chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician's assistant concerning a school age pt who was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. On 20Sep05, the pt came into the physician's office with about 15 chickenpox lesions. No treatment was given. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional information has been requested.
Patient arrived at vaccine site at approximately 1535 reporting that she had received the Janssen COVID vaccine approximately 3 months ago but was not given proof of vaccination. She requested to receive the Pfizer COVID vaccine as she is required to have proof of COVID vaccination. PHN called PHN supervisor and the medical team. Dr from the medical team approved Pfizer vaccine series for the patient. Patient returned to vaccine site and received dose 1 of the Pfizer COVID vaccine (lot FF8839) at approximately 1800. Patient wait in observation area for 15min, no report of adverse symptoms. Patient left walking with steady gait at approximately 1815.
Patient received a Moderna 1st dose at the age of 17, instructed patient to be monitored for a longer period of time. No adverse symptoms noted.
Flu like aymptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 14:00 (Batch/Lot number: unknown) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot number: Unknown Anatomical site: Left arm Administration time: 13:00), administration date: 21May2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 12Jun2021 07:00, outcome "not recovered", described as "Flu like aymptoms". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Redness & induration noted less than 24hrs after shot given - progressively getting more reddened, swollen & tender to palpation. Area on (R) thigh measures 3 in x 3 1/2 in.
Axillary lymphadenopathy on ipsilateral side as injection 1 day after injection. Resolved within 1 week
received the vaccine shot and three months later came down with a severe case of shingles./Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: received the vaccine shot and three months later came down with a severe case of shingles./Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 25-JUL-2023 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory details were unknown at a time of reporting.
I developed tinnitus (high pitched continuous ringing) in my right ear on 3/19/2021 after the date of my first COVID-19 vaccination on 03/01/2021.   On 04/08/2021 I developed louder tinnitus (louder high pitched continuous ringing) in my right ear after the date of my second COVID-19 vaccination on 03/22/2021.   I have never had continuous tinnitus before.
h/a; inc temp (sl); aching; lung congestion; has had sx since recvd flu vax; seen by MD;
Redness, swollen and tenderness of left arm after administration of vaccines (MENACTRA, Tdap).
This spontaneous report was received from a Certified Medical Assistant (C.M.A) regarding a 5 year old patient of unspecified gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored PROQUAD (lot # L032761, expiry date 24-FEB-2017) dosing regiment unknown. Call was because of a data logger. It was reported that the vaccine administered was subjected to temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes. The vaccine was not subjected to any previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not filed. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2021 12:30 (Lot number: EL9262) at the age of 71 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Diabetes 2" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Diverticulosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; METFORMIN; VITAMINS A & D; YES 2 ZINC. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "Experiencing elevated BP"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "Stiff neck and back muscles unable to turn head or sleep on back"; BLOOD GLUCOSE ABNORMAL (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "FBS/Glucose."; BODY TEMPERATURE INCREASED (non-serious) with onset 30Jan2021 12:00, outcome "recovering", described as "Elevated temp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures included OTC Acetemophin and Ibuprofen, Rx. Muscle Relaxan. Follow up (12May2021): Follow-up attempts completed. No further information expected.
Headache, Myalgia & Arthralgia Narrative:  also reported chills
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021 at 4:33 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Jan-2021 at 4:33 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.18. . Concomitant products were not reported.  On 06-Jan-2021, Excursion time was 3 PM, temperature was 35 respectively, total doses given for the day was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 06-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  On 06-Jan-2021, vials were stored in cooler 2, at following time and temperature respectively, 11 AM: 41, 12 AM: 40, 1PM: 45, 2 PM: 45, 3 PM: 35, 4 PM: 44 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Vaginal Ulcers, had gone to the er over 2 times, then was referred to a gynecologist who emitted me to the hospital and spent a multiple days emitted.
I started having chills, then my teeth were clenching, and then my arms and legs were twitching uncontrollably. This occurred for about 6 hours. Since I have epilepsy, I contact my neurologist after hours line and talked to the doctor on call. After describing my symptoms, she said that my seizures were not due to my epilepsy. I have never been conscious during an epileptic seizure and I was fully aware and able to communicate clearly during this one. After 9 hours of sleep, I have had a headache, dizziness, and tired all day today.
Immediate reaction. Painful, red, swollen where she received sub q shingles. Also had sore neck. Received pneumonia and shingles both in same arm. Feeling better since first day when she had chills fever and sweating. She took Tylenol for fever and pain.
Following 1st dose client developed bruising - 2 to 3 days after. Persisted. No CNS changes. Bruising persisted over several weeks. She received 2nd dose on schedule 2/25/21. She was seen 3/8/21. Platelet count was 8000. Again, Repeat CBC pending from today.
2 day p/vax small blisters formed on leg, adjacent to site of vax;3 days later, blisters scabbed over;rx: ery pd 120mg BID x 10 days;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 86 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 25-JUN-2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Came down with type A flu; Strep throat; This case was reported by a consumer via sales rep and described the occurrence of influenza a virus infection in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In October 2019, immediately after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced influenza a virus infection and streptococcal sore throat. On an unknown date, the outcome of the influenza a virus infection and streptococcal sore throat were unknown.   It was unknown if the reporter considered the influenza a virus infection and streptococcal sore throat to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received flu vaccine last month and shortly afterwards she came down with type A flu and streptococcal throat. Limited information was available. The reporter denied permission to follow up. This is 2 of the 2 linked cases reported by the same reporter.
