chrisvoncsefalvay/vaers-outcomes huggingface dataset:
c/o itching & burning sensation of skin, face, neck, chest, back upper & lower extremities were red & swollen;pt given adrenaline & DPH;
Lost my hearing in my left ear.  Have ringing in my left ear.  My site has been reduced
expired dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
This is a spontaneous report from a contactable nurse who reported from physician's office via a sales representative. This contactable nurse reported similar events for 3 different patients. This is one of 3 reports. An elderly patient (over 65 years of age) of an unspecified gender and ethnicity received, on an unspecified date (in early February), PREVNAR13; Lot: J67647) single dose, via an unspecified route of administration,. Relevant medical history and concomitant medications were unknown. The patient experienced redness and itching on an unspecified date. Clinical outcome of the events was unknown at time of this report.
Sore Throat; Pain at injection site (LEFT); Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), VACCINATION SITE PAIN (Pain at injection site (LEFT)) and FATIGUE (Fatigue) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Clotting disorder and Anemia. Concomitant products included RIVAROXABAN (XARELTO) and IRON for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), VACCINATION SITE PAIN (Pain at injection site (LEFT)) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE SULFATE (CORICIDIN D COLD FLU AND SINUS) at an unspecified dose and frequency. On 26-Jan-2021, OROPHARYNGEAL PAIN (Sore Throat) had resolved. On 28-Jan-2021, VACCINATION SITE PAIN (Pain at injection site (LEFT)) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient skipped dose of Xarelto on 1MARCH2021 and 2MARCH2021 (before and day of vaccination) without recommendation of HCP.
Itch and hives at injection site 2 hours  after flu vaccine was administered.  Baseball size welt following day.
Pt came in and showed me a large knot/mass under her arm-- the arm in which the vaccine was administered. Immunization site was warm to the touch and hard. Pt stated that knot under her arm was painful.
Pt developed lightheadedness and mild headache 15 minutes after the vaccination. HR was noted to be 120. After several minutes of observation, vital signs normalized and pt reported that her symptoms resolved. She elected to go home (was not driving) and declined EMS services.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 4 (booster), single (Lot number: Gj2524) at the age of 71 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Lymphocytic lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks: Yes. The patient received Paxlovid from 03Mar2023 to 08Mar2023 for treatment of COVID-19. Known allergies: No.
Patient had Shingles outbreak a day or so after the vaccination. Treated with VALTREX for 3 days.
Initial unsolicited report received from a nurse on 20-Jun-2017. This case involves a four-year-old male patient who was vaccinated with a first dose of QUADRACEL (Batch number: C5222AA) in LLE (site and route of administration), second dose of MMR (Batch number: M045393) in RLE (site and route of administration and second dose of VARIVAX (Batch number: M045205) in LLE (site and route of administration) (expiry date, route and dose were not reported for all three vaccines) on 25-May-2017 at 11:30 AM. Patient's illness at time of vaccination was reported as no. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies: none. Any other vaccination within four weeks prior to the suspect vaccination was not reported and other medications were used. On 25-May-2017 at 04:30 PM, five hours post vaccination, the patient experienced fever of 99 degree F, vomit, dry heaving, dense pain, swelling and suspected viral infection, patient did got a scratch on his leg from trying to pull the needle out. Other laboratory investigations were not reported. Corrective treatment were includes MOTRIN and TYLENOL (reported as dad seeking advice). The patient's outcome for all the events was reported as recovered. It was reported that on an unknown date, patient was feeling better and denied diarrhea and temperature was 98 degree F. In site of scratch was clean and without redness or drainage. List of documents held by sender: none.
chickenpox; This spontaneous report was received from a physician assistant refers to a 4-year-old female patient. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, units, frequency, lot# and expiration date unknown) for prevention of chicken pox. It was unknown who administered the dose to patient. On a later unspecified date, within the last 6 months the patient experienced chicken pox. The patient sought the medical attention. The outcome of chicken pox was reported as recovered, so the physician does not want to send the samples. Causality of the event was not reported. No PQC (product quality complaint) was present.
No additional AE; a patient received an expired dose of MMR-II; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male.  The patient's medical history included  respiratory failure, tracheostomy, and ill-defined disorder. The patient's concurrent conditions included  digeorge's syndrome, and tetralogy of fallot. Concomitant therapies were not reported.  On 27-APR-2023, the patient started therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, lot #U011995, expiration date: 15-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).  On 27-APR-2023, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse event (AE) (no adverse event). At the time of reporting, the outcome of the event a patient received an expired dose of MMR-II was not known. The action taken with M-M-R II regarding a patient received an expired dose of MMR-II was reported as Not Applicable.
