chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am now 6 days out from the vaccine and I am still having intense headaches, like my temples and forehead are pushing outward. I have intense muscle/nerve? pain at the  base of my neck to the right and left along my trapezius muscle, along my shoulders.  My trigeminal neuralgia, which when it flares I tend to feel  to the left of my nose (as if I had a sinus infection), is in high gear. (I can ususally keep it under control.) I think the vaccine is wreaking havoc on my pre-existing neuralgic/trigeminal condition.  Also, about 12 hours after receiving the shot I had shakes, high fever (99.9 compared to my usual 97.7) . But that went away.
BLOOD CLOT; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via telephone concerned a patient of an 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: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient tested positive for Covid-19 (suspected covid-19 infection, suspected clinical vaccination failure). On an unspecified date, the patient experienced blood clot. The patient was hospitalized (date unspecified) for 17 days and has been discharged with oxygen. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection, blood clot and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000183554.; Sender's Comments: V0- 20210642886-Covid-19 vaccine ad26.cov2.S  Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS  20210642886-Covid-19 vaccine ad26.cov2.S- Blood clot, Suspected Covid-19 infection. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.
VACCINE WAS ADMINISTERED AFTER THE EXPIRY TIME, ADMINISTERED APPROXIMATELY 24 HOURS  AFTER VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a physician 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  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced incorrect product storage. On 09-SEP-2021, the patient experienced vaccine was administered after the expiry time, administered approximately 24 hours after vial puncture. The action taken with covid-19 vaccine  was not applicable. The outcome of the vaccine was administered after the expiry time, administered approximately 24 hours after vial puncture and incorrect product storage was not reported. This report was non-serious.
acute postvaccinial lymphadenitis beginning post-vaccine day 5, involving left axillary, supraclavicular and cervical nodes, non-suppurative, no systemic symptoms; smallpox vaccine administered to left deltoid
"COVID arm" I developed a red, swollen, painful arm on the 8th day after the injection.  I did have a sore arm the day after, but that quickly went away.  This is new and worse.
Pt recvd MMR vax & w/in 24 hrs to 48 hrs following vax pt devel t103 w/enlargement of the occipital lymph nodes; sx resolved the next day; approx 10 to 14 days following vax pt devel small pinpoint rash primarily on the chest & trunk;
Narrative: Received J&J COVID-19 vaccine on 3/25/2021. Received Moderna COVID-19 vaccine on 4/20/2021. Error detected by nursing after vaccine was administered. No adverse effects noted at time of administration or day following. Providers were informed of extra dose.
I started feeling a lot of pressure in my sinuses and ears on Thursday, 28th, and I took decongestants and Ibuprofen until Monday morning when I went to walk-in clinic at my doctor's office. I lost hearing in my right ear on Saturday the 30th.  I got Amoxicillin for 10 days twice a day to help with my symptoms. It is helping somewhat but my ear still has a lot of pressure in it and I still have no hearing on my right ear. I will go to my doctor on Monday, the 8th, for follow up. I still feel a bit stuffy but not as bad. Notes: I did have COVID-19 in January 2021  before my vaccines -  BAM infusion. I had my regular flu shot on October 5th. Symptoms immediately after the vaccine: Had a sore arm; starting the evening of the shot, I had a few chills and headache and I took Tylenol and went to bed and by the next morning, I was better.
Rash over abd both arms and legs-vesicles that broke and dried up lasted over 2 weeks with fatigue
All meat and most foods now have the same smell as what my dog and son  defecate. The meats have tasted horrible as well.  The only foods that actually taste edible are super sweet foods with high caloric content and some bland pastas. I have lost muscle mass and fat over the last two weeks totalling 4.5 lbs.
Pt was given Covid 19 12yr older booster too early.  He waited 15min after vaccine with no adverse reaction.
