chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Decreased appetite, Fatigue, Illness
Clinical narrative: loss of appetite; fatigue/completely drained/ragged tired; he got sick the next day/has been sick; whenever he tried to do something, he will break out in a cold sweat; This is a spontaneous report from a contactable consumer other non-health professional (patient) via medical information team.  A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: Unknown, Expiration date: Unknown), via unspecified route of administration on left arm on 28Jan2021 (age at vaccination 78-year-old) at 1st dose, single for covid immunization. The patient had no medical history. There were no other products. On 28Jan2021 patient took 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 29Jan2021 (day after) the patient experienced loss of appetite, fatigue, and completely drained. Reportedly on 29Jan2021 patient had been sick. The patient experienced ragged tired, totally drained, and whenever he tried to do something, he will break out in a cold sweat. Patient stated that he got a COVID shot on 28Jan2021 (last Thursday), and he had been sick ever since. Patient stated that the sickness does not seem to be going away, it was about the same, it did not seem to be getting any better. Patient was wondering how long this is supposed to last, and if there was something he could do. Patient wanted to know how long he will be experiencing these symptoms. The case was assessed as non-serious as per reporter. No investigation assessment was done. Reporter confirmed that he had no other vaccines on the same day as his COVID vaccine. Reporter did not have his COVID Vaccination card with him at the time to provide Lot number. The outcome of the event was not recovered for sick and unknown for all other events.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Eye pain, Headache
Clinical narrative: dizziness; injections site reactions including: swelling itchiness, and warm to the touch; Swelling, itchy, hot to touch at injection site; injections site reactions including: swelling itchiness, and warm to the touch; fever of 103 at highest; her eyes hurt; weak; lethargic; headache; slight aches/Achy/whole body hurt; skin was sensitive; she felt like she had the flu; felt very sick; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via intramuscularly in left arm on 29Jan2021 at 10:50 am as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via intramuscularly in left arm on 08Jan2021 at 10:50 am as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Jan2021 at 00:00, patient experienced achy, weak, headache, eyes hurt, lethargic, whole body hurt, fever of 103 at highest. She also said on Saturday around 12:00 am, is when she felt very sick, her skin was sensitive. It was reported that Today, she still feels slightly dizzy, has a headache and slight aches. Patient also experienced dizziness. Sunday, her temperature went down to 99.2 degrees Fahrenheit. On 31Jan2021 at 07:00, patient experienced Swelling, itchy, hot to touch at injection site. She stated she doesn't typically have reactions to vaccines, and that symptoms are improving from peaking on Saturday 30Jan2021. She's wanting to know if these are normal and how long AEs might last. Today she still feels dizzy, has HA and slight aches. No duration is reported for other AE's. Referred to MD for treatment. She wanted to know if it was normal not to feel right after having the shot on Friday. She is a dental hygienist. She provided her weight as being between 145-150. NO ER or physician's office required. Patient medical history was reported as provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. The outcome of the event dizziness, felt very sick, felt like she had the flu, skin was sensitive was unknown and outcome of the events injections site reactions including: swelling itchiness, and warm to the touch was not recovered and outcome of the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Injection site pruritus, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: dizziness; injections site reactions including: swelling itchiness, and warm to the touch; Swelling, itchy, hot to touch at injection site; injections site reactions including: swelling itchiness, and warm to the touch; fever of 103 at highest; her eyes hurt; weak; lethargic; headache; slight aches/Achy/whole body hurt; skin was sensitive; she felt like she had the flu; felt very sick; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via intramuscularly in left arm on 29Jan2021 at 10:50 am as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via intramuscularly in left arm on 08Jan2021 at 10:50 am as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Jan2021 at 00:00, patient experienced achy, weak, headache, eyes hurt, lethargic, whole body hurt, fever of 103 at highest. She also said on Saturday around 12:00 am, is when she felt very sick, her skin was sensitive. It was reported that Today, she still feels slightly dizzy, has a headache and slight aches. Patient also experienced dizziness. Sunday, her temperature went down to 99.2 degrees Fahrenheit. On 31Jan2021 