chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel like being on airplane; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel like being on airplane".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Chills; Body ache; Fever; I''ve been sick, I just feel so sick; Cold; Runny nose; Sore throat; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Tired"; CHILLS (non-serious) with onset 18Nov2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "Body ache"; PYREXIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "Fever"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "I''ve been sick, I just feel so sick"; NASOPHARYNGITIS (non-serious) with onset Nov2021, outcome "unknown", described as "Cold"; RHINORRHOEA (non-serious) with onset Nov2021, outcome "unknown", described as "Runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Sore throat". Additional information: Patient don't know where have it and where to put it. Patient was in bed and just feel so sick." Patient asked whether these were normal side effects or should patient need to go doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Chills; Body ache; Fever; I''ve been sick, I just feel so sick; Cold; Runny nose; Sore throat; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "Tired"; CHILLS (non-serious) with onset 18Nov2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 18Nov2021, outcome "unknown", described as "Body ache"; PYREXIA (non-serious) with onset 18Nov2021, outcome "unknown", described as "Fever"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "I''ve been sick, I just feel so sick"; NASOPHARYNGITIS (non-serious) with onset Nov2021, outcome "unknown", described as "Cold"; RHINORRHOEA (non-serious) with onset Nov2021, outcome "unknown", described as "Runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Sore throat". Additional information: Patient don't know where have it and where to put it. Patient was in bed and just feel so sick." Patient asked whether these were normal side effects or should patient need to go doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2021 18:30 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "chills"; FATIGUE (non-serious) with onset 11Feb2021, outcome "recovered" (12Feb2021), described as "extreme fatigue".  Additional Information: Prior vaccinations (within 4 weeks) was reported as none. Relevant tests was reported as none. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Restlessness, Speech disorder
Clinical narrative: Coughing; can't speak that good right now; Restless; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date 21Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "He has kidneys" (unspecified if ongoing), notes: He has kidneys; "he is diabetic" (ongoing), notes: he is diabetic; "rather emesis his body is just staining'" (unspecified if ongoing), notes: rather emesis his body is just staining'; "rather emesis his body is just staining'" (unspecified if ongoing), notes: rather emesis his body is just staining'. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset Nov2021, outcome "unknown", described as "Coughing"; SPEECH DISORDER (non-serious) with onset Nov2021, outcome "not recovered", described as "can't speak that good right now"; RESTLESSNESS (non-serious) with onset Nov2021, outcome "unknown", described as "Restless".  Additional Information: Is COVID-19 was Vaccine a Pfizer product. COVID-19 Vaccine manufacturer was unspecified. Dates for COVID-19 Vaccine Start and stop date was unspecified. NDC number of COVID-19 Vaccine was unknown. UPC number of COVID-19 Vaccine was unknown. Reason for no lot number of COVID-19 vaccine was patient was unwilling to complete the report. Expiry Date of COVID-19 Vaccine was unknown. Patient complained about her husband that he has kidneys (Further clarifications unknown) and he is diabetic (Intent: Medical history) and he has rather emesis his body is just staining (Further clarifications unknown) or what but today he got the arm booster (Pfizer COVID-19 Vaccine). He got his booster today (means yesterday) and noticed that he started a little coughing and cannot speak that good right now, restless.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.      No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: a few days later she was really tired for a couple of days; Slept more than she usually does; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 07Mar2021 02:00 (Lot number: EN6199) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing); "Arthritis" (ongoing); "Colitis" (unspecified if ongoing); "benign tremor in her left hand" (ongoing); "Hot flashes" (unspecified if ongoing); "high blood pressure" (ongoing). Concomitant medication(s) included: LIALDA; XELJANZ taken for arthritis; PROTRADON taken for tremor; ATORVASTATIN taken for hypertension; ASPIRINE. Vaccination history included: Bnt162b2 (1st dose, I had no reaction to the first two shots), for COVID-19 immunization, reaction(s): "I had no reaction to the first two shots". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "a few days later she was really tired for a couple of days"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Slept more than she usually does".  Additional information: The patient told that  she wanted to get the Pfizer Covid 19 vaccine booster shot but because she was on Xeljanz, her doctor said she would have to stop Xeljanz a week before and a week after. The patient got her first two shots of the Pfizer Covid 19 vaccine a few months ago and wanted to get the booster shot. The patient had no reaction to the first two shots until a few days later; she was just really tired for a couple of days and slept more than she usually do. The patient did not want to give up Xeljanz, which she took for arthritis, because she was scared  hands and fingers would swell and hurt and knuckles would get real big again. The first day, she took Xeljanz, it made all that go away. Her hands did not hurt and was able to do yarn work with Xeljanz. One day the caller went to bed at about 4:00 in the afternoon and slept all night long. The caller never felt anything else other than that. The caller got the Prolia shot a couple of weeks ago for bone density and that shot hurt.