chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea after her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea after her 1st dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D [VITAMIN D NOS] for Blood pressure abnormal.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced NAUSEA (nausea after her 1st dose). At the time of the report, NAUSEA (nausea after her 1st dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drug included Pepto Bismol.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient took 2nd dose of Moderna COVID-19 vaccine on 29 Apr 2021 in her left non dominant upper arm.   This case was linked to MOD-2021-118782 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Batch number was added. Concomitant drugs were added.
Vials were initially stored in the fridge on 08-Jul-2022 and administered on 10-Aug-2022; HCP was not aware of any symptoms for any patient after the vaccine was given; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (HCP was not aware of any symptoms for any patient after the vaccine was given) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vials were initially stored in the fridge on 08-Jul-2022 and administered on 10-Aug-2022).    No concomitant medications were reported. HCP was not aware of any symptoms for any patient after the vaccine was given. It was reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.
Patient came to pharmacy on 6/20/2018 and reported side effects associated with SHINGRIX vaccination (1st dose) administered on 5/19/2018. Patient complained of rash (10 inches diameter) at the site of injection, itching, fever, body ache and swollen throat that required physician visit.
Since receiving the second and third shots, i have experienced extreme changes in my menstrual cycle; severe cramping, extreme fatigue, bleeding lasting longer than 2 weeks (at times, lasting 32 days).
Reported metallic taste in mouth that lasted about 60 minutes. Slightly improved after drinking water. Had been wearing N-95 mask for duration of appointment, approx. 80 minutes with observation time. Denies any signs of anaphylaxis.
Shot administered on Tuesday October 17 in the lobby of the facility. On Wednesday I had a burning on the underside of my left arm. This continued until Friday night when I developed severe pain in my shoulder and left arm.  On Saturday I developed a large patch of bubbles where the shot was administered. The pain has increased and is very hard to tolerate. This is written Sunday morning October 23 and I am waiting to get into a facility...might be hard on Sunday.
Per, mother felt, pt developed fever of 102 F, axillary, Thursday evening. He received vaccines the day before. She gave him 1500 mg ibuprofen and fever began to decrease with 3 hrs. He was afebrile by Friday. She notified her MD and made appt but did not take him in because fever resolved. I followed up with M.D. to let them know the family was refusing to keep appt because fever resolved. Mother did not notify me until Mday. Vis sheets and signs of reaction education provided to parent after vaccine given.
Patient's mom asked for Moderna vaccine.  Moderna vaccine was given to a 16 years old patient by mistake.
Had large, blistered area from right buttocks and up right side. MD contacted me today and states area seems to be varicella zoster. Viral and bacterial culture were obtained.
After the 2nd shot on 10/15, I had a bad headache on 10/16 and 10/17. On 10/17 my arm had red blotches going down to my elbow underneath the injection site and hurt like bad bruises.
Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid-19) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes Diabetes medicines treatment information includes Infusion of bam
Pt presented with numbness feeling in arm and leg on both sides of body. She is also experiencing pain in all extremities (since the shot.)  2/6/09 Received PCP office records of 11/11/2008. FINAL DX: numbness in extremities, depression Records reveal patient experienced UE & LEs numbness since 10/29/08.  Right arm pain into hand. Pt referred for counseling & was to return should symptoms persist.  No further records available.
Redness, swelling, itchiness at site of injection (L deltoid) and distally to L medial elbow.
Cellulitis-itchy swollen red hot injection site reaction. Saw MD for amoxicillin therapy.
got shingles; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got shingles) (serious criteria GSK medically significant) and 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The reporter said why did every person he/ she talk to says that they had shingles, got vaccinated against it. The reporter asked if it sound familiar. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
He got the senior flu shot 9/22/11, had general aches, fever about 3 hrs later. Next am - still felt tired, poor appetite, felt dizzy after reaching up to get something out of cupboard before eating, had syncope. On only OTC vitamins, etc. Minor cut to head.
twitching in her left lower eye lid; twitching in her left lower eye lid/ she had her eye-lids twitch or spasm before but not for this long; This is a spontaneous report received from a contactable consumer (patient). A 51-year-old female patient received BTN162B2 (PFIZER-BIONTECH COVID-19 vaccine, lot number not provided), via unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history included eye-lids twitch or spasm (she had her eye-lids twitch or spasm before) from unspecified date. The patient's concomitant medications were not reported. Patient stated that she was having a side effect after receiving the first dose of the Pfizer COVID-19 vaccine on 03Feb2021. She stated that she was experiencing twitching in her left lower eye lid. She stated that at first it was mostly at night, however, it was also happening during the day. She described it as pretty constant and annoying. She stated, she had her eye-lids twitch or spasm before but not for this long and the only thing she had done differently was get the COVID vaccine. The patient wanted to know if this was a commonly reported side effect. Patient wanted to know if she should get the second dose of the Pfizer COVID-19 vaccine since she had this reaction to the first dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
On 5/11/00, the pt broke out with whelps on face, abdomen. No temp was noted. Mom took pt to PMD and was told to give pt Benadryl. The MD told MOM that he didn't think it was due to the MMR. Whelps are on face, upper abdomen. Face is reddened.
Patients daughter (also a physician) stated by 7 PM of the night of the vaccine that she was unable to walk. Normally patient uses walker but had to use wheelchair. She had lower extremities were shaking. She fell in a deep sleep around 10 PM and was sweating. No fever present. Physician daughter started her on a MEDROL dose pack on 9/23 and symptoms resolved around 9 PM.
administration of expired Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 03-JUN-2023, the patient received Twinrix. On 03-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administration of expired Twinrix). The outcome of the expired vaccine used 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: 05-JUN-2023 Pharmacist reported administration of expired Twinrix to a patient. Patient received a dose of Twinrix on June 03, 2023 which was expired on May 20 2023, which led to expired vaccine used. The reporter consented to follow up.
Dizziness during 15 minute waiting period. Felt better and went home. VS 126/83, HR 82, RR 18, O2 Sat  97%
About a week after the first vaccination and one day after the second vaccination I developed a red rash on my arm adjacent to the injection site.  With the second shot the area is very warm, swollen, and tender to touch.  The first time there was very little pain or itching.  The second is more uncomfortable.
It was reported that a 42 year old male received Fluzone SV '98-'99 USP on 10/23/1998. Reportedly, on 10/31/1998, the pt experienced "focal erythema, edema left deltoid to elbow and arthralgias, progressively worsening. Treated with prednisone which has reduced symptoms but not cleared up." From additional information received on 11/20/98, the pt's information and additional vaccination information was given.
"Pt felt flushed, difficulty swallowing- similar to sx from allergic reactions in the past. no sob. no angioedema" -- from ER report  pt called 9-1-1, given IV benadryl and sub-q Epinephrine en route to hospital. Treated at ER. Pt given Pepcid 20m IV and Solu-medrol 40mg IV x1 in ER. Stable and discharged home on 9/22/14 at approx 15:31
COVID-19 prior to Paxlovid treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 prior to Paxlovid treatment) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Penicillin since an unknown date. Past adverse reactions to the above products included Allergy with Penicillin. Concomitant products included ALLOPURINOL for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 prior to Paxlovid treatment) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient previously received a COVID-19 Vaccine. It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Device Date : 29-May-2022.  Company Comment: This spontaneous case concerns a 51-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for Covid-19. After the treatment with Paxlovid patient had rebound covid symptoms and was tested positive for covid-19 as on 29-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving the third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid for COVID-19. After the treatment with Paxlovid patient had rebound covid symptoms and was tested positive for covid-19 as on 29-May-2022. The current pandemic situation of COVID-19 may remain as confounder to the event COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In 2018, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient developed flu like symptoms after her first SHINGRIX dose. This case has been linked with case US2018136199, US201813203 and US20181362015, reported by the same reporter.
Extreme headache about 12 hours after. Took Ibuprofen and it went away. Day 2 and headache is gone.
