chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: More frequent, heavier menstrual cycles. Increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping; More frequent, heavier menstrual cycles. Increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping; More frequent, heavier menstrual cycles. Increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping; This is a spontaneous report from a non-contactable other hcp. A 40-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 13Jan2021 09:00 (age at vaccination 40 years) as dose 2, single for covid-19 immunisation. Medical history included diabetes, fibroids, high cholesterol. Concomitant medication(s) included lisinopril (LISINOPRIL); atorvastatin (ATORVASTATIN); insulin glargine (LANTUS); dulaglutide (TRULICITY); metformin hydrochloride (METFO).The patient previously received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK5730, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Dec2020 11:00 (age at vaccination 40 years) as dose 1, single for covid-19 immunisation. Patient visited doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jan2021the patient experienced more frequent, heavier menstrual cycles. increased from 4-5 days to 7 - 18 days, increase in tampon/pad usage, increase cramping. Patient received treatment for reported events Procedure to replace IUD. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headaches began approx. 2 weeks after 2nd dose and have continued daily. This is june 7th; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Apr2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. The patient medical history included chronic obstructive pulmonary disease (copd), and thyroid disorder (reported as thyroid). The patient had no known allergies to medications, food, or other products. The patient concomitant medications taken within two weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR); salbutamol (VENTOLIN); levothyroxine (MANUFACTURER UNKNOWN); and pramipexole (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 10:00 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021 08:00, the patient experienced severe headaches began approx. 2 weeks after 2nd dose and have continued daily. This is June 7th. Therapeutic measures were taken as a result of severe headaches that began approximately two weeks after second dose and had continued daily and included treatment with over the counter (otc) medications. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The outcome of the event was not recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain, Pain
Clinical narrative: pain/3 other patients complained about the same issue; severe pain in my left ear/3 other patients complained about the same issue; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history were Breast cancer and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced pain/3 other patients complained about the same issue, severe pain in my left ear/3 other patients complained about the same issue on an unspecified date with outcome of unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021665582 Same reporter/drug/events, Different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Cough
Clinical narrative: front chest pain and back pain when had deep breath; front chest pain and back pain when had deep breath; cough; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 29Apr2021 12:00 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination. Patient do not know about any known allergies. On 29Apr2021 15:00, the patient experienced front chest pain and back pain when had deep breath, and cough. No treatment received for adverse events. The outcome for all the event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at site of shot; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received BNT162B2,  intramuscular, administered in Arm ,at the age of 63 year old, on 20Jan2021 22:30 (Batch/Lot Number: EL3247) as dose 1, single and on 20Feb2021 14:30 (Batch/Lot Number: EL3247) as dose 2, single for covid-19 immunisation.  Medical history included, blood pressure and thyroid. Prior vaccination included Prevnar, shingles and Mery. Concomitant medications included ongoing telmisartan for blood pressure and  levothyroxine for hyperthyroidism, both from 09Jan2021. After each shot 1 and 2, on 20Jan2021 and 20Feb2021, 4 hours later, patient experienced soreness at site of shot. No relevant tests were done. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia, Swelling
Clinical narrative: fever; Excruciating pain; Swollen; Extremely fatigued; This is a spontaneous report from a non-contactable consumer (patient) reported for herself. A female patient of an unknown age received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient's medical history included strep throat, fibromyaglia, high blood pressure, depression, anxiety, tinnitus in right ear, Chiari malformation and stomach ulcers. Concomitant medication was not reported. On unknown date, it was reported that patient experienced fever, excruciating pain, swollen and extremely fatigued. The outcome of events was recovered on an unknown date.  No further information was reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Decreased appetite, Dizziness, Fatigue
