chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; Documented hypersensitivity to administered product; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included egg allergy.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced rash and documented hypersensitivity to administered product. On an unknown date, the outcome of the rash and documented hypersensitivity to administered product were unknown.   It was unknown if the reporter considered the rash to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got rash after vaccination in the past because she had an egg allergy. The reporter stated that the type or brand of flu vaccine was unknown and she does not have further details available. The reporter consented to follow up
Within 20 mins of taking the shot, the patient complained of itch at injection site, slightly red - so we removed BAND-AID and cleaned area and patient stated it was better. Patient woke up this morning, covered in a rash from head to toe (BUE, BLE, Torso) Rash is reddened, and patient complains of itching. Mom states BENADRYL was given this morning. Shortness of Breath and difficulty breathing were both denied.
Took the vaccine and got shingles/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: This case was reported by a patient's son/daughter via interactive digital media. The patient received a dose of Shingles vaccine and got shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
pt recvd vax & a liver biopsy determined that had Hep B; No further details were provided;
HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA; HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa. Concomitant products included DOXYCYCLINE for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA). At the time of the report, HIDRADENITIS (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) and CONDITION AGGRAVATED (HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of HIDRADENITIS SUPPURATIVA FLARE UPS IN GROIN AREA was not provided.  No treatment medication information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Live-Significant Follow up-Moderna vaccine first dose date was updated, Event outcome was updated.
About six hours after receiving the vaccine I felt fatigued. Two days after receiving the shot I began having symptoms in addition to extreme fatigue, including nausea, low fever, headache, and muscle aches. Now it is 11 full days after the vaccine and symptoms have not abated at all. The doctor ordered a Covid test and blood work. They also prescribed zofran and meclazine which have not helped. It has been difficult trying to advocate for myself without coming across as an anti-vaxxer or conspiracy theorist. I wish doctors would believe me when I say this is caused by the vaccine. I am not an anti-vaxxer and was enthusiastic about getting the vaccine, but now I am frightened by my body's reaction to it.
I started to get severe headaches, burning sensation in my ears, nausea, disoriented. It went away for a couple weeks, and has started back.
pain in the groing ("female area she said") area just inmediately after the shot; "tea bag" under her left eye; "legs discomfort" (below the knees); feets burning during the nigth and frozen during daylight.; pain on both knees "my knees ick"; lower back pain; left eye pain like"zzuuu"; dizziness at times ready to vertigo; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot) and EYE INFLAMMATION ("tea bag" under her left eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Groin hernia.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), EYE INFLAMMATION ("tea bag" under her left eye), LIMB DISCOMFORT ("legs discomfort" (below the knees)), BURNING FEET SYNDROME (feets burning during the nigth and frozen during daylight.) and ARTHRALGIA (pain on both knees "my knees ick"). On 20-Aug-2021, the patient experienced GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot). At the time of the report, BACK PAIN (lower back pain), EYE PAIN (left eye pain like"zzuuu"), DIZZINESS (dizziness at times ready to vertigo), GROIN PAIN (pain in the groing ("female area she said") area just inmediately after the shot), LIMB DISCOMFORT ("legs discomfort" (below the knees)), BURNING FEET SYNDROME (feets burning during the nigth and frozen during daylight.) and ARTHRALGIA (pain on both knees "my knees ick") had not resolved and EYE INFLAMMATION ("tea bag" under her left eye) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Significant Follow up received on 15-SEP-2021: Batch# updated and patient name spelling corrected. On 19-Sep-2021: Significant follow up: Patient History Information added. Newevents added. Events missed from the initial version added. Outcome updated to not recovered/not resolved.
Sudden headache, nausea, then itching all over, rash on chest then stomach.  Swollen and redness like golf ball size at and around site the next morning.  Still itching the next morning after taking Benadryl and Tylenol every 4 hours as suggested by physician.
Case number PHEH2014US018201, is an initial spontaneous report from a pharmacist received on 09 Sep 2014. This report refers to a 46-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN, (batch number: 145205) intramuscularly at a dose of 0.5 ml on 04 Sep 2014. It was reported that the FLUVIRIN received by her was stored at 49 F for two hours. No adverse event was reported following the medication errors (incorrect storage of drug).
