chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patients and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of RECOMBIVAX HB lots # L033343 and L039660 with expiration dates 13-SEP-2017 and 04-FEB-2018 respectively (concentrations, dosages and therapy routes were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA009575, 1608USA010369, 1608USA010371, 1608USA010372). Additional information has been requested.
Severe swelling after nurse injected flu shot through my tattoo. I asked of that was okay to do and she said yes. It's very hot and sore and very swollen at site and in a pretty wide area around. It's sore in my shoulder and down to elbow making it hard to drive today. Saw nurse at work and was instructed to ice the area and take Tylenol for the pain.
Immediately started to itch in arms, chest and head. Then developed hives on right arm about 15 minutes after injection. Took Benadryl 25mg orally at 2:45 pm once the hives started and had taken  ibuprofen 400mg before the vaccine at 2:00pm.
Chills, muscle and joint pain, headache, fatigue, redness/swelling/itching/pain at injection site
Pt had PNEUMOVAX injected on 8/1/17. Pt contacted his PCP the following day w/ complaints of flu-like symptoms. Also, the area around the injection site was red and swollen. Pt was seen by his provider on 8/3/17 and diagnosed w/ cellulitis.
No additional AE; a patient was inadvertently administered  a second dose ( 10/10/2023) of PROQUAD two weeks after the first dose 09/26/2023; This spontaneous report was received from a medical assistant (other health professional) and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-SEP-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: rHA) (PROQUAD) injection, 0.5ml/series, lot #W038809, expiration date: 04-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). On 10-OCT-2023 (two weeks after the first dose), the patient was inadvertently administered a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: rHA) (PROQUAD) injection, 0.5ml/series, lot #W038809, expiration date: 04-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). There were no symptomatic adverse events (AEs)/additional AEs/product quality complaints (PQCs) reported.
about a month after the vaccination, I am having feeling uncomfortable/unpleasant left side chest pain, lasting 10-20 minutes at least 3 times per week. This left chest pain is continuously occurring as of now.  I had not had such left side chest pain before vaccination.
Woke up with blurred vision in left eye on Saturday, May 30.  Went to see eye doctor after Memorial Day Weekend.  20/50 in left eye (was 20/20).  So far diagnosed with inflammation of optic nerve.  Going to a retinal specialist June 2.  Talk of seeing a neurologist as well to figure out why there's inflammation - he's too young.  Dr is wondering if it is due to COVID shot 3 weeks ago.
Lump on my left boob like on top and it hurt; Chill; This is a spontaneous report from a contactable consumer (Patient). A 22-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158; Expiry Date: unknown), via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 22-years-old) as dose 1, single for covid-19 immunisation. The patient medical and concomitant medications were not reported. It was reported No investigation assessment and patient history. On 15Apr2021, the patient experienced "lump on my left boob like on top and it hurt" and chill. Treatment was given with Tylenol for the events. Reporter seriousness for both the event was unspecified. NDC number and UPC number of Covid vaccine was unknown. It was reported that the patient got her vaccine yesterday and she had a lump on her left boob like on top and it hurt and she had chill also. It was quick but its just here still there, it doesn't hurt to breathe but like lump. Consumer stated, The expiration its April15, no she got her shot on this. The date for second dose was provided as 06May2021. The patient confirmed she hadn't had any lab test. When probed for the condition is worsened, improved or persisting, consumer stated, "yeah." Outcome of the events were unknown.   No follow-up attempts are needed. No further information is expected.
Patient received Diptheria Tetanus 0.5cc/IM on 3/26/08.  Patient returned to ED stating "the DT shot gave her an infection".  Declined treatment: followed up with primary physician (3/28/08).
Patient presented w/ erythemic bulla, vesicular lesions over the injection sight on the L arm. Patient also presented w/ NVD, subjective fever, and chills. Member was provided education on lesions care. and discharged w/ oral antihistamines and topical steroids.
