chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; hot rash; fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (diarrhea), PYREXIA (fever) and RASH (hot rash) in an 82-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 80777010296) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 19-Jan-2021 and Pfizer on 09-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (amlodipine besylate), Allergy to antibiotic (amoxicillin), Drug allergy (atorvastatin), Drug allergy (codeine), Drug allergy (dextromethorphan hydrobromide), Allergy to NSAIDs (ibuprofen), Allergy to antibiotic (Levofloxacin,), Drug allergy (levaxin), Drug allergy (lisinopril), Drug allergy (metoprolol), Allergy to antibiotic (noroxin), Drug allergy (tirosint), Drug allergy (prevastatin) and Egg allergy.    On 06-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PYREXIA (fever). On an unknown date, the patient experienced DIARRHOEA (diarrhea) and RASH (hot rash). At the time of the report, DIARRHOEA (diarrhea) and PYREXIA (fever) had resolved and RASH (hot rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2023, Body temperature: temperature of 100 degree fahrenheit. On 08-Oct-2023, Body temperature: temperature of 100 degree fahrenheit.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient past Moderna-covid 19 vaccine included third dose on 29-Dec-2021 with batch number 059H21A and fourth dose on 27-Oct-2022 with batch number 059F22A. She received the vaccine on Friday and then on Saturday and Sunday she had a fever. Patient queried that if she could take treatment medication Benadryl in every 6 hours. Patient was doing better than yesterday. Then she also experienced a hot rash and diarrhea. Everything is gone except the rash. It has been started that patient had a bad reaction - blood clots with the Pfizer vaccine.   This case was linked to MOD-2023-745139 (Patient Link).
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were provided. No treatment was provided.   This case was linked to MOD-2021-405660, MOD-2021-405864 (Patient Link).
Initial report received on 24 September 2009 from a health care professional. This case pertains to one of a cluster of three patients involving misuse. The same reporter provided information regarding three patients who had been exposed to an investigational product involving a clinical trial sponsored by Sanofi Pasteur (reference number FIM07), but who were not enrolled in the study. All three patient's received investigational product instead of marketed influenza vaccine. Information regarding the other two patients is reported in cases 2009-04114 and 2009-04157. A healthy 25-year-old pregnant female , had received a first intramuscular right deltoid injection of investigational product INFLUENZA VIRUS VACC USP TRIVAL A&B HIGH DOSE, SUBVIRION-U, (lot number UD12307) on 23 September 2009. Obstetrical history included one prior pregnancy that resulted in one live birth with no congenital anomalies. The date of the patient's last menstrual period was on 09 January 2009, and her expected date of delivery is on 16 October 2009. Prenatal tests include Serology test performed in July 2009 (reported as 2006), and an ultrasound on 28 May 2009 that were normal. The patient had not experienced any adverse events. Documents held by sender: None
Left arm was sore at injection spot immediately following the flu shot and never recovered. Shooting pain in arm (from elbow to shoulder with emphasis on injection spot) during spontaneous motion or when lifting arm above shoulder level or twisting across by body to the right (basically when the muscle/ tendon is flexed in a specific way). Health Center recommended six physical therapy sessions and then review the injury to determine whether more physical therapy is needed.
SARS-CoV-2 (2019-nCoV) Nucleic Acid Amplified Test performed on 7/26/21 at 15:49. Test came back positive. Case investigation completed at time of note and case manager documented patient was experiencing starting 7/22/21 cough, runny nose, sore throat, nasal congestion, chills, fatigue, and muscle aches.
Within 1 minute of giving the vaccine, patient became pale,diaphoretic, dizzy, nauseous, and had dilated pupil. She was helped to a chair. She complained of a tickling and scratching of her throat and was given 25 mg of Benadryl. After another 3-4 min her color came back and all symptoms resolved. She sat with us for another 20 min to rule out any immediate allergic reactions. Pulse 60 bpm. Blood pressure  110/50 sitting.
5-6 times coughing out bloody mucous; breathing as a bit painful, stabbing pain; urge to cough always; trouble sleeping; throat pain; difficulty of breathing; slight nausea; almost puking; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping) and OROPHARYNGEAL PAIN (throat pain) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038CZ1A and 638C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Fruit allergy.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking). At the time of the report, SECRETION DISCHARGE (5-6 times coughing out bloody mucous), PAINFUL RESPIRATION (breathing as a bit painful, stabbing pain), COUGH (urge to cough always), INSOMNIA (trouble sleeping), OROPHARYNGEAL PAIN (throat pain), DYSPNOEA (difficulty of breathing), NAUSEA (slight nausea) and VOMITING (almost puking) outcome was unknown.            No concomitant medications were provided  The patient was trying to get an appointment with his doctor but he is on the verge of retiring and the license has expired already. Patient did not take any medication with the symptoms, just increased water intake. The patient confirmed not taking any regular prescribed medications or any supplements.   This case was linked to MOD-2021-285176 (Patient Link).
