chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Weight
Clinical narrative: cough; Running a fever; Got a fever; Really bad headache; Headache lasted for couple of hours; She took the shower and she got really light headache; She is vomiting; Today she is throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 13:20 (Lot number: FL0007, Expiration Date: 12Jan2022) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT.  The following information was reported: COUGH (non-serious), outcome "not recovered", described as "cough"; PYREXIA (non-serious), outcome "not recovered", described as "Running a fever; Got a fever"; VOMITING (non-serious) with onset 19Dec2021, outcome "not recovered", described as "She was vomiting; Today she was throwing up"; HEADACHE (non-serious), outcome "not recovered", described as "Really bad headache; Headache lasted for couple of hours; She took the shower and she got really light headache". Relevant laboratory tests and procedures were available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Reporter gave to patient, 200mg Advil last night for fever and it helped for fever.  Additional information included: Reporter stated, the patient was approximately 5 foot tall, and 90 pounds (reporter was not sure hence not captured in tab). Date of vaccination: Reporter stated, Dose 1 received on Saturday, 18Dec2021 at 1:20 pm on her left. The patient had no any vaccination 4 weeks prior to COVID 19 Vaccine. Reporter stated, she had asthma, so she was taking her asthma medications, she took Flovent and reporter don't had the box that had her information. Reporter stated, the fever she started, first she got really bad headache a really bad headache, and an hour after she had 'cough' and the headache lasted for couple of hours and then she got a fever and then today she was throwing up. Still experienced.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 (Lot number: EW0186) at the age of 31 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, First Covid vaccine: , Date: 07May2021, NDC/expiration: unknown, Lot: EW0173, Site: left arm), administration date: 07May2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Inflammation, Urticaria
Clinical narrative: inflammation/had inflammation on hands and feet and face; head fogginess; hives on her back and chest/ few hives and raised welts on her back; headache; 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 61 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Dec2021 (Lot number: FH8030) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy medication" (unspecified if ongoing), notes: She would take an allergy medication periodically prior to this. only take it if she needs. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset 02Dec2021, outcome "recovering", described as "hives on her back and chest/ few hives and raised welts on her back"; HEADACHE (non-serious) with onset 02Dec2021, outcome "recovering", described as "headache"; FEELING ABNORMAL (non-serious) with onset 03Dec2021, outcome "recovering", described as "head fogginess"; INFLAMMATION (non-serious) with onset 04Dec2021, outcome "recovering", described as "inflammation/had inflammation on hands and feet and face". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient stated that she received her first dose of the vaccine last 02Dec2021 and on the same day she developed hives on her back and chest, experiences headache. She had head fogginess that started the next day on 03Dec2021 and then, she also had inflammation on her hand and a little on her face and feet started on 04Dec2021. She also stated that the hives lasted for two weeks. She took an allergy medication Allegra', to offset it when she started feeling the reaction on 03Dec2021, and the hives are just starting to feel better on 10th day, she would only take medicine if she needs to. She would take an allergy medication periodically prior to this. She just doesn't like taking medications and she would only take it if she needs to. She wanted to know if she can get her 2nd dose after experiencing this side effects. She does not think she is a candidate for second dose and wanted to ask someone guidance about getting second dose based on her symptoms.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis, Rash
Clinical narrative: Psoriasis like rash on legs; Rash across whole body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 12:00 (Lot number: EW0172) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC ALLERGY; NEXIUM [ESOMEPRAZOLE SODIUM]. Vaccination history included: Pfizer (DOSE 1, SINGLE, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 31Mar2021, when the patient was 52 years old, for covid-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "recovered with sequelae", described as "Psoriasis like rash on legs"; RASH (non-serious), outcome "recovered with sequelae", described as "Rash across whole body". The events "psoriasis like rash on legs" and "rash across whole body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of psoriasis, rash.  