chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fluzone high dose quadrivalent is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse event; Initial information received on 25-Sep-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old female patient and is reported influenza quadrival A-B high dose HV vaccinE [Fluzone High-Dose Quadrivalent] is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received a dose 0.7 ml of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength, expiry date: not reported lot U8132DA via intramuscular route in unknown administration site for immunization.  On 25-SEP-2023 fluzone high dose quadrivalent is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse event (poor quality product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event fluzone high dose quadrivalent is tainted, as the vaccines have exceeded the two-day window due to a possible excursion, that one of vaccine was given to a consumer with no reported adverse event.   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.
Received 2nd vaccine at 1:30pm on a Sunday afternoon. Woke up in the early hours of Monday not feeling great, didn't sleep well. Woke up at 8am for work with extreme chills, aches and pains. Tried to get up to get water, was so nauseous and lightheaded, I felt like I was going to pass out. Could barely stand up straight. Walked back to room and collapsed onto bed. Dry heaved into a trash can for a few minutes, feeling like I was about to throw up. Did not throw up. Took 2 Tylenol layed in bed, unable to move as I was extremely dizzy, nauseous and generally unwell. Fever of 99.?? (I forget). Fell asleep and woke up 2 hours later feeling better. Tylenol wore off around 5pm. Extreme chills and body aches came back. Fever of 100.4. Did not want to eat but had a few pieces of bread. Went to bed like normal that night. Felt almost back to normal the next day, still a little nausea with low energy but no fevers.
pt states she had fever, nausea, vomiting and diarrhea for one and half days.
Area on right lateral thigh is red about 7cm X 8cm and warm to touch.
The patient was accidently administered the Pfizer vaccine instead of the Moderna vaccine  for her second dose.  The last I spoke with the patient she had not experienced any side effects from the accidently switch
Patient received vaccine on 09/28/2014. On 10/05/2014, he stopped by the pharmacy to discuss the rash that appeared all over his arms and body. He bought BENADRYL OTC that day. Recently visited doctor; rec'vd BENADRYL and steroid and is recovering.
Faint/syncope within 1 minute of Gardasil vaccination. Patient was sitting and fainted forward-caught by Dr and positioned onto bed. No trauma.
PATIENT FELT NAUSEAUS, WAS SWEATING, FELT DIZZY AND HOT, AND ALSO THIRSTY APPROXIMATELY 5 MINUTES AFTER ADMINISTRATION OF VACCINE.  PATIENT WAS GIVEN 25MG OF DIPHENHYDRAMINE BY MOUTH APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF VACCINE, AND COLD WATER TO SIP.  PATIENT'S SYMPTOMS IMPROVED WITHIN 5 MINUTES AND CONTINUED TO IMPROVE OVER THE COURSE OF A 30 MINUTE OBSERVATION PERIOD.
This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A 85 year old, female patient of an unknown race, received PREVNAR 13 on an unknown date in 2012, single dose. The relevant medical history of the patient included asthma and allergic to penicillins since unknown durations. The relevant concomitant medications of the patient were unknown. The relevant past product history of the consumer included PNEUMOVAX since an unknown date in 2003 at an unknown dose and frequency for an unknown indication. It was reported that on an unknown date in 2012, the patient experienced redness in her arm and skin of the arm peeled off. The relevant laboratory data were unknown. Therapeutic measures taken if any, in response to the reported events was unknown. The consumer had recovered from the reported evens on an unknown date in 2012 at the time of report.
Within 1 and 1/2 days pt had chills, vomiting, abd pain, and diarrhea. he was fine by the next day and no residual issues.
