chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia, Arthralgia, ErythemaMultiform, SOA, arm soreness with swelling, red, blotchy Narrative:  Myalgia, arthralgia, SOA, arm soreness with swelling, red, blotchy. Rec'd fluids at ER, will follow up with PCP if not cleared by 2/5.
No additional adverse effect; expired vaccine administered; This initial spontaneous report as received from a nurse refers to a 8 year old patient of an unknown gender. No information regarding patient's concurrent conditions, pertinent medical history, drug allergies and concomitant therapies were provided.   On 28-AUG-2020 the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) (dose, route of administration were not provided) (lot # S019435, expiration date 23-AUG-2020) for prophylaxis. The nurse reported that the vaccine was administered to child 5 days pasted expiration date and requested to know if it is still safe for the child. The nurse states that the vaccine was stored in proper storage conditions throughout the date of administration. An evaluation of the expired dose of hepatitis a vaccine, inactivated VAQTA was provided to the nurse. No additional adverse effects reported.    combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Began radiating immediately, then arm and shoulder began hurting immediately, a few days later noticed couldn't lift arm past shoulder height without sharp pain and continues to this point.  Muscle pain is improving but still painful in the joint, dones' lift arm above shoulder.
no adverse effects reported; two patients received PROQUAD that was improperly stored; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 03-APR-2019, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneously for prophylaxis (dose, lot # and expiration date were not reported). It was unknown whether sterile diluent that was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored. No adverse effects were reported.  Administered dose of vaccine experienced the temperature excursion of minus 13 degrees Celsius for 5 minutes. Data logger was involved. There were no previous excursions reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003295:
A week after getting pfizer shot I started to menstrually bleed without stopping. Some times very heavy. I have had to get depoprovera shot to try to control bleeding. It did subside for about 6 months but has returned. The next step is hysterectomy.
3hr p/vax pt devel ringing in both ears began ringing in rt ear remains cont while lt ear became intermittent & eventually cleared up;pt devel high frequency hearing loss;dizziness;
Patient states the vaccine caused a flare up of her fibromyalgia. Patient states flare up lasted one week.
Information has been received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # K010216, expiration date 17-SEP-2016, (strength, dose and route unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 at 14:30 as dose 1, single (Lot number: EN6203), in left arm, on 21Mar2021 at 14:30 as dose 2, single (Lot number: ER8727), in left arm, on 09Oct2021 at 10:30 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 09Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FL3198) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIGH BLOOD PRESSURE" (unspecified if ongoing); "PENICILLIN" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN; SPIRONOLACTONE; HYDRALAZINE; ROSUVASTATIN, stop date: 09Sep2022. Past drug history included: Phenothiazine derivates, reaction(s): "Known allergies: Phenothiazine Derivates". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (15Sep2022) Negative; (17Sep2022) Negative; (18Sep2022) Negative; (19Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had received Other medication in 2 weeks. The patient had received t COVID 19 Treatment, brand- Paxlovid 300-100 mg EUA, treatment start date/ stop date - 09Sep2022/14Sep2022. The other medication in 2weeks product: olmesartan 20 mg tab brand: glenmark, spironolactone 25mg tab brand: zydus, hydralazine 25 mg tab brand: avet, Rosuvastatin 20 Mg in 2weeks stop date: 09Sep2022. The patient known allergies was penicillin and phenothiazine derivates.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health care professional concerning a 65 year old female who on 11/14/01 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. About 1 hour later, the pt experienced acute pain, swelling, redness and an indurated lesion at the injection site which measured 11cm X 9cm with some smaller lesions surrounding the large one. She was given a Medrol Dosepak and Keflex 250mg q 6 hours for 10 days to cover the cellulitis. The next day, the skin was still indurated, but had decreased in size. On 11/19/01, the pt was checked again and the redness was gone but the indurated area was still 5cm. It was reported that she was taking Vicodin for pain relief. On 12/4/01, the pt reported that her fibromyalgia had flared up probably from the pneumococcal vaccine 23 polyvalent. Upon internal medical review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. Follow up info from the health care professional reported that the pt had a history of fibromyalgia and occipital nerualgia and was seen frequently in the office for the management of her fibromyalgia. On 11/19/01 the pt was seen again in the office complaining of pain in her left occipital region, from her history of occipital neuralgia, she was administered a nerve block on the left side for the pain. On 11/27/01 the pt was seen in the office and the physician documented that the pt had experienced some cellulitis from the pneumococcal vaccine 23 polyvalent that the pt received on 11/13/01. At this visit it was noted that the pt's left arm had recovered, the redness and induration were completely gone. On 12/4/01 the pt was referred to a neurologist for her complaints of fibromyalgia. Upon internal medical review, the pt's cellulitis was considered an other important medical event (OMIC). Additional info has been requested. Follow up info received on 3/8/02 from the physician's assistant indicated that the pt experienced almost immediate severe pain and fire like burning at the L deltoid injection site. On 11/15/01 she returned to the office with an 11cmx9cm erythematous, warm indurated area with some smaller secondary lesions as well. She had two more follow up visits following. She was treated with Keflex 250mg q 6hr and a medrol dose pack. It was reported that the pt was still complaining of pain in the left deltoid region. Upon internal review, the pt's cellulitis was considered an other important medical event. Additional info has been requested.
