache was assessed as non-serious   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Asthenia, Blood pressure measurement, Body temperature
Clinical narrative: weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Eye irritation, Feeling abnormal, Flushing
Clinical narrative: weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Hyperhidrosis, Hypotension, Muscle spasms
Clinical narrative: weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vomiting
Clinical narrative: weak; hot flashes; cramping; joints hurt; her hands & feet were so cold they hurt (like when holding snow with bare hands); her hands & feet were so cold they hurt (like when holding snow with bare hands); anxiety; dizzy; her body feels weird; sweating; b/p low; throat hurts; tachycardia (119-135); 100.4; chills; body ache; nausea; vomiting; pounding headache; eyes burning; face & neck felt flushed; This is a spontaneous report from a non-contactable nurse (patient). A 41-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 11Jan2021 16:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, hypoglycemia, vitamin d deficiency, migraines, and allergy to Ilizone (unspecified). The patient was not diagnosed with COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included loratadine (ALAVERT), phentermine, ibuprofen, and paracetamol (TYLENOL). The patient was administered with first dose of bnt162b2 on 21Dec2020 for COVID-19 immunization (product-COVID 19, brand-Pfizer, lot number-EH9899, administration time-11:45 AM, administrator route-intramuscular, vaccine location-right arm). The patient previously took salbutamol sulfate (VOLMAX) and experienced allergy. No other vaccines in four weeks prior to COVID vaccination. On 11Jan2021 17:00, the patient experienced body temperature of 100.4 (no unit reported), chills, body ache, nausea, vomiting, pounding headache, eyes burning, face and neck felt flushed, tachycardia (her watch kept alarming 119-135), weak, hot flashes, cramping, joints hurt, her hands and & feet were so cold they hurt (like when holding snow with bare hands), anxiety, dizzy, her body feels weird, sweating, b/p (blood pressure) low, and throat hurts. There was no treatment given for the events. The patient has not been tested for COVID post vaccination. The patient is recovering from the events.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Itchy rashes all over the body resembling Urticaria. Started on day two, peaked day 5, still continuing.; Itchy rashes all over the body resembling Urticaria. Started on day two, peaked day 5, still continuing.; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ 1686), via an unspecified route of administration on the left arm on 07Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included pre-diabetic and hyper cholesterol. Concomitant medication included metformin and rosuvastatin calcium (CRESTOR). It was reported that the patient experienced itchy rashes all over the body resembling urticaria. Started on day two (09Jan2021 at 09:00), peaked day 5, still continuing. The patient was given topical steroid cream, benadryl and loratadine as treatment for the events. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: metallic taste in their mouth after the vaccine; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is the first of two reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The pharmacist reported that she also had 2 other patients who had reported metallic taste in their mouth after the vaccine on an unspecified date. The outcome of the event was unknown.   Information about Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026363 same reporter/drug, similar event, different patient;US-PFIZER INC-2021027151 same reporter/drug/event, different patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Hypersensitivity, Insomnia, Nasal congestion
Clinical narrative: allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications.  The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it.   Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: allergy like symptoms/allergy; nose running; congested and blockage in her nose; shortness of breath; couldn't sleep during the night; burning sensation in her chest; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the upper left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications.  The patient reported that she took it yesterday and an hour into it she started having a burning sensation in her chest. What happen next, around 8pm, she started having allergy like symptoms that lasted throughout the night. She was experiencing nose running, congested and blockage in her nose, and shortness of breath. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. For treatment, she took Mucinex tablets for allergy. She couldn't sleep during the night until this morning. She had to breathe through her mouth because she couldn't' breathe through her mouth. This was the first dose, her second dose is due on 02Feb2020 and she wants to know if she can skip it.   Before she got it she contacted her primary care due to having allergies before the vaccine and asked if she should take; she was told to hold on but then she went ahead and took it. Within the first 30 minutes she was ok but in an hour is when she had the burning sensation in her chest. The burning sensation lasted about an hour. The dose was administered around 4pm on 12Jan2021.The caller reports that the Mucinex and she has breathing treatment, nebulizer treatments for her lungs, that she did and these things helped. Early this morning she felt she can now close her mouth and breathe normally. It was administered in the upper left arm. She did not require a visit to the doctor or ER. The patient has had no reactions to vaccines in the past nor were any administered on the day of or within the prior 4 weeks. Therapeutic measures were taken as a result of allergy like symptoms, congested and blockage in her nose and shortness of breath which included Mucinex. The patient recovered from burning sensation in her chest on 12Jan2021, from allergy like symptoms/allergy and shortness of breath on 13Jan2021 while the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza, Myalgia
