chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; corneal shingles in my right eye; very painful.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID 19 VACCINE for prophylaxis.   Previously administered products included Covid vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and the 2nd dose of COVID 19 VACCINE. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), ophthalmic herpes zoster (serious criteria medically significant) and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine several years ago from the date of reporting. After receiving Shingles vaccine and 2nd dose of Covid vaccine, the patient got corneal shingles in his/her right eye. The patient reported that, it was very painful. It was unknown if the reporter considered the ophthalmic herpes zoster and pain to be probably related to Covid vaccine. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation were not provided.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-OCT-2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), (by an unspecified healthcare professional) at a healthcare facility/office, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 21-NOV-2012, the patient was treated by a nurse practitioner, for a blistering vesicular eruption, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
After 10 minutes, patient complained that her arm had gone progressively numb.  I asker her to remain another 10 minutes and there was no improvement.  She wanted to go home, so I told her that I would call her in 2 hours.  When I spoke to her 2 hours later, the arm had returned to normal with no impaired function
Feels uneasy and weak; Pulse is consistently in the 90-100's range; She is out of breath at times with exertion; She is out of breath at times at rest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPNOEA AT REST (She is out of breath at times at rest) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced DYSPNOEA AT REST (She is out of breath at times at rest) (seriousness criterion medically significant) and DYSPNOEA EXERTIONAL (She is out of breath at times with exertion). On 26-Apr-2021, the patient experienced ASTHENIA (Feels uneasy and weak) and HEART RATE INCREASED (Pulse is consistently in the 90-100's range). At the time of the report, DYSPNOEA AT REST (She is out of breath at times at rest), ASTHENIA (Feels uneasy and weak), HEART RATE INCREASED (Pulse is consistently in the 90-100's range) and DYSPNOEA EXERTIONAL (She is out of breath at times with exertion) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Heart rate: 90-100's /min (High) 90-100's.         Concomitant product use was not reported.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
inc erythematous, edematous plague around inject site beginning 5-7 days p/inject; also warmth to touch;
2 weeks after 2nd dose developed possible zoster in same arm along C8 dermatome.
(L) deltoid redness, hot, swollen.  Follow-up - Correct patient's last name; patient's last name updated.
Developed 100.6 temp, headaches & body ache on 10/30/2012 8 pm & finally 2-3 am 10/31/12 started feeling better. Currently 10/31/12 11am is feeling improved but still feels tired.
Pain and swelling at site, fever 100.4, headache, fatigue, lightheaded - beginning day after, lasted 2 days. Swelling and pain lasted longer.
Severe itching- treated but not resolved with Benadryl. Fainted once, felt light-headed. Nausea, decreased appetite.
fever after getting the 1st booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever after getting the 1st booster dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after getting the 1st booster dose). At the time of the report, PYREXIA (fever after getting the 1st booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient had fever for 7-10 days after getting the 1st booster dose.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-545536 (Patient Link).
Large knot on spot of injection occurred with a hour.  The next day I had flu like symptoms that lasted all day.  Fever ranging from 99.9 to 100.8.  Tired all day and took three naps.  Face felt flush.  Both arms and legs ached.  Lethargic.
Excess mucus production, choking on sputum, body rash,- Similar reaction when nut products consumed in the past. 1 alavert sublingual tablet taken, 2 puffs of albuterol inhaler and benadryl tablet taken
pt recvd vax 31OCT95 & 1NOV95 pt exp cellulitis of whole upper rt arm & was hospitalized;pt remained hospitalized @ the time of report;
redness on the arm; little itchy on the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on the arm) and PRURITUS (little itchy on the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ERYTHEMA (redness on the arm) and PRURITUS (little itchy on the arm). At the time of the report, ERYTHEMA (redness on the arm) and PRURITUS (little itchy on the arm) outcome was unknown. Not Provided      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 medications were reported.  No treatment medications were provided by the reporter.