Clinical narrative: dry cough; ached all over; felt like I was in a daze / Nothing seemed real; left arm pain; feeling very fatigue; 0 appetite; nausea; temperature 102.3; chills; dizziness; nearly walking into things almost stagger; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982 and expiry date not reported), via intramuscular, administered in Arm Left, on 06Jan2021 20:00 (at the age of 47-year-old), as dose 1, single, for COVID-19 immunisation in hospital. The patient medical history was not reported. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccination. Patient had no illness at the time of vaccination. On 15Jan2021, the patent worked at night shift. The patient went home to sleep. On 16Jan2021 19:00, the patient woke up with left arm pain tolerable. As evening went off, the patient was feeling very fatigue, 0 appetite, nausea, chills, temperature 102.3. The patient experienced dizziness at night of 16Jan2021 only, nearly walking into things almost stagger, nerve sought any help with it and just slowed down went on normal until was resolved. The patient went back to bed till next day. The patient felt same on the next day (17Jan2021) and still had increased temperature but not so high. The patient experienced aches all over and felt like in a daze the whole day and nothing seemed real. The patient experienced dizziness at night Arm felt as though was hit with a board and no redness. It was reported that no residual effects from this except occasional dry cough, but it was also almost allergy senses, so not sure that vaccine was related. Patient received no treatment for the events. The outcome for dry cough was not recovered while for other events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Nausea, Pain, Pain in extremity
Clinical narrative: dry cough; ached all over; felt like I was in a daze / Nothing seemed real; left arm pain; feeling very fatigue; 0 appetite; nausea; temperature 102.3; chills; dizziness; nearly walking into things almost stagger; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982 and expiry date not reported), via intramuscular, administered in Arm Left, on 06Jan2021 20:00 (at the age of 47-year-old), as dose 1, single, for COVID-19 immunisation in hospital. The patient medical history was not reported. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccination. Patient had no illness at the time of vaccination. On 15Jan2021, the patent worked at night shift. The patient went home to sleep. On 16Jan2021 19:00, the patient woke up with left arm pain tolerable. As evening went off, the patient was feeling very fatigue, 0 appetite, nausea, chills, temperature 102.3. The patient experienced dizziness at night of 16Jan2021 only, nearly walking into things almost stagger, nerve sought any help with it and just slowed down went on normal until was resolved. The patient went back to bed till next day. The patient felt same on the next day (17Jan2021) and still had increased temperature but not so high. The patient experienced aches all over and felt like in a daze the whole day and nothing seemed real. The patient experienced dizziness at night Arm felt as though was hit with a board and no redness. It was reported that no residual effects from this except occasional dry cough, but it was also almost allergy senses, so not sure that vaccine was related. Patient received no treatment for the events. The outcome for dry cough was not recovered while for other events was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: dry cough; ached all over; felt like I was in a daze / Nothing seemed real; left arm pain; feeling very fatigue; 0 appetite; nausea; temperature 102.3; chills; dizziness; nearly walking into things almost stagger; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982 and expiry date not reported), via intramuscular, administered in Arm Left, on 06Jan2021 20:00 (at the age of 47-year-old), as dose 1, single, for COVID-19 immunisation in hospital. The patient medical history was not reported. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccination. Patient had no illness at the time of vaccination. On 15Jan2021, the patent worked at night shift. The patient went home to sleep. On 16Jan2021 19:00, the patient woke up with left arm pain tolerable. As evening went off, the patient was feeling very fatigue, 0 appetite, nausea, chills, temperature 102.3. The patient experienced dizziness at night of 16Jan2021 only, nearly walking into things almost stagger, nerve sought any help with it and just slowed down went on normal until was resolved. The patient went back to bed till next day. The patient felt same on the next day (17Jan2021) and still had increased temperature but not so high. The patient experienced aches all over and felt like in a daze the whole day and nothing seemed real. The patient experienced dizziness at night Arm felt as though was hit with a board and no redness. It was reported that no residual effects from this except occasional dry cough, but it was also almost allergy senses, so not sure that vaccine was related. Patient received no treatment for the events. The outcome for dry cough was not recovered while for other events was recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Glycosylated haemoglobin, Inflammation, Pain in extremity, Vertigo
Clinical narrative: Hand pain more intense; Vertigo; Inflammation arm, face, left hand; This is a spontaneous report from a non-contactable consumer (patient). A 66-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on 02Feb2021 13:30 (Lot Number: EL9263) as dose 1, single for COVID-19 immunization. Medical history included diabetes from 1993 and ongoing, cancer from Jul2017 to Nov2018 (received chemo, lumpectomy radiation), high blood pressure, depression,inflammation in both wrists hand from 30May2020 (incisions in left hand), had both knees replaced in Oct2018 and Nov2018 (however right knee collapsed & had to be redone same day+ time), inflammation in back and knee, and stroke. Concomitant medication(s) included diclofenac sodium taken for inflammation from 2020 and ongoing; hydrocodone taken for pain from 2019 and ongoing, cancer, diabetes, high blood pressure, depression and cholesterol medications. The patient previously received second dose of shingles vaccine on 11Jun2021; within time frame for COVID vaccine. The patient's HbA1c was 6.9 in fall 2020. The patient's blood pressure was 137/70 in Dec2020 ( was taking 3 medication for blood pressure). The patient experienced vertigo and inflammation arm, face, left hand on 03Feb2021 and had hand pain more intense on an unspecified date. The patient did not receive treatment for vertigo and inflammation. The outcome of vertigo and inflammation was not recovered and outcome of hand pain more intense was unknown. The patient's doctor wanted patient to go to local hospital for work; however the patient had not done so because of skepticism.  