Patient received expired Tenivac vaccine with no AE; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case from physician.  This case involves a 7-year-old male patient who received expired 0.5 mL dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6265AA, expiry date: not reported] via an intramuscular route in the right arm for prophylactic vaccination on 20-Apr-2021 [expired product administered].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL); HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B); and HEPATITIS A VACCINE INACT (HAVRIX).  It was also a case of actual mediation error due to expired vaccine used administered (latency: on the same day).  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 the 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.
Patient is being admitted to facility as a new patient and caller received his immunizations, while reviewing his immunizations she noticed that ROTATEQ was administered at 5 weeks versus 8 weeks; Patient is being admitted to facility as a new patient and caller received his immunizations, while reviewing his immunizations she noticed that ROTATEQ was administered at 5 weeks versus 8 weeks; This spontaneous report has been received from a consumer concerning a 5-week-old patient of unknown gender and ethnicity. The patient's concurrent conditions, known allergies/reactions, medical history and concomitant medications were no reported.   On an unspecified date, the patient was admitted to a facility (hospitalization) for an unknown reason (adverse event) as a new patient. During admission, the patient's previous immunizations were reviewed. It was noticed that the patient had been vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen, vaccine batch/lot number and expiration date were not reported) orally, for prophylaxis; at 5-weeks-old instead of 8-weeks-old (product administered to patient of inappropriate age). The outcome of unspecified the event was not reported, neither was the causality assessment between the unspecified event and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).
The patient has had sneezing, nosebleeds, coughing, chest tightness, and "heavy" breathing. He consulted with a physician who concluded that it was a strain of flu, but not from vaccination. Prescribed rest, aspirin, cough medicine, lots of fluids (soups and tea). This lasted 2 weeks for complete recovery.
This spontaneous report was received from a certified medical assistant and refers to an unknown number of unspecified patients of unknown demographics. No information regarding any of the patients' medical history, concomitant medications and concurrent conditions was provided. On unknown in 2017, dates between 02-FEB-2017 and 04-MAY-2017, the patients were vaccinated with doses of improperly stored PROQUAD (lot number: M036158, expiration date: 12-FEB-2018, lot number: M038860, expiration date: 13-MAR-2018; albumin status therapy type, dose and route of administration were not reported). The vaccine was stored in a temperature between -14 and -10 degrees Celsius for 2256 hours. No previous temperature excursions were reported, the Digital Data Logger was not involved. A properly stored sterile diluent was used to reconstitute the doses of PROQUAD. No adverse events were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004513: US-009507513-1705USA004569: US-009507513-1705USA004567:
This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuffy nose couple days ago) in a sixty-four-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch no. 051C21A) for COVID-19 vaccination.  No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced NASAL CONGESTION (Stuffy nose couple days ago). At the time of the report, NASAL CONGESTION (Stuffy nose couple days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient was scheduled to take his second shot vaccine.
Pt vaccinated with MMR on 27JUL90 on 4AUG90 developed fever 101-104, very red & pronounced macular rash over trunk, abdomen & upper extremities, decreased appetite, refusing to eat per mom. Lasted til 10AUG90 when temp decreased & rash fad
Flare up of auto immune disease to extreme levels of fibromyalgia pain and chrons GI problems, severe headache, vertigo, brain foggyness, severe chills
Information has been received from a certified medical assistant concerning a patient who in approximately December 2005, was vaccinated intramuscularly with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot#649697/1038P).  In approximately December 2005, the patient experienced a reaction that extended from his/her shoulder to his/her hand.  It was noted to be extremely painful, and severe erythema was noted.  The reporter indicated that the patient had a cellulitis-like reaction.  The patient was treated with antibiotics, and the condition resolved.  There was no product quality complaint.  It was noted that the physician was concerned about this lot number.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill.  Additional information has been requested.
