chrisvoncsefalvay/vaers-outcomes huggingface dataset:
13 month old received a dose of Quadracel vaccine/ no symptoms; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse manager.   This case involves a 13 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patients past medical history and family history were not provided.  Concomitant medications included PROQUAD and HEPATITIS A VACCINE, on unknown date.  On 09-Apr-2019, the patient received a 0.5ml dose 4th in series of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA, expiry date 14-Nov-2019 via intramuscular route in the right thigh.  It was an actual medication error due to inappropriate age at vaccine administration.  It was reported that 13 month old received a dose of Quadracel vaccine.  The patient did not experience any adverse reaction after the injection.   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.
pain, swollen arm & very hot & rest of arms are cold; inc itching rt arm; lt arm nl;
pt comlained of shoulder pain almost immediately after injection.  vaccine site was appropriately.  pt waited in clinic for 30 mins and then was released home.  to report on vsafe system and call doctor if persists
Patient came into the pharmacy on 1/31/2016 stating his right arm was still sore "a deep sore" where vaccine was given he said, since he received the flu shot on 1/2/16. nothing unusual about his month, job related activities or current illnesses that could indicate why his arm was still sore.
sneezing; runny nose; This is a spontaneous report from a contactable consumer or other health Care Professional. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL3424) via an unspecified route of administration on 05Feb2021 13:00 at single dose for COVID-19 immunization. Medical history included hypothyroidism, she took thyroid pill in the morning. The concomitant medication was not reported. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Jan2021. On 08Feb2021 16:00 she started sneezing for the next 2 hours with a runny nose, she thinks that she had a reaction after 72 hours of receiving the vaccine, she went for 2 hours sneezing, and sneezing repeatedly and also had a runny nose, she then thought it was was a cold, dummy her, took 1 Nyquil and laid down for 4 hours after that she was good. She had no vaccines on the same day as her covid vaccine, and had no vaccines in the 4 weeks prior to the vaccine. She had not to go to the Emergency room or see a physician for her sneezing and runny nose. Therapeutic measures were taken as a result of sneezing and runny nose. The event considered non serious. The outcome of the events was resolved on 08-FEB-2021 18:00.
sore right arm that lasted one week; A spontaneous report (United States) was received from a consumer concerning a 76 Year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced limb discomfort.  The patient's medical history was provided as COVID-19,high blood pressure and high cholesterol.  The patient was also taking  concomitant medications like vitamins,unknown medication for high blood pressure and high cholesterol.  On 13 Feb 2021, prior to the onset of the events, the patient received their first dose ,0.5ml of  planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularlly on her right arm for prophylaxis of COVID-19 infection.   On the same day,patient experienced a sore right arm. It was lasted for one week .  The patient also reported that her second dose of vaccine is scheduled to 13 Mar 2021.    The outcome of the event was reported as resolved on 20 Feb 2021.  No treatment information was provided .  Action taken with mRNA-1273 in response to the events was not reported.; Sender's Comments:  MOD-2021-023555:same reporter, different patient
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 nos. 031A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 11:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:27 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced 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). 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 reported as 45.23 on 13-Feb-2021 and 45.32 on 20-Mar-2021.  Concomitant products were not provided. On 13-Feb-2021, Excursion time was 09 AM, temperature was 32 total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09- Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 20-Mar-2021, Excursion time was 09 AM, 10 AM temperature was 34, 37 total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021. On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  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 Fisher brand 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.
Seven days after vaccine administration, the patient developed an erythematous macular rash on her forehead that spread caudally over the next three days and became confluent.  Rash was accompanied by fever (Tmax 102) which was responsive to ibuprofen.  No signs of infection noted.  Her twin brother, immunized the same day, has had no reaction or illness.
Patient received 1st COVID vaccine on 3/17. On 3/24, he experience pleuritic chest pain and was admitted to the hospital for pericarditis confirmed by EKG. During this hospitalization, he was incidentally found to have left main stenosis 60-70% on the LHC, requiring PCI. Patient did not have an acute MI - hence Dressler Syndrome was thought to be less likely. He was discharged after a week on 3/30/21 with colchicine and other cardioprotective medications. He received his 2nd vaccine on 4/7/21. On 4/14/21, patient was readmitted for pleuritic chest pain attributed to recurrent pericarditis.