No follow-up attempts are possible. No further information is excepted.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Recurring hives all over body; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 59-year-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The medical history included blood pressure high, hypothyroidism, gluten sensitivity, penicillin allergy, egg allergy and fruit allergy (olive). Concomitant medications included levothyroxine and lispersl. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/ Lot Number: not reported) via an unspecified route of administration in the left arm on an unknown date as a DOSE 1, SINGLE for COVID-19 immunisation. On 03May2021, the patient experienced recurring hives all over body. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event recurring hives all over body was not resolved at the time of this report.  The batch/lot number for BNT162b2 were not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Onychomycosis, SARS-CoV-2 test
Clinical narrative: Nail fungus on all 10 of my fingernails.; This is a spontaneous report from a contactable healthcare professional (patient).  A 42-years-old (also the age at time of vaccination) non-pregnant (also at the time of vaccination) female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 14Apr2021 09:00 (also reported as 12Apr2021 09:30 -pending clarification) (Batch/Lot Number: EW0150) as DOSE 1, SINGLE for COVID-19 immunization.  Medical history included Severe nerve damage since 30Jun2013 and ongoing due to car accident with tanium rod pelvic on unknown date, and ongoing anxiety. Family medical history included high blood pressure and diabetes. Concomitant medications included pregabalin (LYRICA) taken for nerve injury from 06Apr2021 and ongoing, escitalopram oxalate (LEXAPRO) taken for anxiety from Jun2013 and ongoing and nature bounty hair , nails, skin v.  On 26Apr2021, the patient had nail fungus on all 10 of her fingernails. She mentioned that it started when she noticed that her nails flipping up and very brittle and hard looking. The nail had lifted from the nail bed. The event required visit to physician office and received (Brand name unspecified) with terbinafine, oral meds, and droplets for nails. Prior to vaccination, the patient was not diagnosed with COVID-19.  It was stated that the patient had been tested for COVID-19 since vaccination (unknown results). As of 06Aug2021, the patient was still taking medications per doctor. The physician also mentioned that it won't completely grow out until 9 months. Outcome of the event was not recovered. The patient received the 2nd dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on 03May2021 09:00 am administered in Arm Right (Batch/ Lot number: EW0170) for COVID-19 immunization. The reporter consider that the Pfizer product had a causal effect to the adverse event. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: precipitated continuous menstruation; This is a spontaneous report from a non-contactable consumer. A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration on 15May2021 as dose 1, single and on 05Jun2021 as dose 2, single both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, it was unknown if the patient has been diagnosed with COVID-19 and post vaccination, it was unknown if the patient has been tested for COVID-19. On an unspecified date of 2021, the patient experienced precipitated continuous menstruation. It was reported that it started from the first dose and still ongoing at the time of report. The event resulted to doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event included patient was prescribed oral contraceptive. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: 2nd vaccine triggered period weeks early; This is a spontaneous report from a non-contactable consumer (patient).   A non-pregnant 13-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Jun2021 11:00 (at the age of 13 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included COVID-19 and concomitant medications were not reported. On 01Jul2021, the patient experienced 2nd vaccine triggered period weeks early with outcome of unknown. The facility type vaccine was reported as Pharmacy or Drug Store. Patient had no other vaccine in four weeks, no treatment for the events, and not COVID test post vaccination. The patient had COVID prior vaccination.   No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: prolonged and heavy menstrual bleeding.; This is a spontaneous report from a contactable consumer (patient). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EW0183) via an unspecified route of administration on 15May2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunisation. Medical history included allergy to banana. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced prolonged and heavy menstrual bleeding on 20May2021. The event resulted in physician office visit and was treated with birth control pills. Outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: my period was delayed; I am having cramps but no period.; This is a spontaneous report from a non-contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0185) via an unspecified route of administration, administered on the left arm on 23Jun2021 (at the age pf 23-year-old) as dose 2, single for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 02Jun2021 on the left arm for COVID-19 immunization. The patient's menstrual cycle was delayed. She has a very regular cycle and do not experience delays, but after her second dose, her period was delayed. She was having cramps, but no period. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle strain
