chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric dose was given to adult mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; 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 adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) 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 adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) 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 adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case contains information for the 101 of 104 patients described by the reporter.  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 CDPH, VAERS, CAIR 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 was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:master case
On 8/28/19 pt started having redness, itching, swelling and pain in the left arm at the Adacel injection site.  No fever, cough, breathing difficulties, hives, vomiting, diarrhea.  Pt has a 6 cm x 8 cm area of erythema on he left arm deltoid area with induration 2 cm x 4  cm with tenderness. No fluctuation,. No lesions.
no adverse event; a dose was administered after 30-day Use By Date; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a dose was administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a dose was administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a dose was administered after 30-day Use By Date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (a dose was administered after 30-day Use By Date).    Concomitant medication details not reported by the reporter. The vial was stored in the fridge on 03-Apr-2023. This was the 1st Bivalent dose for the patient. Treatment details was not reported by the reporter.
Information has been received from a physician concerning a 21 year old female ("who is a family friend of the physicians") who was vaccinated with her second dose of GARDASIL at another physician's office. Two weeks later the patient experienced seizure and brain swelling and was hospitalized for two or three weeks. Therapy with GARDASIL was discontinued. On unspecified date, the patient recovered. The physician also reported the patient has now returned to college. Attempts to verify the existence of a patient have been unsuccessful. No further information is available.
Sore; Very Tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included MEASLES VIRUS VACCINE LIVE ATTENUATED (MEASLES) for prophylaxis.   On 28th May 2019, the patient received the 1st dose of Shingrix and MEASLES. On 29th May 2019, 1 days after receiving Shingrix, the patient experienced pain in arm and fatigue. On 30th May 2019, the outcome of the pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient stated that her arm was sore after vaccination but she does not know which arm received the Shingrix product or the measles product. The patient also felt fatigued. The reporter gave permission for her physician to be contacted. The reporter was unable to provide any additional information.
Fever- 102 degrees F. Also severe pain at injection site - was unable to walk or bear weight for hours after waking up the morning after the vaccine. He had this same reaction with the previous 3 as well but this seemed worse/ more severe this time.
My adverse event started on 12/21/2022 in the evening. I had  body aches, cough,  extremely tired and fever. I did 2 home COVID-19  tests which  was on 12/21/2022 and 12/23/2022 were negative. I called my doctor and he send prescriptions to the pharmacy for Z-pack and Benzonatate. I didn't tested  positive for COVID-19   at all. I did home remedies to help such as I drank honey tea. I also took Tylenol became calling my doctor. I felt like I had a flu but it wasn't flu. I fully recovered from 01/15/2023-01/16/2023. I never had runny nose. My fever went  away  after taking the Z-pack.  After taking the Z-pack I was having  bowl constantly. I guess it was from the antibiotics. I tried everything I can to stop it. I did ate oatmeal,  and rice  to help it.  Recently  I ate cantaloupe and other things to help with my bowl movement.  Now I finally have perfect bowl movement.
Severe pain in arm, neck, shoulder. Unable to move arm, numbness in fingers, achy pain in arm neck and shoulders as well as shooting pain. Pain increasing daily this is day 9, pain is the most intense today.
heavy weight on chest. pain in jaw  , er visit  tests and admitted . pericarditis
Due to leakage, administered less than 0.5ml.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 39-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number L3GM3, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 21st September 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: The pharmacist reported that a dose of Fluarix given to the patient and during administration there was leakage of the liquid, therefore the volume administered was lower than 0.5 ml (Milliliter). The reporter consented to follow up. Additional Supportive Information: The use of Fluarix to the patient and during administration there was leakage of the liquid, therefore the volume administered was lower than 0.5 ml, which led to incomplete dose administered.
