chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a adult patient who received ENGERIX B (batch number 79ZS7, expiry date unknown). Co-suspect products included ENGERIX B (batch number A9LB7, expiry date unknown) and ENGERIX B (batch number ZR2M5, expiry date unknown). On 29th February 2016, the patient received the 1st dose of ENGERIX B. On 28th March 2016, the patient received the 2nd dose of ENGERIX B. On 28th June 2016, the patient received the 3rd dose of ENGERIX B. On 28th June 2016, not applicable after receiving ENGERIX B and ENGERIX B, not applicable after receiving ENGERIX B and ENGERIX B and an unknown time after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced therapy non-responder and pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too short and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The reporting pharmacist was the dispensing pharmacist. The age at vaccination was not reported. The regimen used was 3 doses on a schedule of 0, 4 weeks and 12 weeks later. On 28th June 2016, the patient received 3rd dose of ENGERIX B, which led to shortening of the vaccination schedule. The patient who was a healthcare worker at the facility received 3 doses of ENGERIX B with an anti-HBsAg level less than 10 mlU/ml 1 to 2 months after receiving 3rd dose. The patient was then given three more doses of ENGERIX B and a titer would be measured in 1 to 2 weeks after the reporting date. The reported batch numbers (792S7, A9LBZ) of ENGERIX B did not exist and was updated to 79ZS7 and A9LB7 as per sales database. There were 2 more healthcare workers at the facility (US2016GSK131990 and US2016GSK131990), who had experienced the same outcome after three doses of ENGERIX B.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female 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 not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 in right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced suspected covid-19 infection. On 06-MAR-2021 20:30, Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 12-MAR-2021 13:20, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This case is associated with PQC number: The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria based on the PQC evaluation/investigation performed.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious..
99.7 fever; chills; diarrhea; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 99.7f fever, chills, diarrhea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) 99.7F Fever, chills, diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 99, 7f fever, chills, diarrhea was unknown.
Pfizer Dose 1 3/10/21 (EN6199) Pfizer Dose 2 4/2/21 (EN6198) COVID Positive 1/17/22  1/17/22: 78-year-old female with heart failure with reduced ejection fraction LVEF 30 35%, atrial fibrillation anticoagulated on warfarin, coronary artery disease status post PTCA and stents, COPD not on home oxygen, CKD stage 3, dementia and hypothyroidism presented with chest pain and shortness of breath.  Due to patient's dementia history is obtained from her son at bedside.  Patient lives with her son and complained of shortness of breath which has progressively worsened over the past 2-3 days with decreased oral intake and the increased confusion.  Patient also complained of chest pain, has been having cough. Patient is vaccinated for COVID-19,  not receive the booster yet.  In the emergency room patient was febrile with T-max of 100.7°, tachycardic, tachypneic and hypotensive.  Hypotension resolved after IV fluids. COVID-19 rapid antigen is positive, INR 2.5, lactic acid 3.1 and creatinine of 1.3 which is close to patient's baseline otherwise unremarkable CMP and CBC.  Chest x-ray showed infiltrate in the right lung base.  Patient received IV fluids and levofloxacin in the emergency room  1/18/22: Albuterol HFA  P.o. Levaquin course  P.o. Decadron course  P.o. Zinc sulfate, vitamin-C and vitamin D  Continue on home Coumadin dose  Hemodynamically stable for discharge  Will discharge home with nursing services  Follow-up with PCP in 3-5 days  Patient agrees with plan of care
This spontaneous report as received from the patient's sister refers to a female patient of unknown age. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (albumin status, lot#, expiration date, dose, route and site of vaccination were not reported). There was no concomitant medication. On an unknown date, the patient experienced high fever. The patient had an office visit on an unspecified date. The outcome of high fever was reported as recovered/resolved on an unspecified date. The relatedness between the event and M-M-R II was not reported. This is one of several reports from the same reporter. Additional information has been requested.
7/20/2021 Client received Janssen COVID 19 vaccine in a long term care facility. 8/2/2021 Client died at long term care facility 8/3/2021 Coordinator received email notification of client's death
Patient became nauseous and did vomit within 5 minutes of IM injection. Monitored for 15 minutes afterwards. No other reactions.
mom states: whelps appeared the morning p/vax; PMD called; tx w/DPH this happened 3 times that day & once today
Severe body aches, fever up to 102 lasting four days, headache, chills/sweating, lethargy/fatigue, injection site pain for weeks.