This spontaneous report as received from a Licensed Practical Nurse. On 29-MAY-2013, multiple unspecified patient were vaccinated with GARDASIL (lot # H014645, exp. 27-MAR-2015) for prophylaxis. The nurse reported the dose of GARDASIL were exposed to 30.1 degrees Fahrenheit for three hours, which was unsupported by stability data. No adverse effects reported. This is one of several cases received from same source. Additional information has been requested.
Information has been received from a pharmacist concerning a 63 year old female who on 21-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot unknown). Concomitant therapy included LAMICTAL, NEXIUM, ADVAIR, SYNTHROID, alendronate sodium (+) cholecalciferol, clonazepam and simvastatin (manufacturer unknown). On 30-SEP-2010 the patient was prescribed Z-PAK from her physician. It was reported that on 30-SEP-2010 the patient was prescribed Z-PAK from her physician. Pharmacist added that patient was just given a prescription for predisone because she had reported that the few days ago she dropped her toothbrush on the floor and rinsed it with a disinfectant cleaner and used the toothbrush, few days later she developed inflammation and developed tingling on the inside of her mouth on one side only. At the time of the report the patient had not recovered. Pharmacist stated that the patient had not started the prednisone as of 05-OCT-2010. Follow-up information was received from a registered pharmacist indicating that the female patient had some tingling on inside of mouth. The patient went to her dentist and dentist dismissed the symptoms and she was fine after that. No further information is available.
Rash on the left shoulder; pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm) and RASH (Rash on the left shoulder) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Pain in extremity on 11-Mar-2021, Rash on 12-Mar-2021 and Drug allergy.   On 11-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm). On 12-Mar-2021, the patient experienced RASH (Rash on the left shoulder). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in the left arm) and RASH (Rash on the left shoulder) outcome was unknown.            Concomitant medications were not reported.   This case was linked to MOD-2021-043046 (Patient Link).
Right tricep area warm, red, swollen 8 x 9 cm redness. Cool compress. BENADRYL 1/2 - 1 tsp every 6-8 hrs PRN.
after the vaccine I had a fever and was able to treat with Tylenol, and within two days my legs and knees were in pain and I had a cough. The pain is behind my knee on both legs and does up to my thigh and down to my ankle. When i sit it hurts realy bad behind the knee, especially when sitting on the toilet.
Noticed a ganglion on the collar bone, noticed another one right under chin; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0183) via an unspecified route of administration in the arm left on 22May2021 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24May2021, the patient experienced a ganglion on the collar bone and on 28May2021, the patient noticed another one right under chin. The patient did not receive any treatment for the reported events. On 28May2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The clinical outcome of the event ganglion on the collar bone and another one right under chin was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Recombivax-HB series started 04/06/01. Second injection given 05/07/01. Pt c/o pan at injection site 06/21/01. Returned to clinic 07/16/02 with c/o pain. lump rt deltoid and pain lifting arm. Referred to general surgeon.
Patient came to pharmacy at 7pm 05/09/19, with a swollen raised bump near her right arm elbow. In our system, patient was administered Shingrix on 05/07/19. Shingrix is for IM administration while the site looks like the vaccine was given  subcutaneously.
Information has been received from a nurse practitioner referring to an unspecified patient of unknown age gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient may have been administered an improperly stored dose of either ROTATEQ (lot # M019691, expiration date 02-NOV-2017, oral; dose was unknown) or GARDASIL 9 (lot # L040054, expiration date 26-DEC-2017; dose and route were unknown) for prophylaxis. The temperature excursion was 35.8 Fahrenheit degree for 16 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved.  Additional information has been requested.
swelling of arm, large red patch (2"x3"), severe muscle ache, arm hot to the touch.  Doctor prescribed METHYLPREDNISOLONE 4 MG DOSEPK.
Patient appeared to be gasping for breath. Had hands by throat. Also put fingers in mouth as if trying to move her tongue so she could breath.  I administered an epipen. EMS arrived in 7 minutes. Patient was ok and alert when she left. She came back later that day to let us know that she was ok.
Swelling and warmth at the site of injection the size of a golf ball.  Entire thigh was swollen.
Body aches in late day/evening. Woke up around 3am the next morning with aches, felt slightly nauseous and almost passed out, aching increased especially across my chest and arms, some numbness in hands, stabbing pain in chest, left shoulder. Took two Advil, pain eased and I was able to go back to sleep. Two more days of aches and feeling lethargic, feeling better every day after that. Arm is still a little sore.
