chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received previously on an unknown date with no issues). On an unknown date, the patient received the 1st dose of SHINGRIX. In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, swelling arm, skin warm, pain in arm, papular skin eruption and pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, skin warm and papular skin eruption were not recovered/not resolved and the outcome of the swelling arm, pain in arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, skin warm, papular skin eruption and pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. In 2018, the patient received 1st dose of SHINGRIX in the left arm and experienced arm soreness that lasted a couple of days. About 3 months later receiving 1st dose, the patient received 2nd dose of SHINGRIX in the right arm. The patient's arm was swollen and she broke out with bumps on her back. The patient was diagnosed with shingles on her back. The patient provided name of her dermatologist. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of Varicella-Zoster virus (VZV) infection and time to onset for event were not provided.
Initial misuse report received from a healthcare professional on 20 November 2013. A '12-year-old' patient (No information was provided regarding the patient) had received a dose of FLUZONE INTRADERMAL inadvertently administered with no adverse event. I.e. inappropriate age at vaccine administration. List of documents held by sender: none.
Flare up of Shingles.  Numbness, Red, itchy.  Started off with just being tired then could feel the numbness. Progressively got worse . Peaked 3 weeks post shot. Currently, a few days before 2nd dose still have some soreness.
pt recvd vax no hx of prev reaction ot vax; all vax given today had been given previously; mom denies prior reactions;
Diffuse arm swelling, pain, red rash, weakness, fatigue, nausea, fever, headache.
Last time I got the shot I was sick for three months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergic to bovine protein" (unspecified if ongoing); "allergic to lactose" (unspecified if ongoing); "gluten intolerant" (unspecified if ongoing); "Celiac Disease" (unspecified if ongoing), notes: states he is gluten intolerant to the point it is almost Celiac Disease. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "Last time I got the shot I was sick for three months".  Additional information: Caller asked if lactose, gluten and latex was a component of the Pfizer BioNTech Covid-19 Vaccine. Asked Caller why was it so important that people are immune compromised, he was told that immune compromised could be Celiac disease where your body starts attacking itself and killing the good tissue with the bad tissue. Caller asked if gluten was a component of the Pfizer BioNTech Covid-19 Vaccine. Caller stated he was gluten intolerant to the point it was almost Celiac Disease. Answer received as that Pfizer uses controlled manufacturing processes that meet quality standards of the pharmaceutical industry. However, Pfizer does not specifically manufacture or test Comirnaty; Pfizer-BioNTech COVID-19 Vaccine; Pfizer-BioNTech COVID-19 Vaccine, Bivalent | COVID-19 Vaccine, mRNA [Monovalent and/or Bivalent] to be free of Gluten. Therefore, we cannot guarantee absence of trace amounts. Caller asked about the COVID-19 Vaccine booster. He was trying to get information from the Pharmacy. The pharmacy asked him if he was allergic to bovine protein. He looked up some information and says 20% bovine protein and lactose. He was highly allergic to lactose. The pharmacy can't tell him if there was lactose in the shot. The pharmacy doesn't ask him till he was in the store and with the shot in hand. He asked if lactose was in the shot and the pharmacy couldn't answer that question for him. He wanted to find out if there was lactose in the Pfizer shot and if not why ask the question.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 10/6/21, Patient was administered her flu vaccine at 07:04 am.  Patient returned to vaccination site about 4 hours after vaccine stating that her arm was sore.  She did not have any swelling or redness, just sore down to the elbow.  She returned to employee health today (10/18/21) stating that it was still bothering her.  She still did not have any swelling or redness but again stated it has been bothering her since her shot.  Patient was given an appointment with the Employee Health physician today (10/18/21).  Was told it was likely nerve pain and placed on an oral steroid treatment.
Migraine headache almost continuously since vaccine. Had not had regular migraine in over 10 year.
