chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205 and Expiry date: Unknown), via an unspecified route of administration, administered in left arm on 07Mar2021 08:30 AM as 2nd dose, single for covid-19 immunisation. Patient's age at vaccination was 40 years. The patient medical history and concomitant medications were not reported. The patient not had prior vaccinations within 4 weeks and no other medications in two weeks. No known allergies. The patient was not had Covid prior vaccination and not Covid tested post vaccination. Historical vaccine information included first dose of BNT162B2 (Lot number: EL9266) administered in left arm on 14Feb2021 08:30 AM for covid-19 immunisation. The patient experienced injection site soreness on 07Mar2021 12:00 PM. The report was received as my arm started feeling sore about 12 hours after injection so evening of 07Mar2021. No treatment received for adverse event. Patient became aware about reaction when it happened to him. Outcome for the event was recovering.   No follow up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: I had 100.2 temperature; Fever/ temperature in evening; Fatigue; Headache; Nauseous; Light-headed; Chills; This is a spontaneous report from a contactable consumer (Patient). An 82-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 82-years-old) as a first dose, single dose for covid-19 immunisation. The medical history included intolerant of iodine, shellfish, slight high blood pressure and known allergies: Comparing. The concomitant medication included 2 mult, levothyroxine sodium, losartan, HCTZ and pravastatin. The patient previously took morphine, demerol, darvocet, oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergy for all of them. The patient not received other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient reported, she had the first shot of the vaccine on 4th which was Thursday of March 10.30, 10:45 in the morning or 10:45. She had 100.2 temperature and seem to get temperature at night, chills, fatigue, nauseous and headache, lightheaded. It's getting better, took an Advil yesterday one and day before one, helps the fever, the temperature. Her second shot is scheduled for the 25th of March. Just want to know what to do. The patient not received treatment for the other events. The patient did not have COVID tested post vaccination. The outcome of the events chills, light-headed was unknown and the outcome of the events fever, fatigue, headache, and nausea was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: I had 100.2 temperature; Fever/ temperature in evening; Fatigue; Headache; Nauseous; Light-headed; Chills; This is a spontaneous report from a contactable consumer (Patient). An 82-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 82-years-old) as a first dose, single dose for covid-19 immunisation. The medical history included intolerant of iodine, shellfish, slight high blood pressure and known allergies: Comparing. The concomitant medication included 2 mult, levothyroxine sodium, losartan, HCTZ and pravastatin. The patient previously took morphine, demerol, darvocet, oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergy for all of them. The patient not received other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient reported, she had the first shot of the vaccine on 4th which was Thursday of March 10.30, 10:45 in the morning or 10:45. She had 100.2 temperature and seem to get temperature at night, chills, fatigue, nauseous and headache, lightheaded. It's getting better, took an Advil yesterday one and day before one, helps the fever, the temperature. Her second shot is scheduled for the 25th of March. Just want to know what to do. The patient not received treatment for the other events. The patient did not have COVID tested post vaccination. The outcome of the events chills, light-headed was unknown and the outcome of the events fever, fatigue, headache, and nausea was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Had three pain down my left arm; I called it a fracto, it's kind of like a breaky achy; Headache; This is a spontaneous consumer from a contactable consumer (patient). A 66-year-old female received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6200) via an unspecified route of administration in left arm on Mar2021 at single dose for COVID-19 immunisation. The patients medical history was reported as none. Concomitant medications were not reported. On Mar2021, patient experienced pain in arm and headache. Patient stated that she called to let us know about her symptoms after having received Pfizer shot, within the first 30 minutes, she had three pain down her left arm, she got the shot in her left arm kind of like, she called it a fracto, it's kind of like a breaky achy kind of like a breaky achy pain you know what she mean a breaky achy pain it wasn't a straight pain, it was kind of like a breaky achy pain going down her arm, it happened three times in a row about a second each time. That's the only symptom she had except for she had the shot on Thursday (Mar2021) night, she had a mild headache for half the day on second day of vaccination (Saturday). Treatment included on Saturday the patient took two Advil. The outcome of event pain in arm was unknown and outcome if event headache was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: After first dose mention of nausea for one week afterwards; This is a spontaneous report from a contactable consumer. A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration on 02Feb2021 (Age at vaccination: 33 Years) as 1ST DOSE, SINGLE for covid-19 immunisation. Pregnant at the time of vaccination reported as unknown. The patient medical history was not reported. The patient concomitant medications were not reported. On 22Feb2021, the patient experienced nausea for one week afterwards after first dose. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The adverse event result in any of the following in Doctor or other healthcare professional office/clinic visit. It was unknown that treatment received for the adverse event. The clinical outcome of event was unknown.  Follow-up (25Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of query which included that: awareness date for report AER#. Response received as she overhead her casually telling another friend about having a bad reaction to the vaccine at dinner on 07Mar2021. As this was a group setting, she waited until the following day, Monday 08Mar2021 - at which point she had a solo phone conversation with her. At this point she provided the details she put in the event description and she communicated that it would be reported at work the following day, Tuesday 09Mar2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pyrexia
