chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: I have lumps above, on and below my lips since my second Covid vaccination; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced i have lumps above, on and below my lips since my second COVID vaccination on an unspecified date. Patient reported that, this was not letting her write more than a few words. The patient had lumps above, on and below her lips since second COVID vaccination. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Incoherent, Somnolence
Clinical narrative: neither she nor her husband could wake up their son for school; Her son was not coherent this morning; This is a spontaneous report from a contactable consumer (parent) or other non hcp.  A 15-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21May2021 16:00 (at the age of 15-Years-old) as dose 1 single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines Administered on Same Date of the Pfizer Suspect. AE not resulted in visit to emergency room or physician office. No AE following prior vaccinations. No family history relevant to AE provided. The patient experienced neither she nor her husband could wake up their son for school and her son was not coherent this morning on 25May2021. Caller stated her 15-year-old son received the first dose of Pfizer's COVID vaccine on Friday, 21May2021 with no symptoms, fever, or discoloration. Caller stated, my son has been sleeping for the last 13 hours (he slept at midnight). This morning we could not wake him up for school for 3 hours. patient mother said her son had no symptoms after receiving his first COVID-19 Vaccine, but on 25May2021, neither she nor her husband could wake up their son for school. She said her son was just getting up now after 1:00PM. She said both she and her husband tried to wake their son up over a couple hours, and it was impossible to wake up their son. she wanted to know if what her son experienced was related to the COVID-19 Vaccine, and if there were any other symptoms she should watch for. she said she and her husband tried waking their son by taking down their son's blankets and shaking him. She said her son was not coherent this morning. She said neither she nor her husband were that concerned that their son was in danger because their son was breathing fine and had no fever. Caller was advised she would be transferred for further assistance. Reported her son had some diagnostic testing coming up on Thursday (27May2021) for ADHD, or anything else with that. she felt that her son's ADHD testing was more adolescent related. No further details provided. Reported her son woke up after 1:00PM and came out of his room to ask to use his phone, and then he went back into his room. No relevant tests were reported. The outcome of the reported events were recovered.  Follow-up (26Jul2021) No follow-up attempts are possible. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival abscess, Gingival pain, Pain, Pruritus
Clinical narrative: gum sore and abscess; gum sore and abscess; itchiness; pain; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 55-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 (age at the vaccination 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergy (patient has seasonal allergies and taking nasal decongestant). The patient concomitant medications were not reported. Patient has a dental appointment on 04Jun2021 due to gum sore and abscess. patient 2nd dose will be on 10Jun2021. Patient wants to know if there will be any issues with the vaccine since she might take antibiotics and Ibuprofen after consultation. patient experienced itchiness and pain on an unspecified date in 2021. Patient taking Tylenol for itchiness and pain. The outcome of the events gums sore, and abscess was not recovered and unknown for another events.  Information on lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Urethritis noninfective
Clinical narrative: UTI-like symptoms (irritation and burning); UTI-like symptoms (irritation and burning); This is a spontaneous report from a contactable consumer (husband reported for his wife). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an intramuscular route of administration, administered in Arm Left on 08Apr2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were none. Family medical history Relevant to AE(s) was none. Patient medical history (including any illness at time of vaccination) was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route (injection) of administration, administered in Arm Left on 21Mar2021, as single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer Suspect were none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. AE(s) following prior vaccinations was not provided. On 28Apr2021, the patient experienced UTI-like symptoms (irritation and burning). The clinical details of the events as follows: Reporter stated that he and his wife received their second Pfizer Covid vaccine doses on 08Apr2021. They have both been experiencing UTI-like symptoms including irritation and burning) that have not resolved. Reporter stated that his wife symptoms began around the same time as his. It was pretty much identical. Started at the same time and are ongoing and persisting. Reporter stated she mentioned something to him about it just in the past Sunday. The patient went to the gynecologist for Urinary tract infection symptoms, where no blood work or urinalysis were performed. She was trying to go to her regular doctor for testing. No Relevant Tests performed. The events did not result a visit to Emergency Room. No Investigation assessment provided. The outcome of the events was not resolved at the time of this report.