Clinical narrative: Severe ankle pain in the left foot.; It's like it was a strain that just became worse after six hours; This is a spontaneous report from a contactable consumer (patient) via COVAES. A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Jul2021 at 17:30 (Batch/Lot Number: EW0196) (at the age of 23-years old) as dose number unknown, single for COVID-19 immunisation. The patient had no medical history. The patient had no reported allergies. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 post vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks of COVID-19 vaccine. The patient experienced severe ankle pain in the left foot, it was like it was a strain that just became worse after six hours on 04Jul2021 at 16:00. It was unknown if the patient received any treatment for the events. The outcome of events was not recovered.  No follow-up activities are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscle twitching
Clinical narrative: Throbbing calf muscles; Splitting headache; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, administered in right arm on 18Jun2021 (at the age of 79 years old) as dose 1, single for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL), osteoporosis, arthritis, and atrial fibrillation (afib). The patient is not pregnant at the time of vaccination and has not had COVID prior to vaccination. Concomitant medication included apixaban (ELIQUIS). The patient previously took sulphur and experienced Allergies to sulphur. No other vaccines in four weeks. The patient experienced throbbing calf muscles, splitting headache, and extreme fatigue on 28Jun2021, 10 days after shot. Side  effects lasted for 4 days. This was the patient's first shot. No treatment was given in response to the events. The patient was not COVID tested post vaccination. The outcome of the events was recovered on 02Jul2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: moderate diarrhea; This is a spontaneous report received from a non-contactable consumer (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration in the right arm on 01Jul2021 16:00 (at the age of 30-years-old) as dose 1, single for COVID-19 immunisation in a Pharmacy or Drug Store. Medical history included COVID-19 before vaccination. The patient's concomitant medications were not reported. No other vaccine was received by the patient in four weeks. The patient not tested for COVID after vaccination. The patient has no known allergies. On 03Jul2021 03:00 PM, roughly 48 hours after receiving the vaccine, the patient experienced moderate diarrhea. It has not gone away yet, but it was only been a day. The patient was hoping it won't last much longer. No treatment was taken for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, C-reactive protein increased, Condition aggravated
Clinical narrative: Arthritic-like pain in multiple joints in days preceding second dose and becoming severe following second dose. Pain specifically in hands, feet, ankles, knees, but originating in hands bilaterally; Arthritic-like pain in multiple joints in days preceding second dose and becoming severe following second dose. Pain specifically in hands, feet, ankles, knees, but originating in hands bilaterally; C-reactive protein at 14 mg/L; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208), via an unspecified route of administration in left arm on 14Mar2021 (at the age of 47-years-old) as dose 2, single for COVID-19 immunization. Medical history included benign prostatic hyperplasia (BPH), eagle's syndrome, bilateral styloidectomy and paraoesophageal hiatal hernia repair. Concomitant medication included Tamsulosin 0.4 mg. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm on an unspecified date in Feb2021 10:45 AM (at the age of 46-years-old) as dose 1, single for COVID-19 immunization and experienced Arthritic-like pain. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any allergies to medications, food, or other products. The patient experienced arthritic-like pain in multiple joints beginning in the days preceding the second dose and becoming more severe following the second dose. Pain specifically in hands, feet, ankles, and knees, but originating in the hands bilaterally and C-reactive protein at 14 mg/l on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included antinuclear antibody (ANA): negative, C-reactive protein: 14 mg/l and rheumatoid factor (RF): negative on an unspecified date in Mar2021. It might be coincidental timing but could possibly be related to vaccine. Patient was prescribed with diclofenac. Since the vaccination, patient has not been tested for COVID-19. Outcome of arthritic-like pain in multiple joints beginning in the days preceding the second dose and becoming more severe following the second dose. Pain specifically in hands, feet, ankles, and knees, but originating in the hands bilaterally was not resolved; outcome of C-reactive protein at 14 mg/L was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304452 same patient/drug/event, different dose
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid factor