Clinical narrative: fever; Her body is not like as before. She is like a sick patient; She has some nausea sort of; This is a spontaneous report from a contactable consumer (patient's husband). A 40-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that the patient had the vaccine second shot 10 days back (Feb2021). She still has a little bit of fever going on and off. Her body was not like as before. She was like a sick patient. She had some nausea sort of. They wanted to know whether everyone in that lot have the same issue. Outcome of the fever was not recovered and other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; tiredness; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 31-years-old male patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation; solution for injection: Batch/Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 05Mar2021 11:30 as 1st dose, single dose for covid-19 immunisation at health clinic. The patient's medical history and concomitant medications were not reported. Patient did not received other vaccines within four weeks. On 06Mar2021 at 12:00pm, the patient experienced fever, nausea, tiredness. Prior to the vaccination, the patient was not diagnosed with covid19. Since the vaccination, the patient had not been tested for covid 19. The patient did not received treatment for the events caused. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number can not be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Had a red rash on my upper left arm where I had my vaccine; This is a spontaneous report from a contactable consumer (herself). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203, Expiration Date: unknown) (at the age of 66-year-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included atorvastatin, calcium carbonate (CALTRATE 600), ubidecarenone (COQ-10) and Vitamins (unspecified) for unspecified indication. The patient reported that "she had a quick question, she got her first Pfizer Covid vaccine a week ago, Friday on the 26Feb2021 and (06Mar2021) yesterday, last night, she noticed that she had a red rash on my upper left arm where I had my vaccine. It didn't hurt, it didn't itch, it's red, little warm but that was day 8, (06Mar2021) yesterday was day 8." The patient stated that "she took her claritin and she put some hydrocortisone cream on it." The patient further reported, "Well she had one other question and she did not know if that's something you can answer or if the other people would answer. she got allergy injections (unspecified medications) every 3 weeks and she was supposed to get it last week, I get four of them, 2 in each arm and I did not get it last week because of getting the Covid vaccine. She wanted to wait. Now do you know how long you have to wait before you can get your allergy injections when you get these vaccines?" The outcome of the event was unknown   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersomnia, Nausea, Pyrexia
Clinical narrative: Low grade fever; Fever started at 100.4 and ever since it has been bouncing back and forth to below 98.6 and also above it like 99; Fatigue; Sleeping a lot; Nausea; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: unknown; Expiration date: unknown), via unspecified route of administration on 23Feb2021 as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Mar2021, 9 days after the vaccination, the patient experienced low grade fever; fever started at 100.4 and ever since it has been bouncing back and forth to below 98.6 and also above it like 99, fatigue, sleeping a lot and nausea. The patient did not know whether that was normal because on the day of reporting, the patient came up with temperature 99 that morning and now it was normal. The patient had a little bit of nausea which went away after couple of hours. It was very mild symptoms and the patient wanted to know if it was due to the shot. The outcome of the nausea was resolved on unknown date, and was unknown for all other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Oropharyngeal pain, Otitis media, Pain
Clinical narrative: soreness on arm; started running a fever 2 days later (mild) for 3 days; cold like symptoms; nasal drainage; headaches; sore throat; mild aches; Otitis Media of the left ear; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, brand: Pfizer), via an unspecified route of administration in right arm on 12Feb2021 15:00 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation at a hospital. Medical history included allergy to nicotine (smoke) and mold. The patient concomitant medications were not reported. The patient did not recieve any vaccination prior to covid vaccine and was not tested for covid after vaccination. The patient previously took first dose of bnt162b2 (BNT162B2, brand: Pfizer), via an unspecified route of administration in left arm on 22Jan2021 16:45 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. On 15Feb2021, the patient experienced the usual soreness on arm the following day after vaccine administration. However, started running a fever 2 days later (mild) for 3 days. Next, she began to have cold