chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial reported received on 19/JAN/2006 from a health care provider.  A male patient (age unspecified) received on an unspecified date an injection of IPOL, lot number and route and site of administration not reported, an injection of Typhim Vi, lot number and route and site of administration not reported, an injection of YF-VAX lot number and route and site of administration not reported.  At an unspecified amount of time later, he developed severe vertigo which required an emergency room visit.  Other medications and pre-existing medical conditions were not provided.  Illness at the time of vaccination was none.  Per the reporter, "lab work was within normal limits". Additional information was not provided.  At the time of this report, the patient had not recovered.
Information had been received on 06-OCT-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 09-OCT-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-JAN-2017, patient was treated by a physician assistant at an urgent care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms which was diagnosed as severe herpes zoster or shingles. Patient has been prescribed valacyclovir for management of her painful condition. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Vertigo; Nausea; Room spinning when bending over or try to roll over in bed; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 27Feb2021 at 10:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypertension and intermediate to severe depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and levomilnacipran hydrochloride (FETZIMA); all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received ondansetron hydrochloride (ZOFRAN) and experienced drug allergy. On 01Mar2021 at 11:00, the patient experienced vertigo, nausea and room spinning when bending over or trying to roll over in bed. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with meclozine (MECLIZINE) 25 mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, nausea and room spinning when bending over or trying to roll over in bed were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
My arm is very swollen and hard (and hot) below the injection site. It is extremely painful.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: ELO140), in left arm, on 03Feb2021 as dose 2, single (Lot number: ELO/40), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Sep2022 as dose 5 (booster), single (Lot number: AS7144B), in left arm, on 25May2023 as dose 6 (booster), single (Lot number: AS7180B), in left arm and on 19Sep2023 at 11:00 as dose 7 (booster), single (Lot number: 3030342), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: shrimp" (unspecified if ongoing); "Known allergies: capers" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was administered with Paxlovid from 25Sep2023 to 30Sep2023.  Product Quality Group provided investigational results on 09Oct2023 for a complaint of a BNT162b2 number FK9895. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FK9895. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (Site withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Loss of taste and smell that began at 2:30am and is beginning to come back but is not resolved.
This case was reported by a consumer via call center representative and described the occurrence of chest burning in a adult male patient who received SHINGRIX for prophylaxis. On 14th August 2018 11:00, the patient received SHINGRIX. On 15th August 2018, 1 days after receiving SHINGRIX, the patient experienced chest burning. On an unknown date, the outcome of the chest burning was recovered/resolved. It was unknown if the reporter considered the chest burning to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife The age at vaccination was not reported. The patient felt burning in his chest the night before last and last night from the date of reporting and it had resolved. No additional details were provided. This case has been linked with US2018149804, reported by same reporter for herself.
Patient was administered vaccine in her left arm per protocol. We did ask that she stay in the post vaccine observation area which she did. Approximately 5 minutes later she did express that she felt her tongue was swelling. She did not have any other symptoms. She was administered 20ml of diphenhydramine 12.5mg/5ml solution. After around 30 minutes her and her husband felt that she was okay to leave and did. Her PCP was notified and we will be following up with her.
330PM vax givn-stopped crying 1/2 hrs then cried non-stop 530-1030PM-rt knee hip swollen unable to get diaper closed rt leg; used ice cold compress; t100.3; called MD dx pertussis reaction; swelling rt thigh reduced p/3rd
Rash on arm within 30  minutes. Spread to patients back and opposite arm within 1 hour. Dizziness and nausea experienced next day.
DONOR REPORTS WAKING UP THIS AFTERNOON WITH  RIGHT EYE SWOLLEN, BLURRED VISION, AND REDNESS.  ADVISED TO GO TO EMERGENCY DEPARTMENT. SEVERAL FOLLOW UP CALLS HAVE BEEN MADE WITH NO ANSWER.
Immunology test abnormal. This case was reported by a nurse and described the occurrence of antigenemia in a 77-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included dialysis and end stage renal disease.  Medical history included polycythemia vera. The subject was reported to be on "lots" of medications. On 17 June 2006, the subject tested negative for hepatitis B.  On 14 July 2006 at 09:20 am, the subject received the 3rd dose of Engerix-B (40 mcg, left deltoid). On 17 July 2006, three days after vaccination with Engerix-B, the subject experienced antigenemia.  At the time of reporting, the outcome of the event was was unspecified.  Per facility protocol, the subject was to be placed in isolation.  Follow-up information was received on 11 August 2006. Follow-up indicated that the subject did require isolation and that the subject was tested for Hbs antibody, HBcIgM, HBeAg and HBCIgG on 21 July 2006 and all were negative (less than 10). The subject was treated for HbSAG on 04 August 2006 and this test was also negative.  Concurrent medications included Zemplar, Protonix, Nephro cap, Phoslo and Ferrous Sulfate.  The outcome of the event was not provided.
