chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (injection, lot # L044058, expiration date 02-MAY-2017)(dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Started to have soreness in the left arm the day after with body aches the next day (12/30). Then developed low grade fever up to 99.9F, chills, and body aches on 1/1/21.
two friends who got the shot, then got shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter has friend who got the Shingles shot, very expensive and then got shingles. The reporter stated, he/she would support a rule where if something did not work as advertised the company would be required to pay the medical expenses incurred. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case has been linked to the case US2021AMR183256 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183256:Same reporter
Next morning after 2nd shot, extreme body pain and headache.   This lasted 4 days.  Took arthritis strength Tylenol and hydrocodone to stop the pain and let me rest. I have been feeling very sick since the 2nd shot to this day, August 11th.  I do not see an end to this body pain, headache, weakness, tired, chills,  lots of chills and the hot burning hot.  No one can explain why I have been sick for 3 months.  I know my blood tests show a very elevated B12 which is unusual because it usually borders lower. All I know is ever since that shot, I'm just sick all the time, putting blankets on and off, in pain because of chills. No other logical reason.   Only reason I took the shot was to get back and forth to another state.   Otherwise,  I figured it was going to kill me if I took the shot.  Having trouble exercising and surfing now.  THANKS A LOT!
Early menstruation. Period was a a week early following the second dose of the pfizer vaccine. This is highly abnormal for body.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Sep2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. Concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Aug2021 at 14:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 07Oct2021, the patient experienced early menstruation. Following the second dose of the vaccine, the patient's period was a week early, which was highly abnormal for her body. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early menstruation was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
pt recv vax 10APR97 & 29APR97 pt devel a generalized rash w/15-20 lesions;
it was rpt from nurse concerning pt who was vax & subsequently devel white blisters in the mouth, redness on the outside of cheek, on side of mouth into which vax was administered;
Swelling of left arm, redness and itching 3 days after PREVNAR injection.
Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of June received the invalid dose, so all families are being notified of the possible error and offered revaccination.
Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 5:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021.  No treatment medication was reported by reporter.
Patient reports waking approx 11 hours after vaccination w/swelling of lower lip, around eyes, some inside mouth, neck & top of (L) arm. Denied difficulty breathing. Self treated w/OTC BENADRYL x 4 over the next 12 hours. Symptoms resolved afternoon of 10/20/11.
Sore arm at injection site, fatigue, headache, Body chills, body aches, nerve time (it felt like my skin was on fire when I moved or was touched. Wearing clothes helped). Mouth sores
Patient received 2nd dose of 5-11 yr PFIZER vaccine at approximately 1600. No s/s of reaction during initial 15 minutes of observation. Patient sitting in chair next to father; per father, the patient dropped something on the floor below her feet and when she went to retrieve, she fell forward to her knees and "crumbled" forward to the ground. No loss of consciousness. Patient alert and oriented by time RN assessed. RN had patient lie down with feet raised. Patient did want to sit up in her father's lap. Denied complaints of headache, dizziness, shortness of breath; no s/s of anaphylaxis. Patient given 8 ounces of water with saltine crackers. Observed for another 15 minutes. Father reported lack of food intake prior to vaccine administration. Additionally, reported that child had no issue or reaction to previous covid vaccine. Upon further assessment, patient OK to exit vaccine clinic with father.
DT went down to 31F and after going down the temperature was turned up for the refrigerator documented as being in range at 39 degrees F and at 35 degrees F but was then administered with no reported adverse event; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from other health professional (Inquiry number: 00598066).  It was reported that an unknown age male patient received DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer (lot number: C5733AA, expiry date not reported) which  went down to 31 Fahrenheit and after going down the temperature was turned up for the refrigerator documented as being in range at 39 degrees Fahrenheit and at 35 degrees Fahrenheit but was then administered on 09-Apr-2021 via an unknown route at an unknown administration site for prophylactic vaccination (product storage error temperature too low).  It was a case of actual medication error due to product storage error temperature too low.  At the time of report, no adverse event 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.
