chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few hours after injection I developed a small rash at injection site which lasted about an hour (no medications taken for it) I became extremely tired and pain spread from the injection site up to my neck and down to my elbow. I did not want to take any painkillers and continued to stretch and move my arm as much as I could. I noticed discomfort and a rash under my armpit area as well. I slept for about 12 hours and woke up feeling significantly better, but the discomfort under my arms persists. I was not sure who to contact for this as it's not an emergency. I am the caregiver for 2 elderly people and it has hindered my ability to care for them in the last 24hrs, so  I just wanted to report my symptoms for others to be aware.
Patient had episode of syncope and vomiting 30 minutes after provider administered flu vaccine.  Patient started feeling weak and went outside on deck and fainted while sitting in a chair. Patient regained consciousness quickly and had 1 episode of emesis. Aide helped patient get to bed and stated he felt fine, and hiccups, and planned to rest. Patient did not wish to seek emergency care.
Shingles; Received two doses year or so ago and diagnosed yesterday with shingles/suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 14-JUN-2014, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received two doses year or so ago and diagnosed yesterday with shingles/suspected vaccination failure) (serious criteria GSK medically significant). On 14-JUN-2023, the patient experienced shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of Shingles vaccine a year or so ago. The patient diagnosed with shingles. The patient stated that he or she tolerated very well and never regretted for getting those shots for sure. The patient reported that the vaccine do not keep you from possibly getting shingles but if you do it is much milder and leave quicker, get those shots you will not regret it. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Information has been received from a physician concerning a 69 year old female who on 01-FEB-2007 was vaccinated with a 0.5 ml dose of Zostavax. On 08-FEB-2007 the patient experienced pain and burning somewhere on her body, not at the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
On 09/13/2022 I received my Covid-19 vaccine. On 11/22/2022 I had a bad sinus infection. After reaching out to the doctor I was tested positive for Covid-19. I was prescribed BIAXIN, symptoms lasted approx. 12 days. After symptoms subsided 12/08/2022 I was re-infected with Covid on 02/28/2023. I started having sinus issues and reached out to the doctor. I tested positive for Covid-19 again and was prescribed BIAXIN. Symptoms lasted for another 2 weeks.
PATIENT REFERS THAT ON 11/25/2009 WENT TO THE ER BECAUSE SHE HAD A VAGINAL BLEEDING (SHE WAS 11 WEEK PREGNANT). HAD A SONOGRAM AND IT WAS REVEALED THAT THE BABY WAS DEAD FOR APROXIMATELY 1 WEEK AND A HALF. SHE WAS HOSPITALIZED, HAD TO DELIVER THE DEAD BABY AND A ENDOMETRIAL SCRAPING  WAS PERFORMED. THE FETUS WAS SENT TO PATHOLOGY TO DETERMINE REASON FOR DEATH. RESULTS FROM PATHOLOGY ARE PENDING.  12/02/09 Medical records received for DOS 11/27/09 Final DX: Incomplete abortion. Vaginal bleeding. Cervix open.   G3P2.  LMP 9/10/09.   12/28/2009 prenatal labs and OB-GYN records received.
Patient states that after she received her vaccine she was moving the hose to the pool and twisted.  She is unsure if her right shoulder is sore from the vaccine or moving the pool hose.  She states that it became sore after 4-5 days and moving the hose.  She called her provider and pharmacy and they instructed her to notify and use a warm compress on her arm and take advil.
SORE SPOTS/ SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore spots/ sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore spots/ sore arm was not reported. This report was non-serious.
Client's parent called. Client reports headache, tired and nauseous for the last 3-4 hours. Approximately 2.5 hours since initial injection. Client had no immediate reaction at the time of injection. Client also has pain and tenderness in right deltoid at the site of the Men B #2 (BEXSERO).
This is a spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerning a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper. One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner of the top where the rubber stopper was dented in causing a hole where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case 201804830 is cross-linked to 201804823, due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It was known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed this case as non-serious. Follow-up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
A 3rd shot was given in error, and discovered later that day when processing info. Provider at facility was informed and monitored patient closely for side affects.
dry heaves; felt tired; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RETCHING (non-serious), outcome "unknown", described as "dry heaves"; FATIGUE (non-serious), outcome "unknown", described as "felt tired". Additional information: The second dose is scheduled on 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax;approx 10 min later,fell over backwards in apparent faint;w/in sec,began moving about restlessly;BP 108/60;P=80;began crying;to er; was stiff,eyes rolled up;
Patient states she was given the vaccine and felt an immediate pain in her arm. About two hours after vaccine administration, she was unable to lift her arm to drink from a cup. The pain persisted for about 2-3 weeks. She then saw her primary care physician who prescribed her prednisone for the pain/inflammation. She states the pain in her arm has lessened but she still has pain in that arm.
Case developed lightheaded, nausea, hot/cold flashes.  Vomited, then felt better.
