chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker, via company representative, refers to a 12 month old patient of unknown gender. On 07-APR-2014 the patient was given an expired dose of MMR II (lot # 0183AE, expiration date reported as 18-JAN-2014) (dose and route were not reported). Concomitant medications were not reported. No adverse effect reported. Additional information is not expected.
Debilitating headache, nausea, chills, aches, pains, light-headed, disorientation, diarrhea, more
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821281 expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211047333.
3 days post injection started to have large, raised, red rash over trunk & back of torso. Now rash beginning to subside and now is getting small red dots on ribs & upper legs w/itching.
Headache, NauseaVomiting, Extreme fatigue Narrative:  Day 1- Injection site discomfort. Day 2-Extreme fatigue & Felt unwell (did not go to work) Day 3 Extreme fatigue & felt unwell (no work) .  Other Relevant History:
30 minutes after vaccines, patient developed urticaria of (L) limb, diarrhea.
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot#M031574, expiration date 11-NOV-2018; lot#M040423, expiration date 03-JUL-2019) (dosage and route were not reported) for prophylaxis (Incorrect product storage). No adverse effect was reported. The vaccine was stored at a temperature excursion of 9 Celsius to 25 Celsius for 1 hour 18 minutes and 0 Celsius to 1 Celsius for 75 hours. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA003596: US-009507513-1709USA003594: US-009507513-1709USA003595:
she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced COVID-19 (she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test). At the time of the report, COVID-19 (she traveled to 2 other places. She came down with mild COVID Disease with Positive PCR test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, SARS-CoV-2 test: Positive.         No concomitant information provided  On 08-Mar-2021, The patient received first dose of moderna COVID-19 vaccine (Lot: 036A21A).  On 05-Apr-2021, The patient received second dose of moderna COVID-19 vaccine (Lot: 025B21A).  On 01-Nov-2021, The patient received 1st booster of moderna COVID-19 vaccine (Lot: 004 F21A).  On 02-May-2022, The patient received 2nd booster of moderna COVID-19 vaccine (Lot: 002M21A).  It was reported that she traveled to 2 other places and came down with mild COVID disease with positive PCR test on 06-Oct-2022, less than a month after bivalent Booster.  No treatment information provided
Administered the expired Fluzone with no reported adverse event; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case received by other healthcare professional via consumer (under Agency Inquiry Number- 00814695).  This case involves a 56 years old female patient who reported administered the expired fluzone with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On 03-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE Solution for injection in pre-filled syringe (lot QFAA2017, expiry-30-Jun-2021) via intramuscular route in unknown administration site.  On 03-SEP-2021 the patient reported administered the expired fluzone with no reported adverse event (expired product administered) following the administration of INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE.  It was reported "There were 16 patients that were administered the expired Fluzone. The Director was going to transfer me to her assistant to obtain all the patient info. Instead I was transferred to her extension and she did not answer it, I got voice mail. I left her a message as to the specific info that we need and options to get it to us: email or call. I have no info on all of these patients. Some of the patient's birthdays were not available. Patient Information o Patient age <1 year enter as 2m, 4m, etc. Many pediatric vaccines need month for age."  Relevant lab data was not reported.  Action taken with QUADRIVALENT INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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.
PATIENT GIVEN SECOND DOSE OF MODERNA TOO SOON. DOSE NOT DUE UNTIL 10/19/21
I had a rash, itchy and swollen on my left arm. I called my doctor and they told me as long as it didn't spread to much not to worry much about it.
soreness in the area where the shot was given; increase in his blood pressure / blood pressure is higher than normal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 1st November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and increased blood pressure. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the increased blood pressure was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for himself. The age at vaccination was not reported. The patient experienced an increase in his blood pressure and his blood pressure was higher than normal.  The patient also experienced soreness in the area where the shot was given. The patient refused to provide any additional details. The follow-up would not possible as no contact details were available.
