chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Had vaccine a couple years ago now has shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years 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 details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported.  The reporter stated that the patient had received the vaccine couple of years ago and presently had shingles. The reporter was asking if the shingles would be milder with the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and lab test confirmation were unknown at the time of reporting.
flu sxs 5OCT95 went to work sickness came on 1st hr, diarrhea, chills, sweats, urge to throw up, faintness, white as a ghost;went home felt better later afternoon 5OCT95
Pt had rash/hard red area 3-4 cm at location of vaccine, some itching. Advised ice/bandage.
This case was reported by a physician via call center representative and described the occurrence of pain localized in a adult patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain localized, localized erythema, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the pain localized, localized erythema, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the pain localized and localized erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The health care professional (HCP) reported that a dose of SHINGRIX administered, where the vaccine was reconstituted with sterile diluent and not the one provided with SHINGRIX vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The patient experienced very mild local redness and tenderness after vaccination with a dose of SHINGRIX. The reporter stated that he might be contacted at a later time for patient information. This case was linked to cases US2018139463 and US2018139464, reported by the same reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details reported 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 had a dose of SHINGRIX less than 2 weeks ago, and had since developed Shingles. The reporting healthcare professional had no patient or product information available but provided information for the patient's primary doctor for follow up. The healthcare professional requested that safety follow up with the patient's doctor for more information.
Lost Hearing in right ear.  Made appt. with PA-C for diagnosis. She checked ears and throat for infection, found none. She stated she wasn't sure of the cause of my complaint so she suggested a 5 day prednisone pack. After day 4, I got the hearing back in my right ear but have tinnitus in both ears that remains to this day.
Acute myocardial infarction in the LAD. Chest pain migrating to left arm down through elbow. Cardiac catheterization s/p DES-pLAD.  Chest pain started roughly 19 hours after the first dose of the Pfizer vaccine.
Child presented to school nurse with hives to chest and back, given 25 mg Benadryl PO at 11:45 AM.  Child went to see family physician for evaluation. At 8:00 pm hives were on face, neck, torso, both legs and arms.  On 4/7/2016 hives only on upper legs.
No reaction from patient, the patient received a Moderna Booster dose from us on 11/24/2021. However the patient had his third dose of Pfizer on 11/18/2021.
Extreme pain in site of injection x 4 days; body aches, chills, headache, diarrhea, fever 102.2 x 3 days
Diffuse alopecia on head / increased hair loss started. Shortly after HPV #1 then seemed a little better. Now has increased hair loss and significantly thinned hair starting 4-6 weeks after HPV # 2
FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination; and ustekinumab (solution for infusion, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious. This case, involving the same patient is linked to 20210410447.
Mild case of varicella. Contracted through school exposure. 2 weeks later sibling become quite ill. Both had received immuniz. from same lot of vaccine.
Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Mild, Additional Details: While injection is taking place, patient was reported to have a very brief loss of consciousness not longer than 10 seconds. Patient was able to regain consiousness on her own while Immunizer was holding her from falling. Patient was observed from any further escalation of condition. Pharmacist on duty immediately assessed situation and assisted the patient and Immunizer until the area is well ventilated for the patient. Patient recovered and was able to stand up and walk/drive home.
headache,  fever up to 102+, dizzy and light headedness, stiff neck, pain in arm (around injection site) L , burning in arm, muscle twitches in arm
thyroiditis, treated with beta-blocker, thyroid levels have now returned to normal (note: this event could be just as easily tied to a positive Covid case in early October 2021 or not related to either the vaccine or disease as quite a time lag exists between all of these events)
Patient has nonproductive cough without other symptoms, and without any history of respiratory problems. Patient tested negative for SARS-CoV-2 today in the office
Extreme discomfort in chest, going down left arm with tingling in left hand. Fatigue, shortness of breath, dizziness. Patient went to emergency room in case it was a heart attack. Symptoms much less pronounced after 2 hours (started at 6am, up until about 8am). Diagnosis is chest pains. Released from ER after 5 hours. Still experiencing light symptoms two days later.
pt recvd vax 24OCT95 & w/in 24hrs devel cough, nausea, vomiting, extreme weakness (especially in the legs), chest congestion, h/a, muscle aches;pt felt may be getting bronchitis (as pt's son had bronchitis);adm to hosp dx'd pneumonia;
24 hours after the injection I started to flush on my face neck and ears. I itched all over especially my eyes and throat. I was very agitated and shaking. I took an allergy Med at 2 pm and again at 7pm. The 2 Nd dose calmed me enough to get to sleep around 11pm. I was very close to going to the ER. In the morning I had a stomach ache like I have experienced before with and allergic reaction. Cramping pain , it lasted all day there was no nausea. The 3 day a headache that seemed appropriate for the vaccine.
