chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient who on 03-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). It was noted that the patient "picked up the zoster vaccine live (Oka/Merck) from a pharmacy approximately 25 steps down the hall from the physician's office, took the vaccine to the office for it to be administered, and had a terrible reaction." The injection site was raised, red, hot, swollen, painful, and warm to the touch. A rash was not present. At the time of this report, the patient was recovering. No product quality complaints were involved. Additional information has been requested.
Woke up on 10th day after 2nd dose with Vertigo, dizzyness, nausea, headache. Never had vertigo in my life before this.
Red swollen L arm ~ 3-4 inches in diameter at shot site improving after 2 days.
Some of the liquid came out; While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE DISCHARGE (Some of the liquid came out) and INTENTIONAL OVERDOSE (While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     Patient did not have COVID positive test or diagnosis.  Concurrent medical conditions included Allergic to cats and Pollen allergy.    On 20-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced VACCINATION SITE DISCHARGE (Some of the liquid came out) and INTENTIONAL OVERDOSE (While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened). At the time of the report, VACCINATION SITE DISCHARGE (Some of the liquid came out) and INTENTIONAL OVERDOSE (While administering the last dose, some of the liquid came out/ they put a little extra in the syringe just in case this happened) outcome was unknown. The concomitant medication was not reported by reporter. On 13-Jan-2021, the patient received first dose of the Intramuscular Moderna COVID-19 vaccine for the indication COVID-19 vaccination. On 10-Feb-2021, the patient received second dose of the Moderna COVID-19 vaccine lot number 010M20A. On 04-Nov-2021, the patient received the first Moderna COVID-19 booster dose lot number 051F21A. It was reported that when patient was administered Bivalent vaccine on 20-Sep-2022 the last dose, some of the liquid came out. The pharmacist mentioned that they put a little extra in the syringe just in case if this happened. The treatment medication was not reported by reporter.
Arm:  itching, redness, slight swelling, noticed the site mark (not seen at time of injection) Weakness, internal shakiness, tiredness, overall lack of energy
Electrical shock up arm.. tingling in hand and fingers still to this day.  Electric tingling on half of face.
30 hours after injection severe  chills, no fever,  after about 2 hours of chills profuse sweating followed by extreme weakness.  Took 3 ibuprofen.  Next day still weak
I went to the medical facility here after experiencing sharp pain in my chest and short of breath and after the doctor ran an EKG they believe I have pericarditis that has been lingering for about 2-3 weeks.
1st dose on 03-nov-21 did not get the 2nd dose, even though it has been longer than 6 months.; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on 3rd November 2021).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient had my first dose shingles vaccine and asked if it was okay to get the second dose, even though it had been longer than 6 months. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Client states he has received anthrax vaccine and he has Myelodysplastic Syndrome Anemia.
Rash and itch on arm one day after injection and still persists more than 2 weeks after vaccination.
The adverse event was not associated with the vaccine. The adverse event was a breakthrough infection. Advised of close contact on 07/03/2022 (contact in 3-4 days previous). Negative test on 07/03/2022. Symptoms developed 07/04/2022. Symptoms: dry cough and some head congestion. Positive COVID-19 test on 07/05/2022. Started Paxlovid course 07/05/2022 pm  (completed 07/10/2022 am).
Severe pain in arm, fever, chills, slight headache, terrible feeling of exustion
Deltoid muscle sore and swollen, red and hot surrounding injection site. Patient took TYLENOL (acetaminophen) to help with symptoms. Swelling persisted for approximately one week. Redness and mild bruising still persist over two weeks later.
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with GARDASIL 9 (lot # reported as N013695, expiry date: 21-MAR-2019, lot # M035486, expiry date: 05-JUN-2019, lot # M040412, expiry date: 30-JUN-2019), that was improperly stored. The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA011555: US-009507513-1707USA011607: US-009507513-1707USA011615: US-009507513-1707USA011419.
Late November starting has nose draining so much it was causing me to cough. I waited two weeks to contact my doctor; The sinus drainage was a lot. I was given a Z-PAK prescription. I feel ok now, I feel fine.