Vaccine not diluted and 10 doses of vaccine given rather than 1 dose of vaccine
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient's relevant medical history relevant concomitant medications, and relevant past drug history were unknown. On 20-SEP-2014 the patient was inadvertently vaccinated with PNEUNOVAX23 (dose and frequency unknown) lot # J004080, expired date 22-AUG-2014, intramuscular in the left deltoid. It was unknown if there was relevant lab data. The patient did not report any problems after receiving expired PNEUMOVAX23. As of 20-SEP-2014, it was unknown if the patient was still on PNEUMOVAX and the outcome of received expired PNEUMOVAX23 was unknown. Additional information has been requested.
pt recv vax & devel abd tenderness, cramps, & diarrhea;pt recovered p/several days;the responsible MD does not believe this event was r/t vax;
"Received the chicken pox vaccine on Monday 3/21/2016 then had a reddened raised area at the site 3/23/2016. I went to Employee Health for Evaluation.
pt recv vax 13JAN98 & 15JAN pt devel a very fine rash & on 17JAN bumps larger but never blistered;also had diarrhea all wk p/13JAN98;around 10PM on 17JAN started screaming & rolling in floor;MD checked in ER @ hosp;did CXR & dx pneumonia;
Day of vaccination- No symptoms. 2nd day -edema, redness, hardening at site. 3rd day- All symptoms intensified. 4th day all symptoms intensified. 5th day all symptoms intensified steroid shot received.
respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from a contactable physician. An 89-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient received one dose of Pfizer vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory failure from COVID19. It was unknown if autopsy was done. The patient was tested for COVID post vaccination via nasal swab: covid-19 virus test positive on 27Jan2021. The events resulted in emergency room/department or urgent care, hospitalization, and patient died.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID post vaccination and respiratory failure with fatal outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association.  More information on the underlying medical condition in this 89-year-old male patient is required for the Company to make a more meaningful causality assessment.   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 RA, IEC, as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from respiratory failure from COVID19; presented to the ER with COVID symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from
No adverse effects reported; a patient received an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistant regarding a 3 years old male patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 03-OCT-2019, the patient received an improperly stored dose (product storage error) of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number S016868, expiration date 24-FEB-2022; strength, dose, and route of administration was not provided) for prophylaxis. There was no adverse effect reported. Current temperature excursion was 46.5 degrees Fahrenheit for 5 minutes. There was no previous temperature excursion. Data logger was involved.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006415: US-009507513-1910USA006268: US-009507513-1910USA006414: US-009507513-1910USA006562: US-009507513-1910USA006576:
Red; Hot; Felt like a blood pressure cuff not being released from elbow to shoulder; Did hurt; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Red), FEELING HOT (Hot), PERIPHERAL SWELLING (Felt like a blood pressure cuff not being released from elbow to shoulder) and PAIN (Did hurt) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 28-Dec-2020 at 2:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021 at 5:00 AM, the patient experienced ERYTHEMA (Red), FEELING HOT (Hot) and PERIPHERAL SWELLING (Felt like a blood pressure cuff not being released from elbow to shoulder). 05-Jan-2021 at 5:00 AM, the patient experienced PAIN (Did hurt). At the time of the report, ERYTHEMA (Red), FEELING HOT (Hot), PERIPHERAL SWELLING (Felt like a blood pressure cuff not being released from elbow to shoulder) and PAIN (Did hurt) had 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.