Patient states she had pain at injection site which radiated the length of her arm and into shoulder and chest.  She also stated she was having difficulty breathing.  Pt was recommended to contact provider and seek immediate medication attention.
Patient received vaccine 1 day after its beyond use date.  Moderna was contacted and stated that the vaccine "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration."
Patient stated noon on 9/19/18 with regards to site appearance. She said she had black/blue bruising and swelling of whole left upper arm, redness and hotness and achy arm. No allergic symptoms reported. She said it looked way worse then she felt.
I started having heart palpitations the day after the vaccine and it was almost constant the first three days and then gradually slowed and stopped after the 6th day.  We were in the middle of a huge snow/ice storm so the doctors office was closed all week and didn't open up until the following Monday due to no electricity. Did go to the doctor after on that Monday to have EKG, but didn't show anything by that time. Was in contact with my doctor via email.
Case number PHEH2016US026202, is an initial spontaneous report received from pharmacist on 07 Oct 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1615401) at dose of 0.5 ml intramuscularly on 06 Oct 2016. The pharmacist stated that, after administration of FLUVIRIN dose, part of vaccine came back out of injection site. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious. Follow up information was received from a physician on 04 Jan 2017. Batch number and reporter comment updated.
Vaccine was administered during the mass drive through event.  During the 15 minute waiting period the patient developed itching and hives.  She was given 50mg oral Benadryl and 80mg IM Depo Medrol.  She did not develop wheezing, angioedema, or any other symptoms.  She was monitored at the event for over an hour following resolution of symptoms. She was released to home with instructions to continue benadryl and to seek emergency assistance if any other symptoms developed.
Mom states pts legs became red on the morning of 09.23.10. Right leg had redness about 2 1/2 x 1" with no swelling. Left leg had redness about 2" x 2" with no swelling. Pt did complain of tenderness to touch. Areas were warm to touch. Pt given BENADRYL.
My COVID-19 symptoms started on 02/25/2023 in the afternoon. I had extreme exhaustion, and sore throat at night. The next morning I had extreme sore throat, headaches and exhaustion. I did a COVID-19 test one on 02/25/2023 which was negative and another one on 02/26/2023 which was positive. On Sunday in the morning I called my doctor's office and the nurse who prescribed me with PAXLOVID for 5 days. They also advised me to take over the counter MUCINEX as per needed. On 03/02/2023 I tested positive back again after finishing the PAXLOVID. I was feeling fine but on 03/06/2023 I had a rebound case of COVID-19. I had head slight sore throat, head congestion and some mucus from post nasal drip. I took again MUCINEX along with other medications such as NYQUIL. I took a test yesterday 03/15/2023 with a COVID-19 home test which was negative. I still have lingering symptoms such as head congestions, slight fatigue and slight mucus.
PATIENT WAS GIVEN PEDIATRIC DOSE IN ERROR. PT JUST TURNED 12 AND WAS ACCIDENTLY GIVEN THE PEDIATRIC DOSE.
feels yucky and bad; 186 lbs. currently; lack of energy; severe body aches; feels fatigued; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (feels yucky and bad), WEIGHT DECREASED (186 lbs. currently), ASTHENIA (lack of energy), MYALGIA (severe body aches) and FATIGUE (feels fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Cholesterol high. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DISCOMFORT (feels yucky and bad), WEIGHT DECREASED (186 lbs. currently), ASTHENIA (lack of energy), MYALGIA (severe body aches) and FATIGUE (feels fatigued). At the time of the report, DISCOMFORT (feels yucky and bad), ASTHENIA (lack of energy), MYALGIA (severe body aches) and FATIGUE (feels fatigued) had not resolved and WEIGHT DECREASED (186 lbs. currently) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
First,  my right arm was sore for four days. That was okay. Second, I have been experiencing constant discomfort on my right arm where the vaccine was injected.  Third, I  have been experiencing numbness all over my right side when I lay on it.  I need guidance before taking the second dose. Please help!