There was no adverse reaction. Reporting as patient came in requesting to get her 3rd dose Pfizer Booster. Patient did not disclose  at time of vaccination that she also received two additional doses in February 2021-- this would total 5 doses. Patient is not designated immune compromised.  Private imports with no outside organization name or lot information for 2/3/2021 and 2/24/2021 It was documented that patient had her 2 dose primary series doses of Pfizer  on 6/10/2021 and 7/1/2021 with 3rd dose being given on 8/22/2022. When nurse was updating the vaccine card and was handed card by patient the nurse noted extra card with the February dates. The nurse questioned the patient about the two February doses and the member confirmed she did receive them . We escalated the issue to our Ambulatory Care practice lead and followed our facility protocol of completing an unusual occurrence report. Advised to submit a VAERS.
Pt recvd 1st vax 13DEC90 & devel itching & rash @ inject site.Pt recvd 2nd vax 22JAN91 & exp tenderness @ inject site,pain in left arm & swelling of wrist & later exp pain in shoulder joint & malaise.
09:08 received the following vaccines: HEPATITIS A MERCK 0020U 1.0CC IM RA, HEPATITIS B GSC AHBVB596CA 1.0CC IM LA, TYPHOID VI SANOFI A0923 0.5CC IM LA, FLULAVAL GSC AFFL197AA 0.5CC IM RA.  PT COMPLAINED OF DIZZINESS AND BLACKED OUT FOR APPX 15 SECONDS BEFORE BECOMING A+OX3.  PT GIVEN IV, BENADRYL AND PHENARGEN IN ACUTE CARE AREA AS A PRECAUTION.  NO FURTHER S/S.
Shingles; This is a spontaneous report from a contactable physician. This Physician reported for a behalf of 6-patients. This report was received via a sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date. The clinical outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021666246 same reporter/drug/AE, different patient
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No Adverse Event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 92th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but it was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Rash on 1/2/21. Nausea and vomiting began on 1/4/21
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Information on patient's concurrent condition and pertinent medical history was not reported. On an unknown date, patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). Concomitant medications were unspecified. On an unknown date, following the administration of ZOSTAVAX the patient experienced shingles. The physician reported that the patient was presently better (date unspecified). No further information was provided. Causality assessment was not provided by the reporter. Additional information is not expected as the reporter did not wish further contact.
covid vaccine breakthrough event  dose 1 2/2/21 013M20A dose 2 3/2/21 010A21A dose 3 11/19/21 034F21A
c/o feeling hot, had  increased heart rate, vomitted and nausea after vaccine was given.  Transported to ED, was no respiratory involvement including anaphylaxis, tightness of throat or trouble breathing. Labs were drawn without acute abnormalities. treated with IV fluids, Toradol and Zofran with improvement and discharged to home. She did have 2nd dose of vaccine on 5/2/2021 without incident
I want to report incident about vaccination. I gave Covid-19 Moderna vaccine LOT # 020B21A , to patient on 03/30/2021. She had appointment at 11:40 am. I injected covid-19 vaccine on her right arm, but vaccine spilled out of the injection syringe at connection and majority did not get into her body. As per my professional judgement, she didn't receive a sufficient dose of vaccine due to syringe failure, so I asked her for permission to administer another shot and she agreed. so I obtained another shot and gave her with her permission. After two days later on 04/01/2021, she reported that she had bad migraine all day and night after arrived home .
This spontaneous report as received from a nurse regarding a 14 year old female patient. No information about medical history, drug reactions and allergies was specified. On 21-AUG-2012, patient was vaccinated with GARDASIL (Lot # 04758E, No expiration date provided) dose 1, 0.5 ml, intramuscular. On 19-OCT-2013, the patient was vaccinated with GARDASIL (Lot # H015863, No expiration date provided) dose 2, 0.5 ml, intramuscular. On 26-JUN-2014 the patient was vaccinated with GARDASIL (Lot K001502, Expiration 06-AUG-2015) dose 3, 0.5 ml, intramuscular outside of prescribing information dosage and administration recommended schedule. No concomitant medications were reported. The lot numbers were confirmed with the nurse. There was no product quality complaint. No adverse effects noted to patient. Lot number 04758E is an invalid lot number for GARDASIL. Additional information has been requested.
Initial report received from a health care professional on 22 September 2011. A 30-year-old female patient received dose 1 of an intramuscular injection (site not reported) of ADACEL, sanofi pasteur Ltd lot number C3921AA, on 12 September 2011. The patients' weeks of gestation at the time of vaccination and the Estimated Date of Delivery were unknown. The date of the patient's Last Menstrual was reported as 26 July 2011. The patient's obstetrical history, current medical history and concomitant medication were unknown. The patient experienced no adverse event. The outcome was reported as unknown. Follow-up information was received from a health care professional on 24 September 2012. The patient developed gestational diabetes and hypertension during pregnancy. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The patient's estimated date of delivery was 02 May 2012. Diagnostic testing included cystic fibrosis negative, AFPU negative and ultrasounds normal. A single male child was delivered at 39 weeks gestation by cesarean section on 23 April 2012. Apgar scores were 9 and 9 at one minute and five minutes respectively. Height was 50 cm and weight was 4 kg. Congenital abnormalities were reported as no. Documents held by sender: None.