chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies with latex with prolonged exposure" (unspecified if ongoing), notes: such as wearing latex gloves daily. Concomitant medication(s) included: VITAMIN B COMPLEX; COLECALCIFEROL; CALCIUM SUPPLEMENT WITH VITAMIN D. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6208, administration time: 10:30 AM, administrator route: Intramuscular, vaccine location: Left arm), administration date: 15Mar2021, when the patient was 51 years old, for COVID-19 Immunisation, reaction(s): "Laryngeal spasm", "panicked", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The vaccine was administered in a school or student health clinic. The patient did not have COVID-19 prior to vaccination and was not tested post vaccination. The patient did not receive other vaccine in four weeks. At the time of the second vaccine, I took famotidine (PEPCID), without incidence other than a sore arm again.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: brain fog; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 14:00 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; KYLEENA. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunisation, reaction(s): "Has anxiety". The following information was reported: FEELING ABNORMAL (non-serious) with onset 10Mar2021, outcome "not recovered", described as "brain fog"; PAIN (non-serious) with onset 10Mar2021, outcome "not recovered", described as "body aches". Therapeutic measures were not taken as a result of feeling abnormal, pain.  Additional information: The patient received vaccine at hospital. Patient did not received other vaccine in four weeks. Patient began having brain fog and body aches several days after second vaccination. Symptoms have continued with no cessation. Patient did not had covid prior vaccination. Patient was 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.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: lethargic for a couple days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). The patient's concomitant medications were not reported. The following information was reported: LETHARGY (non-serious), outcome "recovered", described as "lethargic for a couple days".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate, Heart rate increased, Ventricular extrasystoles
Clinical narrative: increased heart rate; very frequent PVC's; chronotropic; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Apr2021 10:00 (Batch/Lot number: unknown) at the age of 78 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hypothyroidism (corrected)" (unspecified if ongoing), notes: Verbatim: hypothyroidism (corrected); "mild hypertension" (unspecified if ongoing), notes: Verbatim: mild hypertension. Concomitant medication(s) included: HCTZ; TESTOSTERONE; LIPITOR; ASPIRIN (E.C.); SYNTHROID. The following information was reported: HEART RATE INCREASED (non-serious) with onset 13Apr2021 10:00, outcome "recovered", described as "increased heart rate"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset Apr2021, outcome "recovered", described as "very frequent PVC's"; CARDIAC DISORDER (non-serious) with onset Apr2021, outcome "recovered", described as "chronotropic". The events "increased heart rate", "very frequent pvc's" and "chronotropic" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, ventricular extrasystoles, cardiac disorder.  Additional information: No covid prior vaccination and not  covid tested post vaccination. The patient had no known allergies. 48 hours after injection, patient experienced increased heart rate and very frequent PVC's. No chest pain or shortness of breath. Verapamil was started and PVC's almost completely disappeared. There was chronotropic and inotropic cardiac reported by patient who is a physician.  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: Chills, Tremor
Clinical narrative: chilled, difficulty getting warm; shakiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 15:00 (Lot number: ER8727) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sleep apnea" (unspecified if ongoing); "depression" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "Pine allergy" (unspecified if ongoing), notes: Known allergies: Pine allergy; "seafood sensitivity" (unspecified if ongoing), notes: Known allergies: Seafood sensitivity. Concomitant medication(s) included: WELLBUTRIN; CELEXA [CELECOXIB]; LEVOTHYROXINE; DIURETIC [HYDROCHLOROTHIAZIDE].  The following information was reported: CHILLS (non-serious) with onset 25Mar2021 23:00, outcome "recovered", described as "chilled, difficulty getting warm"; TREMOR (non-serious) with onset 25Mar2021 19:00, outcome "recovered", described as "shakiness". Therapeutic measures were not taken as a result of chills, tremor.  Additional information:No other vaccine in four weeks. Other medications (Wellbutrin, Celexa, levothyroxine, diuretic) had given in two weeks. No covid prior vaccination and covid tested post vaccination.The patient experienced shakiness after 4-5hours.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Lethargy, Somnolence
