chrisvoncsefalvay/vaers-outcomes huggingface dataset:
period within 2 hours of the vaccination (not near the date where I was supposed to have my period); tired; feeling unwell; nausea; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 15Mar2021 at 09:30 (at the age of 44-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 05Apr2021 at 09:45 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. The patient did not take any concomitant medication. The patient previously took Augmentin on unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 11:30 within 2 hours of the vaccination, the patient experienced period (not near the date where she was supposed to have her period), tired, feeling unwell and nausea.  The clinical outcome of the event period (not near the date where she was supposed to have her period), tired, feeling unwell and nausea was unknown. On 05Apr2021 at 11:30 within 2 hours of the vaccination, the patient experienced period (not near the date where she was supposed to have her period), tired, feeling unwell and nausea. The clinical outcomes of the events period within 2 hours of the vaccination, tired, feeling unwell and nausea were recovered on an unknown date in Apr2021. The patient did not receive treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care.  No follow-up attempts are needed. No further information is expected.
PREFILLED SYRINGE WITH TEMPERATURE  EXCURSION INJECTED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned an adult female.. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 0900 hrs to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced incorrect product storage. On 31-MAR-2021 09:00, the subject experienced prefilled syringe with temperature excursion injected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the prefilled syringe with temperature excursion injected and incorrect product storage was not reported. This report was non-serious.
4 patients were administered vaccines from a vial that has been punctured for greater than 12hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 045A21A, and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced PRODUCT STORAGE ERROR. On 03-Nov-2021, PRODUCT STORAGE ERROR had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   These doses were administered from the same vial which was initially punctured on 26OCT2021 and administered up until 3NOV2021. Concomitant medications were not provided. Treatment information was not provided.
Syringe issue; Wound bleeding; Finger injury; Accidental exposure while administering drug; This spontaneous report was received from a nurse referring to another nurse, who was a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 18-AUG-2020 (also reported as "yesterday"), the patient was preparing the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # S022599 (expiration date: 25-FEB-2022) for a patient administration. Then, when she was gently rolling the syringe, the bottom portion of the syringe broke off in "full circle" and it cut the nurse's finger. She experienced bleeding which was managed with placing an gauze pad and a BANDAID. The bleeding stopped after an hour. Upon probing, the entire round base came off the barrel of the syringe. The round base remained intact as it broke of the barrel, but the base remained hanging on the plunger of the syringe. This occurred before the needle was placed on the syringe. The patient did not miss the dose as replacement dose was provided.  No causality assessment was provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; 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
Mother reports that approximately 3 hours after vaccination she noticed severe redness on entire right thigh and several hives on infant's abdomen.
Beginning the night of vaccination (2/25/2022), patient experienced fever, sore arm and headache; given Motrin. Three to four days after the vaccination (2/28/2022 or 3/1/2022), patient experienced soreness, pain and swelling in mouth. Patient not eating because of the discomfort. The gums and roof of mouth still swollen as of today 3/4/2022 (when parent called the pharmacy). Fever, headache and sore arm resolved. Patient able to go to school but is still experiencing discomfort. Fever is no longer present. Advised parent to take patient to be seen today for evaluation.
The patient was vaccinated with FLUZONE HIGH DOSE QUADRIVALENT instead of COVID-19 VACCINE; The patient was vaccinated with FLUZONE HIGH DOSE QUADRIVALENT twice instead of COVID-19 VACCINE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Regulatory Authority (RA) (Reference number- 00868442) and transmitted on 22-Nov-2021. This case involves a 66-year-old female patient who had no appetite (decreased appetite), fever of 100.3 (pyrexia) and fatigue after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of Coronavirus disease (COVID-19) VACCINE (wrong product administered and extra dose administered) The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination. On 18-Nov-2021, the patient received 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ7760C, expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination instead of booster dose of COVID-19 VACCINE. It was a case of an actual medication error due to extra dose administered and Wrong vaccine administered (latency same day) On 19-Nov-2021 the patient developed a non-serious no appetite (decreased appetite), fever of 100.3 (pyrexia) and fatigue 1 month 12 days following first dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and 1 day following last dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. It was reported "The caller stated that a patient came into the office to receive a COVID Booster vaccine on 18 NOV 2021, however the patient was given the FLUZONE HIGH DOSE QUADRIVALENT injection in error. The caller stated that the patient has now received 2 doses of the flu shot, as she received a prior flu shot on 07 OCT 2021. The patient reported fatigue, fever of 100.3 and no appetite on 19 NOV 2021. The caller wants to know how to care for the patient. consumer who received two Fluzone HD. She asks for appropriate follow-up" No other relevant test was provided. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of clinical events was unknown 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. 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.
