chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose was ok. She had what she was told what would happen, it would just be like a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 17:00 (Lot number: EW0183, Expiration Date: Aug2021) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing), notes: She feels she falls in range. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jun2021, outcome "not recovered", described as "First dose was ok. She had what she was told what would happen, it would just be like a sore arm.".  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Carpal tunnel syndrome, Paraesthesia
Clinical narrative: I have a tingling, burning sensation on the top of my arms, almost like a sunburn and carpal tunnel. The tingling extends into my fingers, but the burning sensation is only on my arms.; I have a tingling, burning sensation on the top of my arms, almost like a sunburn and carpal tunnel. The tingling extends into my fingers, but the burning sensation is only on my arms.; I have a tingling, burning sensation on the top of my arms, almost like a sunburn and carpal tunnel. The tingling extends into my fingers, but the burning sensation is only on my arms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 12:00 (Lot number: ew0150) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing); "Known allergies: Poultry" (unspecified if ongoing); "Known allergies: Eggs" (unspecified if ongoing); "Known allergies: Sesame" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Known allergies: I am allergic to most antibiotics" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA; NASONEX. Vaccination history included: Bnt162b2 (Product: COVID 19 , Brand: Pfizer, Lot number: ew0150 , Lot unknown: False , Administration date: 22May2021, Administration time: 12:00 PM, Dose number: 1, Vaccine location: Left arm), administration date: 22May2021, when the patient was 40 years old, for Covid-19 Immunisation. The following information was reported: PARAESTHESIA (non-serious), BURNING SENSATION (non-serious), CARPAL TUNNEL SYNDROME (non-serious) all with onset 15Jun2021 18:00, outcome "unknown" and all described as "I have a tingling, burning sensation on the top of my arms, almost like a sunburn and carpal tunnel. The tingling extends into my fingers, but the burning sensation is only on my arms.". It was unknown if therapeutic measures were taken as a result of paraesthesia, burning sensation, carpal tunnel syndrome.  Additional information: The patient was not tested positive for covid prior vaccination. The patient was not tested positive for covid post vaccination. No other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Polymerase chain reaction, Tinnitus
Clinical narrative: ringing in the ears. Very disturbing it is like chirping. Dr diagnosed it as Tinnitus; unable to sleep well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 09:00 (Lot number: ER 8735) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EN8735, administration date=15Mar2021, administration time=10:00., dose number=1, vaccine location=Left arm), administration date: 15Mar2021, when the patient was 64 years old, for covid 19 immunization. The following information was reported: TINNITUS (non-serious) with onset 19Apr2021 12:00, outcome "not recovered", described as "ringing in the ears. Very disturbing it is like chirping. Dr diagnosed it as Tinnitus"; INSOMNIA (non-serious) with onset 19Apr2021, outcome "not recovered", described as "unable to sleep well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, insomnia.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in jaw, Palpitations
Clinical narrative: Palpitation; Woozy; jaw pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09May2021 11:07 (Lot number: EW0173) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart palpitations", start date: 05Jan2013 (ongoing), notes: It started out of nowhere and was on and off from Jan-Apr-May, I saw doctor was put beta blocker; "woozy", start date: 05Jan2013 (ongoing), notes: It started out of nowhere and was on and off from Jan-Apr-May, I saw doctor was put beta blocker. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date/Time: Date: 18Apr2021, Time (24hr): 11:50 am, Site and Route of Injection: Anatomical Site of injection: (L) Arm, Route of administration: Intramuscular, Batch/Lot number: EW0169), administration date: 18Apr2021, when the patient was 70 years old, for Covid-19 immunisation, reaction(s): "Palpitations".  The following information was reported: DIZZINESS (non-serious) with onset 09May2021 11:07, outcome "recovered" (2021), described as "Woozy"; PAIN IN JAW (non-serious) with onset 09May2021 11:07, outcome "recovered" (2021), described as "jaw pain"; PALPITATIONS (non-serious) with onset 13May2021, outcome "recovered" (2021), described as "Palpitation". Therapeutic measures were not taken as a result of dizziness, pain in jaw, palpitations.  Additional Information: No prior vaccinations (within 4 weeks).  Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention
Clinical narrative: fluid retention in my fingers (both hands).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 09:30 (Lot number: EN6205) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FLUID RETENTION (non-serious) with onset 22Mar2021, outcome "not recovered", described as "fluid retention in my fingers (both hands).". Therapeutic measures were not taken as a result of fluid retention.  Additional information: It was reported that he was experiencing fluid retention in his fingers (both hands). His thumbs seem OK. Fluid retention first occurred about 1 week after dose one but he did not associate it with the vaccine since he was expecting an immediate reaction (which he did not have), local pain at injection site (which he did not have) nor did he have other reported general symptoms.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: fine intentional tremors on bilateral hands/fingers lasted for 1 and 1/2 weeks; This is a spontaneous report received from a 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 26May2021 11:00 (Lot number: EP6955) at the age of 44 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "auto immune disease - RA" (unspecified if ongoing). There were no concomitant medications. The following information was reported: TREMOR (non-serious) with onset 26May2021, outcome "recovered" (2021), described as "fine intentional tremors on bilateral hands/fingers lasted for 1 and 1/2 weeks". Therapeutic measures were not taken as a result of tremor.  Additional information: No, other vaccine in four weeks and no, other medications in two weeks. No, Treatment required for AE. No, Covid prior vaccination and patient was not tested post vaccination. No, Known allergies  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: I had a headache; myalgia; dizziness; fatigue; supraclavicular lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 15:00 (Lot number: ER2613) at the age of 31 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Apples" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "allergies: Avaguard" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Betadine, reaction(s): "allergies: Betadine". The following information was reported: HEADACHE (non-serious) with onset 15Jun2021, outcome "not recovered", described as "I had a headache"; MYALGIA (non-serious) with onset 15Jun2021, outcome "not recovered", described as "myalgia"; DIZZINESS (non-serious) with onset 15Jun2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 15Jun2021, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 15Jun2021, outcome "not recovered", described as "supraclavicular lymphadenopathy". Therapeutic measures were not taken as a result of headache, myalgia, dizziness, fatigue, lymphadenopathy.  Additional information: After vaccination, I had a headache, myalgia, dizziness, fatigue for 3 days and the symptoms went away. I figured out today that supraclavicular lymphadenopathy is noted on the left side. I am not sure since when it happened. No covid prior vaccination. Not tested covid tested post vaccination  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jun2021 (Lot number: ER8736) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Nickel" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Bnt162b2 (lot number EW0164, dose number 1, vaccine location Left arm), administration date: 26May2021, when the patient was 15 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Jun2021 20:45, outcome "recovered", described as "Dizziness". Therapeutic measures were not taken as a result of dizziness.   Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm, extreme exhaustion; extreme exhaustion; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28May2021 10:15 (Lot number: EW0182) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Peaches" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "Mrsa" (unspecified if ongoing). Concomitant medication(s) included: PHENTERMINE; TOPIRAMATE. Past drug history included: Levaquin, reaction(s): "Known allergies: levaquin"; Amoxicillin, reaction(s): "Known allergies: amoxicillin". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28May2021 17:00, outcome "recovered" (2021), described as "Sore arm, extreme exhaustion"; FATIGUE (non-serious) with onset 28May2021 17:00, outcome "recovered" (2021), described as "extreme exhaustion". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Metamorphopsia
Clinical narrative: dizziness; distorted vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 12:00 (Lot number: ew0167) at the age of 14 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hay fever allergies" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 15Jun2021 08:00, outcome "not recovered", described as "dizziness"; METAMORPHOPSIA (non-serious) with onset 15Jun2021 08:00, outcome "not recovered", described as "distorted vision". The events "dizziness" and "distorted vision" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dizziness, metamorphopsia.  Additional Information: No any treatment received for events. Prior to vaccination patient tested positive for covid-19. Patient did not tested for covid-19 post vaccination. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Menstruation delayed