This spontaneous report as received from a nurse practitioner refers to a 15 year old male patient with penicillin allergy, acne, asthma and attention deficit hyperactivity disorder (ADHD). The patient's medical history included possibly had a "malignancy" on his ankle at age 3 years. On 02-OCT-2013, the patient was vaccinated with the first dose of GARDASIL (lot# and expiry not reported), 0.5 ml, intramuscular (IM). Concomitant therapies included CLEOCIN, loratadine (manufacturer unknown), albuterol sulfate, DUONEB, amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, ADDERALL, PUMICORT, SINGULAIR and albuterol sulfate (manufacturer unknown). During that same visit, on 02-OCT-2013, he was given a prescription for minocycline (unspecified manufacturer) to treat his acne. The patient then developed a rash on his body. At that time, the nurse practitioner thought the rash was caused by the minocycline so she had him discontinue the minocycline. The patient was prescribed prednisone and the rash resolved (unspecified date). The patient received the second dose of GARDASIL (lot# and expiry not reported), 0.5 ml, intramuscular (IM) on 02-DEC-2013. He then developed another rash on his body and was seen at the office on 11-DEC-2013. He was treated with prednisone and the rash resolved (unspecified date). On 01-APR-2014, the patient received the third dose of GARDASIL (lot# and expiry not reported), 0.5 ml, intramuscular (IM) and he again developed a rash on his body. The nurse practitioner thought that the rashes started each time within 24 hours of receiving a dose of GARDASIL. She now thought the rashes were probably caused by GARDASIL. The minocycline was never restarted after it was discontinued. The patient had been prescribed oral prednisone again to treat the rash and he was currently recovering. No lab diagnostics were performed. Additional information has been requested.
last two days, he has been light headed; couldn't eat, tired, headache, fever, vomiting, and dizziness; couldn't eat, tired, headache, fever, vomiting, and dizziness; couldn't eat, tired, headache, fever, vomiting, and dizziness; couldn't eat, tired, headache, fever, vomiting, and dizziness; couldn't eat, tired, headache, fever, vomiting, and dizziness; couldn't eat, tired, headache, fever, vomiting, and dizziness; all of the side effects; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (couldn't eat, tired, headache, fever, vomiting, and dizziness), VACCINATION COMPLICATION (all of the side effects), DIZZINESS (last two days, he has been light headed), DIZZINESS (couldn't eat, tired, headache, fever, vomiting, and dizziness) and FATIGUE (couldn't eat, tired, headache, fever, vomiting, and dizziness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DECREASED APPETITE (couldn't eat, tired, headache, fever, vomiting, and dizziness), VACCINATION COMPLICATION (all of the side effects), DIZZINESS (couldn't eat, tired, headache, fever, vomiting, and dizziness), FATIGUE (couldn't eat, tired, headache, fever, vomiting, and dizziness), HEADACHE (couldn't eat, tired, headache, fever, vomiting, and dizziness), PYREXIA (couldn't eat, tired, headache, fever, vomiting, and dizziness) and VOMITING (couldn't eat, tired, headache, fever, vomiting, and dizziness). On 28-Feb-2021, the patient experienced DIZZINESS (last two days, he has been light headed). At the time of the report, DECREASED APPETITE (couldn't eat, tired, headache, fever, vomiting, and dizziness), VACCINATION COMPLICATION (all of the side effects), DIZZINESS (last two days, he has been light headed), DIZZINESS (couldn't eat, tired, headache, fever, vomiting, and dizziness), FATIGUE (couldn't eat, tired, headache, fever, vomiting, and dizziness), HEADACHE (couldn't eat, tired, headache, fever, vomiting, and dizziness), PYREXIA (couldn't eat, tired, headache, fever, vomiting, and dizziness) and VOMITING (couldn't eat, tired, headache, fever, vomiting, and dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the first dose of the vaccine on 26Feb2021 and did not experience any side effects until 27Feb2021. He said he got all of the side effects. He described these as couldn't eat, tired, headache, fever, vomiting, and dizziness. He also said that for the last two days, he has been light headed. Patient also stated that he had the virus in December.  Treatment
Narrative:  UNKNOWN CAUSE OF DEATH; PATIENTS WIFE REPORTED THAT PATIENT DID NOT FEEL WELL ON 4/7 AND PASSED AWAY SOMETIME THROUGHOUT THE NIGHT ON 4/8. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine.
Large area around injection site became hives,  burning sensation, red, itchy, swollen, hard, lumpy, hot to the touch and very painful. It?s still ongoing as of today 02/05/2021