chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pulse abnormal
Clinical narrative: fatigue; no appetite; nauseous; chills; headache; Sore arm; My pulse was over 100 again resting but went back normal by late morning; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 16Feb2021, for COVID-19 immunisation, reaction(s): "Slight sore arm", "headache", "total fatigue", "loss of appetite", "pulse went up 139". The following information was reported: FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "fatigue"; DECREASED APPETITE (non-serious) with onset 10Mar2021, outcome "unknown", described as "no appetite"; NAUSEA (non-serious) with onset 10Mar2021, outcome "unknown", described as "nauseous"; CHILLS (non-serious) with onset 09Mar2021, outcome "not recovered", described as "chills"; PULSE ABNORMAL (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "My pulse was over 100 again resting but went back normal by late morning"; HEADACHE (non-serious) with onset 09Mar2021, outcome "unknown", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Onset latency for the events fatigue, decreased appetite and nausea was 01 day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little pain where shot was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) 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. Vaccination history included: Bnt162b2, for COVID-19 immunisation, reaction(s): "she was ok". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "little pain where shot was given".  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: Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Muscle aches; fatigue; slight headache; no appetite; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 18:30 (Lot number: EN6207) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre diabetic" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. Concomitant medication(s) included: SINGULAIR; METFORMIN; CETRIZINE; IBUPROFEN. The following information was reported: MYALGIA (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "Muscle aches"; FATIGUE (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "fatigue"; HEADACHE (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "slight headache"; DECREASED APPETITE (non-serious) with onset 12Mar2021 18:45, outcome "not recovered", described as "no appetite". Therapeutic measures were taken as a result of myalgia, fatigue, headache, decreased appetite.  Additional information: Patient had not received other vaccine in four weeks. Patient has received covid prior vaccination and was not tested positive post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Eating disorder, Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: hurts to eat; hurts to eat; twinges on the right side of neck in the lymph nodes which is now a knot; twinges on the right side of neck in the lymph nodes which is now a knot; extreme fatigue; 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 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6203, Expiration Date: 01Jun2021) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "left kidney donation", start date: 2001 (unspecified if ongoing), notes: Verbatim: left kidney donation; "flu season/preventative for colds and flu" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased (ongoing); VITAMIN C [ASCORBIC ACID] taken for influenza, start date: Sep2020 (ongoing); ZINC taken for hypersensitivity, start date: Sep2020 (ongoing); VITAMIN D3, start date: 2015 (ongoing). The following information was reported: FATIGUE (non-serious) with onset 08Mar2021, outcome "recovered" (09Mar2021), described as "extreme fatigue"; LYMPH NODE PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset 09Mar2021, outcome "not recovered" and all described as "twinges on the right side of neck in the lymph nodes which is now a knot"; EATING DISORDER (non-serious) with onset 10Mar2021, outcome "not recovered", DYSPHAGIA (non-serious) with onset 10Mar2021, outcome "unknown" and all described as "hurts to eat".  Additional information: Patient received the Covid-19 vaccine on 08Mar2021. She donated her left kidney in 2014. The recipient was doing good. Later that day she was extremely fatigued. It went away about 12 hours later. She had twinges on the right side of her neck in the lymph nodes which was now a knot was reported as worsened. Event: hurts to eat was reported as worsened. The Concomitant Products Simvastatin, patient started taking at age 32 or 34. As patient experienced hurt to eat, which was not a bad thing because she needed to lose some weight.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Arm was sore; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 63 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN6207) at the age of 63 years as single dose for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE taken for crohn's disease; METHOTREXATE; TRELEGY taken for chronic obstructive pulmonary disease. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: Investigation Assessment was no. Transferring agent stated, I have a caller on my back line. He is calling for himself and his wife. They both received the first dose of the COVID-19 vaccine, the wife is reporting her arm was sore and she has had a headache. The caller is reporting he had a high fever, he said above 100 degrees and he would like to know if those side effects are normal. Age at adverse event, reporter stated, her age is 63, I believe. Other medications: reporter stated, she has a rescue Inhaler in between and then she has Oxygen (further not clarified). Treatment: Reporter stated, No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye allergy, Feeling abnormal, Nasopharyngitis, Sinusitis