Clinical narrative: Two days after the first vaccine dose I had a bad breakout of acne on my forehead, nose and chin. My cycle is currently over a week late.; My cycle is currently over a week late.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: sulpha drugs" (unspecified if ongoing). There were no concomitant medications. The following information was reported: ACNE (non-serious) with onset 29May2021, outcome "unknown", described as "Two days after the first vaccine dose I had a bad breakout of acne on my forehead, nose and chin. My cycle is currently over a week late."; MENSTRUATION DELAYED (non-serious) with onset 29May2021, outcome "unknown", described as "My cycle is currently over a week late.". Therapeutic measures were not taken as a result of acne, menstruation delayed.  Additional information: Known allergies was reported Sulpha drugs. No other vaccine in four weeks patient had received. No other medications in two weeks patient had received. Patient received no COVID prior vaccination. Patient received no COVID tested post vaccination. It was reported that two days after the first vaccine dose she had a bad breakout of acne on her forehead, nose and chin. Her cycle was currently over a week late. Other side effects she was noticing the day after the second dose were joint and muscle pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Insomnia
Clinical narrative: anxiety; depression; insomnia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Mar2021 08:30 (Lot number: EN6204) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE; ROSUVASTIN; KRILL OIL. Past drug history included: Morphine, reaction(s): "known allergies: Morphine", notes: known allergies: Morphine, Prevnar13. Vaccination history included: Bnt162b2 (Dose 1, lot number (EN6202), administration time was 08:00 AM), administration date: 03Mar2021, when the patient was 68 years old, for Covid-19 immunisation; Prevnar13 (known allergies: Morphine, Prevnar13), reaction(s): "known allergies: Prevnar13".  The following information was reported: ANXIETY (non-serious) with onset 01Apr2021, outcome "not recovered", described as "anxiety"; DEPRESSION (non-serious) with onset 01Apr2021, outcome "not recovered", described as "depression"; INSOMNIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "insomnia". The events "anxiety", "depression" and "insomnia" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of anxiety, depression, insomnia.  Additional information included: About 3 days after the 2nd dose, insomnia started. Nothing helped. It was still ongoing, and anxiety and depression were bad. Trazodone had given some relief, but not entirely reliable. Patient's need help. No other vaccine in four weeks. Other medications in two weeks were Losartan; Hydrochlorothiazide; Rosuvastin; Krill O. No Covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphemia, Electromyogram, Feeling abnormal, Headache, Hypoaesthesia
Clinical narrative: Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Headaches; brain fog; stumbling over words; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 14:00 (Lot number: ER8730) at the age of 40 years as dose 1, single and administered in arm right, administration date 13Apr2021 15:00 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA (non-serious), TREMOR (non-serious) all with onset 24Mar2021, outcome "not recovered" and all described as "Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips"; HEADACHE (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Headaches"; FEELING ABNORMAL (non-serious) with onset 24Mar2021, outcome "not recovered", described as "brain fog"; DYSPHEMIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "stumbling over words". The events "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "headaches", "brain fog" and "stumbling over words" 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 hypoaesthesia, hypoaesthesia oral, paraesthesia, tremor, headache, feeling abnormal, dysphemia.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Patient did not received other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Magnetic resonance imaging, Paraesthesia, SARS-CoV-2 test, Tremor
Clinical narrative: Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips; Headaches; brain fog; stumbling over words; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 14:00 (Lot number: ER8730) at the age of 40 years as dose 1, single and administered in arm right, administration date 13Apr2021 15:00 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious), PARAESTHESIA (non-serious), TREMOR (non-serious) all with onset 24Mar2021, outcome "not recovered" and all described as "Numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips"; HEADACHE (non-serious) with onset 24Mar2021, outcome "not recovered", described as "Headaches"; FEELING ABNORMAL (non-serious) with onset 24Mar2021, outcome "not recovered", described as "brain fog"; DYSPHEMIA (non-serious) with onset 24Mar2021, outcome "not recovered", described as "stumbling over words". The events "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "numbness/tingling/vibrating sensations in lower legs(knees down), hands and lips", "headaches", "brain fog" and "stumbling over words" 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 hypoaesthesia, hypoaesthesia oral, paraesthesia, tremor, headache, feeling abnormal, dysphemia.