Additional information: No other vaccine in four weeks. Rash across whole body. Psoriasis like rash on legs. Symptoms started with 2nd dose but 3rd dose caused systematic symptoms which have required steroid treatment. Ae resulted in: (Doctor or other healthcare professional office/clinic visit). Patient had no covid prior vaccination. patient was not tested for covid post vaccination. patient had no known allergies. Patient had no other medical history. No other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101826033 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 14:00 (Lot number: EN6198) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PALMITOYLETHANOLAMIDE taken for inflammation, start date: 2020 (ongoing); CBD OIL taken for inflammation, start date: 2020 (ongoing); VITAMIN D [COLECALCIFEROL], start date: 2018 (ongoing); LEXAPRO taken for anxiety, start date: 2017 (ongoing). Vaccination history included: Bnt162b2 (Dose no: 1, Time: 14:00, Anatomical Site of injection: Left arm, Lot no:EN6198), administration date: 09Feb2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; NAUSEA (non-serious), outcome "recovered", described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (10Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Investigation
Clinical narrative: had covid in Jan2021 and started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and is happening again after the booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Lot number: EW1076) at the age of 52 years as dose 2, single and administered in arm left, administration date 09Apr2021 (Lot number: EW1062) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Jan2021 (unspecified if ongoing). Concomitant medication(s) included: KARIVA. The following information was reported: INTERMENSTRUAL BLEEDING (non-serious) with onset 17Dec2021, outcome "recovering", described as "had covid in Jan2021 and started spotting during it even though it wasn't during my cycle. The same thing happened after each vaccine dose and is happening again after the booster". The event "had covid in jan2021 and started spotting during it even though it wasn't during my cycle. the same thing happened after each vaccine dose and is happening again after the booster" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of intermenstrual bleeding.  Additional information: Patient tricycled birth control so she only get her period once every three months. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, she had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Nausea, Syncope
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. The initial case was missing the following minimum criteria: product. Upon receipt of follow-up information on 01Mar2022 this case now contains all required information to be considered valid. A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 10:30 (Lot number: FJ8767) at the age of 61 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Body aches", "Fever"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "Body aches", "Fever". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 16Dec2021 11:00, outcome "recovered", described as "Passed out"; SYNCOPE (medically significant) with onset 16Dec2021 11:00, outcome "recovered", described as "Fainted"; COLD SWEAT (non-serious) with onset 16Dec2021 11:00, outcome "recovered", described as "Clammy"; NAUSEA (non-serious) with onset 16Dec2021 11:00, outcome "recovered", described as "Nauseous"; DIZZINESS (non-serious) with onset 16Dec2021 11:00, outcome "recovered", described as "Dizzy". Therapeutic measures were not taken as a result of loss of consciousness, syncope, cold sweat, nausea, and dizziness. Additional information: The patient reported issues (side effects, complaints etc.) with a Pfizer product and the reported issue occurred after use of a Pfizer product. Approximately 24hrs after the patient received her third Pfizer Covid vaccine she passed out. She became clammy, nauseous, and then fainted. She experienced no other side effects associated with this shot, like she did with the first 2. She expected fever and body aches but did not experience those this time. It was a shock to be picked up from the floor. No additional vaccines administered on same date of the Pfizer product. There are no other products that were taken together with those indicated above. No prior vaccinations received (within 4 weeks). There was no predisposing factor, and no culture was performed. The patient was not admitted to hospital due to the event. Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Neck pain
Clinical narrative: A lot of fatigue; Shoulder pain; Neck pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FH8028) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer- Unknown), when the patient was 63 years old, for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset Dec2021, outcome "recovered" (14Dec2021), described as "A lot of fatigue"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovered" (14Dec2021), described as "Shoulder pain"; NECK PAIN (non-serious) with onset Dec2021, outcome "recovered" (14Dec2021), described as "Neck pain"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered" (14Dec2021), described as "Headache".  Additional information: It was really more from the second injection (Incomplete sentence). The side effects especially from the 2nd injection which the patient had 02Dec, the patient had a lot of fatigue and had shoulder and neck pain and headache for almost 2 weeks. Date of adverse event started: the patient stated, "It would have been around the 02Dec or 03Dec to 14Dec2021."   