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: chills; tired; headache; feels cold so cold; checking her temperature and it is 101.7; she feels awful today; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, NDC number, expiry date: not provided), dose 2 via an unspecified route of administration on 24May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, NDC number, expiry date: not provided), dose 1 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she (68 years old) received Pfizer covid vaccine second dose yesterday and on an unspecified date in May2021, the patient feels awful today and that she woke up cold and had chills, patient was tired, and has a headache. The patient was still tried to go about her day but feels so cold and that it feels like she was catching a cold and has chills. States the patient took her temperature a while ago and it was 101.7 degrees Fahrenheit on May2021. Therapeutic measures were taken as a result of the events with extra strength Tylenol. Outcome of the events was unknown.  Additional information on the lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: chills; tired; headache; feels cold so cold; checking her temperature and it is 101.7; she feels awful today; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, NDC number, expiry date: not provided), dose 2 via an unspecified route of administration on 24May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown, NDC number, expiry date: not provided), dose 1 via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she (68 years old) received Pfizer covid vaccine second dose yesterday and on an unspecified date in May2021, the patient feels awful today and that she woke up cold and had chills, patient was tired, and has a headache. The patient was still tried to go about her day but feels so cold and that it feels like she was catching a cold and has chills. States the patient took her temperature a while ago and it was 101.7 degrees Fahrenheit on May2021. Therapeutic measures were taken as a result of the events with extra strength Tylenol. Outcome of the events was unknown.  Additional information on the lot/batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her mid legs and around her knees; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0202) via an unknown route of administration (at the age of 27 years old) on 23May2021 at 15:30pm as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  On an unknown date, the patient experienced rash on her mid legs and around her knees. The patient stated that she received the second dose of her Pfizer COVID 19 vaccine at around 3:30 pm. Since then patient has been experiencing a rash on her mid legs and around her knees. It was 2-3 inches in length and on the front and back of her legs. Patient found information on injection site reactions but was not sure if other had experienced rashes on parts of their body not related to the injection site. The outcome of the event was reported as unknown.  Consumer was not willing to complete the report. Hence, limited information available.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: has a temperature of 100.8; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0175) via an unspecified route of administration, administered in Arm Left on 24May2021 at 10:30 am as dose 2, single dose for covid-19 immunization (at the age of 78-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0175) via an unspecified route of administration, administered in Arm Left on 03May2021 at 10:30 am as single dose for covid-19 immunization (at the age of 78-years-old). It was reported that after receiving the second dose of vaccine, the patient had a temperature of 100.8 on 25May2021 morning. He also stated that he had no other symptoms and was asking what he should do. On 25May2021, the patient underwent lab tests and procedures which included body temperature which result showed 100.8. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Restless legs went away after Covid Vaccine; This is spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Covax US Support. A male patient of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Un-known) both via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunisation. The patient medical history included ongoing restless legs syndrome (has restless legs and has had it for most of his life, 20 years). The patient concomitant medications were not reported. The patient experienced that restless legs went away after he had the first Pfizer Covid Vaccine. It was about 4 months prior. Patient got the second vaccine, and it was coming back a little bit but not as bad as it was. Patient stated that the Covid vaccine made his restless legs better. Patient asked if he can get a third vaccine. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Inappropriate schedule of product administration, Lymphadenopathy, Nausea
Clinical narrative: Left armpit pain; Feels like swollen lymph nodes; Nausea; Chills; Left arm pain; Dose 2 administration date 23May2021; Dose 2 administration date 23May2021; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0185) via an unspecified route of administration in left arm on 23May2021 at 15:00 (at the age of 53-years-old) as single dose for COVID-19 immunization. Medical history of the patient included Hyperactive bladder from an unknown date and unknown if ongoing. Patient had no known allergies. Other medications (concomitant) in two weeks included mirabegron (MYRBETRIQ) taken for an unspecified indication, start and stop date were not reported; solifenacin succinate (VESICARE) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: unknown) via an unspecified route of ad-ministration in left arm on 31Mar2021 as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 23May2021 at 17:00, patient experienced left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain. Treatment received in response to the events included Motrin. Outcome of the events Left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain was not recovered.  Follow-up attempts are needed. further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity
Clinical narrative: Left armpit pain; Feels like swollen lymph nodes; Nausea; Chills; Left arm pain; Dose 2 administration date 23May2021; Dose 2 administration date 23May2021; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received second dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0185) via an unspecified route of administration in left arm on 23May2021 at 15:00 (at the age of 53-years-old) as single dose for COVID-19 immunization. Medical history of the patient included Hyperactive bladder from an unknown date and unknown if ongoing. Patient had no known allergies. Other medications (concomitant) in two weeks included mirabegron (MYRBETRIQ) taken for an unspecified indication, start and stop date were not reported; solifenacin succinate (VESICARE) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine in four weeks. Patient previously received first dose of PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: unknown) via an unspecified route of ad-ministration in left arm on 31Mar2021 as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 23May2021 at 17:00, patient experienced left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain. Treatment received in response to the events included Motrin. Outcome of the events Left armpit pain, feels like swollen lymph nodes, nausea, chills, left arm pain was not recovered.  Follow-up attempts are needed. further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Fatigue, Illness, Menstrual disorder
Clinical narrative: Not having period; Fatigue; Coughing; Started getting sick; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 44-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 06May2021 (Batch/Lot Number: EW0773) as dose 1, single for COVID-19 immunisation. Patient medical history included skin infection. Concomitant medications included prednisone for skin infection, 20 mg tablet once daily from 22Apr2021 to 01May2021. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that, she had diarrhea starting on 06May2021 for 2 weeks, that just stopped on the 21May2021. She started getting sick two or three days after vaccine on 10May2021 at around 09.00 AM. She did not know if it was related or not. She had been sick for almost three weeks and had several different symptoms. She was never sick and never had the flu or cold in 3 years and after the covid vaccine she was sick in 3 days, it was on-going, it got worse a week after it started, around 18May2021. She was having fever every morning and she took Tylenol and the fever went away but it came back every morning, She also experienced fatigue, and cough on 13May2021. She was wondering if she should get the second dose or not as she was due for it on Thursday. She had no treatment, just self-treatment like Tylenol, she didn't go to doctor. She was not having a period. She always took her birth control and was regular and she should've started her period on Sunday and she hadn't started yet. She knew she was not pregnant. The outcome of the event of diarrhea was recovered on 21May2021. The outcome of the events of sickness, fatigue, fever and cough was not recovered. The outcome of not having period was unknown.  Follow-up attempts needed. Further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Not having period; Fatigue; Coughing; Started getting sick; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 44-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 06May2021 (Batch/Lot Number: EW0773) as dose 1, single for COVID-19 immunisation. Patient medical history included skin infection. Concomitant medications included prednisone for skin infection, 20 mg tablet once daily from 22Apr2021 to 01May2021. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that, she had diarrhea starting on 06May2021 for 2 weeks, that just stopped on the 21May2021. She started getting sick two or three days after vaccine on 10May2021 at around 09.00 AM. She did not know if it was related or not. She had been sick for almost three weeks and had several different symptoms. She was never sick and never had the flu or cold in 3 years and after the covid vaccine she was sick in 3 days, it was on-going, it got worse a week after it started, around 18May2021. She was having fever every morning and she took Tylenol and the fever went away but it came back every morning, She also experienced fatigue, and cough on 13May2021. She was wondering if she should get the second dose or not as she was due for it on Thursday. She had no treatment, just self-treatment like Tylenol, she didn't go to doctor. She was not having a period. She always took her birth control and was regular and she should've started her period on Sunday and she hadn't started yet. She knew she was not pregnant. The outcome of the event of diarrhea was recovered on 21May2021. The outcome of the events of sickness, fatigue, fever and cough was not recovered. The outcome of not having period was unknown.  Follow-up attempts needed. Further information is expected.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Pyrexia