at 07:00, patient experienced Swelling, itchy, hot to touch at injection site. She stated she doesn't typically have reactions to vaccines, and that symptoms are improving from peaking on Saturday 30Jan2021. She's wanting to know if these are normal and how long AEs might last. Today she still feels dizzy, has HA and slight aches. No duration is reported for other AE's. Referred to MD for treatment. She wanted to know if it was normal not to feel right after having the shot on Friday. She is a dental hygienist. She provided her weight as being between 145-150. NO ER or physician's office required. Patient medical history was reported as provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. The outcome of the event dizziness, felt very sick, felt like she had the flu, skin was sensitive was unknown and outcome of the events injections site reactions including: swelling itchiness, and warm to the touch was not recovered and outcome of the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia, Sensitive skin
Clinical narrative: dizziness; injections site reactions including: swelling itchiness, and warm to the touch; Swelling, itchy, hot to touch at injection site; injections site reactions including: swelling itchiness, and warm to the touch; fever of 103 at highest; her eyes hurt; weak; lethargic; headache; slight aches/Achy/whole body hurt; skin was sensitive; she felt like she had the flu; felt very sick; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via intramuscularly in left arm on 29Jan2021 at 10:50 am as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246), via intramuscularly in left arm on 08Jan2021 at 10:50 am as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 30Jan2021 at 00:00, patient experienced achy, weak, headache, eyes hurt, lethargic, whole body hurt, fever of 103 at highest. She also said on Saturday around 12:00 am, is when she felt very sick, her skin was sensitive. It was reported that Today, she still feels slightly dizzy, has a headache and slight aches. Patient also experienced dizziness. Sunday, her temperature went down to 99.2 degrees Fahrenheit. On 31Jan2021 at 07:00, patient experienced Swelling, itchy, hot to touch at injection site. She stated she doesn't typically have reactions to vaccines, and that symptoms are improving from peaking on Saturday 30Jan2021. She's wanting to know if these are normal and how long AEs might last. Today she still feels dizzy, has HA and slight aches. No duration is reported for other AE's. Referred to MD for treatment. She wanted to know if it was normal not to feel right after having the shot on Friday. She is a dental hygienist. She provided her weight as being between 145-150. NO ER or physician's office required. Patient medical history was reported as provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. The outcome of the event dizziness, felt very sick, felt like she had the flu, skin was sensitive was unknown and outcome of the events injections site reactions including: swelling itchiness, and warm to the touch was not recovered and outcome of the other events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Face oedema, Headache, Pain in extremity, Swelling face
Clinical narrative: bottom of face is still swollen- Feels like there's liquid in it; Had plastic surgery and those scars are redder today; headache; arm was hurting; swollen face/ swelling in face/ bottom of face is still swollen- Feels like there's liquid in it; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Jan2021 (Batch/Lot number was not reported) (at the age of 56-years-old) as 1STDOSE, SINGLE for covid-19 immunisation. Medical history included facial surgery/face lift on Nov2020 and plastic surgery from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously took botox on Nov2020. The patient stated that had a face lift in Nov2020 and her face was slow to heal. Patient reported a swollen face after receiving the first dose of the pfizer covid 19 vaccine along with a headache on 30Jan2021. Patient wanted to know was the swollen face because her facial surgery had not healed or was it a reaction to the vaccine. On Sat- 30-40 min later, patient had swelling in face and her arm was hurting yesterday- headache today and bottom of face was still swollen and Feels like there's liquid in it. In Nov caller had plastic surgery and those scars were redder today. Patient wanted to know what she could take for her headache that she thought was related to the pfizer covid 19 vaccine. The patient was enquiring about any information regarding the use of the pfizer-bioNTech covid-19 Vaccine in people who have cosmetic fillers or Botox. Patient stated that she never had anaphylaxis to a vaccine and she had face lift surgery in Nov. Wanted to know if she had an allergic reaction to the vaccine or if it was from the surgery and she was not fully healed. Also stated that her left arm was hurting yesterday but was fine today. Outcome of the events swollen face/swelling in face/ bottom of face is still swollen- Feels like there's liquid in it and headache was not recovered. Outcome of the events arm was hurting, bottom of face is still swollen- Feels like there's liquid in it and had plastic surgery and those scars are redder today was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: diarrhea; blotchy red rash; Nauseous; chills; fever; wheezing; This is a spontaneous report from a contactable consumer or other non-health care professional. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number: not reported), intramuscular in left arm on 27Jan2021 at 14:00 (at the age of 38-years-old) as 1st dose single for COVID-19 immunization. It was reported that patient was not getting the vaccine at the hospital but at the local facility. Patient's medical history was reported as none. Concomitant medications were not reported. Patient did not had vaccine prior to vaccination in four weeks. On 27Jan2021, (After the first vaccine last Wednesday and right afterward), patient developed a blotchy, red rash on chest and collarbone less that 10 minutes after getting it. Patient mentioned that she reported it to the observer and they said that it looked like a reaction and she was given a Benadryl. After 40 minutes it was going away and she was sent home. She said that she took another Benadryl after she went home. The rash went away and had not come back. On the same day, patient reported that she also felt really nauseous (had a feeling of sick) that night, chills occurred few hours after the injection probably around 1800 and a fever of 99.9. Patient reported that the chills were extreme and she was layered with clothing and she was still freezing. She has never had that happened before. She took Tylenol for her chills and fever. On 28Jan2021, the patient had diarrhea. On an unspecified date in Jan2021, the patient had wheezing. The patient reported that she was scheduled for the second dose on 17Feb2021. She did a follow up phone appointment with her doctor because she was worried. Her doctor told her to contact Pfizer concerning her symptoms because they were unsure. Patient wanted to know if it was contraindicated to get the second dose, if the second dose would be worse and if the symptoms contraindicated for the second dose. It was reported that patient mentioned that a Vancomycin (intravenous (IV) antibiotic, Lot, NDC, or expiry date: Not available) had before given her a similar reaction. Outcome of the blotchy, red rash, chills (went away within hour) and fever was recovered on 27Jan2021. Patient did not have fever later that evening or the next day, recovered from nauseous (in the evening) and diarrhea on 28Jan2021 and for wheezing was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Wheezing
Clinical narrative: diarrhea; blotchy red rash; Nauseous; chills; fever; wheezing; This is a spontaneous report from a contactable consumer or other non-health care professional. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number: not reported), intramuscular in left arm on 27Jan2021 at 14:00 (at the age of 38-years-old) as 1st dose single for COVID-19 immunization. It was reported that patient was not getting the vaccine at the hospital but at the local facility. Patient's medical history was reported as none. Concomitant medications were not reported. Patient did not had vaccine prior to vaccination in four weeks. On 27Jan2021, (After the first vaccine last Wednesday and right afterward), patient developed a blotchy, red rash on chest and collarbone less that 10 minutes after getting it. Patient mentioned that she reported it to the observer and they said that it looked like a reaction and she was given a Benadryl. After 40 minutes it was going away and she was sent home. She said that she took another Benadryl after she went home. The rash went away and had not come back. On the same day, patient reported that she also felt really nauseous (had a feeling of sick) that night, chills occurred few hours after the injection probably around 1800 and a fever of 99.9. Patient reported that the chills were extreme and she was layered with clothing and she was still freezing. She has never had that happened before. She took Tylenol for her chills and fever. On 28Jan2021, the patient had diarrhea. On an unspecified date in Jan2021, the patient had wheezing. The patient reported that she was scheduled for the second dose on 17Feb2021. She did a follow up phone appointment with her doctor because she was worried. Her doctor told her to contact Pfizer concerning her symptoms because they were unsure. Patient wanted to know if it was contraindicated to get the second dose, if the second dose would be worse and if the symptoms contraindicated for the second dose. It was reported that patient mentioned that a Vancomycin (intravenous (IV) antibiotic, Lot, NDC, or expiry date: Not available) had before given her a similar reaction. Outcome of the blotchy, red rash, chills (went away within hour) and fever was recovered on 27Jan2021. Patient did not have fever later that evening or the next day, recovered from nauseous (in the evening) and diarrhea on 28Jan2021 and for wheezing was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: little by little, she developed a cold; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 77; Units: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Jan2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccine little by little, she developed a cold. The event was assessed as non serious. Patient second dose was scheduled on 05Feb2021 (reported as this friday). She enquired whether if it is okay if she receives the vaccine with a cold. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Malaise, Nausea