After the second vaccination employee experienced minor symptoms on day 1 and day 2 with headaches, feeling hot/cold alternating, arm pain, muscle aches.  Day 3-5, employee became more sick with mild intermittent chest pains, extreme exhaustion, muscle aches and spasms, dizziness, headaches, feeling hot and cold alternating, but no fevers noted.  Day 7, employee started to feel better, but symptoms continued with fatigue which persisted for a several days until she was back to baseline
Within 30-60 min post vaccination had dizziness and nausea. Denied SOB, rash, swelling, problems breathing or swallowing. Denied problems with previous immunizations to include influenza vaccine. The symptoms persisted and the following day he also reported that he was feeling weak, shaky and had a decrease in appetite. He sought medical care and was assessed as having an adverse effect of the flu vaccine.Was reevaluated on 23 Oct for persistence of symptoms. No worsening. Reported that he would have waves of intermittent dizziness and a sensation that his balance is not right. Denies fever. Follow up on 26 Oct noted improvement but has not returned to baseline. Episodes of dizziness persisted, no weakness and has been able to run 3 miles without difficulty. On 29 Oct he underwent a neurology evaluation. No pathologic process could be identified, and his neuro exam was normal. Ordered MR was not performed as symptoms resolved before it could be scheduled  Symptoms: DIZZINESS AND GIDDINESS(R42), NAUSEA(R110), WEAKNESS(R531).
Swollen joints in hands, elbow and knee. Have not had any auto immune issues in 20 years. Not being treated for the last 20 years. After 84 hours all systoms of RA came on suddenly.
pt vomited w/o prior sx choked & lost consciousness momentarily; t100.9 highest; no redness or swelling @ inject site; treatment APAP;
Dose administered in left thigh instead of deltoid; This non-serious case was reported by a other health professional via call center representative and described the occurrence of vaccine administered at inappropriate site in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2NJ, expiry date 10-JUN-2024) for prophylaxis.   On 08-MAR-2023, the patient received Kinrix (left thigh). On 08-MAR-2023, an unknown time after receiving Kinrix, the patient experienced vaccine administered at inappropriate site (Verbatim: Dose administered in left thigh instead of deltoid). The outcome of the vaccine administered at inappropriate site was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-APR-2023 The reporter was medical assistant. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The Kinrix was given on left thigh instead of the deltoid, which led to vaccine administered at inappropriate site.
This is an initial spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received the fourth dose of PREVNAR via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, after receiving 4 doses of PREVNAR, the patient developed medically significant pneumococcal disease for which the patient was hospitalized on an unspecified date. Relevant laboratory data was unknown. The physician reported that the strain of the bacteria was unknown. Therapeutic measures were taken as a result of the event and included treatment with vancomycin. The outcome of the event was unknown at the time of the report. Follow-up (11Jun2012): Follow-up attempts completed. No further information expected.
MEDICATION ERROR.  PATIENT CAME INTO CLINIC REQUESTING JANSSEN VACCINE.  AFTER ROUTINE INTERVIEW, SHE WAS DEEMED OK TO TAKE THE VACCINE AND IT WAS GIVEN.  WHEN THE NURSE WENT TO INPUT THE VACCINE INTO THE STATE REGISTRY, SHE SAW THAT THE PATIENT HAD BEEN GIVEN PFIZER COVID VACCINE 4 DAYS BEFORE AT ANOTHER FACILITY.  THE PATIENT WAS CALLED AT HOME AND SAID SHE GOT THE JANSSEN VACCINE ON PURPOSE AFTER THE PFIZER BECAUSE SHE HEARD SHE WOULD GET BETTER COVERAGE IF SHE TOOK MORE THAN 1 KIND OF COVID VACCINE.  PATIENT WAS COUNSELED TO CDC RECOMMENDATIONS AND THAT SHE MAY EXPERIENCE AN INCREASE OF SIDE EFFECTS.
Red, swollen and itchy arm, fever and chills. For several days. In the beginning.  After about 2 weeks very weak and shaky legs.  Varicose veins became very painful/. Blood tests show high amount of inflammation
Patient received second bivalent vaccine by mistake today. I read last dose as 11/07/2021 (while it was 11/07/2022)
COUGH, HEADACHE, FATIGUE, SHORTNESS OF BREATH, BODY ACHES, CHILLS
p/vax pt exp sore throat, swollen glands, tired; saw MD; strep & mono screen were done & both neg;
pt recvd vax 22JUN93 & exp swelling of the throat; pt went to ER & was treated for an allerg react;
Patient had 2nd dose of COVID PFIZER vaccine at 0900, being monitored for 15 minutes, left the clinic without any adverse reactions. Patient returned the urgent care clinic  around 1230 with swollen face, arms, vomited before arrived to the clinic, felt feverish, denied tightened on throat. Inserted peripheral IV on right antecubital, administered Solumedrol 40 mg, IV NS 1000 ml. Patient stated that she felt better after the treatment. Patient recalled that her throat felt heavy before solumedrol dose. Patient started complained of her throat  feeling heavy and bothering her, administered EPI 0.5 mg IM. Monitored patient closely, VS taken every 30 mins. Called ambulance to transfer patient to ER for higher level of care
Patient called and stated she had blotches on right upper arm following administration of pneumococcal vaccine.  Counseled pt to consult her physician.
?Pfizer-BioNTech COVID-19 Vaccine EUA  Swelling of left hand.  Cleared up next day. Cleared up next day. Same side as injection.   Swelling of feet while sleeping.  Cleared up next day. Joint pain especially shoulders, hips knees. Cleared up next day. Dizziness and fatigue.  Ongoing.
Employee was sitting at the computer after her vaccine, and was holding her head in her left hand with her elbow on the table. She thought her fingers were becoming numb because she was leaning on her hand, but the numbness in her left hand 4th and 5th fingers have continued from 2/4/2021 until she reported it to Employee Health and Safety on 02/12/2021. She states that as a transporter, it is difficult for her to hold on to wheelchairs, and she feels as though her grip is compromised.
Patient complained of a red and achy arm. This occurred on the arm she received the vaccination. The redness and aches went from the site of injection down to her hand. She also mentioned feeling chills for about 2 hours after vaccination.
Leg swelling 5 minutes after immunization. Also increased warmth with wheal formation. The reaction occurred over DTaP site.
2 days post vax #3, devel red, raised, itchy rash to body & inside mouth. Swelling of face, feet & hands.
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella vaccine. Subsequently, the pt experienced shingles. Additional info has been requested.
Swelling @ site of inject; t99.5, crying & fussy x 3 hrs; 17AUG92 spoke w/mom pt fully recovered;
I am currently 30 weeks pregnant with twins (28 weeks at the time of vaccine). Estimated delivery October 23 (at 38 weeks).   My right arm was initially sore for a couple of days after the vaccine, but the soreness subsided and I felt completely normal. Today, two weeks later, the injection site has become increasingly sore to the point where my arm is extremely tender and it is painful to move. No other symptoms at this time.
Did not go to doctor return to pharmacy and show the pharmacist 10/30/2018 (pharmacist stated I see had my PCP I don't feel it necessary. The area was extremely sore/tender to touch, injection area was red and very warm, swollen at and around the injection site, knot appeared and remains (reduce in size) as of 10/31/2018, the redness has dissipated at the injection site; however, the injection area is slightly discolored as of 10/31/2018. I felt I should report it. Note: Started feeling nausea and light headache onset 10/30/2018 not sure if its associated with the injection.
Dizziness, Headache, Fever, 24 HOURS AFTER INJECTION HAD INJECTION SITE REDNESS AND SWELLING, FEVER, CHILLS, HEADACHE, AND DIZZINESS. SYMPTOMS RESOLVED AFTER 24 HOURS Narrative:  Other Relevant History:
Diarrhea; SEVERE VOMITING; SEVERE EXHAUSTION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, severe vomiting, and severe exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe vomiting, diarrhea and severe exhaustion was not reported. This report was non-serious.
pt recv vax in rt outer arm, c/o pain, redness, swelling on rt arm inside;tx w/ATB for cellulitis;successfully;
diarreaha for 3 days and then went away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "diarreaha for 3 days and then went away". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was also on immunosuppressant therapy. After second covax had diarreaha for 3 days and then went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Numbness and tightness left side of throat. Numbness in left side of face. General tiredness
Client did not have his card when he came to the clinic for his second dose. Was asked if it had been 28 days and he said he was sure it had.  However was only 17 days.  Spoke with him today and he states he did have flu like symptoms, then some SOB the following day, lasting 3-4 days. Did not seek medical attention and is feeling fine now.
red raised area 3" length and 2" wide. shot was administered on outside on the my arm, far away from the deltoid muscle.
The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023; No adverse event; Adult patient received expired Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Bivalent Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 16-Jan-2023 and was administered on 22-Feb-2023).    No concomitant information was reported. Suspect product dosage text was reported as additional booster. The 2.5 ml vial was initially stored in refrigerator on 16-Jan-2023 and did not underwent any temperature excursions. No treatment information was provided. This case is reported for adult patient 3 out of 6 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-717807, US-MODERNATX, INC.-MOD-2023-717810, US-MODERNATX, INC.-MOD-2023-717812, US-MODERNATX, INC.-MOD-2023-717811 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717812: US-MODERNATX, INC.-MOD-2023-717810: US-MODERNATX, INC.-MOD-2023-717811: US-MODERNATX, INC.-MOD-2023-717807: