chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Hot flush, Pain in extremity
Clinical narrative: Stomach cramps; sore left arm; upset stomach; very little energy; weak; Hot flashes; This is a spontaneous report from a contactable consumer. This 78-years-old male consumer reported for himself that. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 22Jan2021 12:00 (Batch/Lot Number: EL9262) as DOSE 1 SINGLE for covid-19 immunization(Age at time of vaccination 78). The patient past Medical history included emphysema from 1999 and ongoing, chronic bronchitis from 1999 and ongoing. After receiving the first dose of the Pfizer covid vaccine. On 22Jan2021 the patient experienced sore arm and, in the evening, he had an upset stomach. On day two when he got up, he was very confused, he had slept all day, he got up and went to the restroom and went back to lay down then woke up later that evening and he was confused since he slept the day through. He was confused because when he went to sleep it was daylight and woke up at night. At the end of day two, he had extreme stomach cramps, they were really bad, he used the restroom a couple of times. It was the worst stomach cramps he ever had on 23Jan202. Since the vaccine he has had very little energy and has felt very weak on an unspecified date in Jan2021. He normally does not take naps; he has noticed since taking the vaccine he will be sitting in his chair and then ends up waking up from taking a nap which is unusual for him. By the end of day two most of the soreness in his arm went away. He has continued to have stomach issues, slightly upset to queasy stomach, not fully recovered, stomach is still out of whack. His stomach cramps were the worst on day two, by day three it was slight cramps and then he has not had them since. He first noticed feeling rather weak and lack of energy when he woke up on the second day after receiving the injection, after sleeping all day not realizing he did sleep all day. The patient is treated with Pepto Bismol for stomach. States it is unusual for him to be having hot flashes and the hot flashes started a week post vaccine and they are persisting. He researched it last night and learned the men and women could get hot flashes. He is concerned since tomorrow will be day 21 post his first vaccine, he has nothing to tell him to go back to facility and no information given about second dose. It is very cold and will be very cold tomorrow and the next day. Advised to contact facility. The event outcome was recovered for sore left arm and Stomach cramps on an unspecified date in Jan2021 and Not recovered for rest of the events.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Body aches; Legs hurting from calves on both sides; Chills; Arm where shot went hurt tremendously; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Right on 08Feb2021 (at the age of 54-years-old) as a single dose for covid-19 immunization. Lot number reported from patient card is either: EM9810 or CM9810. Time vaccination was given was between 2pm-3pm. The patient medical history was not reported. There were no concomitant medications. Prior vaccinations within 4 weeks had no adverse events. Prior vaccinations he had Flu shot two months ago. On 08Feb2021, the patient had body aches, legs hurting from calves in both sides. Arm where shot went hurt tremendously but was better today. He is still sore. Had chills where he was hot and then cold, but that is gone. He still has the body aches. Had his legs hurting before, but just on one. He got the COVID-19 Vaccine and it amplified it more. Both legs started hurting like a muscle aches but hasn't done any exercising besides walking. Was hot and cold on the 08Feb2021, and in the evening started feeling all of the aches. Especially when he lays down to get comfortable. He has to move around. Just had mild body aches now. He felt like going to doctor visit, yesterday felt like going but didn't visit, it was hurting, woke up with milder aches today. Next COVID-19 Vaccine in 01Mar2021. Outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain, Product preparation issue
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; Significant body aches; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 3rd of 15 reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration and date (dose number unknown) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 and they reported significant body aches on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 4th of 15 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient received pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml and reported significant body aches. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report received from a contactable Physicians. This Physicians reported similar events for 15 patients. This is the 5th of 15 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number: Not Provided) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received COVID vaccine reconstituted with 1.3 ml instead of 1.8 ml and they reported significant body aches on an unspecified date. Many had GI symptoms (nausea, vomiting and diarrhea) they have reported this to VAERS and have reviewed how to avoid this issue going forward. The seriousness of the events was reported as non-serious. Outcome of significant body aches was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain, Product preparation issue
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; They reported significant body aches; This is a spontaneous report from contactable physician. This physician reported similar events for fifteen patients. This is 6th of fifteen reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, 1.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml, they reported significant body aches, on an unspecified date. It was also reported that Many had GI symptoms (nausea, vomiting and diarrhea). The clinical outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Overdose, Pain, Product preparation issue
