chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). The patient was treated with VITAMIN E [VITAMIN E NOS] at an unspecified dose and frequency and UBIDECARENONE (CO Q 10 [UBIDECARENONE]) at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Previous information regarding COVID-19 vaccination was not reported.  Concomitant product use was not provided by the reporter.  Patient had Myocarditis after one of her Moderna Covid-19 vaccines. Patient physician told her to take Vitamin E with Co Q Ten to combat the Myocarditis.  Company Comment This spontaneous case concerns a female patient of unknown age, with no medical history reported who experienced the seriousness medically significant expected event of myocarditis unknown days after a dose of  SPIKEVAX NOS  vaccine. Concomitant product use was not provided by the reporter. Patient had Myocarditis after one of her Moderna Covid-19 vaccines. The benefit-risk relationship of SPIKEVAX NOS  vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-739687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739687:Patient case
Several days after my Covid booster, I developed a case of chronic, raging hives (and angiodema) that has continued for 6 months (and counting). It has gotten progressively worse over time, and has not responded well to antihistimes (even at 4x regular dosing, per my allergist) and has not responded to Xolair. I also have developed a case of HSP/IgA vasculitis since my booster (confirmed by biopsy). I had this condition as a child, and I believe my booster may have caused it to be reactivated for the first time ever. I've had widespread bruising over my legs, torso, and arms, along with the hives. The bruising started about a month ago. I've also had joint pain and ringing in my ears ever since my booster.
Got his/her flu shot Oct. 1 and now have the flu anyway; Initial information received on 02-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 79-year-old and unknown gender patient who got his/her flu shot oct. 1 and now have the flu anyway after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On October 1, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of got his/her flu shot and now have the flu anyway (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown.
Moderna COVID-19 Vaccine EUA  Approximately 3 minutes after her vaccine pt became unconscious and unresponsive for a short time. Pt was quickly awoken by RN. Pt states that she has a history of syncope following venipuncture that she forgot to disclose. Approximately 15 post episode pt stated that her vision had been restored but her hearing still felt "off". Pt was given 12 oz water, crackers and juice. Pt called roommate to pick her up to bring her home. Approximately 25 minutes later, pt reports some left arm pain but was feeling better. At 1345 pt was discharged by her own choice and left with her roommate. Pt still felt "off" but reported that this was likely just due to anxiety. Pt and roommate given instructions to go to nearest ER if symptoms returned.
Approximately 5-10 min after vaccination of Tdap pt went in to a seizure/syncope type reaction which lasted about 5 min, once pt pulled through she vomited X1, 911 was immediately cold, during this time pt's vitals were monitored in which pt was stable. Prior to Tdap vaccine pt and parent stated she has had no reactions to vaccine and has had Dtap before. Mother stated she gets very worked up with any medical processes or procedure and stated pt passed out 3-4 year ago at her PCP office when was having an incision and drainage in which sulfa was given. Pt and mother stated that they were sent to ER by PCP because they said she had a seizure reaction, was referred to neurologist who stated that nothing else needed to be done and could be a one time thing or syncope and to keep an eye on it. EMS and fire department took over pt's care, EMS transported pt to hospital. Pt was in stable condition upon leaving with EMS and mother and brother. Pt and mother expressed gratitude and verbalized understanding of treatment and need for follow-up with PCP and neurologist after discharge from hospital.
Delayed body aches, suspected fever and chills subsided with ibuprofen for 6 hrs then progressively worsened.  Extreme body aches with weakness, headache, on and off fevers for the following 24 hrs.  After 2-3 days,  a bruise about 1.5 inches away from the injection site in the lateral bicep. It persisted for 1 week afterwards and was sore to the touch until slowly disapated.
BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a male of unspecified age. 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: 1822809, expiry: UNKNOWN) dose was not reported, administered on 15-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 16-FEB-2022, the patient experienced body aches, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and body aches. This report was non-serious.
Subsequent to vaccine, two day period of flu-like symptoms (chills, aches, migraine accompanied by tinnitus). Tinnitus lingered after other symptoms subsided. It manifests as a constant, high-pitched ringing sound in my ears at all times, and has not abated since post-vaccine.
Stated had an itch and looked and found a rash. Rash red clusted at injection site to 5 inches around site.