Clinical narrative: muscle ache/ some muscle ache, joints; muscle ache like flu symptoms; I experienced some muscle ache, joints; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiration date not reported) via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The first dose of the COVID-19 vaccine on 07Jan2021 and was scheduled for his second dose on 28Jan2021 in (state name). He also mentioned that he experienced the side effects of the vaccine (described as muscle ache like flu symptoms) 5-6 days after the first dose. Consumer stated, "I had my first COVID vaccine Pfizer, last Thursday on 07Jan2021. On 12Jan2021 when I woke up, I experienced some muscle ache, joints. I was just wondering is it possible to have a side effect 6 days later after the shot or should they come immediately after the shot?" Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Vomiting
Clinical narrative: Intense indigestion followed but intense vomiting; Intense indigestion followed but intense vomiting; This is a spontaneous report from a contactable Nurse reporting for herself. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), via an unspecified route of administration at right arm on 23Dec2020 15:00 at single dose, then received the second dose of BNT162B2 (lot number: E10140), via an unspecified route of administration at left arm on 11Jan2021 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypertension, and depression, and allergy to latex. Concomitant medication included desvenlafaxine succinate (PRISTIQ), hydrochlorothiazide, olmesartan medoxomil (BENICAR HCT). Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced intense indigestion followed but intense vomiting on 25Dec2020 11:00. Occurred 48hours after 1st injection and 56 hours after 2nd. Was much more intense after 2nd injection. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on an unknown date in Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged and painful lymph node in left armpit; Enlarged and painful lymph node in left armpit; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EC3246), via an unspecified route of administration at left arm on 12Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first dose of BNT162B2 (Lot number: EK5730) at left arm for covid-19 immunization. The patient experienced enlarged and painful lymph node in left armpit on 13Jan2021 with outcome of not recovered. No treatment received for the adverse events.  No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: horrible muscle pain in the left leg/ horrible muscle pain in the left side of her leg; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/bath number and expiration date not provided), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller had been having horrible muscle pain in the left leg for 2 weeks now after her first dose in 21Dec2020 and wanted recommendations on what she should do and if she should get her second dose and what the duration of symptoms was. Caller was asking if she can go back and get the second dose at a later date. Told caller no information regarding use outside of 3 weeks, however, her healthcare professional would have access to information from CDC. Caller was the activity director at a long term care facility. Received first dose of COVID-19 Vaccine on 21Dec2020. Has been having horrible muscle pain in the left side of her leg that had been going on for two weeks. Some days it was really bad. Stated she was in constant pain for two weeks. This happened to be a bad day. Stated it was taking her oxygen just to talk to this the agent. Was very leery about taking COVID-19 Vaccine and this was exactly why. She was agitated. Wanted to know if there's something Had been told there's nothing that can be done and to contact her local provider. She stated that sucks. The patient was due for the second dose in 4 days. Doesn't know if she should take it or not. The event was non-serious per the reporter. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Polymerase chain reaction, SARS-CoV-2 test, SARS-CoV-2 test false positive
Clinical narrative: after receiving the vaccine, he tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient's mother). A 20-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date), dose number 1, intramuscularly on 23Dec2020 at a single dose for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications were not reported. The patient was scheduled to receive his second dose on 13Jan2021. On 12Jan2021, after receiving the vaccine, he tested positive for COVID-19. He was totally asymptomatic. To make sure that it was not a false positive, he did a PCR test. The patient was waiting for the results at the time of report. The patient did not get the second dose and was asking when he should receive the second dose. On 17Jan2021, the reporter updated that after the positive COVID-19 Test, the patient took two more tests and returned negative. The outcome of the events was recovered.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site rash, Vaccination site swelling