3 minutes after receiving the IM injection patient had seizure like reaction follow by a burst of energy. Symptoms resolved in less than 1 minutes
PT VACCINATED WITH DTP/MMR/OPV DEVELOPED FEVER, STIFF NECK
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 22-FEB-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (Lot # K009105, expiration date 21-JAN-2016) 0.5 ml, intramuscular (anatomical location was unspecified). The patient's concomitant medications were not provided. No adverse effects reported. No additional information was provided. No product quality complaint was involved. Additional information is not expected because there is no consent to contact the reporter.
felt not so good/felt worse as the day progressed; I was shaking; I can't remember much of the day; slept 17 hours; my injection site had the lump a size of a goose egg/down to the size of a quarter; muscles hurt; joints hurt; injection site red; injection site tender; This spontaneous case was reported by a dental hygienist and describes the occurrence of MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours) and INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours), INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter), MYALGIA (muscles hurt), ARTHRALGIA (joints hurt), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PAIN (injection site tender). On 17-Jan-2021, MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours), MYALGIA (muscles hurt) and ARTHRALGIA (joints hurt) outcome was unknown. At the time of the report, INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PAIN (injection site tender) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, COVID-19 screening: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medication include "Ibuprofen"
Iz on 5/3/06; onset 5/4/06 redness; slightly increased on 5/5/06 8cm erythema surrounding centrally cleared IZ. (+) erythema, (+) /// but good Rom, no c/o pain. Treated: ice, ibuprofen, observe and recheck 5/8/06.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender. On an unspecified date in March 2006, the patient was vaccinated with the first dose of VAQTA. The on an unspecified date in April 2011, received the second dose, all of them for prophylaxis. No adverse effects reported.
Tinnitus in both ears beginning that evening and continuing to the present. Have delayed second dose. Concerned it is permanent, and/or that second dose could make it worse.
Within 48 hours of getting the injection, patient bilateral arms broke out in a bumpy, itchy rash that has gotten worse over the course of 2 weeks and spreading and becoming more red and itchy.
p/being exposed to a child in school pt devel fever & 80+ pox as dx by MD-chickenpox
We arrived on 02/10/2021 to give second doses to residents at Medical Resort. Upon arrival we were told several had contracted COVID-19 after their first immunization. Upon reviewing their records, it had been greater than 14 days of recovery, per CDC recommendations, they should have received their second doses. The director of nursing and the facility physician however told us we were not to vaccinate the residents until 30 days from their last negative test. After discussing guidelines and recommendations they would not change their minds. This is 1 of 18 patients that did not receive their second dose in the 6-week window at this facility.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Patient is pregnant. Has "frozen shoulder" Unalbe to lift arm. Feels like immunization site was high and close to color bone as per husband who reported. Wife is a dentist too.
Fever, Swollen Legs very restless, Dr. was called but just said to keep an eye on him and that is what we did.  But he would seem to get better then he started having seizures.  And at first they said febraile seizures then he just kept having them.  So we went to a neurologist and they said unknown seizure disorder. But he was normal till this happened. Per 60 day follow up: Pt has not recovered. He has a learning disability and seizures still. He will never be able to be left alone. And we have to help him with alot of things in his everyday tasks. Also has developmental delay.  Follow up on 12/03/03: "Vaccine recipient has not recovered from the adverse events that were reported for this vaccination.  He still has a learning disability and seizure disorder and he always will."