Info has been received from an internet publication concerning a surgeon who in 85 was vax'd w/Hep B vax recombinant. It was reported that the surgeon was infected w/Hep B and may have infected at least 28 of his PTs. More than 1,500 PT's who the surgeon treated btwn 1995 and Feb. 99 were tested, and researchers determined that the MD had passed the virus on to 8 PT's, and likely infected 2 others, and may have infected 18 more. It was noted that the MD apparently did not respond to the immunization and was routinely exposed to the blood of PTs while working under primitive conditions. It was not reported if the surgeon sought medical attention. Information was also received in a published abstract (Undiscovered hepatitis B transmission from an hepatitis B E antigen positive surgeon to his patients over a four-year period). Three cases of acute hepatitis B were reported at a regional health service, all patient were operated on at hospital A by the same general surgeon. The surgeon (X) was found to be HbaAg positive with a viral load of >5x10^g copies/ml. A retrospective cohort study was conducted on 1562 patients on whom surgeon X had operated from June 1995 through February 1999. Moreover, a case control study was carried out to study risk factors for HBV transmission. Surgeon X transmitted HBV to 29 patients (1.9%), of whom 2 remained HBV carriers. In addition, one case of secondary transmission was identified, in which the patient died from fulminant hepatitis B infection. DNA sequencies obtained from surgeon X were 100% identical to sequences in 7 of the 29 cases and in the case of secondary transmission. Surgeon X was a non-responder after HBV vaccination (manufacturer unknown) and appeared to be infected for more than ten years. At least 11 patients were infected during "low risk" procedures. Transmission from surgeon to patient can occur without discovery for along period of time. Prevention required a more stringent policy for the vaccination and testing of surgeons. It may require revision of policies allowing surgeons to perform "non-exposure prone" procedures, since these are not without risk of HBV transmission. No further information is available. This is a consolidation of two reports concerning the same patient. The primary source has changed from a domestic source to a foreign source. Therefore, this report no longer meets criteria for submission.
Sciatic nerve pain that starts from the right buttocks to right foot; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031b21A and 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Peanut allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot). The patient was treated with NAPROXEN SODIUM (ALEVE) for Sciatica, at a dose of 220 mg about 12 tablets today, and it did not do anything. 4 tablets; CELECOXIB (CELEBREX) for Back pain, at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot) had not resolved.            Treatment medication included two different chiropractors. Patient went to his orthopedic surgeon, he ordered an MRI. date was July 7, 2021 and he was in agony every day.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow-up relevant history allergy to peanuts and Treatment medication changed to Celebrex and tramadol.
pt recv vax 26NOV96 & on 27NOV96 pt exp a 1inch lump across which p/24hr pt became an indurated patch 3x5 inches on arm, a fever, chills, sweating, & pruritus;
Myalgia, Fever, sore arm, unspecified GI complaints Narrative:  Patient reported body aches, fever, sore  arm and unspecified GI complaints.
59 year old male patient comes into the Urgent Care with complaints of an allergic reaction to measles vaccine with rash on the ankle and back extending to the upper buttocks, eye discharge, runny nose, and productive coughing with green sputum interfering with sleep x28 days, onset one month after measles vaccine on 2/20/2015. Symptoms moderate and constant. Pt noted that the symptoms began approximately at the time he should have returned for the second MMR vaccine. Pt has been self-medicating with ciprofloxacin from past prescription, starting yesterday.
All normal side effects started 6 hours after shot.  Started with chills, fever, body aches, migraine headache, extremely tired, dizzy, nausea.  Vomiting  started 11 hours (5:00 am) after COVID-19 vaccine and lasted another 12 hours.  Vomited at least 5 times.  All side effects except a fever were gone after 24 hours from the onset of side effects.   The fever was gone after 38 hours from the injection.
Varicella vaccine received 1/16/17. 1/22/2017 skin erythematous, pustular/vesicular rash to face, trunk, legs.
This spontaneous report as received from a registered pharmacist via Company Representative refers to a 76 year old female patient. In April 2012 the patient was vaccinated SC with a 0.5 ml dose of ZOSTAVAX (lot # not reported). The pharmacist reported that a patient received ZOSTAVAX in April 2012 and later got shingles in the summer of 2012. Varicella zoster virus (VZV) packet declined. At the time of reporting, the outcome was unknown. The relatedness was unknown for ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unspecified date in September 2016 (reported as 1 month ago), the patient was inadvertently administered with an improperly stored doses of M-M-R II (lot # L007216, expiration date 03-MAR-2017, albumin status rHA) and VARIVAX (lot # M000996, expiration date 07-JAN-2018), (strength and dose were not provided for both vaccines), subcutaneously. There were not concomitant medications reported. No adverse effects reported. Additional information is not expected since the reported denied the consent to contact her.
mom stated pt had been running a fever; pt given APAP but cont to have fever into the noc; mom noted brief episode of jerking followed by sleeping phase; taken to ER; pt vomited;
It was reported that a 55 year old female patient received a dose of Fluzone administered in her right deltoid, lot # U0729AA, the date of administration is not known at this time. Within 5 minutes of receiving vaccination, the patient became flushed and had increased heart rate. Benadryl was administered and within a couple of hours symptoms subsided.
