chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A literature report was received on 03/24/2003, concerning a 77 year old female vaccinee who experienced recurrent uveitis, irritation, reduced visual acuity,  fever and malaise approximately 3 weeks after receiving virus influenza vaccine (brand unspecified) on approximately 10/30/1988. The vaccinee was part of a retrospective study to investigate the possibility that influenza vaccination is a cause of recurrent uveitis in patients with a history of pre-existing ocular inflammatory disease. The  vaccinee has a relevant history of rheumatoid arthritis and previous iritis induced by complicated eye surgery. On 11/19/1988 the vaccinee noted a sudden change in her left eye. She was examined by a physician who noted a mild periorbital flush and early "keratitis" A lubricating ointment was prescribed 48 hours later her visual acuity fell to 6/21 (20/70). Slit lamp examination revealed corneal striae, but no anterior chamber reaction. There were 1+ vitreous cell, vitreous haze, and biomicroscopic evidence of cystoid macular oedema. She was treated with  topical prednisone acetate 1% every 2 hours and ibuprofen (400mg).  Nine days later, her visual acuity improved to 6/6 (20/20) and the eye was quiet. Attempts to taper her medication produced a mild exacerbation, but her condition stabilized over the next 60 days. She was able to discontinue the medications with visual acuity of 6/6(20/20). The author concluded that influenza may act as a non specific stimulus of the immune system and thereby, reactive uveitis. The exposure to influenza vaccine triggered a recurrence of ocular inflammation. Update1. 05/06/2003: A report was received from a health care professional indicating that the vaccinee had recovered without sequalae on an unspecified date. Cross reference with: PJP200300142, PJP200300143, PJP200300146.
improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a Licensed Practical Nurse (LPN) concerning a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies or reactions, and concomitant medications were not reported.   On 10-SEP-2021, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) had a temperature excursion with a temperature of 48.7 Fahrenheit degrees during a timeframe of 10 minutes, then both vaccines were improperly stored. On 13-SEP-2021, the patient was vaccinated with the improperly stored vaccines (product storage error) which included: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot number 1707460 with expiration date on 14-MAR-2022 and also with Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number T026961 with expiration date on 02-APR-2023 both as prophylaxis; strength, dose, and route of administration were not reported for the vaccines. Previous temperature excursions were not reported.
A report received from a healthcare professional on 05Nov02 concerning a 55 year old female vaccinee who experienced an injection site reaction two days after receiving Fluvirin on 29Oct02. On 31Oct02 the vaccinee complained of redness and tenderness of an 19x 10cm area at the injection site. The pt received methylprednisolone to treat the symptoms of the event. The outcome of this event is unk. There was insufficient information to determine the reporter's causality assessment.  See Ref: PJP200200683, PJP200200684, PJP200200685, PJP200200686.
Varicella zoster out break T5 dermatone left side of body, no history of similar
Alternating chills and sweats, pain and inflammation at site of injection,  body fatigue, weakness, nausea, abdominal pain
fainted and collapsed; eyes were opened and she went blind in both eyes; turned white, lips turned green; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted and collapsed) and BLINDNESS (eyes were opened and she went blind in both eyes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker (smokes cigarettes).    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 SYNCOPE (fainted and collapsed) (seriousness criterion medically significant), BLINDNESS (eyes were opened and she went blind in both eyes) (seriousness criterion medically significant) and SKIN DISCOLOURATION (turned white, lips turned green). At the time of the report, SYNCOPE (fainted and collapsed), BLINDNESS (eyes were opened and she went blind in both eyes) and SKIN DISCOLOURATION (turned white, lips turned green) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided Patient was taking  birth control pills.  Company comment- Very limited information regarding these events has been provided at this time; Sender's Comments: Very limited information regarding these events has been provided at this time
Small bruises 2mm  1st on inside upper left  next day 2nd bruise 5? lower same arm few days later 3rd bruise  opposite inside forearm few days later 4th bruise  on right shoulder/neck on 6/2/2021
Adult Hep A vac. given to 18 y/o. No adverse event noted.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter. It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to Department of Public Health, VAERS, Immunization Registry and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided. This case contains information for the 08th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:master case
I began feeling nerve pain and tingling all over my body, but primarily in my legs. It could be described as little electrical shocks beneath the skin. It feels like my nerves are firing constantly and I fear that they are being damaged. It began within 24 hours of receiving the vaccine, and has not stopped. I do plan to see my doctor.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32) in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022 at 3:46 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 13-Mar-2022 at 3:46 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 13-MAR-2022 at 15:46:32) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient's ethnicity was reported as white. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions. Concomitant product use was not provided by the reporter. It was unknown if the patient received any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination. It was unknown if the patient received other vaccines given on the same day and it was also unknown if the patient received other vaccines within one month prior to any dose of Moderna vaccine. It was unknown if the patient experienced any adverse events or not. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine was administered on 13-Mar-2022 at 15:46:32. It went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided.    This case was linked to MOD-2022-542869 (Patient Link).
