chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 67 years old female patient who experienced swelling at injection site, red swatches and they were hot to the touch and bruising at the injection site about 1.5 inches in diameter, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were not reported. On 19-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ004AB, expiration date 30-Mar-2019) via intramuscular route in the left deltoid. The patient developed a non-serious swelling at injection site, red swatches and they were hot to the touch that lasted for several days, and bruising at the injection site about 1.5 inches in diameter following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was bruising at the injection site about 1.5 inches in diameter, red swatches and they were hot to the touch and swelling at injection site. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling at injection site and bruising at the injection site about 1.5 inches in diameter, and as Recovered / Resolved on an unknown date for red swatches and they were hot to the touch.
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    It was unknown if the patient was ever been diagnosed with or tested positive with COVID-19.  Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Patient complained of dizziness and not being able to see properly after she stepped out of the clinic, 10 minutes after receiving a  second dose of varivax:  manufacturer is Merck & co.; Lot number 1149F;Expiry date 09/28/2008.  She also complained of  weakness in her legs, nausea but no headache. Bp (lying) was 110/78 Pulse 72, respirations non-labored and regular.  Mom stated then that she had experienced a similar response to a previous vaccine but could not recall the name of the vaccine or date it was administered. Pt was allowed home after 20 minutes of observation as symptoms had disappeared with rest and a drink of cold water.  Mother was instructed to notify the Health Department if concerned or take her to the E.R. if symptoms reoccurred.
frozen vaccinations after having been at a temperature of -11C; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, Hib (Hiberix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 12th November 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Havrix, Hiberix, Bexsero, Bexsero Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix and Menveo. On an unknown date, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Havrix, Hiberix, Bexsero, Bexsero Pre-Filled Syringe Device, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Boostrix and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The nurse potentially administer frozen vaccinations after having been at a temperature of minus 11 celcius, which led to incorrect storage of drug. The reporter did not consent to follow up.
On his left elbow / redness like a bug bite; The area is hot to the touch; Looks like possibly an allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2021, the patient received the 1st dose of Shingrix. On 9th June 2021, 7 days after receiving Shingrix, the patient experienced erythema, feeling hot and allergic reaction. On an unknown date, the outcome of the erythema, feeling hot and allergic reaction were not recovered/not resolved.   It was unknown if the reporter considered the erythema, feeling hot and allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received his 1st dose in the right arm. A week post vaccination, the patient had a reaction on his left elbow and described it as redness like a bug bite and the area was hot to the touch. The patient also said it looked like possibly an allergic reaction. The reporter consented to follow up.
Patient states 15 minuets after vaccine was administered she felt feverish, chills last night started having headaches today in clinic has temp 101.0 pulse 121 pulse ox 100%.
Patient felt tightness in jaw within 15 minutes of administration of vaccine.  Patient developed bright red maculopapular rash over vaccine administration site (right deltoid)  45 minutes after delivery of the vaccine.  Rash spread rapidly to encompass entire upper arm and right shoulder. Within two hours, edema developed- area appeared bright red, hot to the touch, with obvious and palpable edema.  That evening, patient self administered an OTC H1 antagonist (Zyrtec 10mg PO), and contacted PCP.    Patient was instructed to add an H2 antagonist in the evening (famotidine 20mg PO), and go to the ER if condition worsened.  Patient now taking a combination of H1 and H2 antihistamines, which slowed the spread of the edema and rash, but not yet eliminated it.  Patient now at initial onset + five days and is still symptomatic, but condition has not worsened.  Still monitoring.
Child received first two doses of Pfizer 5-11 at age 11.  At age 12, she received the booster dose of Pfizer vaccine using the age 5-11 dose at the insistence of her parent.
