chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure abnormal, Blood pressure measurement, Dizziness, Fatigue
Clinical narrative: sleepy; aching all over; felt tired; Nauseated; pain in epigastric area; Dizzy; blood pressure was 128/60; head was heavy; 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 mRNA VACCINE, Solution for injection), administration date 30Mar2021 12:50 (Lot number: ER8733) 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: HEAD DISCOMFORT (non-serious) with onset 30Mar2021 13:05, outcome "unknown", described as "head was heavy"; DIZZINESS (non-serious) with onset 30Mar2021 15:45, outcome "not recovered", described as "Dizzy"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 30Mar2021 15:45, outcome "unknown", described as "blood pressure was 128/60"; NAUSEA (non-serious) with onset 30Mar2021 16:36, outcome "unknown", described as "Nauseated"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Mar2021 16:36, outcome "unknown", described as "pain in epigastric area"; SOMNOLENCE (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "sleepy"; PAIN (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "aching all over"; FATIGUE (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of head discomfort, abdominal pain upper. Additional information: Clinical course: The patient received the vaccine on 30Mar2021 at 12:50 PM. Stayed for 15 minutes and reported that head was heavy. Drank water at 1 PM and at 1:35 PM, drank 100cc of water with paracetamol (TYLENOL), had another 500 and at 3 PM, had prednisone. At 3:45 PM, the patient was dizzy. Blood pressure was 128/60. Had another 500cc of water. At 4:30 PM, felt continuous dizziness. Drank 400cc of coconut water. At 4:36 PM, the patient was nauseated and had pain in epigastric area. Took 15cc of Gaviscon and at 5:30 PM, had another 200cc of water but was still dizzy. At 5:50 PM, patient was sleepy, aching all over and felt tired. Patient was still dizzy at the time of report.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort, Nausea, Pain, Somnolence
Clinical narrative: sleepy; aching all over; felt tired; Nauseated; pain in epigastric area; Dizzy; blood pressure was 128/60; head was heavy; 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 mRNA VACCINE, Solution for injection), administration date 30Mar2021 12:50 (Lot number: ER8733) 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: HEAD DISCOMFORT (non-serious) with onset 30Mar2021 13:05, outcome "unknown", described as "head was heavy"; DIZZINESS (non-serious) with onset 30Mar2021 15:45, outcome "not recovered", described as "Dizzy"; BLOOD PRESSURE ABNORMAL (non-serious) with onset 30Mar2021 15:45, outcome "unknown", described as "blood pressure was 128/60"; NAUSEA (non-serious) with onset 30Mar2021 16:36, outcome "unknown", described as "Nauseated"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Mar2021 16:36, outcome "unknown", described as "pain in epigastric area"; SOMNOLENCE (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "sleepy"; PAIN (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "aching all over"; FATIGUE (non-serious) with onset 30Mar2021 17:50, outcome "unknown", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of head discomfort, abdominal pain upper. Additional information: Clinical course: The patient received the vaccine on 30Mar2021 at 12:50 PM. Stayed for 15 minutes and reported that head was heavy. Drank water at 1 PM and at 1:35 PM, drank 100cc of water with paracetamol (TYLENOL), had another 500 and at 3 PM, had prednisone. At 3:45 PM, the patient was dizzy. Blood pressure was 128/60. Had another 500cc of water. At 4:30 PM, felt continuous dizziness. Drank 400cc of coconut water. At 4:36 PM, the patient was nauseated and had pain in epigastric area. Took 15cc of Gaviscon and at 5:30 PM, had another 200cc of water but was still dizzy. At 5:50 PM, patient was sleepy, aching all over and felt tired. Patient was still dizzy at the time of report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Feeling like he is getting a cold; This is a spontaneous report received from a contactable pharmacist (patient's friend).  A 63-year-old male patient received BNT162B2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 31Mar2021, outcome "unknown", described as "Feeling like he is getting a cold".  Additional Information: The patient had the first shot dose of the Pfizer COVID-19 vaccine 3 weeks ago. The pharmacist was calling on behalf of the patient who is feeling like he is getting a cold (feels like he is coming out with cold) today (31Mar2021) before he gets the second dose tomorrow. The patient was scheduled to get his second dose tomorrow (also reported as the day of the reporting - 31Mar2021).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: cramps became so severe after being vaccinated with the Pfizer vaccine, that she cannot stretch her calves without cramping and must now begin PT to try to help with symptoms.; 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 right (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "AML" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "cramps became so severe after being vaccinated with the Pfizer vaccine, that she cannot stretch her calves without cramping and must now begin PT to try to help with symptoms".  Additional information: Other medications in two weeks: vitamin D3, mag w potassium, Hyland's leg cramp.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Anxiety, Feeling abnormal, Overdose
