chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness
Clinical narrative: Dizziness/very dizzy; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Apr2021 13:15 (lot number: EWO150) at the age of 70-years as dose 1, single for COVID-19 immunisation and methimazole (TAPAZOLE) (Batch/Lot number: unknown). Relevant medical history included: "Heart Problems" (ongoing), notes: born with the heart problem; "Prolapse Valve" (ongoing); "Heart attack", start date: 2011 (unspecified if ongoing), notes: 2 heart attacks, 10 years apart; "Heart attack", start date: 09Jan2021 (ongoing), notes: 2 heart attacks, 10 years apart; "Diabetes", start date: 2011 (ongoing); "Asthma" (ongoing), notes: Born with asthma; "High blood pressure", start date: 1991 (ongoing); "Circulation problem with legs", start date: 2017 (ongoing); and "Thyroid Problem", start date: 2011 (ongoing). There were no concomitant medications. Vaccination history included: Flu Vaccine (had to go back to the doctor 3 times), administration date: 2017, for Immunisation, reactions: "Pneumonia", "Coughing", "Sneezing", "Short of breath", and "Very sick." The following information was reported: DIZZINESS (non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "Dizziness/very dizzy". The action taken for methimazole was unknown. Therapeutic measures were taken as a result of dizziness. Additional information: 5 days after her first shot (as reported), the patient experienced dizziness. She was very dizzy. She was fine now as far as the vaccine thing goes. Treatment included TYLENOL. Her daughter received the Moderna and she just had flu like symptoms for 2 days and a mild case of vertigo for 2 days. The event did not require emergency room as the patient was trying to be brave. She stated that if a person has a heart condition and goes to the ER, they want to keep her overnight to observe her and she didn't want to do that. She also did not visit a physician office. No additional vaccines were administered on the same date of the Pfizer suspects. Prior vaccinations within 4 weeks were reported as none.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101070997 same reporter, patient, and drug; different dose and events
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Heavy menstrual bleeding, Muscle spasms, Pain, Renal pain
Clinical narrative: left upper kidney pain.; Kidney has continued throbbing; I started a heavy period which I have not had in years since I am on the Nuvaring; Also included cramping and left breast pain that continued for a week; Also included cramping and left breast pain that continued for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jul2021 10:00 (Lot number: Fa6780) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NUVARING. The following information was reported: PAIN (non-serious) with onset 04Aug2021 09:00, outcome "not recovered", described as "Kidney has continued throbbing"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 04Aug2021 09:00, outcome "not recovered", described as "I started a heavy period which I have not had in years since I am on the Nuvaring"; MUSCLE SPASMS (non-serious), BREAST PAIN (non-serious) all with onset 04Aug2021 09:00, outcome "not recovered" and all described as "Also included cramping and left breast pain that continued for a week"; RENAL PAIN (non-serious) with onset 06Aug2021, outcome "not recovered", described as "left upper kidney pain.". The events "kidney has continued throbbing", "i started a heavy period which i have not had in years since i am on the nuvaring", "also included cramping and left breast pain that continued for a week", "also included cramping and left breast pain that continued for a week" and "left upper kidney pain." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, heavy menstrual bleeding, muscle spasms, breast pain, renal pain.  Additional information: The patient did not have any other vaccine on same date and no other medications in two weeks. The patient did not have covid prior vaccination and was not tested covid post vaccination. The patient did not have any other vaccine in four weeks. The patient did not have allergies that she was aware of. Clinical course: It was reported that 8 days later, patient started having a heavy period which she had not in years since she was on the Nuvaring. Also included cramping and left breast pain that continued for a week. On 06Aug2021 (day 10), she started having her left upper kidney pain. On 17Aug2021, the kidney has continued throbbing.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heavy menstrual bleeding
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 10:00 (Lot number: E100198) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing); "known allergies: penicillium" (unspecified if ongoing); "ADHD" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL; IBUPROFEN; TYLENOL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN D3.The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 18Aug2021, outcome "unknown", described as "Menstrual period came morning of 18Aug and has been a lot heavier than usual."; DIARRHOEA (non-serious) with onset 16Aug2021, outcome "unknown", described as "diarrhea". Therapeutic measures were not taken as a result of heavy menstrual bleeding, diarrhea. Additional information: The vaccine was administered in Pharmacy or Drug Store. The patient did not receive other vaccine in four weeks. The patient did not have covid prior vaccination. The patient had no covid teste post vaccination. Adverse event: On 16Aug2021 to 17Aug2021, the patient had diarrhea. Menstrual period came morning of 18Aug2021 and has been a lot heavier than usual. Filled menstrual cup 3 times in 9 hours normally first day was light. Second day was heavy but was never as heavy as it was to day. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Insomnia, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: it makes everything swollen like my nose, teeth and everything; Not able to sleep; I have severe arthritis that deform the fingers; No circulation in my hands.My hands are swollen; If I lay down on bed, feel pain within few seconds and get out of bed and put my hands down like on standing position hanging down; This is a spontaneous report received from a non-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 1, single for covid-19 immunisation. Relevant medical history included: "I have severe arthritis" (unspecified if ongoing), notes: I have severe arthritis that deform the fingers. The patient's concomitant medications were not reported. The following information was reported: SWELLING (non-serious), outcome "unknown", described as "it makes everything swollen like my nose, teeth and everything"; INSOMNIA (non-serious), outcome "unknown", described as "Not able to sleep"; ARTHRITIS (non-serious), outcome "unknown", described as "I have severe arthritis that deform the fingers"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "No circulation in my hands.My hands are swollen"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "If I lay down on bed, feel pain within few seconds and get out of bed and put my hands down like on standing position hanging down". The events "it makes everything swollen like my nose, teeth and everything", "not able to sleep", "i have severe arthritis that deform the fingers", "no circulation in my hands.my hands are swollen" and "if i lay down on bed, feel pain within few seconds and get out of bed and put my hands down like on standing position hanging down" were evaluated at the physician office visit.  Additional Information: Patient stated that she had first dose Pfizer Covid Vaccine and it triggered everything that she had gone medically, it triggered all of that at her body, she was not able to sleep, and she had to run to her Primary Doctor. She had severe arthritis that deform the fingers, she reported vaccine made everything swollen like her nose, teeth, and everything. She basically had no circulation in her hands and hands are so swollen that if she had to lay down on bed, she felt pain within few seconds and she like to get out of the bed and put her hands down like on standing position hanging down." Patient stated that Pfizer shot triggered her body to attack her own immune system, so now she will  not supposed to take second vaccine (dose) shot."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Heavy menstrual bleeding, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Drug Ineffective; suspected COVID-19; Unusually heavy periods following injection that still persists today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EP7533) at the age of 20 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug Ineffective"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "suspected COVID-19"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01Jun2021, outcome "not recovered", described as "Unusually heavy periods following injection that still persists today". The patient underwent the following laboratory tests and procedures: covid-19: (unspecified date) positive; sars-cov-2 test: (2021) negative. Therapeutic measures were not taken as a result of heavy menstrual bleeding. Clinical course: Unusually heavy periods following injection that still persists today. With no other contributing factor. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test post vaccination: Covid test result: positive. Device date was reported as 23Aug2021.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Eye pain, Headache, Nausea
Clinical narrative: I a having severe headache that is not resolving by taking medication; The pain is gradually hitting my left eye like stabbing pain; Neck and shoulder pain; Neck and shoulder pain; Nausea; Loss of appetite; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 07:30 (Lot number: Ewp187) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "RA positive" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA; SENNA LAXATIVE. The following information was reported: HEADACHE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "I a having severe headache that is not resolving by taking medication"; EYE PAIN (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "The pain is gradually hitting my left eye like stabbing pain"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 25Aug2021 09:00, outcome "not recovered" and all described as "Neck and shoulder pain"; NAUSEA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Nausea"; DECREASED APPETITE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Loss of appetite". Therapeutic measures were taken as a result of headache, eye pain, neck pain, arthralgia, nausea, decreased appetite.  