chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Induration; Redness; Injection site pain; warmth; This is a spontaneous report from a contactable other hcp (patient). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 18Jun2021 at 19:00 (at the age of 42-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included osteoarthritis. The concomitant medications of the patient included ascorbic acid (VIT C). The relevant past drug history was reported as no. The patient was not pregnant at the time of vaccination. The patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 28May2021 at 19:00 (at the age of 42-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 19Jun2021 at 07:45, the patient experienced induration, redness, injection site pain and warmth. Therapeutic measures were taken as a result of events that included patient took Motrin 200mg, Tylenol. The outcome of the events was reported as not resolved.  Information on the lot/batch number has been requested.
positive COVID-19 test; Arm was a bit sore; This is a spontaneous report from a contactable consumer (patient's wife) received from a Pfizer sponsored program.  A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at arm left on 19Jan2021 (at the age of 69 years) at single dose for COVID-19 immunisation.  Medical history included heart stent and blood pressure abnormal, both from an unknown date and unknown if ongoing.  Concomitant medication included omeprazole (PROTONIX).  The patient experienced COVID-19 test that was positive on 23Jan2021 and arm was a bit sore on Jan2021.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 23Jan2021. Therapeutic measures were taken as a result of COVID-19 and included treatment with infusion of the monoclonal antibodies (Eli Lilly) on 27Jan2021. The patients outcome of the events was unknown.
Site of injection became hot and swollen.  Client took her daughter to the doctor who diagnosed a Strep infection related to the injection site.
Monday, 11/9  the afternoon the shot was given - his arm became a little red and itchy. Tuesday, 11/10, morning  the redness and swelling was much larger and increased during the day. Wednesday, 11/11  Physician prescribed Ciprofloxacin. Thursday, 11/12  Redness and swelling continued even after two doses of Ciprofloxacin. By the end of the day the area had extended down the arm from the injection site to the elbow and encircled below the bicep; then gradually improved. Sunday, 11/15  Antibiotic stopped. Monday, 11/16  Redness and swelling gone; slight amount of itching still present.
Severe chills for about 20 minutes followed by fever for about 30 minutes. Drank orange juice and cold. Applied cold compress. Went to bed about 9:30 PM and slept uninterrupted till about 7 AM.
Localized redness measuring 6.5 in x 5.5 in, tenderness, and mild swelling.
Hurt all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Hurt all over). The outcome of the general body pain was not reported.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     It was unknown if the company considered the general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2nd dose of Shingles vaccine and hurt all over. Follow up was not possible as no contact details were available.
During injection, as needle was already in arm patient jerked his arm away.  No known adverse effect but reporting as the patient arm jerked after the needle was already inserted.   Patient said he didn't know why he moved away.
On 9/25/13, patient woke up with pain in her jaw/neck on the right side.  Then on 9/26 she developed an eye droop and then later in the day her mouth began to droop as well.  She went to the ER and was dx'd with Bell's Palsy.  She was treated with Amox for 14 days for presumptive Lyme and a Prednisone taper for 12 days.
Dose #1: 02/2021 Dose #2: 03/2021 Dose #3: 10/2021 Dose#4:  09/15/2022. After receiving Dose #4, I woke up the next day with considerable dizziness. As soon as I lifted my head off of the pillow, I felt the room spinning and extremely dizzy (almost nauseating). I rested my head back down immediately and closed my eyes until it passed (less than a minute). Slowly, I sat back up felt dizzy again so I closed my eyes and waited until it passed (still sitting up). I then stood up and nearly lost my balance, dizzy again. After a few minutes, I tried to get up again and slowly, I was able to do so, however, I kept feeling small bout of dizziness that were shorter in duration. I decided to stay home that day as I was afraid I would lose my balance and fall, much less, be able to drive. The next day, I woke up dizzy again and it lasted throughout the day-but much shorter in duration from onset to recovery (happens only after moving my head up from a rested position). As time progresses, I still feel dizzy but am able to drive and carry out my daily routine-albeit with short episodes of dizziness. With each day, I feel it is slowly resolving, very slowly. I am otherwise healthy, 5'3"; 144lbs and a mother of 3. No medications and live an active lifestyle; no major health related surgeries or physical trauma.