Subacute paranoid delusions and A/V hallucinations for 1 week (since 3/29), in setting of severe insomnia since second covid vaccine on 3/24. No personal or family psychiatric history. No substance use. Increased risk for delirium and encephalopathy in general given fragile brain. All medical workup for new-onset psychosis has been negative. Patient is being admitted to the inpatient psych unit.
Had both shingles vaccines, still developed shingles/Suspected vaccination failure; Shingles; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shingles vaccines, still developed shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine and Shingles vaccine.   The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAR-2023  This case was reported by a patient via  interactive digital media. The patient had both shingles vaccines. However, she still developed shingles after. The reporter stated that just because you got the shingles vaccines, it would not prevent you from getting shingles. The reporter thought that the event might had been related to the drug. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible, as no contact details were available.
Pt got an infection at the site of injection-went to MD and was put on antibiotics.
hot arm at injection site; red arm at injection site; swelling at injection site; sore and painful at  injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 21st October 2022, 1 hr after receiving Shingrix, the patient experienced injection site pain. On 24th October 2022, the patient experienced injection site warmth, injection site erythema and injection site swelling. On 23rd October 2022, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter stated that the patient received her first Shingrix vaccine on 21st Oct 2022, in the left arm.   The reporter stated that her arm was sore and painful at the injection site when she received the vaccine and that resolved a few days later.  The reporter also mentioned about 3 days ago her arm became hot, red and swollen at the injection site area and has not resolved. The reporter gave consent to follow up.
LARGE RED, HARD AREA THAT HAS GROWN OVER THE LAST 3 DAYS AT THE SITE OF INJECTION
By evening a nickel size welt appeared at injection site.  It was red, swollen, and hard.  Plan: Watch.  Gone:  By Friday Sept. 4, 2009.
I had pain and soreness in left arm and chest area and there is a knot at the injection site to this day.
light-headed, almost dizzy; really tired; Terrible headache; Pain on my arm; lump; Felt warm; lump was half a tennis ball size; Numbness in elbow down to the wrist on the same arm for 2 days; Swollen glands on neck on the left side; 102 fever; I had COVID again; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light-headed, almost dizzy), FATIGUE (really tired), HEADACHE (Terrible headache), PAIN IN EXTREMITY (Pain on my arm) and MASS (lump) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-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 DIZZINESS (light-headed, almost dizzy), FATIGUE (really tired), HEADACHE (Terrible headache), PAIN IN EXTREMITY (Pain on my arm), MASS (lump), FEELING HOT (Felt warm), MASS (lump was half a tennis ball size), HYPOAESTHESIA (Numbness in elbow down to the wrist on the same arm for 2 days), LYMPHADENOPATHY (Swollen glands on neck on the left side), PYREXIA (102 fever) and SUSPECTED COVID-19 (I had COVID again). At the time of the report, DIZZINESS (light-headed, almost dizzy), FATIGUE (really tired), HEADACHE (Terrible headache), PAIN IN EXTREMITY (Pain on my arm), MASS (lump), FEELING HOT (Felt warm), MASS (lump was half a tennis ball size), HYPOAESTHESIA (Numbness in elbow down to the wrist on the same arm for 2 days), LYMPHADENOPATHY (Swollen glands on neck on the left side), PYREXIA (102 fever) and SUSPECTED COVID-19 (I had COVID again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 in response to the event was not applicable   Patient states she had COVID previously and lost her sense of taste and smell that November 2020.
This was a booster shot (3rd). Side effects began within hours of administration and lasted for 3 days. They included debilitating  body aches, migraine, sore throat, labored breathing, fatigue, somnolence and loss of appetite that kept me in bed for days. Ibuprofen and Tylenol made no difference. The experience felt like a serious case of flu but without the fever. The same side effects were experienced after the 2nd shot although the time after the 1st shot was uneventful.
