chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started hurting during the hold.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 65 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Started hurting during the hold."  Additional Information: Patient reported after start of therapy he got his covid vaccine and stopped taking his medication sometime in Mar2021. Patient reported he does not remember how long patient stopped taking his medication but started hurting during the hold. md aware. Patient answered some of the time to the question how often patient forget to take his medicines. Patient reported after start of therapy he forgets to take his medication once a month. md unaware. Advised patient to notify patient mg. No adverse reactions reported. Patient answered some of the time to the question how often patient runs out of medicine. Patient reported after start of therapy patient ran out of his medication due to changing pharmacies. md aware and gave patient samples. No adverse reactions reported. Patient did not report any side effects. No further information reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
METALLIC TASTE; TASTE BITTER; Injection site bleeding; Injection site stinging; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received j and j national consumer product (form of admin and route of admin were not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced metallic taste. On MAR-2021, the subject experienced taste bitter. On MAR-2021, the subject experienced injection site bleeding. On MAR-2021, the subject experienced injection site stinging. The action taken with covid-19 vaccine ad26.cov2.s, and j and j national consumer product was not applicable. The outcome of the injection site stinging, metallic taste, taste bitter and injection site bleeding was not reported. This report was non-serious.
14JUN98 17 days p/vax mild malaise, sl fever, aching;15JUN98, 16JUN98 welts began to appear-similar to chickenpox inj site red, swollen;felt like bumps w/fluid;no itching-welts on face, not vesicles;also c/o noc sweats;
pt cried constantly for 6-8 hr p/vax & cry was high pitched; denied any fever; APAP given q 4 hr as instructed; MD notified & aware but no further follow-up or treatment;
T78.3XXD ANGIOEDEMA, SUBSEQ 3/16/2023 EXPRESSIVE APHASIA
felt phlegm in her throat; burning sensation in her esophagus; she burped more than normal; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (felt phlegm in her throat), BURN OESOPHAGEAL (burning sensation in her esophagus) and ERUCTATION (she burped more than normal) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCTIVE COUGH (felt phlegm in her throat), BURN OESOPHAGEAL (burning sensation in her esophagus) and ERUCTATION (she burped more than normal). At the time of the report, PRODUCTIVE COUGH (felt phlegm in her throat), BURN OESOPHAGEAL (burning sensation in her esophagus) and ERUCTATION (she burped more than normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Heart rate: unknown (High) Heart was very accelerated. On 11-Apr-2021, Oxygen saturation: 98 % (normal) oxygen saturation level was normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported she stopped taking rosuvastatin two weeks before receiving the vaccine.   Treatment information was not provided.
About 5 or 4 days ago my scalp towards the top of the head hurt while going to sleep on my back. I assume that I probably scratched my head while shampooing my hair. Then next day my right eye started to bother me. I thought I had bumped my eye while trying to clean the discharge I have in the mornings with q-tips. But finally it got worse until it hurt me. So I went to the ophtlamologist today who according to his diagnosis I had shingles. I just got an antiviral medication for the next seven days and drops to help clean my eyelids. This is so bothersome, sometimes while trying to read I see blurry.
Went to urgent care about 3:30 PM was diagnosed with Angioedema of lips. Steriod  shot and prescription.
THE LEFT ARM WAS RED, SWOLLEN, ITCHING, AND WARM FROM AROUND THE ZOSTAVAX INJECTION SITE (BACK OF THE ARM) DOWN TO THE ELBOW.  IT BEGAN THE MORNING AFTER THE ZOSTAVAX AND INFLUENZA VACCINATIONS AND AS OF TODAY (10/23/17) HAS STARTED TO SUBSIDE. NO TREATMENT WAS SOUGHT, COUNSELED THE PATIENT TO USE A COMPRESS AND TAKE BENADRYL TO HELP WITH THE REACTION.
She had no pain from the initial shot but then that night she stated she felt horrible, aches and pains and her cough worsened. a week later she said that the symptoms were just as bad, she was extremely tired also. Nauseated as well. She did not believe that she had a fever.
This spontaneous report as received from a healthcare worker (pharmacist technician) refers to a patient of unknown age and gender. The patient's medical history included been hospitalized at an unspecified hospital for an unspecified issue. On 27-FEB-2014, upon hospital discharge, the patient was vaccinated with PNEUMOVAX23 (25/0.5) lot # J014399 expiry date 20-NOV-2014 (dose and route not reported. Concomitant medication was not reported. On an unspecified date in 2014, the patient was readmitted to the hospital with cellulitis. The healthcare worker reported that the patient was given an unspecified antibiotic for treatment. The outcome of cellulitis was not reported. The event cellulitis was serious due to hospitalization. Additional information has been requested.
