chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had left lower extremity pain x 4 days with left lower extremity swelling x 2 days. Patient diagnosed with an extensive deep vein thrombosis in left lower extremity.
Got COVID in 5 months last year; Got COVID in 5 months last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tachycardia" (ongoing), notes: irregular heart break; "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Got COVID in 5 months last year". The patient underwent the following laboratory tests and procedures: Body temperature: 130.7, notes: I had 130.7 fever and it went from 103.7 to 104 for about 5 days; 103.7, notes: I had 130.7 fever and it went from 103.7 to 104 for about 5 days; 104, notes: I had 130.7 fever and it went from 103.7 to 104 for about 5 days; SARS-CoV-2 test: very much light, notes: strep throat but it was very much light. Clinical course: Reporter also wanted to add under issue when she had the COVID for the first of time she had two very large abscess white abscess in her throat she also had Pharyngitis with it and she had Laryngitis with it and she had 130.7 fever and it went from 103.7 to 104 for about 5 days and within she had the strep test done because may be she had the strep test in urgent care, strep throat but it was very much light Diphtheria look very much like Diphtheria and they did not know what it was but she did not want to be admitted to the hospital because they will keep on ventilator and die like her uncle (further not clarified) had so but yeah but she was very sick she had laryngitis pharyngitis those big passed balls in back of her throat and she could not hardly swallow. yeah she was pretty much miserable and then the heart problem so she had two, so the second time it wasn't newly as bad like a bad cold but yeah even though she had two Pfizer vaccine and the booster did nothing for her.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300223692 same patient, different doses and events;
Client spouse called for booster dose appointment as client sight impaired, provided vaccine card showing primary series complete and monovalent dose, pre-visit screening did not note that client received the bivalent dose in 9/2022. Client was given a second bivalent dose on 12/20/2022 when a second vaccine card noted this as writer was documenting dose provided after administering the dose. Client received prior to the dose, screening completed prior to the dose and 15 minute wait completed after the injection.  Client was stable throughout with no untoward effects noted.  Client was notified that a second booster bivalent dose had been received.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient called to report dizziness in middle of night. When she got up to use the bathroom at about 2am, patient fainted/passed out while sitting on the toilet. She hit her head when she fell. Called pharmacy 11/16 and we told patient to report to emergency room, patient refused and said she will take a tylenol instead. We then told patient to contact PCP to get checked out.
This spontaneous report was received from a medical assistant, referring to an unspecified number of patient, of unknown ages and genders. No medical history or concurrent conditions were reported. Since 02-NOV-2015, an unspecified number of improperly stored doses of ROTATEQ (Lot # reported as L00568, expiry date on 10-JUL-2016) were inadvertently administered to an unspecified number of patients. No adverse events were reported. This is one of 4 reports received from the same source. Additional information has been requested.
Headache Narrative: HEADACHE FOR TWO DAYS, INJETION SITE SORENESS.
Bell's Palsy; Arm sorness; This is a spontaneous report from a contactable consumer (wife) from a Pfizer Sponsored Program. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 51-year-old, administered in Arm Right on 01Mar2021 13:00 as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced arm soreness in Mar2021 (after vaccination). The patient experienced bell's palsy/experienced no mobility in the left side of the face and was diagnosed with bells palsy on 08Mar2021. The patient went to the ER in response to bell's palsy. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Marked swelling of left arm with pain and redness at site of vaccine immunization on left deltoid.
fatigue; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN5318, Expiration Date: 31May2021) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Administration time: 08:15, Lot Number: EN5318, Expiry date: 31May2021, Anatomical Location: Right arm), administration date: 26Jan2021, when the patient was 54 years old, for Covid-19 immunisation, reaction(s): "Soreness in arm", "inability to lift arm above head ", "chills", "fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Feb2021 14:00, outcome "unknown", described as "sore arm"; FATIGUE (non-serious) with onset 17Feb2021 18:00, outcome "unknown", described as "fatigue".  No follow-up attempts are possible. No further information is expected.
