chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: After first dose a terrible itch and rash in my butt.; After first dose a terrible itch and rash in my butt.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6205 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 08Mar2021 at 11:00 AM (age at vaccination: 63 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included fibromyalgia. Concomitant medications included estradiol, levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONIN), and cyclobenzaprine hydrochloride (CYCLOBENZAPRIN). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not have any known allergies. On 08Mar2021 at 06:00 PM, the patient experienced after first dose a terrible itch and rash in my butt. She had neither problem before this. The patient did not receive any treatment for the events. 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: Rash, Rash pruritic, SARS-CoV-2 test
Clinical narrative: itchy bumps; rash on thighs, calves and buttocks.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 22-year-old) as dose 1, single for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Concomitant medications included ethinylestradiol, norgestimate (TRI FEMYNOR). The patient previously took cefaclor (CECLOR) and amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. 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. On 10Apr2021 the patient experienced itchy bumps/ rash on thighs, calves and buttocks, the rash occurred after the second vaccine, started two days sooner. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment that reported as yes, with recurrence after second dose. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent other test and the result was negative. The clinical outcome of the event itchy bumps/ rash on thighs, calves and buttocks was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain
Clinical narrative: day after dose 1: mild-moderate body aches, especially in joints, severe fatigue; day after dose 1: mild-moderate body aches, especially in joints, severe fatigue; day after dose 1: mild-moderate body aches, especially in joints, severe fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 01Apr2021 16:00 (at the age of 39 years old) as dose 1, single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. No covid prior to vaccination. The patient's medical history was not reported. The patient's concomitant medications included prenatal vitamins (ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) and probiotics taken for an unspecified indication, start and stop date were not reported. Patient took no other vaccine in four weeks. On 02Apr2021 at 09:00, after dose 1, the patient experienced mild moderate body aches, especially in joints and severe fatigue. Patient not tested for covid post vaccination. No treatment received for the events. The outcome of the events was recovered with sequelae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Skin disorder
Clinical narrative: Bumps all over legs and arms; blisters; Itches; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in right arm on 23Apr2021 at 13:45 (at the age of 55-year-old) as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included chronic mononucleosis, chronic fatigue and chronic migraines. The patient previously took ibuprofen and experienced drug hypersensitivity. Concomitant medication(s) included bupropion, raloxifene, estradiol, estriol (BIESTROGEN) and aloe spp, rhamnus purshiana bark (CASCARA SAGRADA plus ALOE). Patient had no COVID prior to vaccination and was not covid tested post vaccination. On 23Apr2021 same date vaccine, patient received other unspecified vaccine. Patient did not receive other vaccine in four weeks. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), dose 1 via an unspecified route of administration, administered in left arm on 02Apr2021 at 13:45 (at the age of 55-year-old) for COVID-19 immunization and bumps started showing five days after first shot. On an unspecified date, the patient experienced bumps all over legs and arms. Looks like fire ant bites. Tiny little, oozy blisters on some if the bumps and Itches like crazy. Three days after the third shot-POOF, started spreading and itching. Patient received Prednisone and Zyrtec as treatment for an events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is excepted.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Nodule, Swelling face
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient (non-pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection,  batch/lot# EW0170), intramuscularly, in left arm, on Apr 17, 2021, at 02:15, single dose, for COVID-19 immunization. The patient's medical history included arthritis, factor 5, endometriosis and fibromyalgia. Allergies to remicade. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included Humira. The patient received other medications within 2 weeks of vaccination. On Apr 19, 2021, patient had facial swelling, nodule formation and tenderness on left-side of face along cheekbone at the site of filller injections. Adverse event resulted in physician office visit. The treatment included prednisone 5mg for all the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not tested for COVID-19. The patient has not recovered from the events. No follow-up attempts possible. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0153) via an unspecified route of administration in the arm left on 29Apr2021 at 17:30 (at the age of 58-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included Thyroidectomy (take levothyroxine 125 mg had thyroid removed one year ago). Concomitant medications included oxybutynin (MANUFACTURER UNKNOWN) 10mg, turmeric (MANUFACTURER UNKNOWN) 1500mg, omeprazole (MANUFACTURER UNKNOWN) 20mg and levothyroxine (MANUFACTURER UNKNOWN) 125mg. 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 COVID-19 vaccine. On 01May2021 at 00:00 the patient experienced hives. It was reported that hives were located everywhere including in her hair. Definitely worse on her body trunk. Therapeutic measures were taken as a result of the event and included treatment with benadryl but it was not helping, more hives were out. The clinical outcome of the event hives was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Dizziness, Fatigue, Lymph node pain
Clinical narrative: Lymph nodes throughout the entire body still swollen and sore at almost 4 weeks; Lymph nodes throughout the entire body still swollen and sore at almost 4 weeks; Stomach pain; nausea; dizziness; fatigue; Low grade fever for 2 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EWO153), via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 12:00 (age at the time of vaccination was 52 years) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. Medical history included high blood pressure, high cholesterol, fractured vertebrae, vertigo and ongoing heartburn. Reportedly, the patient had no known allergies. The patient had no other vaccine in four weeks. Concomitant medication(s) included lisinopril, acetylsalicylic acid (ASPIRIN CHILDREN) both taken for an unspecified indication, start and stop date were not reported and unspecified heartburn medicine. The patient did not have covid prior vaccination. On 10Apr2021, the patient experienced lymph nodes throughout the entire body still swollen and sore at almost 4 weeks, stomach pain, nausea, dizziness, fatigue, and low grade fever for 2 weeks. It was reported that the adverse event were lymph nodes throughout the entire body still swollen and sore at almost 4 weeks. Stomach pain and nausea, dizziness, and fatigue. Low grade fever for 2 weeks. The patient underwent lab tests and procedures which included Rapid Covid Test Nasal Swab: negative on 17Apr2021 and fever: low grade on 10Apr2021. The patient was tested for covid post vaccination. All events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. It was unknown if treatment was received for events. The outcome of all events were not recovered. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Lymph nodes throughout the entire body still swollen and sore at almost 4 weeks; Lymph nodes throughout the entire body still swollen and sore at almost 4 weeks; Stomach pain; nausea; dizziness; fatigue; Low grade fever for 2 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EWO153), via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 12:00 (age at the time of vaccination was 52 years) as dose 1, single for COVID-19 immunisation at pharmacy or drug store. Medical history included high blood pressure, high cholesterol, fractured vertebrae, vertigo and ongoing heartburn. Reportedly, the patient had no known allergies. The patient had no other vaccine in four weeks. Concomitant medication(s) included lisinopril, acetylsalicylic acid (ASPIRIN CHILDREN) both taken for an unspecified indication, start and stop date were not reported and unspecified heartburn medicine. The patient did not have covid prior vaccination. On 10Apr2021, the patient experienced lymph nodes throughout the entire body still swollen and sore at almost 4 weeks, stomach pain, nausea, dizziness, fatigue, and low grade fever for 2 weeks. It was reported that the adverse event were lymph nodes throughout the entire body still swollen and sore at almost 4 weeks. Stomach pain and nausea, dizziness, and fatigue. Low grade fever for 2 weeks. The patient underwent lab tests and procedures which included Rapid Covid Test Nasal Swab: negative on 17Apr2021 and fever: low grade on 10Apr2021. The patient was tested for covid post vaccination. All events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. It was unknown if treatment was received for events. The outcome of all events were not recovered. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: On days 11,12,13 & 14 - have experienced 6 sever nose bleed events, lasting 10 minutes each or longer.; This is a spontaneous report from a contactable consumer (patient) reported for himself that: A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN0169) via an unspecified route of administration, administered in Arm Left on 19Apr2021 10:30 (Age at Vaccination 61-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Food allergy to lemon from an unknown date and unknown if ongoing, coronary artery disease from an unknown date and unknown if ongoing Verbatim: I am a heart patient with coronary artery disease, stent placement from 29Dec2016 to an unknown date Verbatim: 2 stents placed in the LAD & L Circ. on 29Dec2016. Concomitant medication(s) included immunoglobulin varicella-zoster (ZOSTER IMMUNOGLOBULIN) taken for an unspecified indication from 17Feb2021 to 17Feb2021; ticagrelor (BRILINTA) taken for cardiac disorder, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:30 AM (Age at Vaccination 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Past drug included Amlodopine, Patient took zoster immunoglobulin in left arm dose 1, statins and experienced drug hypersensitivity, amlodipine and experienced drug hypersensitivity. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. The patient experienced on days 11,12,13 & 14 have experienced 6 sever nosebleed events, lasting 10 minutes each or longer on 30Apr2021 10:00. It was reported that on days 11,12,13 & 14 - have experienced 6 sever nosebleed events, lasting 10 minutes each or longer. No prior similar instances in the last 5 years. I am a heart patient with coronary artery disease, 2 stents placed in the LAD & L Circ. on 29Dec2016.Therapeutic measures were taken as a result of on days 11,12,13 & 14 - have experienced 6 sever nosebleed events, lasting 10 minutes each or longer. Doctor or other healthcare professional office/clinic visit, treatment received for the adverse event First aid to stop the bleeding. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Migraine, Nausea
Clinical narrative: aches; Fever (101.9); fatigue; nausea; chills; "ice pick" migraines severe; This is a spontaneous report from a contactable consumer (patient) or other non HCP.    A 54-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8731), via an unspecified route, administered in arm left on 14Apr2021 at 20:00 PM (age at vaccination was 54 years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Prior migraines (ceased with menopause) from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included omeprazole, rosuvastatin, vitamin d [vitamin d nos]; all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Facility type vaccine was pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of bnt162b2. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8730), via an unspecified route, administered in arm left on 23Mar2021 at 02:00 PM (age at vaccination was 54 years-old) as DOSE 1, SINGLE for covid-19 immunization. On 22Apr2021 at 08:30 AM, the patient experienced fever (101.9), aches, chills, fatigue, nausea, ice pick migraines-severe. The adverse events lasted for approximate 36 hours. No treatment was received for the events. The patient underwent lab tests and procedures which included body temperature: 101.9 (fever) on 22Apr2021. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; Fever (101.9); fatigue; nausea; chills; "ice pick" migraines severe; This is a spontaneous report from a contactable consumer (patient) or other non HCP.    A 54-years-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8731), via an unspecified route, administered in arm left on 14Apr2021 at 20:00 PM (age at vaccination was 54 years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included Prior migraines (ceased with menopause) from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included omeprazole, rosuvastatin, vitamin d [vitamin d nos]; all taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Facility type vaccine was pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of bnt162b2. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8730), via an unspecified route, administered in arm left on 23Mar2021 at 02:00 PM (age at vaccination was 54 years-old) as DOSE 1, SINGLE for covid-19 immunization. On 22Apr2021 at 08:30 AM, the patient experienced fever (101.9), aches, chills, fatigue, nausea, ice pick migraines-severe. The adverse events lasted for approximate 36 hours. No treatment was received for the events. The patient underwent lab tests and procedures which included body temperature: 101.9 (fever) on 22Apr2021. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling, Rash morbilliform, Urticaria
Clinical narrative: hives; lips and eyes are swollen; lips and eyes are swollen; measles-like red bumps on legs and hips; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports.   A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EW0171) via an unspecified route of administration in the arm left on 02May2021 at 10:45 (at the age of 50-year-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Hashimoto's disease and anxiety. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), escitalopram oxalate (LEXAPRO), progesterone (MANUFACTURER UNKNOWN) and estrogen (MANUFACTURER UNKNOWN); all from unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 11Apr2021 at 10:45 (at the age of 50-year-old) as a DOSE 1, SINGLE for COVID-19 immunisation and experienced hives and penicillin on unknown date for unspecified indication and experienced diarrhoea, not allergic, just intolerant. 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 02May2021, the patient experienced hives, lips and eyes are swollen and measles-like red bumps on legs and hips. It was reported that the hives did not occur before four hours after second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutics measures were taken as a result of reported events and treatment included with unspecified allergy medication. The clinical outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe joint pain; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer (Patient) reported that, a 48-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was unable to locate or read the details), dose 2 via an unspecified route of administration, administered in Arm Right on 13Mar2021 11:30 am (48-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome and hypertension from an unknown date and unknown if ongoing. The patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was unable to locate or read the details), dose 1 via an unspecified route of administration, administered in Arm Right on 20Feb2021 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included dexlansoprazole (DEXILANT) and venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination and covid not tested post vaccination. Approximately 3 weeks on 10Apr2021, after the 2nd vaccine patient began having severe joint pain that she have never had before. Her husband also has this. No treatment received. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021495434 same reporter/drug/event , different patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Rheumatoid factor, Rheumatoid factor positive, SARS-CoV-2 test