Information has been received from a Certificate Medical Assistant (CMA) and registered nurse (RN) regarding a patient of an unknown age and gender. The RN stated that on 02-AUG-2013, the patient received a dose of PROQUAD (lot number: J001052, expiration date 28-JUL-2014) (dose and route were not provided) that had been improperly stored. The RN stated that the patient had not experienced adverse effects. No additional details had been provided at that time. This is one of several reports from the same source (other MARRS #s 1308USA013854, 1309USA013043 and 1309USA013045). Additional information is not expected.
Headache, Myalgia, Fever, Diarrhea, chills, extremely tired
Pt recvd 2nd dose of Hep B vax & exp soreness & devel local swelling & hives; No further details were provided;
Pt had fever of 101F-102F, listless, lethargic, moaning and hypotonia.
Quite Skin rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient had a rash from the Covid shot (Vaccine) and also reported that I woke up with quite skin rash and stated I know that, It was a side effect and  enquired as "Can I take Benadryl or Benadryl cream on the rash?" The patient stated I want to know, Can I take a Benadryl. You know the Benadryl has been anti-histamine to help with itching rash and can I take Over the Counter Benadryl?". The outcome of the event was unknown.
13 year old received vaccines above. Initially seemed well, patient then stood up while stumbling. Vaccinated. Nursing stopped the report hearing that patient on the ground. Patient hit head. Contusion.
Felt flu like symptoms, very exhausted, could not stand for more than a few minutes at a time. This went on for over a week. I went back to the doctor's office and was told that this couldn't possibly be from the vaccine and no notes were taken.
pt states woke up 8JAN97 w/h/a that evening a sore throat devel;11JAN97 lt arm @ inj site became red swollen & warm to touch;pt came in to see MD & was started on DPH;
Upper arm pain in left deltoid with intermittent positional  paresthesia for 4 weeks  Treatment PT and standard of care for muscular complaint including NSAIDs
12/21/21  4:30 pm MST, right side of neck was becoming painful; 5:30 pm MST, right knee begin to throb / painful & 12/22/21  3:00 am, have  pain in both ovaries - had partial hysterectomy in November 1987.  As of 10:36 am MST (time of completing this form, I still experience the ovarian pain  where the ovaries are located.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Stiff arm-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Patient got flu shot. After about 1-2 minutes she fell down and hit her head. Father stated daughter looked lightheaded, rolled her eyes back, and fell and hit her head. Stated she had a seizure. I did not notice a seizure.
My son has had numerous colds / upper respiratory illnesses ever since starting daycare in June 2022. Due to those repeated exposures to upper respiratory illnesses, I too have gotten sick numerous times. I usually just treat it symptomatically at home and am fine. With my upper respiratory symptoms in February 2023, I developed an extremely sore throat and ultimately sought care from my doctor on Feb 9, 2023. I tested positive for strep throat and then had worsened upper respiratory viral symptoms (cough, nasal drainage, congestion). I was on 10 days of antibiotics for the strep throat and have not had any illness requiring treatment from a doctor since. I have had 1-2 more upper respiratory illnesses since this time.
Vesicle on lips 3-4mm with mild erythema; left shoulder eschar. Auto-inoculation.
Chills.  Took 3 ibuprofen went to bed fine the next Am
This case was reported by a other health professional via sales rep and described the occurrence of enlargement of lymph nodes in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on 26th May 2018, refer case US2019GSK045360). On 30th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. The patient was treated with medication unknown (Ice Pack (Nos)) and naproxen (Aleve). On an unknown date, the outcome of the enlargement of lymph nodes was unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient received the 2nd dose of SHINGRIX on the left arm and she experienced swollen lymph node in armpit of vaccinated arm. The reporter declined consent for follow up.
Sore and painful left shoulder. Weakness in entire left arm and hand. Unable to use full motion of shoulder and arm. Pain 24/7.
Tooth rot from the anthrax vaccine. All dental visits while at work resulted in more fillings. After retiring they began to chip away with many completely breaking.