chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Light-headedness; slight nausea; Slight arm-ache around the vaccine shot spot; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Apr2021 16:45 (Lot number: ER8737) at the age of 23 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Glucose-6-phosphate dehydrogenase deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 17Apr2021, outcome "recovered" (18Apr2021), described as "Light-headedness"; NAUSEA (non-serious) with onset 17Apr2021, outcome "recovered" (18Apr2021), described as "slight nausea"; VACCINATION SITE PAIN (non-serious) with onset 17Apr2021, outcome "recovered" (18Apr2021), described as "Slight arm-ache around the vaccine shot spot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, nausea, vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site being sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2021 04:21 (Lot number: EC9263) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prostate relax" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE (ongoing); TAMSULOSIN taken for prostate tenderness (ongoing); ACEBUTOLOL taken for blood pressure abnormal (ongoing); NIFEDIPINE taken for blood pressure abnormal (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "injection site being sore".  Additional Information: It was stated that there were no previous vaccines. The concomitant medications had been started  since long time. There was no relevant tests.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Knee pain" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN taken for arthralgia. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "ringing in the ears".  Additional information: The reporter was a husband reported for a 56-year-old female patient (wife). It was reported that, the patient had no chronic health conditions. Stated that, the patient was taking ibuprofen for knee pain. No other meds. Stated that, the event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Incorrect dose administered, Middle insomnia, Pain in extremity, Product leakage
Clinical narrative: My arm has moderate injection site pain; the shot popped apart at the threaded portion of the syringe, vaccine went everywhere; Vaccine went everywhere; it was unclear if any made it into my arm; keeps me awake at night; painful to raise higher than elbow height; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 14:15 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: Not provided) in the left arm at 02:15 PM), administration date: 19Mar2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "My arm has moderate injection site pain"; MIDDLE INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "keeps me awake at night"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "painful to raise higher than elbow height"; PRODUCT LEAKAGE (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "the shot popped apart at the threaded portion of the syringe, vaccine went everywhere"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "Vaccine went everywhere"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "it was unclear if any made it into my arm". Therapeutic measures were not taken as a result of vaccination site pain, middle insomnia, pain in extremity.  Additional Information: During injection, the needle was inserted into patient's left arm. Once inserted, the person administering the shot pushed the syringe, and the shot popped apart at the threaded portion of the syringe. Vaccine went everywhere and it was unclear if any made it into her arm. The person administering the shot was surprised, but said that it 'has happened before'. The needle was still in her left arm, was pulled out, and another vaccine was quickly prepared and administered without issue. The patient's arm had moderate injection site pain (kept her awake at night and painful to raise higher than elbow height). The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient was not diagnosed with COVID prior vaccination, was not tested for COVID post vaccination, and had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: My arm has moderate injection site pain; the shot popped apart at the threaded portion of the syringe, vaccine went everywhere; Vaccine went everywhere; it was unclear if any made it into my arm; keeps me awake at night; painful to raise higher than elbow height; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 14:15 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: Not provided) in the left arm at 02:15 PM), administration date: 19Mar2021, when the patient was 38 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "My arm has moderate injection site pain"; MIDDLE INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "keeps me awake at night"; PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "painful to raise higher than elbow height"; PRODUCT LEAKAGE (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "the shot popped apart at the threaded portion of the syringe, vaccine went everywhere"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "Vaccine went everywhere"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 16Apr2021 14:15, outcome "unknown", described as "it was unclear if any made it into my arm". Therapeutic measures were not taken as a result of vaccination site pain, middle insomnia, pain in extremity.  Additional Information: During injection, the needle was inserted into patient's left arm. Once inserted, the person administering the shot pushed the syringe, and the shot popped apart at the threaded portion of the syringe. Vaccine went everywhere and it was unclear if any made it into her arm. The person administering the shot was surprised, but said that it 'has happened before'. The needle was still in her left arm, was pulled out, and another vaccine was quickly prepared and administered without issue. The patient's arm had moderate injection site pain (kept her awake at night and painful to raise higher than elbow height). The patient did not receive other vaccine in four weeks and other medications in two weeks. The patient was not diagnosed with COVID prior vaccination, was not tested for COVID post vaccination, and had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: nausea; diarrhea; This is a spontaneous report received from a contactable consumer from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 14Apr2021 (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 Apr2021, outcome "unknown", described as "nausea"; DIARRHOEA (non-serious) with onset Apr2021, outcome "unknown", described as "diarrhea".  