63 YO FEMALE PT C/O N/V DIZZINESS AND THE SENSATION OF BEING POKED IN THE CHEST. HX DM AND HTN CODE GREEN CALLED, VSS, CLIENT REFUSED TO GO TO HOSPITAL LEFT AMA STATES SHE WILL SEE HER PCP IT LIKELY IS HER HIGH BP AND BS. MONITORED X30 AND DROVE HOME BY SPOUSE.
Henoch-Schonlein purpura with purpuric rash on upper and lower extremities from 8/3/2021. Joint swelling, scrotal swelling intermittently. Severe abdominal  pain 8/19/2021  requiring hospitalization and steroids
little bumps underside of right forearm; a little bit swollen underside of right forearm; redder underside of right forearm; Itchy underside of right forearm; developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (little bumps underside of right forearm), RASH (developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm), PERIPHERAL SWELLING (a little bit swollen underside of right forearm), ERYTHEMA (redder underside of right forearm) and PRURITUS (Itchy underside of right forearm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's medical history was not reported.  The patient's past medical history included Poison ivy rash.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SKIN MASS (little bumps underside of right forearm), RASH (developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm), PERIPHERAL SWELLING (a little bit swollen underside of right forearm), ERYTHEMA (redder underside of right forearm) and PRURITUS (Itchy underside of right forearm). The patient was treated with TRIAMCINOLONE DIACETATE (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) (topical) on 31-Jan-2021 for Adverse event, at a dose of UNK dosage form (once) and TRIAMCINOLONE DIACETATE (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) (topical) on 01-Feb-2021 for Adverse event, at a dose of UNK dosage form (once). At the time of the report, SKIN MASS (little bumps underside of right forearm), RASH (developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm), PERIPHERAL SWELLING (a little bit swollen underside of right forearm), ERYTHEMA (redder underside of right forearm) and PRURITUS (Itchy underside of right forearm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included low dose blood pressure medication. The patient did not come in contact with poison ivy.
8 x 12 S cm red, itchy, slightly raised lesion on right buttock, not painful, normal gait, developed less than 24 hour after immunization.
inflammation on her Lip; Cracked lip; Yellowish Discharge on her Lip; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (inflammation on her Lip), CHAPPED LIPS (Cracked lip) and LIP INFECTION (Yellowish Discharge on her Lip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 81OTLIA) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease since 2006 and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHEILITIS (inflammation on her Lip), CHAPPED LIPS (Cracked lip) and LIP INFECTION (Yellowish Discharge on her Lip). At the time of the report, CHEILITIS (inflammation on her Lip), CHAPPED LIPS (Cracked lip) and LIP INFECTION (Yellowish Discharge on her Lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
3.8.2021 screening for courts. Breakthrough Covid -19 positive.  Asymptomatic
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm felt hot), BLISTER (I could see bubbles through my skin), BLISTER RUPTURE (bubbles popped), FATIGUE (fatigued) and VACCINATION SITE ERYTHEMA (red) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2020 and Atrial fibrillation. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (arm felt hot), BLISTER (I could see bubbles through my skin), BLISTER RUPTURE (bubbles popped), FATIGUE (fatigued), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swelled up to 2 times the size of her other arm). The patient was treated with CHLORAMPHENICOL (ANTIBIOTIC [CHLORAMPHENICOL]) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE WARMTH (arm felt hot), BLISTER (I could see bubbles through my skin), BLISTER RUPTURE (bubbles popped), FATIGUE (fatigued), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swelled up to 2 times the size of her other arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This case was reported by a nurse via sale rep and described the occurrence of injection site erythema in a 13-year-old female patient who received BEXSERO (batch number 149001A, expiry date 30th September 2016). Co-suspect products included GARDASIL and PNEUMOVAX 23. On 5th April 2016, the patient received the 1st dose of BEXSERO (intramuscular), GARDASIL (intramuscular) and PNEUMOVAX 23 (intramuscular). In April 2016, less than a week after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling, injection site warmth, fever, abdominal pain, headache and latex allergy. In April 2016, the outcome of the injection site erythema, injection site swelling, injection site warmth, fever and abdominal pain were recovered/resolved. On an unknown date, the outcome of the headache and latex allergy were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, fever, abdominal pain, headache and latex allergy to be related to BEXSERO. Additional details were provided as follows: The patient received the doses of BEXSERO, GARDASIL and PNEUMOVAX 23 (office records showed BEXSERO administered in the left arm with GARDASIL and PNEUMOVAX administered in the right arm). The nurse was surprised by this information because they had thought it was opposite, with BEXSERO in the right arm. As a result she was now unsure in which arm BEXSERO was administered. It was reported that, the reaction (injection site swelling, redness and warmth with some red streaks going down from the injection site) occurred in the patient's right arm. The patient also had systemic symptoms of low grade fever, abdominal pain and headache. On 7th April 2016, the patient was seen by the office and was suspected of having a latex allergy, so the reporter thought the reaction was caused by the latex in the tip cap of BEXSERO.
pt recv vax 14JUN & 2JUL96 pt devel more than 60 vesicles that were consistent w/chickenpox on arms, legs, chest, thighs & neck;presented to MD;
Case number PHEH2013US025517 is an initial spontaneous report received from a health care professional on 09 DEC 2013. This report refers to a 2-year-old female patient. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1309601; expiry date: APR 2014) 0.5 ml intramuscularly on 04-DEC-2013. No adverse event was reported following this medication error (inappropriate age at vaccine administration). No other information was available.
Swelling; Itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness). On 03-Feb-2021, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE ERYTHEMA (Redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.