chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient has no Known allergies. Concomitant medication(s) included: IBUPROFEN (within 2weeks of Covid vaccine). The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24May2022, outcome "unknown", COVID-19 (medically significant) with onset 24May2022, outcome "not recovered" and all described as "COVID-19". Clinical Course: The patient was tested positive for Covid on 24May2022. Therefore, started to take the Paxlovid on the same day. After taking the Paxlovid pills, the patient was tested negative for Covid on 31May2022. However, she started to have runny nose again on 02Jun2022 so that she took another test on 03Jun2022.she tested positive again. The patient wanted to report this Covid rebound case. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: I was tested positive for Covid on 24May2022; (31May2022) Negative, notes: I was tested negative for Covid on 31May2022; (03Jun2022) Positive, notes: I took another test on 03Jun2022. I tested positive again. Therapeutic measures were taken as a result of covid-19 with Paxlovid from 24May2022 to 28May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Auditory hallucination and left sided facial twitching.  Headaches and vomiting.
HCP reporting a patient received 2 doses of VARIVAX in 2018, but her titers taken in 2022 show the patient is not immune.; This spontaneous report was received from a registered nurse regarding a female patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates in 2018, the patient was vaccinated with two doses of varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis.  On an unknown date in 2022, the patient's titers showed that she was not immune (Antibody test negative). At the time of reporting, the outcome of the event was not provided. She sought medical attention.   The causal relationship between antibody test negative and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
The patient experienced extreme fatigue, some body aches, and a fever of 101F approximately 24 hours after receiving the second dose of the Shingrix vaccine. Her first dose was 2/16/19 and she experienced no adverse effects with that dose.
Vaccine was picked up from state department on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose three days past the vaccine usage date. Patient reported no known symptoms.
Chief Complaint   Pt here for muscle pain/stiffness. Pt stated, 'About 1d after my COVID shot, I started feeling bad. Neck pain that goes down my arm (R), extreme fatigue and achy. I've lost 5lbs in 3d.' MEDS UTD  History of Present Illness     "I had that COVID shot Thursday (l arm).  Friday I started having cramps in my neck--base of my skull, R arm, into the base of my jaw."  Worse with laying down, sleeping on L side.  "Hurt too much to get up" (had wife help him up to bathroom).    Tried?  Bayer back and body only.  Tried some topical ben gay (made worse), vibration therapy.  Hot shower seemed to help.  Review of Systems     + for chills, HA, diarrhea.  Worst yesterday.  Missed work yesterday.  Had been eating/drinking well until recently.    Assessment/Plan      1. Adverse reaction to vaccine T50.Z95A    2. Myalgia after COVID-19 vaccination M79.10     1.  Adverse vaccine response will be reported.  This seems to be fairly significant due to being 5d after.  2.  Will try Tyl 1000mg up to tid and Ibu 400 up to tid-qid for next 3 days--try to get dose of each at hs tonight.  Push fluids.  Prednisone 20mg/d x 5d.  Call report tomorrow on status.  3.  At this time, will likely avoid 2nd Moderna covid vax in this pt due to reaction.  4.  Note provided for off work yesterday through tomorrow.   Orders:   predniSONE, 1 tab(s), Oral, Daily, X 5 day(s), # 5 tab(s), 0 Refill(s), 03/08/21 14:14:00 CST
12CMX10CM RED AREA ON RIGHT POST UPPER ARM. NO FEVER NO NUMBING OR TINGLING. TX WARM COMPRESS WITH MOTRIN
Headache, Myalgia, Arthralgia, Fever, fatigue, fever 102.8 with second dose....symptoms with both doses Narrative:   Other Relevant History:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with vaccination. The patient was vaccinated with, .65 ml ZOSTAVAX on 09-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced pink colored, raised area that is warm to touch. The raised area is as long as a palm of the hand, but not as wide. No treatment information was reported. The outcome of pink colored, raised area that is warm to touch was reported as not recovered/not resolved. The relatedness for pink colored, raised area that is warm to touch is unknown for ZOSTAVAX. No other information provided. Additional information is not expected.
Low fever of 99.0 on 3/25.  Took Tylenol and slept ten hours.  Symptoms cleared next four days and returned on Tuesday 3/2, with fever 99.1 and fatigue.  Symptoms continuing 3/3, 3/4, 3/5, and today 3/6.  Contacted physician and instructed to rest and hydrate.
Body aches, chills, fever, headache, sweats, dizzy, arm soreness, tender at injection site
Day 1 post: muscle pain in arm.  Day 2 post:Muscle pain in arm, unable to raise arm vertically.  Excessive  pain in upper part of arm. (injection given very close to the top of arm near joint). Also pain in shoulder & right side of neck.  Headache behind right eye.   Day 3 post: muscle pain in arm.  massive diarrhea in late PM.   Headache behind right eye all day, mild arm pain.
