chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first Shingrix dose more than 6 months ago; Mild case of shingles in August 2022; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. In August 2022, more than 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Nov-2022 Reporter's comment: The reporter was the patient.  She received her first Shingrix dose more than 6 months ago from reporting (date was unknown to the patient).  The patient had developed a mild case of shingles, which was recovered.  She had nothing else to report. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
CLIENT CONTRACTED COVID DESPITE BEING FULLY VACCINATED AT TIME OF EXPOSURE/POSITIVE PCR TEST ON 8/11/21
Red circle 6 cm x 6 cm, warm to touch, swollen, itchy, dizziness.
I had some swelling in my lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (I had some swelling in my lymph nodes) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (I had some swelling in my lymph nodes). At the time of the report, LYMPHADENOPATHY (I had some swelling in my lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Narrative:  Not reporting a reaction to the vaccine. Reporting VAER as required for pt who received COVID vaccine and passed away some time after receiving the vaccine. Pt passed away months after receiving COVID vaccine d/t other causes (likely cardiac arrest per report).
This spontaneous report as received from a pharmacist refers to a 22-year-old female non-pregnant patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patient was vaccinated with the first and the second dose of MMR II (dose, lot#, expiration date and route of administration were not reported). On an unspecified date, the patient had serologic testing that showed her response to measles was Immunoglobulin G (IgG) negative. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action taken was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a registered nurse concerning a neonate of unknown gender. The patient was vaccinated on 02-JUL-2014 at 11:11 AM, the same day that the patient was born, with the first dose of an improperly stored RECOMBIVAX HB lot number J012520, expiration date: 30-JUN-2016, (dose was not reported). It was reported that the vaccine storage temp dipped to 0-1 degrees for 18 different episodes from 14-MAY-2014 to 21-JUL-2014 according to minimum/maximum. It was not possible to identify how long the temps were down. All recorded temps, before midday and after midday were the normal within 2-8 degrees. The vaccine was removed once problem was identified and has not been used after 21-JUL-2014. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Abdominal pain; Stomach ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) and ABDOMINAL PAIN UPPER (Stomach ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain) and ABDOMINAL PAIN UPPER (Stomach ache). At the time of the report, ABDOMINAL PAIN (Abdominal pain) and ABDOMINAL PAIN UPPER (Stomach ache) outcome was unknown.            The concomitant medication was not provided.  The treatment information was not provided.  The action item  with mRNA 1273 with the events was considered as not applicable.   Reporter did not allow further contact
At about 4:00 on 2/14/21, I experienced sharp pains in my abdomen along with loose bowel movements and mild nausea; I took naproxen and the pains went away, but not the nausea.  The next day I had temperatures ranging from 99.5 to 102.4. nausea. loss of appetite, fatigue, poin in injection site, and body aches; I drank Gatorade, took ibuprofen, and slept on and off the entire day.   On 2/16/21, I had cold sweats from 7:00 am to 11:00 am, mild nausea, body aches, mild fatigue, poin in injection site, and a headache when looking at the computer; I took ibuprofen, drank Gatorade, and rested.  On 2/17/21, I had mild nausea, pain in injection site, and mild body aches, but still not quite fully better.  On 2/19/21, I felt 100% back to normal.
I had previous 4 covid vaccines (initial series, 2 boosters, all Pfizer) with no side effects at all.  Recently had Moderna (becausethat is what the facility was offering)  Felt normal the day of vaccination, woke up the next morning with Left hip pain that strongly resembled sciatica that I had had 5 years prior due to herniated disk on my right side. Pain became more severe throughout the day. 11/23 /2022 went to ER in town I was visiting.  I remembered that I had the Moderna vaccine 2 days prior but that I had also been doing strenuous activity. A CT Scan was ordered which showed no cause for the pain I was experiencing.  No other side effects experienced (sore arm, fever, fatigue, etc)
High fever within hours, chills, muscle aches, very sore arm progressing up the side of my neck.  Fever is back again today.
Patient presented to hospital 5/22 for acute psychiatric emergency. At the time of admission basic labs where obtained and were significant for platelet count of 4,000 (rest of complete blood count unremarkable). Medications and infectious history reviewed and were unremarkable. He has significant ecchymoses and petechiae on initial physical exam.  He was started on treatment for Immune Thrombocytopenic Purpura with dexamethasone and Intravenous IgG with significant improvement in platelet count to over 100K.
