chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: The rash appeared all over her body, started on her stomach then appeared on legs and arms; Rashes started on stomach first and then went to arms and legs the next day. It is still itching; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FW0167), via an unspecified route of administration, administered in Arm Right on 14May2021 14:00 (at the age of 59-year-old) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no prior vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient had no AE(s) following prior vaccinations. There was no history of previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect considered as suspect. The patient had no family medical history relevant to AE(s). After she received her first dose of the vaccine on 14May2021, the patient developed rashes all over her body. The rash appeared all over her body, started on her stomach on 15May2021 (noon) then appeared on legs and arms on 16May2021 (noon). Rashes started on stomach first and then went to arms and legs the next day. It was still itching. It was about the same and had not gotten any worse. The rash was a mild case, not blistering or red. The patient was using Benadryl lotion on the rash as treatment. The patient was wondering if she got the rash should she get the second dose. The patient was deferred to her physicians office for this question. AE(s) did not require a visit to Emergency Room or Physician Office. Outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: Arm bruised at injection site 3 weeks post vaccine; had bleeding immediately post injection first dose; This is a spontaneous report from a contactable Nurse. A 38-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8730) via intramuscular route of administration in Left arm on 13Apr2021 at 09:30 AM (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient experienced arm bruised at injection site 3 weeks post vaccine on an unspecified date; had bleeding immediately post injection first dose on 13Apr2021 at 09:30 AM. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pruritus
Clinical narrative: General soreness; Itchiness in arm; headache came on within hours, and was made far worse by exposure to bright light\sunlight.; This is a spontaneous report from a contactable consumer (patient). A 48-years-old non pregnant female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EUO177), via an unspecified route, administered in arm left on 16May2021 at 09:45 AM (age at vaccination was 48 years) as dose 2, single for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included hashimoto, obesity and known allergy to trees, cats, dogs, ragweed; all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), phentermine (ADIPEX [PHENTERMINE]), metformin, hydrochlorothiazide (HYDRODIURIL), multivitamin; all taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EUO170), via an unspecified route, administered in arm left on 25Apr2021 (age at vaccination was 48 years) as dose 1, single for covid-19 immunization and experienced mild sore arm, mild headache. On 16May2021 at 01:15 PM, after the second injection, the patient's headache came on within hours and was made worse by exposure to bright light\sunlight. Staying in the dark was more effective than OTC unspecified pain medications. On 18May2021, the next 2 days, the patient experienced general soreness\itchiness in arm. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Outcome of all events was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Erythema, Feeling hot, Irritability
Clinical narrative: I start having bad reactions with it my hand; is lot swelling, red; it's itching me; I start having bad reactions with it my hand; is lot swelling, red; it's itching me; red; fever; chills; have fever and it feels warm; aches and pain and right now I feel that side its swollen; Back ache in body; itching and irritating and cold; itching and irritating and cold; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported herself. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Left arm on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not specified. On an unspecified date, the patient experienced I start having bad reactions with it my hand; is lot swelling, red; it's itching me, red, fever, chills, have fever and it feels warm, aches and pain and right now i feel that side its swollen, back ache in body, itching and irritating and cold. When probed for if consumer still experiencing issue, Reporter stated, Well the chills is kind of going in a way but the site is still red swollen and itching they had lot me. Reporter stated, "I took the second shot of my Pfizer Vaccine (Covid-19 Vaccine) on Friday the 14th and I start having bad reactions with it my hand is lot swelling, red and it's itching me and I have fever, chills, aches and pain and right now you could feel if you feel that side its swollen and its red and if I touch it is like very hot it just feel, if you have fever you touch somebody they have fever and it feels warm that's all the side effects." Reporter asked What should I do about this itching and irritating and cold. Therapeutic measures were taken as a result of back ache in body included Tylenol and Aspirin. The outcome of the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: I start having bad reactions with it my hand; is lot swelling, red; it's itching me; I start having bad reactions with it my hand; is lot swelling, red; it's itching me; red; fever; chills; have fever and it feels warm; aches and pain and right now I feel that side its swollen; Back ache in body; itching and irritating and cold; itching and irritating and cold; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported herself. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Left arm on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not specified. On an unspecified date, the patient experienced I start having bad reactions with it my hand; is lot swelling, red; it's itching me, red, fever, chills, have fever and it feels warm, aches and pain and right now i feel that side its swollen, back ache in body, itching and irritating and cold. When probed for if consumer still experiencing issue, Reporter stated, Well the chills is kind of going in a way but the site is still red swollen and itching they had lot me. Reporter stated, "I took the second shot of my Pfizer Vaccine (Covid-19 Vaccine) on Friday the 14th and I start having bad reactions with it my hand is lot swelling, red and it's itching me and I have fever, chills, aches and pain and right now you could feel if you feel that side its swollen and its red and if I touch it is like very hot it just feel, if you have fever you touch somebody they have fever and it feels warm that's all the side effects." Reporter asked What should I do about this itching and irritating and cold. Therapeutic measures were taken as a result of back ache in body included Tylenol and Aspirin. The outcome of the events were unknown.  Information on Lot/Batch number was available. Additional information has been requested  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Caller reports that it felt like his throat was closing, narrowing a bit, and felt like something was stuck in his throat; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 18May2021 (at the age of 49-years-old) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18May2021, the patient stated he got his shot about 30 minutes ago and it felt like there was a lump in his throat, and it felt abnormal, almost like his throat was closing a little bit. He stayed for observation for 15 minutes, and when he was driving home, it felt like his throat was closing, narrowing a bit, and felt like something was stuck in his throat. The 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 completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Fatigue
Clinical narrative: tired; weak/ less energy; chest pain on exertion; This is a spontaneous report from a contactable consumer. Report 2 of 2. Caller is reporting on herself and her daughter. This is the report for callers daughter. A 43-years-old female patient (reporter's daughter) received Pfizer Covid19 vaccine (Formulation: Solution for injection, Batch/Lot Number was unknown, Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration, on an unknown date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was not reported.  On an unknown date reporter stated that after getting the first dose of the vaccine Mother had continues to have less energy every day, and chest pain on exertion, her daughter has gone through the same thing. Her daughter had been to the doctor 3 or 4 times for different things. For her daughter, it happened very shortly after the first vaccine. Her daughter had to miss work since so she was tired and so weak, or take a half day. Her daughter explained it as something was just not right. They came to the conclusion that it had to be the vaccine. The out come of all events were unknown.  Follow-up (16Jul2021): 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 completed. No further information is expected
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills
Clinical narrative: Felt chilly after the second dose; Lost of taste; This is a spontaneous report from a non-contactable consumer (patient) reported for himself. A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185, Expiry date: unknown) via an unspecified route of administration, in right arm on 08May2021 12:30 PM (at age of 47 years old) as dose 2, single for Covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733, Expiry date: unknown) via an unspecified route of administration, in left arm on 17Apr2021 12:00 PM as dose 1, single for Covid-19 immunization. Patients concomitant medication included Fenofibrate taken for an unspecified indication at 145 mg received within 2 weeks of vaccination. patient had no known allergies. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and patient been not tested for COVID-19 since the vaccination. The patient felt chilly after the second dose on the second day, 09May2021 of the shot and recovered on the third day, 10May2021. He also experienced lost of taste on 09May2021, but not recovered yet. Patient did not take any treatment for the events. Outcome of the events chills was recovered on 10May2021, and loss of taste was not recovered. No follow-up attempts are possible. No further information is expected
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness; Fever; Muscle aches like muscle soreness; severe vomiting; violent headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EN6204, Expiry date: unknown) (age at the time of vaccination was 17 years), administered in Arm Right on 14May2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient experienced dizziness, violent headache, fever and chills, muscle aches like muscle soreness, fatigue. The patient received treatment included pain relievers like Tylenol, like acetaminophen stuff and that is the only medication I had took. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Dizziness; Fever; Muscle aches like muscle soreness; severe vomiting; violent headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EN6204, Expiry date: unknown) (age at the time of vaccination was 17 years), administered in Arm Right on 14May2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient experienced dizziness, violent headache, fever and chills, muscle aches like muscle soreness, fatigue. The patient received treatment included pain relievers like Tylenol, like acetaminophen stuff and that is the only medication I had took. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain in extremity