Physician requested a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received two doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the circumstance or information capable of leading to medication error was unknown.   Additional Information: GSK receipt date:21-Nov-2022 Reporter's comment: Administration dates of two doses were not available, pharmacist could only saw dose one was shipped in September 2020 and dose two was shipped in January 2021. No further information provided on call but pharmacist consented to follow up from safety via email. The reporter consented to follow-up. Additional supportive information: A physician had requested a third dose of Shingrix be given to a patient, which led to circumstance or information capable of leading to medication error.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age. It was reported that GARDASIL (lot number not provided) and PNEUMOVAX 23 (lot number not provided) might have been administered after experiencing 3 exposures to 29.5F for a cumulative total time of 62 hours.  Number of patients unspecified. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Nurse told to only get one Shingrix; Pain; Itchy; Shingles in groin area; Increased heart rate; Dizziness; Weakness; Headache; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax vaccine in 2013).   On 17th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th October 2022, 49 days after receiving Shingrix, the patient experienced shingles, heart rate increased, dizziness, weakness and headache. On 5th December 2022, the patient experienced pain and pruritus. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the shingles, dizziness, weakness, headache, pain and pruritus were not recovered/not resolved and the outcome of the heart rate increased was recovered/resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the shingles, heart rate increased, dizziness, weakness, headache, pain and pruritus to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR186542   Additional Information: GSK Receipt Date: 12 DEC 2022 Reporter's comment: The reporter was the patient. The patient stated that received Shingrix vaccine on in the right arm. The heart rate was resolved but the dizziness, weakness, and headache had not. One week after receiving the Shingrix vaccine the patient had a case of shingles in her groin area, that has now resolved.  The patient reported that had no medication. The nurse told her she would only have to get one Shingrix vaccine now since she had a Zostavax vaccine back in 2013. Reporter consented to follow up. The reporter gave permission for GlaxoSmithKline to contact her HCP. Additional supportive information: On 12-May-2022, she had a second case of shingles on her buttocks that was itchy and painful. It has not resolved, however no separate case needs to created as both the events were merged in one case. The case US2022185879 was identified as duplicate of case US2022AMR186542. The case US2022AMR186542 was deleted and all future correspondence will be added in the present case US2022185879 which stands as case of record.; Sender's Comments:  US-GSK-US2022AMR186542:Same reporter
arm pain- lasted several days; muscle aches- lasted approximately 12 hours; chills- lasted approximately 12 hours; fatigue- lasted approximately 12 hours; fever (101)- lasted approximately 12 hours
no adverse event; Caller reported vaccines administered after temperature excursion.; Caller also reported vaccines were administered IM.; This spontaneous report was received from a medical assistant and refers to the patient of unknown age and gender. There was no information about patient's concurrent conditions, concomitant therapies, or medical history provided.  On 28-NOV-2022, the patient was vaccinated with dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 ml, lot #U029619, and expiration date: 22-SEP-2023, albumin status has been verified as recombinant human albumin (rHA) (anatomical location was not provided); and dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, lot #W005206, and expiration date: 14-FEB-2024 (anatomical location was not provided); both intramuscularly for prophylaxis (incorrect route of product administration). Administered doses of vaccines have been stored in the temperature of 58.5F for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and 24.3F for varicella virus vaccine live (oka/merck) (VARIVAX) for 3 hours (product storage error). There was no previous temperature excursion reported.
pt returned to office w/hives;no resp distress;no wheezing;vital signs stable;
Patient reported that following the shot she had pain in her shoulder which started immediately and got more intense.  (Reported no redness/tenderness/swelling).  Went to doctor, who referred her to the orthopedist.  This week, patient heard from the orthopedist said that there was a "definite bursitis inflammation attack".  Received a cortisone shot.
This spontaneous report as received from a nurse practitioner refers to a 48 year old female patient. On an unknown dates the patient was vaccinated with 2 doses of VARIVAX (Merck) (lot#, expiration date, dose, route and indication not reported) in the past. A recent titer showed the patient was with no immunity to varicella in 2013. The outcome of the event was reported as not recovered. It was not reported if the patient had sought medical attention. Additional information has been requested.
Received PREVNAR-13 and FLUZONE HD on 9/16/16 in separate arms. Stated she had a low grade fever, stomach ache, headache for 2 days afterwards, then on 4th day after her injection site where PREVNAR-13 was given because red/swollen/warm. Went to MD  and diagnosed with cellulitis. Given KEFLEX 500mg twice daily.
Treatment of COVID-19; Treatment of 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 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: gh9694) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Reglan, reaction(s): "known allergies: Reglan", notes: known allergies: Reglan. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Tested negative 8 days after start of treatment; (Mar2023) Positive, notes: Tested positive 11 days after start of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received antiviral treatment (paxlovid) from 04Mar2023 to 08Mar2023. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
Developed rash on contralateral arms @ 20 minutes then spread to rest of body. Then developed SOB/facial swelling. Received Epi pen x1 with some response, and brought to ED. VS remained stable 150-160/100-110. Exam notable for diaphoresis, RRR, CTAB no wheezes.