Headache; Sore throat; Slight fever; Body ache, pain all over; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 26Mar2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) and birth control pills from an unspecified date. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 04:00, the patient experienced headache, sore throat, slight fever, joint pain and body ache, the worst part was the pain all over. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive any treatment for the events. The clinical outcome of the events headache, sore throat, slight fever, joint pain and body ache, the worst part was the pain all over was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected
This spontaneous report was received from a supervisor, referring to a currently 12 months old male patient. The patient's historical drugs, medical history, drugs allergies and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent. On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneously, lot# R018142 and expiration date 25-JUN-2020, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was of 6 Fahrenheit degrees (degrees F) to 14 degrees F, during 2 hours 20 minutes. However, a previous temperature excursion of 15 degrees F to 46 degrees F for 11 hours was also reported. A digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1903USA000678; US-009507513-1902USA012055; US-009507513-1903USA000677; US-009507513-1903USA000680; US-009507513-1903USA000681; US-009507513-1903USA000682; US-009507513-1903USA000683; US-009507513-1903USA000685.
VERY LARGE LOCAL REACTION  + ERYTHEMA, WARMTH AND MINIMAL INDURATION FROM DELTOID TO ELBOW- NONTENDER
sudden hearing loss; Vestibular migraines; Severe tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 09:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation, administered at pharmacy or drug store.  Relevant medical history included: "Severe Tree Nut Allergy - Lethal" (unspecified if ongoing). Prior to vaccination, the patient was  not diagnosed with COVID-19. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 2021; OMEPRAZOLE; ATORVASTATIN; VIT D [COLECALCIFEROL]; SAMBUCOL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 23Mar2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 14Apr2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: SUDDEN HEARING LOSS (disability) with onset 24Nov2021 04:00, outcome "not recovered", described as "sudden hearing loss"; VESTIBULAR MIGRAINE (disability) with onset 24Nov2021 04:00, outcome "not recovered", described as "Vestibular migraines"; TINNITUS (disability) with onset 24Nov2021 04:00, outcome "not recovered", described as "Severe tinnitus". The events "sudden hearing loss", "vestibular migraines" and "severe tinnitus" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: vestibular function test: (2021) unknown. Therapeutic measures were taken as a result of sudden hearing loss, vestibular migraine, tinnitus: hearing aids, audiogram, vestibular function test. Since the vaccination, the patient has not been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.  Amendment: This follow-up report is being submitted to amend previous information. It was confirmed that the product was administered.
This spontaneous report as received from a medical assistant refers to a patient who was vaccinated with the first dose of GARDASIL on an unspecified day in 2008 "about 4 years old", and was to receive the second dose of GARDASIL on 12-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. There was no adverse event reported. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information is not expected.
3 welts and redness noted on patient's left deltoid. Patient stated she received Tdap vaccine in that area 2 days prior. Patient has been having fever 102.8 to 104 for past 24 hours.
Information has been received from a health professional concerning a 6-year-old white male who on 20-JUN-2000 was vaccinated with a dose of Varivax. On 30-JAN-2006 the patient experienced vaccine failure. It was noted that the child had known contact with another case of varicella. Follow up information indicated that no further information was available. No additional information is expected.
administration of pfizer peds with Lot #FL2757 was given after expiration date of Sept. 30
COUGHING WHEN LYING DOWN; COLD SWEATS AT NIGHT, WITH BLANKETS BEING WET; WEIGHT LOSS/LOST 20 POUNDS; CONGESTION; FEVER; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced coughing when lying down. On 19-APR-2021, the subject experienced cold sweats at night, with blankets being wet. On 19-APR-2021, the subject experienced weight loss/lost 20 pounds. On 19-APR-2021, the subject experienced congestion. On 19-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F, and Weight (NR: not provided) Lost 20 pounds. Treatment medications (dates unspecified) included: amoxicillin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from coughing when lying down, fever, cold sweats at night, with blankets being wet, weight loss/lost 20 pounds, and congestion. This report was non-serious.