Lot number may be EL9269. Within 30 days off balance. Gravely voice. Progressed to extreme weakness in legs and arms. Fatigue. Change is gait.
Patient in Clinic today wanting a Dose of J& J per her Dr.  Patient received 1st dose Pfizer 7/18/2021 at Clinic, 8 days later she had swelling and went to ER and was admitted for several days.  Physicians feel that she was allergic to some component(s) of  Pfizer Covid-19 vaccine, advised by Physicians not to receive another dose of either Pfizer or Moderna.  she going out of country soon needs a completed vaccine card to enter country and physician advised  her to get Johnson and Johnson .  Call placed by this nurse to SCHD Director of Preventable Health for  receive agreed she was able to get a dose of J and J 1st dose, and recommended to  pt. to follow up with personal physician about getting a J and J booster in 2 months.  1St dose J and J in left  buttock due to previous cancer issues.
quarter size round red spot at injection site; painful to touch; she can't sleep on that side due to pain; pain when raising arm; red glob; experiencing painful injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: experiencing painful injection site). On 20-MAY-2023, the patient experienced injection site erythema (Verbatim: quarter size round red spot at injection site), tenderness (Verbatim: painful to touch), pain in arm (Verbatim: she can't sleep on that side due to pain), pain upon movement (Verbatim: pain when raising arm) and erythema (Verbatim: red glob). The outcome of the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema were not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, tenderness, pain in arm, pain upon movement and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2023 The patient reported that received 2nd dose of Shingrix and experienced painful injection site with a red spot the size of a quarter at the injection site and also reported a larger area below the injection site as a big red glob which was painful to touch.  The patient said it was painful to raise arm and that she could not sleep on that side due to pain. The reporter consented to follow up.
Patient was vaccinated on 12/29/2020 and 1/19/2021, so was fully vaccinated when testing positive for COVID-19 on 9/30/21.
- Localized redness and swelling around inj (round about the diameter of a golf ball).  - Felt warm to the touch. - Did not itch or hurt.
Exposed to COVID-19 virus after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 virus after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 virus after vaccination). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 virus after vaccination) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    .
a patient who is due for the second dose of Shingrix (patient will hit the 6 month mark within the next few days),; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that the patient was due for the second dose of Shingrix and they were not sure how to proceed with completion of the series. It was likely that, due to COVID-19, the patient will receive the second dose late. This case has been linked with case US2020071754, reported for same reporter.
On Wed., July 14, my left hand started tingling. As the morning progressed, my hand and arm started feeling numb. Mid-afternoon, my left foot began feeling numb; the numbness spread up my entire leg. By the time I got home (6 pm), I needed assistance to get into the house, because my left leg wasn?t working and my foot was dragging. On Thursday July 15, I went to a local clinic; they immediately sent me to the ER. I was then transported to the ER, where I was admitted. Over the next five days I had CT scans of head, neck and spine; MRI?s of the same; a lumbar puncture; and an echocardiogram. I was given acyclovir; solumedrol; and heparin and amlodipine because my BP was elevated (180/100 Thursday afternoon). With the help of a physical therapist and a walker, I was able to get around, and my balance and stability improved, although the numbness in my arm and leg remained. At discharge, I was given a walker and an AFO brace to assist my walking. I was unable to return to work until August 4, 2021.
death Narrative: Pt received second Moderna COVID vaccine dose on 2/9/21. Pt enrolled in hospice house for end-of-life care 4/8, however, diagnosis was not available in database for enrollment in hospice. Pt's son emailed affairs to report the passing of the patient 4/11/21 with no additional details or reasoning; death has not been verified. Was pt previously covid positive? no Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? Yes, CHF potentially a contributing factor to hospice status and death Any occurrence of an ADR at time of administration or during time of observation? No Was there an ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized prior to death No What are the possible cause of death? unknown, pt enrolled in hospice services outside of the facility.
Persistent vomiting and bloody stool. Referred to ER and diagnosed with small bowel obstruction, unspecified. Admitted for observation and further management. Resolved spontaneously.
