chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dysphonia, Limb discomfort
Clinical narrative: I lost my voice; Very hoarse; Had covid arm; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 14:00 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "peripheral neurorapthy" (unspecified if ongoing), notes: Verbatim: peripheral neurorapthy; "Allergies: Shellfish" (unspecified if ongoing), notes: Verbatim: Shellfish; "allergies: contrast dye" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Vicodin, reaction(s): "known allergies: vicodin"; Sulfa drugs, reaction(s): "known allergies: sulfa drugs". The following information was reported: APHONIA (non-serious) with onset 23Mar2021 16:00, outcome "not recovered", described as "I lost my voice"; DYSPHONIA (non-serious) with onset 23Mar2021 16:00, outcome "not recovered", described as "Very hoarse"; LIMB DISCOMFORT (non-serious) with onset 23Mar2021 16:00, outcome "not recovered", described as "Had covid arm". The events "i lost my voice", "very hoarse" and "had covid arm" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of aphonia, dysphonia, limb discomfort.  Additional information: Facility type vaccine was Hospital. Patient lost her voice/very hoarse the evening of the vaccine. It has not returned. It has been 2 weeks and 2 days. Patient went to urgent care and her family doctor who said to wait it out. Patient was scheduled to receive her 2nd dose this Sunday. Patient had allergies. She did not get anaphylaxis but lost her voice and had Covid arm. Patient had not received other vaccine in four weeks. She was under several other medications in two weeks. She was not tested positive prior vaccination and was not tested positive after vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Calcification of muscle, Shoulder injury related to vaccine administration, Tendon calcification, X-ray abnormal
Clinical narrative: Extreme shoulder pain SIRVA
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Ear congestion, Ear discomfort, Neurological symptom
Clinical narrative: A few days after my 2nd vaccine, I felt congestion/blockage in my ears. I assumed it was a cold and not related but it never got better. I noticed higher pitched/garbled sounds in my left ear; and there was a constant whooshing sound. I went to my primary care doctor who referred me to an ENT. The ENT checked my ears and sent me to an audiologist who confirmed I had lost hearing in the bass frequency in my left ear. Structurally the ear anatomy is fine so ENT sent me for an MRI, which ruled-out acoustic neuroma. ENT said it is neurological and we don't know why it happened. Because of the timing, I believe it is related to the COVID-19 vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: A few days after my 2nd vaccine, I felt congestion/blockage in my ears. I assumed it was a cold and not related but it never got better. I noticed higher pitched/garbled sounds in my left ear; and there was a constant whooshing sound. I went to my primary care doctor who referred me to an ENT. The ENT checked my ears and sent me to an audiologist who confirmed I had lost hearing in the bass frequency in my left ear. Structurally the ear anatomy is fine so ENT sent me for an MRI, which ruled-out acoustic neuroma. ENT said it is neurological and we don't know why it happened. Because of the timing, I believe it is related to the COVID-19 vaccine.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral
Clinical narrative: some loss of hearing in left ear after the booster shot was administered
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Discomfort, Dysgeusia, Fatigue, Feeling of body temperature change
Clinical narrative: 2/12/22-5am-noon all tastes became bitter - only drank water didn?t eat 4am-10am 2/12/22: hot/cold flashes- ibuprofen per package instruction 4am-8:30 pm 2/12/22: fatigue, whole body felt heavy, ibuprofen otc per package & rest 4am-8:30 pm 2/12/22: slower cognition/thought processes, at times felt like eyes were having nystagmus, treated with decreased quick movements and rest 4:30-10:00am 2/12/22: increased mucus production
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nystagmus, Secretion discharge
Clinical narrative: 2/12/22-5am-noon all tastes became bitter - only drank water didn?t eat 4am-10am 2/12/22: hot/cold flashes- ibuprofen per package instruction 4am-8:30 pm 2/12/22: fatigue, whole body felt heavy, ibuprofen otc per package & rest 4am-8:30 pm 2/12/22: slower cognition/thought processes, at times felt like eyes were having nystagmus, treated with decreased quick movements and rest 4:30-10:00am 2/12/22: increased mucus production
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection, Eye pruritus, Eye swelling, Hordeolum, Pain
Clinical narrative: My eye was infected and started to swell up to the point that I could barely see. The doctor at the urgent care believes it to be a stye and it lasted for about a month with medications. I remember after getting my second covid shot, I went to class and took an exam and in the middle of it my left eye started itching/stinging and the next morning I woke up to a swollen eye.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heavy menstrual bleeding, Pyrexia
Clinical narrative: Chills headache low grade fever. Menstrual period has increased from 5 days too 9 days with heavy bleeding. Fatigue.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: My ear, my back and my neck heated up and I got the prickling sensation on my skin; My ear, my back and my neck heated up and I got the prickling sensation on my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: ER2613) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN POTASSIUM taken for hypertension. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization. The following information was reported: FEELING HOT (non-serious), PARAESTHESIA (non-serious) all with onset 30Mar2021, outcome "recovered" and all described as "My ear, my back and my neck heated up and I got the prickling sensation on my skin". Therapeutic measures were not taken as a result of feeling hot, paraesthesia.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Chest pain, shortness of breath, and cough after 7 minutes of administration.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Facial paralysis, Mobility decreased, Myalgia