Breakthrough case admission after 3 vaccines Moderna 3/3/21 Lot# 030A21A;  Moderna 31/31/21 Lot# 006B21A;  Moderna 12/7/21 Lot# 005C21A
Headache, dizziness, and a skin rash that it has form of scales (white color) for more than 3 weeks and systemic. Patient has not seen a physician for this rash or visited Emergency Room.
Pain at injection site; flu like symptoms; body ache; headache; Dose number= 3; This is a spontaneous report received from a contactable Consumer or other non-HCP. The reporter is the patient.  A 48-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 10:30 (Lot number: EWW0196) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR. Vaccination history included: Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose Lot number= #EL3247, Previous dose administrator route: Intramuscular, Previous dose Dose number= 1, Previous dose vaccine location= left arm), administration date: 24Feb2021, when the patient was 48 years old, for COVID-19 Immunization; Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose Lot number= #EL3247, Previous dose administrator route: Intramuscular, Previous dose Dose number= 2, Previous dose vaccine location= left arm), administration date: 17Mar2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:30, outcome "unknown", described as "Dose number= 3"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Pain at injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "flu like symptoms"; PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "body ache"; HEADACHE (non-serious) with onset 19Nov2021, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of vaccination site pain, influenza like illness, pain, headache.  Additional information: No other vaccine administered in four weeks. No known allergies reported for the patient. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.   Follow-up attempts are completed. No further information is expected.
Patient received a vaccine on 10-Nov-2021 which had got expired on 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 10-Nov-2021 which had got expired on 09-Nov-2021) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 10-Nov-2021 which had got expired on 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 10-Nov-2021 which had got expired on 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that total of 168 doses were administered having Lot number as 048C21A.  The dates of administration were 10-Nov-2021 and 11-Nov-2021.  No information was reported on date of the storage of vaccine in refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information
(None-symptoms). DTaP administered instead of Tdap. Physician notified; health dept. contacted.
Arm was swollen March 17 after getting blood pressure taken March 16 in same arm.
Patient complaining of tightness in the throat 5 minutes after receiving the flu vaccine. No swelling of the tongue or face, no rash, no hives, no SOB, no nausea/vomiting, no chest pain. Patient received BENADRYL 50mg IM on the right deltoid and prednisone 60mg PO. Patient had no change in symptoms at any time after receiving medications. Patient placed on oxygen 2L, EMS contacted and transported to ER.
Painful rash 5" long by 2" wide. Took ibuprofen and benedryl as soon as discovered. Applied ice pack also.
6 days later the injection site started to itch and by day 8 the redness is the size of a baseball and is itchy
This spontaneous report was received from an office manager concerning an unspecified patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot number M020926, expiration date 11-AUG-2018 (dose and route were not reported) for prophylaxis. Temperature involved 47°F to 77°F for 4 hours. The temperature excursion reported was 32° F to 35° F for 41 minutes. A data logger was involved. No adverse event was reported. Additional information has been requested.
Increased pain at injection site; increase in temp, although temp was NOT taken; "ached all over" enough so that employee called in sick to work on 06/07/2012; Treated w/ Tylenol PRN.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female with no pertinent medical history, drug reactions or allergies who on 02-SEP-2011 was vaccinated intramuscularly with the first dose of GARDASIL (Lot#: 669313/0692AA, Exp.: 13-AUG-2013) 0.5mL and on 04-NOV-2011 was administered the second dose of GARDASIL (Lot# not reported). There was no concomitant medication. After receiving the first dose of GARDASIL, the patient completed a urine pregnancy test on unspecified date and found out she was 8 weeks pregnant. The patient's last menstrual period was 08-SEP-2011 (also reported 24-SEP-2011 by a nurse who was mother-in-law of the patient), and estimated delivery date was 14-Jun-2012. When received the second dose of GARDASIL, the patient informed the nurse who administered the vaccine that she was pregnant. The patient had not seen a physician yet. No adverse symptoms were reported. Follow up information has been received from a registered nurse who stated that she remember the patient, and stated "everything was fine, no complications, and the baby was without any congenital anomalies." The R.N. also stated she did not know if the patient completed the GARDASIL series and did not know where she received the first dose. No further information is available at this time. Additional information is not expected.
When I received the vaccine, about an hour or two later my arm started to ache badly. In the morning my arm was aching even worse and I felt like someone had punched me. It was difficult to lift my shoulder but not as bad where I couldn't move it. Throughout the day I started getting a headache, and I do frequently get headaches but this didn't feel like one I normally get, and it was deep in the back of my neck and behind my eyes and it made it very hard to see and focus because it was so painful. I tried taking about 500 mg of over-the-counter extra strength Tylenol and it didn't do too much for me. Working throughout the day was a struggle and the vaccine also made me fatigued during work the next day. The migraine didn't go away until the end of the week and either Friday or Saturday I started feeling normal and the pain had subsided. After that I didn't have any trouble.
On Nov 6th, I serve Virgo.  I had vomiting and loss of balance.  I had headaches and migraine.  I had severe hypotension.  I went to ER once and urgent care twice.  They did a PCP three time.  I am on PSMOA.  I had to decrease my work hours because of my symptoms.  Now I am prescribed a ton of medicine.  I am waiting on seeing an ENT doctor.