like symptoms with nasal drainage, headaches, sore throat, and mild aches for a week. Then the second week, continued with the cold like symptoms, but the drainage got so bad it caused an ear infection. Ear infection caused major pain in the left ear along with sore throat glands left side, headache persistently for several days, so much that she had to see a clinic to get an evaluation and medicines for the infection. Diagnosis was reported as Otitis Media of the left ear. The events resulted in doctor or other health care professional clinic visit. Treatment recieved for the reported events were prescribed medicines. Outcome of the events was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: soreness on arm; started running a fever 2 days later (mild) for 3 days; cold like symptoms; nasal drainage; headaches; sore throat; mild aches; Otitis Media of the left ear; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient (non-pregnant) received second dose of bnt162b2 (BNT162B2, brand: Pfizer), via an unspecified route of administration in right arm on 12Feb2021 15:00 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation at a hospital. Medical history included allergy to nicotine (smoke) and mold. The patient concomitant medications were not reported. The patient did not recieve any vaccination prior to covid vaccine and was not tested for covid after vaccination. The patient previously took first dose of bnt162b2 (BNT162B2, brand: Pfizer), via an unspecified route of administration in left arm on 22Jan2021 16:45 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. On 15Feb2021, the patient experienced the usual soreness on arm the following day after vaccine administration. However, started running a fever 2 days later (mild) for 3 days. Next, she began to have cold like symptoms with nasal drainage, headaches, sore throat, and mild aches for a week. Then the second week, continued with the cold like symptoms, but the drainage got so bad it caused an ear infection. Ear infection caused major pain in the left ear along with sore throat glands left side, headache persistently for several days, so much that she had to see a clinic to get an evaluation and medicines for the infection. Diagnosis was reported as Otitis Media of the left ear. The events resulted in doctor or other health care professional clinic visit. Treatment recieved for the reported events were prescribed medicines. Outcome of the events was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Oropharyngeal pain, Pharyngeal erythema
Clinical narrative: Feeling really sick from my chills; Feeling really sick from my chills; My throat is very red and it hurts me a lot; I just feel really terrible from my throat; My throat is very red and it hurts me a lot; I just feel really terrible from my throat; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6205) as UNKNOWN SINGLE DOSE for covid-19 immunisation Medical history included covid-19 from an unknown date. The patient's concomitant medications were not reported. The patient experienced feeling really sick from chills, throat is very red and it hurts him a lot, the patient just felt really terrible from my throat. The reporter want to know if this has to do something with vaccine or the patient was getting Covid again. The reporter had Covid already (further clarification unknown) and thought getting the vaccine would prevent it from getting it again. The reporter do not have any other symptoms since that." On an unspecified date with outcome of unknown ,    No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose decreased, Breast pain, Breast swelling
Clinical narrative: pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints of the vaccinated arm; extreme tiredness; all joints in my arm began to sting; extremely nauseous; sweaty; light-headed/mild dizzy spells; unable to think clearly; sudden down in blood sugar; foggy-headed; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any vaccine in four weeks and not had COVID prior vaccination. Medical history included high blood sugar, asthma, scarlet fever survivor and patient had known allergy to latex. Concomitant medications included cinnamomum verum (CINNAMON TABLETS), quercetin, rhodiola rosea (RHODIOLA), and st johns (as reported). On 02Mar202 01:30, within 1 minute after vaccination, patient experienced all joints in arm began to sting. and was extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar. The doctor had patient to drink water and eat fruit. Patient reported it took about 15 minutes to be able to think clearly and was foggy headed for at least 24 hours. On 03Mar2021, (the after) patient experienced burning pain in joints of the vaccinated arm, extreme tiredness, and mild dizzy spells. On 05Mar2021, 3 days (yesterday) after vaccination, had pain in right boob and patient think maybe it was swollen as well as aching in upper right arm. Patient reported it still hurts today. Patient not tested COVID post vaccination. The patient underwent lab tests and procedures which included blood glucose: high. Therapeutic measures were taken as a result of extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar with water and fruit. The outcome of the events reported as recovered with sequelae (Recovered with lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Hyperhidrosis, Nausea