Clinical narrative: I AM VERY HEALTHY -WORK OUT 3-4X PER WEEK. NO MEDICATIONS. I PREVIOUSLY HAVE A DOCUMENTED ADVERSE REACTION TO PFIZER.  I CHOOSE MY JOB OVER THE SHOT. THIS IS SECOND TIME NOW HAVING SEVERE SYMPTOMS. 103 FEVER SHAKES PAIN UNABLE TO MOVE ARM FACIAL PARALYSIS AND NEUROPATHY SHOOTING PAIN IN RIGHT SIDE OF FACE AND MOUTH TINGLING. SHAKING/RIGORS. MUSCLE ACHES BEYOND NORMAL.  SHORTNESS OF BREATHE.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Paraesthesia oral, Pyrexia, Tremor
Clinical narrative: I AM VERY HEALTHY -WORK OUT 3-4X PER WEEK. NO MEDICATIONS. I PREVIOUSLY HAVE A DOCUMENTED ADVERSE REACTION TO PFIZER.  I CHOOSE MY JOB OVER THE SHOT. THIS IS SECOND TIME NOW HAVING SEVERE SYMPTOMS. 103 FEVER SHAKES PAIN UNABLE TO MOVE ARM FACIAL PARALYSIS AND NEUROPATHY SHOOTING PAIN IN RIGHT SIDE OF FACE AND MOUTH TINGLING. SHAKING/RIGORS. MUSCLE ACHES BEYOND NORMAL.  SHORTNESS OF BREATHE.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "pain on her left arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: the injection site is a little swollen; feels warm with little pain; feels warm with little pain; 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) (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: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "the injection site is a little swollen"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "feels warm with little pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: He has lower back pain; 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 39 year-old male patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Lot number: EP7533) at the age of 39 years as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 05Apr2021, outcome "not recovered", described as "He has lower back pain".  Additional Information: It was reported that, he received his first dose on Monday, 05Apr2021, late in the evening. Since then, he has lower back pain. He was asking if this was normal. He would like some guidance. He was asking if he should see a doctor. He does not normally go to the doctor.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: received his first dose yesterday and had experienced sting on his arm and they gave him a topical steroid. He's wondering if the steroid will not interfere with the efficacy of the vaccine; 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 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "received his first dose yesterday and had experienced sting on his arm and they gave him a topical steroid. He's wondering if the steroid will not interfere with the efficacy of the vaccine". Therapeutic measures were taken as a result of pain in extremity.  Additional information: Any medical questions addressed by this program forwarded/referred to Medical Information was reported as yes: Customer and/or medical inquiry forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: felt achy; tired; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 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 "felt achy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: 2-3 days after receiving 2nd Covid vaccine felt achy, tired and had chills. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: About week later had low grade temperature. Wondering is it possible to get side effect a week later after getting vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "About week later had low grade temperature. Wondering is it possible to get side effect a week later after getting vaccine.". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below was the verbatim report. reporter reporting for son. patient Received 1st dose of covid vaccine. About week later had low grade temperature. The reporter was Wondering is it possible to get side effect a week later after getting vaccine. There were no unaddressed medical questions referred to medical information.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity
Clinical narrative: arm soreness for 5 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 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6204) at the age of 64 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: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "recovered" (16Mar2021), described as "arm soreness for 5 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional Information: The adverse event did not require Emergency Room or physician office visit. The patient had both 1st and 2nd Doses of the Pfizer COVID Vaccine within 4 weeks. Family history was reported as none. The event was reported as non serious by the reporter.     No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hair growth abnormal, Pain assessment