Additional Information: The patient receive medications within 2 weeks of vaccination are Concerta and senna laxative. Patient received treatment of ibuprofen 800 mg. Patient didn't had known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: I a having severe headache that is not resolving by taking medication; The pain is gradually hitting my left eye like stabbing pain; Neck and shoulder pain; Neck and shoulder pain; Nausea; Loss of appetite; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 07:30 (Lot number: Ewp187) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "RA positive" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA; SENNA LAXATIVE. The following information was reported: HEADACHE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "I a having severe headache that is not resolving by taking medication"; EYE PAIN (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "The pain is gradually hitting my left eye like stabbing pain"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 25Aug2021 09:00, outcome "not recovered" and all described as "Neck and shoulder pain"; NAUSEA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Nausea"; DECREASED APPETITE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Loss of appetite". Therapeutic measures were taken as a result of headache, eye pain, neck pain, arthralgia, nausea, decreased appetite.  Additional Information: The patient receive medications within 2 weeks of vaccination are Concerta and senna laxative. Patient received treatment of ibuprofen 800 mg. Patient didn't had known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Pain in extremity
Clinical narrative: The first vaccine I experienced mensural bleeding, bleeding and having clump, one side clump; I have arm soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jul2021 (Lot number: EW0187) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "The first vaccine I experienced mensural bleeding, bleeding and having clump, one side clump"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I have arm soreness".  Additional information: Nurse stated, "I am calling, I probably have some side effects from this vaccine because I am experiencing, the first one I was done I experienced some menstrual bleeding. The first vaccine I experienced mensural bleeding." Nurse stated, "Yes, bleeding and having clump, one side clump. Bleeding with the clump and this one and when I took the second dose then the bleeding started again."When confirmed the events occurred the same day vaccine was administered, Nurse stated, "Yes, I know I have arm soreness which is expected you know the area. I have soreness on the site which is expected. You know I expect soreness on the arm but I wasn't expecting the bleeding.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Heavy and painful menstrual cycles; Heavy and painful menstrual cycles; Menstrual cycles now last 14 days in duration.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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: DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 26Apr2021, outcome "not recovered" and all described as "Heavy and painful menstrual cycles"; OLIGOMENORRHOEA (non-serious) with onset 26Apr2021, outcome "not recovered", described as "Menstrual cycles now last 14 days in duration.". Therapeutic measures were not taken as a result of dysmenorrhoea, heavy menstrual bleeding, oligomenorrhoea.  Additional information: The patient did not take any vaccine within four weeks and no other medications within two weeks. The patient did not have covid prior vaccination and had not tested covid post vaccination. The patient had no known allergies. The patient was administered vaccine in a public health clinic.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Computerised tomogram, Dizziness, Feeling hot
Clinical narrative: Five days after vaccine I developed significant swelling in my left neck; The day of vaccine I was very dizzy; a warm sensation in my chest; a warm sensation in my chest; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:30 (Lot number: EW0169) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ASPIRINE; LOSARTAN; SPIRONOLACTONE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: SWELLING (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Five days after vaccine I developed significant swelling in my left neck"; DIZZINESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "The day of vaccine I was very dizzy"; CHEST DISCOMFORT (non-serious), FEELING HOT (non-serious) all with onset 25Aug2021, outcome "not recovered" and all described as "a warm sensation in my chest". The events "five days after vaccine i developed significant swelling in my left neck", "the day of vaccine i was very dizzy", "a warm sensation in my chest" and "a warm sensation in my chest" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, dizziness, chest discomfort, feeling hot. Additional information: Five days after vaccine I developed significant swelling in my left neck. The day of vaccine I was very dizzy and a warm sensation in my chest. Vaccine facility type was doctor's office/urgent care and facility country was Country. The patient did not receive any other vaccine in four weeks. The treatment included CT scan, blood work and antibiotics. The patient did not have Covid prior to vaccination and not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Five days after vaccine I developed significant swelling in my left neck; The day of vaccine I was very dizzy; a warm sensation in my chest; a warm sensation in my chest; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 16:30 (Lot number: EW0169) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; ASPIRINE; LOSARTAN; SPIRONOLACTONE. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: SWELLING (non-serious) with onset 25Aug2021, outcome "not recovered", described as "Five days after vaccine I developed significant swelling in my left neck"; DIZZINESS (non-serious) with onset 25Aug2021, outcome "not recovered", described as "The day of vaccine I was very dizzy"; CHEST DISCOMFORT (non-serious), FEELING HOT (non-serious) all with onset 25Aug2021, outcome "not recovered" and all described as "a warm sensation in my chest". The events "five days after vaccine i developed significant swelling in my left neck", "the day of vaccine i was very dizzy", "a warm sensation in my chest" and "a warm sensation in my chest" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of swelling, dizziness, chest discomfort, feeling hot. Additional information: Five days after vaccine I developed significant swelling in my left neck. The day of vaccine I was very dizzy and a warm sensation in my chest. Vaccine facility type was doctor's office/urgent care and facility country was Country. The patient did not receive any other vaccine in four weeks. The treatment included CT scan, blood work and antibiotics. The patient did not have Covid prior to vaccination and not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Eye disorder, Vertigo