Follow-Up (11Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 45-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of COVID-19 vaccine (manufacturer unknown), for immunisation. The patient developed urticaria (hives all over body), with outcome of unknown. Additional information: No product complaint associated with this case. Life-threatening: no. Intervention/Medically important: no. Death: no. No prolonged hospitalization. Disabling/incapacitating: no. Congenital anomaly/Birth defect: no. Hospitalization required: no. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A 6-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FL0007, expiration date: Feb 28, 2022), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient developed  urticaria (hives all over back), and upper abdominal pain (stomachache), with outcome of unknown. Additional information: Reporter's grandson developed hives all over his back and had a stomachache after receiving the first dose of the Pfizer COVID-19 vaccine. They took him to the doctor. The doctor said it was most likely a reaction to the vaccine, and said he should not get the second dose since the reaction could be worse. The expiration date on the vaccination card was Sep 2021. She encountered three different stories. She got in contact with someone else who provided them with an updated expiry date from Sep 2021 to Dec 2021, which was when he got the vaccine. Now Pfizer was telling her it was Feb 2022. This report was related to study or program. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: fever; lymphadenopathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 13:41 (Lot number: EL3247) at the age of 51  as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); IRBESARTAN taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Time: 13:01, Anatomical site of injection: Rt. Arm, Route of administration: Intramuscular, Batch/Lot number: EL3247, Dose: 1), administration date: 22Feb2021, for COVID-19 Immunization; Flu, administration date: Oct2021, for Immunization; Tetanus vaccine (For tetanus vaccine - 20 years ago had 6 month reaction on my arm (lump that would flare up at night with pain)), for Immunization, reaction(s): "Lymphadenopathy". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 24Nov2021 09:00, outcome "recovered", described as "lymphadenopathy"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of lymphadenopathy.   Additional information: the event requires the initiation of new medication of Tylenol. Complete only if a 3rd dose was administered. Check one option: Booster dose due to high of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Need an N/A response in mass it was opened to 18+ earlier than other states.  Comments/Narrative: 2nd Covid Vaccine: I had Lymphadenopathy with a golfball (half-sized) lump on my neck + lumps under my armpit. I had fever etc.+ This was reported previously.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Headache, Neck pain, Pain in extremity
Clinical narrative: Leg pain; Neck pain; Fibromyalgia; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Highly sensitive to medicines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Leg pain"; NECK PAIN (non-serious) with onset 2021, outcome "unknown", described as "Neck pain"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Fibromyalgia"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of fibromyalgia.  Additional information: The patient indicated she called on Saturday. Created a DSU report. Was instructed to call back and choose option three. Received Injection (first dose) 30Nov2021. "Tuesday. Saturday night a lot of leg pain, Sunday still hurt. On Tuesday much worse. Wednesday really bed. Medicines that will call to have leg pain. Not tried anything new. Vaccine on Tuesday. The patient was not able tell if her leg was hurting her. Her leg had been hurting her ever since. Born (DOB), 53 or 54 years of age. HCP went ahead and ordered her ultrasound to make sure she did not had any blood clots. She did not. Battle neck pain and some headaches. Seemed like it was more consistent than what it was. Naproxen and Parafon Forte for Fibromyalgia. Her leg pain had not gotten any better. Worked for HCP. Wanted her to get it. When was her leg pain going to stop. She was so highly sensitive to medicines that it scared her. HCPs indicated to get. They were not going to handle the pain."  Indicated she will reach out to Rheumatologist.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Diarrhoea, Illness, Influenza
Clinical narrative: flu; got really really sick; congestion; cough; sore throat; fever; diarrhea; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 20Oct2021 (Lot number: FF2588) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetes" (ongoing); "Verbatim: high blood pressure" (ongoing), notes: Verbatim: high blood pressure. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, lot written as PF EL3249), administration date: 14Jan2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose, lot EN6198), administration date: 22Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; ILLNESS (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "got really really sick"; NASAL CONGESTION (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "congestion"; COUGH (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "sore throat"; PYREXIA (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "fever"; DIARRHOEA (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "no appetite".