Administered MCV4 and Hep A vaccine in client's Rt arm IM.  Client conversing with me and her mother throughout but showing some anxiety.  Lt arm vaccines given after were HPV and Tdap.  Shortly after completed with Lt arm, client's eyes rolled back and she appeared to be having a mild seizure. She laid back on table.  Around 15 secs passed and she sat up with help but was very lethargic. Said she was nauseated.  Client's mother went to waiting room to get family member while I stayed with client.  On return we discussed her going to her Dr or the ER.   Client family member attempted to carry her out and she passed out again in hallway.  Held and eased down to floor by family.  No harm to client during transfer.  I called 911 to have client evaluated  for safety purposes. No allergic reaction evident/ no redness, hives or breathing issues, just what appeared as a mild initial seizure and fainting episodes.  Client evaluated by EMS. Blood sugar and vitals within normal limits. Mother verbalized no known previous reactions to any vaccines.  Client transported to local ER for evaluation.  My vaccination info provided to client's mother and my contact information given.
Mom states pt got immunizations Monday 9/10/07 and that by Tuesday afternoon (9/11/07) patient was very cranky and "she looked like she had a huge purple bicep on left arm"; Mom gave her Tylenol yesterday (9/11/07) and "arm looks better today", but still a bit swollen and sensitive to touch.
Sirva on RA. Immunization given too high.  Arm was hurting, not getting better, but worse. Pt went to MD and was prescribed steroids which are helping.
burning sensation; Discomfort; intermittent arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 1st dose of Shingrix. On 30th July 2019, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced burning sensation and discomfort. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the burning sensation and discomfort were unknown.   It was unknown if the reporter considered the pain in arm, burning sensation and discomfort to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. For a week, the patient felt like she just got the shot and experienced discomfort, sore, hurts not swollen or itchy. The patient thought this pain would go away but she still gets it intermittentenly throughout the day sometimes it wakes her up during the night. The caller's arm was hurting and burning during the call. The caller got the shot at and she had since moved to her winter residence.  The reporter consented to follow up.
FEVER FOR AT LEAST 12 HOURS DRENCHED IN PERSPIRATION DIZZINESS INJECTION SITE WAS SWOLLEN, HOT AND PAINFUL DIFFICULTY BREATHING WEAKNESS
Mom reports pt screamed continuously w/o ever stopping for 3-4 days despite APAP;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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), on 01Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: COVID-19 VACCINE taken for covid-19 immunisation as dose 1, single as dose 2, single as dose 3 (booster), single; ATORVASTATIN, stop date: 25Aug2022; TAMSULOSIN; SYNTHROID; VIT D3. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (02Sep2022) Negative, notes: tested negative 02Sep2022; (05Sep2022) Positive, notes: Paxlovid rebound, tested positive 05Sep2022,. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Known allergies was reported as none. Other medication in 2weeks were reported as yes.
5 days p/vax pt devel cellulitis-redness, swelling, hot 10cm x 15cm in size around the site;began @ day 2 w/ a lump @ site-didn't have the nl DT rxn
When the headaches started it was mostly brief on the back of my head to the right and sometimes moved around. The headaches started to get more frequent. I went to the doctor, and they did a CT scan and X-ray. I was diagnosed with Chronic Rhinosinusitis and Chronic ethanol sinusitis. She also sent me for an MRI, and everything was normal. They also prescribed me two rounds of antibiotics.  I am also taking another medication twice a day. I am also suppose to see a neurologist.
Information has been received concerning fraternal twins that had the same shots on the same day. One child suffered ear infections and displayed speech and behavior regressing and the other did not. The only difference in their medical histories was that the regressed child had the hepatitis B vaccine (manufacture unknown) at 1 month of age and his twin sister had the hepatitis B vaccine (manufacture unknown) at 6 months of age. Upon internal review, behavioral disturbance and speech disorder were considered to be "Other Medical Events". No further information was reported.
Narrative: He reports having sx of right inguinal rash, abdomianl cramping, and wheezing about 3 days after the initial vaccination. Despite multiple attempts at further history gathering, Patient was only able to give the following details: *Right inguinal rash: itch and red, has had previously and put some sort of topical cream on it. He did not apply or try and therapies and did not contact his heath care team. *Wheezing and abomdinal pain: has had in the past. Unable to describe severity, associated sx, trippers, alleviating/exacerbating factors, timing, etc. States he has inhalers at home, but non are on med list. He notes taking his normal medications and the issues resolving within a day and not impacting his ADLs/IADLs.