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 18:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Fever".  Additional Information: Is the patient also the reporter No. Is COVID 19 Vaccine a Pfizer product? Yes. Reason for no lot number: of COVID 19 Vaccine: Other: LOT: Reporter Stated, she had to go find the card. It is somewhere in her room, she do not have it with her. Reporter stated, her daughter was seven. She was starting seven in Jan. she got her first Pfizer dose in the Friday around 6 'O' clock evening and since Saturday she was running a fever. It was being already 4-5 days. she mean how many days this will last. Vaccine Name: Pfizer COVID 19 Vaccine While paraphrasing the concern: Reporter stated, Yes  2-3 days she understand but she started Saturday. Friday evening, she got the vaccine. Saturday she was having fever. Reporter was informed about the role of Pfizer Drug Safety. Reporter was informed about Pfizer Medical Information and provided with the contact information. In response to further probing: Reporter stated, No she do not have time since she did not have the information what to do, so she will call another number. Reporter was unwilling to complete the report. Thus further probing could not be done. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed. Hence limited information available over the call. Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Inflammation, Lymphocyte count, Platelet morphology, White blood cell count
Clinical narrative: heart issues; heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 18:40 (Lot number: FF2590) at the age of 47 years as dose 1, single and administered in arm right, administration date 13Nov2021 18:40 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues"; INFLAMMATION (non-serious), outcome "unknown", described as "heart inflammation". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After eating food she has started some rashes on her face and ears and again after eating the dinner she started again with some rashes on her face and the ears; After eating food she has started some rashes on her face and ears and again after eating the dinner she started again with some rashes on her face and the ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 27Nov2021 11:30 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), RASH (non-serious) all with onset 27Nov2021, outcome "not recovered" and all described as "After eating food she has started some rashes on her face and ears and again after eating the dinner she started again with some rashes on her face and the ears".   Follow-up (03Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: she is like breaking out in hives; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Nov2021 11:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for covid-19 immunisation. The following information was reported: URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "she is like breaking out in hives"; RASH (non-serious) with onset Nov2021, outcome "unknown", described as "Rash".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Nausea, Vomiting
Clinical narrative: Flushed; Vomiting; Nausea; Redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: FLUSHING (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Flushed"; VOMITING (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Vomiting"; NAUSEA (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Nausea"; ERYTHEMA (non-serious) with onset 25Nov2021 16:00, outcome "recovered" (Nov2021), described as "Redness".  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: I believe there were a couple of follow-ups sent to this throughout the week linked to the reference number. I am not sure the vaccine received, but I am 99% sure vaccinated.  Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she is now a very sick woman; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "not recovered", described as "she is now a very sick woman".  Additional Information: Please see report. The information provided was published online in a news website called (Site Name). The translation of the text follows. There is also a link with a video that contains the report and relevant video. Kindly acknowledge receipt. Shocking testimonies of women about the side effects of the Pfizer vaccine. A young woman and a mother of a girl in adolescence are the two witnesses who appear on the (withheld) show and testify their personal experience of the side effects of the Pfizer vaccine. But it is not a simple narrative. We are dealing with a shocking description of how a woman and a teenage girl, suddenly, unjustifiably and inexplicably saw their lives fall apart. She is the teenager you is not able to speak and instead her mother explains the facts and tells the story. The narration begins from the first moment of receiving the vaccine and follows a five-month progression of the side effects that, based on the facts, they were caused by the Pfizer vaccine. The young woman, who has been working as a health care professional, has been in and out of hospitals and testing center for five months, trying to get an answer about what is happening to her. From a perfectly healthy person she is now a very sick woman. With the girl things are much harder. Within days of her vaccination, all the systems of her body began to collapse. In this broadcast of (withheld) station, a senator is attending these testimonies. Watch the testimonies and hear the cry of these two women: (site name) (screenshot withheld) families discuss adverse reactions to covid-19 vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: body ache; Loose hair; chills; fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Mar2021 12:00 (Lot number: EL9269) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "known allergies: Iodine" (unspecified if ongoing), notes: known allergies: Iodine; "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: TOPROL XL; TRIAMTERENE. The following information was reported: PAIN (non-serious) with onset 01Jun2021 12:00, outcome "recovering", described as "body ache"; ALOPECIA (non-serious) with onset 01Jun2021 12:00, outcome "recovering", described as "Loose hair"; CHILLS (non-serious) with onset 01Jun2021 12:00, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 01Jun2021 12:00, outcome "recovering", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, alopecia, chills, pyrexia.  