chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effect reported.; patient received improperly stored PROQUAD on 3/11/2020 which was administered via unspecified route.; This spontaneous report was received from an physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drug, concurrent conditions, concomitant therapies and previous drug reactions or allergies were not provided.     On 11-MAR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot number S027460, which has been verified to be valid, and expiration date reported and validated as 02-MAR-2020; (dose number, vaccination scheme, route of administration and anatomical site of vaccination were not provided), as prophylaxis (product storage error). The vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). Additionally, the reporter stated that the vaccine was exposed to a temperature between 6 degrees Fahrenheit (F) to 14 degrees F - 10.4 degress F, for a time frame of 15 minutes, as recorded by digital data logger. There was a previous temperature excursion reported at a temperature between 6 degrees F to 14 degrees F - 11.1 degrees F for a time frame of 15 minutes. No additional adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001308: US-009507513-2007USA001370: US-009507513-2007USA001612: US-009507513-2007USA001668:
Patient had an onset of (non-itchy) flatten red rash /erythema around the vaccination arm, right side of shoulder, and back, and a raised hive on left cheek 5 minutes after the administration. Patient took a chewable Benadryl tab to alleviate the onset of rash / hives. Patient was reassessed after 10 minutes: hives were less apparent, slowly resolving, rash was not as red, and patient did not exhibit any other symptoms.
Information has been received from a physician concerning a female between 15 and 16 years old who was vaccinated with a 0.5 ml dose of Gardasil (yeast). After receiving the vaccine, the patient fainted. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Large (twice the size of a silver dollar) red swollen welt, extremely painful enough to keep me from sleeping for three days.  Then the pain subsided.  Still has swelling, patchy rash, very itchy.  It's been over a week and it doesn't look to be going away.  Very nervous to get the second shot.
losing their hair/lost hair; This spontaneous report from two contactable consumers reporting same event under the same suspect product for 7 patients. This is one of 7 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as singe dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Reporter stated seven patients off the top of head that were losing their hair since they had the vaccine, also reported these seven patients were having hair changing or falling out right after Pfizer vaccination, 7 patient who have lost hair. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101342968 same drug/event, different patient
Soreness at injection site (began approximately 2-4 hours after injection and resolved by 3rd day) Chilling (minor, intermittent, started on 1st day following injection and resolved by 2nd day) Fatigue (started on 1st day following injection and resolved by 2nd day) General malaise (started on 1st day following injection and resolved by 2nd day) All symptoms were tolerable and resolved without treatment
Large local reaction involving the whole upper arm redness, swelling (marked) associated with itchy, shoulder to elbows.
I had a fairly severe case of Covid, diagnosed on December 28, 2020.  I would estimate that symptoms lasted for 3-4 weeks.  I received my first Covid vaccine on March 13.  I awakened in the middle of the night after the shot with fever of 102, chills, nausea, and a headache.  My arm was swollen and throbbing with a large red circle where the shot had been administered.   These symptoms continued until Monday at around noon,  for over 24 hours. I am writing to you because I think the CDC must study whether or not people who have had Covid should be taking these shots, certainly not both shots.  I will NOT be taking the second shot.
PATIENT STATES THAT WITHIN 2 HOURS OF RECEIVING THE FLU VACCINE SHE LOST HER VOICE OR WAS HOARSE.  FELT LIKE THERE WAS FLUID IN LUNGS, COUGH, FELT LIKE SHE WAS WHEEZING.  SYMPTOMS LASTED FOR A COUPLE OF HOURS. BREATHING WAS OK. HOARSE UNTIL NEXT DAY.
Initial report was received from a patient on 02 November 2011. A 63-year-old female patient had received an injection of FLUZONE (lot number, route and site of administration was not reported) on 31 October 2011. On the same day following vaccination, the patient experienced severe muscle spasms and aches and pains "muscle aches". The patient corrected treatment was BENADRYL. No further information was available at the time of the report. The patient outcome was reported as not recovered/not resolved. Follow-up information was received from a consumer on 20 January 2012, who is also the patient. She reported that the reaction she had experienced lasted 2 days; however she continued taking BENADRYL and was fine after that. The patient was unable to obtain information on the lot number. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
PATIENT DID EXPERIENCE A REACTION WITIN 5MINS AFTER VACCINATION WITH PFZIER 1ST SHOT. SHE EXPERIENCED BLURRY VISION, LOSS OF HEARING AND DIZZINESS FOR 15MINS WITH HOT FLASHES. GAVE HER APPLE JUICE AND HAD HER PUT HER FEET UP ON CHAIR. AFTER 20 MINS SHE WAS FEELING FINE AGAIN AND LEFT WITH DAD.
Sept 6th, 7:00 p.m. had double vision. Went to Hospital Emergency Room on Sept. 7th, 2:00 pm. and they ran blood work, and MRI. Results showed no stroke, bleeding on the brain or tumor. ER Dr. couldn't diagnose why I was having double vision which is neurological disorder. Referred me to Neuro Ophthamologist.