02/03/22 presents to ED for "Psychiatric Evaluation". PMHx of "anxiety, depression, and ADHD"
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-DEC-2014 the patient was vaccinated intramuscularly with an expired dose of RECOMBIVAX HB (therapy type was not reported, 1 ml, lot # J014312, expiration date 07-SEP-2014). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Patient a few months under 18 got the Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine). On 28-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient a few months under 18 got the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information reported.
the patient experienced a fever of 101 degrees F, along with enduration, redness and warmth at the injection site. Physician informed-no treatment ordered.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 78-year-old female patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 18th August 2018, the patient received the 2nd dose of SHINGRIX. On 18th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills and drug dose administration interval too short. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: The patient got 1st dose of SHINGRIX on 20th July 2018. The patient received 2nd dose of SHINGRIX at shorter than recommended interval, which led to shortening of vaccination schedule. The patient also experienced chills after the vaccine for the last 2 days before the date of reporting that had not resolved.
fever, fussiness, vomitting starting 7 days after Rotavirus vaccine.  Had partial sepsis workup done.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID-19 in the beginning of January and still has symptoms) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation (significant health issues). In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (got COVID-19 in the beginning of January and still has symptoms). At the time of the report, COVID-19 (got COVID-19 in the beginning of January and still has symptoms) had not resolved. Concomitant and Treatment information were not provided. Reporter did not allow further contact. Company comment: This case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID-19. The events occurred approximately 7 months after the second dose of mRNA-1273. The patient was vaccinated with two doses of mRNA-1273 however, no exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected non serious event of COVID-19. The events occurred approximately 7 months after the second dose of mRNA-1273. The patient was vaccinated with two doses of mRNA-1273 however, no exact administration dates were provided. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023; No adverse event; Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023), PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023), PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna Primary series - vaccines Expired on 28-Feb-2023, administered this vaccine on 17-Mar-2023) and PRODUCT STORAGE ERROR (vaccines Expired on 28-Feb-2023, but was not delivered to pharmacy until 07-Mar-2023, vial was initially stored in the refrigerator on 7-Mar-2023).    No concomitant drug was reported. Vial size reported as 5.5 ml. It was reported that the vial did not undergo any temperature excursions. No side effect reported. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716329, US-MODERNATX, INC.-MOD-2023-716138 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716329:Same reporter US-MODERNATX, INC.-MOD-2023-716138:Same reporter US-MODERNATX, INC.-MOD-2023-716138:
Information has been received from a pharmacist concerning a 92 year old female with sulfonamide allergy who on 29-JUN-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (lot # 656394/0162U).  On 11-JUL-2007 the patient developed blisters all over on her arms, behind her knees and on her back.  It was reported that the patient did  not have prior history of shingles.  The pharmacist referred the patient to her physician.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been received from the pharmacist who stated that the patient developed rash and she thought it as shingles.  The physician determined it was not related to vaccine.  At the time of report the patient had recovered.  No further information is expected.
"absolutely exhausted"; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ("absolutely exhausted") in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020L20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Supraventricular tachycardia, Asthma, Arthritis, Hypothyroidism, Hypertension and Hyperlipidemia. Concomitant products included METOPROLOL, PRAVASTATIN, LEVOTHYROXINE and HCTZ for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FATIGUE ("absolutely exhausted"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE ("absolutely exhausted") outcome was unknown.
Sir are immediately for 30 seconds, then around bedtime, very sore arm all night and most of Wednesday 2/3 and minor pain on 2/4 2/3 morning unsteady and queezy for 1/2 day Irritated throat 2/3 and 2/4, throat still still raw
Some of the vaccine dripped out; some of the vaccine dripped out; A spontaneous report was received from a Consumer concerning a 45 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced device connection issue and vaccine under dose.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 19 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in the left non-dominant arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient experienced vaccine dripped out. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events vaccine underdose and device connection issue was unknown.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 030M20A) with no associated AEs reported.
Information has been received from a pharmacist referring to a 69 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 09-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, lot number and expiration date were unknown) subcutaneously. On 11-SEP-2016, the patient's arm had swelled. The patient called the pharmacist to seek medical attention. Treatment was given for the event. The outcome of the event was reported as recovering. The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
sore arm; itchy spot; red rash about 1 inch above the vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy spot), VACCINATION SITE RASH (red rash about 1 inch above the vaccine site) and VACCINATION SITE PAIN (sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy spot) and VACCINATION SITE RASH (red rash about 1 inch above the vaccine site). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PRURITUS (itchy spot), VACCINATION SITE RASH (red rash about 1 inch above the vaccine site) and VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Pt recvd vax 29OCT91 & became very pale & sleepy for about 4 hrs, shortly p/getting vax; not crying; hard to wake during these 4 hrs; local swelling @ site of DTP shot; p/, happy but sleepy;
Myalgia fatigue Narrative:  missed time from work following second dose due to above effects
Body chills/shakes started when I went to bed around 11pm and stopped only after taking ibuprofen. The next morning I experienced body aches, especially in my legs and additional body chills through the afternoon until around 4:00pm. I had no fever when I checked during that time.
The patient reported getting a rash about the size of his palm on his arm near the injection site about a week or so after the vaccine. He said it is not bothersome but just wanted to verify it is a normal side effect like he read online.
"(+) Local reaction to INFANRIX vaccine in (L) thigh" (MD) Parent "(L) Leg swollen. Onset was Tues. after vaccines." Rectal temp 101.5, Tylenol given by parents (5/27/09) (MD) no obvious swelling on 5-28-09 by direct observation.
Pt recvd vax 2MAR93 & 3MAR93 7PM began crying-no reason APAP given, leg not sensitive; cried times 3 hrs; no fever @ that time; no prev reaction to DTP; MD felt reaction to pertussis;