chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; temperature excursion for MMR II and VARIVAX; This spontaneous report was received from a medical assistant (also reported as nurse) and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 16-NOV-2020, the patient was vaccinated with incorrectly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dose, therapy type: rHA, lot # S015962, with expiration date on 23-MAY-2021 (route of administration was unknown) and varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # S025608 with expiration date on 18-AUG-2021 (route of administration was unknown) for prophylaxis. Administered vaccines underwent the temperature excursion of 16.7 degrees Fahrenheit for 1 hour on 09-NOV-2020 (reported as 09-NOV-2021) and 11.8 degrees Fahrenheit for 1 hour on 06-NOV-2020 (reported as 06-NOV-2021). Digital data logger was not involved. No adverse event was reported.
No adverse effects were reported; patient was inadvertently administered one expired dose of MMR II; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history or concurrent conditions.  On 22-APR-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) 1 dose, subcutaneous, for prophylaxis (lot # N009168 with expiration date on 20-MAR-2019) (expired product administered). The vaccine was reconstituted with properly stored MRK sterile diluent (lot # R034106 with expiration date on 22-JUN-2021). No adverse effects were reported. At the moment of this report the outcome of patient was inadvertently administered one expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Heart palpitations, began about 5-10 minutes after leaving facility, lasted 1/2 hour-40 minutes.  Fine after that.
I started feeling tired and then it progressed to the muscles, headache has been perpetual for about 4 months. Then chills hit, they were uncontrollable. The fatigue, shivering, headache and overall achy feeling. Joint pain and overall exhaustion.
I had pretty severe swelling, redness and very hard to move my fingers and joints on both hands, I believe due to the inflammatory osteo arthritis that I have.  It lasted approximately 5/6 days.
redness and pain at the injection site; redness and pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 13:00 (Lot number: EL9269) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 11Feb2021, outcome "recovered" (14Feb2021) and all described as "redness and pain at the injection site".  Additional information: The events did not require visit to physician office or ER. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient had no additional vaccine administered on same date of BNT162B2 vaccine.   No follow-up attempts are possible. No further information is expected.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 12-Apr-2022; Vaccine was expired on 01-Apr-2022 and administered on 12-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 12-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 12-Apr-2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 12-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 12-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, when the vaccine received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the correct expiry date for lot was 01-Apr-2022. It was reported that 115 patients were administered with expired doses of vaccine with LOT 026L21B from 02 Apr 2022 to 19 Apr 2022, beyond use date of 01 Apr 2022.  The vial was initially stored in refrigerator on 04-Apr-2022 and the vial did not undergo any temperature excursions.  No treatment information was reported.
I began to be awakened at night with pain in my right shoulder in August of 2021. It went into a frozen shoulder. I am submitting my VAERS form to report a frozen shoulder in August 2021. I had Pfizer Covid shots on 3/20/21 and 3/31/21. And then again 11/1/21.  It just kept getting worse after that. I began by seeing Dr. in October 2021.  Then after that I began PT for the frozen shoulder.  The frozen shoulder became so bad I had no range of motion.  I am a sculptor. Then I began seeing another Dr. I had several injections of prednisone and cortisone into the shoulder. And lots of Physical Therapy.  After these months of Injections and PT the range of motion and pain is better.  But, so far I cannot work in clay over 4 hours at one time.
3 year old reported to awaken at day care 10/3/2006 with seizure like activity. Mother reported child received DTaP 2 days prior to onset seizure as "catchup" vaccine. Dr. stated patient hx included foaming at mouth with right upper arm tonic/clonic activity. Rescue arrived with resolution seizure (no meds given) and transported to hospital. Child reported to have a second seizure, given 2mg Ativan, intubated and transferred to Dr. Exam/labs normal and child released 10/4/06 to parents stable. No known cause for seizure.  No other vac reported, no trauma, illness, fevers, toxic ingestions.  11/7/06 Received medical records from 1st hospital which reveal patient seen in ER for altered mental status. Patient awakened from nap at daycare with shaking of right arm, face & eye twitching.  On exam in ER, teeth were clenched & eyes deviated to left then to right & clenching left hand.  He was minimally responsive to pain.  Received valium & ativan & suffered respiratory arrest requiring intubation.  Patient was subsequently transferred to second hospital. DX: altered mental status; seizure; and respiratory failure. 1/16/07 Received medical records from 2nd hospital which reveal patient admitted 10/3/06- 10/4/06 with seizure & altered mental status.  Received patient intubated, sedated & paralyzed. After labs & LP done, weaned & extubated.  No neuro deficits noted & no further seizure activity.  To be followed by peds neuro on d/c to home. FINAL DX:  new onset seizures.
Swelling, redness at site, fever, vomiting, severe headache, diarrhea.
Expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment medicines were reported.  Vial moved from freezer to refrigerator on 1DEC 2021.
Burning when it went in,   tingling left arm down to hand,  left left foot.     Feels like it's getting worse.    Advised to see PCP.
Information has been received from a pharmacist via a company representative referring to a couple of unspecified patients of unknown age and gender. The patients' concurrent and historical conditions were not reported. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were unknown). Concomitant therapies were not reported. On unknown dates the patients developed unspecified eye complications. The outcome of the event was unknown. Additional information has been requested.
Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient called to report her own reaction. Inadvertently, she reported that she saw on the internet that there were other people whom developed Skin reactions with blisters on their skin after the Moderna Bivalent booster. No treatment information was provided.
This is a spontaneous report from a contactable consumer or other non hcp.  A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in Arm Right on 11Jun2021 as dose 1, single for covid-19 immunisation. Medical history included cardiac disorder ongoing Heart problems; multiple allergies Allergic to everything. The patient's concomitant medications were not reported. consumer stated received her first dose of the Pfizer-BioNTech covid19 vaccine last Friday. She has since been experiencing a rash which she has been treating with Benadryl (Lot 1795513, Expiry Jul2022, UPC 125471702) every 4 hours. She went back to her doctor who stated they would normally give a steroid shot in this situation but didn't want to affect the efficacy of the dose she received. Caller is a consumer who took her first dose of the Pfizer COVID shot last Friday, and she had a terrible rash reaction to it all over her body. Caller states that she has been taking Benadryl all week and she is still broken out. Patient saw her doctor this morning and her doctor said that she normally would give the caller a steroid shot, but the doctor decided not to give the steroid to the caller because the doctor was afraid the steroid would deplete the care that the one COVID shot had given to the caller. Patient is wondering about if a steroid injection could affect the effectiveness of the COVID vaccine. Patient reports that the same day as her shot, her tongue had a strange feeling and her throat is sore and she has blisters on her tongue, and these are ongoing. Patient woke up the next morning with the rash, which is also still ongoing, but improved. Patient states that she was holding off on getting the vaccine because she is allergic to everything, so she was afraid, but she ended up taking it and now she wishes she hadn't. Therapeutic measures were taken as a result of rash/ terrible rash reaction to it all over her body (rash). The outcome of the events was recovered and Indicated she would not be receiving her second dose was unknown.  Follow-up (PRD 18Jun2021): This is a follow up spontaneous report from a contactable consumer. This consumer 75-year-old female consumer(patient) reported information included.  Description of complaint: PC for non-suspect product. While completing a safety report for the suspect product, caller mentioned she has been taking Benadryl all week for a rash, and she is still broken out.
Pain in arm; got worse; Swelling; looked awful; felt like needle when touched; very bad; Itching/3 x 4 inches on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful) and PARAESTHESIA (felt like needle when touched) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful), PARAESTHESIA (felt like needle when touched), FEELING ABNORMAL (very bad) and PRURITUS (Itching/3 x 4 inches on upper arm). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), CONDITION AGGRAVATED (got worse), PERIPHERAL SWELLING (Swelling), CONDITION AGGRAVATED (looked awful), PARAESTHESIA (felt like needle when touched), FEELING ABNORMAL (very bad) and PRURITUS (Itching/3 x 4 inches on upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment as Allegra, cold Compress was given. No concomitant medication was given.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up received as dose 2 details were updated, events for dose 2 added.
A patient received Adacel instead of Daptacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00577378).  This case involves a six-month-old male patient who received a third dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5689AA and expiry date not reported) via an intramuscular route in the left thigh for prophylactic vaccination on 14-Apr-2021 instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE for prophylactic vaccination.  This was a case of actual medication error due to extra dose administered (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements. 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 called Friday morning stating that left arm is sore from injection body is weak and has fever. He states a little bit swollen and it hurts. Symptoms started last night.
Approx 11/1/22, Tingling, burning, numbness, shooting pain from lower back to feet. Loss of feeling in bowels and urinary tract. Loss of balance and ability to walk by 11/29/22
Patient received Moderna 2nd booster instead of Pfizer 2nd booster as desired.
Raised rash that appeared about 3-4 days after injection. Rash is at site of location. Slightly itchy
numbness in hands/ numbness in feet; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single and second dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness in hands/ numbness in feet. Patient called to ask she has numbness in her hands and feet, she thinks, after her first and second dose of the Pfizer vaccine and she wanted to know if getting the booster will make them worse. Clinical outcome of the events was reported as unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
experienced malaise; experienced; he could not sleep; chills; nausea; episodes of coughing; This case was reported by a consumer and described the occurrence of malaise in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 1st dose of Shingrix. On 19th February 2020, 1 days after receiving Shingrix, the patient experienced malaise, fever, insomnia, chills, nausea and cough. On an unknown date, the outcome of the malaise, insomnia, chills, nausea and cough were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the malaise, fever, insomnia, chills, nausea and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on 18th February 2020 around 9 AM and began to experience fever and malaise.  The patient could not sleep, continuing to experience fever, chills, nausea, and episodes of coughing. The fever subsiding but he continued to have some malaise. The patient went to the GSK Website for Shingrix, and said that he ticked the boxes for listed adverse event but did not experience other events besides those that were listed.
Dizziness, Fever, Joint pain, soreness at injection site,  Narrative:
Received routine update Tdap 0715 7/24/12 - called to let me know by the evening she had body aches & headache. Ran fever up to 102 the next day & had joint pain. Temp gradually came down. Reports it lasted 48 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 70 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Sep2023 to 06Sep2023.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine bnt162b2, bnt162b2 omi ba.4-5 in this patient cannot be completely excluded.
Pt returned to clinic 1 hour post vax with urticaria. Pt was treated with Benadryl.
I felt very tired verbatim/ exhausted; low energy; felt lousey for about 6-8 hours; This is a spontaneous report received from a contactable consumer (reporting on herself). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EK9231and Expiration Date was not reported), via an unspecified route of administration in in Arm Left on 12Jan2021 12:00 as single dose for COVID-19 immunization. Medical history included, asthma, urticaria from an unknown date and unknown if ongoing , crohns disease all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunisation and experienced drug ineffective, covid-19 pneumonia, rash. The patient previously took cephalexine and experienced drug hypersensitivity. It was reported that when patient received her second injection, 2 was out of Quarantine for Covid. Also she asked  her doctor If she Should even both to have this injection because apparently she had had Covid pneumonia, through by 02Jan2021. She was feeling a lot better , she was advised by her doc to go ahead & have it., which she did. No problem from Noon when she got shot to Noon Next day, but after lunch ,felt very tired, exhausted & low energy, was very wcepcited, lay on the cover, went to bed early & woke up next day feeling fine. Test: Blood test for HLA-B27 had lite @ 3x the testing Date: 15 years ago Also 25 yrs ago Result: Yes always 3x Comment: This is for Ankylosing spondylitis, Crohn's disease, Citifies, All of which she have had, the as ongoing.The outcome of the events was unknown.
PATIENT CAME BACK IN AND REPORTED (AND SHOWED ME) A RAISED ERYTHEMATOUS RASH ON RIGHT FOREARM THAT APPEARED 24-48 HOURS AFTER THE VACCINE WAS GIVEN. RASH DOES ITCH AND HAS NOT SPREAD PER PATIENT REPORT.
Patient passed out about 5 minutes after getting the  covid vaccine. Pharmacist was called right away and the patient was found lain on the floor, coherent and talking to the mother. She rested there for a few minutes, drank some water. She looked ok and refused further EMS help when EMS arrived.
3 days after vaccine, developed tachycardia, intermittent, resting to 130bpm. No Shortness of breath or chest pain. No abnormal rhythm. Recurred day 4, 5, 6 in the mornings only. No change in diet or caffeine intake.
Case previously recorded as MA2009-5694. Case received on 20 NOV 2009 via MedCom, from a healthcare professional the following information: A 3-year-old male patient was vaccinated i.m. with 0.5ml FLUVIRIN, batch no. 10127801, on 20 NOV 2009. No adverse events were reported. MedCom no.: NA09-008676.
headache, "feels like something in throat" nauseous. Evaluated by EMS- Cleared