Sore throat, stuffy nose cough, chest congestion. Lasted 2-3 weeks better for 2 weeks then another onset on September 20 with same symptoms but more severity.
Patient presented to a vaccination clinic. Di d not have record of former vaccines with them. Patient believed they were eligible for vaccination. Upon later entering vaccinations into immunization registry it was learned that she had received a boost dose on 4/12/22 of Moderna 0.25ML.. At this point no adverse reactions have been observed. We are reporting this for administration of vaccine outside of CDC/agency schedule guidelines.
vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 76 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Feb2021 at 10:00 as dose 2, single (Lot number: 006m20a), in left arm, on 26Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 012f21a), in left arm and on 28Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 048l21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension, cholesterol" (unspecified if ongoing); "hypertension, cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Sep2022, outcome "unknown", described as "vaccine_brand=Pfizer / BioNTech, vaccine_brand_other=Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 Vaccine previously and was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
LEFT THIGH SWELLING WITH BLOTCHY RED RASH, WARM TO TOUCH.  LOCAL REACTION.  PT CURRENTLY ON AUGMENTIN AND ERYTHROMYCIN FOR ORBITAL EYE INFECTION.  PT TREATED WITH BENADRYL PRN IF LEG BOTHERS HIM.
Started having aching joints at 4 that evening that progressed to chills  and increased pain in joints.  Fever went up to 103.7 and finally dropped the next morning to 101.6.  By 4pm that day my temp was back to normal.   I have taken flu shots yearly and never had any reactions to them.
injection site rash; it turned pretty pink and looks inflamed; 2 inches by 3 inches, itching and rash; it did hurt for a few days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (it turned pretty pink and looks inflamed), VACCINATION SITE PRURITUS (2 inches by 3 inches, itching and rash), VACCINATION SITE PAIN (it did hurt for a few days) and INJECTION SITE RASH (injection site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (it did hurt for a few days). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (2 inches by 3 inches, itching and rash). On 21-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (it turned pretty pink and looks inflamed). On an unknown date, the patient experienced INJECTION SITE RASH (injection site rash). On 15-Jan-2021, VACCINATION SITE PAIN (it did hurt for a few days) outcome was unknown. At the time of the report, VACCINATION SITE INFLAMMATION (it turned pretty pink and looks inflamed), VACCINATION SITE PRURITUS (2 inches by 3 inches, itching and rash) and INJECTION SITE RASH (injection site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included Tylenol.   This case was linked to MOD-2021-040891 (Patient Link).
Went in for over 65 Pneumococcal Conjugate Vaccine, at the time of the shot I was in a lot of pain, around 4:00 p, the day of June 1, 2017. I was told that it may go away in a few days. I waited and it did not and then I went back to pharmacy, they said that would contact Program. I went to my Dr. office for pain and only had very limited results. Still in a lot of pain today. May not even be able to do my job for much longer.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB inj 40 interchangeably with ENGERIX-B totaling 4 doses. No adverse effects reported. NO Product Quality Complaint (PQC) was involved. Additional information has been requested.
Local Cellulits @ injection site, started day after imm. administered. Treated with cephalexin then changed to Bactrim. Resolved in 8 days.
"Chills, soreness at injection site fever  99-101.3 chills, body aches ."  "Motrin for the fever" "woke up feeling great" on 1/4/21
Disease recurrence; COVID-19; COVID-19; . This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4275392-00 (Agency).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, all intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2021 as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Thyroid problem" (unspecified if ongoing); "cholesterol problem" (unspecified if ongoing); "seasonal allergies manifested by tiredness" (unspecified if ongoing), notes: seasonal allergies manifested by tiredness; "seasonal allergies manifested by tiredness" (unspecified if ongoing), notes: seasonal allergies manifested by tiredness; "non tobacco user" (unspecified if ongoing); "non-alcohol user" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset Oct2021, outcome "recovering", COVID-19 (medically significant) with onset Oct2021, outcome "unknown" and all described as "COVID-19"; DISEASE RECURRENCE (hospitalization, medically significant) with onset Jan2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2021) Positive; (Jan2022) Positive.  The reporter's assessment of the causal relationship of "covid-19" and "disease recurrence" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, covid-19, disease recurrence and the use of suspect product cannot be fully excluded.
3/29-redness and warm to touch at the injection site recommended antihistmine (claritin,zytetec, benadrly), and ice compress 10mins/10 off; caller verbalized understanding.
Information has been received from a 3rd party claims administrator concerning a female patient (age not provided). On 09JUL2012, the patient received ZOSTAVAX, subcutaneous injection. On an unspecified date the patient developed a shingles outbreak after receiving the vaccine. The outcome of shingles was not provided. Additional information has been requested.
Narrative: Patient reported severe diarrhea post covid vaccine (first dose) lasting only one day. However pt received vaccine on 1/11/2021, and diarrhea occurred on 1/21/2021. Symptoms: Diarrhea & diarrhea lasted only one day Treatment:
Patient said the night after receiving the flu shot...his right hand became painful in the middle of the night. The next day, he experienced numbness in  the right hand.
Patient developed rash to bilateral arms approximately 15 minutes after dose administered.  right arm rash worse than left.  Rash was from elbows down on forearms only.  Administered 50 mg Benadryl liquid and after 15 minutes rash to L arm  had disappeared and rash to R arm had lessened.  Patient did not complain of itching or difficulty breathing.  Rash was flat and blotchy red.  Rash was almost completely gone after 20 minutes.
Patient developed a sore throat and multiple red and yellow sores on his posterior pharynx after receiving each of the HPV vaccines. The first time sores started 1-2 days after IZ and lasted 5 weeks. The second time sores started 1 day after IZ and lasted 2-3 weeks. The 3rd time sores started 1 day after IZ and continues 2 weeks later.
My daughter had a grand mal seizure after being dropped at daycare on Wednesday October 28th.  She was taken via ambulance to the hospital and admitted overnight.   She was released and had another one on Friday morning.  We returned to the hospital and was transferred to another hospital for an overnight stay with EEG.  Released and returned on 11/5 due to having 8 grand mal seizures in one day.  Hospitalized for 6 days.  Drug induced coma on the Sunday of that hospital stay because they couldn't get seizures to stop.  Numerous doctor visits and transfers around finally gave us a shaky diagnosis of Lennox Gasteaux Syndrome.  Neurologist wasn't completely sure because she didn't fit all the symptoms but it was close.  We had to buy a helmet for her because she was having drop seizures.  She landed in the hosptial 2 more times for stitches on her chin from the drop seizures.  Then all of a sudden in late May 2010, she went to bed one night and woke up the next morning and hasn't had a seizure since.  The neurologist is very confused because they said Lennox Gasteaux doesn't just go away.  When I told my pediatrician, the first thing she said was that she knew Fluzone has caused seizure activity before.  So I am here because I am certain that this flu shot cause the problems my daughter had to endure for 6 months.
Pt exp high pitched cry & lethargy for 3 days p/DTP #2, resolved spontaneously- hx from parents;
After the vaccine, usually has accumulation for mucous in the nose.  Scheduled for surgery in May with ENT to expand passageway.  Has had nose bleeds before.  Woke up blew his nose, felt it running and then had severe nose bleed.  Was clotting up and then blew it out.  Also had used a chemical using his bathtub and the nosebleeds have occurred every morning for the last 3-4 days.  Anytime he gets ready to go to the doctor it stops.  Just first thing in the morning upon wakening and only after he blows his nose.  Which he called the 24-hour nurse line and she instructed him on how to stop the bleeding, and told him not to blow his nose.  He was examined by his ENT in Oct/Nov was told that he was normal other than the balloon procedure.  Is going to FU with his ENT.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Near Negative; (Dec2022) Solid positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 with Paxlovid from 13Dec2022 to 18Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AEs; Medical Assistant calling in to report a temperature excursion on GARDASIL 9. Medical Assistant reports the vaccine was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a 15-year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 22-JUN-2022, the patient was vaccinated with improperly stored (product storage error) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe, 1 time dose, lot #: T028929, expiration date: 08-MAR-2023 (exact dose, strength, site and route of administration were not provided) for prophylaxis. No additional information regarding temperature excursion was provided. There was no additional adverse event reported.
local reaction r.arm near site, swelling pain, headache, sore throat fatigue sinus congestion, arm remained swollen, 2.5in x 3.5in and warm to touch. most went away in 48 hrs, swelling persisted
Injection site (R)U arm 2 x 3 inch - reddened, raised, hard, itchy, burning - seen 10/18/11 - now 1 x 2 inch - discolored, small lump, no burning, positive tenderness & didn't feel well 10/13/11 PM.
a male received an initial dose of Menveo on 14Aug2023 and an early 2nd dose on 24Aug2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAMVA950A, expiry date 31-JUL-2024) for prophylaxis.   Concomitant products included MENVEO.   On 24-AUG-2023, the patient received the 2nd dose of Menveo. On 24-AUG-2023, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too short (Verbatim: a male received an initial dose of Menveo on 14Aug2023 and an early 2nd dose on 24Aug2023).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date 24 August 2023: A nurse reported that the patient received an initial dose of Menveo on 14th Aug 2023 and an early 2nd dose on 24th August 2023. No symptoms reported. The reporter consented to follow up via email. The patient received early 2nd dose of Menveo which led to shortening of vaccination schedule.
fever; movement arm; chills; body aches; felt as hit by a truck; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 1st dose of Shingrix. On 22nd May 2019, 1 days after receiving Shingrix, the patient experienced fever, mobility decreased, chills, general body pain and feeling abnormal. On an unknown date, the outcome of the fever, mobility decreased, chills and general body pain were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the fever, mobility decreased, chills, general body pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination and age group of the patient were not reported. The patient received 1st dose of Shingrix in an unknown arm. On tuesday afternoon, the patient received vaccine and on wednesday morning, he felt as though he had been hit by a truck. The patient had low grade fever, chills, ached all over and could hardly lift his arm. On the day of reporting, the patient felt better. The reporter consented to follow up