chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore throat on an unspecified date and it went away and patient was getting ready to take the second dose. The outcome of the event was recovered on unspecified date.  Information on the lot/ batch number has been requested.
Runny nose; Foot pain; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain). At the time of the report, RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Foot pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
This spontaneous report as received from a pharmacist via company representative refers to a 60 year old patient of unknown gender. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot number JD13137 is an invalid lot number for zoster vaccine live, expiration date 31-JAN-2015), in the right arm (dose and route not reported). The pharmacist reported that approximately in September 2014, the patient experienced localized redness that formed a circle approximately "the size of a palm" following administration of the vaccination of ZOSTAVAX on 26-SEP-2014. The reaction took approximately one week to resolve. The patient did not seek treatment for the reaction or not have any additional reactions. This is one of several reports received from the same reporter (this case concerns patient 2). Additional information has been requested.
pain in your arm after the shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in your arm after the shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (pain in your arm after the shot). At the time of the report, MYALGIA (pain in your arm after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Pt developed a rash the day of the vaccine on mouth/ears/lips/face. Mom said it was still present on 3/18/16 when I examined but could not appreciate recommended BENADRYL PRN. Pt also developed lymph node enlargement on (R) posterior neck 3/17/16. He is to follow up in 1 wk to reassess. Rash resolved on my exam, lymph node reevaluation pending.
Mistakenly given without an order. Confused patient with sister who was also in for a visit. Mother has been notified.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot#N005274 with expiry date: 03-APR-2018  (dosing details, anatomical location and route were unknown) for prophylaxis. It was reported that the vaccines were exposed to a temperature range of 9C to 25C (9.9C) for a duration of 13 hours and 15 minutes. During previous temperature excursion vaccines were exposed to a temperature range of 9C to 25C (11.5C) for 7 hours and 45 minutes. Data logger was involved. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA009615:
pt recvd vax & following vax devel mumps;No further details were provided;
Initial information regarding an unsolicited valid non-serious case received on 11-Oct-2018 from a physician. This case was linked to 2018SA285341 (same reporter). This case involves a 46 years old patient of unknown gender who experienced blue or green bruising, hot to the touch, swelling, while he/she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies taken. On 10-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA (expiry date: 30-Jun-2019) via unknown route in the left arm. On an unknown date, the patient experienced blue or green bruising, hot to the touch and swelling one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 11-Oct-2018, patient required visit to doctor. It was a case of actual medication error due to incorrect product storage. It was reported that there being a suspicion that the vaccines might have gotten to cold and perhaps frozen in the refrigerator. Final diagnosis was swelling, hot to the touch and blue or green bruising. Lab tests not reported. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a consumer concerning her 10 year old daughter who in March 2007 was vaccinated with the first dose of Gardasil with no reaction, and who on 17-SEP-2007 was vaccinated IM with the second dose, 0.5 ml, of Gardasil (lot # not provided). There was no concomitant medication. On 17-SEP-2007 following the vaccination, her daughter experienced pain at the site of injection. She recovered later on the same day. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt 26-Sep-2014) concerns a 82 year-old female patient who had a FLUZONE flu shot last year and was fine. On 19-Sep-2014, the patient received AFLURIA (batch number T5930, 0.5mL x 1) intramuscularly in the left arm for the prevention of influenza. No other injections were given. On 19-Sep-2014, the patient experienced pain at the injection site (left arm) when she visited the pharmacy on 26-Sep-2014. She also reported that she had been experiencing the pain for a week now, since she got the AFLURIA shot. Her arm was extremely sore and painful. The pain was dull, but hurts the patient to the point where she was not able to sleep at night. She did not specify what makes the pain better or worse. Outcome was reported ongoing.