Clinical narrative: Increase hair growth since 2nd dose vaccination requiring weekly hair cut.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 49 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Mar2021 (Lot number: ENG207) at the age of 49 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "Allergies: Sulfa drug" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing). Concomitant medication included: OTEZLA. Past drug history included: Aspirin, reaction: "Allergies: Aspirin"; Tylenol, start date: Feb2021, for Painful headache behind left eye; Ibuprofen, start date: Feb2021, for Painful headache behind left eye. Vaccination history included: BNT162B2 (Dose 1, arm left; Lot number ENG202; Administration time 04:00 PM), administration date: 25Feb2021, when the patient was 48 years old, for COVID-19 immunization, reactions: "Painful headache behind left eye", "Extremely tired", "Slept for 23 hours straight afterwards". The following information was reported: HAIR GROWTH ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "Increase hair growth since 2nd dose vaccination requiring weekly hair cut.". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: she got swollen glands; fevers; 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 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she got swollen glands"; PYREXIA (non-serious), outcome "unknown", described as "fevers".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: mentioned he had his first shot on 31Jan2021 and missed his second dose because he was not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 31Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "mentioned he had his first shot on 31Jan2021 and missed his second dose because he was not feeling well".  Additional Information: Patient mentioned he had his first shot on 31Jan2021 and missed his second dose because he was not feeling well. Patient would like to know if it was okay for him to take the second dose past 21 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm with the first one (First shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 08Mar2021 (Lot number: EN6204) at the age of 59 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), outcome "unknown", described as "sore arm with the first one (First shot)".  Therapeutic measures were taken as a result of pain in extremity.  Additional Information: "Motrin." Dosage of Motrin: The patient took two of them. They are 200 milligrams and the patient took two of them. The patient was not hospitalized.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Sinusitis
Clinical narrative: sinus infection; running out of her temperature; 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 03Mar2021 (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: SINUSITIS (non-serious), outcome "recovering", described as "sinus infection"; BODY TEMPERATURE DECREASED (non-serious), outcome "unknown", described as "running out of her temperature". The patient underwent the following laboratory tests and procedures: body temperature: running out of her temperature.  Additional information: Reported that she received the 1st dose of vaccine on 03Mar2021. But she missed her 2nd shot that was scheduled on 24Mar2021. She had a sinus infection and running out of her temperature. Her doctor advised her not to take her 2nd shot until her sinus infection had been cleared up. She mentioned her doctor was recommending to take her 2nd dose now since she was recovering from the sinus infection. Wanted to know how she can sign up again for the 2nd shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (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: URINARY TRACT INFECTION (non-serious), outcome "unknown", described as "UTI".  Additional information: Caller was calling on an employee who has a question, the employee had the vaccine on 24MAR2021. The second vaccine was next Wednesday, 14APR2021. Caller wants to know if the employee can take cipro or cipra for UTI while receiving vaccine. They haven't taken it, just wanted to know first. Caller adds that online it just says people can take antibiotics, and there was no interaction. Caller adds that the employee was waiting for approval to take the cipro. Caller adds she does not know the name of the medication - but confirms it was spelled cipro. Caller adds that online does not say Pfizer, it just says that covid19 vaccine has no interaction with antibiotics, so she was calling for guidance. caller does not have any information on the product the employee received. Caller adds that she was good, but not that good. Caller confirms it was the Pfizer Covid19 vaccine that she was calling about.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cyclic vomiting syndrome, Migraine
Clinical narrative: A Cyclic Vomiting Syndrome Episode was triggered 1 hour after receiving vaccine.; causing a migraine which triggers my CVS episodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: ER8729) at the age of 18 years as dose 1,single for covid-19 immunisation. Relevant medical history included: "Cyclic vomiting syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CYCLIC VOMITING SYNDROME (non-serious) with onset 06Apr2021, outcome "recovering", described as "A Cyclic Vomiting Syndrome Episode was triggered 1 hour after receiving vaccine."; MIGRAINE (non-serious) with onset 06Apr2021, outcome "recovering", described as "causing a migraine which triggers my CVS episodes". The events "a cyclic vomiting syndrome episode was triggered 1 hour after receiving vaccine." and "causing a migraine which triggers my cvs episodes" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of cyclic vomiting syndrome, migraine.  Additional information: A Cyclic Vomiting Syndrome Episode was triggered 1 hour after receiving vaccine. We suspect it was triggered by the vaccine potentially causing a migraine which triggers my CVS episodes. I was in the ER for 11 hours to receive care due to episode. 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. The patient had not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Limb discomfort