Less than 24 hrs of injection small bumps on arms, swelling heat at injection site. Injection site heat lasted through the week of 2/26. Rash spread down both arms - chest, back to stomach. Swelling of lymph nodes in arm pits felt like baseballs were under my arm pits. Rash slowly moved down legs to feet. Burning itchy extremely hot bottom of upper arms. Skin dark red. Red blotches moved to top and bottom of hands. Nothing on my face. Dr visits - 2/19 walk in care at dr office. Could not get apt and my dr was off. Nurse practitioner unsure of cause and called in another dr. Both felt was from ZOLOFT.   2/26 Dermatologist - Dr saw the rash and advised to get to the emergency room ASAP. Felt rash was erythrodermic psoriasis. ER administered IV drip of prednisone and PEPCID plus saline drip. ER dr said felt that rash was allergic reaction to ZOLOFT even though I started taking the drug January 18th.    Next dr visit February 28th with Dr. She felt that rash was due to flu shot - From preservatives. Previous flu shots had no reactions. Those shots were pre-filled vials, not taken from a bottle. Taking prednisone for 6 days now and on my last pill. Still taking ZOLOFT. Redness is subsiding but skin peeling on body and hands.
Patient developed chicken pox. Typical with delicate vesicles which evolved into crusted lesions.
To date... Heart Palpitations: SEP 13*, 16*, 21, 30; OCT 19, 31; NOV 4, 16 Stinging+Pressure sensation in heart area: NOV 21, 22, 25, 27; DEC 7 * denotes an odd quivery buildup to flutter Each occurrence lasted no longer than a few minutes. Pain/discomfort present but not excruciating.
N17.9 - AKI (acute kidney injury) (CMS/HCC) R11.2 - Nausea with vomiting E11.10 - DKA (diabetic ketoacidoses) (CMS/HCC)
103 temp, projectile vomiting, hard chills, nausea, headache, joint pain, unable to stand without falling, no memory of most of day.  Arm is still very red, swollen, painful  & is moving down my arm
Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Janssen Vaccine 5/19/21. Presented to ED when hypotensive at dialysis ctr on 3/28. In ED she was in afib with RVR with HR 120-160, Covid +. Pressures were marginal (60/30s) but mentating well. Given dose of digoxin, abx, and arterial and CVC lines placed. CTA chest showed PNA and PE. Therapeutic paracentesis w/7L removed. Progressed to 4 pressor shock, required intubatioin 3/31. Transitioned to DNR. Treated with dexamethasone,tamiflu, cefepime, vancomycin, and flagyl. Pt expired on 4/9/22.
pt recv vax 1JUL97 & 28SEP97 pt devel zoster w/dermatome lesions;the lesions were more papular than vesicular w/4-5 around the umbilicus & several on back;
chills; fever; muscle ache; muscle spasm; she felt really tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (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: CHILLS (non-serious) with onset 31Aug2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 31Aug2021, outcome "unknown", described as "fever"; MYALGIA (non-serious) with onset 31Aug2021, outcome "unknown", described as "muscle ache"; MUSCLE SPASMS (non-serious) with onset 31Aug2021, outcome "unknown", described as "muscle spasm"; FATIGUE (non-serious) with onset 31Aug2021, outcome "unknown", described as "she felt really tired".  Additional information: It was reported that, patient took the first dose of the vaccine yesterday August 31 and was scheduled to get the second dose September 22 (22 days). Later at night after receiving the first dose of the vaccine she experienced chills, fever, muscle ache, muscle spasm and she felt really tired. She wants to know how long this will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sxs began 2 day's after receiving TDAP vaccine. Received TDAP 7/22/09. (L) arm numbness. (L) Hand.
Expired vaccine administered 10/8/22 when it expired 09/30/22. Per manufacturer, extended stability data shows stability through 10/19/2022.
Pt. passed away 2 days after vaccination. At time of vaccination pt. already in moribund state related to long term diabetes mellitus1 with ESRD, chronic foot wound since 2017, severe osteoarthritis. In March 2021 pt. hospitalized d/t severe pain. Findings were acute encephalopathy likely multifactoral, abnormal EEG and NSTEMI. Pt. refused further diagnostic in the hospital and resumed home hemodiaysis with help of her spouse. Hospice care was considered by the couple shortly before the time of vaccination.