Herpes encephalitis (Primary Dx);  Details of the Hospital Course:  Patient is a 83 y.o. male with history significant for polymyalgia rheumatica on chronic steroids 1 mg prednisone daily (dx 3 yrs ago), history of PE/DVT for which he is prescribed outpatient Eliquis (2020), benign essential tremor, hypertension prescribed outpatient valsartan, recent admission for intractable headaches. Patient lives in the independent living was brought to the hospital by EMS for reported confusion and combativeness. Patient upon arrival is unresponsive and already intubated upon my examination however per records of EMS he had a last known well time on the evening of 4/30 at about 8:00 p.m.. He reportedly is AAO x3 at baseline and completes all of his ADLs independently. When found by EMS he was having reportedly incomprehensible speech and was found lying with the head near his radiator and noted to have a right frontal hematoma.  Patient was admitted to the ICU secondary to acute encephalopathy and intubated for protection of airways. Patient was placed on empiric antibiotics for encephalitis, patient was evaluated by neurology and ID. He had an LP x2. Meningitis encephalitis workup was negative. He was continued on acyclovir for total of 14 days for viral encephalitis. His mental status slowly improved. He was noted to have her incidental renal cell mass which will need outpatient follow-up with urology. Will need close follow-up with neurology as outpatient. He had pending paraneoplastic antibody testing which was sent out to the clinic and pending on discharge.  He unfortunately had a fall with head laceration requiring sutures by general surgery. He was seen by Physical therapy and will need a skilled nursing facility. He was amenable to this.  Uncontrolled hypertension blood pressure was improved and he was started back on verapamil and valsartan  History of PE/DVT he was diagnosed with a PE in November 2020 and had previous DVT. He is asked to follow-up with hematology to discuss further anticoagulation needs. He can resume if safely under the supervision of skilled nursing facility.  He reports alcohol use which is 1 glass of wine and scotch daily. He was monitored for DTs which he did not have and low suspicion for Wernicke's encephalopathy.
My daughter received the flu shot on 10/27/17. She was 2 years old. Around 3 weeks after the shot, she came down with an extremely high fever lasting for NINE days. Fever was at least 102-105.5 daily for nine straight days. I took her to the pediatrician 3 times and the Urgent Care 2 times during the 9 days. No one could tell me what was wrong with my child. They ran all types of tests from UTI, flu, chest X-ray and all came back negative. On about the 4th day, her lips and toes had a purplish tint to them so we rushed her back to Urgent Care and they told me "This happens sometimes with high fevers..." Finally, at the end of the 9 days, they sent me to Hospital to have bloodwork done and it showed high levels of Monocytes. I also read that high levels of Monocytes also means that the body has high levels of Aluminum (hence, from the vaccine).
body aches; on and off chills; red lump on her shoulder on the same arm she received the vaccine; Headache; Dizziness; This is a spontaneous report from a contactable female consumer communicated to Pfizer sales representative. This consumer (patient) reported that, a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm on 11Feb2021 (Batch/Lot Number: EL9265) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3246) via unspecified route of administration on 20Jan2021 as single dose for covid-19 immunization. No side effects experienced after the first dose. The patient experienced body aches, on and off chills, red lump on her shoulder on the same arm she received the vaccine, headache, and dizziness on Feb2021. It was reported that, hour 12-24 post vaccine she had body aches, on and off chills, hour 36 post vaccine pounding headache and dizziness and she also noticed a red lump on her shoulder on the same arm she received the vaccine that has now subsided. The outcome of the event red lump on her shoulder on the same arm she received the vaccine was recovering while the outcome other events was unknown.   Follow-up attempts completed. No further information expected.