Extremely swollen calves of both legs - every single day since date 10/15/21 designated.
covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 at 10:00 as dose 1, single (Lot number: EW6200), in left arm, on 19Mar2021 as dose 2, single (Lot number: P6955), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: TT2589), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: P54991) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "I have arthritis" (unspecified if ongoing), notes: I have arthritis; "had breast cancer 11 years ago" (unspecified if ongoing), notes: had breast cancer 11 years ago. Concomitant medication(s) included: BACLOFEN, start date: Jun2020; TRAMADOL, start date: Jun2020; CELECOXIB, start date: Sep2021. Past drug history included: Amox-clav anti-biotic, reaction(s): "Known allergies; amox-clav anti-biotic"; Gabapentin, reaction(s): "Known allergies; gabapentin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; Positive, notes: The only unusual thing I'vedone is take a rapid test. It started within a few hours of that. It was positive; Positive, notes: the next day I took another and it was positive, too. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient received pregabapentin on Sep2021.  Follow-up attempts are completed. No further information is expected.
My daughter woke up and said she did not feel good. Her forehead was hot. We took her temperature and she had a fever. While leaving the bathroom, she fainted. She had a fever and stayed home the next day.
I experienced a long haul of joint pains. I am a very active person and did not notice any joint pain prior to receiving my second dose. The pains were in my elbows and knees mainly. I had problems getting up from the floor if I was sitting down. I still have mild symptoms from time to time, even though they were chronic, for months, after receiving my second dose.
Pt experienced confusion, disorientation, dizziness, lightheadedness, weakness, & stiff neck following vaccination. Patient was sent home from work and symptoms persisted after rest.
low grade temp started 25JUN92; t104.6 max on 27JUN; temp returned to nl 1jUL92; also exp n&v & chills; had flank pain also; pt will see nephrologist 7AUG92; bil pyelonephritis & ?medullary sponge kidneys; final dx of hospitalization;
chills and fever; chills and fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date, for COVID-19 immunisation. On an unspecified date, the patient experienced chills and fever (pyrexia, chills). The outcome of events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Developed a new SHV1 cold sore outbreak on lower left side of lip. Haven?t had one in a while, so it is possibly related to stimulating my immune system. I keep valacyclovir 500 mg on hand for occasional outbreak, so I began my course of treatment immediately upon feeling the cold sore appear.
Pt was hot and clammy. Became very pale and had low pulse. He stated his heart was racing and he couldn't swallow.  He stated he felt this way every time he gives blood minus the difficulty swallowing.  We took off his jacket and sweater and opened doors to cool him. We called 911, Gave him water and a granola bar. He stated he was feeling better. 911 responded.
Immediately after imms pt became lightheaded and dizzy. Had no breakfast. Juice provided. Pt recovered and left with stepmom. 10/21/03 Stepmother notified office of progressive reaction and treatment for vision, breathing problems and tight throat at Urgent Care. Treatment per stepmother consisted of Benadryl, Epi and prednisone.
She was really very sick; arm became swollen after the 1st booster; arm became swollen and it itched; chills after the 1st booster; fever after the 1st booster; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (She was really very sick), PERIPHERAL SWELLING (arm became swollen after the 1st booster), PRURITUS (arm became swollen and it itched), CHILLS (chills after the 1st booster) and PYREXIA (fever after the 1st booster) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She was really very sick), PERIPHERAL SWELLING (arm became swollen after the 1st booster), PRURITUS (arm became swollen and it itched), CHILLS (chills after the 1st booster) and PYREXIA (fever after the 1st booster). The patient was treated with TRIAMCINOLONE for Swollen arm and Itching, at an unspecified dose and frequency. At the time of the report, ILLNESS (She was really very sick), CHILLS (chills after the 1st booster) and PYREXIA (fever after the 1st booster) outcome was unknown and PERIPHERAL SWELLING (arm became swollen after the 1st booster) and PRURITUS (arm became swollen and it itched) had resolved.            No Concomitant medication were reported.  On an unknown date patient received Moderna Covid-19 vaccines Dose 1 and Dose 2.    Patient had to apply Triamcinolone and it went away after a week and a half.   This case was linked to MOD-2022-645567, MOD-2022-645571 (Patient Link).   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid as treatment drug from 22Apr2023 to 26Apr2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182002 same patient, different drug/event;
pain at injection site- 24 hours warmth at injection site- 24 hours fatigue- 24 hours
Havrix given and tolerated well. After Gardasil was given the patient went limp and was lowered to the floor.  Jerking movement noted.  Aware of her surroundings 5-10 seconds later.
INCORRECT DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042a21a, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced incorrect dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of incorrect dose administered was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000175101. The suspected product quality complaint has been confirmed to be voided (did not meet product quality complaint criteria) based on the PQC evaluation/investigation performed.