Clinical narrative: pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints of the vaccinated arm; extreme tiredness; all joints in my arm began to sting; extremely nauseous; sweaty; light-headed/mild dizzy spells; unable to think clearly; sudden down in blood sugar; foggy-headed; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any vaccine in four weeks and not had COVID prior vaccination. Medical history included high blood sugar, asthma, scarlet fever survivor and patient had known allergy to latex. Concomitant medications included cinnamomum verum (CINNAMON TABLETS), quercetin, rhodiola rosea (RHODIOLA), and st johns (as reported). On 02Mar202 01:30, within 1 minute after vaccination, patient experienced all joints in arm began to sting. and was extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar. The doctor had patient to drink water and eat fruit. Patient reported it took about 15 minutes to be able to think clearly and was foggy headed for at least 24 hours. On 03Mar2021, (the after) patient experienced burning pain in joints of the vaccinated arm, extreme tiredness, and mild dizzy spells. On 05Mar2021, 3 days (yesterday) after vaccination, had pain in right boob and patient think maybe it was swollen as well as aching in upper right arm. Patient reported it still hurts today. Patient not tested COVID post vaccination. The patient underwent lab tests and procedures which included blood glucose: high. Therapeutic measures were taken as a result of extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar with water and fruit. The outcome of the events reported as recovered with sequelae (Recovered with lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thinking abnormal, Vaccination site pain
Clinical narrative: pain in my right boob; maybe it is swollen; aching in my upper right arm; burning pain in my joints of the vaccinated arm; extreme tiredness; all joints in my arm began to sting; extremely nauseous; sweaty; light-headed/mild dizzy spells; unable to think clearly; sudden down in blood sugar; foggy-headed; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Right on 02Mar2021 13:30 as 1st dose, single dose for COVID-19 immunization. Patient did not receive any vaccine in four weeks and not had COVID prior vaccination. Medical history included high blood sugar, asthma, scarlet fever survivor and patient had known allergy to latex. Concomitant medications included cinnamomum verum (CINNAMON TABLETS), quercetin, rhodiola rosea (RHODIOLA), and st johns (as reported). On 02Mar202 01:30, within 1 minute after vaccination, patient experienced all joints in arm began to sting. and was extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar. The doctor had patient to drink water and eat fruit. Patient reported it took about 15 minutes to be able to think clearly and was foggy headed for at least 24 hours. On 03Mar2021, (the after) patient experienced burning pain in joints of the vaccinated arm, extreme tiredness, and mild dizzy spells. On 05Mar2021, 3 days (yesterday) after vaccination, had pain in right boob and patient think maybe it was swollen as well as aching in upper right arm. Patient reported it still hurts today. Patient not tested COVID post vaccination. The patient underwent lab tests and procedures which included blood glucose: high. Therapeutic measures were taken as a result of extremely nauseous, sweaty, light-headed, and unable to think clearly- very much like experiencing a sudden down in blood sugar with water and fruit. The outcome of the events reported as recovered with sequelae (Recovered with lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Underdose, Vaccination site bruising, Vaccination site pain
Clinical narrative: Injected me pretty high up on my shoulder that was a lot of pain; have a black and blue mark about a size of a quarter, up there the shot site; I didn't get a full does of second vaccine; felt bad; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient herself). A 72-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 04Mar2021 (at the age of 72-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 on 09Feb2021 (at the age of 72-year-old). Relevant medical history included low immunity. Concomitant medications were not reported. On an unknown date the patient experienced "injected me pretty high up on my shoulder that was a lot of pain then I felt a lot of cold fluid running down on my arm instead of getting in my body, was really cold like quite away after that wiped" (as reported), black and blue mark about a size of a quarter, up there the shot site, she didn't get a full does of second vaccine and felt bad.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Headache, Influenza like illness
Clinical narrative: Flu-like symptoms; Headache; Chills; Felt dehydrated; This is a spontaneous report from a non-contactable consumer.  A 39-years-old male patient (Age at vaccination was 39 Years) received bnt162b2 (BNT162B2, Batch/Lot Number: EL3246), via an unspecified route of administration, administered in Right Arm on 06Mar2021 16:15 as 2nd dose, single dose for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Historical vaccine includes bnt162b2 (BNT162B2) 1st dose on 13Feb2021, administration site (right arm), lot number EL3246. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included adderall and lexapro taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient has not been tested for COVID-19. The Pfizer US Drug safety unit questioned regarding confirmation of the primary reporter. Was asked that this primary reporter was the person who reported the events to you and If you were not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events, also asked would you please help to provide who reported the events to you. Whether the patient reported the events to you or not? This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. Reply was responded to mail that I was not the patient in this case the primary reporter was a patient the form indicated I could include the initials of the patient. The patient reported the events directly to me and the awareness date was Sunday, 07Mar and the report was submitted the same day. On 07Mar2021The patient experienced, flu-like symptoms, headache, chills, felt dehydrated. No treatment received for the adverse event. The outcome of all event was reported as recovering.   Follow-up(11Mar2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of reporter. This report included the confirmation reporter as primary reporter was a patient and awareness date.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Swelling face