Clinical narrative: sweating; not feeling well/Feeling pretty poorly; Dizzy; Nauseous; This is a spontaneous report from a contactable consumer via medical information team. This is three of three reports. A male patient (physician) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Unknown) via an unspecified route of administration on an unspecified date at 07:00 as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Unknown) via an unspecified route of administration on an unspecified date for COVID-19 immunization. On unspecified date, on the of vaccination the patient was scheduled to perform surgery at 08:00. About 08:00-09:00 on the day of vaccination the patient started feeling pretty poorly, not feeling well, sweating, dizzy and nauseous to the point that patient had to postpone the surgery he was supposed to perform. The consumer reported that was a pretty extreme reaction to the vaccine. The clinical outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: very sore arm at the injection site; very sore arm at the injection site; This is a spontaneous report from a non-contactable consumer(patient). This 61-year-old male patient reported that he received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 17Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient (frontline worker), received his first dose of the Pfizer COVID vaccine on 17Jan2021. On an unspecified date the patient had a very sore arm at the injection site which he was never had with a vaccine before, and the patient had no side effects except these. The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Pyrexia
Clinical narrative: fever of 101; joint pain; diarrhea; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via intramuscular route of administration on 26Jan2021 at 10:00 (at the age of 82-year-old) as first dose, single in left arm (shoulder) for COVID-19 immunization. The patient's medical history included breast cancer. Concomitant medications were not reported. Patient was healthy before vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021 at night, on the day of vaccination, the patient had diarrhea. On Wednesday she felt fine. On 28Jan2021 Thursday, the patient experienced joint pain, on only her thigh in the left leg and noticed fever which was at 100.1 on 31Jan2021, Sunday morning. Patient took aspirin and it went down. On 01Feb2021, her temperature was normal and was 97.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 100.1 Fahrenheit on 31Jan2021, body temperature: 97.5 Fahrenheit on 01Feb2021, which was normal. The clinical outcome of the event joint pain was recovering and outcome of all other events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Body temperature increased, Chills, Dysgeusia
Clinical narrative: chills; Nausea; Backache; fever/low grade temp of 99.5; took her temperature and measured 99.6F; stated that she has been really fairly ill/being sick; metallic taste; mild soreness in her arm; This is a spontaneous report received from a contactable Consumer(patient) via medical information team. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 27Jan2021, after 15 minutes of vaccination, the patient experienced having a metallic taste and mild soreness in her arm. On 29Jan2021, the patient ended up being sick at work, stated that she was been really fairly ill experienced chills, nausea, backache, fever. She took alternating dosages of Advil and Tylenol as prescribed by her doctor. Right now, she took her temperature and measured 99.6 F. She mentioned that she normally had low grade temperature 99.5 F in temperature. She was curious if the response was from the vaccine. The patient wanted to know if it would continue longer or may be something else. Stated that she was fine. Stated that anytime she was put under anesthesia that she gets sick. No further details provided. Does not know if what in the vaccine is similar to that. Wanted to know if she was good to go. Stated that she assumed it was a response but wanted to double check before she goes into work tomorrow. Wanted to know how long the response would last. Later clarified that it was for the Covid vaccine. Outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: chills; Nausea; Backache; fever/low grade temp of 99.5; took her temperature and measured 99.6F; stated that she has been really fairly ill/being sick; metallic taste; mild soreness in her arm; This is a spontaneous report received from a contactable Consumer(patient) via medical information team. A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On 27Jan2021, after 15 minutes of vaccination, the patient experienced having a metallic taste and mild soreness in her arm. On 29Jan2021, the patient