chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic rash all over his body; This is a spontaneous report received from a contactable nurse (Parent). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EW0191), via intramuscular route of administration on 18Jun2021 at 19:00 (at the age of 12-year-old), as dose 1, single in right arm for COVID-19 immunisation. The patient's medical history was reported as none. Concomitant medications were not reported. On 21Jun2021, 2 days and 5 hours after the administration of first dose of vaccine, the patient experienced allergic rash all over body. The patient received vaccine on 18Jun2021, Friday and on 21Jun2021 night, he began to have rash, like an allergic rash all over the body. Patient never had this before and the reporter did not know if it was related to vaccine. Patient was taken to doctor at the urgent care, where he was prescribed with Prednisone 20 mg 1 tablet by mouth daily for 3 days and Benadryl 25 milligrams. Reporter attributed the events to vaccine because that was the only thing that was different since the rash broke out. Therapeutic measures were taken as a result of allergic rash all over body and no lab works were performed. Patient was due for his second dose on 09Jul2021. The clinical outcome of the event was unknown.; Sender's Comments: Based on known drug safety profile and close temporal association, the event of allergic rash is assessed as related to the product BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Metallic taste , cold sensation.  5 mins later tongue and throat swelling, face and chest hot and tingling, shortness of breath
This spontaneous report was received from a nurse refers to a 3 patients of unknown age and gender. On an unknown date the patients were vaccinated an improperly stored dose of VAQTA (dose, route of administration and lot # were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recieved first dose covid-19 vaccine of pfizer lot # EL3247 at a third party faciltiy in Jan 2021. pt did not have vaccine card and was in line to get Moderna covid 19 vaccine as a second dose. pt verbally stated that she had recieved moderna as her first dose of vaccine. While site lead was checking her shot record histroy with the thrid party facility the pt was given moderna covid 19 vaccine lot number 002a21a in her Right deltoid at 2:44pm on 3/24/2021. pt was monitored at facility for minium of 30 mins and after notifiying facility medical staff was sent home with moderna vaccine fact sheet and insturcutions to seek medical attention if needed. pt was informed not to recieve any other doses of Covid-19.
Moderna covid-19 vaccine EUA On day 8 I had a red rash appear near the injection site, it was hard/lump underneath the redness which was about the size of a quarter/half dollar. It was slightly itchy.  I am reporting this on day 9 and it got a little larger in size but is not raised as much or as hard underneath the redness.
patient not receiving the full dose of FLUZONE HIGH DOSE QIV due to the vaccine leaking out with no reported adverse event; Initial information received on 19-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 73 years old female patient who did not received the full dose of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] due to the vaccine leaking out with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Sep-2022, the patient received 0.5 ml  dose of suspect influenza quadrival A-B high dose HV vaccine (strength and formulation not reported) (lot UJ900AA; Expiry Date 30-Jun-2023) via intramuscular route in Right deltoid administration site for prophylactic vaccination.  On 19-Sep-2022 the patient did not received the full dose of influenza quadrival A-B high dose HV vaccine due to the vaccine leaking out with no reported adverse event (incorrect dose administered). It was stated that she attached the needle to the pre-filled syringe and when she went to immunize the patient the vaccine started leaking out of the prefilled syringe and she does not know how much of the vaccine actually went into the patient. It was asked if patient needs to be revaccinated or if she can give the rest of the vaccine left in the pre-filled syringe. Patient was still in the office and was able to get a full dose of the vaccine and she doesn't see any damage to the syringe and states the needle was attached properly, the syringe itself was leaking out the vaccine.  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Tingling fingers 20 minutes after immunization in same arm which lasted about 5 minutes.  Developed chills during night.  Didn't temperature.
Swollen lymph nodes in armpit on the side with the shot. This happened last time I had the shot, on the other arm/matching lymph nodes. I also had a hypertension headache. The back and top of my head hurt. This did not happen last time.
