chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reports some redness after the shot, 2 days later she had bruising all over down to her elbow, pain into her armpit and difficulty lifting her arm. She reported this to the pharmacy 11/15/23 shot given 11/8/23. Pt had a video visit with a doctor, but the doctor could not asses her arm without seeing it to examine. The doctor recommended the patient report to urgent care to have it checked a few days ago. Pt did not go to urgent care or seek additional treatment. The pharmacy recommended she still be seen to have her arm evaluated medically. She stated it was slightly better still painful and she has difficulty lifting her arm above her head. She is using ice and heat for pain.
July 31, 2012: Seizures caused by fever, admitted into hospital due to seizures being back-to-back. The hospital had to administer seizure medicine b/c the seizures would not stop on their own.  Hospital ran several teat to make sure it wasnt something additional.  Aug. 27, 2012: red bumps all over back and legs
Reported metallic taste in mouth 5 minutes after vaccination (vaccine received at 11:07 AM). By 11:37 AM, the metallic taste was still present but  improving. Staff denied unusual foods prior to vaccination. No other signs/symptoms reported or found when assessed by onsite MD.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown dates the patients were administered improperly stored doses of GARDASIL (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. No adverse events were reported. This is one of the 3 reports reported by the same reporter. Additional information has been requested.
2 wks later due to dark spots, worsening of skin rash; motor dysfunction & progressive muscle weakness; dx of muscular dystrophy;
At 10:30PM, I felt like I was going to pass out. Being so lightheaded, I could not move off the floor. I then developed tingling in my arms and legs. My muscles were weak and it was hard to move. I then vomited twice. This lasted until I fell asleep on the floor, perhaps 45 minutes. When I awoke 2 hours later, the dizziness and weakness subsided.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 18-NOV-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date-22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
That evening I felt super tired,  for the next few weeks I had constant sleep interruptions,  flashing lights & loud sounds would wake me. Started getting migraines (never had one in my life before this) 1 or 2 a week. Ringing in my ears. Body & joint aches. Eventually let to zero sleep some night,  that?s when I finally decided to go to the doctor. Then he just blamed Covid & gave me ambien for sleep.
Patient received a rabies vaccination 7-27-07 on 7-28-07 in the AM. He noticed a red rash to his right arm and wrist, which later spread to his left arm and there spread to his upper back and had some itching.
On the morning of 6/12/12 patient woke up with redness in her cheeks and was itchy on her chin and along her jaw line. Temperature was 97.9 degrees F. Morning of 6/12/12, the area of the site of injection was splotchy red and warm to the touch. Rash on left arm is predominantly at the dorsal end of the deltoid muscle. Rash measuring 6 cm below injection 2 cm in width and 2 cm long.
Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was flushed. At 0930, I developed hives on my neck, chest and arms. I immediately went back to the vaccination site (I was still in the hospital at work) and was administered 25mg oral Benadryl and monitored for 30 minutes. The hives resolved, but I still felt unwell. At 1600 I noticed a swelling in my right upper thigh about the size of my hand. It was about 2 inches inferior to my inguinal crease and was the width of my thigh. It was mildly painful to the touch. My injection site was red, inflamed and itchy. I continued taking 25-50mg Benadryl Q4  and took 100 mg at night due to itchiness on my eyes, face, neck, chest and arms. This is still present, although less each day, as of Monday 1/4/21 morning. I have felt feverish but have not had a recorded fever. I took some Ibuprofen for the pain in my arm at the injection site. The redness, swelling and itchiness has decreased each day at the injection site, but is also still present as of Monday 1/4/21 morning. I still feel unwell and have continued diarrhea throughout the weekend.
Severe Allergic Reaction; Developed a Severe Rash; Severe Allergic Reaction; Developed a Severe Rash; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: FA6780) via an unspecified route of administration in left arm on 29Jun2021 as dose 2 single for COVID-19 immunization. Patient had no medical history and was not taking any other Products. Concomitant medications of the patient were not reported. Patient previously received historical first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: ER8735) via an unspecified route of administration on 08Jun2021 as dose 1st single for COVID-19 immunization. On 01Jul2021, 48 hours after receiving second dose of vaccination, patient experienced severe allergic reaction; developed a severe rash. Patient received treatment with Antihistamine. Outcome of the event not recovered/not resolved.  Follow-up attempts are needed. Further information is expected.