Clinical narrative: Strange; Vivid dreams; Occasional anxiety; Overdose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2021 11:00 (Lot number: EP7534) at the age of 42 years as dose 1, 1.3ml single for covid-19 immunisation. Relevant medical history included: "known allergies-Sulfa" (unspecified if ongoing), notes: known allergies-Sulfa; "ADD" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: LISINOPRIL; ADDERALL; ALLEGRA. Past drug history included: Amoxicillin, reaction(s): "Drug allergy". The following information was reported: FEELING ABNORMAL (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Strange"; ABNORMAL DREAMS (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Vivid dreams"; ANXIETY (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Occasional anxiety"; OVERDOSE (non-serious) with onset 14Mar2021 11:00, outcome "unknown", described as "Overdose". Therapeutic measures were not taken as a result of feeling abnormal, abnormal dreams, anxiety, overdose.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. He believed this was the result of an overdose because the first dose received was 1.3mL (shown to him by the clinician after they did three preparations and admitted it was their first time administering the vaccine). He only realized the anomaly yesterday when he received his second dose of 0.3mL. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation
Clinical narrative: Having trouble going to the restroom; have been constipated for last 3-4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Mar2021 (Lot number: ER8733) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METFORMIN HYDROCHLORIDE; AMLODIPINE. The following information was reported: CONSTIPATION (non-serious) with onset Mar2021, outcome "unknown", described as "Having trouble going to the restroom; have been constipated for last 3-4 days". Therapeutic measures were taken as a result of constipation.  Additional information: The patient took over the counter laxative magnesium citrate as treatment of the event.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This is a spontaneous report received from contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A 72-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunization. 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 "Arm sore".  Additional Information: While assisting the patient with looking up the prescription, she stated that she got her COVID-19 shot and it made her arm sore, and it lasted for 3 days.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizzy/dizziness; like vertigo for whole morning; 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 85 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, single), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "dizzy/dizziness"; VERTIGO (non-serious), outcome "recovered", described as "like vertigo for whole morning".  Additional information: The patient reported some adverse event after the Pfizer Covid vaccine. She reported that she receive the second dose of Pfizer COVID Vaccine on Wednesday and four days later she experienced dizziness like vertigo the whole morning later in the day it got better and she does not have anything.  No follow up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Myalgia
Clinical narrative: he doesn't feel right, kind of numb; within 2 hours it put him in bed, completely exhausted; Headache; Muscle ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 09:50 (Lot number: ER2613) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "they took his upper right lobes, lungs", start date: 2018 (unspecified if ongoing), notes: Verbatim: they took his upper right lobes, lungs; "COPD" (unspecified if ongoing), notes: Verbatim: COPD. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for chronic obstructive pulmonary disease; INCRUSE taken for chronic obstructive pulmonary disease. The following information was reported: FATIGUE (non-serious) with onset 18Mar2021, outcome "unknown", described as "within 2 hours it put him in bed, completely exhausted"; HEADACHE (non-serious) with onset 18Mar2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Muscle ache"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "he doesn't feel right, kind of numb". Therapeutic measures were taken as a result of headache.  Clinical course: The patient stated that he called about the COVID 19 vaccine. He said that he had the vaccine on 18Mar2021 and of course within 2 hours it put him in bed, completely exhausted. He reported a headache, muscle aches, he said that these side effects were expected but what he did not expect was that he still had the headache. He reported that he was partially recovered by 19Mar2021 because he still had achy muscles for a couple of days and still had the headache. He said that he ended up taking a couple of extra strength Tylenol, that eases it, he took a couple more hours later and it would almost dissipate it but before completely gone it was banging again. He then clarified that completely got rid of it. The muscle aches lasted a couple days. Specific outcome unknown. He said that there were a couple days where he just do not feel right, kind of numb: Date: it was one day of that a week and a half ago, it happened a couple of times up until now-could not really gave an onset date for that. Headache treatment was extra strength Tylenol, 500mg each tablet, he takes 2 initially generally in the morning, 2 in the evening if still having a problem. LOT number SCA040, expiration date Feb2024. UPC: Not provided. AE did not require a visit to Emergency Room, Physician Office. No Prior Vaccinations (within 4 weeks). No AE(s) following prior vaccinations. No Family Medical History Relevant to AE(s). No Additional Vaccines Administered on Same Date of the Pfizer Suspect. He said that he was leaning towards not getting the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: Kaleidoscope vision; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 15:00 (Lot number: EN6203) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Egg allergy" (unspecified if ongoing), notes: eggs; "Medical iodine allergy" (unspecified if ongoing), notes: Medical iodine. Concomitant medication(s) included: VITAMIN A; VITAMIN C; VITAMIN D3; AIRBORNE; PROBIOTICS. The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 15Mar2021 11:00, outcome "recovered" (2021), described as "Kaleidoscope vision"; HEADACHE (non-serious) with onset 15Mar2021 11:00, outcome "recovered" (2021), described as "Headache". The events "kaleidoscope vision" and "headache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of visual impairment, headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 11:00, the patient experienced kaleidoscope vision in right eye lasting about an hour and then a mild headache for 24 hours.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 02:30 (Lot number: EN6202) at the age of 69 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 ([{product: COVID 19, brand: Pfizer, lot number: EN6202, lot unknown: False, administration date: 14Mar2021, administration time: 02:30 AM, vaccine location: Left arm, dose number: 1}]), administration date: 14Mar2021, for Covid-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021 02:00, outcome "recovered" (Apr2021), described as "Sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. 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.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: hard time walking; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (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: GAIT DISTURBANCE (non-serious) with onset 31Mar2021, outcome "unknown", described as "hard time walking". Additional information: The patient called and stated that he got the first dose on 12Mar2021 and he will be having the second dose today, 31Mar2021 but he mentioned that when he woke up, he felt bad because he was having a hard time walking and might not able to attend the second appointment. He wanted to know if he can reschedule the second dose of the vaccine appointment if possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fear, Nightmare
Clinical narrative: nightmares; fear; Anxiety; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 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: NIGHTMARE (non-serious), outcome "unknown", described as "nightmares"; FEAR (non-serious), outcome "unknown", described as "fear"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety".  Additional information: The patient had side effects such as having nightmares, multiple times a week which leaves her with horrible fear and anxiety.   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-2021372242 same reporter/drug and event, different patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Throat irritation
Clinical narrative: Chills; Scratchy throat; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) at the age of 66 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: CHILLS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "Chills"; THROAT IRRITATION (non-serious) with onset 13Mar2021, outcome "not recovered", described as "Scratchy throat". Therapeutic measures were taken as a result of chills, throat irritation.  Additional information: The patient reported that she had quite a few different side effects from the beginning after receiving the COVID-19 vaccine. She reported that she is still having chills and she has a real kind of, not sore throat, but a scratchy throat. She reported that the other side effects that she had just kind of disappeared but she is still having chills. She drank some hot tea and she got warmed up and then she hasn't gotten rid of the chills since. She stated that the chills began the day after she got the first original shot on 13Mar2021. She reported that she did not pay that much attention to it and that she felt maybe that was something she was just going through. She reported that when the chills kept going on, she just drank some tea and lemon and honey which warmed her up but then the chills came back again, the chills did not want to go away. She reported that her chills are about the same, that she will try to drink something warm to get the chills down. She stated that drinking something warm would help her for a while and then the chills come back.