Received a half a dose instead of a full dose on their booster shot; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (Received a half a dose instead of a full dose on their booster shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 027A21A and 026B21A) for COVID-19 prophylaxis.     Patient was not allergic to medications, food and other products. Patient never had COVID + test or diagnosis.  Concurrent medical conditions included Blood pressure management, Cholesterol, Kidney disorder and Type 2 diabetes mellitus. Concomitant products included INSULIN for Type 2 diabetes mellitus, ATORVASTATIN and METFORMIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (Received a half a dose instead of a full dose on their booster shot). At the time of the report, UNDERDOSE (Received a half a dose instead of a full dose on their booster shot) outcome was unknown.            Concomitant medication also included blood thinner medication, blood pressure medication, kidney medication, cholesterol medication, diabetes 2 medication.  On 01-APR-2022, patient received second booster lot number 045J21A.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-597349 (Patient Link).
Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19; Unanticipated cycle menstruation; Green sputum; Complete lost of taste; Complete lost of smell; Sinusitis; Cough; high fever of 103.5 °F; Profound headache; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19), MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste) and ANOSMIA (Complete lost of smell) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included INFLIXIMAB (REMICADE) for Ulcerative colitis.   On 15-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. On 08-Jul-2021, the patient experienced MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste), ANOSMIA (Complete lost of smell), SINUSITIS (Sinusitis), COUGH (Cough) and HEADACHE (Profound headache). 08-Jul-2021, the patient experienced PYREXIA (high fever of 103.5 °F). On 11-Jul-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19). On 11-Jul-2021, COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19) had resolved. At the time of the report, MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste), ANOSMIA (Complete lost of smell), SINUSITIS (Sinusitis), COUGH (Cough), PYREXIA (high fever of 103.5 °F) and HEADACHE (Profound headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 103.5 (High) 103.5 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was tested via PCR (nasal swab) in the hospital. An extra nasal swab was made for genomic testing. On 12-Jul-2021, the patient received monoclonal antibody therapy for severe COVID-19. Patient was treated as an out-patient so was not hospitalized.  When the patient was vaccinated, it had been over 8 weeks since the patient last received the Remicade infusions.   This case was linked to MOD-2021-257972 (Patient Link).
Raised red circle around the injection site for the past 13 days, occasionally itchy, some mild joint aches.
Left upper inner thigh swollen, red, hard with pruritus and became worse 72 hours after injection. Subsided on 3-21-10.
A rash appeared on my arm about 13 days after getting the shot. It could?ve showed up a couple days ago but I didn?t notice until today. It?s warm to the touch but doesn?t hurt or itch.
fever; chills; achy all over; painful arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 19-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site).   At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent and concomitant therapy were not provided. On 23-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 "10PK-0.5 ml SD-PFS LLok wTip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient received moderna vaccine on 5/13/21 and 6/10/21. Presented to ER on 7/28/22 due to GI bleed. FOund to be COVID positive on 7/28/22. Asymptomatic. DIscharged on 8/1/22
Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Severe, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Severe, Additional Details: Patient became extremely lethargic while sitting on the chair 2  to 3 mins after receive first dose of pfizer covid-19 vaccination. Alert and oriented x3, c/o intermitent blurry vision, Bp 73/28  HR 108. Asked for water, given above 5oz. No s/s allergic reaction.  Taken to ER by ambulance 4 to 5mins later while still extremely lethargic.
Got really sick; it was almost like I had the flu; got all the side effects; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Got really sick; it was almost like I had the flu) and ADVERSE EVENT (got all the side effects) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU on 18-Dec-2020.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Got really sick; it was almost like I had the flu) and ADVERSE EVENT (got all the side effects). At the time of the report, INFLUENZA LIKE ILLNESS (Got really sick; it was almost like I had the flu) and ADVERSE EVENT (got all the side effects) outcome was unknown.            Treatment information was not provided.  No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Patient Dosage text has been updated
This spontaneous report as received from a 59 year old female patient. On 03-JUL-2013 the patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Lot# not reported). On 03-JUL-2013 the patient experienced large red marks of approximately 2" in diameter. The patient also noted small blistering and itchiness. The patient did not seek medical attention. No treatment was given. At the time of this report the patient was not recovered. Additional information is not expected.
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 03/03/22 at 3:00PM. Patient has not reported to Medical Clinic with symptoms at this time.
Round scaly spots show up random; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin scaly in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In AUG-2022, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced skin scaly (Verbatim: Round scaly spots show up random). The outcome of the skin scaly was not recovered/not resolved.   It was unknown if the reporter considered the skin scaly to be related to Shingles vaccine.     It was unknown if the company considered the skin scaly to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. In 2022, the patient had round scaly spots show up in just random places, never hurt but some still had not healed. The follow up would not be possible as no contact details were provided.
After receiving the flu shot, the patient developed adverse reactions of sore arm on the injection site, a low-grade fever, headache, nausea and vomiting.