Diarrhea; cramping; injection site sore; lost weight, she was usually 140 pounds but she had lost 04 pounds down to 136 over the last week; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3248 and Expiration date was not reported) via an unspecified route of administration on 14Jan2021 at 10:00 AM  (patient age at time of the vaccination was 67 years) in the left arm as a single dose for COVID-19 immunisation. Patient medical history included atrial fib and stomach problems. Family medical history was reported as none. The patient concomitant medication included acetylsalicylic acid (ASPIRIN) at dose of 325 mg, once daily by mouth from taking for years to ongoing for atrial fib. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021, the patient had diarrhea and cramping and it was persisted. The patient also experienced injection site a little sore on same date but that went away. She also lost weight, she was usually 140 pounds but she had lost 04 pounds down to 136 over the last week since the 15Jan2021. The patient visited to physician/emergency room for diarrhea. The patient was not hospitalized for the event diarrhea. The patient was unsure if diarrhea was related to stomach problems because two years ago she had stomach problems. Added she has not been able to go back to work since she started having diarrhea. The patient underwent lab tests and procedures for investigation which included: Covid Test: Negative on 20Jan2021, C difficile: Negative, E coli: Negative on 25Jan2021. The patient mentioned she had stool cultures that were still pending. She was scheduled for the second dose of the vaccine 05Feb2021. The outcome of the events diarrhea, cramping and weight loss was not recovered. The outcome of the event injection site sore was recovered on 19Jan2021.  Follow-up attempts are completed. No further information is expected.
Pt developed a short, generalized seizure lasting approximately 15 seconds on 9/17/01.
A few hrs after I rec'd the flu vaccine, I was fatigued, sleepy. Went to bed about 10pm. Began to ache all over. No headache. Got worse. Could not sleep. Took Tylenol 500 mg and Benadryl 50 mg. No sleep all night. Got up about 7am. Made coffee. Realized I had no taste or smell when I tried to drink the coffee. Slightly nauseated. No congestion. No appetite. Exhausted. Took another Tylenol 500 mg and Benadryl and just sat on the couch. Exhausted and achey. Took another Tylenol 500 mg and Benadryl and went to bed about 2pm. Woke up, took temperature: 100 degrees F. Back to sleep. Got up about 6pm. Still exhausted, achey. Fed my dogs. Went back to bed about 8pm. Woke up about 10:30pm and felt perfectly normal. No temp, no aches. Taste/smell gradually returned the next day, but no other symptoms. Got Covid test on Oct 8, 2020. Results: Negative. Still feeling well. Got Covid test for documentation and to R/O Covid.
HYPOTENSION 5/5/2022 COLITIS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/5/2022 COLITIS  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/17/2022 COLITIS  HYPOTENSION 5/5/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/5/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/17/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Information has been received from a nurse practitioner concerning her approximately 30 month old grandson with a little autism prior to receiving the vaccination who on an unspecified date was vaccinated with a dose of MMR II. It was reported that the patient's autism accelerated. The outcome was unknown. It was not specified if the patient sought medical attention or not. Upon internal review, the autism accelerated was considered to be other important medical event. Additional information has been requested.
Began to experience widespread body rash (hives), which would come and go with varying degrees of discomfort the last week in December. The rash was so severe the night of December 31st, that on January 1st I went to the ER. Ever since it has lingered, and without extensive use of various antihistamines it's very unsightly and makes it difficult to sleep. Appears everywhere on my body, including the tops and bottoms of my feet, my head and face, my hands, torso, arms, etc. Seen by 3 medical professionals, 1 PA and 2 Dermatologists. Each of them disagreed on the cause and treatment, only one acknowledged the possibility it may have been due to my booster. But there's nothing else I can think of that could be causing this. I am not using any new laundry detergent, shampoo, had any extensive contact with pets, or anything else. The only thing that makes sense in my opinion is that it's from my booster. I don't regret getting the shot but I want to report it so other people who suffer from my symptoms may also be helped.
Large light pink rash, about 6 inches in diameter, around injection site on left arm. Not itchy currently, showed up about 11 days after vaccination.
Patient got this at another location and then reported a skin reaction to PCP. her arm became red and warm one day after the vaccine. They became itchy and painful in the following days. looks like Covid arm but is not with Moderna.
?Covid Toes? Red bumps that are tender and itchy on 5 of 10 toes that slowly progressed over the course of multiple weeks
Tingling in face. My face got hot, red & flush. My ears turned red too. Came on about 20 minutes after the vaccine, and lasted about an hour.
Left arm swelled up; left arm swelled up into a knot for two days and was painful; Left arm swelled up into a knot; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date and did fine).   On 25th August 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site swelling, injection site lump and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were recovering/resolving and the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site lump and injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-Sep-2022 Reporter's comments: The patient self-reported this case. The patient volunteered 2nd dose received in left arm swelled up into a knot for two days and was painful. Patient said after two days pain and swelling subsided. The lot number and expiration date were unknown. The reporter did not agree to follow up from GSK.