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Patient did not received other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Severe headache; injection site red and swollen; injection site red and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Jun2021 13:00 (Lot number: EW0178) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Granulomatosis with polyangiitis" (unspecified if ongoing), notes: other medical history: Granulomatosis with polyangiitis; "Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN; LEVOTHYROXINE; BUPROPION. Vaccination history included: Bnt162b2 (lot number EW0186,, lot unknown False,, administration date=19May2021,, dose number=1,, vaccine location=Left arm), administration date: 19May2021, when the patient was 55 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 10Jun2021 01:00, outcome "not recovered", described as "Severe headache"; INJECTION SITE ERYTHEMA (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 10Jun2021 01:00, outcome "not recovered" and all described as "injection site red and swollen". Therapeutic measures were not taken as a result of headache, injection site erythema, injection site swelling. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Within 2 to 3 hours of the first vaccine I developed ringing in both ears.; This is a spontaneous report from a contactable consumer. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 08:00 (Lot number: ER8729) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: VIACTIV [CALCIUM]; VITAMIN D [VITAMIN D NOS]. The following information was reported: TINNITUS (non-serious) with onset 14Apr2021 11:00, outcome "not recovered", described as "Within 2 to 3 hours of the first vaccine I developed ringing in both ears.". The event "within 2 to 3 hours of the first vaccine i developed ringing in both ears." was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Facility type vaccine was other. There was not any other vaccine in four weeks. Other medications in two weeks were Multi vitamin, vitamin D, Viactiv and cholesterol. On 14Apr2021 at 11:00, within 2 to 3 hours of the first vaccine patient developed ringing in both ears. The physician said there was no treatment for tinnitus. Patient did not experience covid prior vaccination. Patient did not test covid post vaccination. On 05May2021, patient took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0172; Expiration date: not provided) via an unspecified route of administration in left arm as dose 2, single for Covid-19 immunization.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular and heavy periods lasting longer than normal up to 8 days (at this point) - After the first shot my period was 2 weeks early; Irregular and heavy periods lasting longer than normal up to 8 days (at this point) - After the first shot my period was 2 weeks early; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 13:00 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious) all with onset Apr2021, outcome "not recovered" and all described as "Irregular and heavy periods lasting longer than normal up to 8 days (at this point) - After the first shot my period was 2 weeks early". The event "irregular and heavy periods lasting longer than normal up to 8 days (at this point) - after the first shot my period was 2 weeks early" and "irregular and heavy periods lasting longer than normal up to 8 days (at this point) - after the first shot my period was 2 weeks early" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation irregular.  Additional information: Patient's current age was reported as 40 (unit: unknown). Facility type vaccine was reported as Pharmacy or Drug Store. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two weeks. Now the patient was getting her period every two weeks since the second vaccine shot. Before that she was always regular. Patient had no covid prior vaccination. Patient was not tested Covid post vaccination. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Got my period day after my first shot, and 15 days later I got my period again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28May2021 17:45 (Lot number: ER8734) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 29May2021 16:00, outcome "unknown", described as "Got my period day after my first shot, and 15 days later I got my period again.". The event "got my period day after my first shot, and 15 days later i got my period again." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient had no known allergies. The patient had received no other vaccines within 4 weeks prior to COVID vaccine. The patient had received no other medications within 2 weeks of vaccination. The patient had not diagnosed with COVID prior to vaccination and the patient had not tested to COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, Lot number: Ew0153, Administrator route: Intramuscular, Administration date: 06Apr2021, Administration time: 10:45AM, Vaccine location: Left arm), administration date: 06Apr2021, for Covid-19 Immunisation. The following information was reported: FATIGUE (non-serious) with onset 05May2021, outcome "recovered" (2021), described as "Exhaustion". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient was not pregnant at the time of this report. The patient did not receive any other vaccine within four weeks prior to COVID vaccine. The patient did not receive other medications within two weeks prior to COVID vaccine. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Known allergies were None  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Somnolence