From date of vaccination, 5/17/00 through middle of June, hair started falling out and thinning. Full blood work-up done on 7/17/00 with no explanation found; all normal. On 9/22/00, noticed new hair growth in areas.
seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures) had not resolved.            No concomitant medication were reported. No treatment medication were reported.  Company Comment: This case concerns a 42-year-old, female patient, with no known medical history, who experienced the serious, unexpected event of seizure. The event occurred two weeks after first dose of mRNA 1273 vaccine. The patient said she had been having seizures ever since it started after first dose, she did not reveal any treatment medication given. The rechallenge is not applicable as event is still ongoing. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-361648 (Patient Link).; Sender's Comments: This case concerns a 42-year-old, female patient, with no known medical history, who experienced the serious, unexpected event of seizure. The event occurred two weeks after first dose of mRNA 1273 vaccine. The patient said she had been having seizures ever since it started after first dose, she did not reveal any treatment medication given. The rechallenge is not applicable as event is still ongoing. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Breastfed child recurrent UTI  beginning w/in week of first dose of Moderna Covid19 vaccine Jan 22, 2021 with no prior history. Then self/patient that received the vaccination had onset of bladder/urinary track irritation/inflammation  March 10th with no prior history of urinary track issues.
No adverse reaction noted at the time of administration or during the immediate 15 minute post vaccination observation period.  This report is being submitted for a potential vaccine administration error. An unknown number of patients may have received doses that were prepared at a different concentration, due to the incorrect dose of diluent used while reconstituting. Submitting for tracking if any patient's vaccinated this day with this lot # report any adverse events in the future.
(L) thigh with golf ball sized edema with central induration but non tender, no discharge. Warm to touch.
Macular Hole; Optical visual changes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MACULAR HOLE (Macular Hole) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ASCORBIC ACID (VITAMIN C ACID), VITAMIN D [VITAMIN D NOS], ZINC, FISH OIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced MACULAR HOLE (Macular Hole) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Optical visual changes). The patient was treated with Surgery for Macular hole. At the time of the report, MACULAR HOLE (Macular Hole) and VISUAL IMPAIRMENT (Optical visual changes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Macular Hole required a surgery 7 weeks after (17 May 2021).  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Having heavy, menstrual bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the parent.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacture Unknown), for Covid-19 immunization.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Having heavy, menstrual bleeding".  Additional Information: Verbatim: Both of my teen daughters have your shots and booster. It was after the second shot that my oldest started having heavy, menstrual bleeding. She already had bad periods but, the bleeding has become so bad that, even the heaviest flow pads cannot absorb the blood fast enough. Our entire house is fully vaccinated and boosted, I just need some questions answered about side effects like my 18-year-old is experiencing. Sincerely, a concerned mom.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
positive home Covid test; positive home Covid test; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Mar2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild seasonal asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Sulfa Rx" (unspecified if ongoing). Concomitant medication(s) received in 2 weeks included: ATORVASTATIN; LOSARTAN; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2022 at 13:00, outcome "recovering" and all described as "positive home Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive; (unspecified date) positive; (unspecified date) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Viral rebound w positive home Covid test (Abbott BinaxNOW) on day 12 following start of Paxlovid, cough, congestion, cold-like sx. Paxlovid treatment was started from 22Apr2022 to 26Apr2022.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated a dose of with BCG VACCINE USP (lot number not reported) intravesically instead of TICE on 17-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. Pharmacist stated the BCG VACCINE USP was reconstituted with sterile, preservative-free saline, 0.9% Sodium Chloride Injection USP as diluent. The BCG VACCINE USP was reconstituted and administered to the patient according to the directions in the TICE prescribing information. No symptoms reported. Additional information has been requested.
