chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of aseptic meningitis in a 17-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), Tdap and Meningococcal vaccine (non-gsk). No past medical history, the subject was healthy. On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of Tdap (administration site and route unknown, batch number not provided), and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). Less than 30 days after vaccination with Tdap, Hepatitis A vaccine and Meningococcal vaccine (Non-GSK), the subject experienced aseptic meningitis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was unrelated to vaccination with Hepatitis A vaccine, Tdap and Meningococcal vaccine (Non-GSK). This case has been linked to case B0739797A : same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searched and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators review 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
she got really sick; fever of 103 (°F); Dose 2, 28 days later in February; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2, 28 days later in February), ILLNESS (she got really sick) and PYREXIA (fever of 103 (°F)) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history reported.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2, 28 days later in February). On an unknown date, the patient experienced ILLNESS (she got really sick) and PYREXIA (fever of 103 (°F)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2, 28 days later in February), ILLNESS (she got really sick) and PYREXIA (fever of 103 (°F)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment medications were provided Action taken with mRNA-1273 is not applicable.
PT vasovagal reaction  2 minutes after injection in observation area. physician on call arrived to access patient
Patient received 0.3 mL of undiluted pediatric Pfizer bivalent booster, equivalent to 42.85 mcg instead of 30 mcg. Patient reports fatigue and headache. Patient was counseled to reach out to pharmacy with any worsening symptoms.
Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a 50-year-old male patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by reporter.   This case was linked to MOD-2021-236555, MOD-2021-236569, MOD-2021-236580, MOD-2021-239232 (Patient Link).
I had some extreme cold sweats and elevated heart rate. Symptoms progressed quickly and all of a sudden my whole body had some weird sensations like my skin was crawling. I took the afternoon off of work and went home took a luke warm bath and continued to experience pain throughout my shoulders, core, and arms. These symptoms subsided over night. The next day I noticed little muscle quivers throughout my body and mass exhaustion for about a week. They were never painful but quite concerning. These have slowly subsided over the past 3 weeks but still happen occasionaly. I went to my regular physician on June 19th and we decided that as long as it kept improving not to take any action. They continue to improve but still happen on occasion.
the nurse gave 2shots,one in arm, one in leg;pt asked if OK & told to get up;pt passed out, hitting head very hard then started to convulse;
About three hours after injection, began experiencing extreme fatigue and muscle aches. Shortly after a low grade fever began and has continued through the night with chills, muscle aches, and headache.
I have had chronic urticaria (chronic hives) since about two weeks after receiving my second vaccine. I have been take antihistamines daily since then, with little relief.
Same day post vax, the pt developed irritability, decreased activity, and poor p.o. intake. Pt hospitalized for 48 hours. A follow up report received 8/1/2000 adds: Mother of pt states Prevnar and MMR were 1st doses. The child was on no medications at the time of vaccine and there were no vaccines received 4 weeks prior to 6/14/2000 and neither this child nor 2 siblings had past adverse events to vaccines. Mother states pt was treated with antibiotics in the hospital. She was given no diagnosis other than "possibly from vaccine or virus". The sequence of events was as follows: on the morning of the vaccine and after he received vaccines, the child had slight fever, appeared fatigued (would not lift head off mom's shoulder). Did not cry and was not active as he normally would be. Vomited one time. He was allergic to formula so had been on soy formula and being weaned off. This was the 1st day of no soy. Only took 2-3 or refused to eat so dehydrated by evening. Was taken to the hospital and started on IV fluids. No further vomiting. Took small amounts of juice by mouth. Exhausted and slept through the night. In the morning he "seemed brighter" and took toast and juice. By 12 noon he was irritable, unhappy, seemed "uncomfortable in the belly". Suppository administered and resulted in very hard stool. Child then appeared happier and comfortable. He continued to increase food and fluid intake. At first his legs seemed weak especially the left and he didn't want to walk, but this gradually abated by 10 PM. The following morning he was discharged.
Itchy throat and minor swelling of tongue. This occurred 10 minutes after given the vaccination. His symptoms lasted for ten minutes and then went away. Epi pen was not given as patient did not admit to tongue swelling until after symptoms were gone.
Pain 7/10 in left arm for 36 hours following injection. Red discoloration of skin surrounding injection site progressively increasing in size, first noticed 24 hours after injection, circular area around 1 inch in diameter, now 13 days post injection around 4.5 to 5 inches in diameter. Area somewhat warmer than surrounding arm and occasionally is with mild itching. Suspicion of cellulitis.
Patient received J&J covid injection 4/1/21. From 4/1-4/7 patient felt very fatigued/lethargic.  4/10-4/13 patient was having intense stomach pains and an intense headache, she felt off and states it was like nothing she's felt before. She thought she was going to have a stroke.  Pt took her B/P on 4/11 it was 182/104, pt took an Aspirin and a half. An hour later it came down to 133/90.  Pt states she wasn't thinking straight, she went to sleep.  5 lb recent weight loss d/t loss of appetite from not feeling well, 4/9 172 lbs, 4/13 167 lbs
Redness around injection site and rashon legs and lower ABD, Pt was given Benadryl in the office and was watched for 30 minutes afterwards. The rash and redness were almost completely gone at the time the pt left.
Patient stated she felt like she had a lump in her throat. IM Benadryl given. Patient stated after dose of Benadryl that she was feeling better.
pediatric patient received first dose of Fluzone Quad on 13Nov2019 and then inadvertently received the second dose on 09Dec2019, no adverse event; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case from a nurse.   This case involves a six months old male patient who was vaccinated with a 0.5ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 13-Nov-2019 and 0.5 ml second dose of same vaccine on 09-Dec-2019 via an intramuscular route in the left thigh (lot number UJ239AB and expiration date 30-Jun-2020).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate schedule of vaccine administered.  No adverse event or symptoms were reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
My father had an MCA stroke the day after his 2nd Moderna vaccination. He got his Moderna shot on Tuesday afternoon and on Wednesday morning he had a stroke with paralysis on left side of his body. He was taken to the ER and admitted to Hospital. We were told he had an MCA stroke. He is still in the hospital as of today.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anaemia" (unspecified if ongoing), notes: Other medical history: Anemia; "Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: COVID 19 Treatment, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  Clinical Course: Morning of day 3 taking medication: throat tightness; morning of day 4: faintness, elevated blood pressure. Medication discontinued. Device Date was 14Jul2022.
Extreme pain in the back, hips and legs upon waking up lasting  3+ weeks. Unable to sit to go to the toilet. Weakness in legs causing a fall. Pain and weakness lessened as day went on only to reappear next morning.   Also extreme fatigue lasting weeks.
Patient reported on 11/8/18 that he went to his MD because his right shoulder was still sore and stiff. Reported having issues moving/rotating arm over his head. Patient presented a prescription for prednisone from MD, stated that MD did not pinpoint a visible problem but prescribed the prednisone to help reduce inflammation at the site and see if that would relieve the symptoms. We have no knowledge of the patient reporting any muscle soreness prior to 11/8/18.
I had complete numbness on my right side of my tongue and right cheek. The tongue lasted one hour and my cheek four hours
Friend got shot, then shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient got the shingles shot and got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
was given Pfizer's vaccine 21 days ago and yesterday i was given Moderna's; was given Pfizer's vaccine 21 days ago and yesterday i was given Moderna's; A spontaneous report was received from a consumer concerning a 93-year-old female, patient, who was administered Pfizer vaccine as 1st dose and Moderna covid-19 vaccine as second dose in 21 days apart.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 03 Feb 2021, patient received 2nd of the two planned doses of Moderna covid-19 vaccine. Her first dose  is Pfizer vaccine which was given  21  days ago.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events "Pfizer's vaccine 21 days ago and yesterday i was given Moderna's" was considered as resolved on 03 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration and product substitution issue for mRNA-1273.  There were no reported adverse events associated with this case.
w/in 24 hr pt started having runny nose, cough & sneezing w/t100;no other problems until 6AUG95 t102.7 to ER - crying, irritable, no s/s other than t105;CBC done & father said was OK;no med given;7AUG95 father states t100-102;otitis
Acute hearing loss as 1/21/2016 - began in AM. Had PREVNAR 1/20. Treated with decongestants, nasal and oral steroids and valacyclovir without improvement. Saw me for routine physical 1/20/2016. Came in with acute onset "blocked ear" on 1/21/2016. Decreased hearing reported. On 1/20 at her physical, review of system revealed no ear complaints. She was treated empirically for suspected serous otitis; Fluticasone and AFRIN recommended. She used the AFRIN. She contacted me 1/25/16 saying hearing had not changed. I prescribed a nasal steroid and recommended ENT eval. She saw ENT specialist 1/25/2016 - report states she had a "sudden profound SNHL AS". Empiric steroids and valacyclovir were given. She had MRI brain/internal auditory canal which was negative. She's had no improvement in loss of hearing.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix (subcutaneous) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not agree for the follow up. The patient experienced severe redness and swelling at the injection sight in the back of the arm. The patient received Shingrix subcutaneously, which led to inappropriate route of vaccination.