injection site soreness; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 2nd dose of Shingrix. On 13th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 16th September 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was in her 70's. The patient received Shingrix and experienced injection site soreness on the same day as the vaccine was administered. The event was resolved by 16th September 2019 when the GlaxoSmithKline employee saw the patient at the gym.  The GlaxoSmithKline employee who reported the event noted that the patient exercised in the gym regularly and appeared to be in good health.  The GlaxoSmithKline employee did not have the patient's name and contact information but would request the patient contact GlaxoSmithKline with additional information.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection/infusion for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 18-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Patient experienced COVID-19.         No concomitant drug reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality of HUMIRA, for the event(s) of COVID-19 was not provided and Possible for Pfizer Biontech COVID-19 vaccine.  No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a 29 year-old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a booster dose of mRNA-1273 vaccine administration. Patient was previously vaccinated with a dose of Comirnaty (Interchange of vaccine products). No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 29 year-old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a booster dose of mRNA-1273 vaccine administration. Patient was previously vaccinated with a dose of Comirnaty (Interchange of vaccine products). No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The next day in the evening he had a slight cough, but otherwise he was fine. Monday he went to school. In the evening he had a slight cough. Tuesday he said his throat felt yucky. He didn't have a runny nose. I sent him to school. He was at school for about 1 hour. Then he said he wasn't feeling good so I picked him up from school. He seemed tired during the day, but he had no fever or other symptoms besides the scratchy throat. Wednesday he got up and seemed fine. As the morning went on he had a fever of about 101 degrees. He didn't feel very well. He was still responsive, but he was just laying on the couch and he felt nauseous. He took a nap in the morning. He woke up and felt a little better. He ate a little bit of food. We went to see a doctor on 12/8/2021. He threw up at the doctor office. When we went back he still had a 101 degree fever. The doctor did a test on him and said he caught a virus. When we went back home we tried giving him Tylenol but he threw it up. We tried giving him fluids so he does not dehydrate. He hasn't threw up anymore today. We haven't given him anymore Tylenol. He has just been laying on the couch and tired. His fever is at 99 degrees.
Initial unsolicited report received from a pharmacist on 10-Sep-2018. This case involves a patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI996AB, expiration date: 30-Jun-2019, route and site of administration was not reported) on 09-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to and product quality issue and syringe issue. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Acute Thrombotic Thrombocytopenic Purpura; This is a literature report for the following literature source(s): "Acute Thrombotic Thrombocytopenic Purpura: Rare and Life-Threatening Side Effect of Recent BNT-162b2 COVID-19 Vaccination".  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: THROMBOTIC THROMBOCYTOPENIC PURPURA (medically significant, life threatening), outcome "unknown", described as "Acute Thrombotic Thrombocytopenic Purpura".; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for reported event ' Acute Thrombotic Thrombocytopenic Purpura' . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
patient received 2nd Pfizer vaccination 11/20/21 and called pharmacy 11/21/21  to complain of adverse reaction("itching from head to toe").  Patient informed me that the reaction also happened after the 1st dose on 10/26/21 and the itching has never stopped.  She did not report the adverse reaction until 11/21/21.  I asked if she was having  difficulty breathing and she she no.  I recommended benadryl every 6 hours and she said she has been taking benadryl since the 1st vaccination.  I told her to call her primary care physician.