Syncopal episode 6 minutes after receiving 4 vaccines possible tonic due to breath holding - Difficult to arouse verbally but responded to sternal rub. Pupils dilated 4:53pm P.O. 99;HR 60 B/P 152/78; 5pm Pulse Ox 99; HR 78; 142/72
Ramsey Hunt Syndrome; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age.  No information was provided regarding the patient´s (pt´s) concomitant medications, concurrent conditions or medical history. On or about 01-JUL-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location and lot # were not provided) by a pharmacist as recommended for the long-term prevention of shingles and zoster related conditions.  Subsequently, on an unspecified date, the pt was treated by a health care provider in a local medical center for shingles and Ramsey hunt syndrome.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The pt had not recovered from the events.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Ramsey hunt syndrome was considered to be a medically significant event.
sore arm; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet, from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1803USA004866), concerning a currently 75-year-old female patient. The patient's medical history included chicken pox infection in 1955. The patient was a cigarette smoker since 1975 to 1995. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies provided.  On 18-JUN-2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis.  On an unknown date, the patient experienced sore arm as an adverse reaction to vaccination. The outcome of the event was unknown.  The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).   This is one of two reports regarding the same patient (MARRS# 1803USA004866).; Sender's Comments:  US-009507513-1803USA004866:
pt recv 2 doses of vax 7MAR96 & 19APR96 & failed to seroconvert;pt titer taken 16MAY(6 indicated .10 units & second titer taken 1AUG96 indicated .02 units;after 5 doses also failed to seroconvert;
This non-serious spontaneous case, initially received form other no-health professional on 13-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 29-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805544 was crossed linked to original case 201804863 due to same reporter.
generally felt bad; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Sep2021 09:00 (Lot number: EW0167) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR; D3 VITAMIN. Past drug history included: Septra, reaction(s): "Known allergies: Allergy". The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "generally felt bad"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: It was reported that, after 1st shot sore arm, generally felt bad for a few days. COVID-19 vaccine was administered: Public Health Clinic. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination.  No follow-up attempts are possible. No further information is expected.
no adverse event, moderna confirmed 216K22A was  viable until 2/21/23 despite beyond use date of 1/22/23
Approx. 4 hours, post vax, child developed hives on hands, feet and extremities. Hives began fading after given Benadryl. No difficulty breathing noted.
Pain, redness and warmth @ injection  site. Treated w/ antibiotic to cover for cellulitis
Information has been received from a physician concerning a 12 or 13 year old female who was vaccinated with GARDASIL vaccine (yeast). At the same time, the patient was vaccinated with hepatitis A virus vaccine inactivated (manufacturer unknown) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) as GARDASIL vaccine (yeast). The physician reported that the patient had a fainted from a dose of GARDASIL vaccine (yeast). The patient was fine in a few seconds. No further information is available.
PATIENT FELT WARM IN GENERAL, HAD DIZZINESS, HIS VISION WENT CLOUDY AND HE VOMITED
Dose drawn up 12/21/22 to be given before discharge.  Discharge delayed so not given but not discarded.  12/23 discharge planned so new dose drawn up but nurse gave expired product instead.  Room temp for 2 days.  No adverse effects.
Hives a few days after receiving vaccine.  Currently seeking medical care with medrol dose pack and benadryl.   Seqirus is manufacturer of vaccine.
Expired dose administered.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30-APR-2023) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 A medical assistant called to inform that on, an expired dose of Menveo was inadvertently administered to a patient, which led to expired vaccine used. The reporter did not consent to follow up.
6 days post vax pt devel fever x 1 day; Had mumps rxn x 2 days;
Fetal demise discovered at 26w4d. EDD 12/12/21.  Patient had 2 unremarkable vaginal deliveries, the third vaginal delivery complicated by gestational hypertension.  This pregnancy was complicated by chronic hypertension and asymptomatic GBS UTI at initial prenatal visit.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
On 25May2021, patient undergone pcr nasal swab test and tested positive for covid with symptoms (loss of smell and taste, malaise, runny nose); On 25May2021, patient undergone pcr nasal swab test and tested positive for covid with symptoms (loss of smell and taste, malaise, runny nose); And I have the COVID I feel really bad asthma is cronic now; diarrhea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A 34-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left on 23Apr2021 (Batch/Lot Number: ER 8735) as single dose, dose 1 intramuscular, administered in Arm Left on 02Apr2021 (Batch/Lot Number: ER 8730) as single dose, both at the age of 34-years-old, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient had the vaccine double shot. And she had the COVID, she felt really bad asthma was cronic now. Since 22May2021 9.00, the patient had all COVID symptoms. Loss of smell and taste, diarrhea, malaise, runny nose and asthma. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures post vaccination which included PCR test (Nasal Swab): positive on 25May2021. The patient took treatment with Seretide inhalation, Tylenol nose drops. Outcome of the events was not recovered.  Information on batch/lot number was obtained. Further information has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.
