chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 05-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-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 had 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 records 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 patient's 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.
Mom stated pt was with his father and when she picked him up the dad stated his arm was red and swollen. R arm injection site measured 3 1/2 inches across 2 3/4 inches down.
I received the first dose of the Pfizer vaccine on February 25, 2021 at approximately 9:30 AM.  About 2 hours later I began to sneeze quite frequently.  About 3 1/2 hours after the shot hives began to break out on both my hands.  Later, during the early evening hours I began to sneeze more rapidly and repeatedly.  I also began blowing my nose repeatedly due to the massive amount of mucous my body was producing. I became very sick with a cold and stayed in the bed Friday (2-26-2021) through Monday (3-1-21).  I also began breaking out in hives on the back of my neck in patches and individual hives over various parts of my body. I went to a  Medical clinic on Tuesday (3-2-21) and was given Zyrtec. Feeling much worse the next day (3-3-21) I went to the Medical clinic and received a COVID test (both the rapid and PCR tests  were negative.  I was prescribed cough medicine and given a steroid shot.  My symptoms persisted after this visit and did not get better.  Particularly, my cough became extremely bad.  I coughed so much my throat became sore from the coughing and became nauseated.  Also, a patch of hives had surfaced under my chin.  I returned to the Medical clinic on March 12th.  I was given a COVID rapid test and a Flu test.  Both were negative.  The chest x-ray was also clear.  I was prescribed the following medications during the March 12th visit:  Albuterol Sulfate Inhaler, Azithromycin pack, Virtussin cough medicine, and sudafed.  My symptoms subsided somewhat, but the cough remained relentless.  I want to a Primary Care Physician on March 16th and was prescribed a Methylprednisolone (6-day steroid) pack.  I also made an appointment to see an Allergist.  I was diagnosed with Asthma and was prescribed Symbicort, fluticasone, and levocetirizine.  The Allergist advised that I continue with the steroid pack as well.  Please note, I have never been diagnosed with or suffered from allergies or asthma prior to taking the vaccine shot.
Information has been received from a 62 year old male registered nurse (concerning himself), with hypertension, drug hypersensitivity to refecoxib (MSD), a sulfonamide allergy, and a history of angioplasty, who in approximately 1997 ("about 10 years ago"), was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included influenza virus vaccine (manufacturer unspecified) and unspecified therapy for hypertension. In approximately 1997, he reported having a "violent reaction" to the vaccination, described as nausea, vomiting, "threatening cramps in the stomach," and "his whole body felt like going down the tubes." He reported the symptoms were "severe" enough that he considered calling 911, though he did not actually do so, nor did he seek any other medical attention. At the time of this report, the patient confirmed he had recovered, though the duration of the events and date of recovery was not specified. The patient had a history of cardiovascular disorder while on prior therapy with rofecoxib (MSD, WAES 0706USA02510). Additional information has been requested.
Pt given DTP 25Feb91 in lt thigh.On 19Mar91 mom of pt reported lt thigh swollen,hand,bruised,but /wout drainage.As of 16Mar91 pt had developed transient fever.Temp not taken.Mom has not adm APAP ie assessing if effective in reducing T.
Approximately 10 hours after I received my injection and I started running a very high fever. I was also vomiting everything that I tried to eat or drink, taking ibuprofen or Tylenol did not do anything to get rid of some migraine like headache that contributes to nausea and vomiting. It?s been two days now and I?m still running a fever averaging around 101, and I am still very tired and sore. I don?t know if this has anything to do with it but I do know that my blood type is O negative
This spontaneous report as received from a consumer refers to her 18 year old daughter with hay fever and with no pertinent medical history, who on 22-MAY-2013, was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) in her left arm. There was no concomitant medication. On 23-MAY-2013 morning, the patient fainted on the bathroom floor. The patient also had developed a headache and the injection site was sore and tender. The patient felt extremely tired. The reporter contacted the physician on 23-MAY-2013, by telephone, and was awaiting a response. No treatment was given for the events. The outcome of the events was reported as recovering. The causality was not reported. No laboratory diagnostic studies were performed. Additional information has been requested.
Pt noticed couple hours after being administered pneumonia vaccine that site was swollen, red, and pain. Pt called pharmacy 9-13-11 to report reaction. As of today, no pain no redness, slight edema remains.
red, tender, swollen area, 2 inch in diameter lower on her upper arm but not in the deltoid; anxious; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from the patient via phone.  This case involves a female patient of unknown age who experienced red, tender, swollen area, 2 inch in diameter lower on her upper arm but not in the deltoid (inflammation) and she was anxious (anxiety), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On 08-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE in the deltoid (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious red, tender, swollen area, 2 inch in diameter lower on her upper arm but not in the deltoid (inflammation) and she was anxious (anxiety), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information available on the batch number for this case.
On January 3, 2022 I was sitting at a desk doing my work and lost my vision, had a piercing amplified noise in my left ear and was unable to stand or walk. I was rushed via 911 to a local hospital. I was administered a TPE within the first two hours and then transferred to another hospital . On January 7, 2022 upon my neurosurgeons recommendation Dr. Stated that the medication he was administering throughout the week was not as successful and that surgery was required. That day I had surgery for the cerebellum stroke suffered.
she got a upper respiratory tract infection after getting the first Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract infection in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upper respiratory tract infection (Verbatim: she got a upper respiratory tract infection after getting the first Shingrix vaccine). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the upper respiratory tract infection was resolved.   It was unknown if the reporter considered the upper respiratory tract infection to be related to Shingrix.     It was unknown if the company considered the upper respiratory tract infection to be related to Shingrix.   Additional Information: GSK receipt date:02-JUN-2023 The patient stated that she got a upper respiratory tract infection after getting the first Shingrix vaccine.  She disconnected the line prior to getting anymore demographics, details of the event such as timing as to when her respiratory infection occurred after her vaccine, or information about the vaccine itself.  She did stated that she took antibiotics which she finished 5 days ago. The reporter did not consent to follow up.
COVID vaccine given by medical assistant from open vial. After administration, MA realized that the open vial was past the appropriate period of time after vial puncture during  which doses can be drawn up. Process reviewed by management with employee. No adverse effects noted.
Member was injected with  0.5 ml  of the Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL  vaccine intramuscular in the   left arm instead of the Tdap vaccine.  At this time, no signs and symptoms of an adverse reaction has been reported.  Member seen by his primary care provider on 7/21/2022.
Soreness at the site of injection, Fatigue, Headache, Muscle Aches, Diarrhea
Immediate pain/soreness in arm greater than usual with vaccination. Next day patient woke up with bruised arm at injection site and swelling below and to the side of the injection site . Swelling area approximately 2inches wide by 3 inches long. Pain and swelling not abated by ibuprofen. Physician contacted 2 days after vaccination and noted trauma from the injection.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dose from a vial that was punctured for more than 12hs) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported. Nurse had an event in the facility where they work that was opened 9 am 23Aug2021. After that it was stored refrigerated between 2-8°C and today 24Aug2021 doses from that vial were administered to 4 patients. Nurse understands the vial expired by 9 pm 23Aug2021 although it was stored refrigerated.
SUSPECTED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative via social media concerned a 74 year old male. Initial information was processed with the additional information received on 02-FEB-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: lung problems. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. It was unknown if the patient had any adverse events with series 1 (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported ,1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, and breakthrough covid-19 infection (dose number in series 2). The reporter stated that "2 of my family did get the new Covid as a breakthrew. Her older husband about 2 weeks but was at home. He is 74 with lung problems. Doing great now. At the gym working out. That boost he had probably saved his life. He had no problems with the vaccines." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000215671 This case, from the same reporter is linked to 20220204795.; Sender's Comments: V0-20220203948-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
A week after my covid vaccine shot I can hear my heartbeat extremely loud. I still hear it and It extremely hard to do basic task such as reading and listening.
Shortness of breath, Covid like characteristics in lung X-ray. Took 2 Covid tests both negative
I hear ringing in my ears like a really high-pitched buzzing sound. I don't pay attention to it all the time and the volume changes from time to time most of the time it's really loud. I wish I didn't have and I wish I knew how to stop. I told my doctor about it and I was given a hearing test. Since the vaccine I have had this happen more and more.
Client c/o feeling dizzy, 12she had the wherewithal to get down onto the floor.  Public Health Nurse placed ice pack to back of neck, offered water and juice. Client became lethargic, pallor, cyanosis of the lips. FD and EMS was on site, provided care and was sent to hospital via EMS.
PER PATIENT HER LEFT ARM DEVELOPED A RED CIRCULAR AREA AROUND THE SITE OF INJECTION THAT BECAME INCREASINGLY LARGE AND LESS CIRCULAR. IT IS WARM TO THE TOUCH AND SEEMS TO BE A "POCKET UNDER THE SKIN".  PATIENT REPORTS THE AREA ITCHES/BURNS/HURTS. IT SEEMED TO BE A SOLID MASS AT FIRST BUT NOW IS MORE PLIABLE.
FEVER 101, BODY ACHES, HEADACHE, CHILLS, NAUSEA, SORE ARM
pt recv vax & devel unspecified sx following vax w/Hep B; MD reported 3 pts; They were assigned WAES94030368 through 94030370; No further details were provided;
had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; had more or less the same reaction that the caller had, Her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible; This is a spontaneous report from a contactable consumer (friend's wife). This consumer reported similar event for 2 patients. This is the second report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had more or less the same reaction that the caller had, her lips felt swollen and they were tingling, she had a taste like lead or metal in her mouth, she was not feeling well and she had disgusting diarrhea, it was black and horrible. The outcome for the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021894470 same reporter/drug, different patient/AE
diagnosed with COVID-19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (diagnosed with COVID-19). 25-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (diagnosed with COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            Concomitant product included thyroid medications. Treatment information was not provided.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Causal association between the drug ineffective and mRNA-1273 is assessed as possible.
IMMEDIATELY FOLLOWING ADMINSTRATION PATIENT APPEARED TO HAVE A SHORT SEIZURE (LESS THAN 5 SECONDS) PT WAS RESPONSIVE IMMEDIATELY ACKNOWLDING HER NAME VERBALLY.  911 WAS CALLED  IMMEDIATELY. SHORTLY THEREAFTER PROBABLY LESS THAN 3 MINUTES ANOTHER APPARENT SEIZURE FOLLOWED,  AGAIN PATIENT WAS IMMEDIATELY RESPONSIVE, AN AMBULACE  ARRIVED AND PATIENT WAS EVALUATED BY EMT.  THE EMT WAS QUITE SURE IT WAS A VASOVAGAL RESPONSE AND DID NOT INSIST THE PATIENT GO TO THE HOSPITAL.
Information has been received from a licensed practical nurse concerning an 18 year old white female with no known drug allergies and no past medical history who on 10/25/95, when she was 10 years and 11 months, was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot #608667/0426B). There was no illness at the time of vaccination. There was no concomitant medication. On 3/22/03, the patient broke out with a rash which was described as approximately 25 chicken pox that were small. Unspecified medical attention was sought. Follow up information received from a licensed practical nurse indicated that on 3/24/03 in the Am the patient developed a modified case of varicella. On 3/31/03 the patient recovered. No further information was expected.
Localized allergic reaction. Uticaria on the left side and rash on his abdomen. Benadryl 50mg IM. IV TKO.
BLOOD PRESSURE SHOT UP TO 220/200 ON SAT NIGHT?.I WAS GIVEN VALIUM 1 MG DRIP?AMILIDOPINE ?.THEN THIS REOCCURED ON MONDAY, 2 DAYS LATER?ONCE AGAIN BACK TO THE ER..BLOOD PRESSURE SLOWLY RETURNS TO NORMAL OVER 1 MONTH OF AMLIDOPINE 10 MG 2X PER DAY PLUS HYDROCORTIZONE 5 MG 3X PER DAY
Dizzy/ Lightheaded; Sore arm; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 21Feb2022 at 17:00 (Lot number: FJ6369) at the age of 20 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: PROZAC; HYDROXYZINE and GLYCOPYRROLATE.  The following information was reported: DIZZINESS (non-serious) with onset 21Feb2022 at 17:15, outcome "not recovered", described as "Dizzy/ Lightheaded"; PAIN IN EXTREMITY (non-serious) with onset 21Feb2022 at 17:15, outcome "not recovered", described as "Sore arm". Therapeutic measures were taken as a result of the pain in extremity.   Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment included tylenol for pain in extremity.   No follow-up attempts are possible. No further information is expected.
pt. complain of tightness of the throat after the first vaccination of Pfzer.  h/o of HTN. BP 161/106, HR 85.   Symptom was resolved and she went home after comfort measure.
burning on injection, redness developed same day, large, erythematous patch developed, 4cm x 6cm, became painful to the touch and began to spread towards the left axilla.