This spontaneous report was received from a registered nurse concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unkonwn date, unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot # K01454, expiration date: 27-AUG-2016, Lot # K022265, expiration date: 22-OCT-2016, Lot # K018180, 17-SEP-2016, Lot # K026666, expiration date: 22-OCT-2016, Lot # L010595, expiration date: 12-NOV-2016), (dose, route and anatomical location of administration not reported). No concomitant therapy was provided. No adverse effects were reported. It was unkonwn if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Had had fever (100.5) starting 12 hours post vaccine along with fatigue and body aches. Fever, fatigue and body aches lasted about 12 hours. Back muscle spasms started about 40 hours post vaccination.. Back spasms are continuing going on 36 hours from starting.
Patient was administered Covid-19 vaccination on 1/10/2021.  Patient called back on 1/20/21 reporting the following symptoms: little bump under the skin an the arm where she got the shot and the area is red and itchy.  Advised patient to call her provider as she had post-vaccination symptoms for more than three days of onset.
A non-serious spontaneous report of diagnosed with influenza with symptoms of cough, nasal congestion and fever has been received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. The patient's medical history includes gestation age of 35 weeks and allergy to lavender soap. The patient's sibling had influenza following FLUMIST vaccination. No concomitant medications were reported. The patient received 0.2 ml FLUMIST on 26-Oct-2010 nasally for protection against influenza. The patient came to the doctor's office on 08-Feb-2011 with complaints of cough, nasal congestion and fever that the patient had during two days. A rapid flu test was done at the office which was positive. A sample was also sent to state lab and it was positive for type A. The patient was prescribed oseltamivir. The outcome of the event was resolved.
got shot in left arm.  sore arm for a day.  that saturday I noticed a hard lymph node in my left neck/collar bone area.  It is still there!  I called doctor and he said to get the second shot which I got 2 days ago.  The lymph node feels a little bigger.
Patient is a 72-year-old female presents the emergency department after a trip and fall.  She got caught up in her walker.  Landed on her left knee.  Hit the left side of her head.  Moderate headache.  No loss of conscious.  No blood thinners.  Patient complains of severe pain in the left knee.  Significant swelling and bruising.
This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. Last week from the reporting date, the patient received a dose of whooping cough/tetanus vaccine in one arm and flu vaccine in the other arm as per primary care physician (PCP) recommendation. The patient had no big deal, his both arms were a little bit sore. It was unknown if the reporter considered the arms a little sore to be related to whooping cough/tetanus vaccine. This case has been linked to the US2018GSK179833, reported by the same reporter.
Cerebral stroke. Symptoms onset was documented by nursing home staff on 1/13/21. Second dose of vaccine was received on 1/12/21. I am unsure at this time if it was the Pfizer or Moderna vaccine.  Patient has severe defecits at this time but the brain is still healing. Several weeks in the hospital, patient now has peg tube and picc line. Flaccid right side and speech severely impacted.
Thick whelps rash began at site of MMR vaccine then spread to arms and face.
Not comfortable, like having covid symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR185059   Additional Information: GSK receipt date :08-DEC2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received his/her 2nd shot and stated that same as the 1st shot it was not comfortable that's like a covid symptoms once again. But he/she was glad to be protected. Additional Supportive information: For tolerance of 2nd dose US2022AMR185059, reported by same reporter. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR185059:Same reporter
EYE SPASM; This spontaneous report received from a patient concerned a 62 year old female. 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: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-APR-2021, the subject experienced eye spasm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye spasm. This report was non-serious.
Red swollen hard leg with red blotches throughout the upper leg. IPV & Hepatitis B vaccines given on (L) upper thigh on 5/2/01.
They got something flipped up the heart; This spontaneous case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (They got something flipped up the heart) 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.    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 EXTRASYSTOLES (They got something flipped up the heart). At the time of the report, EXTRASYSTOLES (They got something flipped up the heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.
unknown cause of death; Initial information received on 19-Feb-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patients died due to an unknown cause after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  It was reported that the reporter had 12 friends that took this and on an unknown date the patient died- unknown cause of death (death) (unknown latency) following the administration of Influenza Vaccine.   Action taken : not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event unknown cause of death. It is unknown if an autopsy was done. The cause of death was reported as Unknown cause of death.  Seriousness criteria : This event was assessed as medically significant and was leading to death. Final diagnosis was (fatal) unknown cause of death.; Sender's Comments: Sanofi company comment dated 22-Feb-2022. This case involves Adult and unknown gender patients died due to an unknown cause after receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.; Reported Cause(s) of Death: Unknown