Additional information: The events were reported as non-serious. The patient was asking if she could take any OTC medications for the events she was experiencing.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After the first dose my ears rang loudly for 5 days.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 24Mar2021 (Lot number: ER8727) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL. The following information was reported: TINNITUS (non-serious) with onset 24Mar2021 16:00, outcome "recovering", described as "After the first dose my ears rang loudly for 5 days.". Therapeutic measures were not taken as a result of tinnitus. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. The patient has not been diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444904 same patient, different dose/AE.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: slightly swollen arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 14:00 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome "unknown", described as "slightly swollen arm". Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Vomiting
Clinical narrative: Vomit; Lethargy; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 14Apr2021, outcome "unknown", described as "Vomit"; LETHARGY (non-serious) with onset 14Apr2021, outcome "unknown", described as "Lethargy"; CHILLS (non-serious) with onset 14Apr2021, outcome "unknown", described as "Chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep, Tremor
Clinical narrative: Light sleep; head, shoulders, and arms were shaking vigorously; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 11:30 (Lot number: EM9810) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Complex Regional Pain Syndrome (CRPS) in right leg" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medications included: PROPRANOLOL; LEXAPRO; SIMVASTATIN; COQ10 COMPLEX; BABY ASPIRIN. Past drug history included: Clindamycin, reaction: "Known drug allergy"; Flagyl, reaction: "Known drug allergy"; Amoxicillin, reaction: "Known drug allergy". The following information was reported: POOR QUALITY SLEEP (non-serious) with onset 07Feb2021 03:00, outcome "unknown", described as "Light sleep"; TREMOR (non-serious) with onset 07Feb2021 03:00, outcome "unknown", described as "head, shoulders, and arms were shaking vigorously". Therapeutic measures were not taken as a result of poor quality sleep, tremor.  Additional Information: After the first shot, as the patient turned in the night and was in light sleep, she was awoken because her head, shoulders, and arms were shaking vigorously (lasted maybe 10-15 seconds). When she fully awoke, it stopped. It happened only once (that she knew of). It happened again the next night. The patient did not receive other vaccine in four weeks. The patient took other medications in two weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021445087 Same patient and drug; Different dose and events
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 15:30 (Lot number: EP7533) at the age of 19 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Celiac" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Apr2021 16:00, outcome "recovering", described as "soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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 patient had no Allergies to medications food or other products.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 11:00 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious), outcome "unknown", described as "sinus infection".  Additional information: The facility type vaccine was pharmacy or drug store. Patient did not receive any other vaccine in four weeks.  Patient did not have covid prior to vaccination. Patient did not have covid post vaccination. Patient had a sinus infection after last shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm; This is a spontaneous report received from a non-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 02Mar2021 10:00 (Lot number: EN6198) 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 IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in left arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: After the first dose: Pain in left arm.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: fatigue; Twelve hours after the second dose the chills start; Pain in the left arm two hours after injection along with shooting pain in other areas of the body; Pain in the left arm two hours after injection along with shooting pain in other areas of the body; This is a spontaneous report received from a non-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 23Mar2021 09:45 (Lot number: EN6207) 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 number=EN6198, lot unknown=False, administration date=02Mar2021, administration time=10:00 AM, vaccine location=Left arm, dose number=1), administration date: 02Mar2021, when the patient was 31 years old, for Covid-19 immunization, reaction(s): "Pain in left arm". The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 23Mar2021, outcome "recovered" (24Mar2021) and all described as "Pain in the left arm two hours after injection along with shooting pain in other areas of the body"; CHILLS (non-serious) with onset 23Mar2021 21:45, outcome "recovered" (24Mar2021), described as "Twelve hours after the second dose the chills start"; FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, pain, chills, fatigue.  