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; significant body aches.; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. This physician reported similar events for fifteen patients. This is 8th of fifteen reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that during a second clinic 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 ml. They reported significant body aches. Many had GI symptoms (nausea, vomiting and diarrhea). The seriousness of the events was reported as non-serious. The outcome of all the events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; significant body aches.; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. This physician reported similar events for fifteen patients. This is 8th of fifteen reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that during a second clinic 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 ml. They reported significant body aches. Many had GI symptoms (nausea, vomiting and diarrhea). The seriousness of the events was reported as non-serious. The outcome of all the events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain, Product preparation issue
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (BNT162B2 Formulation: solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 15 persons received pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 and they reported significant body aches on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain, Product preparation issue
Clinical narrative: Received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; Received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL; Significant body aches; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 10th of 15 reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration and date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced significant body aches. The report received as; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL. They reported significant body aches. Outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain, Product preparation issue
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; Persons received COVID vaccine resconstituted with 1.3 ml instead of 1.8 mL; They reported significant body aches.; This is a spontaneous report from a contactable physician. This Physician reported similar events for 15 patients. This is the 11th of 15 reports. This Physician reported for a patient. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that during a second clinic 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL. They reported significant body aches on an unspecified date. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable Physician. This Physician reported similar events for fifteen patients. This is 12th of fifteen reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date 15 persons received pfizer vaccine from vials that had been reconstituted with 1.3 ml instead of 1.8 ml, they reported significant body aches. Many had GI symptoms (nausea, vomiting and diarrhea). They have reported this to VAERS and have reviewed how to avoid this issue going forward. The outcome of both events was unknown.   Follow-up (23Feb2021): This is a follow-up spontaneous report from a contactable physician. This physician reported in response to HCP letter sent to physician via telephonic follow-up activities that included:  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; This is a spontaneous report from a contactable Physician. This Physician reported similar events for fifteen patients. This is 14th of fifteen reports. This Physician reported for a patient that. An unspecified age and gender patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, It was reported that during a second clinic 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL. They reported significant body aches. Many had GI symptoms (nausea, vomiting and diarrhea) They have reported this to VAERS and have reviewed how to avoid this issue going forward. The outcome of the events was unknown.  No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain, Product quality issue, Underdose
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; nausea; vomiting; diarrhea; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 15th of 15 reports. This physician reported for a patient that A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on an unspecified date as 1.3 mL, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml, they reported significant body aches, nausea, vomiting, diarrhoea, on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; They reported significant body aches.; nausea; vomiting; diarrhea; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; This is a spontaneous report from a contactable physician. This physician reported similar events for 15 patients. This is 15th of 15 reports. This physician reported for a patient that A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on an unspecified date as 1.3 mL, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml, they reported significant body aches, nausea, vomiting, diarrhoea, on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer COVID-19 Vaccine: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Feb2021 patient experienced sore arm; she has not had any problem other than a sore arm since the Pfizer COVID-19 Vaccine. When she got the Pfizer COVID-19 Vaccine she was given a lot of information. The paperwork she was given said she should have the second dose of Pfizer COVID-19 Vaccine 3 weeks after the first dose. She is scheduled for the second dose of Pfizer COVID-19 Vaccine 4 weeks and 2 days after the first dose was administered. She is concerned about whether that 4 weeks and 2 days period is too long between doses; if it is ok to get the second dose that long after the first dose. The outcome of the event was unknown.  information about lot/batch number requested.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Fatigue, Therapeutic response unexpected
