chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022; The vaccine expired on 25-Mar-2022 and administered on 13-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 25-Mar-2022 and administered on 13-May-2022) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 25-Mar-2022 and administered on 13-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022). At the time of the report, PRODUCT STORAGE ERROR (The vaccine was expired on 25-Mar-2022, initially stored in the refrigerator on 02-May-2022 and administered on 13-May-2022) and EXPIRED PRODUCT ADMINISTERED (The vaccine expired on 25-Mar-2022 and administered on 13-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  HCP stated that their facility had an error where 5 doses of the Moderna COVID-19 vaccine was administered after the expiration date of 25-Mar-2022. The administration occurred on 13-May-2022. None of the 5 patients had reported any adverse reactions to this dose. The vial was initially stored in the refrigerator on 02-May-2022. The vial did not undergo any temperature excursions.  No treatment information was reported.
6 days post vax the pt experienced a mild rash with less than 50 lesions. There was no fever. Follow up information indicated that the pt developed full blown varicella.
Patient stated that 3 seconds after receiving the H1N1 vaccine she started shaking, sweating, dizziness, shortness of breath, broke out in hives, her skin turned pale and she is now coughing.  She was told by her doctor to use her inhaler, nebulizer and EPI-PEN. She was given BENADRYL for itching.
Information has been received from a nurse concerning a 43 year old female who 10 years ago was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced negative equivocal antibody titers. Medical attention was sought. No problems reported. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Rash; Swelling on face and arms; Swelling on face and arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient received bnt162b2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset Nov2021, outcome "not recovered", described as "Rash"; SWELLING FACE (non-serious), PERIPHERAL SWELLING (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "Swelling on face and arms". The events "rash", "swelling on face and arms" and "swelling on face and arms" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of rash, swelling face, peripheral swelling. Additional information: This report was received via a regulatory authority. The patient took antihistamines as treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Breakthrough case admission after 2 vaccines PFizer 4/28/21 Lot# BW0153 ; Pfizer 5/23/21 Lot# EW0176
pt recv vax 25MAY95 & became red & swollen (palm sized on Tuesday 30MAY denies fever, feels fine; red area 1" side, 2 1/2-3" long appeared down arm; refused medical attention; 5JUN95 allerg rxn;
Very itchy right eye, for 2.5 days, (same length of time as arm soreness), followed by sudden onset, noticeable vision loss with diagnosis of epiretinal membrane and vision loss from BCVA from 20/20 or 20/40
As per daughter, patient developed fever, cough and SOB.  Seen by private MD, antibiotic prescribed. She has taken this particular antibiotic in the past. From November through January, patient has had 5 episodes of facial and lip swelling, hives and severe itching. Was treated each time in ER with steroids and presently taking Benadryl 50 mg po as needed. Daughter stated, since flu vaccine mom appears to have a weaken immunity, highly sensitive to various things (peanuts, dust, fabric softener) which she had been exposed to in the past and never had a reaction.
5AM - headache, fever 100.7 deg,  heart BP 160/104  BPM 105.  Chills & night sweats. Joint pain, fatigue, confusion. Administered aspirin and cold compress.  Bed rest and liquids.  Recovery after 24 hours.
01/12/22 presents to EC ED for "shortness of breath". PMHx of "A. fib on Xarelto, CAD, CHF, hypertension"
OFF LABEL USE; VACCINE BEING GIVEN  ERRONEOUSLY OFF LABEL TO A 16  AND 17 YEAR OLD (VACCINE ADMINISTERED TO INAPPROPRIATE AGE); This spontaneous report received from a patient concerned a 17 year old of unspecified sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced off label use, and vaccine being given erroneously off label to a 16 and 17 year old (vaccine administered to inappropriate age). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine being given erroneously off label to a 16 and 17 year old (vaccine administered to inappropriate age) was not reported. This report was non-serious.
Left M1 MCA stroke in 45 year old female with no hypertension/no hypercholestrolemia/no diabetes)
Swollen arm pit. Feels sore like a bruise when I touch it. It feels soft and very swollen.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency,route and lot # were not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Rash on upper chest, no profuse hives.  Pt. expressed sensation of "thick" tongue.  Pt. was evaluated by EMT staff, stable vitals, lungs clear, pink, warm, dry,. Pt. self administered  (2) bendadryl tablets. Pt. agreed to be transported to local hospital for evaluation.
Sigmoid stricture. Hospital admission and surgery. This visit was within 6 weeks of receiving the COVID vaccine.
1/25/2023 I was feeling tired and had a stuffy and runny nose and a little sore throat. It was not that bad.  Since my daughter had a positive COVID test, I tested for COVID with an at home COVID test and it was positive. I called my doctor and I had a telehealth later that day. The doctor prescribed Paxlovid had me stop my Rosuvastatin until five days after taking the Paxlovid. I started taking it that day and the next day the symptoms were a little worse, mostly my sore throat. On 1/27/23 I talked to the doctor again. She told me I could take over the counter cough syrup. I was also prescribed Prednisone if the sore throat seemed worse over the week-end. I began taking the Prednisone and my sore throat began to get better as well as the other symptoms.
Heart rate was sky high, couldn't breathe, throat closed, anxiety was bad, range of motion was bad, arm swelled, got big knots in arm pain and swelling.  Can't pick anything up because arm hurt so bad. Went to ER 2 days after,  they put me on heart monitor, gave me IV fluids, examined the knot, got my heart rate down, and gave me Tylenol, thats all they did.  I still have all the symptoms. Lump still comes and goes, it still burns, I can't lift my arm over my head and I can hardly use my harm.
dizziness; malaise; severe headaches; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizziness), MALAISE (malaise), HEADACHE (severe headaches) and FATIGUE (fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), MALAISE (malaise), HEADACHE (severe headaches) and FATIGUE (fatigue). The patient was treated with OXITRIPTAN (TRIPTAN [OXITRIPTAN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), MALAISE (malaise), HEADACHE (severe headaches) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter.
The day of the vaccination I had a knot that came up at injection site and wrapped around to my underarm. It was hard, hot, burning and itchy all the time. I took ibuprofen for the pain and ice pack. I had it for a week and it is still a little tender at injection site. I'm also very tired. I have had several tests and nothing is wrong but I am extremely tired all the time and having difficulty sleeping.
The first one, the reaction I had my watered for a day, what happened next was my entire arm broke out in a rash and my lymph nodes swollen, eventually went away.
The patient was found to have an elevated ANA as well as double stranded DNA on her recent testing. 11.4.21 Patient present to ED on 4.27.21-for TIA symptoms of left sided facial weakness with drooping, elevated blood pressure 181/91, fatigue & tachycardia 119.  Facial drooping-resolved-possible neurological side effect from vaccine
Woke up with a fever, chills, body aches, joints hurting,headache. Fever would not get below 99 with tylenol, but got up to 103.5. This happened 3 times each 4 hours after a 1000 mg does of Tylenol. At midnight I took 2 ibuprofen bc I had the max amount of Tylenol for the day. Woke up the next morning feeling normal, but still had joint aches. I understand most of the symptoms are normal, but I thought the 103.5 fever was very high.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-08-15, rash NOS on 2022-08-22.
The injection site was really sore. Ran high fever and had flu like symptoms for about 15 hours. Then those symptoms stopped but the injection site pain continued. The intensity of the pain grew for about 3 weeks. Then pain extended to neck and shoulder blade. Went to urgent care  for the  arm/neck/shoulder pain. Took neck X-rays. Given a steroid shot and an another shot I think for inflammation. Prescribed a muscle relaxer.
Rash; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder; This is a spontaneous report from a contactable other healthcare professional (patient).  A 56-year-old female patient receive bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration in the left arm from 12Jan2021 12:30 to 12Jan2021 12:30 as SINGLE DOSE (first dose of the vaccine by injection) for COVID-19 immunisation.  The patient medical history was not reported.  Ongoing concomitant medication included propranolol 80mg once daily by mouth, apixaban (ELIQUIS) 5mg one twice daily by mouth, omeprazole 40mg once daily by mouth, hydrochlorothiazide 12.5mg once daily by mouth, and atorvastatin 80mg once daily by mouth. The patient stated she got the Pfizer COVID 19 vaccine and she experienced tenderness at the site of the injection that progressed and got more painful and swollen until she could hardly raise her shoulder but she could use her arm and her hand. She got the shot on Tuesday and still had some symptoms the next Monday. On an unspecified date, the patient experienced rash. The patient also asked, can you take Tylenol or Ibuprofen before or after vaccination?  I have heard it can it lessen the immune response. With the first dose of the vaccine my arm hurt from Tuesday and the last day of it hurting was the following Monday, so about a week. Someone told me with the second vaccine the pain is higher. I am fine and still getting the second dose. The outcome of the event rash was unknown; while the rest of the events was recovered on 18Jan2021.  Information on the lot/batch number has been requested.
SICK AGAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. 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 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced sick again. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick again, fever and chills was not reported. This report was non-serious.
Patient came in for a first dose Shingrix vaccine. Patient stated never having a Shingrix vaccine and that he received the old vaccine (i.e Zostavax) "many years ago". Vaccine was administered and then patient was questioned about having completed pneumonia series. Patient was unsure and so account was checked. Account showed that patient had already received and completed Shingrix series back in 2019 at a different pharmacy. Verified that patient received that vaccine series with other pharmacy as well.
Rash on neck, tingling, throat swelling. BP 148/86 (pulse 75), O2 sat 96%. Benadryl 50 mg IM x 1. Resolved. BP 137/83 (pulse 80).
Parent called 5/19/2010 stating that patient developed a "tennis-ball sized" lump on her left arm. I informed her she had received the Tdap in that arm, and that swelling does develop sometimes. She said that they iced it and the swelling has gone down. Their doctor told them to call us to report it so we could do a VAERS.
received / only the lyophilized portion of Menveo / liquid component /not administered; received / only the lyophilized portion of Menveo / liquid component /not administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 14th June 2021, the patient received Menveo. On 14th June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported are as follows: The age at vaccination was not applicable for this report. The nurse reported that, the patient received the only the lyophilized portion of Menveo, they were not sure if the vaccines were reconstituted with another diluent than recommended but the liquid component of Menveo was not administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not had any patient's data yet This was 2 of the 2 cases reported by same reporter The reporter was consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021130498:same reporter (1st patient)
SURGE OF ENERGY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced surge of energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from surge of energy on MAR-2021. This report was non-serious.
4:08pm - Patient received vaccination, approx. 3-4 minutes after had a syncopal episode with weakness and diaphoresis. Blood sugar=120, Hgb=11.7, BP=73/43, Pulse=40, O2 SAT=98%. 500 ML 0.9% NaCL provided, Patient transferred to ER.
runny nose; This is a spontaneous report from a contactable consumer or other non hcp. A 20-years-old male patient received BNT162B2 (: PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as a Single dose for covid-19 immunization. The patient past medical history and concomitant medications were not reported.  The patient experienced runny nose 10 days but was fine after on Mar2021. However, 4 days later he woke up with an incredible ringing in my ears and a spike headache that he has never experienced that in his life. He also reported a rash under one of his eyes that later spread to the other eye, as well as insomnia. He has seen his HCP and was referred to an Audiologist, who he has visited 3 times since then. He was diagnosed with 50% loss of hearing and 10500 Hertz tinnitus, which the Audiologist mentioned is high. He was prescribed with high dose Prednisone for 7 days, but caller mentioned it did not help and had no effect whatsoever. His HCP wanted to be super cautious and recommended a brain scan this week just to make sure he didn't develop a blood clot. He has reached out to CDC and asked for medical advice, but he stated that everyone is giving him the same answers - there is not enough data. He is on the verge of suicide and said, I can't live with this for the rest of my life. I can't sleep and can't think, its driving me crazy. The event outcome was recovered on Apr2021.  He is desperate for answers and even tried reporting to VAERS but there was no way to submit it.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Someone came in for a 2nd dose of the Moderna Covid-19 vaccine. He got booster dose amount of 0.25mL instead.; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Someone came in for a 2nd dose of the Moderna Covid-19 vaccine. He got booster dose amount of 0.25mL instead.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Dec-2021, the patient experienced UNDERDOSE (Someone came in for a 2nd dose of the Moderna Covid-19 vaccine. He got booster dose amount of 0.25mL instead.). On 16-Dec-2021, UNDERDOSE (Someone came in for a 2nd dose of the Moderna Covid-19 vaccine. He got booster dose amount of 0.25mL instead.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter.
I had a cough, runny nose, and fatigue. I went to the doctor, and they gave me a COVID-19 test and I tested negative. They diagnosed me with Bronchitis. I was prescribed doxycycline, benzonatate, and albuterol. I am feeling much better now.
Shingles back of right neck/C5 distribution and left back/T5 distribution; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles in 40s / original shingles in my 40s, left back -T5 distribution). Previously administered products included Zostavax with an associated reaction of herpes zoster (received about 15 years ago from reporting and got verymild attacks of Shingles every few years in different parts of the body). Concurrent medical conditions included borderline diabetes and hypertension. Concomitant products included metformin and amlodipine (Amlodipin).   On 15-FEB-2023, the patient received the 1st dose of Shingrix. In MAR-2023, 4 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles back of right neck/C5 distribution and left back/T5 distribution). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR071523   Additional Information: GSK Receipt Date: 17-MAY-2023 After the 1st vaccine about 4 weeks later patient got mild Shingles back of right neck C5 distribution and left back T5 distribution. She did not consult with her primary care physician because she knew the diagnosis and did not particularly thought antivirals were necessary. She did realize that generally, Shingrix vaccine was not associated with actually getting the Shingles, but she had afraid she definitely got it with both vaccines. With both vaccines, she did not experience much of other generalized symptoms (pain at the injection site with the second vaccine).  Today (on the day of reporting), she had mentioned to pharmacist about her Shingles episodes after receiving recent Shingrix vaccines as she felt they needed to know. She was just letting GSK know about her experience with Shingrix vaccines just for GSK interest and nothing more. At the end of the day, she was very grateful that Shingrix vaccine was available for all and that hopefully, she would never get Shingles again. The reporter had consented to follow-up. This case had been linked with US2023AMR063356 (for 2nd dose) by same reporter for same patient.
possible Guillian Barre syndrome.  Progressive weakness, numbess beginning at feet and progressing upwards