ended up being sick at work, stated that she was been really fairly ill experienced chills, nausea, backache, fever. She took alternating dosages of Advil and Tylenol as prescribed by her doctor. Right now, she took her temperature and measured 99.6 F. She mentioned that she normally had low grade temperature 99.5 F in temperature. She was curious if the response was from the vaccine. The patient wanted to know if it would continue longer or may be something else. Stated that she was fine. Stated that anytime she was put under anesthesia that she gets sick. No further details provided. Does not know if what in the vaccine is similar to that. Wanted to know if she was good to go. Stated that she assumed it was a response but wanted to double check before she goes into work tomorrow. Wanted to know how long the response would last. Later clarified that it was for the Covid vaccine. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-years-old female patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller mentioned she received the Pfizer-BioNTech COVID-19 Vaccine Dose 1 and reported to have had a sore arm. She got the second dose and reported having sore arm and severe headache. She took ibuprofen (2 capsules at 4:30AM, 2PM and 3PM after the shot) and eventually the headache resolved. The caller asked if it was okay to take ibuprofen or this would have compromised the vaccine. The caller asked whether she could use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She received the response which included the interim  guidelines note that, & quot; Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms was not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses was not available at this time.& quot;  If she was the patient, she should discuss that with her healthcare provider. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: broke out in a rash all over her body; hives; she is still itching; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: ELK3302, Expiration Date: not reported) via an unspecified route of administration in left arm on 28Jan2021as a single dose for COVID-19 immunization. Patient historical vaccine included 1st dose of BNT162B2. Patient had not received other vaccines on the same day as the COVID vaccine. Medical history included high blood pressure. Concomitant medication(s) included metoprolol. The patient experienced, broke out in a rash all over her body was reported as worsened, hive and she is still itching on 28Jan2021. The clinical outcome for the events was not recovered.  Additional Context: the patient stated that she had her second COVID shot and broke out in a rash all over her body and also stated that it started on Thursday and she was still itching. The patient mentioned that she went to her doctor, and the doctor thought that maybe the patients hands were just from dishwashing but the patient stated that it was her whole body. The patient stated that she asked the doctor for a Benadryl shot, but the doctor told her she can't take Benadryl with the shot, and was asking whether it was true. The patient did not know how to get rid of the hives. The patient stated that the first dose was okay, but this one was hell. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Fatigue, Feeling abnormal, Malaise
Clinical narrative: like someone sucked all the energy out of her; have general feeling of not feeling well; muscle pain; I am so tired I can hardly go; She is 5 feet 5 inches now, she is shrinking; aching; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FN5318 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 (at the of 83-year-old), as single dose for COVID-19 immunization. Medical history included atrial fibrillation from Apr2016 to an unknown date. Concomitant medications included apixaban (ELIQUIS) 5 mg , twice daily, taken for atrial fibrillation from Apr2016 and ongoing and blood thinner. The patient reported that she had her first dose of vaccine on Saturday 30Jan2021 and on 01Feb2021, the patient got up during the night and noticed she was so tired she can hardly go, she also experienced muscle pain, felt unwell like someone sucked all the energy out of her. so tired can hardly go, I have muscle pain, have general feeling of not feeling well, On an un-known date, she also experienced aching. It was also reported that the patient was 5 feet 5 inches and was shrinking. The reporter wanted to know if this could be related to the vaccine and how long does it last. The patient reported she was hurt so bad she was treated her symptoms with Advil. Declines to provide HCP information. NDC and expiration date unknown, not listed on card. The reporter stated that the Lot number starts with either E or F and clarified it as F. She also had difficult time with the last number to the lot number, stated that it could possibly be K, but reported it as 8. The outcome of the events so tired she can hardly go, muscle pain, felt unwell like someone sucked all the energy out of her was reported as recovering, while events aching and shrinking were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: like someone sucked all the energy