Tuesday (aug 25, 2020):  received two shots at his 9 month check up (really 10 mos old ). He received the polio and 1st Hep B vaccine.  Tuesday Late Night: started with a low-grade fever and got up to 100. Restless sleep Wednesday: Morning temp was 103.2 so I gave him Tylenol. Kept up with Tylenol all day and he reached temp of 103.7. He was lethargic, only wanted to breastfeed (no table food), and constant crying.  Thursday: Still screaming/throwing head back. Temp down to 101. Gave Tylenol. Only stopped screaming long enough to breastfeed. Called doctor. They didn?t want to see him since it had only been two days and said this reaction is normal.  Friday: Still screaming/throwing head back, temp at 100. Started pulling on ears, neck, and hair. Gave Tylenol.  Saturday: Fever is gone, still screaming, small rash started on face and behind ears and side of neck Sunday: Still pulling on ears, neck, and hair. No fever. Rash is all over body now. Still screaming/throwing head back but there are longer breaks between episodes. Monday: Called doctor but she isn?t there today. Rash looks redder and more irritated. Went to urgent care. They did strep test (came back negative) and checked his ears (they looked fine). He prescribed Tylenol.   Tuesday: No temp, still has rash, not as irritable but still signs of being uncomfortable
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 51.3 F for 30,75 hours and in 59.4 F for 4,5 hours) doses of PNEUMOVAX 23 (lot # L048264, expiration date 10-JUN-2017; dose and route of administration were not reported) for prophylaxis. No adverse effect and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Follow up information has been received on 13-DEC-2016. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1611USA001103: US-009507513-1611USA001105: US-009507513-1611USA001102: US-009507513-1611USA001104: MERCK 1610USA011275:Mfr number.
pain when I lift my arm.  the pain arises only when I lift my arm. The pain is on my shoulder only. the leit side of the arm
INDEX FINGER SWOLLEN; DEGENERATIVE DISC DISEASE IN LOWER BACK; OSTEOPOROSIS; OSTEOARTHRITIS; This spontaneous report received from a patient concerned a 62 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 11-APR-2021 for covid-19 vaccination. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 index finger swollen, degenerative disc disease in lower back, osteoporosis, and osteoarthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from index finger swollen, and degenerative disc disease in lower back, and the outcome of osteoporosis and osteoarthritis was not reported. This report was non-serious.
Pt recvd vax 30NOV92 & exp stinging upon inject; 5 hrs following vax pt exp soreness of the upper arm; could not tolerate arm being touched for 2 to 3 days; some mild aching in the lt upper arm persisted;
A patient was administered improperly stored Recombivax; no adverse effects reported; This spontaneous report was received from a registered nurse and refers to a male patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot number R028528, expiration date 04-JUN-2021 (dose, route, lot number and expiration date were not reported) for prophylaxis.         The total time and highest temperature was above 47 degrees F (57.2 degrees F) for 6 hours. A data logger was involved.
Systemic: Allergic: Itch Generalized-Medium, Additional Details: Patient called pharmacy today (06/22/2021) to report itching after second dose of Pfizer COVID vaccine lasting 5 days so far. Patient counseled to take benadryl and follow up with primary care provider.
High fever, severe headache, loss of appetite, increased thirst, nausea, fatigue. Same symptoms I had when I was sick with coivd.
Within an few hours of receiving FLUMIST developed abdominal cramping, followed by diarrhea.  Fatigue, weight loss, abd pain and cramping, depression these persisted from Thanksgiving holiday till present.  Initially, diagnosed as IBS and then later Celiac disease.  Patient still intermittantly has symptoms.
vitreous detachment; severe arthritis/diagnosed with rheumatoid arthritis; joint pain; dizziness/vertigo; dizziness/vertigo; neurological effects; severe external and internal tremors; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm right, administration date 07May2021 (Lot number: EW0182) at the age of 49 years as dose 2, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/facility. The patient's relevant medical history and concomitant medications were not reported. 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. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot number: EW0153, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: VITREOUS DETACHMENT (disability) with onset May2021, outcome "not recovered", described as "vitreous detachment"; RHEUMATOID ARTHRITIS (disability) with onset May2021, outcome "not recovered", described as "severe arthritis/diagnosed with rheumatoid arthritis"; ARTHRALGIA (disability) with onset May2021, outcome "not recovered", described as "joint pain"; DIZZINESS (disability), VERTIGO (disability) all with onset May2021, outcome "not recovered" and all described as "dizziness/vertigo"; NERVOUS SYSTEM DISORDER (disability) with onset May2021, outcome "not recovered", described as "neurological effects"; TREMOR (disability) with onset May2021, outcome "not recovered", described as "severe external and internal tremors". The events "vitreous detachment", "severe arthritis/diagnosed with rheumatoid arthritis", "joint pain", "dizziness/vertigo", "neurological effects" and "severe external and internal tremors" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vitreous detachment, rheumatoid arthritis, arthralgia, dizziness, vertigo, nervous system disorder, tremor: Prednisone, Hydroxychloroquine. Since the vaccination, the patient had not been tested for COVID-19.