Clinical narrative: lethargic; dizzy; stayed asleep until around 6:30-7:00AM the next morning; This is a spontaneous report received from a contactable consumer.  A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 16Apr2021 10:00 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing). The patient took concomitant medications. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), administration date: 26Mar2021, when the patient was 56 years old, for COVID-19 immunisation, reactions: "lethargic". The following information was reported: LETHARGY (non-serious) with onset 16Apr2021, outcome "recovered" (18Apr2021), described as "lethargic"; DIZZINESS (non-serious) with onset 16Apr2021, outcome "unknown", described as "dizzy"; SOMNOLENCE (non-serious) with onset 16Apr2021, outcome "unknown", described as "stayed asleep until around 6:30-7:00AM the next morning".  Additional information: Concomitant medications included blood pressure medication every day taken for high blood pressure. The events did not require visit to emergency room of physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick for 3 days; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A 54 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick for 3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Disturbance in attention, Fatigue
Clinical narrative: Fatigue; difficulty concentrating; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 16:00 (Lot number: EW0169) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN; CLARITIN [CLARITHROMYCIN].  The following information was reported: FATIGUE (non-serious) with onset 19Apr2021 07:00, outcome "recovered" (Apr2021), described as "Fatigue"; DISTURBANCE IN ATTENTION (non-serious) with onset 19Apr2021 07:00, outcome "recovered" (Apr2021), described as "difficulty concentrating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, disturbance in attention.  Additional Information: Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks: Atorvastatin 20mg, Claritin. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Loss of personal independence in daily activities, Magnetic resonance imaging, Migraine, SARS-CoV-2 test
Clinical narrative: My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day-to-day events; My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day-to-day events; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2021 09:15 (Lot number: EL8982) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing), notes: Other medical history: asthma/ADHD; "Asthma" (unspecified if ongoing), notes: Other medical history: asthma/ADHD; "allergies penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "allergies: cipro", notes: Known allergies: penicillin/cipro. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer,, Lot number=EK9231,, Administration time =08:30 AM,, Vaccine location =Left arm,, Dose number =1), administration date: 15Jan2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: MIGRAINE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Feb2021, outcome "not recovered" and all described as "My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day-to-day events". The event "my migraine exacerbated. having attacks after the second dose almost every day. affecting my daily living. my work, my time with family, my day-to-day events" and "my migraine exacerbated. having attacks after the second dose almost every day. affecting my daily living. my work, my time with family, my day-to-day events" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, loss of personal independence in daily activities.  Additional information: My migraine exacerbated. Having attacks after the second dose almost every day. Affecting my daily living. My work, my time with family, my day to-day events. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. Patient did test for covid post vaccination. It was unknown if covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Intense low back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 10:30 (Lot number: ER8732) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Herniated disc in lower back years ago" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 17Apr2021 16:00, outcome "not recovered", described as "Intense low back pain". The event "intense low back pain" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of back pain.  Additional Information: Intense low back pain. Patient had intermittent issues with back, his first shot was on a Thursday, and woke up Sunday morning with back pain that she could not associate with anything. No heavy lifting or twisting that usually causes bouts. Patient went to primary, received a prescription for a methylprednisolone pak, and felt better within 24-48 hours. No known allergies. No covid prior vaccination. Covid not tested post vaccination. No other vaccine in four weeks and no other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: I had a sore arm; headache; 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), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I had a sore arm"; HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: The patient took the first shot in the left arm and took the 2nd shot in the right arm. In the first shot (left), the patient had a sore arm and headache, in the 2nd shot (right) had no effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 49-year-old patient received BNT162B2 (BNT162B2), administration date 15Apr2021 (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 16Apr2021, outcome "unknown", described as "headache". Additional Information: The patient received first dose of vaccine yesterday, Pfizer, COVID. The patient was a 49 year old, healthy adult, athlete. On 16Apr2021, the patient experienced pretty good headaches and asked if it was safe at this point to take Excedrin or Tylenol for the 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: Retinal tear, Vitreous floaters