Did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2022 Reporter's comment: The pharmacist reported that the patient did not receive second dose of Shingrix within the recommended window post the first dose. The reporter did not have lot or expiry date of the first dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been linked to the case US2022181026, reported by the same reporter.; Sender's Comments:  US-GSK-US2022181026:Same reporter
mom reported 20OCT94 pt had high pitched screaming all noc & an (unremembered) fever of about 103;
Initial unsolicited case received from a consumer (patient) on 11 Oct 2017. This case involves an 80-year-old male patient who was vaccinated with 0.5 ml one dose of FLUZONE HIGH-DOSE (Batch number, expiry date, dose in series and site of administration were not reported) intramuscularly on 07 Oct 2017. Patient medical history was reported as Tinnitus diagnosed in 2011. The patient previously received a dose of FLUVIRIN on an unknown date last year and he felt fine. Concomitant medications were not reported. On 07 Oct 2017, about one hour after the vaccination, patient started with feeling lightheaded slightly dizzy and off balance. It was reported as patient required an ER visit and he was seeing a doctor. Relevant lab tests were not reported. As a corrective treatment patient received Meclizine. Outcome of the both the events were not recovered. List of documents held by sender: none.
This spontaneous case reported by a physician, describes the occurrence of asthma (seems as the asthma is off charge) and bronchitis (seems as a very bad bronchitis) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included asthma. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced asthma (seems as the asthma is off charge) and bronchitis (seems as a very bad bronchitis). At the time of the report, asthma (seems as the asthma is off charge) and bronchitis (seems as a very bad bronchitis) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Had few welts after injection. The next morning woke up freezing/temp 101.6/ aches all over / headache/ every muscle hurt   Took aleve. At 6 am. Took 2 ASA at 1230 pm.  Felt exactly like I felt when I had covid. Continued to have itchy small red areas pop up through out the day.
Around 20:00 on 11/12/2023, started to become stiff, having difficulty to move my body.    About an hour later, I started to experience chills and began shaking uncontrollably.  I did take 500 mg of Tylenol, laid into bed, covering myself with blanket and suffered.  The next day, I could still barely move, took more Tylenol, and slept until 13:00 on 11/13/2023.  Through the remainder of the day, I started to feel better.  By that evening, I could move normally though my arms and legs muscles were sore, as if I had been lifting weights.  While the soreness has started to diminish, it is still present at the time and date of this report.  I have still not fully recovered.
NUMBNESS ON THE RIGHT SIDE OF THE FACE; LOSS OF TASTE ON THE RIGHT SIDE OF THE TONGUE; TINGLING ON THE RIGHT SIDE OF THE FACE; CRAMPING ON THE RIGHT SIDE OF THE FACE CLOSE TO THE NOSE UNDER THE EYE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of stroke. 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-APR-2021 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 10-APR-2021, the subject experienced numbness on the right side of the face. On 10-APR-2021, the subject experienced loss of taste on the right side of the tongue. On 10-APR-2021, the subject experienced tingling on the right side of the face. On 10-APR-2021, the subject experienced cramping on the right side of the face close to the nose under the eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the right side of the face, loss of taste on the right side of the tongue, tingling on the right side of the face, and cramping on the right side of the face close to the nose under the eye. This report was non-serious.
Dizziness, Headache & Syncope Narrative:  2nd dose received 0830 on 2/2/21. At 1900 hours body aches & chills. At 2400 hours awoke with abdominal discomfort, became dizzy, then loss of consciences for few seconds and fell to kitchen floor injuring head. Next morning on 2/3/21, syncope in bathroom and loss of consciousness for few seconds and fell to floor. While on floor being held by husband, 2 more episodes of syncope. Went to ER admitted.
10 day duration: Swollen arm covered with rash, labored breathing, hives, itching all over.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (01Jun2022) Negative, notes: I tested negative on 01Jun; (10Jun2022) Positive, notes: Now on 10Jun I tested positive again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: No Other medication in 2weeks. No treatment received. No Known allergies. No Other medical history. The lot number for the vaccine  BNT162b2 (COMIRNATY), was not provided and will be requested during follow up.
left shoulder pain few hours after immediately and more so a few hours after injection into the  next/present day.  Hurts to lift it in any direction.
On 3/14/11, mother noted that the patient had redness and swelling at the vaccination site. She states that the patient's armpit on the affected side appeared unusual. She was instructed to contact her primary care provider, who advised observation. This then resolved over the next two days.
4/11/07 @3:10pm - patient went to the doctor for pain in stomache, diagnosed as Acid Reflux. We were given a flyer fo HPV, and we all agreed that patient needed to recieve the vaccine. Approximately 3 hours after that, patient complained of cramping in her pelvic area (right, left, and middle of her pany-line area). She took 1-600mg Ibuprophin, which eased the pain. She still complains of pain in that area today. I called the nurse who gave the vaccine, and she said this was not a symptom. Just thought I'd write what we have experienced after recieving the HPV vaccine.
Redness, swelling, soreness, itchiness and tenderness on L arm where he received meningococcal vaccine.  Clinician is treating for cellulitis with antibotics and Tylenol as needed for pain.
It was reported, "A mother reported that her 4 month old daughter received Rota Shield, DTAP, Hib and IPV on 3/30/99. The infant "screamed the whole day", cried and seemed to have stomach pains. She also developed a fever of 103F. The infant recovered within 24 hours." Additional information was received on 11/3/99 and included corrections to pt's name, form completed by name, pt's weight and number of siblings.
At 1705 36 year old female stated she has itchy throat and also noticed facial redness, denied other symptoms. Vital signs: b/p: 107/81, p: 70, O2: 100% Room air, R:17, Benadryl 25 mg capsule given at 1710. Patient stated she felt better at 1725 and husband came to drive her home.
Information has been received from a RN concerning a pt who on 10Apr97 was vaccinated with a dose of varicella virus vaccine live (lot 622625/0085E). Subsequently, in Sept 2000, the pt developed chickenpox. The pt was not seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA010589, WAES0409USA01060, WAES0409USA01061, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
18 YO received Havrix adult dose; 18 YO received Havrix adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 25th May 2022, the patient received the 1st dose of Havrix adult. On 25th May 2022, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 27-Sept-2022 Reporter's comment: No symptoms were reported. The reporter consented to follow-up via email. Additional supportive information: The patient received an adult dose of Havrix, which led to overdose and adult product administered to child.
I washed my hair on Saturday. Had significant hair loss - HUGE amount of hair. I've lost 30 percent of the hair on my head. It continued to fall out and  to have hair loss for one week.  Saw doctor - She said the immune system was stressed and hair fell out. Dr. e-visit - Tuesday, the 9th.
Extremely heavy period for 2 days leading to anemia, I am experiencing anemic symptoms daily despite starting taking iron.
Hot red swollen area the size of the palm of his hand, covering the entire right deltoid. He had no other symptoms. No treatment was taken.  The symptoms completely resolved.  However 2 weeks later he developed RUQ fullness which was relieved with flatulence.  He did not seek medical attention at this time.  He had routine labwork on 12-13-16 as part of his routine checkup.  He saw the medical provider on 12-19-16 and discovered that he had elevated liver enzymes: ALK Phos 642 ALT 454 AST 385. He was taking Lipitor, Prilosec, Valsartan, Acyclovir and ASA at the time.  He discontinued these meds on 12-19-16, had a normal liver ultrasound. Plans to repeat the bloodwork in a few weeks.
I initially developed an erythematous, pruritic rash on the posterior neck, trunk, arms and distal legs. In the next 24 hours the rash improved on the trunk but became more severe on the extensor surfaces of the arms (mostly near the elbows), knees and shins, with a few lesions on the anterior trunk. The rash is pruritic and pruritus is minimally improved with Benadryl. The pruritus and erythema is most improved with NSAIDs or Prednisone. The rash has continued for 5 days (still present), the lesions have lightened and pruritus is controlled  with the use of daily Prednisone and PRN Ibuprofen 600-800mg but it is still present on the knees, shins and elbows. The appearance seems to be consistent with erythema nodosum, which I have not previously had. I have no prior history of allergic reactions to vaccines or history of delayed hypersensitivity reactions.