chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Feeling abnormal
Clinical narrative: person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp); person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp); person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (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 (product=COVID 19, brand=Pfizer, lot_unknown=False,, dose_number=1), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), CHILLS (non-serious), BODY TEMPERATURE DECREASED (non-serious) all with onset 25Mar2021, outcome "recovered" (Mar2021) and all described as "person reported 48 hrs of feeling bad after 2nd dose including chills (low body temp)". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of feeling abnormal, chills, body temperature decreased.  Additional information: It was unknown prior to vaccination, was the patient diagnosed with COVID-19.It was unknown since the vaccination, has the patient been tested for COVID-19.It was unknown that patient  received any other vaccine within 4weeks prior to covid-19 and does not have any adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had arm soreness for one day/His arm was a little sore yesterday and today he is fine; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team.  A 86 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 86 years as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, (Lot number: Not provided)), administration date: 21Feb2021, for covid-19 immunization, reaction: "Shingles". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "had arm soreness for one day/His arm was a little sore yesterday and today he is fine".  Additional information: Patient received Pfizer vaccine on 25Mar2021 and had arm soreness for one day. Caller stated both her and her husband (86 y/o) had their first Pfizer vaccine dose 21Feb2021 and were scheduled for 14Mar2021 for their second dose. The caller received her dose and the husband had developed shingles and was advised by his physician to wait and get his second dose. The Caller narrated, "He got his second shot on 25Mar2021 after the shingles went away. His arm was a little sore yesterday and today he was fine". Caller was querying if this timing was ok for the second vaccine dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335688 same patient, different dose and event
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis
Clinical narrative: Extreme fatigue; chills; sweats; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 09:45 (Lot number: 3248) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "pacemaker" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CARVEDILOL. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer BioNTech,, lot number=EL3248,, lot unknown=False,, administration date=02Mar2021,, administration time=09:45 AM,, vaccine location=Left arm,, dose number=1), administration date: 02Mar2021, when the patient was 71 years old, for Covid-19 immunisation.  The following information was reported: FATIGUE (non-serious) with onset 23Mar2021 19:00, outcome "recovered" (24Mar2021), described as "Extreme fatigue"; CHILLS (non-serious) with onset 23Mar2021 19:00, outcome "recovered" (24Mar2021), described as "chills"; HYPERHIDROSIS (non-serious) with onset 23Mar2021 19:00, outcome "recovered" (24Mar2021), described as "sweats". Therapeutic measures were not taken as a result of fatigue, chills, hyperhidrosis.  Additional information: The patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. It was reported that side effects from the vaccine started the day of the second vaccination: 23Mar2021 and lasted about 24 hours.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: having sore arm at injection site after both Pfizer BioNTech Covid-19 vaccine doses; having sore arm at injection site after both Pfizer BioNTech Covid-19 vaccine doses; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (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: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "having sore arm at injection site after both Pfizer BioNTech Covid-19 vaccine doses". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Retching, Vomiting
Clinical narrative: not feeling well; Headache; Muscle pain / muscle ache; throwing up; dry heaves; This is a spontaneous report received from contactable reporter (Consumer).  A female patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Dose 1, Manufacturer Unknown (Lot Number: Not provided)), for COVID-19 Immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain / muscle ache"; VOMITING (non-serious), outcome "unknown", described as "throwing up"; RETCHING (non-serious), outcome "unknown", described as "dry heaves".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 90 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Arm hurt a lot/Sore arm; Shivers/could not get warm; 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.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (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 (First Dose), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm hurt a lot/Sore arm"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "Shivers/could not get warm".  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, Headache, Pain, Pain in extremity
Clinical narrative: Patient experienced headache; Body ache; Chills; Sore arm; 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 (PFIZER-BIONTECH COVID-19 VACCINE) (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 (First dose), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Patient experienced headache"; PAIN (non-serious), outcome "unknown", described as "Body ache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain; site swelling; Tiredness; Chills; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 (Lot number: ER8733) at the age of 57 years as dose 1, 30ug single for covid-19 immunisation. Relevant medical history included: "Type II diabetes" (ongoing), notes: She thinks that she was diagnosed over ten years ago.; "Hypertension" (ongoing), notes: She states that she was diagnosed over 10 years ago.; "kidney disease" (ongoing), notes: She states that she was diagnosed 8 to 10 years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "not recovered", described as "injection site pain"; VACCINATION SITE SWELLING (non-serious) with onset 24Mar2021, outcome "recovering", described as "site swelling"; FATIGUE (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Tiredness"; CHILLS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Chills". Additional Information: The patient has not taken any other products. The patient wanted to know what she can do about her injection site pain, site swelling, tiredness, and chills. Injection site pain started yesterday, 24Mar2021, as well as site swelling started last night. Tiredness started also yesterday, and chills yesterday last night. She received her first dose of the COVID-19 vaccine yesterday, 24Mar2021. She was supposed to have a letter stating that she has those problems, and she brought the letter with her, but they did not take. The time of vaccination was around 12:45 or 12:46PM. The patient has no history of all previous immunization with COVID-19 Vaccine, and has no additional vaccines administered on same date of the COVID-19 Vaccine. The adverse events did not require emergency room nor physician office visit. The patient has no prior vaccinations within 4 weeks and has no adverse events prior vaccinations. The patient has no family medical history relevant to the adverse events and has no relevant tests done.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: normal arm pain; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 23 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, (Lot number: not provided)), for Covid-19 Immunization, reaction: "headache". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "normal arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The caller reported that she had normal arm pain after receiving her first dose this Thursday. She also reported having headache after first dose of vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 23 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (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: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in both ears/Tinnitus both ears constant; 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 19Mar2021 11:30 (Lot number: EN6207) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; CALCIUM. Vaccination history included: Bnt162b2 (dose 1, lot number: EN6200/EN76200 (as reported), administration time 11:30 am, vaccine location Right arm), administration date: 26Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 24Mar2021 12:30, outcome "not recovered", described as "ringing in both ears/Tinnitus both ears constant". The event "ringing in both ears/tinnitus both ears constant" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus. Additional information: Patient had other medications in two weeks: statin, multi vitamin, calcium supplement. Facility where the most recent COVID-19 vaccine was administered in other (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no COVID prior vaccination and was not COVID tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness / Muscle aches; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 10:20 (Lot number: EN6203) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 04Mar2021, outcome "recovered" (05Mar2021), described as "Muscle soreness / Muscle aches". Therapeutic measures were not taken as a result of myalgia.  Additional Information: The patient stated that after the first dose of vaccine, she felt fine. She experienced muscle soreness after the first dose of the vaccine when she was age 64 and it was three weeks ago (04Mar2021). She had muscle soreness on the same day that she got the first dose of the vaccine but the muscle soreness was gone by the next day (05Mar2021) and did not require treatment. She was on other medications but they had nothing to do with the events. The patient stated that she could feel the first dose and could feel a muscle ache. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency room or physician office. The patient did not receive prior vaccinations within 4 weeks, had no family medical history relevant to the adverse event, and no relevant tests done.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021334925 Same patient and drug; Different dose and events
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt a little tired; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Feb2021 (Lot number: EN6201) 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 24Feb2021, outcome "unknown", described as "felt a little tired". Additional Information: The patient had the 1st one and felt a little tired on the 2nd day.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: experienced pain and swelling in the arm where I received the shot/pain & swelling in arm where the vaccine was administered; experienced pain and swelling in the arm where I received the shot/pain & swelling in arm where the vaccine was administered; fatigue; headache; This is a spontaneous report received from a contactable reporter (other healthcare professional). The reporter is the patient.  A 46 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunization. Relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: Hashimoto's. Concomitant medication included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]; SERTRALINE. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: Unknown), for covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset Mar2021, outcome "unknown" and all described as "experienced pain and swelling in the arm where I received the shot/pain & swelling in arm where the vaccine was administered"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache".  Additional information: The patient had the second dose of COVID-19 vaccine on 26Mar21. She experienced pain and swelling in the arm where she received the shot, had fatigue and headache. After receiving the second dose of COVID-19 vaccine, the following day she experienced common side effects including: pain & swelling in arm where the vaccine was administered, headache and fatigue. Her medical history included hypothyroidism (Hashimoto's) and she used 112 mcg levothyroxine/daily and 25 mg sertraline/daily.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347945 same patient, different drug/AE
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Neck had stiffen up on me terribly; I can't really turn to the left or the right without anything; Pain is getting worse and worse; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) at the age of 67 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 (Dose 1, single, Manufacturer Unknown (Lot Number: Not provided)), for Covid-19 immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "Neck had stiffen up on me terribly"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 05Mar2021, outcome "unknown", described as "I can't really turn to the left or the right without anything"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Pain is getting worse and worse". Therapeutic measures were taken as a result of musculoskeletal stiffness, joint range of motion decreased, pain.  Additional Information: On 05Mar2021, the patient received second COVID shot and about an hour after, her neck had stiffen up on terribly like she can't really turn to the left or the right without anything and it had been like that since. She reached out to her health provider but she was told to call this number. She wanted to go to the emergency room and wanted to see her medical provider when she called today (date unspecified) because the pain is getting worse and worse. She thought that it will subside when she rested. She took ibuprofen (treatment) but it was getting worse and it was getting tighter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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.  A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medications included: TESTOSTERONE. Past drug history included: Testosterone.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: The patient reported that he had his first dose yesterday (at the time of reporting). The patient only had a sore arm. The patient was a 61-year-old asthmatic that receives testosterone once a week. The patient had a question about the testosterone and COVID vaccine if the medications together could possibly minimize his immune system.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: After first dose had extreme fatigue; 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 female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 04Mar2021 12:15 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; BUSPIRONE; PRILOSEC [OMEPRAZOLE]; DOXEPIN. The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "recovering", described as "After first dose had extreme fatigue". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Feeling more nauseous everyday; diarrhea; 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 79 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 (Lot number: EN6199) at the age of 79 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Microscopic colitis", start date: 2017 (ongoing), notes: Diagnosed 4 years ago; "occasional nausea" (unspecified if ongoing); "Acid Reflux", start date: Sep2020 (ongoing). Concomitant medication(s) included: FAMOTIDINE taken for gastrooesophageal reflux disease, start date: Sep2020 (ongoing). Vaccination history included: BNT162B2 (Dose number: 1, Time: 15:00PM, Batch/lot number: EN6201, Anatomical location: Left Upper arm), administration date: 24Feb2021, for COVID-19 Immunisation. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Feeling more nauseous everyday"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea".  Additional information: The patient had no prior vaccinations (within 4 weeks). The patient did not receive additional vaccines administered on same date of the Pfizer suspect. Clinical course: Feeling more nauseous every day- very mild nausea, started with the first dose, but got worse with the second. Patient explained that with her microscopic colitis, she had diarrhea without warning. Patient stated that she thought the nausea may be a commination of both the vaccine and her microscopic colitis. The events did not result to emergency room or physician office visit. The events were reported as non-serious. The patient did not undergo any relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Middle insomnia, Pain
Clinical narrative: woke up at 2am; chills; sweating; body ache; skin sensitivity; vomiting; extreme fatigue; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Mar2021 12:00 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRON 2CARE4; PRILOSEC [OMEPRAZOLE]; DOXEPIN; BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration time: 12:15 PM, Vaccine location: Left arm), administration date: 04Mar2021, when the patient was 28 years old, for Covid-19 immunisation, reaction(s): "extreme fatigue". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021 16:00, outcome "recovering", described as "extreme fatigue"; MIDDLE INSOMNIA (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "woke up at 2am"; CHILLS (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "sweating"; PAIN (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "body ache"; SENSITIVE SKIN (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "skin sensitivity"; VOMITING (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of fatigue, middle insomnia, chills, hyperhidrosis, pain, sensitive skin, vomiting. Additional Information: The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021348086 same patient/drug, different doses/events