Clinical narrative: Headache; Fever; I was so tired after I got the first shot; I was feeling sick; This is a spontaneous report from a contactable consumer (patient). A 49-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EBK33, UPC/ NDC number / Expiry Date of COVID Vaccine: Unknown), via an unspecified route of administration on 02Apr2021 (at the age of 49 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in Apr2021, the patient had experienced headache and fever, was so tired after the first shot, for next sixteen hours and felt sick. The patient took Paracetamol (TYLENOL) and everything was perfect. On an unknown date in 2021, the outcome of the events was resolved.   Information on Lot/Batch number is available; Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache/ headache all the day/ head hurt more; Body ache; This is spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/ lot number and expiration date were not reported (consumer stated KW0171, patient don't know it's, see patient could not read those 31. May be its 0171; O or D, patient don't know), NDC number, UPC number and Expiration date: Unknown), via an unspecified route of administration on an unspecified date in May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0167), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced sick for 2 days with fever and like a flu type symptoms. It was reported that the patient had second dose of the Pfizer shot on Friday (on an unspecified date in May2021). Patient got like headache and body ache on an unspecified date in May2021, but body ache was away, but headache did not seem to, it was not a severe or worst, but you know was bothering. The patient body ache was gone but headache like not on the temple kind of thing and still experiencing. The patient did not want medical and wanted to know that was still part of this. The patient has been a day off from work for, patient mean they gave a day off, but patient have had 3 days off then the patient was experiencing all days off headache all day. The patient wanted to report but did not need go through hospital. The patient just wanted to know was that part of the side effects that people were experiencing. The patient further stated that the head hurt more on talking with Pfizer drug safety. Patient stated, "patient was calling because patient was wondering, had second dose on Friday and patient was experiencing body ache and headache, body aches went away but headaches patient was still experiencing. Since, patient mean it's already been what Friday Saturday Sunday Monday and today Tuesday and patient was still getting, patient was still having headaches." The patient enquired was this a part of a side effect because the headache did not want to go away. The outcome of the event headache was not resolved and resolved on an unspecified date in May2021 for the other event.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pyrexia
Clinical narrative: The first I was sick for 2 days with fever; Fever; Flu-type symptoms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EW0167) via unknown route of administration on unspecified date as dose 1 single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that after first I was sick for 2 days with fever. The first one was fever and like a Flu-type symptoms. I was like in bed for 2 days. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Did hurt 1 day; This is a spontaneous report from a contactable consumer (patient relative). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that my niece (withheld) took shot of Pfizer and did hurt one day and that was it. The outcome of the event was recovered on an unspecified date.  Information on the lot/batch number has been requested
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever like 101; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 24May2021 (at age of 22-year-old) as dose 2 single for COVID-19 immunization. Medical history and Concomitant medication were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) on 03May2021 (at age of 22-year-old) for COVID-19 immunization. It was reported that patient had been having a fever like 101 on 25May2021 and she gave him Ibuprofen and Advil and today he will work. She stated she was not sure if he has a fever or not. She confirmed her son received the Pfizer Covid vaccine for both doses. Caller states she was thinking maybe he needs another one. The outcome of event was unknown.  Information about batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: after her first dose she experienced lower back pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She mentioned that after her first dose she experienced lower backpain. She mentioned that she and her husband had the first dose on 06May2021 and would like to know when they will get the second dose.  The outcome of the event was unknown.  Follow up attempts are needed. Information about lot/batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021606338 different patient, same drug and event.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Since receiving my second dose of the Pfizer vaccine I have not had a headache; This is a spontaneous report received from consumer (patient) from a Pfizer sponsored program. A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 2, single for covid-19 immunisation. The patient medical history included headache, migraines from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient stated that had severe headaches and migraines all my life. Since receiving my second dose of the Pfizer vaccine I have not had a headache since. The outcome of the events was unknown.  Follow attempt needed. Information related to lot/batch no. has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash and some hives all over his arms; Rash and some hives all over his arms; This is a spontaneous report from a contactable consumer. This consumer reported for her boyfriend (patient). A 52-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry Date was not reported), via an unspecified route of administration on 21May2021 (at the age of 52-year-old) as single dose for covid-19 immunization. Medical history included Blood pressure high. Concomitant medication included valsartan taken for Blood pressure high. Reporter stated, "The RX number is 166. The LOT# it looks like she cannot read it very well. It looks like it is PFRE000177. You know what that could be EW. It is just hard to read this writing. She do not know if it was EW 0177 or if it was E000177. Reporter stated, "Actually she had a question. Her boyfriend and she went on Friday to get their Pfizer shot, the first one and he had some like a rash and some hives all over his arms (May2021). Would it be okay for him to take Benadryl and also stated, no treatment was received as they haven't gone to the Doctor because she did not know if they can give him Benadryl or she mean that he just got like hives, know rash on his arms. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Eyelid ptosis, Fatigue, Weight