Additional information: After the first dose,Pain in left arm. After the second dose, Pain in the left arm two hours after injection along with shooting pain in other areas of the body. Twelve hours after the second dose the chills start. The following morning all of those symptoms were gone and there was only fatigue. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a headache; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 14:50 (Lot number: EN6198) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "fainted", notes: As a child many decades ago, she fainted after a Penicillin shot. Vaccination history included: Bnt162b2 (Dose 1), administration date: 23Feb2021, for Covid-immunization. The following information was reported: HEADACHE (non-serious) with onset 16Mar2021, outcome "not recovered", described as "had a headache". Therapeutic measures were taken as a result of headache.  Additional information: It was reported that the patient received both doses of the Pfizer Covid Vaccine. The patient reported that she was reporting it because the headache lasted so long and the Nurse Practitioner had not heard of it lasting like that. The patient stated that she was a little aware of the headache before 16Mar2021. The headache kept on and kept on and right now it was a slight pressure. She also stated that sometimes it progressed through the day, like during the day when she was distracted it was not as bad and then at night she was aware of it. The patient started taking Naproxen because the Ibuprofen was not helping.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: left arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 25Mar2021, outcome "unknown", described as "left arm soreness".  Additional information: The left arm soreness came on fairly immediately after the vaccine injection. She has a titanium in right arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: some arm soreness; slight headache; exhausted/ slept lot for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 10:40 (Lot number: EN6201) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Runny nose", start date: 16Mar2020, stop date: 2020, notes: 16Mar- runny nose (lasted for weeks); "No smell", start date: 19Mar2020, stop date: 2020, notes: 19Mar- no smell/no taste (lasted a month); "no taste", start date: 19Mar2020, stop date: 2020; "Cough", start date: 20Mar2020, stop date: 2020; "Tightness across shoulders", start date: 25Mar2020, stop date: 2020; "Exhausted", start date: 25Mar2020, stop date: 2020, notes: 25Mar- tightness across shoulders, exhausted, (lasted several more weeks. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Vaccination Date: 30Jan2021, Time: 3, Location: Arm left, Lot number: EL3248), administration date: 30Jan2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Feb2021, outcome "recovered", described as "slight headache"; FATIGUE (non-serious) with onset 18Feb2021, outcome "recovered", described as "exhausted/ slept lot for 2 days"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "some arm soreness". Therapeutic measures were not taken as a result of headache, fatigue, pain in extremity.  Additional Information: No, other product were taken together with those indicated above. Patient did not require visit to Emergency Room. No, AE(s) require a visit to Physician Office. On 24Mar2021 Patient Contacted doctor but had to fill in form only, no testing for covid available except if fever and hospitalized. Patient was unable to talk with her primary care doctor, so finally got now It was reported that patient was using Antipyretic. Ibuprofen 200 mg, Dose/Route of administration, 2(200) mg tablets, patient took ibuprofen several hours after first dose of vaccine and again, several hours after second dose of vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Insomnia
Clinical narrative: I felt intense pain in my lower abdomen towards the right side; difficult to sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: EW0158) at the age of 20 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts, pistachios, augmentin; "known allergies: pistachios" (unspecified if ongoing), notes: known allergies: Peanuts, pistachios, augmentin. The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "known allergies: augmentin", notes: known allergies: Peanuts, pistachios, augmentin. Vaccination history included: Bnt162b2 (lot number=EP6955, lot unknown=False, administration time=01:45 PM, vaccine location=Left arm, dose number=1), administration date: 20Mar2021, when the patient was 20 years old, for COVID-19 immunisation, reaction(s): "My period came a week earlier than it was supposed to". The following information was reported: ABDOMINAL PAIN LOWER (non-serious) with onset 12Apr2021, outcome "recovered" (13Apr2021), described as "I felt intense pain in my lower abdomen towards the right side"; INSOMNIA (non-serious) with onset 12Apr2021, outcome "recovered" (13Apr2021), described as "difficult to sleep". Therapeutic measures were taken as a result of abdominal pain lower, insomnia.  Additional information: Patient took ibuprofen and tylenol around the clock and she was not sure if reported events were connected to receiving the vaccine. Covid prior vaccination: No. Covid tested post vaccination: No. Other vaccine in four weeks: No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: stomach issues for a day and a half and then it went away; This is a spontaneous report received from a contactable reporter(s) patient's sister, (Consumer or other non HCP) reported for a patient that:  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: GASTRIC DISORDER (non-serious), outcome "recovered", described as "stomach issues for a day and a half and then it went away".  Additional information: one of the callers two sisters that she mentioned while providing her own Covid 19 vaccine experience. The caller reported that her sisters had stomach issues with her Covid 19 vaccine. She had stomach issues for a day and a half and then it went away. When probed for information regarding the callers sisters experience with the Covid 19 vaccine she declined to file safety report. She stated she did not know much about them, they were not in her area.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Really bad arm pain. Ibuprofen does not cut it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 14:30 (Lot number: EW0162) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Administration time: 06:30 PM, Vaccine location: Right arm, Brand: ER8730, Lot number: EW0162), administration date: 26Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Apr2021 18:00, outcome "not recovered", described as "Really bad arm pain. Ibuprofen does not cut it.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine was reported as Pharmacy or Drug Store. No known allergies were reported. No other medical history reported. The patient had neither received any other vaccine in four weeks nor received other medications in two weeks. The patient was neither diagnosed with Covid prior vaccination nor tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain
Clinical narrative: After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot.; After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 09:30 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL; ZOLOFT. Past drug history included: Demerol, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (Product=COVID -19, brand=Pfizer, Lot unknown=False,, Administration time=10:00 AM,, Vaccine location=Right arm,, Dose number=1), administration date: 17Mar2021, when the patient was 60 years old, for Covid-19 immunisation, reaction(s): "sore arm". The following information was reported: LYMPH NODE PAIN (non-serious), BREAST PAIN (non-serious) all with onset 11Apr2021, outcome "recovered" (2021) and all described as "After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot.". Therapeutic measures were not taken as a result of lymph node pain, breast pain.  Additional information: No serious criteria reported. Patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: multi-vitamin, tylenol, Zoloft. Only side effect of first vaccine was sore arm for a few days. After second vaccine only side effect was sore breasts/lymph nodes on left side (opposite of the side I got the shot on) days 4-6 after shot. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination,  patient was not tested for COVID-19. Allergies to medications, food, or other products Demerol.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, SARS-CoV-2 test
Clinical narrative: Burning in back region after first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 12:45 (Lot number: EN 6198) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SPIRONOLACTONE; BENEFIBER [CYAMOPSIS TETRAGONOLOBA GUM]; ESTARYLLA. The following information was reported: BURNING SENSATION (non-serious) with onset 22Feb2021 14:00, outcome "not recovered", described as "Burning in back region after first shot". The event "burning in back region after first shot" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of burning sensation.  Additional information: As a treatment for the event,  Gabapentin is prescribed. Mo known allergies and medical history noted.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: Sore arm; headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 12:00 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Administration time=12:00 PM, Vaccine location=Left arm, Dose number: 1), administration date: 22Mar2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "Sore arm"; HEADACHE (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "headache"; CHILLS (non-serious) with onset 13Apr2021 12:00, outcome "recovered" (Apr2021), described as "chills". Therapeutic measures were not taken as a result of pain in extremity, headache, chills.  Additional information: Facility type vaccine was workplace clinic. Patient neither had COVID-19 prior to vaccination nor was covid tested post vaccination, also patient did not had any other vaccine in four weeks. In response to the query regarding the awareness dare of the events and the patient who took the vaccine, the reporter reported that she (reporter) did not received the vaccine in this case, and she was reporting for my husband (Patient). Reporter also told that the date she wrote is the date when her husband (patient) told her about the adverse effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: The first shot I was tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 09:30 (Lot number: ER8727) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE BESILATE; TOPAMAX. Past drug history included: Depakote, reaction(s): "drug allergy"; Levaquin, reaction(s): "drug allergy"; Percocet, reaction(s): "drug allergy". The following information was reported: FATIGUE (non-serious) with onset 13Apr2021, outcome "unknown", described as "The first shot I was tired". The event "the first shot i was tired" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of fatigue.  Additional Information: No treatment AE reported. No Covid prior vaccination. No Covid tested post vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Gait disturbance, Pain