Clinical narrative: Eye and facial swelling; Eye and facial swelling; This is a spontaneous report from a contactable consumer (patient).   A 42-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Right on 07Mar2021 as FIRST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks of COVID vaccine. The patient previously took clindamycin and experienced drug hypersensitivity. On 07Mar2021 16:30, the patient experienced eye and facial swelling. The patient has not received any treatment for adverse events. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Head discomfort, Headache, Nausea
Clinical narrative: Nausea; head rush; headache; fatigue; chills; This is a spontaneous report from a non-contactable consumer or other non hcp. A 20-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205 ),via an unspecified route of administration, administered in left Arm on 06Mar2021 at 5:00PM as First Dose, Single Dose for COVID-19 immunization. The patient's Medical history were not reported. The patient did not suffer from COVID-19 prior vaccination. The patient did not take any other vaccine within 4 weeks of vaccination. Concomitant medications in two weeks included Loryna birth control, minocycline 100mg.The patient did not test for COVID post vaccination. On 06Mar2021,at 10:30 PM, the patient experienced Nausea, head rush, headache, fatigue, chills. No treatment was received with regards to the events. The outcome for the events was note recovered/not resolved. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Restlessness
Clinical narrative: Body aches; Fever; Nausea; Restlessness; This is a spontaneous report from a contactable nurse (patient). A 34-years-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: not reported), dose 2 via an unspecified route of administration, administered in Left Arm on 06Mar2021 18:00 (at the age of 34-years-old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2, dose 1 via an unspecified route of administration, administered on 13Feb2021 18:00 (at the age of 34-years-old) as 1st dose, single dose for COVID-19 immunization. Patient did not take any other vaccine in four weeks. Patient had no Covid prior vaccination. Patient was not tested for COVID post vaccination. On 07Mar2021 03:00, the patient experienced body aches, fever, nausea, restlessness. Patient had not tested Covid post vaccination. No treatment received for adverse events. Patient was unable to locate or read the details of Lot. Patient was not recovered from events.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; severe chills; headache; This is a spontaneous report from a contactable Pharmacist. An adult patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration in Mar2021 as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously reported BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. It was unknown If Covid prior vaccination.  On an unspecified date in Mar2021, patient experienced fever, severe chills and headache. Patient did not receive any other vaccine in four weeks. It was unknown, if patient received treatment. It was unknown If Covid tested post vaccination. The outcome of the event was recovering.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Malaise, Rash
Clinical narrative: swollen lymph nodes under left arm; rash; headache; overall malaise; chills; This is a spontaneous report from a contactable consumer (patient herself) reported that an elderly (65+ Years) non pregnant female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm, on 04Mar2021 at 11:00 AM as a single dose for COVID-19 immunization. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm, on 11Feb2021 at 11:00 AM as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had a history of known allergies to Skelaxin. Concomitant medications included Tramadol (TRAMADOL), Atorvastatin (ATORVASTATIN), both for unknown indication and from unknown date. The patient had not received any other vaccines in four weeks. On 05Mar2021 at 05:00 PM the patient experienced swollen lymph nodes under left arm, rash, headache, overall malaise, chills. No treatment was received for the adverse events. The patient had not been diagnosed with Covid-19 prior vaccination and had not been tested for Covid-19 post vaccination. The outcome of the events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Menopause, Menstrual disorder, Nausea
Clinical narrative: I have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covide19 shot I got my period; headache; dizzy; nauseous feeling; arm pain; 2 days after the first dose of the covid-19 shot got her period; This is a spontaneous report from a non-contactable consumer (patient) .A 52-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 04Mar2021 (at the age of 52 years old) at a single dose for COVID-19 immunisation. The patient medical history included High Cholesterol and Statins allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient received historical vaccine Shingrix on 05Feb2021 in two weeks of vaccination. Concomitant medications included Celecoxib (CELEBREX), fish oil, Colecalciferol (VITAMINE D), Zinc, Probiotics. On 06Mar2021 the patient stated not some much as a reaction but have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covid-19 shot got her period. The shot did cause headache, dizzy, nauseous feeling, arm pain as well for about 2 days so far. No treatment was received. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covide19 shot I got my period; headache; dizzy; nauseous feeling; arm pain; 2 days after the first dose of the covid-19 shot got her period; This is a spontaneous report from a non-contactable consumer (patient) .A 52-year-old non pregnant female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 04Mar2021 (at the age of 52 years old) at a single dose for COVID-19 immunisation. The patient medical history included High Cholesterol and Statins allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient received historical vaccine Shingrix on 05Feb2021 in two weeks of vaccination. Concomitant medications included Celecoxib (CELEBREX), fish oil, Colecalciferol (VITAMINE D), Zinc, Probiotics. On 06Mar2021 the patient stated not some much as a reaction but have been in menopause state haven't had a period in over 1yr. 2 days after the first dose of the covid-19 shot got her period. The shot did cause headache, dizzy, nauseous feeling, arm pain as well for about 2 days so far. No treatment was received. The outcome of the events was recovering.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Skin irritation