Clinical narrative: joint pain in left wrist which follwed by joint swelling left lateral distal ulna which was quite predominant on anatomical postieror side.sought medical assitance from pcplab worked showed elevated; joint pain in left wrist which follwed by joint swelling left lateral distal ulna which was quite predominant on anatomical postieror side.sought medical assitance from pcplab worked showed elevated; positve RA factor; elevated WBC; This is a spontaneous report from a contactable other hcp. A 57-years-old female patient received bnt162b2 (COMIRNATY; Formulation, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 00:30 (Batch/Lot Number: EL9265), Age at vaccination is 57 year as DOSE 2, SINGLE for covid-19 immunization. Medical history included neoplasm malignant from an unknown date and unknown if ongoing. Concomitant medications included estrogens conjugated taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. The patient experienced joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated and positive ra factor, elevated wbc on 06Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included rheumatoid factor: positive, Sars-cov-2 test: negative, Nasal Swab, white blood cell count: elevated, x-ray: negative on 06Feb2021. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, positive ra factor, elevated wbc. No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased, X-ray
Clinical narrative: joint pain in left wrist which follwed by joint swelling left lateral distal ulna which was quite predominant on anatomical postieror side.sought medical assitance from pcplab worked showed elevated; joint pain in left wrist which follwed by joint swelling left lateral distal ulna which was quite predominant on anatomical postieror side.sought medical assitance from pcplab worked showed elevated; positve RA factor; elevated WBC; This is a spontaneous report from a contactable other hcp. A 57-years-old female patient received bnt162b2 (COMIRNATY; Formulation, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 30Jan2021 00:30 (Batch/Lot Number: EL9265), Age at vaccination is 57 year as DOSE 2, SINGLE for covid-19 immunization. Medical history included neoplasm malignant from an unknown date and unknown if ongoing. Concomitant medications included estrogens conjugated taken for an unspecified indication, start and stop date were not reported. The patient previously took morphine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunization. The patient experienced joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated and positive ra factor, elevated wbc on 06Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included rheumatoid factor: positive, Sars-cov-2 test: negative, Nasal Swab, white blood cell count: elevated, x-ray: negative on 06Feb2021. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, joint pain in left wrist which followed by joint swelling left lateral distal ulna which was quite predominant on anatomical posterior side sought medical assistance from pcp lab worked showed elevated, positive ra factor, elevated wbc. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe joint pain/My husband also has this; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient was not experienced covid prior to vaccination and was not tested covid post vaccination. The patient had no known allergies. The reporter stated that, approximately 3 weeks on 10Apr2021, after the 2nd vaccine patient began having severe joint pain that she has never had before. Her husband (patient) also has this (on an unspecified date). Patient did not receive any treatment for the AE. Outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021495003 same reporter/drug/event , different patient
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Vaccination site pain
Clinical narrative: experienced (atypical to me) extremely debilitating cramps; menstrual blood shedding in large clots.; Only slight soreness at the injection site; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in the left arm on 28Apr2021 (at the age of 26-year-old), as DOSE 2, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included depression, anxiety and sunflower seed allergy from an unknown date and unknown if ongoing. Prior to the vaccination the patient was not diagnosed with COVID-19. Concomitant medications included Ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unspecified indication and Sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. The patient previously took menthol (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication and experienced allergy. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration, administered in the left arm on 07Apr2021 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunization and experienced vaccination site pain (slight soreness at the injection sight). The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced only slight soreness at the injection site and on 03May2021, got first period (5 days after second dose), experienced atypical to her extremely debilitating cramps and menstrual blood shedding in large clots. The patient did not received treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Joint swelling, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Hand swelled; Swelled especially knuckles; Stiffness in all knuckles especially middle finger, looked like baseball mitt, knuckles felt "fused"; Pain in all knuckles especially middle finger; First dose and second dose administered to patient on 08Mar2021; This is a spontaneous report from a contactable consumer(patient). A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 08Mar2021 at 13:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), environmental allergy, depression, arthritis and cold sores from unknown start date and unknown if ongoing. The patient previously received BACTRIUM, KEFLEX, lisinopril, benzodiazepines (BZDs) and experienced allergy from unknown start date and unknown if ongoing. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), acyclovir (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), nefazodone (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) for unspecified indication start dates and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in left arm on 08Mar2021(same date with first dose) (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 at 12:30 (23 hours after injection), the patient experienced right hand swelling especially in knuckles, pain/stiffness in all knuckles especially the middle finger which looked like baseball mitt and knuckles felt fused. The patient was unable to bend middle finger at all or grasp for 2 weeks. Therapeutic measures were taken because of the events which included treatment with ice, diclofenac and TYLENOL, but there was no pain/swelling relief from ice, diclofenac or TYLENOL. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of right hand swelling especially in knuckles, pain/stiffness in all knuckles especially the middle finger was resolving at the time of report.No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Lacrimation increased, Ocular discomfort, Ocular hyperaemia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-years-old female (non-pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 59-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications were not reported. The patient received other medications in two weeks. The patient had no covid prior vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number not reported), via an unspecified route of administration on 04Feb2021 14:00 (at the age of 59-year-old), as dose 1, single for covid-19 immunisation. 05Mar2021 14:00, within 24 hours after receiving the 2nd COVID19 vaccine the patient began to feel pressure around my eyes. They were red, watery, and swollen. The patient thought it was a sinus infection so she was prescribed an antibiotic. But after 2 weeks her eyes were still red, swollen, and very painful. The patient finally went to an eye doctor and he gave eye drops (steroids) and referred to a specialist for right angular closure/glaucoma. The eye drops cleared the problem in her eyes but just saw the ophthalmologist last week. After an extensive evaluation she determined that it was most likely a reaction to the vaccine because she had seen at least 2 other patients that had a similar response after receiving the vaccine. The patient received treatment with eye drops (steroids). The events resulted in doctor or other healthcare professional office/clinic visit. The events were recovered on an unspecified date in 2021.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 59-years-old female (non-pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date in Mar2021 (at the age of 59-year-old) as dose 2, single for covid-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications were not reported. The patient received other medications in two weeks. The patient had no covid prior vaccination. The patient had not been tested for covid post vaccination. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number not reported), via an unspecified route of administration on 04Feb2021 14:00 (at the age of 59-year-old), as dose 1, single for covid-19 immunisation. 05Mar2021 14:00, within 24 hours after receiving the 2nd COVID19 vaccine the patient began to feel pressure around my eyes. They were red, watery, and swollen. The patient thought it was a sinus infection so she was prescribed an antibiotic. But after 2 weeks her eyes were still red, swollen, and very painful. The patient finally went to an eye doctor and he gave eye drops (steroids) and referred to a specialist for right angular closure/glaucoma. The eye drops cleared the problem in her eyes but just saw the ophthalmologist last week. After an extensive evaluation she determined that it was most likely a reaction to the vaccine because she had seen at least 2 other patients that had a similar response after receiving the vaccine. The patient received treatment with eye drops (steroids). The events resulted in doctor or other healthcare professional office/clinic visit. The events were recovered on an unspecified date in 2021.