The second dose of Jynneos vaccine was administered 0.5 milliliter intradermally instead of 0.1 milliliter.; Case reference number US-BN-2023-000895 is a spontaneous case report initially received from a pharmacist (reference number: USBAV23-0650) on 16-May-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at unknown dose, via unknown route and at an unknown site of administration for an unknown indication.  On 16-May-2023, an unknown amount of time after receiving the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at a dose of 0.5 millilitre, intradermally (explicitly coded as 'intradermal injection') at an unknown site of administration. It was reported that a nurse accidentally administered 0.5 millilitre instead of 0.1 millilitre.   At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 17-May-2023 included the local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos, at a dose of 0.5 millilitre, intradermally, which is considered as intradermal injection. At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. Intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos, at a dose of 0.5 millilitre, intradermally, which is considered as intradermal injection. At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. Intradermal injection is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
pt was vaxed w/Hep B vax & devel hemolytic anemia & a pos Cooms' test; pt requirred hospitalization; addtl details are being requested;
As per patients wife patient went into hospital a short time after receiving immunization and was diagnosed with guillain barre syndrome. Patient is still in hospital and is paralyzed from waist down.
Palms of hands started itching 5 minutes, weakness, hot and cold, felt faint, throat closed up, blood pressure dropped.
Initial information received on 28-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist via other company (Pfizer). This case involves a 77 years old female patient who experienced allergic reaction to tetanus shot- rash all over herself, while she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Penicillin and Niacin allergy. On an unknown date in year 2012, the patient received injection of suspect TETANUS TOXOID produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic reaction to tetanus shot- rash all over herself (rash generalised) with unknown latency following the administration of TETANUS TOXOID. Lab data was not provided. Final diagnosis was allergic reaction to tetanus shot- rash all over herself. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
pt recv vax; approx 8 hr p/ vax,pt became "sweaty", exp n & devel an itchy rash on hands,chest & legs;to MD on 17feb94;no further f/u;
Dose administered after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-Aug-2022 Reporter's Comments: The reporter stated that a dose of Bexsero was administered after the expiration date. Permission was not provided to store the patients contact information. No other information was provided as the reporter was disconnected when put on hold. Additional Supportive Information: The patient received a dose of Bexsero after the expiration date, which led to expired vaccine used.
injection site swelling; injection site redness; flu-like symptoms; This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and influenza like illness. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and influenza like illness were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and influenza like illness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced redness, swelling around the injection sites which was 4 to 5 inches. The patient also had flu like symptoms. The reporter did not have the patient identifiers or batch number and expiry date of Shingrix.
Site: Pain at Injection Site-Severe, Additional Details: Arm still painful, having trouble lifting things.
Information has been received from a nurse concerning a 9 year old patient who in 1997 was vaccinated with varicella virus vaccine live (Oka/Merck). In May 2007 through 18-JUN-2007, the patient experienced a mild case of chickenpox. The symptoms were mild with a rash on the torso. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
Caller states that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses.; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from contactable consumer. This consumer reported similar events for 37 patients. This report is for 28th patient of 37 patients. A 38-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration on 13May2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration, at an unknown administration site on 22Apr2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was stated that, on 09Aug2021, the patient was tested positive for covid virus, after being fully vaccinated. Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included body mass index: 32.4 on an unspecified date, sars-cov-2 test: positive on 09Aug2021. There was an investigation assessment, and a product complaint was initiated. The outcome of the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Flu shot given 10/13/15. Noticed (R) deltoid was swollen, red and warm on 10/14/15 at 2130. On 10/15/15 at 0530, (R) deltoid was swollen, red, warm, and a raised red rash was descending down the (R) upper arm. Consequent (R) neck and (R) shoulder soreness. Seen by MD on 10/15/15.
After returning home from 4mo well child visit, cried for 3 1/2 hr. The next day had bowel movement with moderate amount of blood in it.