chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicines was not reported by reporter.  Treatment information was not provided.
IT HAS BEEN PAINFUL TO LIFT UP THE ARM (SAME SIDE THAT WAS INJECTED); ISSUE WITH THE ARM MUSCLES (SAME SIDE THAT WAS INJECTED); This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced it has been painful to lift up the arm (same side that was injected), and issue with the arm muscles (same side that was injected). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the issue with the arm muscles (same side that was injected) and it has been painful to lift up the arm (same side that was injected) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210314164 and 20220109828.
Patient had left clinic and returned to work.  Patient had vertigo episode about 45 min after receiving vaccine - became dizzy, multiple episodes of vomiting and diarrhea, pallor.  Patient drove back to clinic arrived at 3:10 pm; patient extremely pale, c/o nausea and dizziness, felt anxious and mild fatigue also.  Temp upon arrival 97.8 (F). Vital signs as Below: 3:12pm: BP-164/100, P-69, RR-22, PO2-96% 3:16pm:  BP-138/96, P-68, RR-22, PO2-95% 3:22pm: BP-144/101, P-74, RR-20, PO2-95% 3:32pm: BP-142/100, P-74, RR-20, P02-97% 3:45pm: BP-117/76, P-70, RR-20, PO2-96% Zofran 1 dose given at 3:25pm, patient laid on side around 3:35pm then seen by in-house provider at 3:54pm. Patient drank small sips of water around 4:00pm and felt better, less nausea and dizziness. Per Dr. patient able to leave with wife as transportation.  Patient contacted by Manager that evening and reported feeling better, all symptoms improved. Attempted to contact patient this am - no answer, left message to call back to verify symptoms resolved. Dr. report: Patient was noted to have vertiginous reaction, starting 45 minutes after 1st dose of vaccine with dizziness and nausea. Patient is known to have a history of vertigo. His symptoms resolved within 30 minutes with treatment including rest and Zofran. No further vertigo or other side effects noted. No signs of acute allergic reaction occurred during this period.
Client c/o burning sensation at the tip of the tongue.  Client seen and assessed by EMT and vitals are as follows BP 150/89, HR 78, O2 97.  Client denies any pain or other symptoms of the moment and no swelling of the tongue note.  Client able to verbalize with ease.  Client advise to contact pcp for any other symptoms arise and cleared to go home by EMT.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 at 09:00 as dose number unknown, single (Lot number: EL 3246) at the age of 70 years, in left arm 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) all with onset Oct2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 28Oct2022 to 01Nov2022.
Sore arm.; This is a spontaneous report from a Pfizer sponsored program support received from a contactable consumer reporting for her husband. A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on an unspecified date (Batch/Lot Number: not provided) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced sore arm. The event outcome was unknown at the time of the report.  Information about lot/batch number has been requested.
My lips began to swell, I felt alternatingly hot/swetty or cold I could not control my body temperature. I also had increased breathing problems. About 1.5 hours later, I felt well enough to drive to the ER.
No adverse event; Dose administered after 30-day Use by Date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 4th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Information has been received from a consumer concerning her 12 month old daughter who on 28 DEC 2006 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy that same day included a dose of Hib conj vaccine (OMPC) (manufacturer unknown), hepatitis B virus vaccine rHBsAG (Yeast) (manufacturer unknown), and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (manufacturer unknown). Approximately two weeks after receiving the vaccines, approximately 11 JAN 2007 the child developed a very swollen lump on her upper left thigh. The child was seen by the pediatrician, it was noted that she developed a cyst, and it was assumed that it was from the vaccines, possibly due to the chicken pox vaccine. The child had received two shots in each leg, and this occurred where the varicella virus vaccine live (Oka/Merck) had been given. The mother was instructed to put compresses on the leg and watch and see if it got bigger. The spot was a 2 X 2 inch area. It did not enlarge, and it did disappear. Additional information has been requested.
pt c/o dizziness & shakiness that inc during the evening; pt could not define time of onset; approx 10Pm pt exp inc in dizziness, fainted regained consciousness but cont w/dizziness, unsteady gait, unable to follow commands; BP 134/88, t99
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown demographics. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017, lot # L026602, expiration date: 19-OCT-2017 and lot # L043214, expiration date: 30-AUG-2017; dose and route were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Child has 4 y old immunizations - 20 minutes later had hives and edema on face, neck, eyelids- upper airway ascites  irritability- Did not improve with BENADRYL. Resolved with EPIPEN 0.15 after 15 minutes.