Extreme sharp throbbing pain in left arm at injection site. Unable to move top half of my arm without stabbing pain. .Have to keep my arm straight at my side. I can bend at the elbow, as long as I don't move upper arm. Soreness from wrist to neck and shoulder. I first noticed the pain and stiffness about 5 hours after shot, and then it increased and was extremely painful and I was unable to sleep lying down. Had to sit up in a recliner most of the night. Arm continues to have sharp , stabbing,  throbbing pain 24 hours later
Patient was sent to the ED from the nursing home for hypoxemia.  Patient was admitted to the hospital with pneumonia due to Covid and treated with remdesivir.
Called the CDC and discussed a vaccine being given outside of the suggested age range. CDC states: "MMRV vaccine is approved by FDA only through age 12, but a dose accidentally given to an older child should still be effective and safe - if there are no contraindications to either MMR or varicella vaccine. As long as the dose was not given within 28 days after another injected live vaccine it may be counted as valid." "The approved age range for MMRV is based on the ages of subjects studied during the manufacturer's pre-licensure clinical trials. It is not meant to imply that a dose given outside that range is unsafe or ineffective"  Contacted parent of the pt and discussed the above information. parent not concerned and did not have any questions at this time.
This case was reported by a physician and described the occurrence of elevated serum glutamate pyruvate transaminase in a 36 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  The patient's medical history includes asthma.  On 09/10/2003 the patient received a dose of Twinrix (dose number one and lot number HAB239A4).  One year later, in September 2004, the patient experienced elevated serum glutamate pyruvate transaminase.  This case was assessed as medically serious by GSK.  the outcome of the event is unknown.
A report has been received from a Pharmacist concerning a patient of unknown age and gender. On unknown date, the patient had received FLUMIST QUADRIVALENT (intranasal). The patient received double FLUMIST at one time. The outcome of the event of two patients received double FLUMIST at one time was unknown. The report was considered to be non-serious by reporter.
heart was fine before 5th vaccine, going to gym exercising, very active after vaccine   shortness of breath  exhaustion, depression
Itching at the injection site/Injection site pain/swelling/redness/itchy; pain at the injection site/Injection site pain/swelling/redness/itchy; Swelling at the injection site/Injection site pain/swelling/redness/itchy; Redness at the injection site/Injection site pain/swelling/redness/itchy; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE PAIN (pain at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE SWELLING (Swelling at the injection site/Injection site pain/swelling/redness/itchy) and VACCINATION SITE ERYTHEMA (Redness at the injection site/Injection site pain/swelling/redness/itchy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE PAIN (pain at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE SWELLING (Swelling at the injection site/Injection site pain/swelling/redness/itchy) and VACCINATION SITE ERYTHEMA (Redness at the injection site/Injection site pain/swelling/redness/itchy). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE PAIN (pain at the injection site/Injection site pain/swelling/redness/itchy), VACCINATION SITE SWELLING (Swelling at the injection site/Injection site pain/swelling/redness/itchy) and VACCINATION SITE ERYTHEMA (Redness at the injection site/Injection site pain/swelling/redness/itchy) outcome was unknown.        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.   Treatment drugs were not provided concomitant drugs were not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Completed ADR Form
Within one day of getting flu vaccine a rash started on the torso which caused itching and then started spreading over the whole body. The severe itching and scratching has caused sores and scabs, this has been going on for almost 3 months now.
All covid vaccinations caused pain with Humira; Low energy; Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All covid vaccinations caused pain with Humira), ASTHENIA (Low energy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid Arthritis).   On 14-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 15-Mar-2020, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period)). On 17-Mar-2022, the patient experienced ASTHENIA (Low energy). On an unknown date, the patient experienced PAIN (All covid vaccinations caused pain with Humira). At the time of the report, PAIN (All covid vaccinations caused pain with Humira) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (dose 1 and dose 2 not in window period)) outcome was unknown and ASTHENIA (Low energy) was resolving. No concomitant medication were reported. No treatment drug were reported. This case was linked to MOD-2022-588245, MOD-2022-588180 (Patient Link).