ES to inpatient Sx: GI - worsening epigastric pain, radiates around to back.  Tested positive for COVID upon admission.
This spontaneous report was received from a registered nurse regarding an unspecified patients of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored VAQTA, lot # L022259, expiration date- 06-APR-2017. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. Temperature/Time: 9.5C for 2 hours and 30 minutes. Data Logger: Yes, yes it was administered. There was a previous temperature excursion 1.5 C for 1 hour, 10.5C for 1 hour and 30 minutes. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
really bloody nose; chills; fever of 101; headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (really bloody nose), CHILLS (chills), PYREXIA (fever of 101) and HEADACHE (headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced EPISTAXIS (really bloody nose), CHILLS (chills), PYREXIA (fever of 101) and HEADACHE (headache). At the time of the report, EPISTAXIS (really bloody nose), CHILLS (chills), PYREXIA (fever of 101) and HEADACHE (headache) outcome was unknown.
Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Back pain.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Experienced a relief for the back pains after receiving the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included high blood pressure medications and injections in spine for back pain.  No treatment information was provided.  It was reported that after receiving both doses of the vaccine the patient was feeling better. Every 6 months, the patient was receiving injections in the spine in order to heal back pain and since received the vaccine the patient was feeling great.
This spontaneous report was received from a physician via a company representative concerning an 86 year old female patient with diabetes, hypertension, lumbar spondylosis, hyperlipidemia and chronic allergies. Patient's medical history included elevated c-reactive protein and elevated eosinophil levels. On 11-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant therapies included PRAVACHOL (20 milligrams), KLOR-CON 10 milligrams(mg), hydrochlorothiazide (dose unspecified), SOMA (350 mg), atenolol (50 mg) and amitriptyline hydrochloride (50 mg). On 31-MAR-2013, the patient experienced palpable purpura and vasculitis covering her body two weeks after receiving ZOSTAVAX. Her physician advised her to immediately go to the hospital. The patient was admitted to the hospital (name unspecified) on 31-MAR-2013 and was given medication to treat her condition (prednisone-dosage unspecified). The patient was discharged on 02-APR-2013. Approximately on an unknown date in April 2013, upon returning home the patient developed a urinary tract infection, and experienced profound weakness and anemia. The patient was readmitted to the unspecified hospital for these symptoms on 18-APR-2013. Upon discharge (exact date unspecified in 2013) the patient was sent to a rehabilitation center (unspecified) where she remained until two days before her death. The events were not resolved at the time of reporting. On 11-MAY-2013, the patient died due to sepsis. It was unknown if the autopsy was done. The physician noted that blood work that was taken from the patient directly preceding vaccination indicated that she had elevated C-reactive protein levels directly before she received the vaccine which may have been an indicator of the declining conditions of the patient. The relatedness for the events was unknown for ZOSTAVAX. The reporter considered the events to be life threatening. Additional information has been requested.
10 minutes after receiving ZOSTAVAX began to complain of redness & itching at injection site.  Requested follow-up by nurse
Pt received BOOSTRIX vaccine on 8/8/14 on 8/11/14 she reported redness and tenderness around site of injection. Pt ended up going to urgent care. She was told she had cellulitis and was given steroid injection and KEFLEX.
pt recvd vax;2 days later, exp HA which lasted for 2 days & a mild n;3-4 hrs later,devel two cancer sores in mouth which were painful;canker sores persisted at time of rpt ;
This spontaneous report was received from a nurse and refers to a 1 year-old White patient of unknown gender. There was no information about the patient's pertinent medical history, drug reactions or allergies provided. On 26-JUN-2017, the patient was vaccinated with improperly stored first dose of VARIVAX, one unspecified dose in the right thigh (lot # M047622 with the expiration date of 02-DEC-2018, route of administration was not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). No adverse effects were reported. The patient was concomitantly vaccinated with a dose of M-M-R II, and hepatitis a vaccine, inactivated (manufacturer: Merck Sharp & Dohme). The administered dose of vaccine experienced a temperature excursion between 9 and 25 Celsius degrees for 2 hours and 16 minutes. Digital data logger was involved. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information is not expected as the reporter had no further information to provide.; Sender's Comments: US-009507513-1706USA009938:
Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; Shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site.; This is a spontaneous report from a contactable Nurse (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscularly on 28Dec2020 14:30 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was hospital. Medical history included migraine from an unknown date. Concomitant medication included erenumab aooe (AIMOVIG), estradiol, diphenhydramine hydrochloride (BENADRYL), trazodone hydrochloride (TRAZODON). No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath, stridor, migraine for 5 days and 10 days later cellulitis at injection site on 28Dec2020 15:00. Patient received Antibiotics, steroids epi as treatment for the adverse events. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event migraine was recovered in Jan2021, other events was recovered on an unknown date. The events were reported as non-serious.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Vaccination site cellulitis, shortness  of breath, stridor and migraine,  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, and concomitant medications.  This case will be reassessed once additional information is available.  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.