Sitting in lobby. Noticed her lips were pale. SHe leaned into her mom c/o not feeling right. Pale. C/O not being able to feel anything. C/O not being able to hear in left ear. Moved extremities on command. Diaphoretic. Ammonia capsule broke. Immediate response. Did not lose consciousness. Had not eaten anything. Gave lollipop and water. Alert and oriented. BP 110/80. Within 2 minutes color in lips pink again. C/O ringing in ears. Ringing in ears last 2-3 minutes. Stable and allowed to go home after an additional 20 minute waiting period.
Fever and rash 10 days after vaccine. Temp up to 100.7. Macular rash on chest only. No treatment.
Has varivax 3-3-00, Had full blown varicella 2/5/02, keep home x 1 week Vaccine failure
Day of shot my left arm felt sore and also  my left arm pit.  By evening it was so sore it hurt to move arm or touch arm pit. Morning after 1 PM second shot, my left eye was almost completely covered in blood.  My arm pit also very sore and found a bruise on the side of my left breast and also on my left hip.   I slept a lot and by the next day everything eased up.   After another day my eye was clear and bruises fading.  The last thing to go away was the soreness in my left arm pit.
she got her first covid vaccine dose and then got covid; she got her first covid vaccine dose and then got covid; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Reporter was asking how long she has to wait after having covid to receive her second vaccine dose. She got her first covid vaccine dose and then got covid causing her to miss her second dose. Now asking how long she would have to wait to get her second dose after having Covid. The outcome of the event was unknown.  Information about lot/batch number requested.
Dizziness, passed out, diarea, throwing up, chills, headache, body aches
Body was completely covered in red rash and hives, and was skin hypersensitive to touch. Very itchy. Twitch began under right eye and has been consistent for almost one week.
This spontaneous report as received from a health care professional refers to a 56 year old female patient with diabetes mellitus (DM), (DM) neuropathy and tinea pedis and no adverse events following prior vaccination. On 08-APR-2013 at 10:00am the patient was vaccinated with a first dose of PNEUMOVAX23 (lot # H015749 exp date 08-JUN-2014) first dose, intramuscular in the right deltoid (dose unspecified). Concomitant therapies included NEURONTIN, clotrimazole, metformin, benazepril, and aspirin. On 08-APR-2013 in the afternoon the patient experienced headache (H/A), generalized swelling and tenderness of site in the right deltoid, objective fever, chills, pruritic rash on right deltoid and upper chest, pain in site. On an unknown date (H/A), generalized swelling and tenderness of site in the right deltoid, objective fever, chills, pain in site had improved, but pruritic rash on right deltoid and upper chest did not improve unchanged. The patient required a doctor's visit and was instructed to take TYLENOL per needed (PRN), steroid taper and emergency room (ER) precautions. Additional information has been requested.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 03-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15f and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Gastrointestinal esophagus flare; pain; chest pain; unable to eat; This is a spontaneous report from a contactable consumer. A 41-year-old female consumer (patient) reported for herself that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9269) via an unspecified route of administration in arm left on 25Feb2021 (at the age of 41-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in arm left on 04Feb2021 for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Relevant medical history included allergy to iodine and sulfa medicine. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17Mar2021 the patient experienced gastrointestinal oesophagus flare, pain, chest pain, unable to eat. All started two weeks after last shot and while severed from March through July, still going on. The events were serious due to disability and resulted in Doctor or other healthcare professional office/clinic visit and Emergency Room visit. The patient underwent heart tests, esophagus scope and other tests (unspecified). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The events were not resolved at the time of report.
Fever up to 102; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection" (unspecified if ongoing), notes: Structured information (Patient episode name): PANDAS. Concomitant medication(s) included: FLU taken for immunisation, administration date 23Oct2021; NALTREXONE. The following information was reported: PYREXIA (non-serious) with onset 15Nov2021 00:30, outcome "recovering", described as "Fever up to 102"; VOMITING (non-serious) with onset 15Nov2021 00:30, outcome "recovering", described as "vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, vomiting.  Additional Information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. List of any other medications the patient received within 2 weeks of vaccination: Low dose naltrexone. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. If other vaccine in four weeks= Yes. Other vaccine 4weeks details other vaccine 4weeks product=Flu (unknown) other vaccine 4weeks vaccine= date =23Oct2021. Other medications in two weeks= Low dose naltrexone. If covid prior vaccination= No. If covid tested post vaccination= No. known allergies= No. Other medical history= PANDAS. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-congenital anomaly/birth defect: No. Relevant medical history and concurrent conditions. Structured information (Patient episode name): PANDAS. Reaction/event as reported by primary source Fever up to 102 and vomiting. Date of start of reaction/event: 15Nov2021 00:30. Outcome of reaction/event at the time of last observation: Recovering/Resolving. Hospitalization Prolonged: No. Treatment Received: No.  No follow-up attempts are possible. No further information is expected.