Stroke; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP).  An elderly male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (life threatening), outcome "unknown", described as "Stroke". It was unknown if covid prior vaccination and if covid tested post vaccination. The individual (a neighbor) said that he felt the vaccine contributed to a stroke he had. Event resulted in life threatening illness (immediate risk of death from the event).  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Day 4 left nuchal pain and scapula excruciating which reduced in intensity from day 6 to become a discomfort and cleared completely  by day 16. No recurrence.  2.) Temp 99.1 degrees fahreinht Diarrhea x2 bowel movements with colic but I also purchased soup from Publix store so I cant blame Moderna for that.
evening post vax pt began t103 & sore arm;would not use arm-shakes, chills, nausea, t104.7;APAP & Ibuprofen & tepid bath;dizzy, fell down, head hurt, lethargic, ear hurt;
Patient has not experienced an adverse reaction from the vaccine itself, but was given the wrong bivalent immunization based on age. He was given the Moderna bivalent which is for 18 and older instead of the Pfizer bivalent.
Information has been received from a 40 year old female who on 11/17/03 was vaccinated IM in the left arm with a dose of pneumococcal 23v polysaccharide vaccine. On 11/19/03, the patient presented to the emegency room with excruciating pain in her arm and swelling at the injection site. The patient noted that within 3 days, the site had swelled to 5 inches in diameter. The patient also noted swelling at the site of the lymph node and swelling over her entire body. She also indicated that she cannot raise her arm at the present time. The patient was admitted to the hospital on 11/19/03, and received a shot of morphine for pain. It did not relieve her pain. She also received x-rays at the site of vaccination, and blood work was done. The results were not reported. The patient was discharged from the hospital on 11/20/03. On 11/23/03, she returned to the emergency room. At that time, she was given prednisone, which did not help. At the time of the report, the patient was still taking the prednisone. She was not admitted to the hospital on this occasion. On 11/25/03, the swelling at the site was reported as 3 inches in diameter, and the patient reported that she was still having excruciating pain at the site. The outcome was reported as not recovered. Follow up information received on 12/1/03 from the patient indicated that she went back into the hospital on 11/25/03. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Additional information has been requested. It has been determined that WAES #0311USA02852 is a duplicate of WAES #0312USA00048. Therefore, WAES #0311USA02852 is being deleted from our files and the reports consolidated into WAES #0312USA00048
She reports having muscle spasms of the neck, and went to ER. Her treatment included oral medication of hydrocodone and flexeril in the ER along with observation.  She was discharged home with oral tramadol, Medrol, and flexeril for pain.  She reports that her symptom's last about 30 hours before subsiding.
Severe muscle/joint aches; severe headache; fatigue; nausea. Redness and swelling at injection.  Symptoms began approximately 20 hours after injection and persisted for approximately 84 hours.
3x3 inch area with red and raised tender induration on left thigh. Not cellulitis at this time but will treat prophylactically with antibiotic.
A few days later participant had a severe nose bleed. Called doctor and dr. advised a chest x-ray but did not get x-ray. Dr. also said to stop using nose spray, and prescribed Mupirocin.
Had the Moderna vaccine, came down with COVID/felt like had cold; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had the Moderna vaccine, came down with COVID/felt like had cold) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced COVID-19 (Had the Moderna vaccine, came down with COVID/felt like had cold). At the time of the report, COVID-19 (Had the Moderna vaccine, came down with COVID/felt like had cold) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant products reported.  The patient had Covid Friday night, woke up Saturday (as reported) and just felt like had a cold and a week later still felt like just had a cold, never got sick. The patient clarified that she had the Moderna vaccine, had the 2 shots and 2 boosters, total of 4 doses. The patient was going to get the 3rd booster but become positive before getting 3rd booster.  No treatment products reported.
for 24 hours I had extreme body aches, headache, nausea, fatigue
Administered Flu shot approx 9:15am by 9:30am pt was dizzy & nauseated - SOB, sent to ED developed slight wheezing treated with O2 & fluids, VALIUM & ZOFRAN. Improved after 2 hours - treated & released to home.
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 5-year-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 12-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Redness, swelling (about 3 inch diameter) mild pain. Minor itching appeared 24 hrs after shots.