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache; Tiredness; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 82 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 82 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: HEADACHE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Tiredness"; CHILLS (non-serious) with onset 31Mar2021, outcome "unknown", described as "Chills". Additional information: The patient had headache, tiredness and chills after receiving the first dose of the vaccine today 31Mar2021. Caller asked if he can proceed with his 2nd dose on 21Apr2021 even though he experienced the mentioned side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: Body aches (particularly in all joints), crushing headache with intermittent nausea; Body aches (particularly in all joints), crushing headache with intermittent nausea; Body aches (particularly in all joints), crushing headache with intermittent nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 13:45 (Lot number: EP-6955) at the age of 36 years as dose 2, single and administered in arm left, administration date 10Mar2021 10:00 (Lot number: EL-3247) as dose 1, single for covid-19 immunization.   The patient's relevant medical history was not reported. Concomitant medication(s) included: fluoxetine and multivitamin [vitamins nos].  The following information was reported: PAIN (non-serious), HEADACHE (non-serious), NAUSEA (non-serious) all with onset 02Apr2021 02:30, outcome "recovered" and all described as "Body aches (particularly in all joints), crushing headache with intermittent nausea". Therapeutic measures were taken as a result of pain, headache.  No follow-up attempts are possible. No further information is expected.  Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for covid-19 since the vaccination. The patient received treatment for the adverse events with Ibuprofen. The patient had allergies to medications, food, or other products.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fear, Nightmare
Clinical narrative: nightmares; fear; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (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: NIGHTMARE (non-serious), outcome "unknown", described as "nightmares"; FEAR (non-serious), outcome "unknown", described as "fear"; ANXIETY (non-serious), outcome "unknown", described as "anxiety". Additional information: The reporter wanted to know if this is a new side effect that's not listed and what can be done.  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-2021372130 same drug and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hypoacusis, Product dose omission issue, Stress, Tinnitus
Clinical narrative: states that she did not get the second dose; can barely hear over the ringing; It has been causing a lot of anxiety and stress.; stress; Screeching tinnitus and ringing in ears; Screeching tinnitus and ringing in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2021 (Lot number: EN6203) as dose 1, (0.3ml) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT DOSE OMISSION ISSUE (non-serious), outcome "unknown", described as "states that she did not get the second dose"; TINNITUS (non-serious), TINNITUS (non-serious) all with onset 26Feb2021, outcome "not recovered" and all described as "Screeching tinnitus and ringing in ears"; HYPOACUSIS (non-serious), outcome "unknown", described as "can barely hear over the ringing"; ANXIETY (non-serious), outcome "unknown", described as "It has been causing a lot of anxiety and stress."; STRESS (non-serious), outcome "unknown", described as "stress".  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes; under his left armpit it is super sore; sore arm on his left arm for a few days; 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 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 45 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 IN EXTREMITY (non-serious) with onset 03Apr2021, outcome "unknown", described as "sore arm on his left arm for a few days"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymphnodes"; AXILLARY PAIN (non-serious) with onset 03Apr2021, outcome "unknown", described as "under his left armpit it is super sore". Therapeutic measures were not taken as a result of axillary pain. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: caused nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 67 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: NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "caused nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Fatigue
Clinical narrative: felt  tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 91 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Feb2021 (Batch/Lot number: unknown) at the age of 91 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing); "High B/P" (ongoing); "Ache bones" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Old age" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN [METFORMIN HYDROCHLORIDE] taken for diabetes mellitus; ASPIRIN (E.C.); TYLENOL taken for pain; GABAPENTIN; METOPROLOL SUCCINATE;METOPROLOL TARTRATE; MAGNESIUM; HYDROCHLOROTHIAZIDE; AMLODIPINE BESILATE. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location: Right Arm), administration date: 22Jan2021, for COVID-19 Immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "felt  tired". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient only felt tired the day after 2nd Shot and after that patient felt great. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache, Insomnia