Awoke forcefully for 19 days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Awoke forcefully for 19 days) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 immunization.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient received dose of NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INSOMNIA (Awoke forcefully for 19 days). At the time of the report, INSOMNIA (Awoke forcefully for 19 days) outcome was unknown.            No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2023: Follow up received with significant information Moderna product added as suspect
I left office and went down to pharmacy with mother to pick up steroid cream rx. Given flu shot here before leaving. When downstairs, c/o arm pain to mother, crying. Was standing in line waiting for rx when she stated that she felt dizzy. Per mother, she became very pale and sweaty, pre-syncopal episode. Mother held her, no shaking episode. No full LOC. No fall. Rapid response called and pt taken to room where I found her sitting up. Per physician, vitals all ok - I took HR at 95.  I lowered HOB to 30 degrees. Responsive and answering questions appropriately. Given juice.  Advised to rest for 10min, then sit up and wait another 5 min before standing. When standing, wait to make sure no dizziness before leaving. Advised mother I would check in before leaving for the day.
diffuse urticaria approximately 24 hours after vaccination, Benadryl 6.75 mg po given, unclear if beneficial at this time
severe headache; Nausea; Body ache/whole body hurts; Fatigue; muscular/ bone pain; muscular/ bone pain; right leg was numb; Annoyed by a minimal noise even listening to people speak; This is a spontaneous report from a contactable other HCP (patient). A 45-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 01Oct2021 15:00 (Lot Number: 23183) at age of 45 years old as single dose for covid-19 immunisation. There was no medical history.   There were no concomitant medications.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took bnt162b2 (lot number=30130BA) dose 1 on 10Sep2021 in Left arm at age of 45 years old for covid-19 immunisation, amoxillin and experienced drug hypersensitivity. The patient was concerned because her body/immune system was very sensitive, Anyways... she received first dose on 10Sep2021, no complications.  Second dose 01Oct2021 (Friday)vaccine was received around 3pm, two hours later she started to get a severe headache, nausea, body ache, fatigue at the same time feeling annoyed by a minimal noise even listening to people speak, as time went by she felt worst, the whole weekend was a nightmare, pain more pain, headache was worst took Tylenol didn't help. She was told the headache was going to go away within two day. Well not in her case. She was persistently experiencing headache along muscular/ bone pain, her whole body hurts. She supposed to get better as time goes by, not in her case. This weekend 22Oct2021-24Oct2021 she woke up 22Oct2021 in the middle of the night with an extreme pain in right are, also right leg was numb. The events resulted in [Disability or permanent damage]. The patient had covid test post vaccination on 15Oct2021: covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test result=negative. The outcome of events was not recovered.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Within 10-15 minutes of immunization, patient began to itch,complain of itchy throat, rubbing nose and nauseated.  This continued with some whining and complaining of "not feeling good".  Call to 911 who, after checking patient, decided to transfer to E-Room for further evaluation.  After arriving to E-Room, Mother reports that his face became red and soon after began to have hives.  At that time, an IV was started, had 2 tsp of Benadryl, 0.2 Sub-Q Epinephrin and Decadron 2.5 mg.  He was given immunizations at 12:30, meds at 13:15, and kept in E-Room for observation until 17:30. He was given instructions for 2 more tsps of Benadryl to be taken at 18:00.  Mother reports on 7/21 that patient had no more symptoms and doing O.K. TPR 99.4, 124, 30 B/P 88/62  Wt. 43.5lbs  Had reported allergies of Latex and Morphine
Nausea, mild headache, increased difficulty breathing over April and got worse in May, weakness.  Went to ER for severe difficulty breathing, admitted to hospital 5/26/21 A-Fib, monitored placed on meds-had TEE 6/21 discovered blood clot left side, increased medications added meds to dissolve clot, had cardioversion 9/21.  still have weakness/fatigue, low blood pressure, lack of endurance, working on strengthening, taking meds, watch diet
Patient expressed concern about pain associated with injection prior to vaccination, she was visibly nervous. Mother insisted that patient had shots before and that this [receiving injection] is not something new. I offered to delay injection, however mother insisted to have the vaccination done, and physically held patient's face away so that the patient does not look at the needle. After injection given, patient immediately complained about injection site pain, and complained about not able to hear. Patient's mother and sibling was at her side, talking to patient saying "but you can hear us," patient was able to respond to mother/sibling. Few minutes later, patient started to complain about not able to see well, and she states that her eyes are swollen. She requested to have some water to drink and cold bottled water was provided to her. Patient denied experiencing any shortness of breath. She had held her ears several times throughout the incident. Patient remained seated and her lower extremities were elevated on another chair the whole time after the injection was given. Patient complained about being lightheaded, however did state that the vision and hearing problem got "a little better" after 15-20 minutes post-injection but that they are still present. We offered to call 911 several times, however patient's mother declined. We offered that there's an urgent care clinic nearby and if the patient wanted to be seen by the clinic - patient's mother agreed. Patient states she wanted to "get some fresh air." Motorized wheelchair was offered to escort the patient to the clinic- declined by patient's mother. Patient was escorted by her mother and was able to walk out the store on her feet.
Narrative: COVID infection following COVID vaccine series 02/09 Pfizer, dose #1 03/01, Pfizer, dose #2 09/18 pt cc: cough, headache, myalgias, rhinorrhea exposure; unknown 09/21 COVID swab, result: detected 09/21 SARS-COV-S Variant Sequencing result: pending
Patient presents with upper abdominal pain, HA, fatigue, cough on the same day of receiving her 2nd dose of her vaccine; she was found to be COVID+ on 5/29/2021 after return of her COVID-19 ER nasal swab test.
Pt began experiencing tingling and tenderness in her extremities similar to a bruise or sunburn.  It would come & go & seemed to "travel" around her body.  On 12/7/07 her feet began to swell.  Symptoms have improved as of 12/11/07.  Dr. thought possibly viral infection.
Fever, chills, nausea, upset stomache, headache, severe muscle pains throughout body, loose stools, tiredness
There were no adverse events. The local Health Department requested that this report be filed as the vaccine was given on 6-24-2022 but the 30 day refrigerator storage date ended on 6-12-2022. We were not aware of the 30 day limit on refrigeration only. Moderna will be contacted to see if the dose may have still been effective.
Extreme pain in left shoulder and arm and very limited range of motion within 2 hours.  I could not lift my arm which made it difficult to bathe and dress.  Pain also caused difficulty sleeping.   I iced it and kept it stable in a sling for a week and then gradually started moving it.  My primary care prescribed Ibuprofen 800mg and Diclofenac gel.   The pain and range of motion has improved over the last 12 days.  I still have some pain with certain motions and have dIfficulty sleeping on my left side.
1) fever and chills  (x24 hours) 2) fatigue  (x24 hours) 3) severe joint and muscle pain (ongoing) 4) limited range of motion ( x1 week)
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown". Therapeutic measures were taken as a result of headache.  Additional information: Patient received bivalent covid vaccine booster around noon, then developed very painful headache around 8 pm that evening. Pain was felt behind the forehead (squeezing pain) and lasted overnight and into the morning. Patient took tylenol following day and experienced some relief of headache but not complete resolution. Patient has no underlying conditions or medications. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Breakthrough case admission after 2 vaccines mOderna 1/13/22 Lot# 028K21A;  mOderna 2/10/22 Lot#045L21A;
Delivered Pfizer-Biotech bivalent omicron vaccines in December. Expiration on bottle was 09/2022. Vaccines best use by date was February 15, 2022 according to the Department. Has the expiration date as 8/2023 so there was confusion of when the doses expired.
Information has been received from a medical assistant referring to 10 unspecified patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. In November 2016 (reported as "either 22-NOV-2016 or 28-NOV-2016"), the patients were vaccinated with improperly stored ROTATEQ (lot # M018957, expiration date 22-NOV-2017, dose not reported) orally for prophylaxis. The doses of vaccine were improperly stored at 49 degree Fahrenheit for 1.75 hours on 22-NOV-2016 and 49 degree Fahrenheit for 1.75 hours on 28-NOV-2016. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009766.
Vaccine for shingles given at 9:15 AM on 1/10/14. On 1/14/14 breaking out started on chest, upper back, around neck and later on face. On Friday 1/17/14 the rash was dark red with blisters and had become extremely painful, went to emergency room at hosp, where shingles was confirmed and prescriptions given for antiviral, pain.
Red circle (not a perfect circle) approximately 2 inches in diameter.   Flat, not raised. Does not itch.
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 26 doses from Lot 065K21A Monovalent doses were administered after the BUD to patients. Treatment medications were not reported.