Clinical narrative: A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened; A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened; A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened/pinkish reddish around the site; A swollen, 3" diameter area around the injection site that is reddened, swollen, appears like a rash and is hardened; This is a spontaneous report from a non-contactable Pharmacist. A male patient of an unspecified age receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccination 1 week before 14Jan2021 (Jan2021). He didn't feel anything wrong until yesterday (13Jan2021), and presented with a swollen, 3" diameter area around the injection site that was reddened, swollen, appears like a rash and was hardened. It looked obvious, was pinkish reddish around the site. Patient was wondering if heard of similar experiences, if it was a real side effect or allergy. Pharmacist told patient to watch it to see if it gets smaller. The outcome of events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Tremor
Clinical narrative: shakes; difficulty walking; This is a spontaneous report from a non-contactable consumer (patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. It was unknown if the patient received other vaccines in four weeks. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shakes and difficulty walking. The reported events resulted in Doctor or other healthcare professional office/clinic visit and hospitalization on an unspecified date. It was unknown if the patient had COVID-19 prior to vaccination and it was unknown if she was tested for COVID-19 post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Tired; Achy joints; This is a spontaneous report from contactable physician (patient) via a Pfizer sales representative. A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 11Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included overweight. The patient's concomitant medications were not reported. On 12Jan2021 (the following day after administration of vaccine), the patient was tired and had achy joints. Events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Nervousness
Clinical narrative: dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizzy; cold chills/chills; a little headache; nausea/nauseated/nauseous; vomiting/ vomited; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiration date: Apr2021) via an unspecified route of administration on left deltoid on 12Jan2021 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient stated she had a shingles vaccine, got dizzy and nauseous, thought this was about 3 years prior to the report. The patient received the first dose of the vaccine after working a night shift. She went home, went to bed and then woke up very dizzy, nauseated, vomited and experienced cold chills on and off. She also stated that about 10 hours after she got the shot, she got dizzy, nauseous, threw up a couple of times, got chills, and had a little headache on 12Jan2021. She stated she was a little nervous about getting the second vaccine. She also worked nights and that she got off her night shift and got the vaccine on 12Jan2021, didn't know if maybe she was a little dehydrated possibly. The events are reported as serious due to medically significant. The outcome of the events nausea/nauseated/nauseous and vomiting/ vomited was recovered on 13Jan2021, for the events dizzy, cold chills/chills and a little headache were recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Anxiety, Chills, Erythema, Headache, Malaise
Clinical narrative: Headache; Muscle ache; Fever; Chills; Painful redness in her left arm where she received the vaccine; painful redness in my left arm where she received the vaccine; Malaise; Rash and redness; rash and redness; she might be allergic to that product; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was none. There were no concomitant medications. The patient was next in line to get the COVID vaccine but has a little concern about the COVID vaccine. When she got the PREVNAR 13 shot she had all the side effects, she got it 2 years ago (unspecified date). She reported fever, chills, malaise, pretty much almost all the side effects listed. She had a headache, muscle ache in her right thigh, fever, chills and painful redness in her left arm where she received the vaccine. Her doctor said she might be allergic to that product. She asked her doctor about the ingredients for the COVID but the doctor didn't know any of the ingredients so she wanted to call us to find out if the same ones in the PREVNAR 13 are found in the COVID vaccine. The reporter explained the side effects of fever, chills, and malaise lasted a day or two and resolved. She also had a rash and redness which lasted longer. They did all go away eventually but she doesn't remember how long it took or what she did to treat. She knew she did not get a prescription. She thought Tylenol was taken but doesn't remember what else, she mentioned maybe Benadryl. She did go back to the doctor's office, nothing was done, just told to take some over the counter products but she doesn't remember what. The first day she was kind of worried. The outcome of the events headache and muscle ache was unknown. The outcome of the events was recovered on an unspecified date.  No follow up attempts are needed; information about lot batch number cannot be obtained.