Injection site was warm; Injection site red; Injection site raised swollen; Injection site itching; This is a spontaneous report from a contactable nurse, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6207), via an intramuscular route in the left arm on 18Mar2021 at 15:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included losartan (MANUFACTURER UNKNOWN), LO LOESTRIN, propranolol (MANUFACTURER UNKNOWN) and EFFEXOR. The patient previously received ALEVE and codeine and experienced an allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Mar2021 at 09:00, the patient reported that the injection site was warm (vaccination site was warmth), red (vaccination site erythema), raised, swollen (vaccination site swelling) and itching (vaccination site pruritis). The adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event injection site was warm, injection site red, injection site raised swollen and injection site itching were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient got 1st dose of primary series of Moderna covid-19 vaccine on Jul-2022 from a competitor. His 2nd dose from competitor was given Pfizer Covid-19 Bivalent in Dec-2022.), COVID-19 IMMUNISATION (Patient got 1st dose of primary series of Moderna covid-19 vaccine on Jul-2022 from a competitor. His 2nd dose from competitor was given Pfizer Covid-19 Bivalent in Dec-2022.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.
Hoarse voice/Voice raspy; Sore throat; Dizzy/Felt Dizzy; Vaccination site stinging/stung; Muscle soreness/COVID shot caused sore muscle; Dry eyes; This spontaneous case was reported by a consumer and describes the occurrence of DRY EYE (Dry eyes), DYSPHONIA (Hoarse voice/Voice raspy), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy/Felt Dizzy) and VACCINATION SITE PAIN (Vaccination site stinging/stung) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Rheumatoid arthritis.    Concomitant products included INFLUENZA VACCINE for Prophylactic vaccination.   On 09-Mar-2002, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In 2021, the patient experienced DRY EYE (Dry eyes), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy/Felt Dizzy), VACCINATION SITE PAIN (Vaccination site stinging/stung) and MYALGIA (Muscle soreness/COVID shot caused sore muscle). On an unknown date, the patient experienced DYSPHONIA (Hoarse voice/Voice raspy). At the time of the report, DRY EYE (Dry eyes), DIZZINESS (Dizzy/Felt Dizzy), VACCINATION SITE PAIN (Vaccination site stinging/stung) and MYALGIA (Muscle soreness/COVID shot caused sore muscle) outcome was unknown and DYSPHONIA (Hoarse voice/Voice raspy) and OROPHARYNGEAL PAIN (Sore throat) was resolving.            No concomitant medications were reported. No treatment drugs were reported.  The reporter's causality for the event(s) of COVID shot caused sore muscle, stung, felt dizzy and dry eyes, and voice raspy was not provided. The reporter's causality for the event(s) of sore throat with Humira (ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-625117 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: Significant live follow up ( received updates to event information, reporter opinion of causality, suspect drug information, Dose details,concomitant drug information and narrative description).
pt recv vax 5MAR97 & w/in 24hr it was reported that pt had devel a large local rxn that was red & warm to touch;
Onset of cough 03/25/2003. Wheezing and increased cough on 03/27/2003. Seen ER and admitted Diagnosed with respiratory syncytial virus. One week later, was again hospitalized this time with diarrhea. Diagnosed with rotavirus. Patient has a twin sister (see her report 248545). 01/31/2006 Reviewed d/c summary for 3/27/03 admission. Diagnosis was RSV bronchiolitis. Symptoms upon admission included cough, runny nose, and wheezing. Reviewed d/c summary for 4/3/03 admission. Diagnosis was gastroenteritis. Diarrhea and dehydration were presenting symptoms
Patient admitted to hospital with stroke after received booster dose of Covid vaccine.  Patient received alteplase.
no additional AE reported; expired PROQUAD was administered to a 5 year old patient; This spontaneous report was received from a pharmacist intern on behalf of pharmacist and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.   On 14-OCT-2020, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S008574, expiration date 16-SEP-2020, 0.5 milliliter given once (reported as x1) (route and site of administration was not provided) for prophylaxis. No additional adverse event was reported. The outcome was unknown.
Sore arm for two days Low grade fever, starting 8 hours after the shot and lasting 24 hours
Pfizer Bivalent booster 5-11 (Orange) VS the 12+ (Gray)
Received 1st dose of Shingrix in 2019 and dose 2 in March 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2019).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Received 1st dose of Shingrix in 2019 and dose 2 in March 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The reporter did not want to provide any other information. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
DIFFUSE HIVES COVERING ENTIRE BODY & FACE, MORE CONCENTRATED ON ARM WERE INJECTION GIVEN, PAIN AT SITE, WARM TO TOUCH. HIVES STARTED AT APPROX. 5PM AND GOT WORSE AS THE NIGHT WENT ON. TX- BENDRYL ZANTAC, PRELONE.
Dfficulty staying asleep, startling and stiffening of body while sleeping, crying, reflux, difficulty keeping formula down.
Began feeling dizzy almost 15 minutes after the injection. Gradually also felt nauseous and foggy.