Clinical narrative: started having extreme vertigo type issues feeling like Im rocking back and forth on a boat it is amplified when I am driving. Also start to feel like I m disoriented; Also start to feel like Im disoriented and can keep my eyelids open when the symptoms start; and can keep my eyelids open when the symptoms start; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 12:00 (Lot number: FA6780) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Alpha-gal allergy" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE CIPIONATE; T3. The following information was reported: VERTIGO (non-serious) with onset 03Sep2021 16:30, outcome "not recovered", described as "started having extreme vertigo type issues feeling like Im rocking back and forth on a boat it is amplified when I am driving. Also start to feel like I m disoriented"; DISORIENTATION (non-serious) with onset 03Sep2021 16:30, outcome "not recovered", described as "Also start to feel like Im disoriented and can keep my eyelids open when the symptoms start"; EYE DISORDER (non-serious) with onset 03Sep2021 16:30, outcome "not recovered", described as "and can keep my eyelids open when the symptoms start". Therapeutic measures were not taken as a result of vertigo, disorientation, eye disorder.  Additional information: Additional information: The patient had no other vaccine in four weeks. The patient had other medications in two weeks: T3, testosterone. Adverse event: Approx 2 weeks post injection started having extreme vertigo type issues (feeling like rocking back and forth on a boat) it is amplified when driving. Also start to feel like disoriented and can keep my eyelids open when the symptoms start. The come and go mostly in the morning and late afternoon. No treatment received for the adverse event. The patient was not tested for covid post vaccination. The patient did not had covid prior to the vaccination. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: the patient came out with a severe case of eczema.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Jan2021 (Lot number: EL9262) at the age of 76 years as dose 1, single and administered in arm right, administration date 21Feb2021 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart condition" (unspecified if ongoing). Concomitant medication(s) included: ENTRESTO taken for cardiac disorder (ongoing); FUROSEMIDE taken for cardiac disorder (ongoing). The following information was reported: ECZEMA (non-serious) with onset Mar2021, outcome "not recovered", described as "the patient came out with a severe case of eczema.". The event "the patient came out with a severe case of eczema." was evaluated at the physician office visit.  Additional information: The patient began concomitant medications two and a half years ago. Relevant Family Medical History was none. Relevant Tests was none. The patient received first dose about 1300 or 1400 and second dose about 1100. The patient did not receive any other vaccines within 4 weeks of vaccination. The patient did not experience any AR following prior vaccinations. It was reported that severe case of eczema was worsened.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: The first menstrual cycle following the vaccine was much heavier than previous ones; 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 27May2021 (Lot number: EW0153) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included Anxiety (unspecified if ongoing). Concomitant medication(s) included SERTRALINE. The following information was reported HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Jun2021, outcome not recovered. Patient did not had known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that the first menstrual cycle following the vaccine was much heavier than previous ones. Each month since, the amount of bleeding during my cycles has increased from the previous month. I should have probably went to the ER, but I was not thinking right nor did I know this be from the vaccine & could be a sign of something more serious. I had Doctor appointments set up and if I experience this again would be going to the hospital as I cannot see how it can get worse than it did last cycle and me still live. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Pain assessment, Vulvovaginal discomfort