Moderate memory loss, hard to focus, dizziness, lightheadedness - daily since vaccine (32 days so far).
Slight fever, headache, tiredness, diarrhea, pain in arm and at injection site., by afternoon of 2nd day, swelling/welt type at injection site, red, warm to touch, itchy
Patient received ZOSTAVAX on 9/22/2017. On 9/24/17 her right arm at the site of the ZOSTAVAX injection was red, swollen, warm to the touch, and painful. She was also feeling a little lightheaded. The size of the redness on her arm was approx 1 x 3 inches. On 9/25/2017 her arm was still red, swollen, warm and painful. The size of the red area on her arm had increase to approx 2 x 4 inches. She had taken BENADRYL at bedtime on 9/24/2017. We called her doctor on 9/25/2017 to let her know of the reaction that had occurred. We will continue to monitor patient's arm every day.
First dose greater than 35 days ago; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose greater than 35 days ago).    Concomitant medications were not reported. No treatment information was provided by the reporter. It was reported that the elderly couple at the pharmacy stated that they received first shot back in Jan-2022. They were looking for a follow up shot.  This case contains information for the 2nd patient of that 2 elderly patient described by the reporter.   This case was linked to MOD-, MODERNATX, INC. (E2B Linked Report). Sender's Comments:  MOD-:Patient-1 case -MODERNATX, INC.-MOD-:Patient-1 case
arm pain, dizziness, passed out x2. Evaluated by EMS-Refusal to transport.
FIRST I BROKE OUT ON FOREHEAD WITH BLEB LIKE, RED, VERY ITCHY BUMPS.  BY THE NEXT DAY, MY LEFT EYE ORBIT, FOREHEAD, HAIR, SKIN AROUND MY LEFT TEMPLE WAS TOO SORE TOO TOUCH.  HURT VERY BADLY.  VERY BAD HEADACHE, PARTICULARLY ON THE LEFT SIDE OF HEAD.  CONTINUED TO HAVE THE RED LESIONS ON FOREHEAD THAT AT TIMES FEEL LIKE PIN PRICKS.  VERY TIRED, FREQUENT HEADACHES, AND SKIN ON AND AROUND FOREHEAD REMAINS SORE TO THE TOUCH. HURTS.  ALSO HAD ITCHY AND REDNESS OF LEFT EYE WHICH I WAS VERY CONCERNED THAT IT MIGHT BE SHINGLES IN MY EYE, THUS I WENT TO MY EYE DOCTOR. MY EYE DOCTOR STATED NO SHINGLES IN MY EYE, BUT DIAGNOSED BREAKOUT OF SAME ON MY FOREHEAD AND PRESCRIBED AN ANTIVIRAL MED.
RASHES ON ARMS AND IT SPREAD TO LEGS WITH SEVERE ITCHING; RASHES ON ARMS AND IT SPREAD TO LEGS WITH SEVERE ITCHING; This spontaneous report received from a consumer concerned a female of unspecified age. 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, and batch number were not reported) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced rashes on arms and it spread to legs with severe itching. On 01-APR-2021, the subject experienced rashes on arms and it spread to legs with severe itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rashes on arms and it spread to legs with severe itching and rashes on arms and it spread to legs with severe itching was not reported. This report was non-serious.
Pt. experienced a headache within 30 minutes of receiving Twinrix injection.  Self medicated with otc analgesic.  Described feeling "puny" for 2 or 3 days afterward.  Symptoms resolved spontaneously without further action.
Patient was sitting on exam table, 60 seconds post injection stated he felt "funny", had a syncopal episode which lasted approximately 1 1/2 - 2 min.
Severe sore shoulder and minor rash by that evening.  intensity of shoulder and rash lasted 3 days, loss of sleep those days. On day 2 post injection I developed sores in my mouth and one in my right nostril, all but one have healed at this point. morning of day 3 i woke up to complete numbness on the right side of my face, didnt notice if I had facial droop. numbness resolved several hours after waking. So almost a week after the injection all that remains is one sore in my mouth.