Severe swelling at injection site with large rash on tricept to bicept. Fatigue. Extreme muscle soreness in tricept. Neck, joint pain. On entire left side of body.
I did not have a reaction to the vaccine. I started having symptoms on 12/13/2021 of a runny nose with a cough. On 12/15/2021, I tested positive for COVID-19. I had terrible sinus pressure, stuffy nose, feeling achy all over and a fever. I tried various over the counter medications to help relieve my symptoms. I was sick for about two weeks. Prior to the vaccines and having COVID-19, I never had allergies. I noticed in January or February 2022, I started having random runny nose, sneezing and itchy eyes. On 06/06/2022 I started having symptoms again of a runny nose with a cough. I tested positive for COVID-19 on 06/07/2022. I went to see my doctor to confirm the diagnosis with a PCR test. I was not prescribed anything but advised to take over the counter medication.
Information has been received from a registered nurse concerning a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with VARIVAX (lot #: M033906 with expiration date: 28-JUL-2018) (dosage schedule, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccine was improperly stored at temperature greater than 15°F but less than 46 °F  (15.5 °F) for 30 minutes and at temperature greater than 6 °F but less than 14 °F (10.1 °F) for 1.5 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001065: US-009507513-1704USA001070: US-009507513-1703USA012554: US-009507513-1704USA001068: US-009507513-1704USA001069: US-009507513-1704USA001064: US-009507513-1704USA001066:
H.pylori infection; had a really bad headache; sore left arm / hurt and ached all the way down and when trying to open it hurt / could only lay on her back and not her side because it hurt; Chills; she hardly slept all night; She can hardly raise her left arm; has a big bump to left arm; quarter size red area and redness all around the area to left arm; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date at 15:00, for COVID-19 immunization. The first BNT162B2 vaccine dose was given on an unknown date. Medical history included ongoing hypertension; she was taking two unspecified medications already. The day following vaccination, the patient experienced a really bad headache, arm sore and chills. She left work, went home and felt like she started to feel better. She hardly slept all night and her left arm hurt and ached all the way down and when trying to open it hurt. She can hardly raise her left arm, it hurt so bad. On left arm she had a big bump and quarter size red area and redness all around the area. She was having headache again. She could only lay on her back and not her side because it hurt. At 3:30 she took paracetamol (TYLENOL) and that took the edge off. On an unspecified date in Feb2021 she was diagnosed with H. pylori infection and had been on an antibiotic. She took ibuprofen (ADVIL) at about 8:30 and put heating pad on her arm. She was regretting the vaccine because she did not know that it would be this bad. Events outcome was unknown. Information on the lot/batch number has been requested.
The pt experienced a rash on body since 7/1/01. Advisedskin care by doctor.
Severe vice like headache morning after vaccine - headache persists despite OTC meds - Wednesday came home from work at 10 AM nausea - went to ER Friday treated for migraine - given IV fluids and migraine cocktail (Toradol, Benadryl and Zofran) headache returned 2 hours after meds given  - headache persists so had Covid test done Sunday afternoon and will make appointment with PCP on 4/19
Around 6-7 pm on 6/17/09, client had small bruise on R deltoid where 1 of the vaccines was administered. On 6/18/09, redness was noted to R deltoid and spread down to middle of the upper arm, along with being hot to touch and swollen. The evening of 6/18/09 mother and client applied rubbing alcohol to R deltoid and surrounding area 5-6 times. The morning of 6/19/09 the bruise is localized to the site of injection and continues to be redness, edema, and hot to touch. Rubbing alcohol applied by client to affected area twice before coming to HD to report.
2 individuals recvd the 2nd dose of vax shortly p/receiving the inject developed arthritic symptoms; This case is considered to be invalid;