chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired in between Dose 1 and 2. Non-vaccine related. Death Certificate indicates, COPD, Type 2 Diabetes & hypertension
4 days after 2nd Pfizer mRNA immunization, patient developed 6/10 retrosternal chest pain. He was given ibuprofen which resolved the pain
About 12 hours afterwards it feels like I caught the flu.  Cold sweats, hot flashes, can't sleep, and feel nauseous.
Intense itching/hives over most of my body.  Received predisone on 3/3, but did not help until late 3/4.
This spontaneous report as received from a pharmacist refers to a 66 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 19-JUL-2014, the patient was vaccinated with the first dose of PNEUMOVAX23 lot # H021941, expiration date 11-JUL-2011, 0.5 ml, intramuscular. No co-suspect and concomitant therapies were reported. The pharmacist stated that patient inadvertently received expired dose of PNEUMOVAX23 on 19-JUL-2014. No adverse effects reported. Patient did not seek medical attention. Additional information has been requested.
No additional adverse effects reported; 6 year old patient was inadverently administered Gardasil 9; This spontaneous report was received from a nurse via the office manager and refers to a 6-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-SEP-2020, the patient was inadvertently vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# S023476, expiration date was reported as 26-MAR-2020, but upon internal validation was established as 26-MAR-2022; exact dose, site and route of administration were not reported) for prophylaxis. No additional adverse effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S023476; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
muscle Aches, headache, general weakness and fatigue. Progresses over next few weeks,by 10/24 swelling in arms, legs feet, hands and neck, difficulty putting on socks and shoes, combing my hair, getting over the lip in the tub to take a shower.Use cane for use with walking and help with getting in and out of car, up from chairs. 11/10  Neck area limits movement of my head, cannot back car. 11/24 Bloodwork shows elevated sed rate - refer to neurologist 12/9  MRI of spine 12/14.Nerve conduction study and EMG 12/17 with neuromuscular doc. muscle biopsy 1/8/2010.  DX Myositis - pregnisone treatment. Ongoing weakness while we experiment with meds and doses.
Localized area of annular, raised erythema measuring 50 X 70 mm surrounding injection site. The area was pruritic. Patient treated with Cetirizine 10 mg initially, then 10 mg qhs for 72 hours.
Muscles on both iner thighs seized up . Made it difficult to stand or bend over.  Also both of my upper arm Muscles became sore. Knees and ankle started to swell hard to life my legs to put on cloths or shoes and can't sit cross-legged anymore.
Severe migraine with aura lasting approximately 2 hours. Symptoms were unilateral pain with unilateral tingling sensations on lips and hand, all on right side; in addition to visual disturbances (described as seeing spots, fuzzy vision), hearing disturbances (described as muffled hearing and static sensation in right ear), light-headedness, and difficulty concentrating.
Abdominal pain, joint pain, headaches, nausea, cannot sleep, visual disturbances, hot flashes, cognitive memory issues. All occurring after vaccine given. Been to many doctors.
CHILL; FATIGUE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chill, fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chill and fatigue was not reported. This report was non-serious.
My adverse event for Influenza A started on 11/20/2022 in the morning around 8:00AM. I had fever, runny nose, cough, body aches, and headaches. I went to the clinic on 11/21/2022 they tested me for COVID-19, RSV and Influenza A. I tested positive for Influenza A. They prescribed with TAMIFLU for 5 days.
Information has been received from a nurse concerning a teenage female patient who was vaccinated with a dose of Gardasil. Subsequently the patient fainted in the physician's office after receiving the vaccination. Subsequently, the patient recovered while in the office and was sent home. The patient did not require additional medical attention. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of death NOS in a 3-month-old male patient who received HIBERIX (batch number 73T35, expiry date 9th June 2019). The patient's past medical history included prematurity. On 17th May 2018, the patient received the 1st dose of HIBERIX (intramuscular) .5 ml. On 19th May 2018, 2 days after receiving HIBERIX, the patient experienced death NOS (serious criteria death and GSK medically significant). On 19th May 2018, the outcome of the death NOS was fatal. The reported cause of death was death. It was unknown if the reporter considered the death NOS to be related to HIBERIX. Additional details were provided as follows: The patient was born prematurely. The estimated delivery due date was 8th April 2018 and his birth weight was 1.440 kg. At 12:00 the patient received HIBERIX in the right thigh. There was no cause of death known. The patient was taken to the emergency room where he was pronounced dead.