Clinical narrative: feeling being under the weather; allergy-ish in the eyes; sinuses; with a cold; 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 female patient received bnt162b2 (BNT162B2), administration date 16Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 09Mar2021, outcome "unknown", described as "feeling being under the weather"; EYE ALLERGY (non-serious) with onset 09Mar2021, outcome "unknown", described as "allergy-ish in the eyes"; SINUSITIS (non-serious) with onset 09Mar2021, outcome "unknown", described as "sinuses"; NASOPHARYNGITIS (non-serious) with onset 09Mar2021, outcome "unknown", described as "with a cold". Therapeutic measures were not taken as a result of nasopharyngitis.  Additional information: Also today is supposed to be her schedule for the second dose. She expressed the. Possibility that she might not make it today in the facility. She is then asking how to reschedule and whether there an allowable time to extend beyond 21 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; 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 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: NAUSEA (non-serious), outcome "unknown", described as "nausea".   Additional information: Patient is requesting to get information like wants to know that he can take (Gravol) Anti nausea medications.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: chills; Left Arm ache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 09:45 (Lot number: EL3248) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hypertension controlled with lisinopril" (ongoing); "Allergy to penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Mar2021, outcome "recovered" (11Mar2021), described as "Left Arm ache"; CHILLS (non-serious) with onset 10Mar2021, outcome "recovered" (12Mar2021), described as "chills". Therapeutic measures were not taken as a result of pain in extremity, chills.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Urine analysis
Clinical narrative: Headache; Muscle pain; Nausea; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  An 83 year-old male patient received BNT162b2 (BNT162B2), administered in left arm, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 83 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure abnormal" and "Cholesterol abnormal", both unspecified if ongoing. Concomitant medication included: BABY ASPIRIN. Vaccination history included: BNT162b2 (First dose, administered in left arm), administration date: 04Feb2021, when the patient was 83 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 08Mar2021, outcome "unknown", described as "Headache"; MYALGIA (non-serious) with onset 08Mar2021, outcome "unknown", described as "Muscle pain"; NAUSEA (non-serious) with onset 08Mar2021, outcome "unknown", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, myalgia, nausea. Additional information: Consumer stated, "I was calling about the side effects the ones that I am having. I got the shot just 2 weeks ago, the second one and about the last 3 days here I am having slight headache, muscle pain and nausea. I just have been taking Tylenol." Consumer was suggested to contact the doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Anxiety, Asthenia, Dizziness, Headache
Clinical narrative: her head really aches; dizzy; anxious; upset stomach; weak; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "her head really aches"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxious"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "upset stomach"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weak"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body pain". Additional Information: The patient received first dose yesterday and was having extremely bad side effects. Reporter stated that, patient (reporter mother) experienced head really aches, very dizzy, very anxious, and had an upset stomach' reporter clarified that her mother was overall Super dizzy, weak, anxious, and was having body pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: her head really aches; dizzy; anxious; upset stomach; weak; body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "her head really aches"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "anxious"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "upset stomach"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weak"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body pain". Additional Information: The patient received first dose yesterday and was having extremely bad side effects. Reporter stated that, patient (reporter mother) experienced head really aches, very dizzy, very anxious, and had an upset stomach' reporter clarified that her mother was overall Super dizzy, weak, anxious, and was having body pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: patient could not remember phone number, did that all the time, mind just slipped and guess getting old; 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), administration date Feb2021 (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: MEMORY IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "patient could not remember phone number, did that all the time, mind just slipped and guess getting old".  Additional information: The patient stated, took the Pfizer vaccine (further not clarified hence captured as Unspecified vaccine) and took it on 28Feb on Saturday and 27th, patient thought 27th and patient wanted to know where need to go to get second shot. Patient was informed about role of Pfizer Drug Safety department. Patient was provided with the number of Pfizer pharmacy as (Number), timings 8 AM to 6 PM, Monday to Friday, EST.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Extreme indegestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 13:15 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DYSPEPSIA (non-serious) with onset 16Feb2021, outcome "unknown", described as "Extreme indegestion".  Additional information: No known allergies. Other medical history reported as none. No other vaccine in four weeks. No other medications in two weeks. Extreme indigestion the day after both shots. No covid prior vaccination. Not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Additional information: The patient had arm soreness. It was bad for about 3 days. The patient couldn't even lay on side.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Dizziness; Weakness; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:30 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: around the time she was 50; "heart patient" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 10Mar2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious) with onset 10Mar2021, outcome "unknown", described as "Weakness"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "tired". Therapeutic measures were not taken as a result of dizziness, asthenia, fatigue.  Additional information: She says she had dizziness and weakness that started last night after she got home from getting the vaccine. She says she got tired and went to sleep at 18:00 until 05:00 which is unusual for her. She says that yesterday she noticed she had dizziness also. Patient has not had any other recent vaccinations or started any new medications. Patient is on medication for high blood pressure and heart problem. Patient has not done any treatment; she just took her medication she takes every day. She says that the dizziness is not that bad, it is not enough to make her fall to the floor, it just makes her look when she is going downstairs, she doesn't fly down the stairs, she looks. She says that she thinks it was worse yesterday than today, she just went to sleep so early there was not much of a day. She says that she got her vaccination about 13:30 and went to sleep about 18:00.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Sleep disorder