Clinical narrative: feeling weak; Fatigued; Aching; She could not walk up the stairs in her home; Unable to sleep due to chills; Pain in the arm; made a cup of hot tea but vomited it up about 90 min later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "Unilateral tumors on adrenal gland" (unspecified if ongoing); "known allergies: shellfish" (ongoing). Concomitant medication(s) included: HCTZ; NIFEDIPINE; TYLENOL. Vaccination history included: Bnt162b2 (1st dose, Left arm), administration date: 23Mar2021, for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "feeling weak"; FATIGUE (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "Fatigued"; VOMITING (non-serious) with onset 13Apr2021, outcome "not recovered", described as "made a cup of hot tea but vomited it up about 90 min later"; CHILLS (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "Unable to sleep due to chills"; PAIN IN EXTREMITY (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "Pain in the arm"; PAIN (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "Aching"; GAIT DISTURBANCE (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "She could not walk up the stairs in her home". Therapeutic measures were not taken as a result of asthenia, fatigue, vomiting, chills, pain in extremity, pain, gait disturbance.  Additional information: At 9:30 pm on 13Apr2021 (day of 2nd vaccine dose), patient began feeling weak, fatigued, and aching, so much so that she had to stop what she was doing. She made a cup of hot tea but vomited it up about 90 min later. That night, she was unable to sleep due to chills, and was so weak that she could not walk up the stairs in her home. On the morning of 14Apr, she tried taking Tylenol twice, but vomited it up both times, at 5 am and 7:30 am. She continues to feel fatigued, weak, with a headache and pain in the arm she received the vaccine. It was reported that there was no covid prior vaccination. Patient not tested for covid post vaccination. There was no other vaccine in four weeks from vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: feeling weak; Fatigued; Aching; She could not walk up the stairs in her home; Unable to sleep due to chills; Pain in the arm; made a cup of hot tea but vomited it up about 90 min later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "Unilateral tumors on adrenal gland" (unspecified if ongoing); "known allergies: shellfish" (ongoing). Concomitant medication(s) included: HCTZ; NIFEDIPINE; TYLENOL. Vaccination history included: Bnt162b2 (1st dose, Left arm), administration date: 23Mar2021, for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "feeling weak"; FATIGUE (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "Fatigued"; VOMITING (non-serious) with onset 13Apr2021, outcome "not recovered", described as "made a cup of hot tea but vomited it up about 90 min later"; CHILLS (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "Unable to sleep due to chills"; PAIN IN EXTREMITY (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "Pain in the arm"; PAIN (non-serious) with onset 13Apr2021 21:30, outcome "not recovered", described as "Aching"; GAIT DISTURBANCE (non-serious) with onset 13Apr2021 21:00, outcome "not recovered", described as "She could not walk up the stairs in her home". Therapeutic measures were not taken as a result of asthenia, fatigue, vomiting, chills, pain in extremity, pain, gait disturbance.  Additional information: At 9:30 pm on 13Apr2021 (day of 2nd vaccine dose), patient began feeling weak, fatigued, and aching, so much so that she had to stop what she was doing. She made a cup of hot tea but vomited it up about 90 min later. That night, she was unable to sleep due to chills, and was so weak that she could not walk up the stairs in her home. On the morning of 14Apr, she tried taking Tylenol twice, but vomited it up both times, at 5 am and 7:30 am. She continues to feel fatigued, weak, with a headache and pain in the arm she received the vaccine. It was reported that there was no covid prior vaccination. Patient not tested for covid post vaccination. There was no other vaccine in four weeks from vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gout, Influenza like illness, Insomnia
Clinical narrative: Extreme fatigue; Days without sleep; Flare up of gout and in a foot that I haven't had gout pain in before; Flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: ER8737) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product: COVID-19, brand: Pfizer, Lot number: EN6204, Lot unknown: False, Administration date: 16Mar2021, Administration time: 01:30 PM, Vaccine location: Left arm, Dose number: 1), administration date: 16Mar2021, when the patient was 45 years old, for COVID-19 immunisation, reaction(s): "Fatigue extreme", "Sleeplessness", "Gouty pain", "Flu like symptoms". The following information was reported: FATIGUE (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Extreme fatigue"; INSOMNIA (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Days without sleep"; GOUT (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Flare up of gout and in a foot that I haven't had gout pain in before"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Apr2021, outcome "recovered with sequelae", described as "Flu like symptoms". Therapeutic measures were not taken as a result of fatigue, insomnia, gout, influenza like illness.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had back pain, chills and pain/body aches, with outcome of unknown. Therapeutic measures were taken as a result of back pain, chills and pain. Additional information: The patient stated Tylenol was not helping. He would like to take Ibuprofen and inquired if it allowed to take Ibuprofen because Tylenol does not do anything for his pain. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: knotted up my neck within seconds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old 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: Bnt162b2 (DOSE 1; LOT# UNKNOWN;), for Covid-19 Immunization. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "knotted up my neck within seconds".  Additional information: Reporter mentioned that after receiving his first dose of the vaccine, he experienced "knotted up my neck within seconds." He also reported that both he and his wife (patient, who is also 61 years old) experienced this same sensation with the second dose, which they both received yesterday.   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-2021423328 Same reporter/ drug/ event for different patients.
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Felt like the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "Felt like the flu".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.