chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 24 hours after injection developed extreme case of hives all over, horrible itching; horrible itching; This is a spontaneous report from a contactable other HCP.   A 72 year non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, via an intramuscular at Arm Left on 04Feb2021 (Lot Number: EJ3002; Expiration Date: 01Apr2021) second dose via an unspecified route of administration at Left arm on 24Feb2021 07:30 PM (Lot Number and expiry date unknown) as a single dose for covid-19 immunisation. On 05Feb20 patient had other vaccine 4weeks prior to the vaccine product was Tetanus unspecified route at left arm of administration. Medical history was included IBS, HYPOTHYROIDISM, ADD. Concomitant medications were included two weeks Arm our thyroid, losartan, norvasc, ADDERALL. Patient had allergies the drug of Codeine. On 25Febs2021 08:00 PM 24 hours after injection developed extreme case of hives all over, horrible itching, saw doctor who treated with Decatron injection, oral prednisone taper, Pepcid, prednisone cream yesterday and then today when the hives and itching was even worse given iv decatron and prescribed vistaril in addition to continuing other meds still intense itching and breaking out in more places. The outcome of the events as not recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events urticaria and pruritus and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: body aches; Extreme Fatigue; pain at the injection site; This is a spontaneous report from a non-contactable consumer (patient).   A 31-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Feb2021, at the age of 31-years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included none. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medication included cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported; vitamin d (VITAMIN D) taken for an unspecified indication, start and stop date were not reported.  The patient experienced extreme fatigue and body aches, and pain at the injection site. The patient has not been tested to COVID-19 post vaccination. The outcome of the events was recovering. No treatment was received for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Start Date/Time: [Pfizer] 8-JAN-2021 12:15 PM/ Start Date/Time: [Pfizer ] 21-DEC-2020 09:30 AM; Left arm at site has been tender since shot.; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received bnt162b2 (BNT162B2 solution for injection, Lot Number was EL32119) dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 12:15 as single dose for covid-19 immunization at Hospital. The patient was not pregnant at the time of vaccination. The patient had known allergies with streptomycin. Medical history included. synthetic ascending aorta and an aortic pig Valve replacement. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0140), via an unspecified route of administration, administered in Arm right on 21Dec2020 09:30 as single dose for covid-19 immunization. The patient's concomitant medications included Toprol XL (METOPROLOL SUCCINATE), losartan (LOSARTAN), Advil (IBUPROFEN), Tylenol (PARACETAMOL), asa (ASA), multi v. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with covid. Post vaccination patient was not tested for covid. On 15Feb2021, patient experienced Left arm at site has been tender since shot. But over last week it has become very tender. At times when arm moved just right feels a knife at that spot. Outcome of Left arm at site has been tender since shot was not recovered, and inappropriate schedule of product administration was unknown.    Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: Painful and swollen lymph nodes; Painful and swollen lymph nodes; Headache; Vivid dreams; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EN6203), dose 2 via an unspecified route of administration, administered in arm left on 26Feb2021 12:15 at age of 30 years old as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included thyroid nodules. The patient's concomitant medications were none. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. There was no covid tested post vaccination. The patient previously took first dose of bnt162b2 (lot number: EM9809) on 05Feb2021 11:15 in left arm for Covid-19 immunization. The patient experienced painful and swollen lymph nodes on left side, vivid dreams, headache, all on 27Feb2021 07:00. No treatment was received for adverse events. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Paraesthesia oral
Clinical narrative: Dizzy; tingling lips; headache; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A 7-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizzy, tingling lips, and headache. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller received first dose of Pfizer-BioNTech COVID-19 Vaccine on 10FEB2021/tested positive COVID-19 on 18Feb2021; This is a spontaneous report received from a contactable consumer(patient) via medical information team. A 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date not reported) via unspecified route of administration, in left arm on 10Feb2021 at 5:45 PM (at the age of 87 years), as a single dose for covid-19 immunization. The patient medical history reported as she has had Heart failure since she was a child and concomitant medications were not reported. There was no prior Vaccinations within 4 weeks. There was no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There was no additional Vaccines administered on same date of the Pfizer Suspect. There was no AE(s) which require a visit to Emergency Room and physician office. On 18Feb2021, the patient tested positive for the COVID-19 Virus. She said she had no symptoms when she tested positive for the COVID-19 Virus. She asked if she should still get her second COVID-19 Vaccine, stating she was scheduled to receive her second COVID-19 Vaccine on 04Mar2021. She stated that her husband had COVID-19 Virus, clarifying her husband had passed. She reported that her COVID-19 Virus quarantine period ended on 28Feb2021(Yesterday). However, her doctor advised her not to take the vaccine and move it on a later date on April. She would like to know if she needs to move the schedule for her second dose. She had a COVID-19 Virus nasal swab test performed on 18Feb2021 at (Pharmacy). She said she had to wait 3 days to receive the COVID-19 Virus nasal swab test results from (Pharmacy). The Relevant Tests includes Positive COVID-19 Virus test. Outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Melanocytic naevus