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Diabetes and high blood pressure were diagnosed prior to his Pfizer COVID vaccines. Description of complaint: Report 2 of 2; The report is cross referenced to report ID: GH0TFC9L. Vaccine Supplemental Form completed in additional context. Caller states she came back from Name withheld and both she and her husband both got really really sick and she read this letter and now thought she had COVID but she tested negative for COVID and thinks she and her husband just got the flu and really did get the flu.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: flu; got really really sick; congestion; cough; sore throat; fever; diarrhea; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 20Oct2021 (Lot number: FF2588) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Verbatim: Diabetes" (ongoing); "Verbatim: high blood pressure" (ongoing), notes: Verbatim: high blood pressure. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, lot written as PF EL3249), administration date: 14Jan2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose, lot EN6198), administration date: 22Feb2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; ILLNESS (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "got really really sick"; NASAL CONGESTION (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "congestion"; COUGH (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "sore throat"; PYREXIA (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "fever"; DIARRHOEA (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "diarrhea"; DECREASED APPETITE (non-serious) with onset 14Dec2021, outcome "recovered" (19Dec2021), described as "no appetite".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Diabetes and high blood pressure were diagnosed prior to his Pfizer COVID vaccines. Description of complaint: Report 2 of 2; The report is cross referenced to report ID: GH0TFC9L. Vaccine Supplemental Form completed in additional context. Caller states she came back from Name withheld and both she and her husband both got really really sick and she read this letter and now thought she had COVID but she tested negative for COVID and thinks she and her husband just got the flu and really did get the flu.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Rash erythematous, SARS-CoV-2 test
Clinical narrative: Bilateral Red rash covering upper torso; Painful, burning sensations throughout effected area; Painful, burning sensations throughout effected area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FC3183) at the age of 49 years as dose 2, single and (Lot number: FC3184) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "Bilateral Red rash covering upper torso"; PAIN (non-serious), BURNING SENSATION (non-serious), outcome "recovered" and all described as "Painful, burning sensations throughout effected area". The events "bilateral red rash covering upper torso", "painful, burning sensations throughout effected area" and "painful, burning sensations throughout effected area" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash erythematous, pain, burning sensation.   Additional information: It was reported hospitalization prolonged no. Patient received treatment for AE was oral corticosteroids. No covid prior vaccination. It was reported covid tested post vaccination: yes. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. Device date was 22Dec2021.  Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have rashes on my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 20Dec2021 17:30 (Lot number: WS3960) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), when the patient was 28 years old, for COVID-19 immunization; Bnt162b2 (2nd dose), when the patient was 28 years old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Dec2021, outcome "unknown", described as "I have rashes on my body". The event "i have rashes on my body" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash.  Additional information: Patient went to urgent care and showed it and discussed with them, they provided some allergy medication but still don't see any change actually. Patient don't know the LOT# but could provide the brand what patient was using. The first one was the Allegra and another one they prescribed me, Pepcid and another one is Benadryl allergy one, that's it. Patient did not reported any prior Vaccination (4 Weeks).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: headache; body aches; fever; fatigue; nausea and chills; nausea and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Dec2021 14:00 (Lot number: FF8841, Expiration Date: 31Mar2022) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "fatigue"; NAUSEA (non-serious), CHILLS (non-serious) all with onset 21Dec2021 02:15, outcome "unknown" and all described as "nausea and chills". Additional information: Event took place after use of product. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; body aches; fever; fatigue; nausea and chills; nausea and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Dec2021 14:00 (Lot number: FF8841, Expiration Date: 31Mar2022) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "fatigue"; NAUSEA (non-serious), CHILLS (non-serious) all with onset 21Dec2021 02:15, outcome "unknown" and all described as "nausea and chills". Additional information: Event took place after use of product. No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Breast pain, Injection site joint pain, Injection site pain