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Vomiting
Clinical narrative: woke up at 2am; chills; sweating; body ache; skin sensitivity; vomiting; extreme fatigue; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 25Mar2021 12:00 (Batch/Lot number: unknown) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRON 2CARE4; PRILOSEC [OMEPRAZOLE]; DOXEPIN; BUPROPION. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration time: 12:15 PM, Vaccine location: Left arm), administration date: 04Mar2021, when the patient was 28 years old, for Covid-19 immunisation, reaction(s): "extreme fatigue". The following information was reported: FATIGUE (non-serious) with onset 25Mar2021 16:00, outcome "recovering", described as "extreme fatigue"; MIDDLE INSOMNIA (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "woke up at 2am"; CHILLS (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "sweating"; PAIN (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "body ache"; SENSITIVE SKIN (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "skin sensitivity"; VOMITING (non-serious) with onset 26Mar2021 02:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of fatigue, middle insomnia, chills, hyperhidrosis, pain, sensitive skin, vomiting. Additional Information: The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021348086 same patient/drug, different doses/events
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: nausea/urge to vomit; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558) (from a Pfizer sponsored program Covax US Support).  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (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: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea/urge to vomit"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness".  Additional information: The reporter was calling on behalf of his father and would like to know if those are the side effects of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: received first dose of Pfizer BioNTech Covid 19 vaccine on 11Mar2021 and developed sciatic nerve pain; 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 (159558). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sciatic nerve pain" (unspecified if ongoing), notes: She has had issues with this before. The patient's concomitant medications were not reported. The following information was reported: SCIATICA (non-serious), outcome "unknown", described as "received first dose of Pfizer BioNTech Covid 19 vaccine on 11Mar2021 and developed sciatic nerve pain". Therapeutic measures were taken as a result of sciatica.  Additional Information: Verbatim and event description: caller had first shot and is due for 2nd shot. After 1st shot had sciatic nerve problems and was prescribed 20mg prednisone. Is wondering if she can go ahead with 2 shot of vaccine. Relayed number and transferred to PMI, (private) took call. Advised will also Fax AE due to long hold times. CEP (withheld). Were any unaddressed medical questions referred or forwarded to Medical Information, No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 22, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had lymphadenopathy (felt a lymph node on the left under my clavicle or collar bone), onset Mar 2021, with outcome of unknown. Additional information: Patient stated she understood that the vaccine can cause lymph nodes to be swollen in the same arm of the vaccine. She reported she can feel a lymph node on the left-side under her clavicle or collarbone. She asked if that could be from the vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: loss of appetite; extreme fatigue; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue".  Additional information: The patient stated that he experienced loss of appetite and extreme fatigue after the first dose of the Pfizer covid vaccine. The patient wanted to know if it was ok to take the second dose due on 01Apr. He did not have any respiratory problems. The patient considered the report as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: Extreme Fatigue; loss of appetite; 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.  A male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (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 12Mar2021, outcome "unknown", described as "Extreme Fatigue"; DECREASED APPETITE (non-serious) with onset 12Mar2021, outcome "unknown", described as "loss of appetite".  Additional information: The patient is due to get his second shot on 01Apr2021 and would like to know if it is okay for him to get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: extreme fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female 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: FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue".  