She is very sick today; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She is very sick today) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (She is very sick today). At the time of the report, ILLNESS (She is very sick today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided.  Treatment information was not provided.  It was reported that vaccine was crap and causing lot of people a lot of problems. Reporter's daughter got the shot at her job because she did not had a choice and she was very sick.
Pt developed a fever of 103 and erythema at injection site the night after the injection.   Symptoms lasted 24 hours. Resolved.
Initial report was received from a nonhealthcare professional on 07 November 2013. An unidentified patient (date of birth, age and gender not reported) had received an injection of FLUZONE QIV (lot number, route, site and date not reported) and an unspecified amount of time later experienced dementia. The reporter was trying to find out if there have been reports of dementia occurring after FLUZONE QIV. No other information was provided. Outcome was not reported. Documents held by sender: None.
Gave MMR at approx 12:30 patient returned to clinic at approx01:30. Hands red itching rash over chest stomach and back. Face and neck splotchy. Complained of itching all over.  Benadryl 25 mg given po. Mother present. Monitored for hour and released with mother states she is feling better. BP 110/68 Pulse 80 Weight 130
Urticaria/hives of trunk, shoulders, forearms, legs and dermatographism beginning 3/28/22.
got shingles after I had the shot / suspected vaccination failure; shingles; it was awful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingles after he or she had the shot and was awful. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Tinnitus in both ears, worse in left. Started a day or two after first vaccination, hadn?t gotten worse or better over the 3 weeks. Just got my second shot 2 hours ago, tinnitus is worse but not severe.
Safety needle broke-off disposable syringe during injection. Medication leaked out onto patient's arm. Not sure how much was injected. Per guidelines, a second dose administered with patient's permission.
Area around injection site, swollen, red, tender advised to try heat/ice and TYLENOL/Ibuprofen Pt notified office on 4-16-15.
Patient fainted and had appeared to seize for approx 1 minute at 0614. Fall from chair resulted in laceration of chin and chipped tooth. Ambulance called and pt taken in for evaluation by stretcher. BP stable 133/84
rapid heart rate, dizziness, instant fever of 100.2, flushed, red spot on injection site
ringing of ears/tinnitus; This is a spontaneous report received from a male contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on Mar2021 as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced ringing of ears/tinnitus in Mar2021, 5 days after receiving the BNT162b2 vaccine. The clinical outcome of the ringing of ears/tinnitus was unknown.  Follow-up attempts are completed. No further information is expected.
Rash on left side body within a couple of minutes felt achy all over hands hurt-painful-felt feverish-chills then sweats-nausea-throat hurts-head hurts stuffed up-coughed up phlem-lymp nodes swollen right arm & under-blood sugars high-weak. 7 1/2 days on Tylenol & Robitussin pacifying it still sick on 10/14.09 allergic to itching. Note: my mom had same flu shot & is fine-done together. Treatment saw Dr at same facility nex day on 10-7-09 at 10:30 am, because I had no fever to her, low thyroid, when my temp gets up 98.0 & higher I feel feverish - new regulations that no treatment can be given - so I'm suffering.
Female person who's 13 years old has had a skin reaction in both arms after getting vaccinated.
Pt presented to the office for Hep A vaccine and Typhoid Vaccine. Both vaccines were given, and during documentation I noticed the exp date of the Typhoid vaccine was expired 11/3/2015.
1st dose of Covid19 vaccine was administered on April 15, 2021. Experienced the normal mild side effects including pain at injection site, redness, mild fever and swelling for the following 2 days which had completely subsided by the 3rd day. Also experienced daily headache, diarrhea and nausea that have not gone away.  On April 25 a secondary mildly itchy, splotchy red rash appeared, radiating from injection site about 3 inches in diameter, along with increased muscle pain, swelling and it was warm to the touch. As of today, April 27, still experiencing occasional nausea, daily headache, several times a day diarrhea and the secondary rash is still there. Have contacted primary care provider via email for at home treatment advice, still awaiting reply.
full body hives; Initial information received on 26-Aug-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves a 21-year-old female patient who experienced full body hives (urticaria), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On 24-Aug-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot: UJ432AB, expiry date not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 24-Aug-2020, the patient developed a non-serious full body hives (urticaria) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urticaria.  The event outcome was unknown for urticaria.
