chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 4 year old patient of unknown gender. Nurse reported that on 13-FEB-2015, the patient was vaccinated with PROQUAD (Merck) (Lot number, dose and route not reported) and VARIVAX (Merck) (Lot number, dose and route not reported. No adverse effects were noted. Additional information has been requested.
Nausea began the day before the shot 3/10 and continued through 3/12 Vomiting began 3/13 AM and continued until 3/14 AM I went to Urgent Care 3/14 AM where labs were completed. Labs showed a lipase over 2800 and was instructed to go to the ER. I went to the ER on 3/14 around 7pm and was admitted around midnight. It was deducted gallbladder pancreatitis. I had an ERCP procedure 3/15 afternoon to remove gallstones. My gallbladder was removed on 3/16 AM. I was released 3/16 evening from the hospital
This spontaneous case, initially received from a pharmacist on 26-Sep-2018, concerns a 72-year-old, elderly, female patient. The patient was allergic to formaldehyde. On 25-Sep-2018, the patient was administered FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250792 and expiry date: 30-Apr-2019), who was allergic to formaldehyde (explicitly coded as contraindicated product administered). No adverse event was reported following vaccination. The reporter assessed the case as non-serious.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with Gardasil.  Subsequently the patient experienced dizziness.  Subsequently, the patient recovered from the dizziness prior to leaving the office.  This is one of several reports from the same source.  Additional information has been requested.
side effects from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the vaccine) in a patient of an unknown age and gender 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 VACCINATION COMPLICATION (side effects from the vaccine). At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
About 16 patients were vaccinated with flu vaccines subcutaneously instead of intramuscularly using 5/8 inches needle, no AE; About 16 patients were vaccinated with flu vaccines subcutaneously instead of intramuscularly using 5/8 inches needle, no AE; Initial information received on 21-Sep-2020 regarding this unsolicited valid non-serious case from a pharmacist was received from a pharmacist.  This case involved about 16 patients (unknown demographics) who were vaccinated subcutaneously instead of intramuscularly using 5/8 inches needle with flu vaccines, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date (lot number and expiry date not reported for all) in unknown administration site for prophylactic vaccination. (incorrect route of product administration)(wrong device used).  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination and wrong device used.  No adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Started getting outbreaks where actual needle was injected in right arm. Has not healed about 6 months ago was first shot. Also starting to get outbreaks on same arm and left arm, back same type of sores. Pt is undergoing skin test (biopsy). Area appears to be a scab.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 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 was not reported. Concomitant medication(s) included: CRESTOR, stop date: 28Sep2022; SYNTHROID.  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: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 treatment with anti-viral product Paxlovid from 29Sep2022 till 04Oct2022. Symptoms came back 4 days after completing Paxlovid, starting on 07Oct2022, for which no treatment was received and patient was recovering at the time of this report.  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 known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2.
Day 1-2 I felt like I had the flu; 101 fever; Chills; Whole body aches; I tried to work, but gave up and just chilled; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (had moderate 3 episodes with my right arm over the last 7 years.) and itchy rash (had 3 episodes with my right arm over the last 7 years.).   In JUL-2023, the patient received the 1st dose of Shingles vaccine. In JUL-2023, 1 day after receiving Shingles vaccine, the patient experienced influenza (Verbatim: Day 1-2 I felt like I had the flu), fever (Verbatim: 101 fever), chills (Verbatim: Chills), general body pain (Verbatim: Whole body aches) and activities of daily living impaired (Verbatim: I tried to work, but gave up and just chilled). The outcome of the influenza, fever, chills, general body pain and activities of daily living impaired were resolving.   It was unknown if the reporter considered the influenza, fever, chills, general body pain and activities of daily living impaired to be related to Shingles vaccine.     It was unknown if the company considered the influenza, fever, chills, general body pain and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that today was the day 4 after 1st Vaccination shot and finally felt better.  The patient stated that on day 1 to 2 he or she felt like he or she had the flu, 101 fever, chills, whole body aches and frequent bathroom trips. The patient tried to work, but gave up and just chilled.  The patient definitely plan to give himself or herself a few days to recoup with the 2nd dose.  The patient had 3 episodes with his or her right arm over the last 7 years.  The patient had moderate pain for a time followed by a itchy rash. The rash never blisters like he or she have seen online and only last a couple of weeks.  The patient stated that each episode was worse and said it was not Shingles and had not yet found a diagnosis.  The patient stated that well it was happened yet again a month back, so he or she decided to get the vaccine. Follow-up would not possible as no contact details were available.