Since receiving the shot, I have now been diagnosed with allergic contact dermatitis to 10 allergens as well as been constantly itchy , had numerous photosensitivity reactions to the sun, scratching constantly, and drug rash allergies (eg CIPRO). I only had type IV reactions to poison ivy prior to the COVID shot and it seems my dermatitis got progressively worse since I received the shot. I have been told I now have an overactive immune system and COVID and/or the vaccine may have played a role (but there is no test to prove it). I am reporting  as it is a concern that this vaccine and/or COVID has sent my immune system into overdrive to the point I have not been placed on Cyclosporine with the hopes of it calming down and begin managing these type IV allergic contact dermatitis allergies without the help of an injectable medication.
Pt was given a dose of Tdap (Boostrix) instead of Dtap.  Pt's mother notified on 8/5/08.
Vaccine was given at 0745, around 1630 started feeling achy, tired, arm soreness. Around 1800, spiked a 102.5 fever, chills, nausea, severe back pain, generalized weakness, fatigue. Took acetaminophen for fever, only came down to 100.2 at the lowest, remained around 101.5 for remainder of day. The next day 2/12 fever, chills, nausea, back pain persisted. Temp max was 101.7 after multiple doses of Acetaminophen. 3/13 fever down to 99.5, aches, nausea and arm pain remained.
Patient developed a facial palsy on right side that started on or around 12/23/2008.  Patient was evaluated for Lyme which was negative.  No other cause determined.
Patient received vaccine at our pharmacy on Monday afternoon and later that evening she sent to the ER complaining of a burning sensation in her lower back. She was given a prescription for Benadryl and came to the pharmacy Tuesday morning to get filled. Had no complaints of the burning sensation at that time.
Vet received covid 19 booster 10/05/21, received flu vaccine 10/07/21 and began to experience diarrhea and the "sniffles".  On 10/14/21 Vet had rash on neck, chest, back, extending down thighs and scrotal area. Vet went to ER 10/28/21 for continued rash, was diagnosed with allergic contact dermatitis, unspecified cause (L23.9) and pruritus, unspecified (L29.9) and received 125mg IM injection methylprednisonlone while in the ER. Vet was prescribed Dosepak as an outpatient, hydroxyzine 25mg by mouth every 6 hours as needed, Zyrtec 10mg by mouth daily and to continue Famotidine as prior (per ER provider). Vet was also prescribed Trazodone cream to apply as needed.
Patient presenting with acute onset intractable nausea and vomiting.  She reports habitual THC use.  She was treated with IV fluids and antiemetics.  Her nausea and vomiting subsided and she is tolerating now a general diet.  She is discharged to home in stable condition. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a nurse practitioner (NP) concerning an adult male scientist who was vaccinated with the first dose of Varivax. Illness at the time of vaccination included a rash. The NP reported that, a few days after being vaccinated, the patient developed varicella-like rash. Unspecified medical attention was sought. It was subsequently determined that the patient's rash was not varicella. The patient's rash subsequently resolved. Additional information is not expected.
chills, entire right arm sore, swollen/painful lymph nodes in right axillary, fatigue, stuffy nose
KINRIX and MMRV in (L) arm. Antibiotic treated, for 10 days.
Dermatomyositis like illness- now chronic - rash, urticaria like, intermittent muscle selling pain, itching.
After the 2nd booster patient started feeling unwell; Achy/Achy basically; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (After the 2nd booster patient started feeling unwell), PAIN (Achy/Achy basically) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 051F21A, 043LC0A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID 19 a couple months ago.) in February 2022. Concurrent medical conditions included Drug allergy (minocycline tetracycline) and Drug allergy (Procainamide).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2022, the patient experienced PAIN (Achy/Achy basically) and CHILLS (chills). On an unknown date, the patient experienced MALAISE (After the 2nd booster patient started feeling unwell). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse reaction, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, MALAISE (After the 2nd booster patient started feeling unwell), PAIN (Achy/Achy basically) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test positive: positive (Positive) Positive.         No concomitant medications was reported. No chronic illnesses medical history was reported relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to moderna COVID-19 vaccine included whopping cough shot. Patient had not experienced the similar events with previous 3 shots and not in past.   This case was linked to MOD-2022-535513 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2022: Follow up received contains no new clinical information.
