chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (lot # reported as N019282), expiration date 09-JAN-2019 and VARIVAX (lot # N021581), expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored Merck sterile diluent. Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 26-JAN-2018, the patient was vaccinated with improperly stored dose of PROQUAD (lot # N019828 (previously reported as N019282)), therapy type: recombinant human albumin (rHA), expiration date on 09-JAN-2019 and VARIVAX. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1806USA007938; US-009507513-1806USA007939; US-009507513-1806USA007940; US-009507513-1806USA007936; US-009507513-1801USA006139.
Fever: baseline 97.5 at time of injection (1630), up to 99.9 at 2300. max temp of 102.0 at 0130 that night with severe headache, chills, and body ache. Took 500mg acetaminophen at 0130, fever down to 100.5 at 0600. Took another 500mg at that time. Fever finally down to 99.9 at 0800 and headache resolving. Felt body aches and mild headache rest of the day, Sunday. Rested well Sunday night and all symptoms seemed resolved by then.
HA & aching all over 4-12-12. Two days later 4-14-12 local rash with blisters on site injection with erythema, hive, 7-8 scattered varicella-like blisters scalp, face, arm, tummy, back at 10-12 days post injection.
shingles since Halloween of 2021; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles since Halloween of 2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HERPES ZOSTER (shingles since Halloween of 2021). At the time of the report, HERPES ZOSTER (shingles since Halloween of 2021) had not resolved.            Patient had 1st and 2nd Moderna dose "earlier in year of 2021" No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
pt had immediate chills and rigors after the shot Started with hives the day after.  These have been progressive Face started to swell , went to ER twice Started on benedryl, pepcid and prednisone
loss of appetite; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support from a contactable other hcp.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 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 loss of appite 24 hours on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: Patient's arm was sore. SHe has limited mobility but I dont think she was not really trying. She had a rash that appeared on her wrist later in the evening on the day of the shot. They were asking me if it was from a bite. I could not tell, could have been either or. I gave her allegra because she did not want benadryl. I told her she should get better everyday, if gets worse to let us know and her doctor. She did not have difficulty breathing or any other issue.
throat was on fire; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat was on fire) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (throat was on fire). At the time of the report, THROAT IRRITATION (throat was on fire) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient has a weak immune system, he has a mutated gene on the 5th chromosome. No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-329527, MOD-2021-329394 (Patient Link).
This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 28 degrees Fahrenheit (-2.222222222 degrees Celsius) and another lasting for 32 hours, with the lowest recorded temperature of 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Got phone call from patient on 8/15; she got first shingrix shot on 8/13, said it hurt at the time; on 8/14, arm was "fine" per patient, though she didn't sleep on it, since it was a bit tender; by 8/15, she said arm was slightly swollen, and redness in area just below injection site. Reaction appears local, patient didn't report any flu-like symptoms. We told her that it's somewhat common, that it should go down in next day or so, but if by tomorrow night it's gotten worse, to seek medical attention (ideally her PCP, but Urgent Care if necessary.
vertigo and could not get out of bed; Initial information received on 10-Sep-2020 regarding an unsolicited valid serious case from a consumer or non-healthcare professional (patient's wife) .  This case involves an 83-years-old male patient who experienced vertigo and could not get out of bed (vertigo), while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  The patient had vertigo after receiving FLUZONE HIGH-DOSE QUADRIVALENT 5 years ago.  On an unknown date, four years ago, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious vertigo and could not get out of bed (vertigo) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient eventually went to the hospital and was better as the year went on.  Laboratory details were not reported.   Additional Description of event: the patient had a bad reaction to the Fluzone High Dose 4 years ago and 5 years ago then skipped it for 2 years. The patient had a prescription for vertigo last year after he was in the hospital but it has lapsed this year. The patient was tested by 3 neurologist and they said his vertigo was part of the migraine family, however it was reported that the but he does not get headaches. Neurologist prescribed him an allergy pill.  Caller did not have the lot number for either flu shot her husband had taken.  Outcome of the event was unknown at the time of report.  Batch number requested..; Sender's Comments: A 83-years-old male patient who presented vertigo unknown latency following the vaccination with FLUZONE HIGH-DOSE QUADRIVALENT. Time to onset is not clearly defined. Medical history, concomitant medication and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information and considering the advanced age of the patient, role the vaccine cannot be assessed.
Upon injection I experienced immediate pain throughout the entire vaccine, which I did not experience with the first dose. I had inflammation around the deltoid muscle and the following day I had pain and soreness that traveled up my trapezius muscle into my neck with some slight neck stiffness and a large lump over my collar bone on that side at the base of my neck. The lump is quite painful to even gentle touch. I also have pain at the site with movement of my left arm, which was the injection site.
Narrative: maculo popular rash on anterior chest and posterior chest and bilateral upper extremity and left arm with wheal with expanding border
Morning after vaccine experienced Fever, Chills, body aches, headache, nausea, and fatigue...took Tylenol and resting, drinking lots of liquids
I felt large sides lumps in my left breast. It did go away. I went to get my breast exam.  About 2 months later, I developed lumps all over both breast. I went to get a mammogram, showed significant fibro sinbirocostic disease. My periods are shorter and are coming 3 to 5 days earlier.
Case number PHEH2016US025901, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (lot number: 1618521) at a dose of 1 ml (accidental overdose) intramuscularly on 03 Oct 2016. Nurse reported that 9 patients received 1.0mL of FLUVIRIN rather than 0.5mL. No adverse event was reported following this medication error (accidental overdose).
This case was reported by a pharmacist and described the occurrence of numbness at the injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced numbness at the injection site and injection site tingling. At the time of reporting the outcome of the events were unspecified. The pharmacist reported during a FLUARIX administration, there were two complaints of numbness and tingling at the injection site. For the other case please see A0999336A.
Rash with similar characteristics to Varicella within 2 days of vaccination.  Fever to 101 only.
MCV4 vaccine was administered on 10/16/13 by medical assistant. Pt came on 10/17/13 with redness, swelling that started after vaccine was given. No fever. On exam right arm erythema, swelling, warmth, tenderness 2 cm below injection site. Given KEFLEX. Pt seen for f/u on 10/21/13 and cellulitis resolved.
Pain in shoulder to hand, started in muscle then achy joints, weakness in strength in that wrist.
This spontaneous report was received from a registered nurse, referring to an unknown number of unspecified patients. The patients' medical history, concurrent conditions, drug and allergy history were not provided. It was reported that since 12-MAY-2017, the patients had been vaccinated with improperly stored doses of VARIVAX (dose, frequency and administration route were not reported) for prophylaxis. The lot numbers and expiration date of the administered vaccines were respectively: M033906; 20-MAR-2018, M045204; 11-NOV-2018, M038225; 07-SEP-2018. On an unspecified date in 2017, the vaccines were exposure to a temperature excursion; the data logger registered a temperature range between 6° Fahrenheit (F) and 14°F during a time frame of 18 minutes. The previous temperature excursion registered was 15°F to 46°F for 21 minutes. The registered nurse mentioned that a properly stored sterile water diluent (manufacturer unknown) (lot number and expiration date were not provided) was used to reconstitute the doses of VARIVAX. No adverse effects were reported. The reporter stated that the vaccines would be supported until labeled expiry. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1707USA001006.
11 a.m. flu vaccination 7:00 pm 3/4" wide & 4" long macule on medial aspect of arm, pruritic & warm to the touch
Redness, swelling, warmth, tenderness locally around vaccine site of Hepatitis A vaccination, about 5 cm in diameter, noted within 48 hours after vaccination. Pain, fussiness, no fever.
Pt developed fever, chills, fatigue and body aches, starting shortly after vaccination. Symptoms resulted in Urgent care visits on 11/20, 11/23, 11/26, then ER visit 11/29, office visits 11/30, 12/2, 12/6. The patient developed aphasia Hospitalized at Hospital with multiple embolic strokes throughout cerebrum and cerebellum. No source of emboli found.
Information has been received from a registered nurse concerning a female patient with no known drug allergies and no pertinent medical history, who on 30-MAY-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) 0.5 mL. On 31-JUL-2007, she received the second dose of GARDASIL vaccine (yeast) 0.5 mL. On 01-DEC-2007, she received the third dose of GARDASIL vaccine (yeast) 0.5 mL. The nurse reported that the patient developed numbness on her right arm and right leg after receiving the vaccinations. The numbness got worse each time she had the vaccinations. She also complained of headaches, so she took some ibuprofen (MOTRIN). The patient saw the physician. Labs diagnostics studies included computerized axial tomography scan and magnetic resonance imaging (MRI), with no date or information reported about the results. At time of reporting, the patient was recovering. Additional information has been requested.
Patient was given 0.5ml instead of 0.25ml booster dose (non immunocompromised). Unable to contact patient.
Soreness noted on 12/6/01 at approx. 18:00. Noted swelling and redness upon getting up this morning. On 12/7/01, warm to touch. Saw PMD this AM and was instructed to take Motrin or Tylenol and continue with ice packs.
(R) deltoid where both vaccines given was red and swollen, not that hot to touch. Think was PNA shot D/T has had Flu before w/o issues.