out of her; have general feeling of not feeling well; muscle pain; I am so tired I can hardly go; She is 5 feet 5 inches now, she is shrinking; aching; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FN5318 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 (at the of 83-year-old), as single dose for COVID-19 immunization. Medical history included atrial fibrillation from Apr2016 to an unknown date. Concomitant medications included apixaban (ELIQUIS) 5 mg , twice daily, taken for atrial fibrillation from Apr2016 and ongoing and blood thinner. The patient reported that she had her first dose of vaccine on Saturday 30Jan2021 and on 01Feb2021, the patient got up during the night and noticed she was so tired she can hardly go, she also experienced muscle pain, felt unwell like someone sucked all the energy out of her. so tired can hardly go, I have muscle pain, have general feeling of not feeling well, On an un-known date, she also experienced aching. It was also reported that the patient was 5 feet 5 inches and was shrinking. The reporter wanted to know if this could be related to the vaccine and how long does it last. The patient reported she was hurt so bad she was treated her symptoms with Advil. Declines to provide HCP information. NDC and expiration date unknown, not listed on card. The reporter stated that the Lot number starts with either E or F and clarified it as F. She also had difficult time with the last number to the lot number, stated that it could possibly be K, but reported it as 8. The outcome of the events so tired she can hardly go, muscle pain, felt unwell like someone sucked all the energy out of her was reported as recovering, while events aching and shrinking were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 12 days after patient was tested positive with covid 19/she had COVID 19; This is a spontaneous report from a contactable nurse (patient) via medical information team. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Dec2020 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient said she got the first dose of the vaccine last 17Dec2020. 12 days after patient was tested positive with covid 19/she had COVID 19 on 29Dec2020. patient also added she was scheduled to get the second dose of the vaccine last 07Jan2021 but was not able to get it. The doctors are not sure if she can get it at any point. She would like to know if she needs to wait 3 months so they can check her antibodies and then get it or not. Another doctor said when she does start, she should get first dose again and then a second. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: has a horrible headache; Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller states she received the first dose of the Pfizer COVID vaccine on Saturday 30Jan2021. Caller states she had typical side effects to include a sore arm and fatigue on an unspecified date in 2021. Caller states today (01Feb2021) she has a horrible headache. Caller would like to know if she could take one of her regular medications that she takes when she gets a headache called Sumatriptan. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Experienced an injection site reaction that included redness about 3 inches both above and below the injection site; Experienced an injection site reaction that included swelling about 3 inches both above and below the injection site; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech covid-19 vaccine, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Jan2021 (at the age of 75-year-old), as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter called on behalf of her mom, who received the first dose of Pfizer-BioNTech COVID-19 vaccine last Monday, 25Jan2021. On an unknown date in 2021, the patient developed an injection site reaction that included redness and swelling about 3 inches both above and below the injection site. No other symptoms noted. It was asking whether the patient would receive the second dose or not. The outcome of both events was unknown.  Information about Batch/Lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Caller had noticed numbness around the life side of her body including the left hand and fingers; Tingly from her scalp to the bottom of her foot; Numbness around the life side of her body/The entire left side of her body, unilaterally, went numb; This is a spontaneous report from a contactable consumer. A 77-year-old female consumer received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on Arm left on 23Jan2021 (Batch/Lot number: EL3249), as 1ST DOSE, SINGLE for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported, she noticed numbness around the left side of her body including the left hand and fingers. The fingers are more numb than any other part of the body on 23Jan2021. She states My doctor thinks it's some kind of a vascular or neurological event. He doesn't recommend the second dose. I want to know if these side effects were associated with the vaccine. The entire left side of her body, unilaterally, went numb and tingly from her scalp to the bottom of her foot. It was first noticed in the hand. She called (Emergency number) as she feared a stroke. They said it was not a stroke. Her hand is still considerably dumb and she has lost some of its use. This occurred approximately 7 hours after getting the vaccine. It has improved. Everything is back to normal besides her left arm from where she got the injection leading down to her hand. Her hand is the worst. The outcome of the events for numbness in hand was unknown and for rest of event it was resolving.