Clinical narrative: Dizziness; Weakness; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 13:30 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: around the time she was 50; "heart patient" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 10Mar2021, outcome "unknown", described as "Dizziness"; ASTHENIA (non-serious) with onset 10Mar2021, outcome "unknown", described as "Weakness"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "tired". Therapeutic measures were not taken as a result of dizziness, asthenia, fatigue.  Additional information: She says she had dizziness and weakness that started last night after she got home from getting the vaccine. She says she got tired and went to sleep at 18:00 until 05:00 which is unusual for her. She says that yesterday she noticed she had dizziness also. Patient has not had any other recent vaccinations or started any new medications. Patient is on medication for high blood pressure and heart problem. Patient has not done any treatment; she just took her medication she takes every day. She says that the dizziness is not that bad, it is not enough to make her fall to the floor, it just makes her look when she is going downstairs, she doesn't fly down the stairs, she looks. She says that she thinks it was worse yesterday than today, she just went to sleep so early there was not much of a day. She says that she got her vaccination about 13:30 and went to sleep about 18:00.   No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 09:30 (Lot number: EL9262) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperuricemia" (ongoing), notes: He produces too much uric acid and it causes kidney stones; "Dizziness" (ongoing), notes: Caller had some slight dizzy spells that the doctors couldn't isolate.; "Back pain" (ongoing); "Covid-19", start date: Dec2020, stop date: Dec2020, notes: Mentions Dec2020 he got COVID 19 but was cleared at by the end of Dec2020. Concomitant medication(s) included: DIAZEPAM taken for dizziness, start date: 1978 (ongoing); ALLOPURINOL taken for hyperuricaemia (ongoing); PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL] taken for back pain. The following information was reported: MYALGIA (non-serious) with onset 10Feb2021, outcome "recovered" (12Feb2021), described as "muscle aches".  Additional information: Patient states he noticed the day after muscle aches but nothing that he didn't expect. The patient did not receive any previous immunization with the Pfizer vaccine and also did not additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccine within four weeks prior to vaccination. The patient did not have any family history. The patient did not have any illness at time of vaccination. The patient did not perform any relevant test.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vertigo, Vomiting, Weight
Clinical narrative: vertigo and dizziness; vertigo and dizziness; Vomiting; Headache; 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 female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (Lot number: EL9262) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "UTI" (unspecified if ongoing). Concomitant medication(s) included: MACROBID [CLARITHROMYCIN] taken for urinary tract infection. Vaccination history included: Bnt162b2 (Batch/lot number: EL3246 , Dosage text: First dose), for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious), DIZZINESS (non-serious) all with onset 06Mar2021, outcome "recovered" (09Mar2021) and all described as "vertigo and dizziness"; VOMITING (non-serious) with onset 06Mar2021, outcome "recovered" (09Mar2021), described as "Vomiting"; HEADACHE (non-serious) with onset 06Mar2021, outcome "recovering", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Somnolence
Clinical narrative: it has worsened; her husband falling asleep in his chair and going to bed at 6.00 or 19.00 and sleeping until 9:00 or 10:00 the next morning; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 13:00 (Lot number: EM98089) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Digestive Issues" (unspecified if ongoing); "Stent" (unspecified if ongoing); "severe chest pain" (ongoing); "heart were blocked" (unspecified if ongoing); "helps with his heart" (unspecified if ongoing). Concomitant medication(s) included: NITRO [GLYCERYL TRINITRATE] taken for chest pain; CO-Q-10 PLUS; ASPIRIN CHILDREN taken for cardiac disorder. Vaccination history included: Bnt162b2 (Lot number: EN6198   , 1st dose), administration date: 09Feb2021, when the patient was 70 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 03Mar2021, outcome "not recovered", described as "Fatigue"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "it has worsened"; SOMNOLENCE (non-serious), outcome "unknown", described as "her husband falling asleep in his chair and going to bed at 6.00 or 19.00 and sleeping until 9:00 or 10:00 the next morning".  Additional information: Caller stated that she and her husband received their second dose of the Covid shot, clarified to be the Pfizer Covid-19 vaccine.  Caller reported later that both she and her husband have been experiencing fatigue. Caller reported that her husband started experiencing fatigue on 03Mar2021.  She stated that he was still experiencing the fatigue, and she believed that it has worsened.  Caller reported that she was unsure if it was connected to the vaccine, but that her husband falling asleep in his chair and going to bed at 6.00 or 19.00 and sleeping until 9:00 or 10:00 the next morning.  She stated that fatigue was a baseline for him but that she felt as though his has worsened since the second vaccine. Caller reported that her husband was on three different blood pressure medications in addition to medications for his stomach, heart, cholesterol, and nitro in case of severe chest pain.  Caller also reported that her husband saw a psychologist and was on a medication from that provider. The reporter stated that the patient has a long history of poor health.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pain