I was bedridden for a few days a week after the vaccine. I was disoriented and stumbling over things and felt dehydrated. I went to the hospital Wednesday night where they diagnosed me w/sepsis and walking pneumonia. I was placed on very strong antibiotics. I spent 2 days in the hospital. Continued taking antibiotics for two weeks afterward and eventually everything cleared up. Also, my t-cells dropped down making it harder for me to fight off the infection.
The vaccine was administered 7 days too early.  Patient was notified of administration error at the time of the incident.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 24-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #,  frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis. The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The vaccine program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
transient episode of dizziness minutes after COVID vaccine administration last less than 2 min spontaneously resolved without any medical intervention
THROWING UP BLOOD, DIZZINESS, DIFFICULTY EATING, FEVER >105 F, FATIGUE, DIFFICULTY BREATHING
1hr p/vax pt exp fever, weakness, & nausea; sx persisted for 3-4 days w/complete resolution in 1 wk; sx returned 2 wks later; Seen by MD;
The healthy patient (3 months prior to vaccine had complete check up with no heart issues), was rushed to ER with A-Fib (Atrial fibrillation) with RVR condition. After being on medication 2 months later, the patient experienced another  A-Fib and was rushed to Medical Center and hospitalized for 10 days.
Client felt nauseated, dizzy and lightheaded after vaccination at the table vaccination site. MD on site was called who evaluated client. She was given water and crackers and was monitored for 30 minutes. Was stable then drove home.
Headache, Rash,  H/A kasted 7 days, Rash at inj site occured day 5 after injectin lasted 7 days. Narrative:   Other Relevant History:
I experienced a fever from 99.9 to 102.2 from the morning of November 8 through the morning of November 9. I also experienced delirium (hallucinations, inability to focus, inability to distinguish waking from dreaming). Once my fever hit 102.2, I took two Tylenol Extra Strength. The symptoms resolved by 4:00 a.m. the next morning.
Night sweats, headache, fatigue.  Fast and elevated heart rate beginning on 3/9/2021 and continuing on 3/10/2021.
10 hrs after the event started to have severe abdominal pain.  Couldn't even get out of bed . Intense pain lasted about a hour.  Was not totally gone for at least 3 weeks . Reported to doctor but they were not concerned.    The next side effect was pain in my upper right thigh for about a hour.  The pain lessened but my legs felt heavy and weak for at least a week . Very fatigued in the legs for 3 weeks .   The next side effect was chills and shaking for about a hour . I'm very afraid to get any kind of boster shot or a second shot of any type
Red, burning, itching rash over most of body- injection at ER. Plus tablets 6 days methylprednisolone 4 mg; Hydroxyzine 25 mg fever for 7 days; rash for 12 days. followed by: swelling in joints and pain in joints 14 days.  - Relief with Ibuprofen 600 mg x 3
PATIENT RECEIVED 0.25ML DOSE; This spontaneous report received from a pharmacist . The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 0.25 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced subject received 0.25ml dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient received 0.25ml dose was not reported. This report was non-serious.  Additional information was received from the patient on 31-Mar-2021. The following information was updated and incorporated into case narrative: This report was associated with product quality complaint: 90000174361. The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria, based on the PQC evaluation/investigation performed.
Initial and follow-up information has been received for the Pregnancy Registry for GARDASIL from a 25 year old female consumer who on 28-MAR-2008 was vaccinated with her third dose of GARDASIL (lot# not reported).  Concomitant therapy included prenatal vitamins (unspecified) once daily.  On 06-APR-2008 the patient found out she was 4 weeks pregnant.  The patient had a positive home pregnancy test.  Subsequently the patient experienced no adverse events and sought unspecified medical attention.  The patient's estimated conception date was approximately 19-MAR-2008, her last menstrual period was 06-MAR-2008 and her estimated delivery date was 10-DEC-2008.  On 05-MAY-2008 an ultrasound was performed for viability, the results showed no defectable fetal parts or cardiac activity within the sac.  On 20-MAY-2008 an ultrasound was performed and showed no fetal pole or yolk sac, which suggested a blighted ovum.  The patient did not provide any information on the first and second dose.  At the time of the report, the outcome of the patient was unknown.  Upon internal review the blighted ovum was considered to be an other important medical event.  Additional information has been requested.
Patient had first regular  menstrual  cycle 9/20/21 then received 2nd covid vaccine and 10/06 the day after the shot in the middle night she stated heavy clotting , dizziness, fatigue, shaky , felt out of body she went to work and almost past out in bathroom , she has had this   for two weeks now, hasn't been able to work. Patient came to us her primary  10/13/21 we drew labs put her on iron pill then next day she had GYN appointment where that was normal, patient still recovering from shot, she is tired and fatigue