Clinical narrative: tired first thing in morning; first shot--arthritis felt kind of better, which was odd; First shot--arthritis symptoms came back; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient reported for herself she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3246, NDC number and Expiry date: unknown) via an unspecified route of administration, administered to left shoulder area/ bicep/ tricep area (as reported) on 20Jan2021 (patient age at time of vaccination was 59 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history includes thyroid issues and taking medicines for that and regular vitamins and concomitant medication were not reported. The patient didn't know if Pfizer if recording positive effects of the Covid vaccine, but patient wanted to report that. The patient first shot a couple weeks ago and right afterwards was like "wow", on 21Jan2021, her arthritis feels kind of better, which was odd. This lasted about 3-4 days and she felt pretty good. Wonders if the Covid shot had anything to do with it. Then the arthritis symptoms came back on an unspecified date in Jan2021, with the first dose the arthritis was better she noticed the day afterwards. Then they came back probably around the 25th or 26th of Jan2021 and she wanted to see if it came on the second shot. Pfizer maybe onto something for people with arthritis. This would pretty much be undocumented trial with the effects from it. Had no other effects. Outcome of the event arthritis was not recovered, and other events were unknown.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever; tiredness; headache; muscle pain; chills; joint pain; This is a spontaneous report from a non-contactable other Healthcare Professional (Patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809), via intramuscular route of administration, administered in left arm on 10Feb2021 at 11:00 AM (at the age of 50-years-old) as dose 2, single for COVID-19 immunisation. Medical history included migraine, hypothyroidism and beta thalassemia. Concomitant medication(s) included levothyroxine (MANUFACTURER UNKNOWN) 100mg; erenumab aooe (AIMOVIG) 70mg. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231), via intramuscular route of administration, administered in right arm on 20Jan2021 at 11:00 AM as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, the patient was not tested for COVID-19. On 11Feb2021 at 10:00, the patient experienced fever, tiredness, headache, muscle pain, chills, joint pain. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; tiredness; headache; muscle pain; chills; joint pain; This is a spontaneous report from a non-contactable other Healthcare Professional (Patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9809), via intramuscular route of administration, administered in left arm on 10Feb2021 at 11:00 AM (at the age of 50-years-old) as dose 2, single for COVID-19 immunisation. Medical history included migraine, hypothyroidism and beta thalassemia. Concomitant medication(s) included levothyroxine (MANUFACTURER UNKNOWN) 100mg; erenumab aooe (AIMOVIG) 70mg. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231), via intramuscular route of administration, administered in right arm on 20Jan2021 at 11:00 AM as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, the patient was not tested for COVID-19. On 11Feb2021 at 10:00, the patient experienced fever, tiredness, headache, muscle pain, chills, joint pain. The patient did not receive any treatment for the events. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Received first dose of covid vaccine at 7pm, woke up the next morning with a severe, throbbing headache, chills, and body aches which lasted all day.; Received first dose of covid vaccine at 7pm, woke up the next morning with a severe, throbbing headache, chills, and body aches which lasted all day.; Received first dose of covid vaccine at 7pm, woke up the next morning with a severe, throbbing headache, chills, and body aches which lasted all day.; This is a spontaneous report from a contactable nurse, the patient. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6201), via an unspecified route of administration on 09Feb2021 19:15 as dose 1, single (at the age of 44-years-old) for covid-19 immunization. The patient medical history and concomitant medications were not reported. After the first dose of covid vaccine at 7pm, the patient woke up the next morning on 10Feb2021 with a severe, throbbing headache, chills, and body aches which lasted all day. Therapeutic measures were not taken for the reported events. The patient did not receive any other vaccine in four weeks. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Malaise
Clinical narrative: was absolutely freezing and would then get hot; never felt so sick in her life; This is a spontaneous report from a contactable consumer or other non health care professional. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date (at the age of 24-years-old) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, while reporter reporting on herself, she reported that her grandson's girlfriend told her that she was absolutely freezing and then would get hot and said that she never felt so sick in her life. She said that it was from the Covid vaccine, but she does not know which one. She does not have a NDC, Lot, or expiration date to provide. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis
Clinical narrative: chill; sweats; This is a spontaneous report from a non-contactable healthcare professional. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in left arm on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient had no medical history. It was unknown if patient had COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. The patient had no concomitant medications. The patient did not receive any other vaccines within 4 weeks of COVID-19 vaccine. The patient previously took Bioxin and experienced drug allergy. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number was not reported) (at the age of 34-years-old), intramuscular, administered in left arm on an unspecified date for COVID-19 immunisation and experienced severe headaches intermittent for over a week, "cloudy" head, sweats/chills, severe sudden onset exhaustion, difficulty maintaining thoughts or focus. The patient experienced chills and sweats on an unspecified date (1 day). The patient received no treatment for the events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Illness
Clinical narrative: feels like she is getting sick; tired; lot of anxiety; This is a spontaneous report from a contactable consumer. This female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 10Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took flu shot for flu vaccination and feels sore. On 10Feb2021, the patient experienced feels like she is getting sick, tired, lot of anxiety. She and her husband just got vaccinated this morning. She feels stuff and she is worried, and it is 5 o'clock, and asked if it is normal or not. She usually gets the flu shot and she feels sore but that does not bother her that much and she felt a little bit not well after the flu shot for the next 24 hours and then the next day, she feels a little bit better. With the covid vaccine she felt a little more not normal and felt like she is getting sick. She felt tired and a lot of anxiety when she went to get the shot. She declined to provide further details to complete report and wants to ask if these are normal side effects. The clinical outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: following inoculation, the patient experienced arm pain; This is a spontaneous report received via COVAES. A non-contactable consumer reported a non-pregnant 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number and Expiration date: not reported) via an unspecified route of administration, administered on the left arm on an unspecified date in Feb2021 (at the age of 66 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, however, it was unknown if the patient was tested for COVID-19 since vaccination. On an unspecified date in Feb2021, following inoculation, the patient experienced arm pain. The outcome of the reported event was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Experienced arm soreness after 1st dose; This is a spontaneous report from a patient via Pfizer-sponsored program. A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included breast cancer from an unknown date in 2013 to an unknown date (she had a breast cancer and had a lump, and everything removed). The patient's concomitant medications were not reported. The patient experienced arm soreness (caller stated that it was like someone took their knuckle, the middle finger knuckle and hit you right where the injection was, also when she lifts her arm in the air it would hurt, not bad just that you can tell that there was something there) in after first dose few weeks ago of Pfizer-BioNTech COVID-19 vaccine on 29Jan2021, caller stated that she took a couple of TYLENOL's and she was ok. She wanted to know what she should expect with second dose. The event was reported as non-serious. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; extreme fatigue; body aches; low grade fever around 99-100 Fahrenheit; This is a spontaneous report from a contactable Nurse. This 40-year-old female Nurse reported for herself: A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL3246), via intramuscular, administered in Arm Left on 20Jan2021 (at the age of 40-year-old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus from 2009 and ongoing. Patient's family history reported as none and no relevant test was performed. The patient's concomitant medications were not reported. Patient was not received any vaccine on same day of Covid-19 vaccine. Patient was not received any other vaccine four weeks prior vaccination. Patient said that she had a little bit of effects after the first dose and even her flu vaccine. Patient clarified that with the first dose she had a sore arm, extreme fatigue, body aches, and a low-grade on 21Jan2021, fever around 99-100 Fahrenheit for about 6-8 hours the next day. Adverse events not required visit to Emergency room or Physician Office. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL0142), via Subcutaneous, administered in Arm Left on 10Feb2021as single dose for covid-19 immunisation and experienced the adverse event almost sure it was administered Subcutaneous on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: around 99-100 Fahrenheit on an unspecified date. The outcome of the event low grade fever around 99-100 Fahrenheit was reported recovered on unspecified date in Jan2021 and all others were unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: excruciating pain in her left shoulder after waking up today; This is a spontaneous report from a Pfizer sponsored program from a contactable female consumer reported (patient). A 70-year-old female patient received second dose of bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for injection), via an unspecified route in the right arm on 15Feb2021 as a single dose for covid-19 immunization. Medical history included left shoulder surgery on 15Jan2021. Concomitant medications included Tylenol which she has been taking and doing physical therapy without issues. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for injection) as a single dose for covid-19 immunization. On an unknown date in Feb2021, patient experienced excruciating pain in her left shoulder after waking up today and no pain at injection site (right arm) was reported. Patient confirmed that the vaccine was given in opposite arm as shoulder surgery, and she was experiencing post-operative shoulder pain before 2nd dose. Patient wanted to know if she is able to take hydrocodone, that was prescribed for shoulder pain after surgery. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on an unspecified date. She asked if she could take antihistamine since she had rash after the first dose. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Headache, Pain