Clinical narrative: i had a tear in my retina; i started seeing floaters in my right eye about 4 days after my first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 12:00 (Lot number: EN6204) at the age of 56 years as dose 1, single for covid-19 immunisation. The Relevant medical history included: "lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not take any other vaccine in four weeks. The following information was reported: RETINAL TEAR (medically significant), outcome "recovering", described as "I had a tear in my retina"; VITREOUS FLOATERS (non-serious) with onset Mar2021, outcome "recovering", described as "I started seeing floaters in my right eye about 4 days after my first vaccine". She started seeing floaters in her right eye about 4 days after her first vaccine, dark black then the next day turned into a black line. She went to the ophthalmologist right away. She had a tear in her retina, had to get emergency surgery (emergency laser eye surgery) the next day, then was still seeing 5 to 7 tiny floaters grey. She saw eye surgeon again he said it was healing but could not promise all floaters would go away. The events "i had a tear in my retina" and "i started seeing floaters in my right eye about 4 days after my first vaccine" were evaluated at the physician office visit. The patient later received second dose of bnt162b2 (BNT162B2), lot number: ER8737, on 19Apr2021 at 12:00, in left arm as dose 2, single for Covid-19 immunization, by that afternoon dark black larger floater returned, her retina could get detached now she was worried as she had another tear.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Extraocular muscle disorder
Clinical narrative: lost muscle movement in his left eye; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXTRAOCULAR MUSCLE DISORDER (non-serious), outcome "unknown", described as "lost muscle movement in his left eye".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast swelling, Paraesthesia, Photopsia
Clinical narrative: flashes behind her eyes; felt like her breast was firm, swollen and sensitive; felt like her breast was firm, swollen and sensitive; tingling sensation on her breast; 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 28Mar2021 (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: PHOTOPSIA (non-serious) with onset 28Mar2021, outcome "unknown", described as "flashes behind her eyes"; BREAST DISCOMFORT (non-serious), BREAST SWELLING (non-serious) all with onset 28Mar2021, outcome "unknown" and all described as "felt like her breast was firm, swollen and sensitive"; PARAESTHESIA (non-serious) with onset 28Mar2021, outcome "unknown", described as "tingling sensation on her breast".  Additional information: According to patient, she experienced flashes behind her eyes while she was getting the vaccine and it felt that it was going to her breast, there was a tingling sensation on her breast and felt like her breast was firm, swollen and sensitive. The patient received second dose on 18Apr.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: her right arm hurts; numbness; 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), administered in arm right (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her right arm hurts"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness".  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, Headache, Pain, Pain in extremity
Clinical narrative: her arm got sore; tired; and 3oclock today she has a bad headache; chills; little achy; 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 13Apr2021 18:47 (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 "her arm got sore"; FATIGUE (non-serious), outcome "unknown", described as "tired"; HEADACHE (non-serious), outcome "unknown", described as "and 3oclock today she has a bad headache"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN (non-serious), outcome "unknown", described as "little achy".  Additional information: 72 hrs ago patient experienced side effects, her arm got sore, tired, and 3oclock today she had a bad headache, chills, and a little achy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing and pulsing in left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 14:45 (Lot number: ER8727) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "ringing and pulsing in left ear". The event "ringing and pulsing in left ear" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional Information: Patient did not receive other vaccine in four week. Patient took over the counter meds as treatment. Patient was not tested for Covid post vaccination. There are no known allergies or other medical history. Patient reported that after first dose, ringing and pulsing in left ear. After second dose, it got worse, hearing loss, muffled hearing and echoing in ear.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus developed within 1 -2 hours after receipt of vaccine and persists.  It was most intense the first couple of weeks.  