Additional information: Caller stated she took the first COVID 19 vaccine three weeks ago and tomorrow was three weeks. Caller stated the last time she called this number she was on hold and spoke to someone who said they would switch her to speak with medical information and the call got lost. Caller stated she was experiencing extreme fatigue and she was feeling concerned about getting the second shot because she does not feel like she has recovered from the first one. Other person on the line said they never got through they were put in the queue and got disconnected. The other person on the line said they spoke to someone like this DSU agent and took relevant information. Caller declined having a report reference number from the other report with the agent. Caller stated she also filed a report with Pfizer on the website. Caller declined receiving a confirmation email from the Pfizer website. The other person on the line stated she filled a report on two different websites (VAERS and Pfizer). The other person stated that they have done all of this and they got disconnected. The other person stated that was exactly what happened last time they were put on a brief hold and was given the  Regulatory Authority number the same one this agent just provided and was put back in the queue and was disconnected and that was the end of it. The other person stated that he wanted to take the survey. The other person stated they were going to get disconnected again and the same thing was going to happen and that it was a terrible system. The other person stated that they had waited for an hour and a half.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; 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 78 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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, single), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain at the injection site".  Additional information: The patient received his second dose of Pfizer-Biontech Covid19 vaccine on 26Feb2021. He is now reporting pain at the injection site, and wants to know if this is common.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Throat irritation
Clinical narrative: throat irritation/burning in her throat "like acid reflux"; immunocompromised/ already received the first dose of the vaccine; immunocompromised/ already received the first dose of the vaccine; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A 61-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. Relevant medical history included: "history of stem cell transplant " (unspecified if ongoing); "immunocompromised" (ongoing); and "allergic to 'a lot of medications'" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THROAT IRRITATION (non-serious) with onset 24Mar2021, outcome "unknown", described as "throat irritation/burning in her throat "like acid reflux""; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 23Mar2021, outcome "unknown" and all described as "immunocompromised/ already received the first dose of the vaccine". Additional information: The patient already received the first Pfizer Covid vaccine dose and wanted to know if it was safe for her to get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361915 different patient, same drug and similar event
Sex: F
Vaccine: COVID19
Symptoms: Fall, Head injury
Clinical narrative: she fell 6 days ago and she hit her head; she fell 6 days ago and she hit her head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program Support. The reporter is the patient.  A female 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: FALL (non-serious), HEAD INJURY (non-serious), outcome "unknown" and all described as "she fell 6 days ago and she hit her head".  Additional information: The caller said that she cannot make it to the vaccination center her 2nd dose vaccine today because she fell 6 days ago and she hit her head.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Caller is unable to attend appointment for 2nd Pfizer shot today and wanted to reschedule due to feeling ill; 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.  A female 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: MALAISE (non-serious), outcome "unknown", described as "Caller is unable to attend appointment for 2nd Pfizer shot today and wanted to reschedule due to feeling ill".  Additional Information: Caller was unable to attend appointment for 2nd Pfizer shot today and wanted to reschedule due to feeling ill which was unrelated to initial Pfizer Covid vaccine. Read FAQs. Transferred to Covid Fact sheet Faxing adverse event's to Pfizer from Support CEP. It was unknown If the reporter's contact information available to you or a sub-contracted party.It was unknown If the Reporter a Healthcare Professional (HCP). It was unknown if the reporter the prescribing HCP. Suspect product start and stop dates were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: painful; 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 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 11:40 (Lot number: EN6198) at the age of 28 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: PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "painful". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection,  batch/lot# unknown), on Mar 26, 2021, at 09:20, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a headache, with outcome of unknown. Additional information: The patient wanted to know what to do about her headache. She received the first dose of the COVID-19 vaccine on Friday, Mar 26, 2021, at 09:20, since then she has had a headache. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: blew his back out; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 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: BACK DISORDER (non-serious), outcome "unknown", described as "blew his back out".  Additional Information: The reported age of patient was 66 with unknown unit. He got his first shot back on the 5th (unspecified date). He was supposed to get the second one on the 26th (unspecified date) but blew his back out and he had to reschedule. He was asking how far apart they can be given and if the second dose can be rescheduled.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.