Information has been received from a physician concerning either 15 or 16 years old male patient who on an unspecified date was vaccinated with a dose of VAQTA (Lot # not reported). On an unspecified date the patient had progressive weakness, some muscle weakness and difficulty walking over couple days and had to be admitted to the emergency room and the hospital. The outcome was not reported. No further details were provided. Additional information has been requested.
Patient came in to get first Pfizer Vaccine of the series. Within one minute Patient stated he was not feeling well. Went to take Patient blood pressure and he passed out for 30 seconds then came to, and was able to answer questions. Blood pressure was about 130/112. EMS was called and responded within 4 minutes. EMS lied patient down, retook blood pressure and it was low. They started a central line on scene and transported to hospital.
Full body hives with increased  redness at injection site. 50mg benadryl taken- hives resolved, except  for area at injection  site.  1-2 inch circular, red, raised rash at injection site which lasted approximately  48 hours.
pt devel fever to 105 (tympanic) during the noc p/the vax & the following morning;had a brief episode of crying;
Information has been received from a nurse concerning a 25 year old female with no drug allergy who on 09-JAN-2009 was vaccinated with the first dose of GARDASIL (661531/1311X), 0.5 ml. Concomitant therapy included DEPO-PROVERA. The nurse indicated that the GARDASIL may have been administered as a subcutaneous injection. Subsequently the patient experienced bruising at the site of GARDASIL administered. The patient did not perform lab diagnostics study. At time of the report the patient was recovered. The patient called the practice. Additional information has been requested.
Patient experienced chest pains for 4 days, 1 day after receiving the COVID-19 booster.; This is a spontaneous report from a non-contactable reporter (physician).  A 14-year-old male patient received bnt162b2 (BNT162B2), administration date 10Jan2022 (Lot number: unknown) at the age of 14 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: unknown; Route of administration: unspecified), administration date: an unknown date in Jun2021, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: unknown; Route of administration: unspecified), administration date: an unknown date in May2021, for COVID-19 immunisation.  The following information was reported: CHEST PAIN (non-serious) with onset 11Jan2022, outcome "recovered" (15Jan2022), described as "Patient experienced chest pains for 4 days, 1 day after receiving the COVID-19 booster". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain.   Additional Information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. The patient's ECGs revealed no heart abnormalities. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
still feel weak/have no energy; how long can I expect the extreme fatigue to last; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (still feel weak/have no energy) and FATIGUE (how long can I expect the extreme fatigue to last) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (still feel weak/have no energy) and FATIGUE (how long can I expect the extreme fatigue to last). At the time of the report, ASTHENIA (still feel weak/have no energy) and FATIGUE (how long can I expect the extreme fatigue to last) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.
Site: Swelling at Injection Site-Mild, Systemic: Seizure-Medium
1 day before second dose, a light rash appeared behind left ear, itchy, slightly burning sensation, tiny pustules, applied 70% alcohol, got relief, condition mild and improving greatly,
7x7cm edematous, erythematous area over vaccination site-warm/tender to touch
Prolonged diarrhea post rotavirus (Cdiff).  Found out he has hypogammaglobulinemia after getting. 9/16/08-records received-presented to ED on 5/22/08- with C/O fever, temp 101. assessment:Acute febrile illness. Presented to ED on 7/25/08 with C/O ear infection fever, vomiting, cough and diarrhea. Admitted 7/29-7/31/08 DC DX: acute gastroenteritis with dehydration. Hypogammaglobulinemia. Clostridium difficile toxin resolved. Presented to ED with 3 week history of diarrhea.