Clinical narrative: stated that his eye his eye is closed/drooped all the way down; tired; This is a spontaneous report from a contactable consumer (patient's wife). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 22May2021 11:00 (Age at vaccination 58 years) as dose number unknown, single for covid-19 immunisation. Medical history included hit with an airbag and his eye was shut (five years ago he was hit with an airbag and and his eye was shut. Stated that he went to the doctor and could not open it all of the way. Stated that for the last two years that he could open it and could see). The patient's concomitant medications were not reported. On 23May2021, the patient experienced stated that his eye is closed/drooped all the way down and on 22May2021, tired. It was reported that caller stated her husband received the Pfizer COVID vaccine on Saturday and since then his right eye has been completely closed. Consumer states since it is closed again like it was back then should he go to the emergency room. The reporter stated the patient was tired. Reporter stated once he got the shot he came home and he mentioned he was tired from the shot. Patient was received treatment for right eye has been completely closed. The event considered related to a medicinal product. The patient underwent lab tests and procedures which included body height: 171 on cm, weight: 61.23 kg. The clinical outcome of event stated that his eye his eye is closed/drooped all the way down was not recovered; while event tired was recovered on 24May2021.  Information of the lot/batch number has been requested.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Malaise, Nausea
Clinical narrative: Tiredness; Nausea; Feeling generally unwell, wimpy; loss of strength; This is a spontaneous report from a contactable consumer (patient). A 90-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186 and Expiration Date: unknown), via an unknown route of administration, administered in deltoid right on 21May2021 at around 14:00 (at the age of 90-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing congestive heart failure about 3 years ago from an unknown date. The patient concomitant medications were not reported. Patient was in the hospital several days before the vaccine for congestive heart failure and his doctor was unsure of the story on that. On 21May2021, shortly after injection patient experienced feeling generally unwell, wimpy, what he was bothering that, it would destroy his ability to do much of anything and had no opportunity for the treatment. On same day, an hour or two hours afterwards he felt tiredness, has loss of strength, barely getting around. It was worse on the day after the inoculation and now maybe slightly less, but still extremely excruciating. It was not going away. None treatment was received for this as he does not know how to do anything that's why he was calling but he was hard of hearing. At night on 21May2021, patient experienced nausea and then it went away rapidly. None treatment was received for this as he was not able to get a doctors appointment for weeks or months. Patient had not visited emergency room or physician office. Prior vaccination, patient has not received any other vaccine within 4 weeks. Outcome of events tiredness and loss of strength was unknown, feeling generally unwell, wimpy was not recovered and for nausea was recovered on 22May2021.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Dyspnoea
Clinical narrative: Chest pain; Breathing difficulty; Part of my body is like burning now; side of my body, my back is burning; This is a spontaneous report from a contactable consumer. A 18-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 (Batch/Lot Number: EW0183) as DOSE:1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced chest pain , breathing difficulty, part of my body is like burning now; side of my body, my back is burning. Consumer stated, I am having some side effects from my vaccine, chest pain and difficulty breathing and then a part of my body is like burning now. Do you know if it's an allergy? I don't know what it is? Consumer stated, Yeah, really bad chest pain like the first day I took it which goes away but today I am experiencing the back of my body really some it should I don't know, something wrong in my body. Consumer stated, the breathing that has gotten better but reactions today, side of my body, my back is burning. Consumer stated, I have just received the first shot. The date that was I believe that was 24MAY at, I believe that 2:05. Expiration Date of first dose of COVID Vaccine: Consumer stated, No, I don't see it expiration date, I only see the date I took the Vaccine. Consumer stated, I would say the first day I experience like chest pain and little difficulty to breathe and then that went away. That was the first day yes and the second day no symptoms and then the third day I have been just happen initially today just like the back of my body is like burning. Consumer stated, I believe on the right side, I got the shot on my right arm I believe. Consumer stated, all medical condition I have just allergies that is it. (Further not clarified. Hence, not captured in tab). Consumer stated, I have not taken any treatment. Consumer was informed about the for the concern and was provided with the number as ## and requested to dial the option 3 and informed about timings as 8AM to 8PM Monday to Friday and 9AM to 3PM Saturday and Sunday as per time. The outcome for the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fear