No adverse effects were reported.; Patient received improperly stored PNEUMOVAX 23.; This spontaneous report was received from a Vaccine coordinator referring to a patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 11-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were unknown) with lot # R033079 and expiration date 06-JUN-2020 for prophylaxis.       The administered dose of vaccine experienced the temperature excursion of minimum 32°F degrees Fahrenheit for and unknown time frame, and had no previous temperature excursion nor a digital data logger involved.; Sender's Comments:  US-009507513-1910USA010401:
Hives on  back legs, arms and stomach; itchiness on  back legs, arms and stomach; Rash on back legs, arms and stomach; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on  back legs, arms and stomach), PRURITUS (itchiness on  back legs, arms and stomach) and RASH (Rash on back legs, arms and stomach) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) and HYDROXYZINE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Hives on  back legs, arms and stomach), PRURITUS (itchiness on  back legs, arms and stomach) and RASH (Rash on back legs, arms and stomach). At the time of the report, URTICARIA (Hives on  back legs, arms and stomach), PRURITUS (itchiness on  back legs, arms and stomach) and RASH (Rash on back legs, arms and stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  Treatment medication included Anti Itch Cream and Anti Itch Pill.  She thought it might be shingles, but confirmed not to be shingles by her dermatologist. The dermatologist gave her Clobetasol propionate cream 0.05%. She went to an allergist Friday that prescribed her hydroxzine 25 mg tab, which she is only taking a half a pill because they make her drowsy.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: No specific follow-up information recorded.
Patient had a area - 10 cm- area of induration with erythema and pain. Central area of erythema with surrounding area of lighter erythema.
Information has been received from a physician concerning a 15 year old female patient who on 24-MAR-2008, was vaccinated with a dose of VARIVAX vaccine (Oka/Merck), 0.5ml, subcutaneously in her right arm. On 24-MAR-2008, the patient experienced swelling and tenderness at the injection site. The physician reported that the symptoms were treated with ADVIL and cold compress. On approximately 26-MAR-2008, the patient recovered. The patient sought medical attention. This is one of two reports received from the same source. No further information is available.
Full body hives outbreak. I have started taking prednisone (2 days ago), as prescribed by a physician, but my hives are still present.
This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 02-MAR-2018, the patient was vaccinated with improperly stored (Oka-Merck)PROQUAD lot#N025717 with expiry date of 17-MAR-2019 for prophylaxis. (dosing details were not reported). The vaccine was reconstituted with properly stored sterile diluent. Temperature: -14 C to -10 C. Time frame: 15 hours 30 minutes. There was previous temperature excursion: -14 C to -10 C for 21 hours 30 minutes. The call was because of data logger. No adverse effects reported. No product quality complaint reported.
Dramatically increased tinitus that has persisted almost 2 months  Probably started that evening but d/t high fever and migraine it was not noted However it has been obviously much worse within 2 days after vaccine and not resolving No treatment
This vial was punctured more than 20 times.  This is client number 21 vaccinated with the same vial
5 year old previously healthy boy who presented to the emergency department with an episode of altered mental status/pre-syncope like event that self resolved or did so with IVF.  This occurred 3 days after his 1st Pfizer Covid vaccination.  He presented to the ED with mild hypothermia to 95F, mild hypoglycemia to 63, and a K+ of 2.7.  He had negative EKG, echo, and troponin in the ed.  He had no fevers.  His drug screen was negative.  His lab abnormalities resolved on recheck.  he was observed for 7 hours in the ED and sent home as he was well appearing.   He did have a mildly sore arm reported on the day of the vaccination and complained of mild belly pain twice the following day, but otherwise had no clear or obvious vaccine reactions.   This episode reported was not clearly vaccine related but is being reported as it's etiology was certain.
Patient received DTaP to left thigh on 01/17/05. Patient returned on 01/19/05, with 9 cm red, swollen warm rash that was non tender. The patient was afebrile and able to walk. He was treated with ice and Benadryl. Mom went to ER for second opinion, he was diagnosed with cellulitis and treated with Omnicef.
passed-out/he fell; light-headed; passed-out/he fell; This is a spontaneous report from a contactable other healthcare professional reported that an 82-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and stents. He was on a blood thinner medication. On unspecified date, he felt light-headed. He passed-out a week and a day after the first injection, when he bent over to get something out of the dishwasher. He was found on the ground with broken dishes and he didn't recall how he fell. He was sent to his cardiologist who did an EKG, a blood pressure reading then took his heartrate, and everything was fine. The outcome of events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 02-JUN-2017, the patient was vaccinated with improperly stored VARIVAX injection, lot # M046004, expiry date: 18-NOV-2018 (dosing details not reported) which was reconstituted with properly stored sterile diluent (MERCK) (lot#, expiry date unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 6 F to 14 F for a duration of 180 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008689: US-009507513-1706USA008691: US-009507513-1706USA008688: US-009507513-1706USA008690: US-009507513-1706USA008692: US-009507513-1706USA008694: US-009507513-1706USA008693.
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 25-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805546 was crossed linked to original cases 201804863 due to same reporter.