Clinical narrative: dizzy; severe body aches; 12 hours after second vaccine I woke with a 101.5 temperature; headache; 24 hours later temperature of 99.1 still have headache and body aches very weak.; This is a Spontaneous report from a Contactable other Health care professional (patient). A 69-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9265) via an unspecified route, administered into left arm on 20Feb2021 04:00 PM (Age at the time of vaccination: 69 and patient was not pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID 19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received other medications in two weeks of vaccination. She had not known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot: number: EL9265) via an unspecified route of administration administered into left arm on 30Jan2021 04:00 PM as DOSE 1, SINGLE for COVID-19 Immunisation. On 21Feb2021 7: 00 AM, 12 hours after second vaccine she woke with a 101.5 temperature, dizzy, severe body aches and headache and 24 hours later temperature of 99.1 still had headache and body aches very weak. The patient underwent lab test and procedure of body temperature and resulted into 101.5 on 21Feb2021 and 99.1 on 22Feb2021. She had not received treatment for adverse events. The outcome of event was recovering.  Follow-up attempts are completed. No further information was expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dizzy; severe body aches; 12 hours after second vaccine I woke with a 101.5 temperature; headache; 24 hours later temperature of 99.1 still have headache and body aches very weak.; This is a Spontaneous report from a Contactable other Health care professional (patient). A 69-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL9265) via an unspecified route, administered into left arm on 20Feb2021 04:00 PM (Age at the time of vaccination: 69 and patient was not pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID 19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received other medications in two weeks of vaccination. She had not known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, had not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot: number: EL9265) via an unspecified route of administration administered into left arm on 30Jan2021 04:00 PM as DOSE 1, SINGLE for COVID-19 Immunisation. On 21Feb2021 7: 00 AM, 12 hours after second vaccine she woke with a 101.5 temperature, dizzy, severe body aches and headache and 24 hours later temperature of 99.1 still had headache and body aches very weak. The patient underwent lab test and procedure of body temperature and resulted into 101.5 on 21Feb2021 and 99.1 on 22Feb2021. She had not received treatment for adverse events. The outcome of event was recovering.  Follow-up attempts are completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: rash on stomach, back and neck; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a female patient (daughter) that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced rash on stomach, back and neck. The patient underwent lab tests and procedures which included sars-cov-2 test was negative. The event outcome was unknown. She wanted to know if it was ok to still receive second dose scheduled 19Feb2021.  Follow-up (12MAY2021): Follow-up attempts were completed. No further information was expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Malaise, Myalgia, Pain in extremity
Clinical narrative: Fever (38.2 C); malaise; lethargy; muscle ache; sore arm; This is a spontaneous report from a contactable physician (patient). A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3240) via an unspecified route of administration, administered in right arm on 19Jan2021 10:30 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EK5730) via unspecified route of administration, administered in right arm on 29Dec2020 08:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced fever (38.2 c), malaise, lethargy, muscle ache and sore arm. The patient underwent lab test which included body temperature 38.2c on 20Feb2021. The outcome of the events was recovered on an unspecified date.   Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (38.2 C); malaise; lethargy; muscle ache; sore arm; This is a spontaneous report from a contactable physician (patient). A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EL3240) via an unspecified route of administration, administered in right arm on 19Jan2021 10:30 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EK5730) via unspecified route of administration, administered in right arm on 29Dec2020 08:30 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 20Feb2021, the patient experienced fever (38.2 c), malaise, lethargy, muscle ache and sore arm. The patient underwent lab test which included body temperature 38.2c on 20Feb2021. The outcome of the events was recovered on an unspecified date.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pain; pressure; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program COVAX US Support. A patient of unspecified age and gender received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced chest pain and  pressure ( on an unspecified date.The outcome of the event was unknown.Pharmacist was calling because a patient had adverse reaction to Covid vaccine and he is calling to see if the patient should take 2nd dose. Relayed PMI information.Cold transferred to PSCC due to long hold times and faxing AE.  Follow-up (18Feb2021): This is a follow-up spontaneous report received from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a patient that No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient.The pharmacist called to COVAX US support for patient 2nd dose clarification.  Information on the lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.