12 hours after vaccine: severe body aches, sever abdominal cramps, vomiting, extreme fatigue. I took one ibuprofen and 1/2 a tab of Norco and was able to work. I repeated the medication twice that day (4 hour intervals). At 24 hours post vaccination, my sever symptoms subsided and I was only slightly achy and mild fatigue. A few months later I began having tendonitis in my left deltoid (where the vaccine was administered).
Initially started with painful vesicular pustular rash, progressed to headache and neck pain. Diagnosed with VZV meningitis and currently undergoing 14 days of IV acyclovir. MRI brain negative and immune work-up negative to date.
Report received from a PharmD on 27-Oct-2008.  PharmD reported that a patient (initials, DOB and gender unspecified), over 18-years-old, experienced shingles/chicken pox after receiving AFLURIA (CSL influenza vaccine, data of administration unknown).  It is not yet known how long after receiving AFLURIA that the patient experienced shingles/chicken pox.  The reporter is not sure if the patient had any other disease states or medications.  Additional information has been requested.  ASSESSMENT:  No serious criteria mentioned.  Causality:  unclassifiable/unassessable;  Follow-up information received on 07-Nov-2008 from PharmD.  A 26 year-old male patient (G.S.L./DOB 16-Jul-1982), received AFLURIA (CSL Influenza vaccine) on the upper deltoid IM on 01-Oct-2008 at 7:30 pm.  Lot 02349111A was administered.  At the time of vaccine, patient had no illness.  No pre-existing conditions or allergies nor concomitant medications were noted.  On 15-Oct-2008, patient started to get itchy around lower extremities and had severe pain in trunk.  Patient saw his physician who diagnosed symptoms as shingles (no mention of chicken pox as noted earlier).  Physician stated treatment would be in vain after shingles breakout.  Patient is recovering.  No further information is expected.  The company considered events as unlikely to be related to the administration of AFLURIA.  Information derived from this AE report dies not change the current safety profile of AFLURIA (FLUVAX).
shortness of breath , HA, fatigue, nausea and vomiting from date of vaccine until current per patient
1st day: Soreness in right arm. 28 hours later: all Joints very achy. Fever of 100.3 degrees. Chills Intestinal distress. diarrhea. gas. overall exhaustion.
I had my vaccination on 09/14/2022. I started to experience mild nausea tinnitus and fatigue on 09/14/2022.  On 09/15/2022 and 09/16/2022 I had arm soreness transient nausea and tinnitus. On 09/17/2022 I had malaise weakness body aches worsened tinnitus headache nausea right lumbar muscle spasms and I was on bed rest. 09/18/2022 Symptoms persisted and I had a near syncope episode. I had right inguinal pain from back to legs almost like an ovarian cyst rupture. Pain persisted throughout the week and I went to the Emergency room on 09/23/2022. I am still having symptoms to include back pain fatigue malaise and body aches.
This spontaneous report was received from a pharmacist via a company representative refers to a 75 year old female patient. On 06-JUN-2015 the patient was vaccinated with ZOSTAVAX (lot # L000449; expiry: March 2016) (dose, route, frequency unspecified). No concurrent medications were reported. Approximately in June 2015 patient developed pain, itching and redness at the injection site after receiving the vaccine. The outcome of pain, itching and redness at the injection site was unknown. Causality was not reported. Additional information has been requested.
First day very nauseous. Three days very tired Then very itchy left arm seven days later. Looks like 20 small spider bites all in one area
Vaccine Not removed From Freezer at 2wk mark - at 3 wks and administered P consult manuf. Notified Pt offer Repeat dose. Repeated 01/25/22
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked with 2018SA218718, 2018SA223733, 2018SA220766, 2018SA220773, 2018SA220774 and 2018SA218532 (same reporter). This case involves four-year-old (four year 14 days) patient of an unknown age who received a dose of DAPTACEL (lot number, expiry date, dose, route and site of administration were not reported) instead of QUADRACEL (lot number and expiry date were not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
pt recvd vax 17AUG95 & 14SEP95 pt devel a varicella like rash w/5-6 lesions located on abd, arm, lt ear & upper chest w/o a fever;
Pfizer Bivalent Covid Vaccine was given over the 12 hours counter time period. The vial was moved to the counter at 5:15pm on 10/7/222, and was first puncture at 5:40pm on 10/7. Vial was not discarded, and vial was used on 10/8/22 at 1:36pm.  Spoke with our Clinical Pharmacist who was able to obtain information from the Pfizer website. She was able to refer to Table 2: Summary of Data to Support Inadvertent Exursions to the Labeled Storage for Vaccine in Punctured Vials and/or Syringes. No additional follow up is needed.
Nauseous, fever (102 degrees F), full-body muscle twitch (once during the night), severe arm soreness.  Still nauseous as of now, but otherwise generally improved.
The patient stated 2 days after her booster injection, she developed swollen lips. We advised her to contact her physician for immediate assistance.