I was administered a 2nd round of the shingles shot Shingrex 50mcg Inj (IM) SNGL DSE 1 VL. INGREDIENT NAME: ZOSTER VACCINE (RECOMBINANT) ADMINISTERED 0.5 ML IN THE MUSCLE AS DIRECTED. THIS WAS ADMINISTERED AT 10:30 A.M. PDT AT THE PHARMACY. 5 HOURS LATER I EXPERIENCED INTENSE PAIN IN THE ARM, BY 10 PM I EXPERIENCED CHILLS, NAUSEA, AND EXTREME HEADACHE. I THREW UP THROUGHOUT THE EVENING AND EARLY MORNING. ARM IS STILL HURTING BUT OTHER SYMPTOMS ARE MOSTLY GONE.
HIVES     near injection site.  Started evening of day after shot. Gone by following morning. No biggie just thought I'd let you know.
This pt was inadvertently vaccinated with a 2nd dose of pneumococcal vax only one year after receiving the first dose. It was reported that at the time of the 2nd vax the pt's arm jerked and there was a question as to whether the pt received the injection intramuscularly or intradermally. On 11/10/00, the pt felt weak and thought his pulse was fast. He also experienced shortness of breath. The pt went inside and put his oxygen on for 45 minutes and then felt better. On 11/11/00, the pt noticed arm swelling, which was initially reported as cellulitis. The pt was treated with Benadryl.
Information has been received from a physician concerning a 13 month old male with no known medical history or allergies who on 06-May-2006 was vaccinated with a SC 0.5 ml first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) rubella virus vaccine live.  There was no concomitant medication.  "Two days after receiving" the vaccine, on 16 May 2006 the patient developed a measles live rash.  The patient also had an ear infection.  Unspecified medical attention was sought.  He was treated with azithromycin (ZITHROMAX).  No laboratory diagnostic tests were performed.  Subsequently, the patient recovered.  There was no product quality complaint involved.  Additional information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 73 year old  male. 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 not reported, batch number: 180890, expiry: unknown) dose was not reported,1 total administered in left arm on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient had confirmed immunological vaccine failure. On 27-April-2021, one month and one day after vaccination the serum was drawn, and SARS-COV-2 S1/S2 IgG Assay antibody test was performed and had shown negative antibody result. The patient was not please with the negative antibody result. and believed that the JANSSEN COVID-19 vaccine was not working with no positive antibody response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210456862-COVID-19 VACCINE AD26.COV2.S -confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Body aches everywhere; Can hardly use his arm that he got the injection in; Has no taste or smell; Has no taste or smell; Weird stabby pain underneath his left armpit; His arm hurts so bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration, administered in Arm Right on 28Apr2021 as dose 1, single for covid-19 immunization.  Medical history included diabetes mellitus from 2020 and ongoing Verbatim: Diabetes, asthma from an unknown date and unknown if ongoing Verbatim: Asthma, ongoing neuropathy peripheral Verbatim: Neuropathy in feet. Concomitant medications included Metformin taken for diabetes mellitus from 2020 to an unspecified stop date; Gabapentin taken for neuropathy peripheral, start and stop date were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021, patient experienced body aches everywhere, can hardly use his arm that he got the injection in, has no taste or smell, has no taste or smell, weird stabby pain underneath his left armpit, his arm hurts so bad. The events did not result in emergency room or physician office visit. The outcome of the event his arm hurts so bad was unknown and the outcome of the other events was not recovered.
COVID symptoms are not severe and only had a cold; COVID symptoms are not severe and only had a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  An 82-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Manufacturer-unknown, Dose no- 1 and 2), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID symptoms are not severe and only had a cold". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial and follow up information has been received from a physician concerning a female pt (age not reported) who on an unspecified date, in the morning, was vaccinated with HPV rL1 6 11 16 18 VLP vaccine yeast. Subsequently, the pt fainted after receiving HPV vaccine (date unk). It was reported that the pt felt dizzy and was kept for observation (previously reported that the pt had no eaten anything). At the time of this report, the pt had recovered from the events (date unk). The physician assessed the events as non serious and reported that she was unsure of the causality of the events. No further information is available.
Patient's arm was swelling and painful from shoulder to elbow and experienced this on Tuesday night. She woke up without a fever yet, was told to contact her doctor. She then went to Emergency room Wednesday afternoon because she still had pain, inflammation and fever. She was admitted overnight for observation in the hospital. Doctor said it was cellulitis and she has an increase WBC count. She was given Ceftriaxone IV and was released on Thursday. She is currently taking oral cephalexin for 7 days. She said she felt better, no more fever but arms are still with pain and swelling . ( as of 5/03/2020 3pm).
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL (dose, route of administration, anatomical location, lot# and exp. date were not reported). No adverse effects were reported. The outcome of the event was unknown. This is one of the two reports received from the same source. Additional information has been requested.
10 days post vax, pt devel fever & became very irritable, high pitched cry, inconsolable; Macular rash on face 2 days later & now rash on back, stomach-red dots; fever, irritability still persists;
Patient was given the moderna booster dose as opposed to the Bivalent booster which is the appropriate approved booster. We have the Pfizer Bivalent which is the one to be administered.