This case was reported by a consumer via call center representative and described the occurrence of weakness in a adult male patient who received ENGERIX B adult for prophylaxis. Concurrent medical conditions included heart disorder. On 26th June 2018, the patient received the 1st dose of ENGERIX B adult. On an unknown date, less than a month after receiving ENGERIX B adult, the patient experienced weakness, dizziness and fatigue. In July 2018, the outcome of the weakness, dizziness and fatigue were recovered/resolved. It was unknown if the reporter considered the weakness, dizziness and fatigue to be related to ENGERIX B adult. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced lightheadedness. At first, the patient said, he did not think the vaccine might have been the cause of the issues. He did have heart problems which could had some of the same symptoms. The patient could not remember how long after the injections that he started to realize there was a problem. He said that they did not go away quickly. The patient had to deal with them for about two weeks sometimes on a daily basis until the symptoms started to taper off. For tolerability after 2nd dose of SHINGRIX, refer case US2018GSK135695.
This spontaneous report as received from a health care worker who was also the patient, a female patient of unknown age. The patient thought she was vaccinated in 2001 with M-M-R II lot # reported as "merck 0195K" and expiration date on 03-FEB-2002. On an unknown date, the patient had her titers drawn and the results showed she was negative for rubeola . At the time of the report, the outcome of rubella antibody negative was reported as not recovered. Additional information has been requested.
Information has been received from a Licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M006112 with expiration date of 16-NOV-2017; strength, dosage, frequency and route unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
59 year old patient inadvertently received FLUZONE HIGH-DOSE QUADRIVALENT, with no AE; 59 year old patient inadvertently received FLUZONE HIGH-DOSE QUADRIVALENT, with no AE; Initial information received on 09-Nov-2021 regarding an unsolicited valid non-serious case from a physician via Media Information (reference number 00849996).  This case involves a 59 years old female patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 09-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ764AA and expiry date: not reported, Suspension for injection) (Frequency once) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error case due to product administered to patient of inappropriate age and overdose (latency: same day).  At time of reporting, no adverse event was reported.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient came in to receive moderna booster. Pharmacist reviewed database and administered moderna. Patient reported no symptoms during the 15 minute post vaccination period. When patient got up and left, he fainted at the end of the aisle and was found by a customer. Patient did wake up and was able to sit down and ambulance was called and took him
Mom reports that patient had about 30 little bumps around the upper injection site the size of her thumb Friday morning and got worse Saturday. Mom just applied topical Benadryl Friday. Saturday she gave her oral Benadryl and put on topical Benadryl cream. mom reports that it improved significantly Sunday. Today mom reports that its mostly gone but does report some bruise like spots around the injection site and is sensitive to touch
Tdap administered 4/28/14 for middle school entry. Awoke 4/29/14 am with bilateral leg pain, right side of face swollen, bilateral jaw pain with difficulty opening mouth. No fever. Also, had headache. Right side of face swollen with drooping mouth and right eyelid lag with excessive tearing. Sent to ED.
Shaking and trembling but no temperature (97.7) at 10 p.m.  It lasted about one hour then stopped after being covered with two blankets.  Fell asleep and at about 3 a.m. started again when he got up to go to the bathroom  for about 10 or 15 minutes and then stopped when he fell asleep.  Upon waking in the morning it was all over and he has been fine the rest of the day so far.
At daycare-teacher said patient had been complaining about foot and stomach pain throughout the morning. Awoke from nap and was irritable, lethargic, and extremely warm to touch. Teacher called me at approximately 3:05pm and took temp while on the phone. Temp was 101.9 under arm. When I arrived at approximately 3:15pm, patient was laying on the floor, shivering with blanket on him. Could hardly get up. When we got to the car I administered (2) junior strength Tylenol to help reduce fever. Called Drs. office to bring him in. Fever at time of appt was 101.9 under arm. Dr. examined patient and said she felt it was coincidental and thought he had a virus. His stomach at the time of evaluation was extremely gassy. She advised me to continue to monitor his fever and warned he may have diarrhea from the "virus." At approximately 8:00pm all symptoms and fever were completely gone. No diarrhea noted-normal stool.
pt recv vax; HA; Hives & hand swelling; DPH given; pt will no longer recv vax because has stopped working;
SIGNIFICANT IRREGULARITY IN MENSURAL CYCLES; ALTERED MENSTRUAL CYCLE; This spontaneous report received from a consumer concerned multiple female patients of unspecified age. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced significant irregularity in mensural cycles, and altered menstrual cycle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the significant irregularity in mensural cycles and altered menstrual cycle was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944982.