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: extreme itchiness all over my body all the time; This is a spontaneous report from a contactable consumer. This 18-year-old female consumer (Patient) reported for herself. An 18-years-old female non-pregnant patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 21Apr2021 at 12:45 hours as DOSE 2, SINGLE (at the age of 18-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration, administered in left arm on 31Mar2021 at 14:15 hours as DOSE 1, SINGLE (at the age of 18-years-old) for COVID-19 immunization and experienced mild itchiness on back. The patient had no known allergies. The patient had no COVID prior vaccination. The patient was COVID tested post vaccination. The patient took no other vaccine in four weeks. On 22Apr2021, the patient experienced extreme itchiness all over body all the time. The patient would itch so bad that it would draw blood. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and the patient was treated with hydroxyzine 10mg three times a day. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 26Apr2021, Nasal Swab, Antigen testing. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint stiffness
Clinical narrative: Stiffness and debilitating pain in joints of hands for 30 days; Stiffness and debilitating pain in joints of hands for 30 days; Inflammatory arthritis; This is a spontaneous report from a contactable health care professional (Physician).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via intramuscularly, in Left Arm on 30Mar2021 (at the age of 31-years) as DOSE 2, SINGLE for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via intramuscularly, in Left Arm on 11Mar2021 (at the age of 31-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient medical history and patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and Since the vaccination, it was unknown if the patient been tested for COVID-19. On 31Mar2021, the patient experienced Stiffness and debilitating pain in joints of hands for 30 days, beginning the day after he received the second dose of vaccine. Preliminary workup for inflammatory arthritis is pending. Patient had attended Doctor or other healthcare professional office/clinic visit for the reported events. Patient was not hospitalized for the reported events. Patient received treatment as NSAID for the reported events. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported that: A 31-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ew0175) via an unspecified route of administration, administered in Arm Left on 26Apr2021 14:30 (Age at Vaccination 31-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Known allergies of bananas, carrots, tree nuts, chocolate, lavender and zpack.Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported, vitamins, and Birth control. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: eiu6202) via an unspecified route of administration, administered in Arm Left on 07Apr2021 01:45 PM (Age at Vaccination 31-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Past drug included bactrim for allergies. Patient did not receive covid prior vaccination. No other vaccine in four weeks. The patient experienced hives on 26Apr2021 19:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Apr2021 Nasal Swab, NAAT, sars-cov-2 test: negative on 19Apr2021 Nasal Swab,Antigen. Ae resulted in: [Doctor or other healthcare professional office/clinic visit] ae treatment Doctors appointment. Therapeutic measures were taken as a result of hives.The outcome of the event was not recovered.No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Paraesthesia
Clinical narrative: Joint pain; achy, throbbing; Tingling in hands, feet, arms, knees; This is a spontaneous report from a contactable consumer (patient). A 25-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route, administered in arm left on 15Mar2021 at 02:00 PM (age at vaccination was 25 years) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Facility type vaccine was other. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included hypothyroid from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID), paracetamol (TYLENOL); both taken within two weeks for an unspecified indication, start and stop date were not reported. The patient previously took zithromycin (Z-pack) and experienced allergies. On 22Mar2021, the patient experienced a lot more joint pain since first dose (achy, throbbing, tingling in hands, feet, arms, knees). Adverse events resulted in visit to doctor or other healthcare professional office/clinic visit. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test
Clinical narrative: experience mild itchiness on my back; This is a spontaneous report from a contactable consumer (patient). A 18-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiry date were not reported) via an unspecified route of administration, administered in left arm on 31Mar2021 14:15 (at the age of 18-year-old) as dose 1, single for COVID-19 immunization (Health Clinic). The patient had no medical history. The patient concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported had not diagnosed with COVID-19 prior to the vaccination. On an unspecified date, the patient had experience mild itchiness on my back. On 26Apr2021, the patient underwent nasal swab SARS-CoV-2 test which was negative. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event which included hydroxyzine 10mg three times a day. The outcome of the event was not recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.