Local reaction/ Rash at injection site. Painful  Resolved by 3/3/22
she went to the hospital this July 26 because she had a total knee replacement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: KNEE ARTHROPLASTY (hospitalization) with onset 26Jul2022, outcome "unknown", described as "she went to the hospital this July 26 because she had a total knee replacement". The patient was hospitalized for knee arthroplasty (start date: 26Jul2022). Clinical course: The patient received her 1st and 2nd dose. She also had the other dose last 27Sep2021 and then she went to the hospital this 26Jul because she had a total knee replacement and before she left the hospital, they gave her a Pfizer shot with the lot number of FP7150 on her vaccination card. She just wanted to know if the shot she received was the new Bivalent vaccine because she does not want to be doubled doses. Created manual AE Form-parent case: 00933109 - related case: 00933112. Medical inquiry was not forwarded.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache, Myalgia, Arthralgia & NauseaVomiting
Positive varicella lesions, low grade fever, maculopapular w/tear drop vesicles starting 07/30/02
Fever for several days; numbness in arm, hand and fingers of injection site; headaches; fatigue for serval days; Two weeks post injection patient is still suffering the effects
Information has been received from a consumer concerning her 13 year old daughter with drug allergies to codeine and IMITREX and no other pertinent medical history who on approximately 12-AUG-2008 ("6 months ago") was vaccinated with the first dose of GARDASIL.  Then the patient received the second dose of GARDASIL and when she had her menstrual cycle.  After that on 17-JAN-2009 ("26 days ago") the patient experienced a migraine.  On 11-FEB-2009 the patient received the third dose of GARDASIL.  There was no concomitant medication.  The patient also happened to start her cycle again and experienced another migraine.  The patient started her menstrual cycle when she was eight year old and she had never had migraines before.  No lab diagnostics studies were performed.  The patient's migraine persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
small knot under skin around injection site, small red ring under the injection site, arm hot to touch, swollen arm
Unable to bring arm above shoulder height; Very painful arm/shoulder like; Very painful arm/shoulder; like a pull muscle; This is a spontaneous report from a contactable other healthcare professional, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the right arm on 23Dec2020 at 17:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy. It was reported that patient was healthy. It was reported that patient received other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 20:00, the patient experienced pain upon movement, shoulder pain, painful arm and pulled muscle. The patient described that as very painful arm/shoulder like, no soreness but more like a pull muscle for two and half days and unable to bring arm above shoulder height. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the events pain upon movement, shoulder pain, painful arm and pulled muscle was recovered on an unknown date in Dec2020.   No follow-up attempts are needed. No further information is expected.
I had my 2nd does of the Pfizer vaccine on February 27, 2021.  The next morning  I awoke with a very bad headache.  I took and Advil.  My husband was making breakfast.  I came downstairs, ate, had a cup of coffee, then got a glass of water and an ice pack and sat on a recliner in the living room.  I don't remember much of the rest.  It was like a dream.  My husband said I let out a yell, my arms flailed and my eyes were very strange.  I lost muscle strength in my lift side mimicking a stroke.  He called 911.  I was taken to Emergency facility where I gained consciousness.  I was then transferred to Hospital.  So far every test has come back negative.  I have an EEG scheduled for this Thursday.
Patient received 1st dose of Moderna Covid-19 and patient had a seizure while waiting in the waiting area.
Received new Spikevax by Moderna. Patient immediately passed out from receiving shot. Pharmacist caught her (she was sitting down). He got her down to the floor. She was out for less than 1 minute, came too very quickly. She did not hit her head. He had time to make sure she was breathing/pulse then started answering his questions. When she completely came to, she informed us about previous syncopal events from receiving vaccines related to an unknown event in her life. She has not had it happen in several years so did not think to mention before. Has received other vaccines recently with no issues.  We called 911 and she was talking and we were able to get some answers while on phone with operator. Did not go to hospital. EMT's asked her questions and did not feel she needed to once she was feeling better. She was able to walk out on her own with us walking with her and was able to drive home.
Within 1 minute of administering vaccine, patient lost consciousness for about 10 seconds.  Once patient awoke, he was still confused and diaphoretic.  At approximately 4 minutes post-vaccination patient lost consciousness again and had stiff movements of arms while unconscious.  Patient awoke on his own and was observed for an additional 20 minutes with no issues.
Patient awoke next AM with sore arm, got shakes and temp over 102.  Pulse 120.  Sick all day Saturday better by Sunday.
Trigeminal neuralgia  pain on right side of face occurred next day after vaccination. Became very severe without being  able to talk, drink or eat on 2/11. Went to ER on 2/12. Discharged on 2/14. Still be in pain and unable to eat solid food.
Pain and tenderness in the surrounding area of the injection site. The muscle soreness in the arm started about an hour after receiving the vaccine and worsened into the evening. The tenderness mostly went away by the next morning, the worst of it being the evening of the dosage.  Tenderness and slight swelling to the lymph nodes in the same arm as the injection site started in the early afternoon the same day as the dosage. This tenderness lasted for about 5 days. Experienced fatigue and a mild headache the evening of the dosage.
Sore arm; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected
Rash and herpes reaction same arm and ankle as  injection site (right arm) as well as labia, swellings lymph nodes under both arms, fatigue and nausea.
Sudden onset of severe dizziness at 7 pm (approx 10 hours after she received flu shot) on 10/18/18 with palpitations, nausea and fast breathing - took Valium 2 mg and Zofran 4 mg, symptoms improved and she fell asleep, she awoke at 5 am with palpitations and mild nausea - took half tab Valium (1 mg) and Zofran and symptoms resolved, went to sleep again and symptoms did not recur.
On 9 February he was given a PREVNAR 13 injection. Within several days he developed a rash which is about 4 cm in diameter at the injection site which was the right deltoid area. Several days thereafter he developed a diffuse rash which was symmetrical in nature and pruritic. Skin. Rash.
Fever of 99.4; Inappropriate dose of Vaccine administered; Off label use; Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 05:30 as dose 5 (booster), single (Lot number: GJ2524) at the age of 62 years, in right arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUARIX QUADRIVALENT), on 19Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT; CLARITIN [CLARITHROMYCIN]. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 19Sep2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 19Sep2022, outcome "unknown", described as "Product use for unapproved combination"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 19Sep2022 at 05:30, outcome "unknown", described as "Inappropriate dose of Vaccine administered"; PYREXIA (non-serious) with onset 20Sep2022 at 18:00, outcome "recovering", described as "Fever of 99.4". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: Patient had no covid prior vaccination and not tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Patient states symptoms of swelling, redness, and welts on the left arm at site of injection
Had shot in left arm no problem, a few hours later started getting a headache chills achs and pains nausea stomache  pain hands and feet numb. still not feeling good.
DIZZINESS; FEVER; EXTREMELY TIRED; This spontaneous report received from a parent concerned a 30 year old female. 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 06-APR-2021 17:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the subject experienced extremely tired. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced fever.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100-101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 07-APR-2021, and was recovering from extremely tired, and fever. This report was non-serious. This case, from the same reporter is linked to 20210416407.
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 08-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error).         The administered dose was involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA003267: US-009507513-2104USA003266: US-009507513-2104USA003268: US-009507513-2104USA003265:
Expected symptoms in first 24 hours - fatigue, muscle aches, extreme arm pain. These symptoms resolved after a day, but I have had a poorly delineated area of erythema, warmth, edema and pruritus at the injection site that began on day two post-vaccine and has been increasing in size until today (day 5 post-vaccination). Started as a small (2 cmx2cm) wheal, now  appears as painful/itching and warm blanching urticaria that takes up the entire width of my upper arm and half the length of the upper arm.
Sore arm; fatigue; trouble sleeping; mild headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non pregnant female patient received BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 08:45AM (Age at vaccination 31-years-old) as DOSE 2, SINGLE and also received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247, Expiry date was not reported) via an unspecified route of administration on 26Jan2021 01:30 PM, administered in Left arm as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included no known allergies. The patient's concomitant medications were not reported. On 10Feb2021 09:30AM the patient experienced sore arm, fatigue, trouble sleeping, mild headache. The patient had not received any other vaccine within 4 weeks and also other medications in two weeks also. Patient had received no treatment for the event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the events was recovering.     Follow-up (11May2021): Follow-up attempts completed. No further information expected
DTAP-HIB given before 15 months of age.  No side effects reported.