Muscular soreness to the point that I could barely roll over in bed or stand up from a sitting position without assistance from my husband. I am a nurse, I work, I play golf several times a month, and I walk about 3 miles per day. I was almost incapacitated. I am not much improved, but my shoulder still is "sore" and I have a crick in my neck. I just thought this should be reported so it can be monitored in other patients. I hope I will soon be over these symptoms. I did not attribute this to the flu shot until a fellow nurse who also had the vaccination about the same time, reported the SAME adverse effects and the same 'crick' in her neck. She is also a nurse at medical center in the behavioral unit where I work.
Pt started getting nodules over entire body and was in pain.  He went to the ER today and was given morphine for pain.  He did not have blood clots.  He was given hydrocodone and ondansetron for home use.
Left arm shoulder stiffed up, couldn't raise arm. Taken Advil and Tylenol. Condition slowly improving but today still in pain.
After receiving the second dose of the Pfizer vaccine, in the observation area the patient vomited and lost consciousness.  EMS treated the person at the scene and was transported to a medical facility.
she was a little sick after the two dose Shingrix shot / Strong reaction/ was sick a couple of days; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma (diagnosed 15 years ago). Concomitant products included vitamin d, triamcinolone (Nasacort), fexofenadine and budesonide + formoterol fumarate (Symbicort).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting vitamin d and Nasacort, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The patient had 2 doses of Shingrix and was a little sick for couple of days. The patient got pretty hard, strong reaction after that one. No further information was provided.
Tiny red spot under the skin and blotches about 1 cm size on several fingers on both hands
This 85 year old white  female received the  Pfizer Covid shot on 1/26 /21    and went to the ED on  1/31/21     and was admitted  on 1/31/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) I63.9 - Stroke determined by clinical assessment (CMS/HCC) R29.810 - Facial weakness
Second round of GARDASIL shot was injected approximately 12PM on 7/23/2018. This is one month earlier than the general vaccine schedule, as the first round was given on 6/21/2018. The suggested schedule for vaccine is for the 2nd vaccination to occur 2 months after the first vaccination and the 3rd to occur 6 months after the first vaccination. Patient was extremely fatigued from 7/24/2018-7/25/2018, and could hardly leave the bed or stay awake. Patient slept approximately 12 hours the night of 7/24/2018, got up for work and made breakfast and shortly returned to bed sleeping 3 more hours. Patient is starting to feel slightly better, but still fairly fatigued as of 3:30PM 7/25/2018.
Initial misuse report received on 02 December 2013 from nurse. A child patient whose gender, age, medical history and concomitant medications were not reported, received a dose of DAPTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. Administered extra dose of DAPTACEL to child who had incomplete vaccine record. Patient did not have any adverse events. List of documents held by sender: none.
Patient states she began experiencing shooting pain in shoulder about 4 days after vaccination. She states it is not constant pain and only occurs when she moves her arm in certain ways. She believes it is bursitis related to her injection occurring too high in her arm.
This spontaneous report as received from a registered nurse refers to unspecified amount of patients. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX. Administration route, date and lot number were not reported. The nurse reported that the ZOSTAVAX was exposed to a temperature of 1.4C for 30 hours. She also reported that the ZOSTAVAX had multiple excursions in which it was exposed to a temperature between above -15C to -10C for an unspecified amount of hours which she "believes" was due to defrost cycles. No adverse effect reported. This is one of three reports received from the same source. Additional information has been requested.
Appears the injection may have been given a little low- not sure it hit the muscle   Site is large- no swelling, but is red. Patient denies any itchiness or pain.
PATIENT NOTICED A RASH AROUND THE INJECTION SITE SHORTLY AFTER GETTING HOME. PARENT WAS NOT NOTIFIED UNTIL  A LATER DATE. PARENT CONTACTED THE OFFICE AND WAS GIVEN AN APPOINTMENT. PT PRESENTED WITH A PAPULAR RASH AT INJECTION SITE AND IN THE PALM OF THE HAND.
patient was nervous before the shot then got flushed and dizzy about 5-10 minutes after the shot. this made the patient more anxious and a little nauseous. she laid down with her feet propped up and had cold compresses on forehead and neck with arms crossed and within 5 minutes patient felt a lot better. she remained laying for another 10 minutes just to make sure she was better prior to getting up. after that she waited in the pharmacy in a  chair for another 15 minutes for observation with no further complications.