It is less bothersome now but there are daily waves of it being quite loud.; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 13:30 (Lot number: EN6199) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Novocaine, reaction(s): "Known allergies: novacaine". The following information was reported: TINNITUS (non-serious) with onset 05Mar2021 14:30, outcome "not recovered", described as "Tinnitus developed within 1 -2 hours after receipt of vaccine and persists.  It was most intense the first couple of weeks.  It is less bothersome now but there are daily waves of it being quite loud.". The event "tinnitus developed within 1 -2 hours after receipt of vaccine and persists.  it was most intense the first couple of weeks.  it is less bothersome now but there are daily waves of it being quite loud." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438317 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: "has pounding headache"; 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 16Apr2021 (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 Apr2021, outcome "unknown", described as ""has pounding headache"".  Additional information: Patients wants to know if it's okay to take aspirin. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Feeling cold, Illness
Clinical narrative: Sick; Cold bones; Chills; my BP went to the roof; 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), administered in arm right, administration date 07Apr2021 (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: ILLNESS (non-serious), outcome "unknown", described as "Sick"; FEELING COLD (non-serious), outcome "unknown", described as "Cold bones"; CHILLS (non-serious), outcome "unknown", described as "Chills"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "my BP went to the roof". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The product was Characterization role  in suspect drug. The Proprietary medicinal product name was Covid 19 vaccine. The reporter was Consumer or other non health professional . The case was HCP postal address. The Adverse Events were unspecified date Sick , Cold bones, Chills and Event were my BP went to the roof. The Covid 19 vaccine a Pfizer product unknown manufacturer  , NDC number of Covid 19 vaccine and UPC number of Covid 19 vaccine. The Reason for no lot number: of Covid 19 vaccine: Other: batch# ER87; My first LOT was 6207 and the second LOT was 8729, second shot and Expiry Date also Unknown. The Consumer stated, "I got shot on 07Apr2021 batch# ER87,  reporter got sick real sick on Thursday and I haven't done anything and reporter got real cold to the bones, like chills and reporter got shot on my right arm then patient went to Pharmacy on Monday and my BP went to the roof." When probed for the concern and asked was it the first shot or second shot:  consumer stated, "is this all blood pressure stuff because of shot. The reporter ain't getting nothing out of it, does this shot give you side effects. The Pfizer medical information department number was given.  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, Headache, Hyperhidrosis, Illness
Clinical narrative: Severe Cold; for 36 hours I couldn't stand on my feet; Severe Sweating; slightly headache; Severe Chills/Shivering; I am still sick; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: EN6204, Expiration Date: Jun2021) 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) with onset 07Apr2021, outcome "not recovered", described as "Severe Cold"; WEIGHT BEARING DIFFICULTY (non-serious) with onset 07Apr2021, outcome "not recovered", described as "for 36 hours I couldn't stand on my feet"; ILLNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "I am still sick"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "Fatigue"; HYPERHIDROSIS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Severe Sweating"; HEADACHE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "slightly headache"; CHILLS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Severe Chills/Shivering". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient went to the doctor like about 10 days after (last Friday, she didn't knew what the date, was 8, the 9th of April) and the symptoms; very severe chills, shivering and cold, sweat, happened 7 days (7April2021) after she took the shot. Before that there was slight headache and like fatigue. It was reported that patient took Pfizer 1st shot two weeks ago, and was still sick. The patient was still suffering chills, headache, cold and sweating all over. The patient wondered how long it was going to last. The patient stated that it was its little bit better. The shivering was not that severe. The patient reported that she would not go for the 2nd shot.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test, Weight bearing difficulty