Clinical narrative: headache; chills; his left arm and shoulder ache; Shoulder ache; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in Arm Left on 17May2021 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 63 years). Medical history included hypertension and diabetes mellitus from an unknown date and unknown if ongoing. ketoconazole and experienced drug hypersensitivity. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in Arm Left on 26Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. The patient experienced on 18May2021 that this is the next day after receiving vaccine, headache, chills and his left arm and shoulder ache. Just doesn't feel good. Tylenol given. Therapeutic measures were taken as a result of all the adverse events included with the product Tylenol. The clinical outcome of the events headache, chills, his left arm and shoulder ache, shoulder ache were recovering.   Follow-up (23Jun2021): Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal chest pain, Pain
Clinical narrative: but now he hurts whenever he walks or just sitting down it hurts; pain right above his hip that's shooting up to his rib cage, he's in constant pain and it hurts when he walks; pain right above his hip that's shooting up to his rib cage, he's in constant pain and it hurts when he walks; This is a spontaneous report from a sponsored program. This is a report of a contactable male consumer (patient). A 49-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0183; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left (because his right side is hurting) on 18May2021 12:17 (Age at Vaccination was 49 years) as dose 1, single for COVID-19 immunisation. The patient medical history included COVID-19 (he had COVID before for about 12 hours and he just loss taste and that was it). The patient's concomitant medications were not reported. The patient family medical history was cancer. It was reported that, He was taking the Pfizer Covid vaccine well because science says he has to get it or keep a mask on. He states that, he got it and they had him sit in the room for 15 minutes and he could leave at 12:32. He does have to say props to the needles because they did not hurt whatsoever when it went in his arm, so props for that. He had no previous immunization with the vaccine considered as suspect and no additional vaccines administered on same date of the suspect. He did not receive any other vaccinations within 4 weeks prior to COVID vaccination. The information about other Products received in 2 weeks was not reported. On 18May2021 15:30, the patient experienced pain right above his hip that was shooting up to his rib cage, he was in constant pain, and it hurts when he walks as worsened. When he tries to walk on it, he has to limp. but now he hurts whenever he walks or just sitting down it hurts. He states that he was working until 11:00 and he was sitting down most of the time, but he was still hurting. The patient did not visit an emergency room or physician office as a result of events. But he also stated that, he will go to the emergency room if he still is hurting later. The patient had his next appointment due on 08Jun2021 for his second dose. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Body temperature, Diarrhoea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# ER8731), at the age of 15, via an unspecified route of administration, in left arm, on May 14, 2021, at 16:00, single dose, for COVID-19 immunization. The patient's medical history included cystic fibrosis. The patient has no known allergies. The patient's concomitant medications not reported. The patient did not receive any other vaccine within 4 weeks prior vaccination. Following vaccination in the evening on May 14, 2021, patient had a high fever spike at 103.6ºF. On May 15, 2021, at 08:00, patient had diarrhea, nausea, abdominal pain, abdominal discomfort and bloating. The patient did not receive any treatment for the events. Prior to vaccination, patient was not diagnosed with COVID-19; and has not tested since the vaccination. On May 15, 2021, lab data included fever (body temperature) was 103.6ºF. The outcome of fever, diarrhea, nausea and abdominal pain: recovering; while for abdominal discomfort and bloating not recovered at the time of report. Follow-up attempts completed. No further information expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# ER8731), at the age of 15, via an unspecified route of administration, in left arm, on May 14, 2021, at 16:00, single dose, for COVID-19 immunization. The patient's medical history included cystic fibrosis. The patient has no known allergies. The patient's concomitant medications not reported. The patient did not receive any other vaccine within 4 weeks prior vaccination. Following vaccination in the evening on May 14, 2021, patient had a high fever spike at 103.6ºF. On May 15, 2021, at 08:00, patient had diarrhea, nausea, abdominal pain, abdominal discomfort and bloating. The patient did not receive any treatment for the events. Prior to vaccination, patient was not diagnosed with COVID-19; and has not tested since the vaccination. On May 15, 2021, lab data included fever (body temperature) was 103.6ºF. The outcome of fever, diarrhea, nausea and abdominal pain: recovering; while for abdominal discomfort and bloating not recovered at the time of report. Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: light headed/dizzy; eyes sensitive to light; warm sensation; foggy/strange sensation; I was feeling fatiqued; Fell asleep; Headache; Legs tingling/ cold at down my legs; burning sensation; pain in my chest and right arm; pain in my chest and right arm; Heart racing; Legs tingling/ cold at down my legs; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received first dose of BNT162B2 (FIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number; EW0175 and expiry date was not reported), via an unspecified route of administration in Arm Right on 29Apr2021 at 11:00 PM (age at vaccination: 58-years-old), as DOSE 1, SINGLE for COVID-19 immunisation at School or Student Health Clinic. The patient medical history included Gunshot wound to the left hemisphere of the brain, chronic sleep issues, minor paralysis to the right side of body as result of TBI and Penicillin allergy (all from an unknown date and unknown if ongoing). Concomitant medications included vitamin C (ASCORBIC ACID) and zinc taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was allergic to penicillin. It was unknown whether, the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021 at 16:00, the patient experienced light headed /dizzy, eyes were sensitive to light, warm sensation in upper right arm, and foggy. After dinner, at about 7pm, he laid down because he was feeling fatigue and then fell asleep. He woke up a few times in the night with a strange sensation running up and down his legs. Legs tingling/cold at times. He had burning sensation and pain in his chest and right arm, chest felt like he had a rubber band wrapped around him. He experienced heart racing, bad headache and legs were cold. He woke up next morning basically unable to do anything for a several hours. He felt foggy, stumbling around and dizzy and felt better in afternoon. He still felt foggy headed but it got better as days pass and he was very tired. He felt a lot better after a few days. The patient had visited to physician's office for the events. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: light headed/dizzy; eyes sensitive to light; warm sensation; foggy/strange sensation; I was feeling fatiqued; Fell asleep; Headache; Legs tingling/ cold at down my legs; burning sensation; pain in my chest and right arm; pain in my chest and right arm; Heart racing; Legs tingling/ cold at down my legs; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received first dose of BNT162B2 (FIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number; EW0175 and expiry date was not reported), via an unspecified route of administration in Arm Right on 29Apr2021 at 11:00 PM (age at vaccination: 58-years-old), as DOSE 1, SINGLE for COVID-19 immunisation at School or Student Health Clinic. The patient medical history included Gunshot wound to the left hemisphere of the brain, chronic sleep issues, minor paralysis to the right side of body as result of TBI and Penicillin allergy (all from an unknown date and unknown if ongoing). Concomitant medications included vitamin C (ASCORBIC ACID) and zinc taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was allergic to penicillin. It was unknown whether, the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021 at 16:00, the patient experienced light headed /dizzy, eyes were sensitive to light, warm sensation in upper right arm, and foggy. After dinner, at about 7pm, he laid down because he was feeling fatigue and then fell asleep. He woke up a few times in the night with a strange sensation running up and down his legs. Legs tingling/cold at times. He had burning sensation and pain in his chest and right arm, chest felt like he had a rubber band wrapped around him. He experienced heart racing, bad headache and legs were cold. He woke up next morning basically unable to do anything for a several hours. He felt foggy, stumbling around and dizzy and felt better in afternoon. He still felt foggy headed but it got better as days pass and he was very tired. He felt a lot better after a few days. The patient had visited to physician's office for the events. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Photophobia, Somnolence
Clinical narrative: light headed/dizzy; eyes sensitive to light; warm sensation; foggy/strange sensation; I was feeling fatiqued; Fell asleep; Headache; Legs tingling/ cold at down my legs; burning sensation; pain in my chest and right arm; pain in my chest and right arm; Heart racing; Legs tingling/ cold at down my legs; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received first dose of BNT162B2 (FIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number; EW0175 and expiry date was not reported), via an unspecified route of administration in Arm Right on 29Apr2021 at 11:00 PM (age at vaccination: 58-years-old), as DOSE 1, SINGLE for COVID-19 immunisation at School or Student Health Clinic. The patient medical history included Gunshot wound to the left hemisphere of the brain, chronic sleep issues, minor paralysis to the right side of body as result of TBI and Penicillin allergy (all from an unknown date and unknown if ongoing). Concomitant medications included vitamin C (ASCORBIC ACID) and zinc taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was allergic to penicillin. It was unknown whether, the patient diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Apr2021 at 16:00, the patient experienced light headed /dizzy, eyes were sensitive to light, warm sensation in upper right arm, and foggy. After dinner, at about 7pm, he laid down because he was feeling fatigue and then fell asleep. He woke up a few times in the night with a strange sensation running up and down his legs. Legs tingling/cold at times. He had burning sensation and pain in his chest and right arm, chest felt like he had a rubber band wrapped around him. He experienced heart racing, bad headache and legs were cold. He woke up next morning basically unable to do anything for a several hours. He felt foggy, stumbling around and dizzy and felt better in afternoon. He still felt foggy headed but it got better as days pass and he was very tired. He felt a lot better after a few days. The patient had visited to physician's office for the events. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin discolouration, Swelling face