Clinical narrative: My menstrual cycle was much heavier with more intense cramping. I had to change my tampon twice between 8am and 12pm.; My menstrual cycle was much heavier with more intense cramping.; I typically have vaginal discomfort due to childbirth 10 years ago but it became much more painful (4 on a scale of 1-10) this cycle; 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 23Aug2021 08:30 (Lot number: FC3182) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 29Aug2021 12:00, outcome "unknown", described as "My menstrual cycle was much heavier with more intense cramping. I had to change my tampon twice between 8am and 12pm."; DYSMENORRHOEA (non-serious) with onset 29Aug2021 12:00, outcome "unknown", described as "My menstrual cycle was much heavier with more intense cramping."; VULVOVAGINAL DISCOMFORT (non-serious) with onset 29Aug2021 12:00, outcome "unknown", described as "I typically have vaginal discomfort due to childbirth 10 years ago but it became much more painful (4 on a scale of 1-10) this cycle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, vulvovaginal discomfort.  Additional information:  it was reported that patient did not receive any other vaccine in four weeks. It was reported that her menstrual cycle was much heavier with more intense cramping. She had to change her tampon twice between 8 am and 12 pm. She typically had vaginal discomfort (due to childbirth 10 years ago), but it became much more painful (4 on a scale of 1-10) this cycle. She stopped using tampons after she had to change the second time, and began using pads to try to ease the pain. The pain continued for the next two days. The heavy menstruation continued for three straight days. The last two days of her cycle were very light. She was diagnosed with PCOS at 22. Patient had COVID prior vaccination and was not tested for COVID, post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Hypersensitivity, Rhinorrhoea
Clinical narrative: allergy symptoms; runny nose; itchy eyes; 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 female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE), for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergy symptoms"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; EYE PRURITUS (non-serious), outcome "unknown", described as "itchy eyes". The events "allergy symptoms", "runny nose" and "itchy eyes" were evaluated at the physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Blood test, Heavy menstrual bleeding, Menstruation delayed, Overdose
Clinical narrative: bleed for 16 days /The period was very heavy and I passed a large blood clot; missed a period for several months; Delayed period; Overdose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: EW0151) at the age of 38 years as dose 2, single and administered in arm left, administration date 07Apr2021 05:00 (Lot number: en6207) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported MENSTRUATION DELAYED (non-serious) with onset 24May2021 16:00, outcome unknown; HEAVY MENSTRUAL BLEEDING (non-serious) with onset Sep2021, outcome unknown; AMENORRHOEA (non-serious) with onset 24May2021 16:00, outcome unknown; OVERDOSE (non-serious) with onset 07Apr2021, outcome unknown. The events delayed period, "bled for 16 days was very heavy, I passed a large blood clot, and missed a period for several months 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 menstruation delayed, heavy menstrual bleeding, and amenorrhoea. The patient had no known allergies. She missed a period for several months. She normally someone who has short cycles, so this was very unusual for her. She had one period afterward and then it did not return until September 3rd, and she bleed for 16 days. Doctor did blood work and did not see anything unusual. Patient tracking her periods so she was curious when the next one will return. The period was very heavy, and she passed a large blood clot. Not normal for her. Monitoring the situation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test
Clinical narrative: I started another period 7 days later; this period is heavy and has more intense cramping.; I started another period 7 days later; this period is heavy and has more intense cramping.; 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 09Sep2021 17:00 (Lot number: FF2589) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I was diagnosed with COVID", start date: Mar2021 (unspecified if ongoing), notes: I was diagnosed with COVID in Mar.; "filshie clamps on my Fallopian tubes" (unspecified if ongoing), notes: I am not on any birth control or hormones, I have filshie clamps on my Fallopian tubes is all. There were no concomitant medications. Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer, Dose Number: 01, Administration time: 03:00 PM, Vaccine Location: Left arm, Lot number: F63180), administration date: 15Aug2021, when the patient was 28 years old, for covid-19 Immunization, reaction(s): "7 days after my vaccination I started my period again & it lasted 5 days.". The following information was reported: DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 15Sep2021 19:00, outcome "not recovered" and all described as "I started another period 7 days later; this period is heavy and has more intense cramping.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysmenorrhoea, heavy menstrual bleeding. The patient had her period a few days before getting her 1st dose, 7 days after vaccination, started her period again & it lasted 5 days. Now, after 2nd dose, started another period 7 days later; this period was heavy and had more intense cramping. Between Aug and this 17Sep, patient had 3 periods. Before getting first vaccination, her periods were always 30 day cycles and regular. Patient was not on any birth control or hormones, had filshie clamps on my Fallopian tubes was all. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Change is menstral cycle. Heavier, longer mensis with blood clots; Change is menstral cycle. Heavier, longer mensis with blood clots; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: Er8737) at the age of 39 years as dose 2, single and intramuscular, administered in arm left, administration date 2021 (Lot number: Ep7534) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious) all with onset 01Apr2021, outcome "not recovered" and all described as "Change is menstral cycle. Heavier, longer mensis with blood clots". The event "change is menstral cycle. heavier, longer mensis with blood clots" and "change is menstral cycle. heavier, longer mensis with blood clots" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding. Additional Information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No known allergy reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Vein discolouration, Vein disorder