He had soreness in the arm after receiving the 1st, 2nd, and 3rd dose; He already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine; he already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 76 year old male patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in the arm after receiving the 1st, 2nd, and 3rd dose causing pain in extremity on an unspecified date with outcome of unknown, he already received 3 doses of the pfizer-biontech covid-19 vaccine leading to off label use and extra dose administered on an unspecified date with outcome of unknown. He wants to know if he should still receive booster dose.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Severe redness  and hardening of the skin around injection site, fever 102F , fatigue , headache , chills within 24 hours of first dose
Pt got his first dose of Covid 19 vaccine with a Pfizer brand administered intramuscular at left arm at 01:11 PM. Pt sat down at 01:20 PM and pt verbalized that he is feeling light-headed/ dizzy. The EOA, , RN stayed with the pt and asked admin  to help patient lay on the floor. At 01:22 PM pt passed out. Admin placed pt laying on the floor with legs elevated and head on the side. Pt was unconscious with pulse and with breathing. Vital signs was checked BP 102/60 mmhg; PR 83 ppm; RR 18cpm, T 97.6 F, Oxygen sat 98% at room air, Blood sugar 128 as taken by  RN. After 30 seconds pt regained consciousness, pt is alert oriented to self, time, place, date and location. Pt stated no complaints of chest pain or SOB. EOA assesses muscle streghth in both upper ad lower extremity and is 5/5. EOA assigned  RN to continuously monitor pt every 15 mins until stable. Pt was advised to call family  for us to inform and EOA highly recommended to have a family member stay with him. Admin  called the wife and wife stated that she will here in an hour. Pt refused to call 911 as well but pt was advised to have a follow up appointment with primary care doctor. Pt stated he has an appointment the next day. Pt also stated he has no history of him passing out after any vaccination. Pt was transitioned from laying to sitting with latest vitals of110/ 68mmh, oxygen sat 99% at room air, PR 72 ppm, RR 10, T 97.6 F.  No complaints of of dizziness .  RN (EOA), and a admin stayed with the patient util family member arrives. By the time family member arrives, RN (EOA) discharged pt without any discomforts.
Two weeks after the 3rd dose of the Moderna vaccine, patient started having an outbreak of hives that would come and go and move to different parts of the body including legs, stomach, back, and arms. The hives appeared daily and would be mildly treated by Zyrtec. Patient started a Methylprednisolone treatment on November 29, which has reduced symptoms to itchiness on body at night and prickling/itchiness on palms and soles of feet.
COVID-19 MODERNA booster was administered too early today 12/28/21. Failed to verify record and vaccine card prior to administering COVID-19 booster. Patient was observed after receiving the vaccine and no adverse reaction was recorded. Error was noted during documentation and after verifying record. Error was reported to RN and leadership. Patient was contacted and did not report any adverse reaction. Patient was not aware of booster regulation or which COVID-19 vaccines she received prior to the booster. Patient was made aware to report any adverse reaction to clinic staff.
On night of 9/23 she had a 103 fever, chills, dizzy and weakness  On 9/24 she fell down unconscious  and threw up on the floor, rushed to hospital via ambulance  on 9/23 she also received the flu vax but the parent didnt know which vax she got   Hospital is guessing it was seizures
administering intranasally; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 17-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intranasal) and Flulaval Tetra Pre-Filled Syringe Device. On 25th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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: 26-Oct-2022 Reporter's comment: The health department had a flu clinic one day before the reporting date. The reporter reported that they were administering Flulaval and an intranasal flu vaccine and a nurse volunteer gave Flulaval intranasally to 3 patients. The vaccine administration facility was the same as primary reporter. The facility address was also reported above in health care professional's details. The reporter consented to follow-up by phone. This was for 2 of 3 linked cases reported by same reporter. Additional supportive information: The patient received Flulaval vaccine intranasally, which led to intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2022AMR154541:Same reporter US-GSK-US2022154655:Same reporter-Deleted US-GSK-US2022154657:Same reporter
This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), HEADACHE (slight headache) and NAUSEA (felt nauseous the entire day) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 038A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUPROPION HYDROCHLORIDE (ZYBAN) for an unknown indication.On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced HEADACHE (slight headache) and PYREXIA (I felt feverish). On 15-Nov-2021, the patient experienced CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), NAUSEA (felt nauseous the entire day), MYALGIA (body aches) and FATIGUE (exhausted). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Nov-2021, HEADACHE (slight headache) and PYREXIA (I felt feverish) had resolved. On 16-Nov-2021, CHEST DISCOMFORT (It felt like pins and needles, lasted less than 5 Minutes), DECREASED APPETITE (no appetite), CHEST PAIN (chest pain in the upper center part on my chest around my clavicle), NAUSEA (felt nauseous the entire day), MYALGIA (body aches) and FATIGUE (exhausted) had resolved. Patient had a chest pain in the upper center part on my chest around my clavicle. It felt like pins and needles and lasted less than 5 Minutes.