Clinical narrative: She cannot sleep; Stomach ache; Stomach upset; Headache is off and on; She is sick of the headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 92 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 (Lot number: EN6206) at the age of 92 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: HEADACHE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Headache is off and on; She is sick of the headache"; INSOMNIA (non-serious), outcome "not recovered", described as "She cannot sleep"; ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Stomach ache"; ABDOMINAL DISCOMFORT (non-serious) with onset 05Mar2021, outcome "not recovered", described as "Stomach upset". Therapeutic measures were taken as a result of headache, insomnia, abdominal pain upper.  Follow-Up (30Mar2021): This a follow-up spontaneous report from a Pfizer Sponsored Program. A contactable consumer (husband) reported for a patient that: additional information regarding adverse events were updated  No follow-up attempts are possible; No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Tic
Clinical narrative: Having physical and vocal tics; Stutter; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ER8730) at the age of 18 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: TIC (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Having physical and vocal tics"; DYSPHEMIA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Stutter".  Additional information: Patient was reported to be weighing 270 (units not reported). Patient stated she was having a severe reaction to Pfizer vaccine and stated she was having vocal and physical tics and stutter very often.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Soreness on arm; muscle ache; fatigue; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2, administered in arm left, administration date 31Mar2021 14:30 (Lot number: EL3247) at the age of 40 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 (1st dose; Lot number: EL3247, Administration time: 01:30 PM, Vaccine location: Left arm), administration date: 10Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Apr2021 09:00, outcome "recovered", described as "Soreness on arm"; MYALGIA (non-serious) with onset 01Apr2021 09:00, outcome "recovered", described as "muscle ache"; FATIGUE (non-serious) with onset 01Apr2021 09:00, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, myalgia, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling hot, Headache, Lymph node pain, Pain in extremity
Clinical narrative: Intermittent bone pain; Feeling very warm; Left lymph node pain; Headache; Sore arm; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 00:30 (Lot number: EL 6955) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALAVERT; IRON; MAGNESIUM; VITAMIN B [VITAMIN B NOS]. Vaccination history included: Bnt162b2 (administration time 09:30 AM, vaccine location Left arm, dose number 1, lot number EL 247), administration date: 10Mar2021, when the patient was 39 years old, for COVID-19 Immunization. The following information was reported: BONE PAIN (non-serious) with onset 01Apr2021 06:00, outcome "not recovered", described as "Intermittent bone pain"; FEELING HOT (non-serious) with onset 01Apr2021 06:00, outcome "not recovered", described as "Feeling very warm"; LYMPH NODE PAIN (non-serious) with onset 01Apr2021 06:00, outcome "not recovered", described as "Left lymph node pain"; HEADACHE (non-serious) with onset 01Apr2021 06:00, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 01Apr2021 06:00, outcome "not recovered", described as "Sore arm". Therapeutic measures were not taken as a result of bone pain, feeling hot, lymph node pain, headache, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Thirst
Clinical narrative: Headache; Increased thirst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A female patient (unknown if pregnant) 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: HEADACHE (non-serious), outcome "recovered", described as "Headache"; THIRST (non-serious), outcome "recovered", described as "Increased thirst".  Additional Information: Headache after receiving the dose. Increased thirst for a few days following administration. The patient did not have COVID-19 prior to vaccination and it was unknown if was tested for COVID-19 post the vaccination. It was unknown if received any treatment for adverse events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: body aches; fatigue; 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: PAIN (non-serious), outcome "unknown", described as "body aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Additional information: The patient wanted to know if it's okay for her to take the second dose since she experienced body aches and fatigue after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Taste disorder