The morning I received vaccine 4/6/21, I had no ill effects. I received the vaccine about 4 and 1/2 weeks after having Covid. The next morning 4/7/21  I had severe aches and pains and a fever of 99-100.5. I stayed in bed all day, the fever ended at 7 pm that evening. That evening I went to bed feeling weak tossed and turned the enter night had very  severe aches and pains worse than normal my entire body from my neck to my legs,  the aches and pains were unbearable. I took cipro at 5 am that morning 4/8/21  due to a UTI infection with a lot of water no food. I got up with the aches and pains I had and felt very nauseous.  I decided to shower and felt faint. I passed out for 30-40 seconds on my bed according to my husband when I came to I had no recollection of fainting, This all happened at around 7am. I ate a few bites of a half of a ham sandwich and  had juice which helped to get me to feeling a bit better. My husband took my pressure that was very low my doctor who I spoke to said this may have caused me to faint but that the vaccine may have led to this as well.  I was weak from it all but started to feel better and I?m fine now.  My next vaccine is April 27, I?m afraid to take it but the doctor advised to take  it.
Patient came in for booster shot, stated he had to go to ER day after vaccine for extreme discomfort, tingling, low fever, rash on head, T B/P, sore left arm and nausea.
A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that inadvertently gave FLUMIST to patient with asthma. The outcome of the event of inadvertently gave FLUMIST to patient with asthma is unknown. The reporter was considered to be non-serious.
Shortness of breath Palpitations  Diarrhea  Abdominal pain
Face swelling and rash on the chin area. Nausea, and vomiting all within 24-48 hours of receiving the vaccine.
After receiving vaccine,1&1/2 hours later, felt feverish, chilly and had sensation of fur over his body. Later, developed a headache and felt that his throat was closing.
Patient called into the pharmacy complaining of bloody noses and blood coming out of ears for the past 3 days (started around 5/1/21). Patient received Moderna on 4/8/21. Patient is not currently bleeding but was instructed to contact his doctor ASAP. Followed up with patient and he states he did contact his physician and has an appointment scheduled for tomorrow.
PATIENT STARTED HAVING ITCHING AND RASHESS THAT STARTED LATER DURING THE DAY AND THE RASHES IS STILL PRESENT AFTER 2 WEEKS HOWEVER IT IS SUBSIDING. PATIENT STARTED TAKING BENADRYL TO RELIEVE THE SYMPTOMS.
This spontaneous report as received from a registered nurse refers to a 12 years old female patient with no drug reaction or allergies. The patient was vaccinated with the first dose of GARDASIL (lot # 663452/0671Y, expired date 18-SEP-2011) on 03-SEP-2009. No other co-suspects were reported. No concomitant medications were reported. On 03-SEP-2009 the patient became very faint and flushed. The patient was in the office at that time, and she had to lie down for a while. The patient was recovered on an unspecified date. Nurse stated the patient did not want to continue with additional doses to complete the series. Additional information is not expected.
administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 102 doses were given from LOT 026C21A  Treatment medication was not provided by the reporter    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non Significant  follow up was received
29OCT93 devel a h/a frontal pain; h/a resolved when Advil was taken; h/a cont until 2NOV93;
Patient received his second dose of shingrix at another facility on 7/31/19. He reported to our clinic on 8/7/19 with complaints of a rash starting 3 days prior.  The provider determined it was shingles upon their assessment and prescribed the patient acyclovir 800mg 5 times per day x 7 days.  Patient saw his primary provider on 8/13/19 who reports patient continued with typical zoster type rash on left torso as well as headache and some ataxia. Unsure if this is related to the shingles or acyclovir. Patient was advised to DC the medication as he only had 1 day left and report any changes to provider as there is a concern for secondary bacterial infection. Patient was also prescribed lidocaine patches.  The nurse spoke to the patient on 8/19/19 as he continues to report the rash, but the headache and ataxia resolved shortly after stopping acyclovir.
DAY OF VACCINE: (Mar. 4, 2021) fatigue triggered a few hours after vaccination  DAY AFTER VACCINE:  (Mar. 5, 2021) all-day fatigue chills fever. (102.7 beginning of day, 102.1 mid-day after Tylenol, 102.9 evening) aches:  head, eyes, neck, stomach, whole body no appetite