Case PHEH2016US023448 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to a 46 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN, (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
platelet count was elevated above 400; sores on roof of mouth; immediate itching & rash on arm at site of injection; immediate itching & rash on arm at site of injection; mild asthma; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 24Apr2021 at 05:00 PM (at the age of 49-years-old) as dose 2, single for COVID-19 immunization in a clinic. Medical history included known allergies to seseme seeds and codeine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID, 100 mg); ergocalciferol (VIT D); tocopherol (VIT E), multivitamins and Tuna Oil; all were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in left arm on 03Apr2021 at 05:00 PM, as dose 1, single for COVID-19 immunization. On 24Apr2021 at 5:00 PM (after second shot), patient experienced sores on roof of mouth, platelet count was elevated above 400, immediate itching & rash on arm at site of injection for 7 days, mild asthma for 24 hours. The event platelet count was elevated above 400 was Serious (Medically Significant). The patient underwent lab test which included platelet count: elevated above 400 on 24Apr2021. Patient did not receive any treatment for the events. The outcome of the events was recovered.
she has been experiencing radiating pain in the arm where the GARDASIL 9 was administered on 11-JAN-2021.; This spontaneous report was received from a nurse midwife and refers to a 42-year-old female patient. The patient's pertinent medical history included "HPV 91618". No known drug allergies was reported.      On 11-JAN-2021, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number 1687292, which has been verified to be valid, the expiration date was reported and validated as 25-AUG-2022), administered intramuscularly, as prophylaxis (reported as for prevention of other types of HPV because the patient already has "HPV 91618") (dose and anatomical site of vaccination were not provided).    On 24-MAR-2021, the patient was supposed to received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), however the patient stated that she has been experiencing radiating pain in the arm where the vaccine was administered (vaccination site pain). According to the patient the pain started on 11-JAN-2021 and has not stopped hurting since then, but she was still able to move and use her arm. Additionally, it was reported that the patient was referred to primary care provider for possible treatment. The second dose administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was postponed.  The causal relationship etween the event of vaccination site pain and the suspect vaccine was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
No details available at this time.  Reaction attributed to Anthrax shot #1 by Emergency Room Physician
Mother called 7-31-08 stating child had redness and knot of left arm and was warm to touch. Redness started yesterday. Child was not complaining with arm and does not act ill.
Received 4 y old vaccines MMR VARIVAX, DTAP-IPV on 5/5/10 on 5/7/10 parent called office 330pm. Rash on arm belly, bottom x 2 day seen in office at 430pm 5/7/10.
Started with a stiff neck with aches at about 9;00pm 12-18-2020 and it lasted about 3 hours. I woke up about 4:00am and my armpit, on the side of injection, was very itchy. I looked in the mirror and it was swollen and red lump in my armpit. I?m guessing lymph node swelling. It resolved about noon 12-19-2020.
nausea getting worse; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and NAUSEA (nausea getting worse) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011a21a) for COVID-19 vaccination.     no medical history was provided.  Concomitant products included DULOXETINE, AZILSARTAN KAMEDOXOMIL (EDARBI) and FUROSEMIDE (FUROfEMIDE) 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 01-Mar-2021, the patient experienced NAUSEA (nausea). On 09-Mar-2021, the patient experienced NAUSEA (nausea getting worse). At the time of the report, NAUSEA (nausea) and NAUSEA (nausea getting worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I feel headache; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I feel headache), MYALGIA (body ache) and PYREXIA (fever) in an adult patient of an unknown 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 HEADACHE (I feel headache), MYALGIA (body ache) and PYREXIA (fever). At the time of the report, HEADACHE (I feel headache), MYALGIA (body ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
I got a rash eight days after the vaccine. It was a rash that started on my left ankle. It spread to my legs and arms. It was itchy and blistered in  a bite like rash that was in clusters. After days I went to Urgent Care four days after the rash started because it was all over both extremities and starting to spread to my torso. I was given an oral steroid and I took Benadryl and Claritin. The rash is better after twelve days but the skin on my hands and feet where rash was are peeling. It is still slightly itchy in all the places where it was present.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Seizure-Mild, Additional Details: Patient was found unresponsive on the floor by bystanders with ? siezure like activity, this RN and RN responsed. EMS called to store and was sent to the ER.