He had a stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (He had a stroke) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had some of the issues in regards to medical conditions.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (He had a stroke) (seriousness criteria death and medically significant). The patient died on 16-Apr-2021. The reported cause of death was he had a stroke. It is unknown if an autopsy was performed.            Concomitant drugs reported included unknown blood thinner.  Patient died, reporter wants to say 16-Apr-2021 and he had a stroke. Reporter knows her male friend had Moderna. Reporter did not have any further information to provide.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment.  This fatal spontaneous case concerns an elderly male patient, with no specific medical history reported, with blood thinner as concomitant medication, who received a dose of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of cerebrovascular accident. Vaccination date was not reported; hence latency and temporal association between vaccination and death date, cannot be properly assessed. The reporter mentioned the patient had a stroke and died. No further information regarding the event, the onset date, and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Patient´s age and concomitant use of blood thinner remains as risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This fatal spontaneous case concerns an elderly male patient, with no specific medical history reported, with blood thinner as concomitant medication, who received a dose of mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected AESI of cerebrovascular accident. Vaccination date was not reported; hence latency and temporal association between vaccination and death date, cannot be properly assessed. The reporter mentioned the patient had a stroke and died. No further information regarding the event, the onset date, and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. Patient´s age and concomitant use of blood thinner remains as risk factors for the event. The benefit risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: He had a stroke
Bexsero expired and was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comment: The reporter reported that the patient was administered Bexsero vaccine which was expired on 31st July 2022. The reporter consented to follow up.  Additional supportive information: The patient received a Bexsero vaccine which was already expired, which led to expired vaccine used.
On September 27th I had right chest pain and shoulder blade pain, I went to an after hour's clinic then sent for an MRI which showed that I had a pulmonary embolism in my lung and was then sent to Emergency Room and admitted for the PE treated with heparin and discharged on Eliquis and currently still taking Eliquis.
78 Y male with hypertension, gilbert syndrome, prediabetes, diverticulosis of colon, gout, vaccinated w 2 doses of PFIZER for COVID-19 (2/5/21 & 2/26/21) who developed cough, fever, bodyaches ~ 9/14.  COVID-19 positive on 9/15 came back positive, yesterday O2 sat was 89% on room air with activity so came to ED   COVID Pneumonia, Acute hypoxemic Respiratory failure - symptom onset on 9/14. COVID positive on 9/15. Last fever on 9/25. CXR showed bilateral opacities.Treated with decadron 6mg x 3 days. He was not a candidate for remdesivir due to elevated transaminases. Supplemental O2 at 2 lpm was successfully weaned to room air and he was discharged to home.   Elevated LFT's - abdominal US was unremarkable. Likely due to acute covid disease. Can repeat once acute illness resolves.    Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  covid pneumonia
flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL taken for blood pressure measurement (ongoing); FUROSEMIDE (ongoing); AMLODIPINE (ongoing); LOSARTAN (ongoing); CLONIDINE (ongoing); HYDRALAZINE (ongoing). The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sever headache and nausea. Bruising around lower stomach. Trouble keeping food down.
Feverish (no fever) with hot and cold spells, headache (the kind that makes eyeballs hurt), whole body aches
after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (after the expiration date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milligram. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (after the expiration date). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (after the expiration date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided. Concomitant medication was not provided.  5 doses of the Moderna covid-19 vaccine were administered by intramuscular injection. None of these patients have reported any known symptoms following vaccination.
Fever, severe body ache, chills. Did not go to the doctor. Symptoms lasted 2 days.
Localized swelling, firmness and redness with itching, 12 x 14 cm.
SYMPTOMS OF THYROIDITIS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had thyroid problems before and had not history of autoimmune disorders. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. he batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced symptoms of thyroiditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms of thyroiditis was not reported. This report was non-serious.
developed fever chills and headache on 2/10, missed work on 2/11. TM states her fever and chill resolved on 2/11, headache is still on going but goes away with Tylenol. TM was previously positive so not set up for testing. TM reports her arm was red and hot at the infection site, still hot on 2/12, TM reports it is ?rock solid?, declined being seen for arm and attributes it to her sensitive skin, return to work on 2/12, cleared to continue working. no further care
Information has been received from a nurse practitioner concerning his 18 year old female step daughter who in 2007 was vaccinated with the third dose of Gardasil. Concomitant medication was not reported. Nurse practitioner reported that the patient completed the series and did not experience a reaction with dose one or two. In 2007 within 24 hours of receiving the third vaccination of Gardasil, the patient experienced nausea and vomiting. The patient sought unspecified medical attention. Subsequently on an unspecified date, the patient recovered from nausea and vomiting. Additional information has been requested.