chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax;1 day later, exp edema,redness & warmth at inj site;
Dose 1 shingrix on 1/17/2019, never got the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 17th January 2019 with batch number 9277N and expiry date 27th June 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The pharmacist asked if need to give the 2nd dose immediately or should revaccinate. The reporter consented to follow up.
Sun reaction- really blotchy- tender- skin- I immediately moved to the shade. The reaction lasted about three hours- I have pictures on my phone.
Sudden after 19 days  of the vaccine  severe abdominal pain and facial swelling, abdominal distention , i noticias facial swelling around parotids and subliminal área,  no fever they take me to emergency, the pain was very intente 10/10.
This spontaneous report was received from a nurse practitioner and refers to multiple patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (lot # M002419, expiration date: 12-JAN-2018; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Patient presented to the ED on 7/19 for shortness of breath and wheezing. At time of visit, she reported being diagnosed with COVID-19 about one week prior (approximately 7/12/22). During her ED visit, patient chose admission to the hospital for additional neb treatments and supportive cares.  She had an additional COVID-19 PCR test upon admission which was positive. Patient was admitted to the hospital from 7/19-7/21. She has been vaccinated and has received one booster. This meets case criteria for vaccine breakthrough case review.
felt like she might get sick, but she didn't; Shingles symptoms; Lethargy; Sore arm; a little tired; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm), HERPES ZOSTER (Shingles symptoms), ILLNESS (felt like she might get sick, but she didn't) and FATIGUE (a little tired) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis and Drug-induced lupus erythematosus. Concomitant products included PROPRANOLOL, LEFLUNOMIDE, FOLIC ACID, GLUCOSAMINE SULFATE (ARTHROSTOP [GLUCOSAMINE SULFATE]), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), METHOTREXATE and PROBIOTIC 10 for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced FATIGUE (a little tired). On 26-Jan-2021, the patient experienced LETHARGY (Lethargy) and PAIN IN EXTREMITY (Sore arm). On 11-Feb-2021, the patient experienced HERPES ZOSTER (Shingles symptoms). On an unknown date, the patient experienced ILLNESS (felt like she might get sick, but she didn't). The patient was treated with LIDOCAINE for Shingles, at an unspecified dose and frequency and PREGABALIN for Shingles, at an unspecified dose and frequency. On 31-Dec-2020, FATIGUE (a little tired) outcome was unknown. On 28-Jan-2021, LETHARGY (Lethargy) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. On 08-Apr-2021, HERPES ZOSTER (Shingles symptoms) had resolved. At the time of the report, ILLNESS (felt like she might get sick, but she didn't) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications included  Certex.  The patient was diagnosed with shingles on 16-Feb-2021 when she went to her doctor. It was a very significant case and it crossed two dermatomes. The patient received steroids to treat it.   This case was linked to MOD-2021-273108 (Patient Link).
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated orally with improperly stored ROTATEQ (lot number reported as L01026, expiration date 22-JAN-2017, dose was not reported). Concomitant therapy was not reported. The temperature of excursion was 50F and the time frame was 6 hours. There was no previous temperature excursion. It was stated that it was due to a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Soreness in arm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Soreness in arm), PYREXIA (Fever) and CHILLS (Chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced AXILLARY PAIN (Soreness in arm), PYREXIA (Fever) and CHILLS (Chills). On 07-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, AXILLARY PAIN (Soreness in arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Got shingles shot then got a mild case 3 mos later/Suspected vaccination failure; Got a mild case, it was horrible; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle shot then got a mild case of shingles 3 months later. The patient reported that it was mild and had been still horrible. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Client began having tightness in neck and face, tingling around mouth, and blotchy skin. Spoke with her primary, he suggested administering epi: 0.5 ml of 1mg:1000mL.  Administered dose in R deltoid 30 minutes following vaccine administration, client began feeling better immediately.
Rapid heart rate,  high blood pressure, no sleep for 11 days after injection, discomfort in chest area, shortness of breath / irregular breathing pattern, felt at times like heart wanted to jump out of chest.
Information has been received via field representative from a nurse referring to an 11 year old female patient with allergic to unspecified antibiotics. On 07-DEC-2015 the patient was vaccinated with her first dose of GARDASIL 9 (intramuscular, dose and lot # were unknown). Concomitant therapy included MENACTRA, vaccinated on the same day in the same unspecified arm. Later that evening, the patient developed hives on her chest. The patient sought medical attention via office visit. BENADRYL was given to treat the event. The nurse was unsure at this time if the 2nd and 3rd series of GARDASIL 9 would be given to the patient due to the hives. The outcome of the event was unknown. The causality was not reported. Additional information has been requested.
Horrible pain at the site of injection, spreading to entire arm, neck, shoulder and back.  High fever 103+ shivers, body aches.  Still sick.
w/in 24 hrs of vax devel h/a low grade temp 99, myalgia x 48 hrs, then temp to 102.4, w/severe h/a, stiff neck & shoulders cough 4 more days; resolution of temp on day #7-h/a persists although less severe;
pressure on his chest; trouble breathing; covid arm; nausea; fatigue; severe and very painful; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure on his chest), DYSPNOEA (trouble breathing), VACCINATION SITE REACTION (covid arm), NAUSEA (nausea) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (pressure on his chest), DYSPNOEA (trouble breathing), VACCINATION SITE REACTION (covid arm), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (severe and very painful). At the time of the report, CHEST DISCOMFORT (pressure on his chest), DYSPNOEA (trouble breathing), VACCINATION SITE REACTION (covid arm), NAUSEA (nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (severe and very painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
severe gastrointestinal pain and loose, frequent loose bowel movements lasting 96 hours; fatigue headache lasting move than five days.
itching, swelling and redness of the injection site within 4 hrs of injection; generalized hives within 12 hrs of injection
Chills; Nausea; Had a fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Had a fever of 101) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Blood pressure abnormal, Cholesterol total abnormal NOS, Thyroid disorder NOS and Heartburn. Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Had a fever of 101). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (Had a fever of 101) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was concomitantly taking blood pressure med, cholesterol med, Thyroid med, and heartburn med.