Large itchy rash on vaccinated arm appearing 8 days after vaccine.  Went away after 2 days.  Benadryl taken
Shortly after receiving immunization (5-10 mins) infant was taken to NA by mother due to tremoring all over. This nurse was then called to situation. Tremoring lasted 1-2 minutes at most. No loss of consciousness, or any other problems notes. This nurse alerted in house MD, Dr who looked at infant, and voiced no concern. Immediately after tremoring infant was still and began drinking from bottle. Mother stated that infant sometimes does this but she was just startled since he just had shots. Has had no previous problems with immunizations. Encouraged mother to stay full 20 minutes and if no problems then ok to go. Mother in clinic today to discuss 10/03/06 and immuns. Says later that pm child had temp, and broke out in rash over trunk and at injection site. Took to FNP and said don't think vaccines were the cause, but wanted child to have brain scan. Encouraged compliance with all PCP orders, and get ok with PCP before receiving anymore immunizations.
This initial spontaneous report was received from a pharmacist via a company representative referring to an unspecified amount of patients of unknown age and gender. On unspecified dates, the patients received ZOSTAVAX (lot # not provided). The pharmacist reported that unspecified patients had brain damage after receiving ZOSTAVAX. The outcome was unknown. Causality was not provided. Upon internal review, brain damage was considered medically significant. Additional information has been requested.
Redness and swelling to L upper arm.  Swelling size of a nickel and redness the size of a small egg, slightly warm to touch.
A couple of weeks after the vaccine, I noticed swelling in my knees, left knee promotively than the right knee. It was very painful. I used ice and knee wraps to help. I had my second dose of Pfizer, my knees swelled even more. The swelling eventually went down. I was walking and doing fine. I had my third dose of Pfizer and my knees started swelling up again. I got chills, rigors, and my blood pressure went up. I had a hard time walking. The swelling eventually went down. I seen a Rheumatologist in March and was ordered lab tests. I am in the process of seeing a different Rheumatologist due to that one being backed up on appts. I got my fourth dose of Pfizer and my legs are swollen again. My left foot does have steel in it.
12 hours after shot, every place my arthritis is diagnosed, I had pain and likely inflammation.
Expired Havrix given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 11th July 2022, the patient received Havrix. On 11th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Jul-2022 Reporter's comment: The lab tech reported that a patient received a dose of Havrix which was already expired on 24th May 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Patient reports receiving high dose flu vaccine 10/4/2017 approximate time 11:00 AM. Patient reports arm was sore tight achy throughout day which is not uncommon. Patient reports waking 10/5/2017 at 5:00 AM and middle digit on left hand was numb and tingling.  Patient states by 10/6/2017 all four digits excluding her pinky finger have become numb. Patient reports she has not regained feeling in her fingers since administration of high dose flu vaccine. Patient states deltoid muscle is no longer achy however she still is experiencing pain in her left forearm.
Pt reports nervousness PTA. After receiving vaccine, pt reported dizziness and feeling "worried from reading reportable side effects sheet." Pt reported eating breakfast this AM. Denies LOC. No s/s of distress noted. Pt offered water and snack at time of arrival to med obs #1, declined. Pt states, "I feel better lying down." Pt ambulatory independently at time of arrival and discharge to home. Provided cold water prior to d/c. Refused w/c, escorted to exit with staff. VSS. VS are as follows: 1000: BP 119/80, HR 81, RR 20, O2 sat 99% on RA 1008: BP 125/81, HR 67, RR 18, O2 sat 96% on RA 1010: BP 110/74, HR 68, RR 18, O2 sat 97% on RA
Pt started to feel hot and nauseous about 5 minutes after injection.  Pt said her stomach 'hurt really bad' and started to vomit a few minutes later.  After several minutes, pt started to pass out, so moved her to the floor for safety.  Several minutes after that, pt started to feel better. Soon after she was sitting up, and later, able to tolerate an orange juice, then leave on her own.