Clinical narrative: the vein appeared greenish and that it maybe clogged or a blood clot; the vein appeared greenish and that it maybe clogged or a blood clot; dizzy; his left leg started to hurt and when he looked at the leg, it had a vein popped out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 18Sep2021 (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: VEIN DISORDER (non-serious), VEIN DISCOLOURATION (non-serious), outcome "unknown" and all described as "the vein appeared greenish and that it maybe clogged or a blood clot"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "his left leg started to hurt and when he looked at the leg, it had a vein popped out".  Additional information: Patient had his first dose of the Pfizer COVID-19 vaccine last 18Sep2021 and "got dizzy for a couple of minutes which may be an allergic reaction". Patient stated that "3-4 days later, he did some work at work and his left leg started to hurt and when he looked at the leg, it had a vein popped out, he couldn't walk, and the vein appeared greenish and that it maybe clogged or a blood clot". Patient wanted to know if "blood clots" had been reported as side effect of the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: Menstrual cycle became VERY irregular; Also became very heavy; besides very frequent; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Apr2021 11:00 (Lot number: EW0167) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Product: COVID 19, brand=Pfizer, Lot number: EW0167, Lot unknown: False, Administration date=Mar2021, Administration time=11:00 AM, vaccine location: Right arm), administration date: Mar2021, when the patient was 41 years old, for Covid-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset Apr2021, outcome "not recovered", described as "Menstrual cycle became VERY irregular"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset Apr2021, outcome "not recovered", described as "Also became very heavy"; POLYMENORRHOEA (non-serious) with onset Apr2021, outcome "not recovered", described as "besides very frequent". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, polymenorrhoea.  Additional information: The patient did not receive any other vaccine within 4 weeks. The patient used to have be 100% regular mensural cycles prior to the first vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was tested for covid  post vaccination on 03Jul2021 by nasal swab and result was negative. The patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Very heavy period and longer by 6 days than usualt; Very heavy period and longer by 6 days than usualt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Aug2021 (Lot number: EW0198) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN CALCIUM. Vaccination history included: Bnt162b2 (dose number: 1, lot number: EW0179, vaccine location: Left arm), administration date: 16Jul2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 04Sep2021, outcome "recovered" (2021) and all described as "Very heavy period and longer by 6 days than usualt". Therapeutic measures were not taken as a result of heavy menstrual bleeding, oligomenorrhoea.  Additional information: Patient received COVID-19 vaccine in pharmacy or drug store for administration. The Patient did not receive other vaccines within four weeks prior to the COVID-19 vaccine. Patient received Atrovastatin 20 mg as medication/vaccine in two weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Vomiting
Clinical narrative: throwing up/vomiting; her body was jerking when she was badly throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A female patient received bnt162b2 (BNT162B2) (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: VOMITING (non-serious), outcome "unknown", described as "throwing up/vomiting"; DYSKINESIA (non-serious), outcome "unknown", described as "her body was jerking when she was badly throwing up". Therapeutic measures were taken as a result of vomiting, dyskinesia. Additional Information: It was reported that out of nowhere the patient started throwing up in school. The reporter was called upon and had to pick the patient from school. It was further reported that the only thing that was different was the shot. The patient had been home and the reporter have given the patient little pills. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: "tingling" in face; face felt numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. This consumer reported similar events for three patients. This is the second of three reports.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as ""tingling" in face"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "face felt numb". The reporter spoke with two of her colleagues who reported feeling the same thing.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021258997 same reporter, drug, similar events, and different patient;US-PFIZER INC-202101257727 same reporter, drug, similar events, and different patient;US-PFIZER INC-202101257727 same reporter, drug, similar events, and different patient.