Clinical narrative: Drowsiness; hot flashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Apr2021 (Lot number: EW0170) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: detergents" (unspecified if ongoing), notes: detergents. There were no concomitant medications. Past drug history included: Ciprofloxacin, reaction(s): "Drug allergy", notes: Ciprofloxacin. Vaccination history included: Bnt162b2 (Product: COVID 19 , Brand: Pfizer, Lot number: ER8734, Lot unknown: False, Administrator route: Intramuscular, Dose number: 1, Vaccine location: Left arm, Administration date: 04Apr2021), administration date: 04Apr2021, when the patient was 47 years old, for Covid-19 immunisation. The following information was reported: SOMNOLENCE (non-serious) with onset 25Apr2021, outcome "recovered" (2021), described as "Drowsiness"; HOT FLUSH (non-serious) with onset 25Apr2021, outcome "recovered" (2021), described as "hot flashes". Therapeutic measures were taken as a result of somnolence, hot flush.  Additional information: AE treatment includes Advil. There was no other vaccine in four weeks and no other medications in two weeks. The patient did not had Covid prior vaccination and did not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased
Clinical narrative: NO ADVERSE EVENT Actually, quite the opposite reaction. I felt it was important to report that my blood sugar levels are so much lower than what I'm used to. I have nothing to attribute this to.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Lot number: EW0173) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "keto" (unspecified if ongoing), notes: In the past I used KETO to keep myself out of the diabetic range. Concomitant medication(s) included: METFORMIN ER; LISINOPRIL HCTZ. Vaccination history included: Bnt162b2 (product COVID 19, brand Pfizer, Lot number EW0172, Lot unknown False, Administration date Apr2021, Administration time 09:45 AM, Dose number 1, Vaccine location Left arm), administration date: Apr2021, when the patient was 58 years old, for Covid-19 immunisation. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious) with onset Jun2021, outcome "unknown", described as "NO ADVERSE EVENT Actually, quite the opposite reaction. I felt it was important to report that my blood sugar levels are so much lower than what I'm used to. I have nothing to attribute this to.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood glucose decreased.  Additional information: Patient received COVID 19 vaccine second dose on May2021 at 10:15 AM. Patient had no other vaccine other than COVID-19 vaccine in four weeks. Patient do not have COVID-19 prior to vaccination. Patient had no known allergy. Other medications in two weeks: Metformin HCL ER 500 Mg Tablet, Lisinopril HCTZ 20-25 Mg Tab. Patient blood sugar levels are so much lower than what used to. I have nothing to attribute this to. The only big change in my life was my taking the COVID-19 vaccine. My numbers lower so quickly now after meals and after I get up in the morning. I definitely noticed a difference in June. I use a (Name withheld) 14 days sensor to measure my blood sugar numbers on my phone. In the past I used KETO to keep myself out of the diabetic range. That lifestyle was very difficult to maintain. My blood sugar numbers lower so quickly now. I want to add regular exercise and a healthy diet to this to see if this will move my AIC to the nondiabetic range. I wanted to report this in case there is something in the Pfizer COVID-19 vaccine that helps to improve blood sugar levels for diabetics. Maybe there's something about this that can be researched further to help diabetics. Patient was not tested COVID-19 positive after the vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vein discolouration
Clinical narrative: The next day after I had your medication down by my wrist was the veins in your hand one of my veins was deep red purple;  it make me little nervous to get the second shot; well I did have the arm problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 11:45 (Lot number: EW0187) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: ATENOLOL; LOSARTAN; GABAPENTIN. The following information was reported: VEIN DISCOLOURATION (non-serious) with onset 12Jun2021, outcome "not recovered", described as "The next day after I had your medication down by my wrist was the veins in your hand one of my veins was deep red purple;  it make me little nervous to get the second shot"; LIMB DISCOMFORT (non-serious) with onset 12Jun2021, outcome "unknown", described as "well I did have the arm problem".  Additional Information: Patient stated that next day after medication, well did have the arm problem but the next day after had medication down by wrist was the veins in hand one of veins was deep red purple and it took it some time to go away. It was about 3 inches long.  Medication: Patient stated, Pfizer, no it was vaccination for COVID vaccine. When paraphrased the concern, patient said that no that wasn't for 15 minutes it was for 4 hours and called his brother and had never seen vein do that and it was about 3 inches long and it was right when woke up, it was like someone has taken you know a mark, so it stood right out it wasn't faint. Yeah, was saying, and was wondering if anybody else has reported that, but because it makes me little nervous to get the second shot. Patient was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 20:00 from Monday to Friday and for Saturday and Sunday timings are 9 AM to 15:00 as per EST. Other Vaccine (Prior to 4 weeks patient stated it was no. Vaccination site details: Available. Time of vaccination patient stated that she doesn't know the specific time it was in the morning, it was at 11 O' Clock, but they were late so about 11:45 because she had to wait. Patient stated that no, she think she will give them a call and she is scared to get the second shot, and get to know what that mean it could be normal don't know but  didn't see it reported on any list that's why she called.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain in extremity