Clinical narrative: Severe Cold; for 36 hours I couldn't stand on my feet; Severe Sweating; slightly headache; Severe Chills/Shivering; I am still sick; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: EN6204, Expiration Date: Jun2021) 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) with onset 07Apr2021, outcome "not recovered", described as "Severe Cold"; WEIGHT BEARING DIFFICULTY (non-serious) with onset 07Apr2021, outcome "not recovered", described as "for 36 hours I couldn't stand on my feet"; ILLNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "I am still sick"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "Fatigue"; HYPERHIDROSIS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Severe Sweating"; HEADACHE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "slightly headache"; CHILLS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Severe Chills/Shivering". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: The patient went to the doctor like about 10 days after (last Friday, she didn't knew what the date, was 8, the 9th of April) and the symptoms; very severe chills, shivering and cold, sweat, happened 7 days (7April2021) after she took the shot. Before that there was slight headache and like fatigue. It was reported that patient took Pfizer 1st shot two weeks ago, and was still sick. The patient was still suffering chills, headache, cold and sweating all over. The patient wondered how long it was going to last. The patient stated that it was its little bit better. The shivering was not that severe. The patient reported that she would not go for the 2nd shot.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphocyte count, Monocyte count, Myalgia, Platelet count
Clinical narrative: Headache; Muscle Pain on vaccination arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), (Age at vaccination :71 years) administered in arm left, administration date 20Jan2021 09:00 (Batch/Lot number: E18987) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pemphicus Vulgaris", start date: Oct1989 (unspecified if ongoing), notes: Oct1989; was diagnosed with Pemphigus vulgaris in which the body was properties to many Anti-Bodies in turn causes a lot of blisters.; "blisters", start date: Oct1989 (unspecified if ongoing), notes: Oct1989; was diagnosed with Pemphigus vulgaris in which the body was properties to many Anti-Bodies in turn causes a lot of blisters.; "High Cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL taken for hypertension (ongoing); IRBESARTAN taken for hypertension (ongoing); AMLODIPINE taken for hypertension; PRAVASTATIN taken for blood cholesterol increased. The following information was reported: MYALGIA (non-serious) with onset 20Jan2021 09:00, outcome "recovered" (21Jan2021), described as "Muscle Pain on vaccination arm"; HEADACHE (non-serious) with onset 21Jan2021 09:00, outcome "recovered" (22Jan2021), described as "Headache". The events "muscle pain on vaccination arm" and "headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, headache.  Additional information : Patient did not receive any prior vaccinations. After Vaccine: 1. Absolute- 7363h.Lymphocytes-S/B-850-3900 .2. Absolute- 1799h  Monocytes- S/B-700-950.3.Platetet-713 Count-Sb 140-400.4.White Blood-11.7h Cell Count-Sb 3.8-10.8.Before Vaccine:06oct2020;1. Absolute- 1808 Lymphocytes-S/B-850-3900.2. Absolute- 540 Monocytes- S/B-700-950.3. Platetet-187 Count-Sb 140-400.4. White Blood-7.5 Cell Count-Sb 3.8-10.8.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Headache; Muscle Pain on vaccination arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), (Age at vaccination :71 years) administered in arm left, administration date 20Jan2021 09:00 (Batch/Lot number: E18987) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pemphicus Vulgaris", start date: Oct1989 (unspecified if ongoing), notes: Oct1989; was diagnosed with Pemphigus vulgaris in which the body was properties to many Anti-Bodies in turn causes a lot of blisters.; "blisters", start date: Oct1989 (unspecified if ongoing), notes: Oct1989; was diagnosed with Pemphigus vulgaris in which the body was properties to many Anti-Bodies in turn causes a lot of blisters.; "High Cholesterol" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL taken for hypertension (ongoing); IRBESARTAN taken for hypertension (ongoing); AMLODIPINE taken for hypertension; PRAVASTATIN taken for blood cholesterol increased. The following information was reported: MYALGIA (non-serious) with onset 20Jan2021 09:00, outcome "recovered" (21Jan2021), described as "Muscle Pain on vaccination arm"; HEADACHE (non-serious) with onset 21Jan2021 09:00, outcome "recovered" (22Jan2021), described as "Headache". The events "muscle pain on vaccination arm" and "headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of myalgia, headache.  Additional information : Patient did not receive any prior vaccinations. After Vaccine: 1. Absolute- 7363h.Lymphocytes-S/B-850-3900 .2. Absolute- 1799h  Monocytes- S/B-700-950.3.Platetet-713 Count-Sb 140-400.4.White Blood-11.7h Cell Count-Sb 3.8-10.8.Before Vaccine:06oct2020;1. Absolute- 1808 Lymphocytes-S/B-850-3900.2. Absolute- 540 Monocytes- S/B-700-950.3. Platetet-187 Count-Sb 140-400.4. White Blood-7.5 Cell Count-Sb 3.8-10.8.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: 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 15Apr2021 (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: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation on her arm". There were no any unaddressed medical questions referred or forwarded to Medical Information. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort
Clinical narrative: has had discomfort like a muscle straining feeling and it is continual; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE DISCOMFORT (non-serious), outcome "not recovered", described as "has had discomfort like a muscle straining feeling and it is continual".  Additional information: This report is not related to a study or programme. The patient reported that, she was currently driving but was called about the Pfizer Vaccine and was wondered if there were any reports of customers having discomfort in their upper thigh and stated that she had discomfort like a muscle straining feeling and it is continual and wanted to know if there have been any complaints of this. She was not sure if this was due to the vaccine but just knows in the last week or so maybe for 10 days, she had this discomfort and could not say it was related to the vaccine or not but wanted to know if there was any report of this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: receiving the Covid vaccine I started my cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 14:00 (Lot number: ER8730) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I am perimenopausal and have an IUD" (ongoing); "Psoriatic arthritis" (unspecified if ongoing); "IUD" (unspecified if ongoing), notes: IUD. Concomitant medication(s) included: VITAMIN D NOS; NEXIUM [ESOMEPRAZOLE SODIUM]; IBUPROFEN; IRON. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 15Apr2021, outcome "unknown", described as "receiving the Covid vaccine I started my cycle". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Facility type vaccine was other. No other vaccine in four weeks. She was perimenopausal and had an IUD. She had not a menstrual cycle (other than occasional very light spotting) in 5+ years. 17 days after receiving the COVID vaccine she started her cycle. It had lasted 5 days already and had soaked approximately 2 pads per day. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Headache, Migraine, Migraine with aura
Clinical narrative: experienced an aura while she was driving, in which she had to pull over until it passed; Migraine/had a complicated migraine/very unusual migraines; Started getting the migraines with an aura; Headache/Severe headache/ throbbing headache/bad headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: ER8732) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Diagnosed in the 1970s. Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis. The following information was reported: AURA (non-serious), outcome "unknown", described as "experienced an aura while she was driving, in which she had to pull over until it passed"; HEADACHE (non-serious) with onset 02Apr2021, outcome "recovered" (2021), described as "Headache/Severe headache/ throbbing headache/bad headache"; MIGRAINE (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Migraine/had a complicated migraine/very unusual migraines"; MIGRAINE WITH AURA (non-serious) with onset 06Apr2021, outcome "unknown", described as "Started getting the migraines with an aura".  Additional information: On 02Apr2021, patient experienced a throbbing headache that continued into half of the day on Sunday. Patient reported the headache then went away. Two days later, she started experiencing migraines and had 6 migraines in two weeks. Patient stated during one of the incidences, she had a complicated migraine, in which she has not had since her 40s. Patient stated that she was not able to respond or tell anyone her name. Patient stated that they were very unusual migraines and sometimes she would have an aura then a migraine, but other times she would experience the headache and no aura. Patient stated that she experienced an aura while she was driving, in which she had to pull over until it passed. Patient stated that she had medicine for bad headaches, but she rarely had to use it. The patient got iron infusions from her hematologist.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Seasonal medical condition of headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 1, single and administration date 15Apr2021 (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: HEADACHE (non-serious), outcome "unknown", described as "Seasonal medical condition of headache". Therapeutic measures were taken as a result of headache.  Additional information: Caller, (name), had their 1st shot 25Mar with her husband named (name withheld), then had their 2nd shot yesterday 15Apr. They have a seasonal medical condition of headache, and they were told from the clinic to not take any pain reliever, example aspirin and tylenol. They usually take Ibuprofen for their seasonal headache. Asked how long for them before they can take medicine for their headache. Refused to transfer to department due to a long queue. She will just ask pharmacists. Submitted and created manual AE form. Provided contact number.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain
Clinical narrative: Right upper thigh up to right inguinal area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 08:30 (Lot number: fwo153) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes type 1" (unspecified if ongoing); "major depressive disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; CELEXA [CELECOXIB]. Past drug history included: Nitrofurantoin, reaction(s): "Known allergy- nitrofurantoin".  The following information was reported: GROIN PAIN (non-serious) with onset 16Apr2021, outcome "recovered" (2021), described as "Right upper thigh up to right inguinal area". Therapeutic measures were not taken as a result of groin pain.  Additional information: Patient had no COVID prior to vaccination. Patient was not tested for COVID post vaccination. Patient had no other vaccine in four weeks. Patient had other medication in two weeks: adderall and celexa.  No follow-up attempts are possible. No further information is expected.