Clinical narrative: it is scaring the caller; shoulder hurt/joint pains in both legs; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On May2021 the patient experienced shoulder hurt/joint pains in both legs. On an unknown date the patient experienced it is scaring the caller. The patient stated that she got her vaccine a week ago and it was fine. The shoulder hurt, it's okay it doesn't bother her. 3 days after, the patient started to have joint pains in both legs and its growing and growing. The patient has to sit or go to bed every one hour. The patient is healthy. All of the doctors don't know what to do. The caller read online and saw that people who had this now cannot walk. This is a weird response of the body and it is scaring the patient. The patient wanted to know what she should do or if she needs to go to a specialist or get blood work done or what. The outcome of both the events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Hypoaesthesia
Clinical narrative: Breathlessness; Legs numb; Anxiety; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8734), via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:15 as DOSE 1, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Apr2021, after first shot 1 week later breathless ness and legs numb and went to ER. Thought it just an anxiety. Only after second shot realized more issues. Case was assessed as non-serious. There was no seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and Since the vaccination, was the patient did not diagnose with COVID-19. The outcome of the events was unknown.    Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Nausea
Clinical narrative: felt flush; dizzy; nauseous; a pounding in her head; She wants to know if the vaccine would cause any side effects with her glatopa medication.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, age at vaccination 49 years), dose 2 via an unspecified route of administration on 25May2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included glatiramer acetate (GLATOPA). The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization.The patient experienced felt flush, dizzy, nauseous, a pounding in her head, she wants to know if the vaccine would cause any side effects with her glatopa medication on 26May2021. Reported as, she got the second Pfizer COVID-19 Vaccine yesterday and when she took her glatopa today she felt flush, dizzy, nauseous, and a pounding in her head. She wants to know if the vaccine would cause any side effects with her glatopa medication. Outcome of the events were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness
Clinical narrative: Feeling weird; Head was hurting; Called out sick; This is a spontaneous report from a contactable consumer (patient's co-worker). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling weird, head was hurting and called out sick. It was reported that caller mentioned that she also had a coworker that was feeling weird and called out sick after the COVID vaccine. The patient's head was hurting, but she was fine after. The outcome of event head was hurting was recovered on an unspecified date whereas the outcome of events feeling weird and called out sick was unknown.  Information on the Lot/Batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Respiratory rate increased
Clinical narrative: Tired; Not wheezing but breathing fast; Heart beat was pumping; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported.   A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 as dose 1, 0.3 ml single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. It was reported that the patient got some kind of side effect that's why he was calling to record. He was in bed and he could feel his heartbeat was pumping (on06May2021) after that day in the evening until Saturday night between 08May2021 and 09May2021. On 10May2021 in the morning he felt normal. . After the first dose, for two days he was so tired (on 07May2021). He saw that it was one of the side effects. The patient also experienced not wheezing but breathing fast on 07May2021 after his first dose. The patient asked if he could take the second dose or not. Someone in his family was a doctor and he said to call that number to see if anyone had the symptoms. The patient did not want medication, he wanted to know if he should move to second dose or not. On 10May2021, the events were resolved.   No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: body chills; headache; soreness at the injection site; tiredness; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC number and Expiry date was not provided), via an unspecified route of administration, administered in left arm on 26May2021 18:30 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.   On 26May2021, the patient experienced tiredness. On 27May2021, the patient experienced headache, soreness at the injection site and body chills experienced on 28May2021. It was reported that after received the first dose of vaccination, the patient stated that she continued to work, but started experiencing tiredness. Patient reported the next day she experienced a headache and soreness at the injection site. Patient reported today that she had experienced body chills and a headache. Patient stated the injection site did not bother her anymore and she felt as if she wanted to cover up with a blanket. Patient didn't felt that bad when she woke up, but as the day progressed, she started feeling body chills. She was using a cold towel. Patient reported that she signed up for be safe and she has not received any notifications. Patient hope these side effects will go away tomorrow. Patient was asking if these was normal side effects. Reporter seriousness for the events reported unspecified. The outcome was reported unknown for all the events. Covid Vaccine was a Pfizer product. Covid Vaccine manufacturer was unspecified. Investigation assessment was not provided.  Information on the lot/batch number has been requested. Follow up letter has been generated for further information.