Patient's mom stated the approximately one hour after he received the (Dtap) shot, he had heavy breathing, appeared tired and pale.  She took him to hospital and during a nebulizer treatment, he coughed once and then stopped breathing.  He was intubated and transferred to another hospital by helicopter.  There he was treated and was in the ICU for 2 days.  He was then transferred to the children's floor for 2 days and then released on 5-22-2004.  Mom states that he recovered except that he continues to have mild cold symptoms. He has an appointment to see an allergist on 6-3-2004.    Nurse follow up on 07/27/04 states: "tachycardia; Rash; Consolidation RUL."  Nurse follow up on 07/27/04 states: "allergic reaction."
PATIENT DEVELOPED LIP SWELLING, PERIORBITAL SWELLING, AND HIVES  AFTER ARRIVING AT HOME FROM THE DOCTORS OFFICE.  WAS TAKEN TO THE EMERGENCY ROOM WHERE EPINEPHRINE, ZANTAC, BENADRYL AND PREDNISONE WERE GIVEN.  PATIENT RECOVERED QUICKLY.
tinnitus; dizziness; influenza 14Sep2022; influenza 14Sep2022; The initial case was missing the following minimum criteria. Upon receipt of follow-up information on 22Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (005570). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), 0.3 ml single (Lot number: GJ25201) at the age of 57 years intramuscular for covid-19 immunisation; influenza vaccine inact split 4v (QUADRIVALENT INFLUENZA VACCINE), on 14Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose 1; Manufacturer Unknown), administration date: 28Dec2020, when the patient was 55-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 14Sep2022, outcome "unknown" and all described as "influenza 14Sep2022"; DIZZINESS (non-serious) with onset 14Sep2022 at 15:22, outcome "not recovered"; TINNITUS (non-serious) with onset 14Sep2022 at 15:22, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus, dizziness.  Additional Information:The tinnitus resulting after immunization was accompanied by dizziness. Both influenced with sleep and balance and balance for 3-5 days. Enough that patient felt responsible to report as a health professional. Drug or alcohol abuse: No, Drug allergies: No, Family history: No.  Tinnitus and Dizziness Causal Relationship: there a reasonable possibility that the event is related to suspect product/s.
Patient developed diarrhea leading to hypovolemic shock.  I dates that I have entered are only a guess.  Two physicians caring for the patient strongly felt that there was a correlation to the patient receiving a high dose flu vaccine approximately a week prior to admission.
Patient complained to mother that his mouth was itching. He then started to wheeze with SOB then became flushed and had one hive on chest. He tolerated BENADRYL, albuterol neb, and ORAPRED well with resolution of his symptoms. I have added varicella to his allergy list. Recommend another dose of BENADRYL in 4-6 hours then as needed. Recommend a second dose of ORAPRED tomorrow but not beyond that.
Tested NAAT positive for COVID 11/4/21 after being fully vaccinated.
pt has been exp tinnitus p/vax OCT95 & sx is ongoing;this was reported by MD:pt has not yet recovered from tinnitus;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-JAN-2015, the patient was vaccinated with a dose of expired VARIVAX (Merck) (dose: 0.5 ml, route subcutaneous, expiration date 07-JAN-2015, lot number not reported). No adverse effects were reported. No product quality complaint was filed. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider/physician recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, the healthcare provider/physician at physician's office administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2015, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Contracted COVID; Contracted COVID; Flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) (Pfizer employee) reported for an adult female patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: VACCINATION FAILURE (medically significant) with onset 18Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 18Nov2021, outcome "recovering" and all described as "Contracted COVID"; INFLUENZA LIKE ILLNESS (non-serious) with onset 18Nov2021, outcome "recovering", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, influenza like illness.  Clinical course: Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received a Shingrix vaccination on 4/18/23. Patient had came in on 4/24/23 to report the adverse reaction. Patient says they starting experiencing symptoms following day on 4/19/23 with erythema, itching that has spread since that day. Patient reports it is lighter and going away in the areas that it started in and spreading downward towards the elbow. The elbow is still currently pink and itchy in comparison to the higher areas. Patient did not report any pain nor feeling unwell at any time. Did not see the primary care physician and did not report to anyone until 4/24/23.
Shingles in right ear. Chronic hearing loss, vertigo, and right facial nerve tingles.
p/vax pt exp a mild case of chickenpox w/approx 20 lesions;pt sought unspecified medical attention;