Diagnosis = post vaccinal brachial plexus neuritis by Neurologist. Had flu shot 10/4/14 - felt pain on injection site, then 2 days after 10/6/14 progressed to tingling, spasm and electrical shooting pain radiating to fingers on left upper extremity. Treatment - gabapentin, ROBAXIN, Prednisone. Spasm on left upper back. Saw Neurologist started 12/9/14.
woke up with lots of pain on our side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (woke up with lots of pain on our side) 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 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (woke up with lots of pain on our side). At the time of the report, PAIN (woke up with lots of pain on our side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 7 (High) the pain was about a 7 on the 1-10 scale.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
she still gets them/ suspected vaccination failure; had the shot and she still gets them; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: she still gets them/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the shot and she still gets them). 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: 03-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter was the patient's cousin. The patient had the shot and she still get them and had to take medications. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Caller is now testing positive for Covid illness 18Aug2022; Caller is now testing positive for Covid illness 18Aug2022; 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 female patient received BNT162b2 (BNT162B2), on 12Jul2022 as dose number unknown (booster), single (Lot number: FJ4991) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "unknown" and all described as "Caller is now testing positive for Covid illness 18Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Aug2022) positive.
pt recv vax & started feeling pain in rt arm & neck;could not raise arm above head;no induration, no point tenderness;good muscle strength but unable to raise arm to head;afeb;warm soaks;suggest bengay;6OCT98 still sore unable to lift arm
Patient is concerned that the vaccine has caused edema in the right pectoral area surrounding the nipple and axilla. There are no other symptoms. At time of exam- provider finds no complication.
This spontaneous report as received from a Registered Nurse refers to a currently 56 year old patient of unknown gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, injection, lot # L003188, expiration date 06-JUL-2016 in the arm (dose and route of administration were not reported). On the same day, the patient received FLUZONE (dose, lot #, expiration date and route of administration were not reported). On an unknown date, the patient experienced nausea, a headache, "terribly achy body" and fever. It was also reported that each of the patient's arms were red and she/he had a knot the size of a baseball at the injection site after being vaccinated with PNEUMOVAX23 and FLUZONE was not reported. The patient sought unspecified medical attention on an unknown date. This is one of the several reports received from the same reporter. Additional information has been requested.
Within 7 days of receiving the vaccine; I developed Covid-like symptoms the day after administration, fever (102.5), chills, aches. Shortly thereafter I developed chest pain, tightness, and heart palpitations.  I saw my PCP and complained about my symptoms. No treatment was issued.  These symptoms mostly resided approximately 21 days after administration, however I have had several bouts of these feelings since the original vaccination. Lasting between 3 and 5 days until the symptoms reside again. This happened in February 2022, and again in May 2022.
0DTAP - IPV expired 08-29-2014 given 9-09-2014.
Information has been received from a physician concerning a 15 year old female with drug allergy (she had rash on her body after Amoxicillin at age 1), who on 15-MAR-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) and she had no reaction to this dose. On 06-AUG-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast), Lot # 660612/0229X, 0.5 mL, IM. It was reported that within an hour or 2 after vaccination, the patient had rash on her chest and back. Patient was given (SOLU-MEDROL) and (MEDROL DOSEPACK) and told to start (BENADRYL). The patient's outcome is unknown. Additional information has been requested.
Booster dose of Pfizer Given IM in left deltoid on 11-29-21 post use by date of 11-24-21. Client notified, initially declined recommended 2nd booster dose and called back to accept. Will be in 11-30-2021 for next dose.
Of 200 plus people who rec'd full series of Engerix-B, 7 people did not respond; Vaccinee is one of five employees who have been identified as non responders following a series of 3 engerix-B injections;
This spontaneous report as received from a healthcare worker regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 04-APR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 25/0.5 Y (lot # K007825, expiry date 13-JAN-2016) dosing details and route unknown. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Pt c/o feeling of heart racing. HR per RN was 115 at first. Pt was pale and slightly diaphoretic, pt feel lump in her throat and difficulty swallowing. Code green called. Pt felt better and continued monitoring after EMS checked.
Parents used wrong birthdate on form to get the child vaccinated early.  They used the same wrong birthdate on dose #1 (7/19/21) to get the immunization as well.  Called mother on 2/15/22 and she said patient had no side effects
Hospitalized 7/20/22-8/18/22 fall, weakness, runny nose, sore throat, increased confusion, fever, cough, respiratory failure, elevated troponin, O2 supplementation, hypoxia,
This is a spontaneous report from a contactable female consumer reporting for herself. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient previously received a pneumococcal vaccine and experienced peripheral swelling. The patient experienced her arm "blew up" (peripheral swelling), arm sore, headache on an unspecified date with outcome of unknown.
pt recv 1st & 2nd dose of varicella vax 8/97 & in 2/98 pt lab evaluations revealed negative varicella titers.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 8.3 and R; 24, 8.4 and R; 24, 9 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
16 X 16 cm Erythemic warm rash on Lt thigh.  Mom putting salve on it.  That is helping.  Pt mom states got whole body rash @ 2 months with vacc.