Clinical narrative: joint ligament pain on my shoulder at the injection shot site; almost it feels kind of dislocated; rest on the injection arm too; then on my elbow; along with the fever of 100.2 Fahrenheit.; like ligament pain on my shoulder; at the injection site; my right breast almost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Lot number: FE3594) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE-1, LOT number of ER8733 , expiration date as 31Jul2021), administration date: 30Mar2021, for Covid-19 immunization; Bnt162b2 (DOSE-2, LOT number of EW0162 , expiration date as 31Jul2021), administration date: 20Apr2021, for Covid-19 immunization. The following information was reported: INJECTION SITE JOINT PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "joint ligament pain on my shoulder at the injection shot site"; JOINT DISLOCATION (non-serious) with onset 22Dec2021, outcome "not recovered", described as "almost it feels kind of dislocated"; PAIN IN EXTREMITY (non-serious) with onset 22Dec2021, outcome "not recovered", described as "rest on the injection arm too"; ARTHRALGIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "then on my elbow"; PYREXIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "along with the fever of 100.2 Fahrenheit."; LIGAMENT PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "like ligament pain on my shoulder"; INJECTION SITE PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "at the injection site"; BREAST PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "my right breast almost". Relevant laboratory tests and procedures are available in the appropriate section. Consumer stated, she wanted to report a side effect and got from my Pfizer booster shot that, the patient received yesterday. It was almost like a joint ligament pain on her shoulder at the injection shot site and then on her elbow and rest on the injection arm too, almost it feels kind of dislocated.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Joint dislocation, Ligament pain, Pain in extremity, Pyrexia
Clinical narrative: joint ligament pain on my shoulder at the injection shot site; almost it feels kind of dislocated; rest on the injection arm too; then on my elbow; along with the fever of 100.2 Fahrenheit.; like ligament pain on my shoulder; at the injection site; my right breast almost; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Lot number: FE3594) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE-1, LOT number of ER8733 , expiration date as 31Jul2021), administration date: 30Mar2021, for Covid-19 immunization; Bnt162b2 (DOSE-2, LOT number of EW0162 , expiration date as 31Jul2021), administration date: 20Apr2021, for Covid-19 immunization. The following information was reported: INJECTION SITE JOINT PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "joint ligament pain on my shoulder at the injection shot site"; JOINT DISLOCATION (non-serious) with onset 22Dec2021, outcome "not recovered", described as "almost it feels kind of dislocated"; PAIN IN EXTREMITY (non-serious) with onset 22Dec2021, outcome "not recovered", described as "rest on the injection arm too"; ARTHRALGIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "then on my elbow"; PYREXIA (non-serious) with onset 22Dec2021, outcome "not recovered", described as "along with the fever of 100.2 Fahrenheit."; LIGAMENT PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "like ligament pain on my shoulder"; INJECTION SITE PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "at the injection site"; BREAST PAIN (non-serious) with onset 22Dec2021, outcome "not recovered", described as "my right breast almost". Relevant laboratory tests and procedures are available in the appropriate section. Consumer stated, she wanted to report a side effect and got from my Pfizer booster shot that, the patient received yesterday. It was almost like a joint ligament pain on her shoulder at the injection shot site and then on her elbow and rest on the injection arm too, almost it feels kind of dislocated.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Lip swelling
Clinical narrative: His lips are swollen; got sick; 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 male patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: FF8841) at the age of 16 years 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: LIP SWELLING (non-serious) with onset Dec2021, outcome "unknown", described as "His lips are swollen"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "got sick".  Additional Information: Caller is asking if swollen lips is a reported side effect with the Pfizer-BioNTech COVID-19 Vaccine. Her 16 year old son got the vaccine yesterday and that's when he got sick. Covid vaccine, adult a Pfizer product. Caller states she is calling about the Pfizer Covid vaccine adult, FF8841. Caller states her son got the vaccine yesterday and he is 16 years old. Caller states his lips are swollen, and that a side effect.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: joints pain that affected movements/knee pain sometimes right and left knee/wrist/elbow/ankles ached; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 29Sep2021 (Batch/Lot number: unknown) at the age of 55 years 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: ARTHRALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "joints pain that affected movements/knee pain sometimes right and left knee/wrist/elbow/ankles ached"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information:In 2021, the patient experienced joints pain that affected movements/knee pain Sometimes right and left knee/wrist/elbow/ankles ached and headache. In 2021, the joints pain that affected movements/knee pain sometimes right and left knee/wrist/elbow/ankles ached and hand ached resolved. pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Arthralgia, Blood grouping, Body temperature, Chills
