chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLIND IN THE RIGHT EYE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies, no drug abuse or illicit drug usage, no relevant medical history and not taking any medications.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, frequency once total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the patient noticed some vision issues. Patient went to the emergency room approximately 3 weeks ago. Patient was then referred to the ophthalmologist. Patient has since gone blind in her right eye. Patient never had any vision problems before. The ophthalmologist confirmed that it wasn't cataracts, glaucoma, macular degeneration, or optic neuritis. The ophthalmologist said that he has no idea what it could be. On an unspecified date in MAY-2021, Laboratory data included: Blood test (NR: not provided) nothing of note was found. Patient was hospitalized for unspecified number of days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blind in the right eye was not reported. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210605555-covid-19 vaccine ad26.cov2.s-blind in the right eye. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 19-JAN-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult  health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-JAN-2016, the patient was treated  by a physician for onset of a severe vesicular rash, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Began breaking out in hives and itchy rashes all over my body. They seemed to be made worse by heat. These rashes would come and go and get better with the help of antihistamines.
interchange of vaccine; a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (a patient received Janssen Covid-19 vaccine after 1st dose of Moderna covid-19 vaccine) had resolved and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) outcome was unknown.        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.   No concomitant medication reported. No treatment information was provided.  Patient administered First dose of Moderna Vaccine on 22-JAN-2021 and second  dose Janssen Vaccine on 07-APR-2021 in Left Arm.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-JUN-2021 contains non-significant information.
after 6 (six) days of the 1st (first) shot, had fever of 100.2 degree  by arm and whole body aches. the symptoms gradually and finally went away in 36 hours
Information has been received from a pharmacist concerning a 91 year old female who on 12-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot #: 663178/1414X). On 25-DEC-2008 the patient developed a painful zoster-like rash on her left shoulder to upper breast. The patient has been treated with VICODIN for pain. The patient sought medical attention via office visit. Additional information has been requested.
Dry mouth; numbing and tingling of left side of face /Numb on left side of neck; numbing and tingling of left side of face; numbing and tingling of left side of face and left side of upper/lower lips; numbing and tingling of left side of face and left side of upper/lower lips; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 at a single dose on left arm for COVID-19 immunization. Medical history included none. Patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced dry mouth, numbing and tingling of left side of face and left side of upper/lower lips, numb on left side of neck on 06Jan2021. Shot was in left arm. Concerned about getting second vaccine. No treatment received in response to the events. The outcome of the events was recovering. The patient was not pregnant. Facility type vaccine was Public Health Clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
This spontaneous report was received from a licensed practical nurse and refers to 20 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX lot # L020003. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt states that approximately 2-3 hrs after receiving PNEUMOVAX during the Monday 11/10/08 Immunization clinic, pt's could not lift R arm and R arm was "sore". Today, 11/12/08 patient states arm is "fine now"
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 11-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Tinnitus in both ears-------------no treatment known, varies in volume from a 1 to 5, have it every day.  Afraid of getting another booster as sound may increase, and quality of life will go down.   Have read on line that others have gotten boosters and it was awful.  One committed suicide that I head of and others considering it, just want noise to go away.
Pt recvd 1st dose of hep B vax 18JAN91 & devel a "black & blue", swollen arm.
Patient was given a COVID-19 vaccine not authorized for their age group. Patient was monitored for 15 minutes after the injection and no side effects were observed at that time. To this date, patient and/or guardian have not reported any side effects or symptoms since being vaccinated. Patient has since completed the vaccination series as recommended.which can be found on the COVID-19 Administration Errors and Deviations document. A discussion has occurred about how the error took place and strategies have been implemented to ensure that the error does not happen again.
I tested positive for COVID-19 on 05/30/2022. I woke up on 05/29/2022 with watery eyes,  a scratchy throat, I had a temperature of 99.9, fatigue, joint pain, Heavy chest, and a wheezy cough, and cold feet. I have had these symptoms for 11 days so far and I still have heaviness in my chest, wheezy cough, loss of taste and smell, and some fatigue.
Patient received vaccine higher up on right arm and immediately felt pain afterwards, continued for about 3 days, got better and then came back. The site was swollen, and bruised lasting maybe a week. Pt is now left with a small bump at injection site, site is still tender and tingling and arm feels heavy. Pt has applied heat, taken MOTRIN OTC and ice, even had a massage. Pt is still feeling discomfort after 3 weeks.
Pt deveoloped red, itchy rash at injection site, hot to touch.  Lasted 2-3 weeks.
Sore arm, low grade fever, intestinal discomfort, upper back and chest pain, shortness of breathe, irregular heart rate
Pt reported to er for puncture wound to foot, rcvd Td and Cipro.  Two days later, pt returned to ER with swollen and painful l/deltoid.  Tx with IV, Leviquin and lab work that r/o cellulitis.  Sent home with cipro.
This spontaneous report as received from a certified medical assistant, via a company representative, refers to a patient of unknown age and gender. No information on medical history, concurrent conditions or concomitant drugs was provided. On 26-JUN-2014 the patient was vaccinated with a dose of M-M-R II (dose, site and route of administration, lot# and expiration date not provided) and a dose of (Oka/Merck) VARIVAX (dose, site and route of administration, lot# and expiration date not provided), which were reconstituted with expired sterile water diluent, lot# H004949, expiration date 31-JAN-2014 (also reported as January 2014). No adverse effects were reported. Additional information has been requested.
About 15 minutes after injection arm became numb and tingly.  Almost like a foot "falling asleep".  About 25 minutes after I started to feel tingly on the same side of my neck as the injection.  It is now 4 hours later and my arm is still numb to my fingers.
pt recvd vax & 12 hrs later exp severe migraine h/a which lasted 8 hrs-followed by mild h/a which persisted for 2 1/2 days; also exp  weakness, shakiness, nausea & burning lower abdo pain lasting 12 hrs;
fever, cough, nasal congestion, nasal drainage, sore throat, and bodyaches
Case number PHEH2014US020733, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 47 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Received vaccines 07/05/2016. Mom called 07/06/16 evening and stated that patient's arm is red and hot to touch where she received her shots. Spoke with ER dime sized, no fever or streaking. Just monitor. Call if any changes.
Patient reported having a fever, local myalgia and pharyngitis after having the TDAP vaccine. Definite time course not known, but suspected to be within 24 hours. Not reported to physician for almost 2 months later.
Myocartidis likely (shortness of breath, spiked heart rate and flutter, flu like symptoms)
Constant headache, ringing in ears, sinusitis. Still experiencing systems, this should not be for this long a time frame.
Patient vaccinated on 7/12/12, noticed redness at injection site on 7/20/12. Patient seen at MD on 7/24/12. Treated w/ BACTRIM DS tabs/ Mupirocin topical for possible infection.
Patient was in office to see provider, patient requesting Pfizer vaccine I had drawn up 0.7mL of diluent for Pfizer, and mixed it with pfizer , our COVID RN nurse brought it to my attention that I had drawn too little of the diluent,  patient still got 0.3mL of it wrong dosage amount was given to patient.
her husband is really sick; He has been nauseous; really tired; sleeping a whole lot; Shaking; had a headache; Left arm is really sore; Cold sweat; This is a spontaneous report from a contactable consumer (patient's wife) reporting for a 59-year-old male patient (reporter's husband). A 59-year-old male patient received bnt162b2 (PFIZER BIONETCH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via intramuscularly in arm left on 23Aug2021 14:00 as dose 1, single (age at vaccination: 59 years) for COVID-19 immunisation. Medical history included pain, anxiety disorder, neuropathy, all from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) 4 mg, daily taken for anxiety disorder Started taking 10 years ago, start and stop date were not reported; gabapentin (NEURONTIN) either 350mg or 400 mg three times daily started 8 years ago, taken for neuropathy, start and stop date were not reported; buprenorphine hydrochloride (SUBUTEX) taken for pain 8mg 3 times sublingual daily started taking it 18 years ago, start and stop date were not reported. Prior Vaccinations (within 4 weeks), other vaccinations within four weeks prior to the first administration date of the suspect vaccines was none. The adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. On 24Aug2021, the patient experienced cold sweat, sleeping a whole lot, Shaking and had a headache, left arm is really sore. It was reported by the reported that her husband is really sick. She feels like someone is squeezing her throat and it hurts really bad and had a hard time swallowing and is sick. Her throat hurts so bad and feels like it is closing. He is sick from the shot too. He had cold sweats and has been sleeping a whole lot. He has been nauseous. He was shaking and had a headache. He tried to work yesterday and the boss sent him home because he was in a daze and really out of it and really tired. It all started on 24Aug2021, she does not know outcome because he is still sleeping, she would like to know if this is a normal reaction. Both received it at the same time and place, he got his after hers, they were not even going to get it and dont know about getting second one. The adverse events did not require a visit to emergency room/physician office. Treatment was received. The pharmacist told him to take Tylenol and if it is not better by the end of the day, he wants her to report back to the pharmacist. The clinical outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient given excessive dosage of Pfizer vaccine on 10-1-2021 Dose given without saline dilutant  experienced any Adverse effects from from dose given
After Moderna COVID vaccination - shot 1, annual mammogram showed enlarged and abnormal lymph nodes requiring  follow-up imaging in 3 months.