Pt stated her arms were sore on Saturday morning. Her right arm became very swollen and reddened/hard. Pts mother took her to the ER on Sunday 8-30-15. She was given MOTRIN/KEFLEX and BENADRYL. No fever noted. On 9/2 pt arm was without swelling, redness, slightly sore. Only one dose of KEFLEX given, KEFLEX dc'd, arm was WNL.
Pt recv vax on 1/29/99; on 2/6/99 pt exp fever, runny nose, cough, rash x 3 day; dx=measles
Pt received HPV Quadrivalent, Gardasil vaccine. While walking from the exam room to the waiting area for the 15 min wait she had a non traumatic vasovagal episode in which mother of patient eased child to the floor. Patient stated she felt ok after about a minute of resting on the floor where the fall occurred. She walked out the waiting area accompanied by mother of patient. Mother then reported 2 minutes later that child had another vasovagal response and vomited once.
The evening of the vaccine, the patient had a temp of 102 and wheezing. Mother of patient gave him an albuterol & he improved. The following day the patient had a local reaction, but no systemic issues.
This is a spontaneous report from a contactable medical assistant. A female child received a dose of PREVNAR13 on an unspecified date. Relevant medical history, concomitant medications and past product history were not provided. On an unknown date, following administration of the vaccination, the child developed a large welt on her leg. An emergency room or doctor visit was not required. The outcome of the event at the time of the report was unknown. Follow-up (29FEB2012). Follow-up attempts completed. No further information expected.
This spontaneous report was received from a medical assistant regarding on a 2 month old patient of unknown gender and no medical history or concurrent conditions informed. On 02-JUL-2015 the patient was vaccinated with inappropriate stored ROTATEQ (lot # K000487, expiration date: 27-SEP-2015) (route, anatomical localization, dose and frequency were not reported). Concomitant therapies were not provided. No adverse effects were reported. Additional information has been requested.
weakness; severe dizziness; felt like the entire room was spinning for 2 days and currently would now just come and go; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS, and VERTIGO (felt like the entire room was spinning for 2 days and currently would now just come and go) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (weakness), DIZZINESS, and VERTIGO (felt like the entire room was spinning for 2 days and currently would now just come and go). On 22-Apr-2021, ASTHENIA (weakness) and DIZZINESS had resolved. At the time of the report, VERTIGO (felt like the entire room was spinning for 2 days and currently would now just come and go) outcome was unknown. Not Provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Thyroiditis subacute/viral thyroiditis; This is a spontaneous report from a Non-contactable consumer reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and Concomitant medication(s) included ciprofloxacin lactate (CIPROFLOXACIN [CIPROFLOXACIN LACTATE]) taken for an unspecified indication. On an unspecified date, (Calculated Time-to-onset (TTO): 0 days), the patient experienced thyroiditis subacute. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202100974883
she had developed C. Diff after she had the vaccine; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 67-years-old via an unspecified route of administration, administered in arm left on 09Feb2021 11:00 (Batch/Lot Number: EL9264) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 11:00 (lot number: EL23247) at the age of 67-years-old for covid-19 immunisation. The patient reported that she had developed C. Diff after she had the vaccine and has no idea how she got the bacteria. She states that she developed Clostridium difficile or also known as C-diff. She states that it is the only thing that happened to her after receiving the second dose of the vaccine. She states that it happened 6-8 weeks on 01Apr2021 after receiving the vaccine. She states she did have to have a culture, a stool culture done because she wasn't feeling well and that is how it was determined it was C-diff. She states that's how it was determined that it was C-DIFF. She states the culture was positive. The patient underwent lab tests and procedures which included culture stool: positive (C. Diff.) on an unspecified date. She states that she is under a doctor's care and is taking medication for the C-diff. She states that until the antibiotic is complete, which will be another 7 days, then has to be retested the C-diff is still ongoing. The patient did not recover from the event.
I also had COVID shot at same time as the Flu shot.   At 11 p.m. while in bed I all of a sudden had searing pain in my ears, groin, dizziness, almost fell several times while attempting to use bathroom.  It was almost like I had to urinate every hour.   and  I had extremely sore arm.  This lasted through the night and had tapered off around 5 a.m.  Still weak in morning and lightheaded.