booster; dysarthria; severe dysphagia; This is a spontaneous report received from a contactable reporter(s) (Other healthcare professional).  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Nov2021 11:30 (Batch/Lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Myasthenia gravis", start date: 2013 (unspecified if ongoing); "known_allergies:Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  The following information was reported: IMMUNISATION (non-serious) with onset 02Nov2021 11:30, outcome "unknown", described as "booster"; DYSARTHRIA (non-serious) with onset Nov2021, outcome "recovering", described as "dysarthria"; DYSPHAGIA (non-serious) with onset Nov2021, outcome "recovering", described as "severe dysphagia". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysarthria, dysphagia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My arm felt heavy late that night and sore all the next day. My arm was normal by Monday.; My arm felt heavy late that night and sore all the next day. My arm was normal by Monday.; my eye felt sore and the next day I noticed it was red; my eye felt sore and the next day I noticed it was red; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 10Apr2021 at 10:45 (Batch/Lot Number: EW0153) as dose 1, single (at the age of 58-year-old) for covid-19 immunisation. Medical history included cancer survivor since 2003. The patient's concomitant medications includes unspecified medications. Patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient experienced her arm felt heavy late that night and sore all the next day on 11Apr2021 at 20:00. It was also reported that the patient eye felt sore and the next day she noticed it was red on 11Apr2021 20:00. The patient did not receive treatment for the events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other unspecified medications within 2 weeks of vaccination. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of all the events was recovering.   No follow-up attempts are needed. No further information is expected.
10 days after receiving the vaccine in my left arm I was dx with Shingles on my left arm, hand and shoulder
elevated temp & rash on neck starting 19JUL92 temp went to 105.8 had sz; hospitalized over noc; mom states WBC WNL; d/c 20JUL92 had DTP/OPV/HIB/MMR/TB Tine 9JUL92; MD felt related to vax;
I (mother of patient) noticed a widespread rash on the back and trunk of patient. The spots are about 1/2" apart and 1/16th" in diameter. They are a light pink/red in color. I also noticed swollen lymph nodes on the left side of her neck.
Site: Pain at Injection Site-Medium, Additional Details: Patient came in today 7/19/21, reporting that they are still experiencing pain at the injection site, in which they received the last 2 vaccines. Gave advice to patient in terms of OTC options for pain relief, as well as making recommendation that patient seek medical care from MD if pain is persisting to identify if there are more permanent issues requiring treatment.
Patient presented to the pharmacy Sunday, May 26, 2013 at 10:30AM with a large (size of a half-dollar) red, raised circle around the injection site. The circle was also very warm to the touch.
I developed a ringing in my ear immediately following the shot, within an hour of receiving the booster shot. I've had a persistent ringing ever since!
This spontaneous report as received from a male consumer of unknown age reporting on himself. The patient's current conditions or medical history were not reported. On an unknown date, reported as on an unspecified date years ago, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot number and expiration date were not reported). On an unspecified date in November 2013, the patient developed shingles, the patient also reported he had developed a rash from the chest all the way around to his back. At the time of the report the patient was not recovered from the event. The patient was using CAPZASIN-P Creme (dosage, frequency, manufacturer unknown) to treat the rash but it was not helping him. Additional information is not expected.
Body aches; Chills; Headaches; 99.2 F; Feeling unwell/ felt unwell/ unwell; This is a spontaneous case, initially received from other healthcare professional (nurse) on 23-Aug-2018 (combined follow up 24-Aug-2018), concerning a 24-year-old adult male patient.  The patient's medical and medication history were not reported.  On 22-Aug-2018, the patient was administered with Afluria Quadrivalent (Influenza Vaccine, Dose: 0.5 ml, batch number: YF37005, expiry date: 17-May-2019, route of administration and anatomical location: not reported) for an unknown indication.  On the same day after vaccination at night, the patient felt unwell. On 23-Aug-2018 at 8 AM, the patient complained of body aches, chills and headache. The patient's temperature was 99.2F. The patient went home without working as he was still unwell.  The outcome of the events felt unwell, body aches, chills, headaches and increased body temperature was not recovered.  The reporter assessed this case as non-serious.; Reporter's Comments: A 24-year-old adult male patient felt unwell on the same day after vaccination with the suspect vaccine Afluria Quadrivalent. On the next day after vacccination, the patient complained of body aches, chills, headaches and body temperature of 99.2F. The causality assessed as related based on the plausible temporal relationship between the suspect vaccine and the events.
had 0 antibodies on a test after getting 2 vaccine; A spontaneous report was received from a consumer concerning a male patient who developed had 0 antibodies on a test after getting 2 vaccine/ drug ineffective.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.      The patient received their first of two planned doses of mrna-1273 (Batch number : 012L20A) on 12 Jan 2021. On 09 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mrna-1273 (Batch number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 12 Jan 2021, patient received first dose and on 09 Feb 2021, patient received second dose of vaccine.  On 11 Feb 2021, the patient reported having no antibodies on a test after getting 2 vaccine/ drug ineffective.   Treatment information was not provided.    The patient received both scheduled doses of mrna-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events had 0 antibodies on a test after getting 2 vaccine/ drug ineffective were not reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
This is a spontaneous report from a contactable consumer (patient herself). This 77-year-old female patient received PREVNAR 13, intramuscular, on 22Sep2015, at 0.5 ml, single. She took it as she was immunologically compromised. Medical history included splenectomy. No other products were taken together with pneumococcal vaccine. The patient experienced inflammation, fever, terrible itching sensation, redness and swelling, all on 22Sep2015. The patient mentioned that she received an injection of PREVNAR 13 in her doctor's office. She had a reaction that was showing up and affected her arm, it was inflamed from her shoulder to half way down to her upper arm mostly in area of 6 and half inches and it was feverish. She had terrible itching sensation, fever and redness. The patient mentioned that she first noticed the reactions like her arm inflamed and fever. The patient received CLARITIN 0.25 mg to ease her itching. She did not undergo any lab work. All events required office visit. Hospital admission was required for fever, itching, redness and swelling. Inflammation did not require hospitalization. All the events resolved on an unknown date. Follow-up (05Jan2016): New information from the same contactable consumer includes: medical history, vaccination date, updated events onset date, seriousness criteria and outcome. Follow-up attempts completed. No further information expected.
Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.  Pt received replacement dose on 7/21/2021
1st dose 24Oct2019, 2nd dose 27Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) (batch number 55R33, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th October 2019.).   On 27th January 2022, the patient received the 2nd dose of Shingrix. On 27th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received a late 2nd dose of Shingrix, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Patient received 2nd dose of SHINGRIX in morning of 6/20/18. Within first 24 hours, patient reported chills, soreness in arm, soreness in neck, and had trouble sleeping that night. The following day, patient said symptoms were better however felt sluggish, run down, but did sleep better the 2nd night. On 3rd day, patient reported feeling much better with improvement in symptoms. Patient was directed to apply ice at injection site and take pain reliever (i.e., acetaminophen).
Case previously recorded as MA2009-4215. Initial case report received from a Nurse via MedCom on 11 NOV 2009. Patient below 4-year-old was vaccinated with 0.25 mL of S-OIV FLUVIRIN (batch no. 102046P1) i.m. on 10 NOV 2009. MedCom reference no.: NA09-008010.
Client states approx 3 hours after receiving the vaccine she had palpitations, client states she notified her PMD and took MOTRIN.
Large red itchy patch on upper arm. That came On tenth day. Today is  twelfth day. Patch still there but half the size.
Severe severe headache. Nausea and diarrhea. Plus sore arm.
Information has been received from a registered nurse concerning a female patient who on 09-JUL-2009 was vaccinated with a second 1ml dose of RECOMBIVAX HB (lot#0438Y thimerosal-free) intramuscular. On 09-JUL-2009, the patient complained that the injection was painful. The patient had sought medical attention in the office. At the time of report, the patient's outcome was not reported.
Patient C/O muscle aches, body aches, flu like S/S, on 11/22/08. Redness, warmth, tenderness to touch at injection site 11/23. Muscle aches/body aches d/c on 11/24. Redness spread 11/26. Seen by health services 11/24 & 11/25. No fever, no N/V, no SOB/wheezing.
SIDE EFFECTS BEGAN 2 DAYS OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced side effects began 2 days out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects began 2 days out was not reported. This report was non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-APR-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, for routine adult health maintenance and the intended purpose for the long-term prevention of shingles and zoster-related illnesses. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. On an unknown date in 2013, the patient was treated at a hospital for an infection in the lungs caused by a varicella virus, which was diagnosed as (varicella) pneumonia. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The patient suffered from herpes zoster and zoster-related pneumonia, with painful and persistent physical injuries and damages, and other serious injuries as a direct and proximate result of being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result, the patient suffered severe and permanent personal injuries, including significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient suffered, is suffering, and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her physical conditions. (Varicella) pneumonia, ZOSTAVAX did not prevent shingles as intended, and persistent strain of herpes zoster/shingles were considered to be disabling. Upon internal review, (varicella) pneumonia was determined to be medically significant. Additional information has been requested.
No additional AEs; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 12 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-DEC-2021, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection,1 dose, lot # U024221, expiring on 04-OCT-2023, for prophylaxis (strength, route and site of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 39.55F for 10 hours (product storage error). The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved
Arm was hurting; Arm was hot; Developed a "freckle" that got bigger but now gone; Arm still has a little internal bump; A spontaneous report  was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was hurting at injection site, developed a freckle that got bigger but now gone, arm was hot at injection site, arm still has a little internal bump.  The patient's medical history was not provided. Concomitant medications reported were Thyroxin, High blood pressure medication for drug use for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot number: 030L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Arm was hurting at injection site, Developed a freckle that got bigger but now gone, Arm was hot at injection site, Arm still has a little internal bump.  Treatment details included Acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm was hurting at injection site, developed a freckle that got bigger but now gone, arm was hot at injection site, arm still has a little internal bump was unknown.
Mensural issues. Spotting, loss of large clots and heavy bleeding in between normal cycle.  At times it?s heavy enough to need tampons.
Local reaction on arm where vaccine was given, swelling and painful. Patient felt generally under the weather as well.