chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 031B21A and 027C21A) for COVID-19 vaccination.     Concurrent medical conditions included Grass allergy and Pollen allergy.   On 31-Mar-2021 at 10:16 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021 at 10:23 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  The vials were supposed to remain frozen until 06-Sep-2021 but instead they were immediately put in the refrigerator upon arrival (on 06-Aug-2021). None of the vials underwent any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Added patient initials and date of birth.
Onset fever 07/20/2006 102 degrees maximum and 07/21/2006 onset rash, 07/23/2006 still papular diffuse rash on 07/31/2006, Itchy eyes. Still with rash.
Was never allergic to anything until I got these vaccinations now I'm allergic to everything; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FP7137) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (disability, life threatening), outcome "not recovered", described as "Was never allergic to anything until I got these vaccinations now I'm allergic to everything". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: If covid tested post vaccination: Yes/Nasal Swab.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (HYPERSENSITIVITY) and BNT162B2.  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.,Linked Report(s) : US-PFIZER INC-202300218333 same reporter/patient/drug, different dose/event;
I returned patient's call today (10/28/08). She reports she had blood shot eyes with a light yellow discharge in each X 5 hours after taking INFLUENZA vaccine. MSO, had elevated flu like symptoms. Vaccine received 10/27/08. Felt better this AM but did F/U with PCP - today. She was diagnosed with possible allergic reaction to Flu vaccine - but has also given prescription for antibiotic for possible eye infection. Received steroid injection. Also  injection site for flu vaccine is OK. Recommended f/u with PCP.
motor; loss of taste; smell loss; shake of arms and legs; mind blur/draws a blank at times/confusion; head foggy/brain fog; disorientation; chills; joint soreness; fatigue; extremely sore arm; headache; nausea; dizziness; This spontaneous case was reported by a health care professional and describes the occurrence of DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog) and ANOSMIA (smell loss) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea) and DIZZINESS (dizziness). On 04-Feb-2021, the patient experienced FATIGUE (fatigue). On 05-Feb-2021, the patient experienced DISORIENTATION (disorientation), FEELING ABNORMAL (head foggy/brain fog), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), CHILLS (chills) and ARTHRALGIA (joint soreness). On 15-Feb-2021, the patient experienced AGEUSIA (loss of taste) and ANOSMIA (smell loss). On 05-Apr-2021, the patient experienced MOTOR DYSFUNCTION (motor). At the time of the report, DISORIENTATION (disorientation), MOTOR DYSFUNCTION (motor), AGEUSIA (loss of taste), FEELING ABNORMAL (head foggy/brain fog), ANOSMIA (smell loss), MUSCULAR WEAKNESS (shake of arms and legs), CONFUSIONAL STATE (mind blur/draws a blank at times/confusion), VACCINATION SITE PAIN (extremely sore arm), HEADACHE (headache), NAUSEA (nausea), DIZZINESS (dizziness), FATIGUE (fatigue), CHILLS (chills) and ARTHRALGIA (joint soreness) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had COVID-19 test which showed negative results. Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On  04-NOV-2015, the patient was vaccinated with dose of ZOSTAVAX vial 194500 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 27JUN95 & 5 mins later while in waiting room pt extremities began to shake;extremities cont to shake for 10-15mins then subsided;pt was observed in the office for an addl 45mins w/o recurrence of shaking;
lethargic; warm to touch on injection site; small bump on injection site; waking up during the night; redness in arm on injection site; tiredness; soreness in arm on injection site; body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), VACCINATION SITE WARMTH (warm to touch on injection site), VACCINATION SITE MASS (small bump on injection site), MIDDLE INSOMNIA (waking up during the night) and VACCINATION SITE ERYTHEMA (redness in arm on injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included No adverse event and Type 2 diabetes mellitus. Concomitant products included DULAGLUTIDE (TRULICITY) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced LETHARGY (lethargic), VACCINATION SITE WARMTH (warm to touch on injection site), VACCINATION SITE MASS (small bump on injection site), MIDDLE INSOMNIA (waking up during the night), VACCINATION SITE ERYTHEMA (redness in arm on injection site), FATIGUE (tiredness), VACCINATION SITE PAIN (soreness in arm on injection site), PAIN (body aches), CHILLS (chills) and PYREXIA (fever). On 15-Feb-2021, PYREXIA (fever) had resolved. At the time of the report, LETHARGY (lethargic), VACCINATION SITE WARMTH (warm to touch on injection site), VACCINATION SITE MASS (small bump on injection site), MIDDLE INSOMNIA (waking up during the night), VACCINATION SITE ERYTHEMA (redness in arm on injection site), FATIGUE (tiredness), VACCINATION SITE PAIN (soreness in arm on injection site), PAIN (body aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.8 High.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included Tylenol.
Employee received both doses of the Pfizer vaccine on 12/17/2020 and 1/5/2021.  She tested positive for Cvovid-19 on 2/16/2021.
I received my first first Moderna shot on 12/30/21. At first I had the common cold like symptoms, like fatigue that are associated with the vaccine. That month I started to have little heart flutters, but after I looked up heart flutters on internet, and it said that they aren't serious, I didn't worry about it. I also had an incident that month when I was driving where my left arm got completely numb. After I received the second shot on 2/3/21, I took 3 days off from work, because I wasn't feeling well. I had flu like symptoms, with no fever, but went back to work, because the symptoms felt mild enough. I had some additional pressure in my ears that came and went. I was still having bad cases of fatigue and light headedness. On February 12, I woke up with extreme fatigue. I felt so dizzy that it felt like my head was at the bottom of a swimming pool. I had to get fingerprinted for work so I drove with symptoms. When I went in to get fingerprinted, I fainted and was rushed to the hospital. My EKG came back normal while I was laying down so I was released that day. My symptoms were worse with intense PVCs, fatigue, neusea, lightheadedness, dizziness, migraines, vision problems and GI issues. I followed up with my PCP and after testing she suspected that I had POTS syndrome. After having to leave my jobs because the symptoms were so bad and I moved back to State for better medical care, I followed up with more doctors and was diagnosed with POTs Syndrome. After phsyical therapy, acupuncture, and lifestyle changes, my symptoms have gotten better but I still have them. Lately, I have had a  lot of PVCs. I have severely lost income, because I couldn't work.
Rash developed on Monday after Friday shot. Bad reaction on the top of my right hand, as well as a sight rash on my left wrist, top of left hand, bottom lip. By Tuesday right hand was blistered and extremely painful, with blisters.  By this morning, skin was peeling and revealing very pink new skin. Painful burning sensation throughout.
I have Covid arm - I woke up in day 7 after the first dose of the moderna Covid vaccine with moderate/visible swelling at the injection site.
Coldness in all toes. pressure and pain in both feet up to the ankles for 3 days. Pain went into the calves for a day. Numbness in right hand on pinky and ring finger down to wrist intermittently for two weeks, same symptoms on the left hand for one day, tongue looked like it was burned in multiple places, very heavy period that started the next day with heavy blood flow for five days and it lasted eight days. I usually have heavy flow for one day and it ends about 6-7 days in with the last three being just spotty.
little soreness in her arm; was not feeling as well; Alopecia; condition aggrvated; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site swelling (1st dose received in July 2019). Concurrent medical conditions included alopecia.   In October 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm, feeling abnormal, alopecia and condition aggravated. On an unknown date, the outcome of the pain in arm and feeling abnormal were recovered/resolved and the outcome of the alopecia and condition aggravated were unknown.   It was unknown if the reporter considered the pain in arm, feeling abnormal, alopecia and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix and experienced little soreness in the arm, and was not feeling as well. The  reporter stated that, the patient recovered in few days from  symptoms. This case has been linked with case US2020003252 and US2020AMR003766, reported by same reporter
Broke arm,broke her shoulder; 2nd dose was suppose to be on March 31st but on 30th she broke her shoulder; tenderness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Broke arm,broke her shoulder), INJECTION SITE PAIN (tenderness on injection site) and PRODUCT DOSE OMISSION ISSUE (2nd dose was suppose to be on March 31st but on 30th she broke her shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, METOPROLOL, CHLORTHALIDONE, CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPRIN) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (tenderness on injection site). On 30-Mar-2021, the patient experienced LIMB INJURY (Broke arm,broke her shoulder) and PRODUCT DOSE OMISSION ISSUE (2nd dose was suppose to be on March 31st but on 30th she broke her shoulder). On 30-Mar-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose was suppose to be on March 31st but on 30th she broke her shoulder) had resolved. At the time of the report, LIMB INJURY (Broke arm,broke her shoulder) and INJECTION SITE PAIN (tenderness on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114387 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114387:Case for husband
Patient was given dose 1 of the Pfizer vaccine series on 1/27/2021 and should have received the second dose on 2/17/2021. The patient was inadvertently given the Moderna vaccine.
She had a fever and withdrew from herself. She stopped eating and drinking. She started screaming with a high pitched scream, arching her back and writhing. She continued to scream and cry without eating or sleeping well for 3 days. She stopped having eye contact. After 3 days the reactions subsided. She came down with an ear infection and continued having severe reflux.
Shingles 3 months post receiving a second /  Vaccine; Shingles 3 months post receiving a second /  Vaccine; This case was reported by a consumer and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 1st March 2021, 88 days after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported but it could be 69 or 70 years. The patient developed shingles 3 months post receiving a second adult zoster (Shingrix) vaccine. On 1st March 2021, the patient began treatment for shingles. The reporter stated that she understands that the vaccine claims a 97 percent prevention rate. Her interest in writing was to understand under what condition and/or circumstances that she could fall in the 3 percent who are susceptible to getting shingles post vaccine and asked to provide her with any information about the conditions and/or circumstances that contribute to this outlier
Little headache; Tiredness; Couldn't exercise; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for immunization. Relevant medical history was unknown. Concomitant medications included raloxifene hydrochloride (EVISTA) and rosuvastatin calcium (CRESTOR). On an unspecified date, the patient experienced a little headache, tiredness and she couldn't exercise. Clinical outcome of the events was unknown at time of this report.   Information on the lot/batch number has been requested.
Administered expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided.  The vaccine was expired on 30-Dec-2021.  No treatment drug information was provided.
large swelling around his right leg; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of unspecified age received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 13Jan2021, at a single dose for COVID-19 immunization. The patient also received insulin (manufacturer unknown), via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history and concomitant medications were not reported. The patient got the COVID vaccine shot on Wednesday, 13Jan2021. At the morning of the report, 15Jan2021, he noticed a large swelling around his right leg. When he takes insulin through his right leg, he sees a few spots, but it usually goes away. This morning, when he woke up, a large area around the right site was swollen and it's not going away. He had been injected insulin around the same site a few times. He called to know if this was normal. The action taken in response to the event for insulin was unknown. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
vaccine vial used was past it's Beyond Use Date, which was 12/29/2022.  We are contacting clinical services to determine efficacy.
Difficulty obtaining deep breath Heaviness in chest, radiating to both arms Reduction in stamina (exercise-induced)  Light headache Light, intermittent dizziness Abdominal pain & nausea, but no vomiting
Client received 1st dose and approx 15 min. later stated "I feel like I'm going to faint and feel hot." Client was kept for observation  for 30 additional minutes. Vital signs taken 3 times and every time WNL.  Client reported history of becoming faint with needles. Allergy to gluten. At 10:35am, client walked away unassisted. No medication or other treatment given.
Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 41-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 4 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118569:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118572:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118616:Same reporter.
C/o headache and palpitations, nausea. Treatment: REGLAN 10 mg PO x 1, BENADRYL 10 mg PO x 1.
Patient reported no adverse reaction until this Monday 12/17 when her arm started getting sore like muscle pain, and traveling to her upper back on the side of the vaccination, it has continued since Monday through today.
No Additional AE/PQC reported; HCP reports that the patient received a dose of VARIVAX that has suffered a TE; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 11-AUG-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters as prophylaxis (lot number: w039292, which was determined to be valid, with an expiration date on 11-DEC-2024) (strength, scheme, route and anatomical location of administration were not reported) (Product storage error).   The administered dose underwent a temperature excursion of -14.3 degrees Celsius for 13 minutes, with a previous temperature excursion of -10.6 degrees Celsius for 38 minutes.   No additional adverse event was reported.  This is one of three cases form the same reporter.