Clinical narrative: had a wave of dizziness enough to make me blink focus; didn't feel right; my arm started to have a reaction; mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 53-year-old 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: DIZZINESS (non-serious), outcome "unknown", described as "had a wave of dizziness enough to make me blink focus"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "didn't feel right"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "my arm started to have a reaction"; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  Additional information: Caller is a consumer, 53 year old female patient, stated: "I need to speak to somebody regarding the Pfizer Covid vaccine I don't have a doctor I went to pharmacy, I sat down at pharmacy as soon as  it punctured and the vaccine entered my body I had a wave of dizziness enough to make me blink focus, didn't feel right, nurse had me sit there for 45 minutes and my arm started to have a reaction and a mild headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Discomfort
Clinical narrative: following his first vaccine dose he had pressure "in the middle of his lower rib cage" in the front States he "felt pressure"; felt like gas; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient in his 40's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DISCOMFORT (non-serious), outcome "unknown", described as "following his first vaccine dose he had pressure "in the middle of his lower rib cage" in the front States he "felt pressure""; ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "felt like gas".  Clinical course: Male in his late 40's. He states that the day following his first vaccine dose he had pressure "in the middle of his lower rib cage" in the front. States he "felt pressure", "could not get comfortable", that it "felt like gas". Stated it was gone within 24 hours and he had no other symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Eye colour change, Ocular discomfort
Clinical narrative: My blood pressure was 140/80; feel lightheaded; my vision seemed slightly impaired and started to tunnel inward; my color had gone grey; felt pressure in the backs of my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 12:00 (Lot number: ER8735) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Allergies to cats; "Allergies: sensitivity to medication" (unspecified if ongoing), notes: sensitivity to medication; "Allergies: fire ant bites" (unspecified if ongoing), notes: Allergies to bites; "Allergies: Latex" (unspecified if ongoing), notes: Allergies to latex. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number=EP6955, administration time=01:30 PM, Left arm), administration date: 17Mar2021, when the patient was 54 years old, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "My blood pressure was 140/80"; DIZZINESS (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "feel lightheaded"; VISUAL IMPAIRMENT (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "my vision seemed slightly impaired and started to tunnel inward"; EYE COLOUR CHANGE (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "my color had gone grey"; OCULAR DISCOMFORT (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "felt pressure in the backs of my eyes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure abnormal, dizziness, visual impairment, eye colour change, ocular discomfort.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: My blood pressure was 140/80; feel lightheaded; my vision seemed slightly impaired and started to tunnel inward; my color had gone grey; felt pressure in the backs of my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 12:00 (Lot number: ER8735) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies" (unspecified if ongoing), notes: Allergies to cats; "Allergies: sensitivity to medication" (unspecified if ongoing), notes: sensitivity to medication; "Allergies: fire ant bites" (unspecified if ongoing), notes: Allergies to bites; "Allergies: Latex" (unspecified if ongoing), notes: Allergies to latex. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot number=EP6955, administration time=01:30 PM, Left arm), administration date: 17Mar2021, when the patient was 54 years old, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: BLOOD PRESSURE ABNORMAL (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "My blood pressure was 140/80"; DIZZINESS (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "feel lightheaded"; VISUAL IMPAIRMENT (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "my vision seemed slightly impaired and started to tunnel inward"; EYE COLOUR CHANGE (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "my color had gone grey"; OCULAR DISCOMFORT (non-serious) with onset 08Apr2021 12:15, outcome "recovered", described as "felt pressure in the backs of my eyes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure abnormal, dizziness, visual impairment, eye colour change, ocular discomfort.  Additional information: Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: I experienced fatigue that lasted for a few days; following my shot where I had short headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 30 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: FATIGUE (non-serious), outcome "unknown", described as "I experienced fatigue that lasted for a few days"; HEADACHE (non-serious), outcome "unknown", described as "following my shot where I had short headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she still feels sick until now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "she still feels sick until now". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: Swelling on the opposite side of the shot in the inner side of the arm; She's not able to bring her arm down flat against her body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46-year-old female patient received BNT162B2 (BNT162B2), administered in arm, administration date 02Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; lot number: unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 02Apr2021, outcome "unknown", described as "Swelling on the opposite side of the shot in the inner side of the arm"; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 02Apr2021, outcome "unknown", described as "She's not able to bring her arm down flat against her body". Additional information: The consumer (patient's friend) reported that after the patient's second dose of the vaccine, when she started noticing swelling on the opposite side of the shot in the inner side of the arm about 9 hours after the shot. She's not able to bring her arm down flat against her body. The patient has no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: Patient was scheduled to take her 2nd dose of the vaccine today but she was sick and had allergies. She was not sure if it was Covid that's why she wants to know if she can still take the 2nd dose today even if she was sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: her mother was unable to walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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 INABILITY (non-serious), outcome "unknown", described as "her mother was unable to walk".  Additional information: Patient's dose 2 was scheduled on 06Apr2021 but she was not able to get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information:Patient received first covax dose 06Mar and due for second dose tomorrow. States she has a terrible cold but not fever, wants to know if she should still go to second dose appointment.Is the Reporter a Healthcare Professional (HCP): Unknown.Is the reporter the prescribing HCP: Unknown.Were any unaddressed medical questions referred or forwarded to Medical Information: YES  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Insomnia, Pain
Clinical narrative: Chills; General achiness; "blah" feeling; Required tylenol to be able to sleep; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 12:30 (Lot number: EN8735) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EN6208, administration time= 11:00 AM, Vaccine location: Left arm), administration date: 14Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as "Chills"; PAIN (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as "General achiness"; FEELING ABNORMAL (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as ""blah" feeling"; INSOMNIA (non-serious) with onset 05Apr2021 23:45, outcome "recovered" (2021), described as "Required tylenol to be able to sleep". Therapeutic measures were taken as a result of chills, pain, feeling abnormal, insomnia.  Additional information: The patient did not received any other vaccine in four weeks. The patient was treated with Tylenol for the events. No COVID prior vaccination and not tested for COVID post vaccination. No known allergies. The patient reported the adverse events at 10 PM Wednesday, 07Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: Pollen allergy after the first dose; 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 19Mar2021 (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: SEASONAL ALLERGY (non-serious), outcome "unknown", described as "Pollen allergy after the first dose". Therapeutic measures were taken as a result of seasonal allergy.  Additional Information: Patient second dose schedule on 09Apr2021 even though the time was not specified. Patient on medications like Zyrtec and Loratadine for Pollen allergy after the first dose of the vaccine. Wasn't able to read the report and transfer the call due to sudden loss of internet connection which made the call disconnected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: sore arm; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 44 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 unknown=False, administration date=15Mar2021, vaccine location=Left arm, dose number=1), administration date: 15Mar2021, when the patient was 44 years old, for COVID-19 IMMUNISATION. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021, outcome "recovering", described as "sore arm"; CHILLS (non-serious) with onset 05Apr2021, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 05Apr2021, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of pain in extremity, chills, headache.  Additional Information: Lot unknown reason was reported as Not available/provided to reporter at the time of report completion. No other vaccine in four weeks, No treatment received for adverse event. Covid prior vaccination and covid test post vaccination was reported as no. Query included: Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date was the date you became aware of the occurrence of the reported events. If you was the patient in the case, your awareness date would be the date that you became aware you was experiencing the reported events. If you was not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates were calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response was reported as 05Apr. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Nausea
Clinical narrative: Feels like crap; Nausea; Feeling unwell; 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 04Apr2021 (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), outcome "not recovered", described as "Feels like crap"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea"; MALAISE (non-serious), outcome "not recovered", described as "Feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Pain in extremity
Clinical narrative: Tiredness; discomfort in his arm for 2 days; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: ER8732) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "armpit pain" (unspecified if ongoing); "tiredness" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "discomfort in his arm for 2 days"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rosacea
Clinical narrative: rosesa; 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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ROSACEA (non-serious), outcome "unknown", described as "rosesa".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.