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 8 week old patient. On 27-JUN-2017, the patient was vaccinated with improperly stored doses of PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766.
Patient came to the event and stated that she had amoxilin allergy. she had discussed with her doctor regarding the vaccine and decided to proceed. Given the allergy back, she was placed in the observation area closest to the clinical team. The team checked on her 5 mins after the dose and she said she was okay. At 10 minute mark, patient started feeling week and had rapid breathing. Help was called immediately. On site physician placed her flat on the ground. Vitals were checked with SBP 137. Her neck started showing rashes. On site physician ordered a dose of diphenhydramine 25mg PO and was administered approximately at the 20 mins mark. Patient was still weak but was responsive to all commands. Epipen was NOT given. Patient was taken to the clinic for further observation. Stable.
She just had covid and she has had all the previous covid vaccines.; She just had covid and she has had all the previous covid vaccines.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9703) and on 22May2023 as dose 6 (booster), single (Lot number: 6J6742) at the age of 71 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation; bnt162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Lot number: EL9264), in right arm, on 10Mar2021 as dose 2, single (Lot number: EN6203) and on 08Oct2021 as dose 3 (booster), single (Lot number: FF8841) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "She just had covid and she has had all the previous covid vaccines.". The patient underwent the following laboratory tests and procedures: Body height: 5'8''; 5' 6''. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).
EXPOSURE TO TEMPERATURE OUTSIDE OF RECOMMENDED STORAGE RANGE, UNKNOWN POTENCY/VIABILITY
A mother reported that her 3 month old son received his second injection of Hib-Titer vaccine on 9/10/99. 4 1/2 hours later, he woke from his nap screaming. She stated that the upper left thigh where he was given the injection was so painful, he would not let her touch it. She feels that the pain in  his leg "may have been due to the injection technique". She brought her son to the MD"s office. He was seen by the physician and administered Tylenol and sent home. That evening the child was up the entire night. His sleeplessness continued for 72 hours but is back to normal. The child has had a decreased appetite since vaccination that persisted as of 10/12/99. Additional information received from the physician on 1/6/00 indicated that the child was crying and irritable following immunization. He was brought back to the office where a diagnosis of pain from immunization was made. He was treated with Tylenol and had "significant improvement". He recovered.
she was sick in bed; could not eat/ could not keep food down; stomach distress; usual soreness in the arm; hurting everywhere (joints); This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 029A21A) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: flu shot in 2021. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Childhood asthma (childhood asthma), Bronchitis (bronchitis continuing bouts of bronchitis but the last time she got sick was fall of 2-19 before the pandemic), General anesthesia (nausea and vomiting), Drug allergy (cortisone shot), Allergy to antibiotic (Allergic to doxycycline (severe diarrhea)), Allergy to antibiotic (Allergic to vibramycin), Drug allergy (Allergic to markain (difficult of breathing)) and Adhesive tape allergy (surgical tape).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)). In April 2021, BEDRIDDEN (she was sick in bed), FEEDING DISORDER (could not eat/ could not keep food down), ABDOMINAL DISCOMFORT (stomach distress), PAIN IN EXTREMITY (usual soreness in the arm) and ARTHRALGIA (hurting everywhere (joints)) had resolved.            No concomitant medication was provided.  It was reported that patient had significant side effects and did not vomit and had no diarrhea. These symptoms were lasted fo 4-5 days.    It was reported that the adverse event did not cause patient to seek medical care and the patient did not experienced a similar event in the past.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-647568, MOD-2022-647558 (Patient Link).
Information has been received from a health professional concerning a 25 day old female patient who on 18-MAR-1992 was vaccinated with a first dose of RECOMBIVAX HB (Lot# unknown). Second dose of RECOMBIVAX HB (Lot# unknown) was given on 10-APR-1992. Third dose of RECOMBIVAX HB (Lot# unknown) was given on 02-MAR-1993. The reporter was not sure where the patient received the vaccines. It was reported that on 23-AUG-2010, at the age of 18, the patient had negative titers for hepatitis B that were ran at another medical center. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Discovered vaccine had been administered using 5/8 subcutaneous syringe into deltoid muscle.  No adverse events reported.