Temp 103.4 <24 hours. Red area <(a dime) in size.
Headaches, chest tightness. There is purple bruising size of half dollar at the site of injection.
Fever 100-103; severe chills; body and joint aches; body and joint aches; weakness; fatigue; swollen lymph glands right armpit; sore injection site; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247, expiry date: unknown), via an unspecified route of administration on the right arm, on 25Jan2021 12:30, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included penicillin allergy, hypertension (HTN), obesity, hypothyroidism, iron deficiency anemia, s/p gastric bypass in 2010 (11 years), and GERD. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination. Concomitant medications (other medications in two weeks) included amlodipine benazapril, levothyroxine and pantoprazole. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0140, expiry date: unknown) received at 59 years of age, via an unspecified route of administration on the left arm, on 04Jan2021 12:30, for COVID-19 immunization. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 01:00, the patient experienced fever 100-103, severe chills, body and joint aches, weakness, fatigue, swollen lymph glands right armpit and sore injection site. The patient was not tested for COVID-19 post vaccination. No treatment was given for the events. The patient was recovering from the events.
Autoimmune Hepatitis Flare; This is a literature report.  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing), notes: elevated liver enzymes associated with fatigue.; "autoimmune hepatitis was controlled" (unspecified if ongoing), notes: on a regimen of prednisone and MMF for, six months. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: HEPATITIS (medically significant), 3 weeks after the suspect product(s) administration, outcome "recovered", described as "Autoimmune Hepatitis Flare". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: 105, notes: significant increase from normal the month; 87; Aspartate aminotransferase: 99, notes: significant increase from normal the month; 73, notes: within two months; Biopsy liver: autoimmune hepatitis; Hepatic enzyme: elevated; lab work-up: autoimmune hepatitis. Therapeutic measures were taken as a result of hepatitis.  Clinical course:A 67-year-old female with a past medical history of hypothyroidism was found to have elevated liver enzymes associated with fatigue. Further lab work-up and liver biopsy revealed autoimmune hepatitis. This patient's autoimmune hepatitis was controlled on a regimen of prednisone and MMF for six months. However, three weeks after receiving the third COVID Pfizer vaccine, this patient's labs exhibited AST: 99 and ALT: 105. These values were a significant increase from normal the month before. Her immunosuppressants were up-titrated with an increase in MMF and the addition of cyclosporine. Her labs improved to AST: 73 and ALT: 87 within two months. <br/>Discussion(s): These cases demonstrate that COVID vaccination may play a role in autoimmune hepatitis flares.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (HEPATITIS) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300091486 Same article/ drug/event and different patient;US-PFIZER INC-202300199135 Same article/ drug/event and different patient;
Patient received vaccine on 8/28/2020. Patient came to pharmacy on 8/31/2020 reporting that her arm was sore, itcy and red in the area of the injection site with some pain as well. patient was advised to take Tylenol or ibuprofen, keep the site clean and monitor to see if anything worsened. Patient was also found to have a low grade fever of 99.9F. Patient stated that it did not seem to be any worse to day than yesterday. Patient was advised to contact PCP and we reached out to PCP as well.
patient reports having itchiness immediately following the vaccination same day.  She then noticed a red spot that seemed to grow to about 5-6 inches in diameter and was warm to the touch.  She went to her local provider to have it looked at and was prescribed azithromycin antibiotic in case it was infection based and not just a localized allergic reaction.
P/receiving Rubella vax experience dizziness & heart palpitations. c/o feeling very hot & face became flushed. Onset of sx was with 30 secs of inject.