Clinical narrative: Diarrhea for the past 4 days; headache; fatigue; dizziness; irritation; This is a spontaneous report received from a contactable consumer (Patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 08:00 as a single for covid-19 immunization. The patient's medical history and concomitant medication were not reported. The patient had no other vaccine in 4 weeks. The patient had no Covid prior vaccination nor tested post vaccination. On 04Mar2021 at 17:00, The patient experienced diarrhea (for the past 4 days),  headache, fatigue, dizziness and irritation (skin irritation). The patient had not received treatment for adverse events. The outcome was recovering for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Arm is like bright red in that area and it's warm; arm is like bright red in that area and it's warm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date (a week since vaccination), patient still had her arm was like bright red in that area and it's warm. Patient saw it was even listed as one of the side effects and she was wondering whether this was okay and how long that would last. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, SARS-CoV-2 test
Clinical narrative: pityrias rosea; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female non-pregnant patient received second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in arm on 09Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1283), via an unspecified route of administration in arm left on 13Jan2021 as a 1st dose, single dose for COVID-19 immunization. It was reported that, no other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and tested for covid post vaccination. The patient stated that, exactly 2 weeks after her 2nd dose experienced pityrias rosea on 23Feb2021. Stated that, the vaccine may not have caused this reaction but just wanted to inform the manufacturer in case there were rising numbers of this incident. Treatment medication included hydrocortisone. On 25Jan2021, the patient underwent lab tests and procedures which included COVID test, resulted as negative, nasal swab. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching sensation all over body; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6024), via an unspecified route of administration on 07Mar2021 at 11:00 (at the age of 56-years-old) as 1st dose, single for COVID-19 immunization. Medical history included heart disorder. The patient had no known allergies. Concomitant medications included clopidogrel bisulfate (PLAVIX), rosuvastatin calcium (CRESTOR) and vitamins nos (VITAMINS NOS). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient had not been tested for COVID-19 post vaccination. On 07Mar2021 at 11:00, the patient experienced itching sensation all over body and was treated with Benadryl pill. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea about 2 hours after getting shot; This is a spontaneous report from a non-contactable consumer (patient himself).  A 30-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EN6202, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 07Mar2021 11:30 (at the age of 30-year-old) as 1st dose, single dose for covid-19 immunisation. Medical history included depression. Concomitant medication included cannabis (CANNABIS). Other medication taken in two weeks included Cannabis. No other vaccine taken in four weeks. On 07Mar2021 01:45 AM, the patient experienced Nausea about 2 hours after getting shot. Patient ate beforehand and used a typical amount of cannabis after got home. Was about 80% of the way to barfing.  Therapeutic measures were taken as a result of nausea about 2 hours after getting shot. AE treatment included I popped two Peptos, a Tum, and a meclizine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. The outcome of the event was reported as resolved.  No follow-up attempts are possible. No further information in expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Malaise, Pain, Vomiting
Clinical narrative: Severe stomach pain; Throwing up; Onto the sides it's very painful; Terrible, wrecking the health; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 04Mar2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced severe stomach pain, vomiting ("Throwing up"), pain ("onto the sides it's very painful") and malaise (was feeling terrible, wrecking the health). Clinical outcome of the events was unknown at time of this report.   No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extreme arm pain starting 3 hours after injection.; This is a spontaneous report from a non-contactable consumer. A 35-year-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 24Feb2021 at 15:30 (at the age of 35-year-old), as first dose, single dose in left arm for COVID-19 immunization at Physician office. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 18:00, reported as 3 hours after injection, the patient experienced extreme arm pain and started resolving completely after 2 days. Pain returned to arm 9 days after injection, however, less painful than initial reaction. Patient did not receive treatment for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was resolved with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.