Clinical narrative: having a biopsy done on some moles that recently changed look and size; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A report received from contactable female consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date in 2021, the patient had some moles that recently changed look and size. It was reported that on 26Feb2021 patient was having a biopsy done on some moles that recently changed look and size and would have a local anesthetic at that appointment and wanted to make sure if she can still get the second dose on 9Mar2021.The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: 2 weeks after first vaccine menopause reversed 13 months into menopause; cramping; pimples; regular period with heavy first day; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 06Feb2021 14:15 (at the age of 57-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ropinirole and daily multivitamins taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 22Feb2021, the patient experienced 2 weeks after first vaccine menopause reversed 13 months into menopause, cramping, pimples, and regular period with heavy first day. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021. It was also reported that the patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 27Feb2021 11:00 (at the age of 57-years-old) for COVID-19 immunisation.  No follow-up attempts are possible. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Carpal tunnel syndrome, Condition aggravated, Fatigue, Headache
Clinical narrative: Ovarian cyst; irregular spotting; Severe headache; injection site pain; Carpal tunnel Syndrome flare; Carpal tunnel Syndrome flare; Psoriasis Flare; myalgia; fatigue; joint pain x 3 weeks; This is a spontaneous report from a contactable other health care professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EK4176, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 19Jan2021 at 10:00 (reported as 10:00 AM) (at the age of 40 years old) as second dose, single for COVID-19 immunisation. Medical history included Gilbert's Syndrome, Psoriasis, and Carpal Tunnel Syndrome, all from an unknown date. Patient was not pregnant and has no known allergies. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medication included amoxicillin, clavulanate potassium (AUGMENTIN [AMOXICILLIN;CLAVULANATE POTASSIUM]) reported as "2nd dose only" taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. The patient was previously given the first dose of BNT162B2 (Lot number: EJ1685), via an unspecified route of administration, administered in left arm on 28Dec2020 at 10:15 AM (at the age of 40 years old) as single for COVID-19 immunisation and experienced menstrual irregularity: much heavier period, joint pain for 2 weeks, psoriasis flare, Carpal Tunnel Syndrome Flare, Fatigue, chill, myalgia and injection site pain. On an unspecified date, the patient experienced Ovarian cyst, irregular spotting, Severe headache, injection site pain, Carpal tunnel Syndrome Flare, Psoriasis Flare, myalgia, fatigue and joint pain x 3 weeks. Treatment was received with current treatment for Ovarian cyst. Events resulted in Doctor or other healthcare professional office/clinic visit. After vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Myalgia, Ovarian cyst, Psoriasis, Vaccination site pain
Clinical narrative: Ovarian cyst; irregular spotting; Severe headache; injection site pain; Carpal tunnel Syndrome flare; Carpal tunnel Syndrome flare; Psoriasis Flare; myalgia; fatigue; joint pain x 3 weeks; This is a spontaneous report from a contactable other health care professional (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EK4176, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 19Jan2021 at 10:00 (reported as 10:00 AM) (at the age of 40 years old) as second dose, single for COVID-19 immunisation. Medical history included Gilbert's Syndrome, Psoriasis, and Carpal Tunnel Syndrome, all from an unknown date. Patient was not pregnant and has no known allergies. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medication included amoxicillin, clavulanate potassium (AUGMENTIN [AMOXICILLIN;CLAVULANATE POTASSIUM]) reported as "2nd dose only" taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. The patient was previously given the first dose of BNT162B2 (Lot number: EJ1685), via an unspecified route of administration, administered in left arm on 28Dec2020 at 10:15 AM (at the age of 40 years old) as single for COVID-19 immunisation and experienced menstrual irregularity: much heavier period, joint pain for 2 weeks, psoriasis flare, Carpal Tunnel Syndrome Flare, Fatigue, chill, myalgia and injection site pain. On an unspecified date, the patient experienced Ovarian cyst, irregular spotting, Severe headache, injection site pain, Carpal tunnel Syndrome Flare, Psoriasis Flare, myalgia, fatigue and joint pain x 3 weeks. Treatment was received with current treatment for Ovarian cyst. Events resulted in Doctor or other healthcare professional office/clinic visit. After vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: already menstruating for a few days when she got the COVID-19 vaccine. However, throughout the day the flow of her period, it gradually became worse and worse; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 10:30 (at the age of 22-years-old) (Lot number was not reported) as first dose, single for COVID-19 immunisation. Medical history included diabetes mellitus. The patient was not pregnant at the time of vaccination and had no known allergies. The patient did not have Covid prior to vaccination. The patient did not receive any other vaccine in four weeks. Other medications in two weeks was reported as birth control. On 05Mar2021 01:45PM, patient reported that she was already menstruating for a few days when she got the COVID-19 vaccine. However, throughout the day the flow of her period, it gradually became worse and worse. It came to the point that patient filled up a super tampon within 3 hours. This has never happened to her before and these symptoms did not start until after the COVID-19 vaccine. The patient did not receive any treatment for the event. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Immediate (very much unwanted) menstruation following both first and second dose; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 12Feb2021 17:30 (lot number: EL3249), as 1st dose, single; and via an unspecified route of administration, administered in the left arm, on 05Mar2021 13:30 (lot number: EL9265), as 2nd dose, single, for COVID-19 immunisation, at a clinic. Medical history included bleeding. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included medroxyprogesterone acetate (DEPO-PROVERA) taken to prevent bleeding; buspirone hydrochloride (BUSPAR); omeprazole; cyclobenzaprine hydrochloride (FLEXERIL); and naproxen, start and stop dates were not reported. The patient previously took ciprofloxacin (CIPRO) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 12Feb2021, the patient experienced immediate (very much unwanted) menstruation despite Depo-Provera to prevent bleeding. This was following both the first and second doses of COVID-19 vaccine. No treatment was given for the event. The outcome of the event was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Vaginal haemorrhage
Clinical narrative: Extreme and sudden vaginal bleeding upon awaking the next day after the first dose; it seems like I am on my period but 11 days early; This is a spontaneous report from a contactable consumer (patient). A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: En 0198), via an unspecified route of administration, administered in Arm Left on 03Mar2021 11:45 (at 32-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. Patient was not pregnant. Facility type vaccine: Health Clinic. Patient had no covid prior vaccination. Patient was not tested for covid post vaccination. No known allergies. Concomitant medications included metronidazole (FLAGYL). The patient experienced extreme and sudden vaginal bleeding upon awaking the next day after the first dose, on 04Mar2021 07:00. After the initial large amount of blood, it seems like she was on her period but 11 days early, which has never happened before. No other symptoms. No treatment given. The outcome of the events was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Distractibility, Hypoacusis, Investigation, Tinnitus
Clinical narrative: Increase in tinnitus levels; harder to hear people talk than before; Very very distracting; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 01Mar2021 14:15 as 1st dose single (at the age of 72-years-old) for COVID-19 immunization. Vaccination facility type was reported as Other. Patient did not receive any other vaccine in four weeks. Patient did not receive any prior COVID vaccination. Patient was not tested for COVID post vaccination. Patient medical history included CLL, stenosis of spine, occasional SVT, previously mild tinnitus, some hearing loss and had known allergies to Aspirin, Ginger, NSAIDs. The concomitant medications were not reported. On 03Mar2021, patient experienced increase in tinnitus levels, which is very distracting now, when in silence, harder to hear people talk than before. First noticed that a few days later. It has not gone away. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation irregular
Clinical narrative: she had breakthrough bleeding; menstrual spotting; she was not supposed to get her period for another week or two.; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 19 years of age), via an unspecified route of administration, administered in arm left on 09Mar2021 (Batch/Lot Number: EN6203) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE) taken for contraception, start and stop date were not reported. It was reported that the patient received her first dose of Pfizer-Biontech Covid19 vaccine 09Mar2021. She mentioned that almost immediately afterward she had breakthrough bleeding and now she has a "full blown period" even though she was on the pill.  She wanted to know whether this has been reported, and if she should be concerned. She added that she got the Covid vaccine on Tuesday 9Mar2021, and since then she has been having a lot of menstrual spotting, she was not supposed to get her period for another week or two. This started almost immediately after she got the vaccine about an hour or two after on the same day. She was unsure if this could be a side effect of the vaccine. Stated it had progressively gotten worse and was now a full blown period. Stated she does not typically have any breakthrough bleeding. The outcome of the events was not recovered.