Fever,  chills, stomach upset, bodyaches, pain at injection site and headache.
Tachycardia (HR>200), light headed, dizzy, cyclical vomiting
Systemic: Nausea-Severe, Additional Details: PATIENT PRESENTED TO EMERGENCY DEPARTMENT DUE TO SEVERE NAUSEA STARTING APPROXIMATELY 2 DAYS POST VACCINATION. PT STATES SHE WAS TOLD BY ED PROVIDER THAT VACCINE RESPONSE WAS MORE ROBUST DUE TO PREVIOUS COVID INFECTION. IT IS UNKNOWN IF THIS EVENT WAS ALREADY REPORTED TO VAERS BY THE ED PROVIDER. RPH ENCOURAGED PATIENT TO REGISTER AND REPORT VIA VSAFE.
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUL-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for CKD stage 4, HTN, CHF, Atrial fibrillation, gout, advanced age. No information regarding death. Was evaluated for pleural effusion in April by pulmonary but was chosen for a conservative management.
Redness, swelling, limping > 24 hours. Tylenol, Keflex 500 BID X 7 days. Follow-up prn.
Tingling / pins & needles lips & tongue - right side. Has progressed "numbness L novocaine shot" (R) side face. No swelling at site no swelling in mouth. Pt noting improvement 11:07 AM. 1:00 No more pins & needles on mouth & tongue...still numbness in parts of right side of face, she feels it is improving.
Starring spell for 30 sec at home, after vax, no other sx's, no color changes, no loss of consciousness, no change in breathing, no h/o seizures. Dx: undertermined.
Patient arrived on 03JUN2021 to receive 2nd dose of Pfizer. Patient reported that following 1st dose of Pfizer and completing standard observation period of 15min, he developed onset of Hives and SOB 1 hour (10am) following administration of the Pfizer vaccine at 0900. Patient reports that he did not seek medical attention and chose to wait out the symptoms. Patient reported that his SOB resolved 30min following onset without medical intervention. Patient reported that his Hives resolved 2hours following onset without medical intervention. Patient 2nd dose of Pfizer was not given due to potential adverse reaction to 1st dose.
Fever, severe body aches, joint pain, site pain, and chills started approximately 12 hours after injection.  Lasted 24 hours. Fever continues now along with slight body aches, site redness, swelling, and itching along with sweating  but no chills. 45 hours after injection . I have been alternating advil and tylenol about every 6 hours. Temperature has ranged with 101.7 being the highest to 99.4 being the lowest.
Pt states that on 01/12 he went to get his 6th Anthrax shot; it was a normal reaction such as burning from Anthrax shot. Pt states that the following day it started swelling;pt also has some redness and tingling sensation in his right hand.
Day of my vaccine, felt fine, I felt terrific about 6 pm I started feeling tired, fatigue aches and chills lasted about 12 hours, then I started feeling bad April 9 , low grade fever 100.9 chills, I felt like crap that Thursday evening. I tested positive for Covid 19. I still feel my heart race.
her lips and gums were mildly swollen; her lips and gums were mildly swollen; This is a spontaneous report from a contactable other hcp.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included latex allergy with only swelling. The patient's concomitant medications were not reported. On Dec2020, the patient reported has mild latex allergy with only swelling and after receiving the vaccine, she noticed her lips and gums were mildly swollen. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Felt body aches through the day of Saturday, in the evening started coughing, runny notes and congestion. When getting ready for bed, noticed a rash on the shoulder where the injection was received, that night temp was at 98 close to 99 but never reached 99. Chills and next morning, congestion, and cough
Pt had syncopal episode with possible convulsion (passed out for about a minute, face turned purple, and had contractions of the arms and hands with sweating) about 10-15 minutes post injection. 911 called. Checked EKG, vitals, BG and was advised to go the ER but she refused for further evaluation.
diarrhea; The initial case was missing the following minimum criteria: Other-info not qualifying for AE reporting - All other source.Upon receipt of follow-up information on 22Sep2022, this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, 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: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.