Clinical narrative: Arthritic-like pain in multiple joints in days preceding second dose and becoming severe following second dose. Pain specifically in hands, feet, ankles, knees, but originating in hands bilaterally; Arthritic-like pain in multiple joints in days preceding second dose and becoming severe following second dose. Pain specifically in hands, feet, ankles, knees, but originating in hands bilaterally; C-reactive protein at 14 mg/L; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6208), via an unspecified route of administration in left arm on 14Mar2021 (at the age of 47-years-old) as dose 2, single for COVID-19 immunization. Medical history included benign prostatic hyperplasia (BPH), eagle's syndrome, bilateral styloidectomy and paraoesophageal hiatal hernia repair. Concomitant medication included Tamsulosin 0.4 mg. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6198), via an unspecified route of administration in left arm on an unspecified date in Feb2021 10:45 AM (at the age of 46-years-old) as dose 1, single for COVID-19 immunization and experienced Arthritic-like pain. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any allergies to medications, food, or other products. The patient experienced arthritic-like pain in multiple joints beginning in the days preceding the second dose and becoming more severe following the second dose. Pain specifically in hands, feet, ankles, and knees, but originating in the hands bilaterally and C-reactive protein at 14 mg/l on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included antinuclear antibody (ANA): negative, C-reactive protein: 14 mg/l and rheumatoid factor (RF): negative on an unspecified date in Mar2021. It might be coincidental timing but could possibly be related to vaccine. Patient was prescribed with diclofenac. Since the vaccination, patient has not been tested for COVID-19. Outcome of arthritic-like pain in multiple joints beginning in the days preceding the second dose and becoming more severe following the second dose. Pain specifically in hands, feet, ankles, and knees, but originating in the hands bilaterally was not resolved; outcome of C-reactive protein at 14 mg/L was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304452 same patient/drug/event, different dose
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Urticaria
Clinical narrative: Very lightheaded for days after had breakout in hives for a day
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Extra dose administered, Fall, Hyperhidrosis, Lip injury
Clinical narrative: Approximately 16 hours after receiving  my third Pfizer shot, I was light headed and dizzy.  I passed out approximately 5 times.  I do not remember falling, I woke up on the floor.  I felt sweaty at that time also.  I got a fat lip from hitting the floor.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Approximately 16 hours after receiving  my third Pfizer shot, I was light headed and dizzy.  I passed out approximately 5 times.  I do not remember falling, I woke up on the floor.  I felt sweaty at that time also.  I got a fat lip from hitting the floor.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Dizziness, Hypoaesthesia, Illness
Clinical narrative: numb arm/fingers on side of injection. Fluttering heart. Adrenaline type energy, then too sick / weak / dizzy to move (Still going for 3 days now). Insomia for 2 days.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: numb arm/fingers on side of injection. Fluttering heart. Adrenaline type energy, then too sick / weak / dizzy to move (Still going for 3 days now). Insomia for 2 days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Lymph node pain
Clinical narrative: Textbook side effects: pain at injection site, low-grade fever, chills, headache, major body aches similar to flu, extreme fatigue, all for 48 hours.  New Symptom during Day 2 a very large, painful and visible golf ball sized swollen lymph node under left arm (injection arm) appeared and has persisted into day 4, though it has decreased in size some.  No side effects with either previous shots.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Textbook side effects: pain at injection site, low-grade fever, chills, headache, major body aches similar to flu, extreme fatigue, all for 48 hours.  New Symptom during Day 2 a very large, painful and visible golf ball sized swollen lymph node under left arm (injection arm) appeared and has persisted into day 4, though it has decreased in size some.  No side effects with either previous shots.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Neck pain, Pain, Pain in extremity, Sneezing
Clinical narrative: 12-14 hours after the injection, I felt arches all over my entire body more to the left side of the body from neck down to the legs.  veins popped up in dark blue color on my left arm and upper chest more to the left side.  the aches lasted about 2 days and the dark blue  veins disappeared about the same time.   Since this injection, I have been sneezing more often and hair falling in bunches more than usual.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: 12-14 hours after the injection, I felt arches all over my entire body more to the left side of the body from neck down to the legs.  veins popped up in dark blue color on my left arm and upper chest more to the left side.  the aches lasted about 2 days and the dark blue  veins disappeared about the same time.   Since this injection, I have been sneezing more often and hair falling in bunches more than usual.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Depression, Dizziness, Electrocardiogram normal, Fibrin D dimer normal