Clinical narrative: Aching every where/She's aching; she's cold, really cold; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 14:45 (Lot number: EN6207) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Head problems" (unspecified if ongoing), notes: She has head problems anyway and she already has medication for headache.; "Covid" (unspecified if ongoing), notes: She had already had covid. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 10Mar2021, outcome "recovered" (11Mar2021), described as "Headache"; PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Aching every where/She's aching"; NASOPHARYNGITIS (non-serious) with onset 11Mar2021, outcome "not recovered", described as "she's cold, really cold". Therapeutic measures were taken as a result of headache.  Additional information: The patient took medication for her headache. She has head problems anyway and she already has medication for headache. No additional Vaccines was Administered on the same date. The events did not cause Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none.     No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: slight dull headache part of the time; Arm was sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EL9264) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cardiac ablation", start date: Jan2020 (unspecified if ongoing), notes: she had cardiac ablation. She was on 4-5 different heart meds since the ablation; "leukemia" (unspecified if ongoing), notes: she had leukemia while she was in the hospital for Afib; "She is high risk" (unspecified if ongoing); "Afib" (unspecified if ongoing), notes: she was in the hospital for Afib. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "slight dull headache part of the time"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore".  Additional information: The reporter was a radiologic technologist but she was retired not. They did pretty good with side effects for the 1st injection, their arms were sore and she had kind of a slight dull headache part of the time but it was okay when you consider not taking the vaccine what could happen that was okay. But their arms were much more sore this time. Product details: First dose on her vaccine card says 92 or LL, someone should have written a little neater. 92 or an LL9264. She clarified when looking at her husbands vaccine card that her first dose lot number looks the same as his, EL9264. The patient later received second dose of BNT162B2 (lot number: EN6205) on an unspecified date (on Monday) and on Tuesday evening her arms were a lot more sore this time and she got blisters right there at the injection and the blisters may have pulled the serum out of her body.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Ever since I got my shot, I am breathing easier; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had a hard time breathing" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset Feb2021, outcome "unknown", described as "Ever since I got my shot, I am breathing easier".  Additional information: Consumer stated, "Well I wanted to report a side effect that I believe is from my Covid shot. Eventually it is very nice side effect. I do not have respiratory issue. I am extremely heathy for my age but after I got the shot I noticed within 24 hours or so that I started breathing easier and ever since I got my shot, I am breathing easier than I was before not that I was complaining that I had a hard time breathing and like I said that it did it for me and I do not have any respiratory issues maybe something about that shot would help people who had respiratory issue."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Post injection headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Post injection headache".  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: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 25Jan2021 09:15 (Lot number: EL9261) at the age of 56 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 date: 04Jan2021, for Covid-19 immunisation, reaction(s): "Joint pain", "GI Symptoms", "Headache", "Muscle ache", "Temperature of 102.9", "chills", "Nausea", "Dry cough", "Fatigue". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  No follow-up attempts are possible. No further information is expected.  Additional information; The patient provide information to you regarding the reported adverse event(s) with the use of the product Yes, I am the patient If  yes above, do you consider the Pfizer product had a causal effect to the adverse event Yes  Pfizer-BioNTech Covid-19 Vaccine Anaphylactic Reaction Data Capture Aid. AER/Manufacturer Report  (Reference number withheld)  AER/Manufacturer Report (Reference number withheld). Reported event term prompting special follow-up activities: Dry cough Reported  Details, Dry cough after onsets symptoms from vaccine it lasted 24 degree Cardiovascular: Yes  Vomiting: Yes 1st Injection lasted start 24-48 degree finish, 2nd injection lasted start 12 -96 degree finish.  The patient was taking any medications prior to the event being reported: Yes (Ocella OCP).The patient did not receive any recent vaccines for any other conditions prior to the event being reported, The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported, The patient  has not been received any other vaccines around the time of Pfizer-BioNtech Covid-19 Vaccine Vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: gland in neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 31Dec2020 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "GERD", start date: 1957 (ongoing); "Asthma", start date: 2000 (ongoing); "Obesity", start date: 1993 (ongoing); "Allergy", start date: 2000 (ongoing); "illness", start date: 2000 (ongoing). Concomitant medication(s) included: FAMOTIDINE taken for dyspepsia, start date: 2019 (ongoing); MONTELUKAST taken for asthma, start date: 2019 (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "gland in neck". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: It was reported that, patient did not visit the emergency room or did not undergone any surgical treatment. It was also reported that, event information start date or best estimated period: Only slightly in Gland in neck about 8 hour after for about 24hours. Patient was not admitted to hospital.  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, Fatigue, Headache
Clinical narrative: Diarrhea; a slight headache; Really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 12Mar2021, outcome "unknown", described as "Diarrhea"; HEADACHE (non-serious) with onset 11Mar2021, outcome "unknown", described as "a slight headache"; FATIGUE (non-serious) with onset 11Mar2021, outcome "recovering", described as "Really tired".  Additional information: Caller on the line calling about the Pfizer COVID 19 shot. After getting the first shot he had to run errands and came back home. Early that evening she started to get a slight headache that she no longer has. She also felt tired, but now she was not as tired. Today, (12Mar2021) she started to have diarrhea. She also wanted to know if she could take Imodium. She also stated, the number on the paper they were provided was very misleading. Stated on the paper it indicates if have a question or experience "this" to call this number, and she called that number and ends up getting us. She stated she was very upset and was going to complain.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Pain; Tiredness; Headache; Muscle pain; Chills; Nausea; She just don't feel good; Sore where she got the shot; arm was really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6203) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2017 (unspecified if ongoing), notes: Verbatim: Breast cancer. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Pain"; FATIGUE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Tiredness"; HEADACHE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Headache"; MYALGIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Muscle pain"; CHILLS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Sore where she got the shot; arm was really sore"; NAUSEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "She just don't feel good". Therapeutic measures were taken as a result of pain, fatigue, headache, myalgia, chills, vaccination site pain, nausea, malaise.  Additional information: Reporter stated that, my wife and I both received a vaccine the first dose yesterday, today I have no side effects but my wife has a whole bunch of them and reporter and patient received vaccine at probably 11 o'clock morning and it was after that her arm was really sore, morning and she really (incomplete sentence), overnight she got it all this. On the day of report, the patient had pain, tiredness, headache, muscle pain, chills, sore where she got the shot, nausea and she just don't feel good. The patient took Tylenol this morning. The patient took few medications. It was reported that she was the same, not improving. The patient was scheduled to go 01Apr2021 to get the second dose. The reporter was asking if she should just go ahead and get it.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: Pain; Tiredness; Headache; Muscle pain; Chills; Nausea; She just don't feel good; Sore where she got the shot; arm was really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6203) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast cancer", start date: 2017 (unspecified if ongoing), notes: Verbatim: Breast cancer. The patient took concomitant medications. The following information was reported: PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Pain"; FATIGUE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Tiredness"; HEADACHE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Headache"; MYALGIA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Muscle pain"; CHILLS (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Sore where she got the shot; arm was really sore"; NAUSEA (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 12Mar2021, outcome "not recovered", described as "She just don't feel good". Therapeutic measures were taken as a result of pain, fatigue, headache, myalgia, chills, vaccination site pain, nausea, malaise.  Additional information: Reporter stated that, my wife and I both received a vaccine the first dose yesterday, today I have no side effects but my wife has a whole bunch of them and reporter and patient received vaccine at probably 11 o'clock morning and it was after that her arm was really sore, morning and she really (incomplete sentence), overnight she got it all this. On the day of report, the patient had pain, tiredness, headache, muscle pain, chills, sore where she got the shot, nausea and she just don't feel good. The patient took Tylenol this morning. The patient took few medications. It was reported that she was the same, not improving. The patient was scheduled to go 01Apr2021 to get the second dose. The reporter was asking if she should just go ahead and get it.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Vertigo
Clinical narrative: Extreme vertigo; It is debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 67 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Extreme vertigo"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "It is debilitating". Therapeutic measures were not taken as a result of vertigo, asthenia.  Additional information: The patient received first vaccine last Saturday and about 10 minutes after left the waiting period, started having extreme vertigo and still have it a week later.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Off label use
Clinical narrative: she is nursing mother; She is been very lethargic since then and very tired; She is been very lethargic since then and very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: OFF LABEL USE (non-serious), outcome "unknown", described as "she is nursing mother"; LETHARGY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "She is been very lethargic since then and very tired".  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021290930 same drug, different patient/event
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache after vaccine administration one hour ago; This is a spontaneous report received from a contactable reporter(s) Nurse (Other HCP).  A patient in their 30's 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 "unknown", described as "Severe headache after vaccine administration one hour ago".  Additional information: No underlying conditions young adult 30s.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.