Pt had an episode of emesis  the evening of the vaccine date and pt had a fever over the weekend after.  Pt also broke out in a rash. Pt seen in clinic by a Healthcare provider
This case was reported by two separate healthcare professionals (CMAs) and described the occurrence of inappropriate route of vaccination in a 4-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX intramuscularly. The subject experienced inappropriate route of vaccination. No additional details were provided. The reporter had no further information. Follow up received from a healthcare professional (CMA) on 17 July 2012. Concurrent vaccination included PENTACEL, Sanofi Pasteur; unknown; unknown given on 17 July 2012; PREVNAR, PFIZER; unknown; unknown given on 17 July 2012. The healthcare professional reported the 4-month-old female received the 2nd dose of ROTARIX (1 ml, intramuscular, unknown site) on 17 July 2012 at 12:30. She explained that the subject received the 2nd dose of ROTARIX by the intramuscular route inadvertently instead of the oral route due to new employee mistake. The employee stated it was a powder that had to be reconstituted, but the lot number was that of ROTATEQ, so the healthcare professional was assuming that the lot number was incorrectly transcribed. It was noted that the vaccination series was delayed. The healthcare professional was concerned and upset about safety for the subject. On 08 August 2012, follow-up was received from a healthcare professional (nurse practitioner). The event was reported as an erroneous administration and was not considered as serious. The concomitant vaccinations, PENTACEL and PREVENAR, were administered intramuscularly. It was reported that the subject received a 2nd dose of ROTATEQ orally after the ROTARIX was given. It was confirmed that on 17 July 2012, ROTARIX was administered via an incorrect route (intramuscularly) in private consultation. The nurse practitioner reported that the method used to inject the ROTARIX vaccine was by syringe. In her opinion, it was that the oral vaccine was in a vial and not in an oral tube that led to the maladministration. No adverse events occurred following the incorrect route of administration of ROTARIX. Follow-up information was received on 05 September 2012 via healthcare professional. The vaccine was administered on 17 July 2012, no adverse reaction to inappropriate dosing. The parent was called twice that day and the following week. No reaction occurred. The healthcare professional confirmed ROTARIX was administered on 12 July 2012 ROTARIX was administered via an incorrect route (intramuscularly) in private consultation. The oral vaccine was placed in an intramuscular syringe with head was the method of injection. In the healthcare professional's opinion what lead to the maladministration was "medical assistant confusion, other type was injectable". Immunization series was not discontinued or delayed. The reporting healthcare professional considered the event serious. Lot number reported as "841FB226A".
This patient received the 2nd dose of the Pfizer vaccine on 2/2/21.  This patient then became symptomatic with COVID like symptoms starting 4/6/21 and tested COVID positive on 4/8/21 via NP PCR swab.
After the vaccines lost temperature they were administered; A spontaneous report  was received from a healthcare facility staff member concerning a White, 76-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, experienced vaccine administered after vaccine lost temperature, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of a 76-year-old male patient who experienced non-serious of after the vaccines lost temperature they were administered. (Out of specification product use) for mRNA-1273, lot # 027L20A), Exp date-unknown. There were no reported AEs associated with this case of Incomplete dose administered
pain in his left arm and even cannot lift a cup of tea; pain in his left arm and even cannot lift a cup of tea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (pain in his left arm and even cannot lift a cup of tea) and MYALGIA (pain in his left arm and even cannot lift a cup of tea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST and LORATADINE for Asthma.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (pain in his left arm and even cannot lift a cup of tea) and MYALGIA (pain in his left arm and even cannot lift a cup of tea). At the time of the report, MUSCULAR WEAKNESS (pain in his left arm and even cannot lift a cup of tea) and MYALGIA (pain in his left arm and even cannot lift a cup of tea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-231335 (Patient Link).
This spontaneous report as received from a pharmacy intern refers to a 79 years old female patient with hypertension, diabetes, depression and allergy to penicillin. The patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX on 19-OCT-2012 (lot# reported as H012523; expiration date 09-OCT-2013). No other co-suspects were reported. Concomitant medications included GLUCOPHAGE, meclizine, glimepiride, lisinopril, amlodipine, sertraline hydrochloride and escitalopram. The same day, on 19-OCT-2012 the patient began to experience redness and swelling at the injection site. On 23-OCT-2012 the patient reported to the pharmacy that at this time she had bumps which appear to be a rash at the site of injection. No other adverse effects had been observed or reported. The patient sought unspecified medical attention. No treatment was given to the patient. The outcome of the events was reported as not recovered/not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.