Poor tone of muscles, i.e. floppy, weak wimpering cry; dec frequency & duration of breast feeding, temp to 101 R;
Patient awakened 08/03/2006 approximately 12:00 am with fever, headache, myalgias, dizziness.  Presented to clinic on 08/03/2006 at 2:00 pm with continued symptoms.  Patient evaluated for other etiology and sent home, advised symptomatic treatment.  Patient called next day-reported feeling much improved.
couldn't get the second dose; A spontaneous report  was received from a HCP concerning about a 41 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced medication error of missed the second dose.  The patient's medical history was not reported.  Concomitant medications were not reported.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:026L20A) via intramuscular in left arm for prophylaxis of COVID-19 infection.  On an unknown date in the month of Feb 2021, the patient realized that she missed her second dose of vaccination as she had to leave the country.  Laboratory tests was not reported.  Treatment information was not provided.  All the events occurred after first dose of vaccination.  Action taken with mRNA-1273 in response to the events are unknown.  The outcome of event not applicable; Reporter's Comments: This report refers to a case of missed second dose of mRNA-1273 unintentionally, with no associated AEs.  Causality for the medication error is not applicable.
Headache; dizziness; nausea; feeling unwell; tired; for three days injection site pain. Injection site pain started immediately; This is a spontaneous report from a contactable consumer (Patient) or other non hcp. A 75-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 subcutaneous on 21Mar2021 11:00 as single dose for covid-19 immunisation.The patient's medical history and concomitant was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies to medications, food, or other products. On 30Mar2021 06:30, he experienced Headache, dizziness, nausea, feeling unwell, tired and for three days injection site pain. Injection site pain started immediately on 24Mar2021. The others 9 days later and may or may not be related to the vaccine. The outcome of all the events were recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a 5 year old female patient with amoxicillin (oral) allergy (body hives). No pertinent medical history was reported. On 06-AUG-2013 the patient was vaccinated with PROQUAD injection, (subcutaneous, 0.5 ml, in the left arm, dose number and lot number unknown). Other suspect therapies included IPV (Sanofi) in her left leg and DTAP (GlaxoSmithKline) in her left thigh. No concomitant medications were reported. On 22-AUG-2013 the patient sought medical attention at an unspecified emergency room for a sore left knee and a maculopapular rash with bullae down both legs. The results of Complete Blood Count (CBC), erythrocyte sedimentation rate (ESR and antistreptolysin-0 test (ASO) titer drawn on 22-AUG-2013 were normal. The patient was treated with a short course of oral steroids (manufacturer unspecified) begun on an unspecified date. Patient was treated and released from emergency room and not admitted. On 23-AUG-2013 the patient was seen at Physician's office for a follow up visit. The physician reported that the rash had improved and the patient's range of motion for left knee had improved. On 28-AUG-2013 the patient sought medical attention again at an unspecified emergency room for left hip pain. Patient was released from emergency room and not admitted to the hospital. No treatment was reported for left hip pain. Physician reported that left hip pain improved and rash had resolved on an unspecified date within 36 hours of emergency room visit on 28-AUG-2013. No further information was reported. The patient was reported as recovered from the events on 30-AUG-2013. Additional information has been requested.
A 16-year-old female patient received on 03Mar2016 around 14:00 or 14:30: TRUMENBA; lot L31514, expiry date Apr2017, NDC 00050100-10_ at 0.5 ml single, intramuscular, in right deltoid, MENVEO at 0.5 ml single, intramuscular, in right deltoid, HPV at 0.5 mg, single, intramuscular, in left deltoid and influenza vaccine at 0.5 mg, single, intramuscular, in left deltoid. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting, pain across both shoulder and pain shooting up her neck, real bad headache, all on 03Mar2016 with outcome of recovered. Four hours after experiencing the side effects the patient went to the ER. During the ER visit the patient received IV fluids and was kept overnight for observation and then released. Symptoms lasted for about three or four days before resolving. The reporter considered the events related to all the vaccines (she believed it was the combination of all 4 vaccines that caused the events).
This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 02-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 30-MAR-2015, the patient was vaccinated with a dose ROTATEQ (lot # K011663) (expiration date and dose were not provided). There was a 72 hours excursion for this vaccine. No adverse events have been reported. This is one of several reports from the same reporter. Additional information has been requested.
Stiff neck with pain,  also  pain top of right shoulder down into  middle-right of upper back more acute  when turning head to the right or left.  This appeared early the day after receiving the first Moderna  Covid-19  vaccine shot and continues today, although  maybe less pain but still the stiffness. This is  occurring into the fifth day after the shot.
pain, swelling at injection site. fever chills ,  tiredness,   vomiting,  upset stomach  overall soreness in muscles
The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional. A patient had received 0.5 ml dose of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: nonTie case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional. A patient had received 0.5 ml dose of FLUZONE instead of 0.25 ml on an unspecified date. No adverse event was reported. List of documents held by sender: nonee
Patient felt dizzy, then passed out for <1 min, pt c/o feeling very hot, nauseated/vomiting.
L arm's injection site, swelling up, warm to touch. Pt was admitted to hospital for observation for overnight (APDT #5 and IPV were given at L arm).  Pt received apdtin on 03/13/03 4:30 PM, then that afternoon, eve pt's mom noted that injection site left deltoid area was red and swelling up. On 3/14/03 left upper arm was swollen. Pt came to clinic on 3/15/03 at 4:30 PM then was admitted for redness, swelling and warmth to upper arm and shoulder area for 24 hours. Pt was given 2nd MMR, 5th APDT and 4th IPV. on left arm on 3/13/03. Pt has Hx of constipation only, no major illness, and lives with parents. Temp at admission was 97.8. Admission diagnosis was localized reaction to immunization vs. cellulitis. Pt was ordered Keflex 500 mg bid. Pt was discharged on 3/16/03 AM. Pt also revisited clinic on 3/17/03 at 9:50 AM.
Pain at injection site; Inadvertantly administered into bursae; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist called to report that the patient inadvertantly received Shingrix into bursae, which led to vaccine administered at inappropriate site. The patient had ongoing pain at injection site. The reporter consented to follow up.
Minor head cold; Lost her sense of smell; Allergy-like symptoms; Contracted COVID; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS, ANOSMIA (Lost her sense of smell, VACCINATION FAILURE, COVID-19, and HYPERSENSITIVITY in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced VACCINATION FAILURE and COVID-19. On an unknown date, the patient experienced NASOPHARYNGITIS, ANOSMIA, and HYPERSENSITIVITY. At the time of the report, NASOPHARYNGITIS, ANOSMIA, VACCINATION FAILURE, COVID-19, and HYPERSENSITIVITY outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) On an unknown date, SARS-CoV-2 antibody test positive, Patient still has antibodies.         No concomitant medications were provided. No treatment medications were reported.  This case concerns a 49 year old female with no reported medical history, who experienced Non-serious unexpected events, AESI, Covid 19, and Anosmia and other unexpected events of vaccination failure, nasopharyngitis, expected event of hypersensitivity reaction. These events occurred approximately 5 months after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable. The  benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine) is not affected by this report. This case concerns a 49 year old female with no reported medical history, who experienced Non-serious unexpected events, AESI, Covid 19, and Anosmia and other unexpected events of vaccination failure, nasopharyngitis, expected event of hypersensitivity reaction. These events occurred approximately 5 months after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-JUL-2015, the patient was vaccinated with a second dose of improperly stored M-M-R II lot # K016154 with exp. 24-SEP-2016, (route and dose were not provided). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 101F, body pain intense including all joints and back, intense pain at injection site, red and hot at injection site, nausea, dry heaves, headache, muscle cramps, dizziness. All symptoms diminished after 36 hours, with  exception of malaise, redness and pain at injection site, headache. Treated with 400 mg of ibuprofen every 6 hours, with 650 mg of TYLENOL twice daily. I was very sick, unable to get up or stand for more than a minute. I needed care as I could not do for myself. I am much better on this 3rd day, but am still feeling very weak. I don't feel compelled to get my second shot. I feel that four years of protection is not worth what I am going through. If it carried protection for a decade or more, that would be a different story.
The skin in area of injection site remained purple-red color and raised over 2 months after the vaccine was administered.
Side effects: Chills, sore arm, body aches, headache, joint pain, and fatigue which lasted for about a day
This case meets criteria for vaccine breakthrough review. SxS include fatigue, cough, N/V, confusion, SOB.
Flush face and tingling of scalp for 3 to 4 hours starting at 11:50 AM. Tightness from elbow to behind right ear for 2 days. Hardness at injection site for 4 days.
Arm hurt (but could raise arm above head for a day); Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 23Mar2021 10:00 (Batch/Lot number: unknown) at the age of 60 years 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: PAIN IN EXTREMITY (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "Arm hurt (but could raise arm above head for a day)"; FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered" (2021), described as "Tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and was unknown if the patient has been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient had chiils; The patient had fever; Body aches for 36 hours. Patient was in bed for 36 hours; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (The patient had chiils), PYREXIA (The patient had fever) and MYALGIA (Body aches for 36 hours. Patient was in bed for 36 hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CHILLS (The patient had chiils), PYREXIA (The patient had fever) and MYALGIA (Body aches for 36 hours. Patient was in bed for 36 hours). At the time of the report, CHILLS (The patient had chiils), PYREXIA (The patient had fever) and MYALGIA (Body aches for 36 hours. Patient was in bed for 36 hours) had resolved.     Concomitant product use was not provided by the reporter.  Patient was in bed for 36 hours.  It was reported that patient had no side effects on her first Moderna Covid-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-583862 (Patient Link).
No adverse events. Pt requested Tdap vacc, was given HepB vacc. Wrong vacc. was administered.