Clinical narrative: headache; tiredness; muscle pain; chills; decresed appetite; fever; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2021 08:15 (Lot number: EN6203) at the age of 78 years as dose 2, single and intramuscular, administered in arm left, administration date 04Feb2021 08:30 (Lot number: EM9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hyperparathyroid", start date: 1954 (ongoing), notes: Age 12; "polycystic ovary syndrome", start date: 1954 (ongoing), notes: Age 12. Concomitant medication(s) included: SPIRONOLACTONE taken for polycystic ovaries, start date: Jul2021 (ongoing); INFLUENZA VACCINE, administration date 20Oct2021. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "tiredness"; MYALGIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "muscle pain"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "chills"; APPETITE DISORDER (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "decresed appetite"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "fever"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "joint pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Symptoms occurred within 12hours after vaccine administered. The symptoms lasted between 24 and 48 hours without recurring symptoms afterwards. patient did not report symptoms to her doctor nor to the hospital that administered since she was sure that they would stop. Blood type was reported as A-. family medical history relevant to AE was reported as unknown. relevant history reported as none. specific relevant test for thromboembolic with thrombocytopenia was reported as none. autopsy information reported as NA.it was unknown whether patient received any prior vaccination(within 4 weeks).Patients medical history (including any illness at time of vaccination) were reported as None.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: headache; tiredness; muscle pain; chills; decresed appetite; fever; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2021 08:15 (Lot number: EN6203) at the age of 78 years as dose 2, single and intramuscular, administered in arm left, administration date 04Feb2021 08:30 (Lot number: EM9809) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hyperparathyroid", start date: 1954 (ongoing), notes: Age 12; "polycystic ovary syndrome", start date: 1954 (ongoing), notes: Age 12. Concomitant medication(s) included: SPIRONOLACTONE taken for polycystic ovaries, start date: Jul2021 (ongoing); INFLUENZA VACCINE, administration date 20Oct2021. The following information was reported: HEADACHE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "headache"; FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "tiredness"; MYALGIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "muscle pain"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "chills"; APPETITE DISORDER (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "decresed appetite"; PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "fever"; ARTHRALGIA (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "joint pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Symptoms occurred within 12hours after vaccine administered. The symptoms lasted between 24 and 48 hours without recurring symptoms afterwards. patient did not report symptoms to her doctor nor to the hospital that administered since she was sure that they would stop. Blood type was reported as A-. family medical history relevant to AE was reported as unknown. relevant history reported as none. specific relevant test for thromboembolic with thrombocytopenia was reported as none. autopsy information reported as NA.it was unknown whether patient received any prior vaccination(within 4 weeks).Patients medical history (including any illness at time of vaccination) were reported as None.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Chest pain
Clinical narrative: Random chest pains on either side; pain in lower left quadrant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 15:30 (Lot number: FA7484) at the age of 26 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Generalized Anxiety" (unspecified if ongoing), notes: other medical history: Generalized Anxiety; "Major Depressive Disorder" (unspecified if ongoing); "Exercise Induced Asthma" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; SINGULAIR; GINKO BILOBA [GINKGO BILOBA]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0186, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 23Aug2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 20Sep2021, outcome "not recovered", described as "Random chest pains on either side"; ABDOMINAL PAIN LOWER (non-serious) with onset 20Sep2021, outcome "not recovered", described as "pain in lower left quadrant". The events "random chest pains on either side" and "pain in lower left quadrant" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, abdominal pain lower.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected