chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented for 2nd dose in Moderna monovalent primary series and received expired vaccine. After administration of vaccine client sat 15 mins. in waiting area for observation of side effects. None noted. Expiration of the vaccine was not noted until 2:00 pm after clinic closed. Vaccine expired 04/01/2023. Client was contacted and informed of the incident, denied any side effects and potential for revaccination. Moderna was contacted to check viability of expired vaccine.
Still fighting the nerve pain; her immune system was not up to par; I was fully vaccinated and got shingles in February/suspected vaccination failure; I was fully vaccinated and got shingles in February; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I was fully vaccinated and got shingles in February/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I was fully vaccinated and got shingles in February). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Still fighting the nerve pain) and immune system disorder (Verbatim: her immune system was not up to par). The outcome of the vaccination failure was unknown and the outcome of the shingles and immune system disorder were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and immune system disorder to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles, post herpetic neuralgia and immune system disorder to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient via interactive digital media. The patient was fully vaccinated and got shingles in February.  The patient was still fighting the nerve pain.  The patient was on chemo so his/her immune system was not up to par.  The reporter stated that people need to get the shingles shot. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Woke up from a nap and had a severe headache and sore throat, chest congestion and a low grade temperature.  Took Waldryn severe cold around 8:00 PM. Around 10:00 onset chills and lowgrade fever.  Around 3:00 AM 1/16/2011 woke up in a pool of sweat, chiils and lowgrade fever still present along with other symptoms.  Around 6:30 PM monitored temperature, raised up to 100.0.  Purchased Theraflu.  Drank around 9:00PM continued to experience same symptoms as before and still fever even after consuming fluids.  Monday Morning, symptoms still present along with fever and chills. Continued to take Theraflu every 6 hours. Around 10:00PM experienced coughing up of phlegm.  Fever, and chills still present.  Tuesday Morning 01/18/2011Still experiencing the same symptoms, in addition to extreme body aches and skin soreness. Low grade fever.
leg pain by patient after receiving her second Covid vaccination.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain by patient after receiving her second Covid vaccination.".  Additional information: Awareness Date was on 28Nov2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient developed an unusual rash ( appeared initially coxsackie like, changed to larger blisters, persisted for several weeks). The patient saw a dermatologist, who did biopsy, concluded in timing (i.e. onset about two weeks after vaccine) that due to MMR. Three months later still with significant post-inflammatory hyperpigmentation, but improving.
Patient experienced a rash at injection site. The parent was not aware of the time frame post vaccine when rash started.
This spontaneous report as received from a nurse refers to multiple patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# N002913, expiration Date: 23-FEB-2019; lot# N002914, expiration date: 04-NOV-2019) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 0 to 1°C (1.2 C) for 34 minutes. There was no previous temperature excursion. The call was because of the data logger. No adverse effects reported. The outcome of the events was unknown.  This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA007198: US-009507513-1708USA007438: US-009507513-1708USA007425: US-009507513-1708USA007441:
Bad headache; Fever; Chills; This is a spontaneous report from a Pfizer sponsored program COVAX US support via a contactable consumer (patient).   A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration on 29Jun2021 as dose 2, single, (31-year-old at the time of vaccination) for COVID-19 immunisation. Medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 vaccine, solution for injection, Lot number was not reported), via an unspecified route of administration on 08Jun2021 as dose 1, single, (31-year-old at the time of vaccination) for COVID-19 immunisation The reporter reported that he received his second dose of the Pfizer COVID-19 vaccine yesterday, 29Jun2021. On an unspecified date on Jun2021, the patient reported fever, chills, and a bad headache. The reporter reported that he is getting better right now and he took 2 Tylenol. The patient reported that he had fever and is feeling like he as a cold today. He took two Tylenol to manage the symptoms - Asking if the symptoms he has may pass onto his children. Referred to care provider for further medical assessment to rule out SARS COV 2. Therapeutic measures were taken for the events. The outcome of the events were resolving.  Follow-up attempts are needed. Information about lot/batch number has been requested.
Tested positive for COVID on 5/24 after exposure to family member. Presented to ER with increased weakness, confusion, fevers and fall at home. Patient admitted to hospital for suspected superimposed bacterial pneumonia and treated with IV antibiotics then subsequently discharged on oral cefprozil to complete 7 days.
Pt was given ROTATEQ vaccine orally, waited 2-3 minutes and then administered IM vaccines. Pt then left with mom. As mom was loading pt into car she noticed red rash/welt type lesion on right side of face and immediately came back into clinic.
Headache, CoughWheeze, Tested positive to COVID 19 Narrative:
adverse reaction/side effect experienced: none; Pnumococcal vaccines administered less than five years apart; This spontaneous report has been received from lawyer, via a Fact sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1810USA005844), concerning an 86-year-old male patient. The patient's medical history included an unspecified pneumococcal vaccine; her concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2011 and 01-OCT-2015, he was vaccinated with separate doses of pneumococcal vaccine, polyvalent (23-valent) (reported as "pneumonia") (manufacturer unknown) (Inappropriate schedule of product administration) as prophylaxis (strengths, doses, routes of administration, anatomical location, lot numbers, and expiration dates were not reported), no adverse events were reported. The outcome of the events was unknown.   This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1810USA005844:
Red, hot, swelling at the injection site, itching, spread to elbow, shoulder, neck and (R) breast. Called MD. No recommendations. 101 degrees fever for couple of days. Took Ibuprofen. 800mg q 6 hours for 5 days.
When he was due for his second shot, he got covid itself.  So he couldn't get the second vaccine.. He faired ok after first shot except tired, short of breath quicker than normal,  irritable,  ... When he got Covid he slept for three days straight....Everything escalated from there.  Sitting back I can see now that he was retaining fluid for a good month or more.  I had to take him to the er, he couldn't breath...on Oct.10th 9:00 pm, EKG showed something weird right away... I will send all paper work from his labs...At the end of it a week in the hospital in congestive heart failure at 42... Catherization showed his arteries are completely clear.  Its Cardio Myopathy, myocarditis. he lost 15 lbs of fluid on lasics.  He had to come home with a  vest that has a defribrulator in it for three months.  And worse yet, he doesn't have health insurance.  He was signed up to go on in November during open enrollment.
Patient has needle phobia, she was so afraid of the vaccine that she had diarrhea before the shot. She felt faint and slouched on the chair and lost consciousness for a brief moment.
5/19/2021, received 2nd vaccine of Moderna at 11:00a.  Immediately, I felt a tingling sensation on my upper left shoulder.  Around 12p I noticed  I was itching.  Then I noticed redness and my upper left arm was hot when I touch it.  Continued throughout the day.  I reported my symptoms to on 5/20/2021.  Was told that was one of the symptoms and to take Tylenol or Advil.  I took Advil.  The Advil helped for a few hours with the fever.  My upper left shoulder stayed red.   As of 5/21/2021 @ 9:48a, My upper left arm is still red and hot.
On the morning of 2/17/2022, I woke up with congestion and fatigue. Since my husband had already been diagnosed with COVID-19, I was already quarantining. I decided to take an at-home test, and I got a positive result. I had a breakthrough case. For a few days, I experienced shortness of breath when walking. I also developed severe diarrhea, which continues at the time of this writing. I am currently awaiting test results to learn if I have celiac disease or inflammatory bowel disease. My doctor believes that my COVID infection exacerbated the symptoms of whichever condition I have.
This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not provided. On 13-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L042265; expiration date: 26-OCT-2017, (administration route was not provided). No concomitant therapies were reported. No adverse effects were reported. The vaccine underwent a temperature excursion (10F) for a time frame of 3 hours and 16 minutes. No previous temperature excursions were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient received dose from a vial with a BUD 23-Apr-2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023) 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. AS7180B) 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023).    No concomitant medications were reported. Vaccine Manufactured date was reported as 26-Sep-2022. No treatment information was provided.  This case contains information for the 1st of 2nd adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721018 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721018:Patient 2
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On 18-MAY-2018, the patient was vaccinated with improperly stored dose of Oka-Merck) PROQUAD, lot# N035173, expiration date 09-JUN-2019 (strength, dose, frequency and route of administration were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine underwent temperature excursion on a freezer. The dose of Oka-Merck PROQUAD was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit during a time frame of 15 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 minutes. No adverse effects were reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1807USA001194: US-009507513-1807USA001195: US-009507513-1807USA001196: US-009507513-1807USA001197: US-009507513-1807USA001199: US-009507513-1807USA001200: US-009507513-1807USA001201: US-009507513-1805USA010447.
Initial misuse report received from a healthcare professional on 21 February 2014 and on 21 March 2014. A 63-year-old patient of unknown gender had received FLUZONE HD. The patient received FLUZONE HD at an incorrect age. No adverse event was reported. The list of documents held by sender: None.
Dermatographia - if I scratch anywhere on my body, 5 minutes later it appears very reddened and hives appear after that last for 20-30 minutes and becomes intensely itchy. Started on day 9 after Moderna booster. Did not happen after dose 1 or 2. Still experiencing symptoms. Now taking over-the-counter antihistamines (Claritin, Benadryl). No other changes in lifestyle/food/clothing/soap/laundry detergent occurred during this time.
Red, hot and raised at injection site.; Red, hot and raised at injection site.; Red, hot and raised at injection site.; Chills; Low grade fever; Fatigue; Body ache; This is a Spontaneous report from a contactable nurse (reported for herself). A 58-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO140), intramuscular on 04Jan2021 12:30 at single dose at right arm for COVID-19 immunization. Medical history included Vasculitis, no Allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included azathioprine (IMURAN [AZATHIOPRINE]), chlorthalidone, duloxetine hydrochloride (CYMBALTA), hydroxychloroquine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Jan2021 14:00, the patient experienced red, hot and raised at injection site. 18 hours after receiving, she developed chills, low grade fever, fatigue and body ache on 05Jan2021. Treatment received for the adverse events included Tylenol. This report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Patient was light headed and dizzy for about a week, including he passed out the day after the vaccine.
1/20/2021 - got two 5 day old blastocysts implanted via IVF 2/3/2021 - first dose Moderna 2/16/2021 - lost female twin, had sub chorionic hemorrhage.  (Both twins were repeatedly tested and had normal chromosomes) 3/3/2021 - second dose Moderna 5/20/2021 - diagnosed complete Placenta previa after bleeding 5/24/2021 - had anatomy scan, surviving male twin has only kidney (renal agenesis)
Patient reported no adverse events related to this injection. However, I was asked to report it as a duplicate injection by my corporate pharmacy division.
swelling of throat, chest pain,tingling in right arm and hand, treated at ER with epinephrine, decadron, diphenhydramine, famotadine, on Saturday pm
Diarrhea x 16 days, started one day after Rota, PENTACEL and PCV13 vaccines. Probiotic given. Improved after change to soy formula (now back on cow milk based formula and fine). (We do not really think vaccine is the cause, but reporting due to diarrhea.
pt recv vax; about 2 hr p/ vax leg became hard & very swollen, including testicles & penis;became completely lethargic for about 4 hr;PC to MD, said to put ice on it;
Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient said 14-15 days after the 2nd Pfizer he woke up in the middle of the night having a hard time breathing. He got up and saw that his entire body, but especially on the thigh and buttock area was covered in soft skin spots. They were red and looked like fluid filled spots. He said he took Benadryl and that helped greatly. He denied eating anything different or changing any detergents or soap in the house. He had no other explanation as to what could have caused the reaction and he believes it to be related to the Pfizer vaccine.
Pregnant: gestational diabetes, due 10/21/2019, 3 previous full term pregnancies with live births vaginally.  Symptoms from recent vaccination (tdap but I don't know the specific details): headaches, nausea, extreme soreness on upper right arm, muscle aches and pains, feeling like I am sick
Day after immun. Pt began to have rash (itchy, like bug bites) intermittently with exercise. Suspect may have been viral. Dx'd with mono 8/10 (sx began 8/7).
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL vaccine (yeast). The patient fainted after she received GARDASIL vaccine (yeast). Subsequently, the patient recovered. Unspecified medical attention was sought. This is one of several reports from the same source. No further information is available.
Fever 100.7, joint pain, headache, fatigue, loss of appetite, symptoms lasted 36 hours
body pain; pain in injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN and INJECTION SITE PAIN in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN and INJECTION SITE PAIN. At the time of the report, PAIN and INJECTION SITE PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Immediately, my digestive system ceased to function resulting in severe, chronic constipation.  I stopped having periods for 3 months.  My hair turned to the texture of straw and started falling out in fistfuls.
Pruritic, indurated, erythematous plaque on left deltoid region at site of vaccination. Topical steroid cream applied and the cutaneous reaction subsided with 48 to 72 hours of its onset.
It was reported that a patient (3 of 4) received a Fluzone SV vaccination on 11/28/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that 48 hours post vaccine the patient experienced swelling and itching that progressed down her left arm past her elbow. Reportedly the patient recovered from this experience. Additional patient, vaccine, correct adverse event onset dates, vaccine administrator and responsible physician information were also provided.
temporally related sz p/4th dose in series; CAT scan neg; State HD called by psychiatrist 13SEP94; pt currently on several psychotropic drugs; f/u pt had grand mal type sz 1/2 hr p/vax; was taken to hosp & CAT Scan; EEG nl;
expired dose of Fluzone High-Dose vaccine was inadvertently administered; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 77 years old male patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] inadvertently.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy received.   On 11-Apr-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB (expiry date: 28-Mar-2019) via unknown route.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 9/17/16 I administered PNEUMOVAX 23 to patient. After the vaccination she informed me that she already received the two pneumonia vaccines. No harm was done. I informed her she didn't need this vaccine that I just gave her. No reports of adverse reactions.
Patient states a 3 inch ring formed around injection site that was red and blotchy, no fever, no aches. Patient stated arm was better the next day (redness had gone away) and no other symptoms associated with vaccine.