Additional information included: The patient received other Pfizer vaccine on 06Mar2021, lot number: ER8730, dose 1, in left arm. The patient did not receive any other vaccine with in four weeks. The patient was diagnosed with covid prior vaccination. The patient was tested with covid-19 post vaccination. Covid test type post vaccination: Nasal Swab. Covid test result: Negative. Covid test date: 01Apr2021. Device Date: 29Nov2021.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report received from a contactable physician. A 57-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# ER8732), at the age of 57, intramuscularly, in right arm, on Mar 28, 2021, single dose, for COVID-19 immunisation. Medical history included dyspepsia (unspecified if ongoing). Concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6206), at the age of 57, intramuscularly, in left arm, on Mar 7, 2021, at noon, single dose, for COVID-19 immunisation. The patient experienced herpes zoster (shingles), onset Apr 2021, with outcome of recovered (May 2021). Additional information: Dose: 2nd. Date: Mar 28, 2021; Time: Noon. Follow-up attempts  completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: She was kind of still fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "was getting over a cold" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 03Apr2021, outcome "not recovered", described as "She was kind of still fatigued". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she had antibodies 3 months after having the virus and then was checked again a month ago and had antibodies but this time there was a number. Caller stated that it has been a while since she had her 2nd dose, and she is now ready to get her booster. She had called because she wanted to plan her booster dose accordingly if she was going to have similar reactions as she did to the 2nd dose. She stated that she had her 2nd dose in the afternoon, so her side effects probably began like 12 to 15 hours later. she said that it was  Saturday because she didn't feel right. She says that she had about 32 hours of side effects. She was kind of still fatigued the following day, but she could function the following day, so they probably ended about 36 hours later.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Lip swelling
Clinical narrative: swollen bottom lip; diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 15:15 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HPV VACCINE taken for immunisation, administration date 22Nov2021; FLU taken for immunisation, administration date 22Nov2021; MENINGOCOCCAL VACCINE taken for immunisation, administration date 22Nov2021; TDAP taken for immunisation, administration date 22Nov2021. The following information was reported: LIP SWELLING (non-serious) with onset 29Nov2021 15:15, outcome "recovered", described as "swollen bottom lip"; DIARRHOEA (non-serious) with onset 29Nov2021 15:15, outcome "recovered", described as "diarrhea". Therapeutic measures were not taken as a result of lip swelling, diarrhoea.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (06Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: headache approximately 22 hours post 2nd dose; low grade fever (100.2 degrees F); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 19:30 (Lot number: FL0007) at the age of 8 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD", start date: May2020 (ongoing). Concomitant medication(s) included: FOCALIN XR ER taken for attention deficit hyperactivity disorder, start date: 01Jun2021 (ongoing). Past drug history included: Amoxicillin, reaction(s): "Known allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 07:30 PM), administration date: 09Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 30Nov2021 17:30, outcome "recovered" (2021), described as "low grade fever (100.2 degrees F)"; HEADACHE (non-serious) with onset 30Nov2021 18:30, outcome "recovered" (2021), described as "headache approximately 22 hours post 2nd dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: The patient had not other vaccine in 4 weeks. The patient had received other medications in 2 weeks with multivitamin. The patient had received AE treatment with 1 dose of 10m children's motrin. Patient had not been covid prior vaccination and had not been covid tested post vaccination. The patient had concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered more than two weeks before the event and any drug used to treat the event or taken after event onset. The developed of low grade (100 2 F) and headache starting approximately 22 hours post the 2nd covid vaccine injection resolved with one dose of 5ml children motrin. There were no family medical history relevant to AE. There were no specific relevant test done.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever; Headache; Chills; Fatigue; body soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 15:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (brand=Pfizer Pediatric, Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM), administration date: 08Nov2021, when the patient was 9 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Fatigue"; PAIN (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "body soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, chills, fatigue, pain.  Additional Information: The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; Chills; Fatigue; body soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 15:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (brand=Pfizer Pediatric, Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:15 PM), administration date: 08Nov2021, when the patient was 9 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "Fatigue"; PAIN (non-serious) with onset 30Nov2021 14:30, outcome "recovering", described as "body soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, headache, chills, fatigue, pain.  Additional Information: The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Occupational exposure to product, Ocular hyperaemia
Clinical narrative: while in the process of diluting the Pfizer Biontech COVID19 vaccine (adult formulation), contents of the vaccine squirted in her eyes; experienced burning and redness; experienced burning and redness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A female patient in her 40's received bnt162b2 (COMIRNATY), administration date 02Dec2021 (Lot number: EW0202, Expiration Date: 31Dec2021) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 02Dec2021, outcome "unknown", described as "while in the process of diluting the Pfizer Biontech COVID19 vaccine (adult formulation), contents of the vaccine squirted in her eyes"; OCULAR HYPERAEMIA (non-serious), EYE IRRITATION (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "experienced burning and redness". No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash erythematous
Clinical narrative: her arm itching off; she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular; she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9-year-old female patient received bnt162b2 (BNT162B2), administration date 23Nov2021 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood iron decreased" (unspecified if ongoing), notes: Verbatim: Iron low. There were no concomitant medications. The following information was reported: PRURITUS (non-serious) with onset 02Dec2021, outcome "unknown", described as "her arm itching off"; RASH ERYTHEMATOUS (non-serious), FEELING HOT (non-serious) all with onset 02Dec2021, outcome "unknown" and all described as "she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular". Therapeutic measures were not taken as a result of pruritus, rash erythematous, feeling hot.  Additional Information: The reporting parent stated that her daughter was nine. She actually got the Pfizer Vaccine her first dose 9 days ago and today she started complaining of her arm itching off and now she has the big red rash on her arm that is hot to touch it is not hurting her but it is hot to touch and it is about the size of golf ball, perfectly circular and I was trying to see if that was normal". Reporter stated, "Can you tell me that, it will can you please let me know I am guessing it's COVID arm, is that normal for her age group". Prior vaccination (within 4 weeks) was none. Vaccination facility was at Doctor's office. No lab test.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash/seems to be having like rash reaction; It is Noticeable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Nov2021 (Lot number: FJ1611) at the age of 16 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 01Dec2021, outcome "not recovered", described as "rash/seems to be having like rash reaction; It is Noticeable". Therapeutic measures were not taken as a result of rash.  Additional information: Reporter had a question, reporter's daughter seems to be having like rash reaction to the Pfizer COVID shot. Was there anyway we can take her to get a medication or do we go back to '(Withheld)' or what we do. Prior vaccination (4 Weeks): Reporter stated: No. Reporter stated, "Sorry, the reporter was not quite sure what was it going to be but the reporter meant it was not too concerning but it was noticeable as we are just trying to get her checked. Reporter seriousness for My daughter seems to be having like rash reaction; It is Noticeable: Unspecified  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Bone pain, Fatigue, Illness
Clinical narrative: Sick; fever over 100; She had the flu; everything hurt; A little tired; All her bones hurt; She was in bed all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EM9810) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EL9264, Expiry: Unknown, Administered in left arm), administration date: 23Feb2021, when the patient was 81 years old, for COVID-19 immunization; Pneumonia shot, for Immunization, reaction(s): "Arm swelled up". The following information was reported: ILLNESS (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "Sick"; PYREXIA (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "fever over 100"; INFLUENZA (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "She had the flu"; PAIN (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "everything hurt"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "A little tired"; BONE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "All her bones hurt"; BEDRIDDEN (non-serious) with onset Mar2021, outcome "unknown", described as "She was in bed all day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She felt really sick and had fever over 100. She also felt like she had the flu and everything hurt but the day after that she felt fine. She had no fever anymore anything. She is asking if this is something like a harsh side effect that might indicate she has a higher immunity and might not need a booster dose. Caller commented she never gets the flu shot, she is not on any medication. She usually does all the natural stuff. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The adverse events has not resulted in Emergency Room and Physician Office. Adverse events following prior vaccinations was yes. Many years ago she was talked into getting the pneumonia shot by a doctor. She had to go to the Emergency Room because arm swelled up really bad. Ever since then she never got a shot.   Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pain, Pyrexia