Clinical narrative: my face is swollen, pink; Itchy face; my face is swollen, pink; This is a spontaneous report from a contactable consumer. This 17-year-old female consumer (patient) reported for herself. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0183; Expiry date- Aug2021), dose 1 via an unspecified route of administration on 17May2021 (at the age of 17-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 18May2021, the patient started experiencing adverse events face was itchy last night and then she woke up around 11:30 and whole face was like pink, swollen and itchy. Outcome of the event was unknown.  Informed about the Medical Information Department Provided. Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Headache, Lymphadenopathy, Myalgia
Clinical narrative: muscle pain worsened; headache worsened; joint pain; vomiting; lymph node swelling; The caller also got hot and stayed hot for like 2 days. It started after the shot, the caller never ran a fever, it was indescribable/ perceived fevers (but does not have a fever); nausea worsened; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737) via an unspecified route administered in arm on 17May2021 (at the age of 36-year-old) as Dose 1, Single for covid-19 immunization. The patient's medical history included asthma (diagnosed 3 months ago), water retention (diagnosed 3 years ago). There was no concomitant medications reported. On 17May2021, the patient stated she got hot and stayed hot for like 2 days, it started after the shot, the patient never ran a fever, it was indescribable/ perceived fevers (but does not have a fever) and her nausea worsened. On 18May2021, patient experienced headache worsened, joint pain, vomiting and lymph node swelling and on 19May2021, the patient had muscle pain worsened was reported by patient. No investigation assessment was reported. The outcome of the events was not recovered at the time of reporting.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: muscle pain worsened; headache worsened; joint pain; vomiting; lymph node swelling; The caller also got hot and stayed hot for like 2 days. It started after the shot, the caller never ran a fever, it was indescribable/ perceived fevers (but does not have a fever); nausea worsened; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737) via an unspecified route administered in arm on 17May2021 (at the age of 36-year-old) as Dose 1, Single for covid-19 immunization. The patient's medical history included asthma (diagnosed 3 months ago), water retention (diagnosed 3 years ago). There was no concomitant medications reported. On 17May2021, the patient stated she got hot and stayed hot for like 2 days, it started after the shot, the patient never ran a fever, it was indescribable/ perceived fevers (but does not have a fever) and her nausea worsened. On 18May2021, patient experienced headache worsened, joint pain, vomiting and lymph node swelling and on 19May2021, the patient had muscle pain worsened was reported by patient. No investigation assessment was reported. The outcome of the events was not recovered at the time of reporting.  Follow-up attempts completed. No further information expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pain in extremity
Clinical narrative: arm pain; Headache; Chest pain when taking breath; This is a spontaneous report received from a contactable consumer (patient). A 15-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0182, Expiration date: Aug2021) via an intramuscularly administered in right arm on 19May2021 at 09:00 AM (age at the time of vaccination 15 years old) as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0217, Expiration date: Sep2021) via an intramuscularly administered in left arm on 09Jun2021 at 09:00 (age at the time of vaccination 15 years old) as DOSE 2, SINGLE for covid-19 immunization at school/student health clinic. The patient's medical history included neutropenia from an unknown date and unknown if ongoing. Prior vaccinations within 4 weeks included allergy shot via intramuscular route, administered in arm right on an unspecified date in May2021. No covid tested post vaccination. No other vaccine in four weeks. No covid prior vaccination. The patient's concomitant medications included ergocalciferol (VIT D), calcium and macrogol 3350 (MIRALAX). The patient experienced chest pain when taking breath on 19May2021 at 11:15 AM, headache on 19May2021 at 02:00 PM and arm pain on an unspecified date. He did not receive treatment for adverse event chest pain and he received treatment of tylenol via oral liquid from 19May2021 to 21May2021 for arm pain and from 09Jun2021 to 11Jun2021 for headache orally. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Pyrexia
Clinical narrative: @ 1.30am  chills, low grade fever, weak. Weak and drained for 2 more days but not bad enough to stay home from work.  Reactions come in waves. Extreme for a while then nothing for a while; @ 1.30am  chills, low grade fever, weak. Weak and drained for 2 more days but not bad enough to stay home from work.  Reactions come in waves. Extreme for a while then nothing for a while; @ 1.30am  chills, low grade fever, weak. Weak and drained for 2 more days but not bad enough to stay home from work.  Reactions come in waves. Extreme for a while then nothing for a while; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) (at the age of 62 years old), dose 2 via an unspecified route of administration, administered in arm right on 16May2021 11:00 as dose 2, single for covid-19 immunisation, administered in pharmacy or Drug Store. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm right on 25Apr2021 12:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 17May2021 at 01:30 am patient experienced chills, low grade fever, weak. Patient was weak and drained for two more days but not bad enough to stay home from work. Reactions came in waves, extreme for a while then nothing for a while. Treatment was not received for the events. She did not have covid prior to vaccination. The patient was not receive any other vaccines within 4 weeks. She was not tested for covid post vaccination. She had no known allergies. The lab data included low grade fever on 17May2021. The outcome for the events was recovering.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: patient started be very tired and needed to take Tylenol you know to somewhat get around to keep my temperature down.; patient started be very tired and needed to take Tylenol you know to somewhat get around to keep my temperature down.; This is a spontaneous report from a contactable consumer (Patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EN6205, Expiry date was not reported) via an unspecified route of administration, administered in right arm (right shoulder) on 26Feb2021 (age at vaccination was 72 Years) as a dose 1, single for COVID-19 immunization. Relevant medical history and concurrent condition included Multiple sclerosis on 31Aug1989. Concomitant medication was not reported. Patient started be very tired and needed to take Tylenol you know to somewhat get around to keep my temperature down on 2021. Patient wanted to ask about any side effects with the COVID shot that she had. She meant it happened after she had the first shot a little bit. When probed for the exact date for the onset of the adverse events, patient stated, first would have been probably on the 5th of March. She started be very tired and needed to take Tylenol you know to somewhat got around to keep her temperature down. It started to went up then and then it kept on increasing, for that she had to take more Tylenol. When probed if the patient was taking any other medications, Patient stated, "Really no, all she took was Tylenol(Treatment) to keep the temperature down, took like a multivitamin. The patient received treatment for events with Tylenol. The outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Hot flush, Hyperhidrosis
Clinical narrative: Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0175) as) via an unspecified route of administration, administered in Arm Left on 18May2021 13:30 DOSE 1, SINGLE for COVID-19 immunization. Medical history was None. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. On 18May2021 15:30 the patient experienced diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on. Device Date: 19May2021.Patient did not received treatment for adverse events. The outcome of the events was recovering.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; Diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on.; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0175) as) via an unspecified route of administration, administered in Arm Left on 18May2021 13:30 DOSE 1, SINGLE for COVID-19 immunization. Medical history was None. Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. On 18May2021 15:30 the patient experienced diarrhea, stomach cramping, hot flashes, sweating, headache, slight fever off & on. Device Date: 19May2021.Patient did not received treatment for adverse events. The outcome of the events was recovering.  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Rash
Clinical narrative: The center of the rash patches began blistering in the centers; Left arm had large blotches; The rash was red with raised patches about 1 1/2 inches across; The rash was red with raised patches about 1 1/2 inches across; Intense Rash (hive like) on left arm; Extremely sore left shoulder; Stiff neck; Her left forearm was still sore and weakened; Her left forearm was still sore and weakened; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0162, expiry date: unknown) via an unspecified route of administration, administered in left arm on 10Apr2021 08:35 (age at vaccination 62-years-old and non-pregnant at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was none. Concomitant medications were not reported. The patient has no known allergies. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via an unspecified route of administration, left arm on 20Mar2021 09:30 AM (age at vaccination 62-years-old and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. On 09May2021 05:00 PM, the patient experienced intense rash (hive like) on left arm, extremely sore left shoulder, stiff neck. The patient experienced stiff neck and extremely sore left shoulder started on 09May2021 5 PM. By 14May2021, her left arm hand had large blotches. The rash was red with raised patches about 1 1/2 inches across. On 15May2021, the centre of the rash patches began blistering in the centres. Rash disappeared within a couple weeks. Her left forearm was still sore and weakened on an unknown date in 2021. The patient was not diagnosed with COVID-19 prior to vaccination and since the day of vaccination, she has not tested for COVID-19. The patient had COVID test on 07Nov2020 and the result was negative. The patient visited clinic for consulting Doctor/other healthcare professional. The patient received treatment for the events experienced intense rash (hive like) on left arm, extremely sore left shoulder, stiff neck and had alignment to reduce neck pain. The patient had chiropractic treatment for the events. The outcome of the event rash on left arm was recovered on an unknown date in May2021, shoulder soreness, left forearm was still sore and weakened and stiff neck was not recovered, outcome of other events was unknown. These events were reported as non-serious.  Follow-up attempts are completed. No further information was expected