Feeling ill, fevers, fatigue every couple of weeks since I have received my Pfizer vaccine. Last for 3 to 5 days in which I have missed a lot of work.
No additional AE was reported. No PQC reported.; An expired MMR II was administered to a 16 month old patient yesterday (1/7/2021).; This spontaneous report was received from a medical student (also reported as medical assistant) and refers to a 16-month-old male patient. His concurrent conditions, medical history and concomitant therapies were not provided.   On 07-JAN-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant human albumin (rHA)) (M-M-R II) lot # R035701, expiration date: 09-DEC-2020 (strength, dose, frequency and route of administration were not reported) as prophylaxis. No additional adverse event (AE) was reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 01-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX lot # J014851, expiration date: 24-OCT-2014, dose: 0.65 ml, subcutaneous which was expired. No adverse effect was reported. Additional information has been requested.
lightheadedness feeling weak ate 1 halo and half a protein bar then drank H2O allowed to rest then discharged in no distress
A non-serious, spontaneous report of administered expired product was received form a nurse concerning an eight-year-old male, subsequent to FLUMIST. The patient received FLUMIST on 26-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. Based on the results of the investigation, the root cause for the medication error were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flue season resulting in some medication errors that occurred shortly after the product expired. Additional information received on 31-Mar-2009 included Product Complaint Investigative results.
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of VARIVAX (Merck) underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
sore injection site arm; feeling tired after the first Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (feeling tired after the first Moderna Covid-19 vaccine.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (feeling tired after the first Moderna Covid-19 vaccine.). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (feeling tired after the first Moderna Covid-19 vaccine.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment medication were provided. Patient had a sore injection site arm and feeling tired after the first Moderna Covid-19 vaccine.   This case was linked to MOD-2022-521319, MOD-2022-521320 (Patient Link).
blurry/double vision, nausea about 5 mins post injection. Did not vomit. Reported that he did have lunch but did not drink much water today. He sat for about 45mins drank a bottle of water and symptoms resolved.
Had no cold-like symptoms the day of immunization but 24 hours later, had chills and hot flashes (did not take temperature); had productive cough with blood tinged and sinusitis, head congestion but did not see MD. Taking herbal remedy and aspirin.
Afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Afib) outcome was unknown.            No concomitant medication information was mentioned.  The caller stated that her husband developed atrial fibrillation (AFib) on an unspecified date after he received the Moderna vaccine. He did not have Afib prior to the vaccine.  Additional information was mentioned patient had developed AFib after receiving the moderna vaccine and has never had that before.  No treatment medication information was mentioned.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-244769 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A few hours after injection into my right deltoid muscle, my arm hurt so much I could not lift it. About 24 hours later, I had severe muscle and joint pains and developed a low-grade fever of 99 degrees (which normally would be insignificant, but my baseline temperature is typically about 96.8). I was exhausted, switched from hot to cold rapidly, and was in substantial pain throughout my entire body. My chronic vestibular symptoms (mainly dizziness) were exacerbated, and on day 3 I developed mild vertigo and had trouble with balance. My heart rate, which is normally tachycardic, became moreso - my heart rate is typically in the 80s lying down and 115 standing up; after the vaccine, it was 110 lying down and 150 standing up. My blood pressure lowed to 110/60. It is now four days since the injection; I spent most of the day unable to keep my eyes open. Muscle and joint pain is mostly gone, and my fever is back down to 98 degrees.
Arm went numb, pain in shoulder in front and back.  Next day still numb. Not red, not swollen, not itching.  Went to ER on 1/30.  No tests ran, MD evaluated and gave pain med and anti-inflammatory med.  As of today, 2/3/2020 pain is gone, still "just a little tingly" in the fingers.
Fever of 101 to 102 , severe headache, fatigue, soreness of arm, diarrhea. Fever and headache better after 36 hrs, diarrhea persistent (at ~60 hrs after the shot). Did not take any medication.
L upper arm with 10 cm By 8 cm erythematous macule with also induration and swelling. It is mild to moderately tender. Warm to the touch.