States hives on both arms & trunk day after injection - resolving with use of OTC catesine cream
little bit of upper respiratory symptoms; feel like I've been hit by a truck; headache; sinus pressure; vomiting; fatigue; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history of patient's body attacking itself during immune responses.The patient's concomitant medications were not reported. On an unspecified date, the patient experienced a little bit of upper respiratory symptoms yesterday. She felt like she had been hit by a truck, had headache, sinus pressure, vomiting and fatigue. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Eye focus issue heart rate over 120 BP low severe diarrehia head ache shaky
severe adverse reaction; This spontaneous report was received from a health care professional via Pfizer and refers to a 64 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.         On approximately 2015 (reported as 5 to 7 years ago), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (lot number was reported as unknown; strength, dose, frequency, route of administration and expiration date were not reported) for prophylaxis.   On an unknown date, the patient reacted severely to vaccination (vaccination complication). The outcome of vaccination complication was unknown.  The causal relationship between the event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age entered as 19, after questioning discovered patient was 17.  Informed Dad the shot was 18 for and older and he did not say anything.  Informed Mother and she stated Dad input the incorrect dates.  Mother stated daughter feels fine.
Rash/there was a rash on the same arm as the injection; burned going in; normal tenderness from the shot until the next day; This is a spontaneous report from a contactable consumer (patient and his wife).  A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL3247, expiration date not reported) via an unspecified route of administration, in left arm, on 11Feb2021 12:48 (at the age of 73-years-old) at dose 1, single for covid-19 immunization from pharmacy. Medical history included diabetes, shingles. The patient had no family medical history. The patient had several other shots, also reported that a few years ago, he had a shingles vaccine and had no reaction, but shortly he got the shingles; it went into his eye and his cornea. Concomitant medication included ongoing glipizide and ongoing metformin taken for diabetes. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine and no additional vaccines administered on same date of vaccination. The patient experienced rash on the same arm as the injection on 02Mar2021, the rash look like scab or Rorschach test/a cluster and size of a half dollar. The patient also experienced burned going in (as reported) on 11Feb2021. The burning sensation went away and there was just normal tenderness from the shot until the next day (11Feb2021). There was no investigation assessment reported. The outcome of burning going in on was recovered on 11Feb2021, normal tenderness from the shot recovered on 12Feb2021 and the other event was not recovered.    No follow-up attempts are possible. No further information is expected.
Undiluted COVID vaccine administered. Error was not noted until about 2 hours after patient had left clinic. Nurse manager, notified provider and then mother of the error. Per my discussion with mom, patient was doing well and experiencing no side effects at the time of my call (~4:30pm on 4/26). Advised to notify our office and/or seek care immediately for significant side effects. No reports of adverse events since error.
enlarged lymph nodes; felt achy; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 15:15 (Lot number: El9262) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (Feb2021), described as "enlarged lymph nodes"; PAIN (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (Feb2021), described as "felt achy"; PAIN IN EXTREMITY (non-serious) with onset 05Feb2021 15:00, outcome "recovered with sequelae" (Feb2021), described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of lymphadenopathy, pain, pain in extremity.  Additional information: No other vaccine in four weeks. No covid prior vaccination. Took other medications in two weeks. Eight (8) days after first shot, the patient had enlarged lymph nodes and felt achy for 2 days. Very sore arm for about one day. The patient recovered with lasting effects. No treatment received. Covid tested post vaccination: Nasal Swab PCR on 08Mar2021: Negative.  No follow-up attempts are possible. No further information is expected.
RASH; HIVES; This spontaneous report received from a consumer concerned a female of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced hives, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives and rash was not reported. This report was non-serious.
Scattered red raised hives in varying size with mild itching on arms, legs, neck and back. The largest hive appeared at injection site 5 days after administered. More hives are erupting  still
PAIN IN ARM AND SHOULDER DURING THE DAY, WITH EXTREME PAIN IN THE ARM AND SHOULDER RADIATING DOWN TO THE HAND UPON RECLINING AT NIGHT. PAIN CONTINUES TO THIS DAY AND INTERFERS WITH MY QUALITY OF LIFE. DOCTOR PRESCRIBED PHYSICAL THERAPY BUT THIS ONLY MADE IT WORSE.
Hoarseness, difficulty breathing, paleness, weakness, a fast heart beat, and dizziness.