Narrative: 47 yr old male with no prior history of VTE, and no know history of VTE in his family (other than stroke) was diagnosed with Pulmonary Embolism with 4 weeks of Moderna Booster (booster on 1/11/22, PE on 2/13/22)
Fever, Rash, NauseaVomiting, Injection site soreness Narrative:  Developed fever/chills and nausea/vomiting 3 hours after receiving the 2nd dose on 1/20/21. Nausea/vomiting continued for 24 hours. Fever lasted until 1/22/21. Also noted rash and soreness at the injection site that lasted for 2  days. Missed work x 2 days. No known prior COVID infection.    Other Relevant History:
Normal for 2 hours then Started vomiting, lost consciousness, screaming, difficulty breathing. Eyes rolled to back of head but did seem to respond to voice, probably not seizure. Lasted a few minutes, then screamed, then slept 2 hours, then normal. No rash or physical findings.
Symptoms occurred off-site post-immunization beginning 7/6/17.  Donor experienced fever, headache, feeling of warmth, nasal congestion, sweating, and paresthesia in left hand.  He did not seek medical care. Donor stated he took one-time dose of Ibuprofen on 7/6/17.
pt recv vax 21OCT97 & w/each dose felt muscle soreness & achy joints w/malaise & some stomach problems;3wk post vax pt still feels tired;also noticed arms going to sleep more w/numbness & tingling;
This spontaneous initial report was received from a nurse, referring to a patient of age and gender unknown. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported than on an unspecified date, the patient was vaccinated with an improper stored immunization series of M-M-R II lot number M045400 and expiration date 14-NOV-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis; reconstituted with a properly stored Diluent. Temperature was reported as 9.5°C, the time frame was reported as 1 hour and 30 mins. There was not previous temperature of excursion reported. There was digital data logger involved. No adverse effects were reported.
Patient received HPV and MenQuadfi vaccine, pt was in waiting room when this nurse was notified that patient fell into mothers' arms in waiting room. Patient regained consciousness, was then brought into an exam room in where patient was placed in supine position with legs elevated. Vitals taken and recorded; MD notified. Patient was given juice, water, and ice pack. Patient felt much better, was monitored for 10-15 minutes. MD assessed patient. Patient observed for another 10 minutes. Patient was able to sit up slowly and then 5 minutes later proceeded to stand up slowly and walk around. Patient then left with parent who felt comfortable and safe monitoring child outside of the office.
Child was vaccinated with MMR on 4/12/04. Developed fever of >103 on 4/20/04 at 9:00p.m. Went to pediatrician on 4/22/04. Had swollen lymph node on left side of neck. MD said the fever and swollen lymph node were probably vaccine related. Mother was instructed to give child Tylenol and Motrin. Fever broke on 4/23/04 in PM. Has not had fever since. Client recovered as of 4/24/04.
RA; no energy/weak; OA; coughing; chilling; diarrhea; headache; we are not hungry but food is tasteless/no taste; fibro; no taste/food was tasteless; She did not feel very well; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for her husband and herself. This is the first of two reports for herself. Only this case is serious. A 72-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot # EN6201, via an unspecified route of administration on 10Feb2021 17:15 as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medications included unspecified products in two weeks. There was no other vaccine in four weeks.The patient experienced coughing, weak, no taste, chilling, diarrhea, no energy, headache all on 11Feb2021. She did not feel very well on the day she took her shot on 10Feb2021 but did not have a fever. She was not hungry but food was tasteless.It was also reported that "she had RA OA and fibro. and take thyroid medicine besides medicine for the others. Adverse event start date: 11Feb2021". No treatment was received for all events and events outcome was not resolved.The patient did not have COVID prior vaccination and no COVID tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021207100 same reporter/product, similar events, different patient
Fever, feeling "off", dizziness, red local reaction, tender to touch (L arm).
This spontaneous report was received from an administrator referring to a 10 week-old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 28-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number: N003984 (expiration date: 19-NOV-2018) or lot number: M044397 (expiration date: 20-JUN-2018), orally, for prophylaxis (strength and dosage schedule were not provided). The specific lot number of ROTATEQ administered to the patient was unknown by the reporter. There was digital data logger involved. The storage characteristics were the following: Temperature: at or above 32 F up to 35 F (35.4F) for 45 minutes. - Previous temperature excursion: No No adverse effects were reported.
One day post vax, the pt experienced redness and swelling of the injection site. In addition the pt developed urticaria lesions to the groin area. Urticaria on abdomen and spread up to the chest, back and arms.
Pt received ACAM2000 on 6/25/09. Experienced robust take - 15mm. noted on 7/2/09. On 7/4/09, pt called with c/o of chest pain, SOB, pain in arm and palpitations. Pt. sent to hospital. States she had EKG, echo - placed on KEFLEX and VICODIN. F/u with PCP and consult to Cardiologist.  7/17/09 ER records received DOS 7/4/09. Assessment: See the following. Patient short of breath last night. Heart racing. Chest pain left and under left rib. Fever, headaches, fatigue, neck stiff.