This case was reported by a other health professional via call center representative and described the occurrence of difficulty breathing in a 9-year-old female patient who received FLULAVAL QUADRIVALENT (batch number PN75E, expiry date 31st May 2018). Previously administered products included flu vaccines. On 25th October 2017 01:23, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 25th October 2017, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced difficulty breathing (serious criteria life threatening), dizziness (serious criteria life threatening), increased blood pressure (serious criteria life threatening) and erythematous rash (serious criteria life threatening). On an unknown date, the outcome of the difficulty breathing, dizziness and erythematous rash were recovering/resolving and the outcome of the increased blood pressure was unknown. The reporter considered the difficulty breathing, dizziness, increased blood pressure and erythematous rash to be possibly related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The patient had been given flu vaccines in the past but this was the first time she had been given FLULAVAL QUADRIVALENT. Following administration of FLULAVAL QUADRIVALENT, the patient got down from the table and sat on the floor and told her mother she couldn't breathe. The patient then said she felt dizzy. She also had a  red  rash all over her body. The rash started to fade but the difficulty breathing lasted a little longer. All symptoms seemed to be resolving when she left the office. The reporter felt at the time the patient couldn't breathe, it was life threatening but now seems to be okay. The doctor took her blood pressure and said it was higher than normal but that was a good thing.
Sore arm for 5 days; Fatigue for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 5 days) and FATIGUE (Fatigue for a day) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm for 5 days) and FATIGUE (Fatigue for a day). On 24-Mar-2021, FATIGUE (Fatigue for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm for 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-097970 (Patient Link).
pt recvd vax; 26jul95 devel ten lesions on chest, back, buttocks; in f/u md reported that lesions were both vesicular & papular;
Chest pain and arm pain. The chest pain is closer to the arm pit feels like a something is swollen. Right arm/right chest. The shot was given in that arm.
excursion lasted for 1 hour and 45 minutes. The maximum temperature of the refrigerator reached 57.49 degrees Fahrenheit with no reported adverse event; The open IPOL was given post excursion with no Adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient where the excursion lasted for 1 hour and 45 minutes and the maximum temperature of the refrigerator reached 57.49 degrees fahrenheit with no reported adverse event and the open ipol was given post excursion with no adverse event after receiving vaccines MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On an 28-Nov-2022 , the patient received an unknown doseof suspect IPV (VERO)(Suspension for injection)(strength: 0.5ml) (lot number: V1A121M and expiry date: 15-Feb-2024) via intamuscular route in left Deltoid site for immunisation.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE(Suspension for injection) (unknown strength, lot number and expiry date )via unknown route in unknown administration site for Immunisation. On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE(Solution for injection) (unknown strength, lot number and expiry date )via unknown route in unknown administration site for Immunisation.  On 28-Nov-2022 the patient had non-serious event of the open ipol was given post excursion with no adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  On an unknown date the patient had non-serious event excursion lasted for 1 hour and 45 minutes. the maximum temperature of the refrigerator reached 57.49 degrees fahrenheit with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.   It was reported "  Action taken :Not applicable.  Outcome was Unknown for both the events.  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 guidelines. 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.