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I got COVID-19. I was exposed sometime and I tested positive; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203 and Expiration date was not reported), via an unknown route of administration on 03Mar2021 at 15:45 in left arm, as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccine in four weeks of vaccination. The patient had no known allergies. The patient medical history included prediabetes and hypertension. The patient received Metformin, Lisinopril, levothyroxine sodium (SYNTHROID), metroprol, colecalciferol (D3), cyanocobalamin (B12), within two weeks of vaccination. Patient was not diagnosed with covid prior vaccination. Post vaccination patient tested positive for COVID. The patient reported that she got COVID-19. She was exposed sometime, and she tested positive on 09Mar21. She was now Covid positive and hopefully recovering. The patient had Covid test post vaccination: covid test type post vaccination (nasal swab), underwent Covid test date on 09Mar2021, test result was positive. Treatment was not received for the reported events. The outcome of the event was reported as recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pain, Pyrexia
Clinical narrative: strong covid sysmtoms; fever; chills; body ache; This is a spontaneous report from a contactable consumer (Patient herself). A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: en6205), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:00 (age at the time of vaccination was 50-year-old) as single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing i have had covid already (11 days) so it was exact same,. Other medications in two weeks Concomitant medications included bupropion hydrochloride (WELLBUTRIN); fluoxetine; ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID; BIOTIN; CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) taken for an unspecified indication, start and stop date were not reported. The patient has no other vaccine in four weeks. The patient has no covid test prior vaccination. The patient has no covid test post vaccination. No treatment for AE. On 14Mar2021 02:00 The patient experienced strong covid sysmtoms, fever, chills, body ache. The outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Pain in left testicle; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 13Mar2021 08:00 (Batch/Lot Number: En6199) as single dose for COVID-19 immunisation. Medical history included chronic lymphocytic leukaemia (CLL), chronic obstructive pulmonary disease (COPD), diabetes. The patient had no known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks. No Covid prior vaccination. The patient had not tested Covid post vaccination. The patient experienced pain in left testicle on 14Mar2021 11:00. No treatment received for AE. Outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Intermenstrual bleeding, Lymphadenopathy, Pain in extremity, Premature menarche
Clinical narrative: Left arm soreness; Soreness on left side of breast as well as right; Lymph nodes enlarged; spotting; 1 week early than normal menstrual cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in the left arm on 09Mar2021 12:00 (Batch/Lot Number: Eng205) as SINGLE DOSE for covid-19 immunisation. Patient had no medical history. Concomitant medication included ashwagandha (ASHWAGANDHA) taken for an unspecified indication, start and stop date were not reported.  On 11Mar2021, the patient experienced Left arm soreness for 2 days. Soreness on left side of breast as well as right. (Lymph nodes enlarged) spotting noticed 6 days after vax, 1 week early than normal menstrual cycle. The outcome of events was reported as unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strange metallic and wood-like taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the unspecified anatomical site on 15Mar2021 at 15:30 (at the age of 44-years-old), as a single dose for COVID-19 vaccination. The patient's medical history was not provided. Prior to the vaccination, the patient was not diagnosed with Covid-19.  Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not provided. On 15Mar2021, the patient had strange metallic and wood-like taste in mouth for 3 hours. The clinical outcome of strange metallic and wood-like taste in mouth was recovered on 15Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Odynophagia, Swelling
Clinical narrative: swelling in my neck; pain swallowing; This is a spontaneous report from a contactable consumer, patient. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), unspecified route administered in left arm on 11March2021 at 04:00 pm (at the age of 56-years old) as a single first dose for Covid-19 immunization. The patient medical history includes cholesterol, blood pressure and asthma. Concomitant medications were reported as Statins for cholesterol on unknown date. The patient had no any allergies to the food medication or other product. On 13Mar2021 at 10.00am, The patient experienced swelling in neck and pain swallowing started about the 3rd day after vaccination. The patient did not undergo lab tests and procedures. The patient had not received any other vaccine within 4 weeks prior to the covid-19. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19, Since having the vaccination. Therapeutic measures were not taken for the event. The clinical outcome of the event swelling in his neck and pain swallowing was not recovered at the time of reporting. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: severe headache; exhausted; fever; chills; feel achy; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch Number: EN6204), via an unspecified route of administration in the left arm on 12Mar2021 at 10:45 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Concomitant medication included Spironolactone, clonazepam, quetiapine, desvenlafaxine for unknown indication, from unknown-to-unknown date, unknown if ongoing. Prior to vaccination, the patient had not diagnosed with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced feel achy, exhausted, chills, fever of 103-104, severe headache on 13Mar2021. No Therapeutic measures were taken as a result of adverse events. The clinical outcome of the events achy, exhaustion, chills, fever and headache were unknown. No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on lower back; Breakouts; This is a spontaneous report from a non-contactable 47-year-old, female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm 15Mar2021 at 02:00AM (at the age of 47-year-old) as a single dose for COVID-19 vaccination. Medical history included hypothyroidism. It was reported that the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient received many other medications (unspecified) within 2 weeks of vaccination. It was unknown whether the patient have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has not tested for COVID-19 since having the vaccine. The patient's concomitant medications were not reported. On 15Mar2021, the patient experienced breakouts and rash on lower back (Skin breakout) 4-5 hours after vaccination. The patient was treated for the breakouts and rash on lower back (Skin breakout) with Antihistamine (MANUFACRURER UNKNOWN). The clinical outcome of the breakouts and rash on lower back (Skin breakout) was recovering. No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle tightness, Skin burning sensation, Viral test
Clinical narrative: Pain in left shoulder blade; Tightness in left shoulder blade; Burning sensation on skin; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) on 12Mar2021 at 12:45 PM (at the age of 42-year-old) on left arm as a first dose for COVID-19 Immunisation. Medical history includes body mass index high from an unknown date. The patient was allergic to latex and penicillin from an unknown date. Concomitant drugs include Cyclobenzaprine (MANUFACTURER UNKNOWN) and Pepcid (MANUFACTURER UNKNOWN) for unknown indication. Patient was not diagnosed with COVID-19 prior to the vaccination. The patient was not receive any vaccination 4 weeks prior to COVID-19 vaccination. The patient experienced pain and tightness in left shoulder blade and burning sensation on skin on 12Mar2021 at 5:00PM. The clinical outcome of the pain, burning sensation on skin and tightness in left shoulder blade were not recovered/not resolved. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: low grade fever (99+); pain in joints; pain in muscles; swollen lymph node under the arm that was vaccinated; difficulty sleeping; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) as a single dose via unspecified route of second dose on 15Mar2021 at 11:30 AM for COVID-19 immunization. The concomitant medications included multi-vitamin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) for unknown indications. The Medical history included Ibuprofen allergy. Past medication included BNT162b2 had taken as a single dose via unspecified route of 1st dose on 22Feb2021 at 11:30 AM (lot number: EL3247). Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, 11 hours after dosing patient woke up with low grade fever (99+), pain in joints, muscles and swollen lymph node under the arm that was vaccinated. He had difficulty sleeping the rest of the night and still 22 hours after dosing) had sore muscles. The therapeutic measures taken were not reported. The clinical outcome of all the events were reported as recovering/resolving at the time of report. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, SARS-CoV-2 test
Clinical narrative: Rash on insides of both elbows. Red and bumpy. Not itching or burning. Rashes reappear every so often since second dose.; This is a spontaneous report from a contactable consumer reported for a patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the anatomical location (arm left) on 19Feb2021 at 08:15 (at the age of 34-years-old), as a second single dose for COVID-19 Immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route on an unspecified date, as a first single dose for COVID-19 immunisation. On an unknown date, the patient experienced rash on insides of both elbows. Red and bumpy. Not itching or burning. Rashes reappear every so often since second dose. The patient did not receive any treatment for the reported events. The clinical outcome of rash is not recovered. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Viral test, Vomiting
Clinical narrative: Throwing up all day-started 2hrs after the vaccine.; This is a spontaneous report from a contactable non health care professional, patient. A 44-years old male patient received BNT162B2{COVID-19 MRNA VACCINE BIONTECH} [batch/lot number# 6205], via unspecified route in the left arm on 03Mar2021 for COVID-19 immunisation. Medical history included high blood pressure, dilated ventricle, ascending aorta dilation and left ventricular hypertrophy. Concomitant medication included lisinopril HCTZ (unknown manufacturer). The patient experienced "Throwing up all day" which started two hours after receiving the vaccine on 03Mar2021. The patient underwent Nasal Swab test twice, on 07Mar2021 and 13Mar2021, both reported as negative. The patient had not been diagnosed with COVID-19 before vaccination. The patient underwent PCR test for COVID-19 after the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not have any allergies related to medication, food, or other products. Patient received anti-nausea medication as a therapeutic action for the event. The clinical outcome of the event was reported as recovered. No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: chills; Nausea; Extreme body pain; Fever; This is a spontaneous case from a contactable consumer, the patient. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL9266) as a first dose in the left arm on 15Feb2021 at 10:30 am and (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) as a second dose in the right arm on 08Mar2021 at 13:30 pm via an unspecified route of administration for COVID-19 immunization(age at the vaccination: 50 years). Medical history and concomitant medications are not reported. Prior to the vaccination the patient was not diagnosed with COVOD-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was at a  Clinic. On 15Feb2021, the patient experienced Fever, chills, extreme body aches, nausea for first dose and no side effects for second dose. No therapeutic measures were taken for the events fever, chills, extreme body aches and nausea. The clinical outcome for the events fever, chills, extreme body aches, nausea are recovered on an unknown date. The patient feels like he didn't get a second dose or something was wrong with the second dose as he did not experience with any events. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Intermenstrual bleeding
Clinical narrative: Period start with some bloody spot; Mild headache.; This is a spontaneous report received from a non-contactable Healthcare Professional. A 55-year-old non-pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6204; Dose number: 1st dose), via an unspecified route of administration on her left arm on 11Mar2021 at 16:00 (at the age of 55-year-old) as a single dose for COVID-19 immunization. The Patient's Medical history was not reported. Concomitant medications included Multi-vitamin (Indication - unknown, manufacturer unknown), Calcium (Indication - unknown, manufacturer unknown) from unknown dates and unknown if ongoing. 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 14Mar2021, two days after the vaccine the patient experienced period with some bloody spot and mild headache. It was reported that patient did not have period for more than 1 year. The clinical outcomes of the event were period with some bloody spot and mild headache were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold
Clinical narrative: body felt cold; Tiredness; This is a spontaneous report from a contactable consumer, a patient and other healthcare professional. A 50-year-old Male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the right arm on 11Mar2021 at 1300 hours (at the age of 50-years-old), as a first single dose for COVID-19 immunisation. Concomitant medications included Zyrtec and multi vitamins (manufacturer unknown), for an unspecified indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 the patient experienced tiredness and on 16MAR2021, the patient's body felt cold, however patient did not have any fever and was able to maintain his normal schedule of work and exercise. The clinical outcome of the event tiredness was recovering. The clinical outcome of the event felt cold was unknown. No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: slight soreness at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Lot/batch no: EL 3247) dose number 1, via unspecified route of administration on right arm as a single dose for COVID-19 vaccination (at the age of 51-year-old). Medical history and concomitant medications were not reported. The patient has allergy to penicillin. The patient neither received any other vaccines within 4 weeks prior to the COVID-19 vaccination nor received any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 15:00, the patient experienced slight soreness at injection site. No therapeutic measures were taken for the event. The outcome of the event was not recovered at the time of this report. On 16Mar2021, the patient received BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Lot/batch no: EL 3247) dose number 2, via unspecified route of administration on right arm as a single dose for COVID-19 vaccination (at the age of 51-year-old). No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Chills, Dizziness, Fall
Clinical narrative: Chills; Lost of bowl control. Urinated and defecated; Fell to floor couldn't get off floor; Dizzy; Weakness; This is a spontaneous report from a contactable consumer, the patient.   A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: Unknown) via an unspecified route of administration in the left arm on 12Mar2021 at 0000hours (at the age of 72-years-old), as a second single dose for COVID-19 immunisation at hospital. The patient's medical history included hypertension and type 2 diabetic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not known), via an unspecified route of administration on an unspecified date, for COVID-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 13Mar2021 at 02:00 hours, the patient experienced chills, followed by weakness and dizziness. He fell to floor and couldn't get off the floor and he lost bowel control, urinated and defecated. He did not receive any treatment for adverse events. The clinical outcome of the events chills, weakness, dizzy, fall and bowel incontinence was recovering. No follow up attempts are possible; information about batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: nausea; Fatigue; slight headache; This is a spontaneous report from a non-contactable consumer, the patient.  A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH mRNA COVID 19 VACCINE) (batch no: EL3247) on left arm as a single dose on 15Mar2021 at 10:00 AM for COVID-19 immunisation. The patient also received first dose of BNT162B2  on left arm as a single dose on 22Feb2021 at 10:00 AM for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. Patient is not enrolled in clinical trial. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19.  On 15Mar2021, patient experienced fatigue, slight headache, and nausea. The clinical outcome for these events were given as recovering. The patient did not received any treatment for these event. No follow-up attempts are needed. No further information is expected.