Clinical narrative: I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Jun2021 13:00 (Lot number: EW0187) at the age of 48 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: Verbatim: Celiac disease; "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia; "Ankylosing spondylitis" (unspecified if ongoing), notes: Verbatim: Ankylosing spondylitis; "Sacroiliitis" (unspecified if ongoing), notes: Verbatim: Sacroiliitis. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; ESTRADIOL. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious), HEADACHE (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 19Jun2021, outcome "recovering" and all described as "I felt dizzy, nauseated; I had headache; I still have the headache, my arm still hurt a lot". Therapeutic measures were taken as a result of dizziness, nausea, headache, vaccination site pain.  Additional information: The patient stated that she was calling because she went to the Withheld yesterday at 1 o clock and got a shot for COVID and they give us a paperwork after getting the shot which listed some common side effects but not all possible side effects. Patient stated she immediately after getting the shot when they give the shot, she felt dizzy, nauseated and she had headache and she still have it. Her was a problem last night and of course she knows its normal and this morning this morning it got worse for her and now it's much better. She took Ibuprofen, Tylenol. Ibuprofen Acetaminophen they told her yesterday the pharmacist told her yesterday to take acetaminophen for her headache, when she got home she did and then she took Ibuprofen last night and she took Ibuprofen this morning and then she took acetaminophen this morning and dosage was 800 mg Ibuprofen, 1000 of the Tylenol last night and today this morning, she still have the headache, her arm still hurt a lot, but she feeling the most part, feeling little better (Hence, not captured as suspect) not so weak, not so achy, not so much pain. The patient did not take any other vaccine 4 weeks prior to the COVID vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis
Clinical narrative: Major sweats; Chills; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Jun2021 11:15 (Lot number: EW0191, Expiration Date: 30Sep2021) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ITP" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Romiplostim for ITP, reaction(s): "No reaction on previous exposure to drug", notes: Verbatim: Romiplastim is 40 microgram. The following information was reported: HYPERHIDROSIS (non-serious) with onset 19Jun2021, outcome "recovered", described as "Major sweats"; CHILLS (non-serious) with onset 19Jun2021, outcome "recovered", described as "Chills"; HEADACHE (non-serious) with onset 19Jun2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache. Additional Information: the PPN patient taken 4 bags a week, that taken of that hold on had to get the exact amount 50 microgram". (Further clarification unknown) If still experiencing these adverse events: patient stated, the headache, yes sorry the Romiplostim is 40 micrograms yes. Outcome of Event patient stated, it was improved but still have the headache and the what so far yeah. Drug was taken for treatment was Aspirin.  Follow-up attempts are completed. No further information is expected   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: extreme tried; diarrhea; in bed and can hardly walk/she is very unsteady when she is walking; she has lost of appetite; dizzy; chills; not feeling well; very weak; very lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-2021748849 (Pfizer).  A 72-year-old female patient received bnt162b2 (BNT162B2), administration date 16Jun2021 (Lot number: EW0183) at the age of 72 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 "extreme tried"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "in bed and can hardly walk/she is very unsteady when she is walking"; DECREASED APPETITE (non-serious), outcome "unknown", described as "she has lost of appetite"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ASTHENIA (non-serious), outcome "unknown", described as "very weak"; LETHARGY (non-serious), outcome "unknown", described as "very lethargic".  Additional information: Reporter stated he is calling for his wife the Pfizer COVID 19 vaccine with the number of EW0183. Reporter stated she took the vaccine on 16Jun2021 and a day later she had extreme tried, diarrhea, in bed and can hardly walk, no appetite, very lethargic and dizzy. Reporter stated his wife is scheduled for the second dose on 07Jul2021. Reporter stated he is not sure if she will get the second dose. Caller stated that his wife got the first dose of the pfizer covid-19 vaccine on 16JUN2021. She started experiencing extreme tiredness, chills, diarrhea, she can hardly walk, she has lost of appetite, very weak and not feeling well, she is very unsteady when she is walking.  No follow-up attempts are possible. No further information is expected.