A report was received from a health care professional on 10/31/2003, concerning a 43 or 44 year old male vaccinee who was deaf 3 days after receiving Fluvirin on 10/24/03.  On 10/27/03, the vaccinee was completely deaf after receiving Fluvirin on 10/24/03.  The vaccinee has consulted with an ENT specialist and has further appointments scheduled with the specialist.  The reporter indicated that the vaccinee has experienced tinnitus for the past 5 years. The vaccinee is not taking any concomitant medications and has no known drug allergies.  The reporter indicated that the vaccinee has received the influenza vaccine each year for the past 5 years and experienced no hearing impairments.  This is the first year the vaccinee has received Fluvirin influenza vaccine.  There was insufficient information to determine the reporter's causality assessment.  Update: 12/05/03: Further information received from a health care professional indicated that the vaccinee was 42 years old and experienced sudden hearing loss in his right ear, which was disabling, 24 hours after receiving Fluvirin on 10/26/03.  The vaccinee had not recovered at the time of this report.  The reporter has assessed the relationship of the vaccine to the event as probable.  Follow up pending. The 15-day follow up received on 1/13/04 states further info received from a health care professional indicated that the vaccinee was still diabled and deafness was permanent on testing on two occasions. Follow up pending.
Right at the time of the injection I felt sick ,then muscle spasms  started and have not stoped and on day 5 sense injection ,the next morning supper tired and my eyesight was scattered I could not focus on anything ,very agitated ,thought I was going blind ,had inflamed  joints bad pain ,had pain in abdomen possibly liver ,by the 3rd day I  regret ever allowing this into my body ,I was feeling fine up until this injection ,and Im very reluctant to get the second shot ,Im afraid it will be even worse ,
hematocrit was 63.2; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HAEMATOCRIT ABNORMAL (hematocrit was 63.2) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 037A21B, 021F21A and 049L21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2020.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced HAEMATOCRIT ABNORMAL (hematocrit was 63.2). At the time of the report, HAEMATOCRIT ABNORMAL (hematocrit was 63.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2017, Haematocrit: 48.4. In 2018, Haematocrit: 43.8 and 43.5. In 2020, Haematocrit: 42.4. On 09-Jun-2021, Haematocrit: 47.6. In May 2022, Haematocrit: abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient did not have a genetic marker. Reporter found that polycythemia can occur in 60 and older. Patient had the first two treatments where they take a pint of blood once a month to get the hematocrit to come down.The patient had hematocrit within normal limits up until June 2021. The patient was trying to find out if there was a correlation, or if anybody reported, between that hematologic problem  and the Moderna vaccine.  No treatment medication was reported.   This case was linked to MOD-2023-729260 (Patient Link).
Unknown - nothing reported. Expired PEDIARIX given to patient. Nothing reported by parents/patient.
Bad joint pain and headaches leading to high white blood cell count leading to hospitalization and diagnosis of Giant Cell. Prednisone, Predisolone for left eye that I was losing sight in. Presently, Actemra weekly injection for total of 3 yrs. Doctors say Actemra stops my immune system from working properly.
About 8 hours post vax the patient developed red spots on her thighs, feet, hands, neck and the back of her head. The patient was seen in the ER and diagnosed with a hand and foot disease. Approximately 10 hours later the red spots were welts the size of pennies. The patient was seen at the Women's and Children's ER and was diagnosed as having a reaction to the vaccination. The patient was treated with Clemastine.
Pt recv vax on 11/10/98; on 11/13/98 pt exp red & warm LA; tx=Warm soaks & Medrol dose pack
ALMOST COULD NOT STAND UP; DIZZINESS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient was part of the Ensemble trial and received a placebo but then was given the Janssen COVID-19 vaccine after the trial ended. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced almost could not stand up, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost could not stand up and dizziness was not reported. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 16:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Case number PHEH2014US023968, is an initial spontaneous report from a pharmacist received on 26 Nov 2014. This report refers to a 15 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly on 24 Nov 2014. On 26 Nov 2014, 48 hours after vaccination, the patient developed flu (strain A). Outcome of the event was reported as unknown. Seriousness and causality of the event was not reported.
Resident received her Moderna Booster on 10.25.21. Dose given was 0.5mL instead of 0.25mL. No adverse reaction reported.