Clinical narrative: Leg heaviness, cold legs and feet, right side facial numbness, tingling across back, full body shakes began 3 days post vaccination and continued for approximately 24 hours. Dizziness/lightheadedness, headaches and heart palpitations also began during that time frame. Dizziness subsided within 1 week. Heart palpitations and headaches have continued for 3 plus weeks. Feelings of panic and depressive lows began for the first time in patient's life during this time frame and have continued to this point.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Palpitations, Panic reaction
Clinical narrative: Leg heaviness, cold legs and feet, right side facial numbness, tingling across back, full body shakes began 3 days post vaccination and continued for approximately 24 hours. Dizziness/lightheadedness, headaches and heart palpitations also began during that time frame. Dizziness subsided within 1 week. Heart palpitations and headaches have continued for 3 plus weeks. Feelings of panic and depressive lows began for the first time in patient's life during this time frame and have continued to this point.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Tremor
Clinical narrative: Leg heaviness, cold legs and feet, right side facial numbness, tingling across back, full body shakes began 3 days post vaccination and continued for approximately 24 hours. Dizziness/lightheadedness, headaches and heart palpitations also began during that time frame. Dizziness subsided within 1 week. Heart palpitations and headaches have continued for 3 plus weeks. Feelings of panic and depressive lows began for the first time in patient's life during this time frame and have continued to this point.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate increased
Clinical narrative: rapid heart beat and chest tightness
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Headache
Clinical narrative: Tiredness,chills,dark bruise on right forearm 4 inches in diameter,headache that lasted for about 5 days after first vaccine shot
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Insomnia, Joint swelling, Loss of personal independence in daily activities
Clinical narrative: Extreme hives all over my body; They itch and burn; skin is hot at all times; Joint swelling; Pain in my ankles and wrists; I can't sleep because of them; Some days I can't work because of them; Excruciating pain and discomfort every day, all day; Excruciating pain and discomfort every day, all day; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:15 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none. Concomitant medication included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient received vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unknown route of administration, administered in Arm Left on 10Mar2021 02:15 PM as dose 1, single for COVID-19 immunisation. On 02Apr2021 at 07:00, Patient woke up with extreme hives all over my body. I have never had them before that day, and now I have had them every single day for 3 1/2 months. They itch and burn, my skin is hot at all times, patient had joint swelling and pain in my ankles and wrists which I also never had prior to 02Apr2021. I can't sleep because of them, some days I can't work because of them. Nothing the doctors have given me has worked and I am in excruciating pain and discomfort every day, all day. Treatment was received for the events as allergy medications, antihistamines, steroids. Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Skin warm, Urticaria
Clinical narrative: Extreme hives all over my body; They itch and burn; skin is hot at all times; Joint swelling; Pain in my ankles and wrists; I can't sleep because of them; Some days I can't work because of them; Excruciating pain and discomfort every day, all day; Excruciating pain and discomfort every day, all day; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 35-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 01Apr2021 10:15 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. Medical history included none. Concomitant medication included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient received vaccine facility in other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unknown route of administration, administered in Arm Left on 10Mar2021 02:15 PM as dose 1, single for COVID-19 immunisation. On 02Apr2021 at 07:00, Patient woke up with extreme hives all over my body. I have never had them before that day, and now I have had them every single day for 3 1/2 months. They itch and burn, my skin is hot at all times, patient had joint swelling and pain in my ankles and wrists which I also never had prior to 02Apr2021. I can't sleep because of them, some days I can't work because of them. Nothing the doctors have given me has worked and I am in excruciating pain and discomfort every day, all day. Treatment was received for the events as allergy medications, antihistamines, steroids. Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Nasopharyngitis
Clinical narrative: perpetual cold; Initial information received on 03-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient who experienced perpetual cold (nasopharyngitis), after receiving  INFLUENZA VACCINE.  Patient have not had the shot in 20 years and have not had the flu.   Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious perpetual cold (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the reporting, the outcome was unknown for the event nasopharyngitis.  There will be no information on the batch number fir this case.
Sex: U
Vaccine: FLU4
Symptoms: Herpes simplex
Clinical narrative: scorching case of herpes; Initial information was received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involved adult (unknown gender) patient who experienced scorching case of herpes (herpes simplex) while receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious scorching case of herpes (herpes simplex) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case.