Developed shortness of breath, hives, itching all over approximately 30 minutes after being given PPD, Influenza vaccine, and Tdap.  Sent to ER; received diphenhydramine, epinephrine, atarax, solumedrol and Rx for medrol dose pack, zantac.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The age of patient was reported as 75.41. Concomitant products were not provided. For Lot no : 019B21A on 30-Mar-2021, excursion time was 9 AM and temperature was 34 respectively, total doses given for the day was 173, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021 and was moved to clinic on  30-Mar-2021. 03 vials was sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
developed headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: HEADACHE (non-serious), outcome "unknown", described as "developed headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two occasions of waking up with very rapid heartbeat, approx. 140-160 bpm, lasting 3-5 minutes. I have never before had heartrate runs of this length. No recurrence since.
Significant right hip pain, aggrevated with extending sitting, caused limited weight bearing ability.  Resolved in approximately 48 hours
Patient came in and said about a month ago she was given PNEUMOVAX shot. When she was home it started to turn red-redness spread down arm was sore and had limited movement this lasted about 5 days. Did not call Doctor. She informed him a last appt.
LOSS OF SENSE OF TASTE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On unspecified date, the patient previously received covid-19 vaccine from an unspecified manufacturer (dose number in series: 1) (form of admin, route of admin, and batch number were not reported), dose was not reported, 1 total administered, for prophylactic vaccination. It was unknown whether patient had adverse events following vaccination with covid-19 vaccine from an unspecified manufacturer (dose number in series: 1). On unspecified date, the patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced loss of sense of taste (dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of loss of sense of taste was unknown. This report was non-serious.
Symptom onset 7/29/22. Admitted to hospital 8/4/22 after failed paracentesis. Treatment includes fluid treatment with lasix and assessment.
This spontaneous report as received from a 60 year old female patient regarding herself. There were no concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 15-SEP-2016 the patient was vaccinated with ZOSTAVAX (dosing details, lot# and expiry were not reported) subcutaneously (developed herpes about 6 years ago and had break outs on her upper lip, maybe 5 times a year). Her sister as a physician suggested her to try ZOSTAVAX, because she knew of someone{unspecified} who was a teenager with HSV3 who had the smallpox vaccine and it cured herpes. The patient stated "My large sore on my lip disappeared in 2 days (approximately 17-SEP-2016) from the day I received the ZOSTAVAX". The patient did not seek any medical attention. There were no product quality complaints (PQC) involved. Additional information has been requested.
No adverse effects reported; inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a physician refers to a 4-year-old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 20-MAY-2019, the patient was inadvertently vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # M045205 and expiration date 11-NOV-2018) (dose, route and frequency unknown) for prophylaxis (expired product administered). No adverse effects were reported. PQC (product quality complaint) was not reported.
My arm was sore and had a little bit o swelling and fever for two day, and pretty achy.  About 2-3 weeks later I had swelling in my armpit and pain.  I did an email consult with my Dr.  they wanted me to come in and couldn't figure out what was wrong, They sent me for labs, ultrasound and mammogram. Everything came back ok. Dr. did not know what the actual cause was.
Patient reports chest discomfort/minor pain starting approximately 2 days following injection. Sitting made the discomfort worse, standing helped to alleviate it. Heart rate did not seem off, but location of pain/discomfort was near heart. Pain/discomfort lasted into the next day following an evening of rest. 400 mg of Ibuprofen administered ~18 hrs after initial onset helped to lessen symptoms.  Additional 400 mg of Ibuprofen and 10mg Loratadine was taken a ~4 hours later. Symptoms did not return the following morning.
9hrs p/vax pt devel spinal pain, nausea, myalgias, felt feverish
Pt developed rash on left ear, neck and upper torso at 9:25 AM, pulse 100 and BP 90/60 Pt received 25 mg Benadryl elixir. Parents were phoned at this time.  At 9:50 AM, pulse 84 and BP 86/62 called mother and asked her to come get child.  Pt to wait in clinic with school nurse until mother arrived.
Severe under armpit swelling with severe pain  to the left side . Swollen lymph nodes
Patient had facial spasms; This is a spontaneous report from a contactable physician. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05May2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 the patient experienced facial spasms. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of facial spasm and included treatment with Klonopin. The clinical outcome of the event facial spasms was resolved on unknown date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Received Pfizer lot EL1284 on 1-4-2021 in left arm.  On 1-5-2021 started to swollen lymph node in left arm pit.
administered Pentacel that was mixed with Quadracel instead of the Pentacel diluent with no reported adverse event; administered Pentacel that was mixed with Quadracel instead of the Pentacel diluent with no reported adverse event; Initial information received on 01-Aug-2022 regarding an unsolicited valid non-serious case received from a physician. GMI number: 01215828  This case involves Infant female patient who was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was mixed with quadracel instead of the pentacel diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received Suspect Pentacel Vaccine mixed with quadracel instead of the Pentacel diluent at dose 0.5 ml once (lot UJ660AA, expiry: 25-Feb-2023) via unknown route in unknown administration site for immunization with no reported adverse event (product preparation error, poor quality product administered).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both events.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Headache, tiredness, muscle pain and tingling down the left arm, feeling unwell, feels swollen but doesn?t appear to be