Information has been received from a registered nurse concerning a 10 year old patient who on an unspecified date was vaccinated with a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed injection site swelling and pain. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
This non-serious spontaneous case, initially received on 26-Nov-2017 from other-health professional, concerning a 35-50-year-old, adult female patient. On unspecified date, (reported as, 6-10 years ago) the patient was administered with influenza vaccine (dose, batch number, anatomical location, manufacturer, trade name, batch number, expiry date: not reported). On unspecified date, the patient experienced headache, fever, nausea, muscle aches, swelling/redness/mark at injection site, swelling other than injection site, hives, weakness, and dizziness. The outcome of the events was not reported.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 14:30 (Lot number: EN6198) at the age of 71 years as dose 1, single and administered in arm left, administration date 18Mar2021 15:30 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LEVOTHYROXINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient experienced sore arm on 26Feb2021 after the first dose and on 19Mar2021 after the second dose. Event did not result to urgent care and physician office visit.  No follow-up attempts are possible. No further information is expected.
Time of vaccine  maybe 10 to 15 minuets later i started feeling very hot, dizzy nauseous, tingling in my left arm from from finger tips all the way , vitals were 130/70 kept under observation the blood pressure went down and my temp was 98.3. After about half an hr i had tingling in my legs and nausea and tingling in my lips. I had taken two Zyrtec before the vaccine. Did feel itchiness inside my mouth.  By 1:30 i ate lunch i felt worse and disoriented. found i was repeating myself a lot. went to the ED and vitals remained stable. nausea persisted and dizziness. was off work for 3 days. Still felt the same for the next day. on the 2nd day i started having a dry cough and chest pain with nausea and dizziness, headache that doesn't go away.
Patient fainted and fell to the floor.  EMS administered first Aid and ref pt to hospital. Refused to be transported  by Ambulance car. Brother tranport pt to Hosp.
No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 10-FEB-2022, the patient was vaccinated with both improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (lot # 1741817, expiration date: 30-JUL-2022, strength and dose were unknown) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (V419) (lot # U7124AA, expiration date: 13-JUL-2024, strength, dose and route were unknown) for prophylaxis (product storage error). The temperature excursion had occurred when both vaccines were exposed to 0.8 degrees Celsius for 35 minutes on 05-FEB-2022 as confirmed by reporter. There was no previous excursion. No additional adverse event was reported.
ADVERSE EVENT: I noticed I had a ringing in my ears that has never stopped, since a week to 10 days after receiving the third dose of Moderna. I saw my PCP, she referred me to ENT. They did hearing tests and basically told me there was nothing they could do. COVID-19 outbreak - 05/02/2022. Symptoms started on 04/24/2022 with a scratchy throat, I had a cough which I thought was allergies. I tested at home on 04/25/2022 with a home test it was negative. I tested today (05/03/2022) and it came back positive. No achiness or anything like that just a pretty hard cough at times. I do not feel bad, it feels like seasonal allergies.
Swelling/induration/redness to vaccine site 24 - 48 hrs after injection, lt thigh only.  Dx: cellulitis -> DURICEF
Pr developed fever, pain at injection site, redness at injection site, and pain of muscles around neck.
Scratchy throat, quickly followed by cough. Then extreme sore throat and extreme difficulty swallowing. Took Benedryl (and debated going to the hospital). Symptoms improved by 10 PM. Cough and sratchy throat still continues.
Swelling; itching; feverish around and below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (feverish around and below the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), ALBUTEROL SULFATE, ESTRADIOL, GLIPIZIDE, OMEPRAZOLE, DICLOFENAC, CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN AND CODEINE), IBUPROFEN and OTHER VITAMIN PRODUCTS, COMBINATIONS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (feverish around and below the injection site). The patient was treated with ALLERGY MEDICATION (topical) for Swelling, Itching and Vaccination site warmth, at a dose of cream and IBUPROFEN for Swelling, Itching and Vaccination site warmth, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE WARMTH (feverish around and below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Consent for safety to follow-up was received.   Patient wants to know if itching is a side effect of the vaccine and if she should receive the second dose of the vaccine.
This spontaneous report as received from an office manager refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored GARDASIL 9 injection, lot # K026246, exp. date 28-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
She reports chronic urticarial hives x 2 months since receiving the booster dose. She did not receive the vaccine at this clinic.