Clinical narrative: Sick; fever over 100; She had the flu; everything hurt; A little tired; All her bones hurt; She was in bed all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EM9810) at the age of 81 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot: EL9264, Expiry: Unknown, Administered in left arm), administration date: 23Feb2021, when the patient was 81 years old, for COVID-19 immunization; Pneumonia shot, for Immunization, reaction(s): "Arm swelled up". The following information was reported: ILLNESS (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "Sick"; PYREXIA (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "fever over 100"; INFLUENZA (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "She had the flu"; PAIN (non-serious) with onset 17Mar2021, outcome "recovered" (18Mar2021), described as "everything hurt"; FATIGUE (non-serious) with onset 17Mar2021, outcome "not recovered", described as "A little tired"; BONE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "All her bones hurt"; BEDRIDDEN (non-serious) with onset Mar2021, outcome "unknown", described as "She was in bed all day". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She felt really sick and had fever over 100. She also felt like she had the flu and everything hurt but the day after that she felt fine. She had no fever anymore anything. She is asking if this is something like a harsh side effect that might indicate she has a higher immunity and might not need a booster dose. Caller commented she never gets the flu shot, she is not on any medication. She usually does all the natural stuff. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The adverse events has not resulted in Emergency Room and Physician Office. Adverse events following prior vaccinations was yes. Many years ago she was talked into getting the pneumonia shot by a doctor. She had to go to the Emergency Room because arm swelled up really bad. Ever since then she never got a shot.   Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Vaccination site pain
Clinical narrative: Pain running down in his left arm where he got the shot from his neck to his shoulder; Pain running down in his left arm where he got the shot from his neck to his shoulder; Pain running down in his left arm where he got the shot from his neck to his shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), outcome "not recovered" and all described as "Pain running down in his left arm where he got the shot from his neck to his shoulder". Therapeutic measures were taken as a result of arthralgia, vaccination site pain, neck pain which included Tylenol.  Additional information:The patient that he just his second dose of the vaccine on withheld and 2.5-3 weeks later that there was pain running down in his left arm where he got the shot from his neck to his shoulder. He was taking Tylenol for a few days and it didn't help. He will be seeing his doctor. He thought that he slept wrong on his neck but that wasn't it since that usually resolved in a few hours. He wanted to know if they had any of same issues with this problem was for the Pfizer Coronavirus vaccine. He Wanted to know if there were different Pfizer vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tired; Slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Lot number: EN6199) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Pfizer EN6200), administration date: 16Feb2021, when the patient was 71 years old, for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tired"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Slight fever".  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: feeling the chest, like her heart is tired or her chest is tired; tired; arm was sore; The brain felt similar as with this reaction to the booster shot; but was more like a cold, like a blood cold was running in for a little bit; had problems to breathe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Lot number: EW0161) at the age of 39 years as dose 1, single and administration date 05May2021 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergic to the weather and pollen and all kinds of stuff" (unspecified if ongoing), notes: Allergic to the weather and pollen and all kinds of stuff; "Allergic to the weather and pollen and all kinds of stuff" (unspecified if ongoing), notes: Allergic to the weather and pollen and all kinds of stuff. Concomitant medication(s) included: CETIRIZINE HCL taken for hypersensitivity, seasonal allergy. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "arm was sore"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "The brain felt similar as with this reaction to the booster shot; but was more like a cold, like a blood cold was running in for a little bit"; DYSPNOEA (non-serious) with onset 2021, outcome "recovered", described as "had problems to breathe"; CHEST DISCOMFORT (non-serious), outcome "recovered", described as "feeling the chest, like her heart is tired or her chest is tired". Additional information: List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. She mentioned with the first and second doses of the Pfizer Covid Vaccine she at first was just and sore, just the . but she is thinking that was normal; but she did feel so, kind of like if she was getting sick and tired like if she had the flu. She also Those reactions to the first and second doses of the Pfizer Covid Vaccine only lasted for about 2 days and after the doses were administered. She reported the reaction with the first dose, but did not report reaction with the second dose, she did not call the doctor to report the reaction with the second dose because she expected that reaction after the first dose reaction.   Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.