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine headache / she can feel like a migraine coming on; This is a spontaneous report from a contactable consumer via Pfizer sponsored program.   A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No 9264, Expiry date May2021), via an unspecified route of administration on 29Jan2021 as single doe for COVID-19 immunisation. Patient medical history included migraine. Concomitant medication of the patient not provided. Patient received COVID vaccine today (reporting day, 29Jan2021), and has a question, she was looked everywhere, she didn't want to bother anyone, but she gets migraine headaches, because of all this hype, she was a little bit of a migraine, can she take Excedrin Migraine after she has had the injection? Patient stated that she can feel like a migraine coming on, this was common for her, to have a migraine, otherwise she was fine, no sore arm, no fever, she was feeling fine. If she does get a migraine, could she take it? Whoever she talked to before, she asked this and they said they would put her through to who would be able to answer it, she has been on hold over an hour, she was on the phone with them for 40 minutes and they read this whole long thing off to her, read this whole proclaimer off, and asked her a million questions, put her on hold, and said they had to transfer. At the time of this report event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Intentional overdose, Pain in extremity
Clinical narrative: Sore arm; Pharmacist administered the shot a little bit higher in the arm of an HCP, so the HCP/Patient asked to repeat it again and the Pharmacist gave the shot again; Pharmacist administered the shot a little bit higher in the arm of an HCP, so the HCP/Patient asked to repeat it again and the Pharmacist gave the shot again; This is a spontaneous report from a Pfizer-sponsored program by a contactable other health care professional (patient). A female patient of unknown age received first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection) via unknown route of administration on an arm, on an unknown date in Jan2021 as FIRST DOSE, SINGLE for COVID-19 immunisation. The medical history and concomitant medication were not reported. It was reported that a pharmacist administered the shot a little bit higher in the arm of a health care professional, so the health care professional(patient) asked to repeat it again and the pharmacist gave the shot again on an un-specified date in Jan2021. The reporter enquired weather it can be considered as double dose. On PRD 03Feb2021 it was reported, phone out 11:18 PM EST. 2nd attempt for Vaccine Call with HCP 1st tab. Call answered by HCP who stated she was busy and could not take the call but suggested to send the forms by email. HCP stated the patient had experienced sore arm. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable Other HCP. This Other HCP reported via telephonic follow-up activity that included: event (sore arm).   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Pain
Clinical narrative: Fatigue; body aches; joint pain; severe chills (painful); low grade fever; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 39-year-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) intramuscular, administered in left arm on 12Jan2021 at 18:30 pm (age at vaccination was 39 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. Medical history included cavernous hemangioma and dermatographia. The patient had known allergy to Sulfa. Concomitant medications were not reported. On 13Jan2021 at 11:00 am, the patient experienced fatigue, body aches, joint pain, severe chills (painful) and low grade fever. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was resolved on an unknown date in 2021.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue; body aches; joint pain; severe chills (painful); low grade fever; This is a spontaneous report from a contactable nurse (patient) reported for herself.  A 39-year-old female patient (patient was not pregnant at the time of vaccination) received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) intramuscular, administered in left arm on 12Jan2021 at 18:30 pm (age at vaccination was 39 years) as UNKNOWN, SINGLE DOSE for COVID-19 immunization. Medical history included cavernous hemangioma and dermatographia. The patient had known allergy to Sulfa. Concomitant medications were not reported. On 13Jan2021 at 11:00 am, the patient experienced fatigue, body aches, joint pain, severe chills (painful) and low grade fever. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was resolved on an unknown date in 2021.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.