Clinical narrative: taste buds are not really there anymore; loss of appetite; 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 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: Unknown) at the age of 54 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: TASTE DISORDER (non-serious) with onset 2021, outcome "recovering", described as "taste buds are not really there anymore"; DECREASED APPETITE (non-serious) with onset 2021, outcome "recovering", described as "loss of appetite".  Additional information: He usually has a very healthy appetite, but it has been going down hill. He has been eating stuff to get something in his stomach.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: Dizziness; tinnitus; 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 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant), outcome "not recovered", described as "Dizziness"; TINNITUS (medically significant), outcome "not recovered", described as "tinnitus". Additional information: Patient have some questions about getting second Pfizer. Patient had COVID-19 Virus in Dec2020 to an unknown date. Patient received the first COVID Vaccine Pfizer about a week and half ago. So, patient was long hours after patient had this COVID Vaccine, patient was left with dizziness and tinnitus for a 'month' but they were subsiding, so patient got first vaccine and it brought all the symptoms back and they hadn't gone away. So patient was questioning if patient should be getting the second one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited for days after 1st and second shot; This is a spontaneous report received from a contactable reporter (Consumer).  A male patient received COVID-19 Vaccine - Manufacturer Unknown, (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: VOMITING (non-serious), outcome "recovered", described as "vomited for days after 1st and second shot". Additional information: Reporter is the patient's grandchild. Reporter stated that she knew that the shot could upset the stomach, that her grandfather vomited for days after 1st and second shot. Reporter stated she has no personal information about her grandfather, that it is her step grandfather; LOT and Expiration date of product unknown, stated she thought it is the Moderna vaccine that he got but she is unsure. Reporter also stated that her grandfather was a veteran and that he did get better from his side effects.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Limb injury, Pain, Product administered at inappropriate site
Clinical narrative: They injured her shoulder when they gave her the 2nd dose; she believes they hit a nerve; Horrific and excruciating pain as soon as they gave the injection and pain has worsened since the injection; they injured her shoulder when they gave her the 2nd dose; she believes they hit a nerve; concerned that she didnt receive a valid dose as she doesnt believe it was in her muscle; 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 67 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (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 Manufacturer unknown), for Covid-19 immunization. The following information was reported: LIMB INJURY (non-serious) with onset 30Mar2021, outcome "unknown", described as "They injured her shoulder when they gave her the 2nd dose; she believes they hit a nerve"; PAIN (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Horrific and excruciating pain as soon as they gave the injection and pain has worsened since the injection"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 30Mar2021, outcome "unknown", described as "they injured her shoulder when they gave her the 2nd dose; she believes they hit a nerve"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 30Mar2021, outcome "unknown", described as "concerned that she didnt receive a valid dose as she doesnt believe it was in her muscle".  Additional information: received the 2nd dose of her pfizer covid 19 vaccine on  march 30th.States they  injured her shoulder when they gave her the 2nd dose; she believes they hit a nerve. States she was given the injection high up on her shoulder where the arm attaches to the shoulder. Reports horrific and excruciating pain as soon as they gave the injection and pain has worsened since the injection. Reports pain is still ongoing.  caller uncertain if full dose received. concerned that she didnt receive a valid dose as she doesnt believe it was in her muscle. asking for information.  States she talked to her  hcp who didnt know anything and she spoke to CDC who couldnt give her any information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: after had vaccine slipped and fell.; 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 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "after had vaccine slipped and fell.". Therapeutic measures were taken as a result of fall. Additional information: Patient had both doses of covid vaccine and was grateful but 3 weeks after had vaccine, she slipped and fell. Health care professional (HCP) put her on an antibiotic, now put on steroid. Patient was concerned that antibiotic and steroid will affect vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in left armpit area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 13:45 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single and administered in arm left, administration date 09Mar2021 13:45 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type II Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 01Apr2021 09:00, outcome "recovered" (2021), described as "Swollen lymph node in left armpit area". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information:  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. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination, patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.