chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate schedule of vaccine; Vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2019, unknown after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 2018, about 6 to 8 weeks later of receiving 1st dose, the patient received the 2nd dose of Shingrix.  The patient received 2nd dose earlier than the dosing recommendation of Shingrix, which led to shortening of vaccination schedule.  About 4 days ago (from the date of reporting), the patient developed Shingles. The patient was very frustrated and did not provide any further details.
Shortness of breath; Soreness; Swollen arm; Neck ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Soreness), PERIPHERAL SWELLING (Swollen arm), NECK PAIN (Neck ache) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 13-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Soreness), PERIPHERAL SWELLING (Swollen arm), NECK PAIN (Neck ache) and CHILLS (Chills). At the time of the report, DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Soreness), PERIPHERAL SWELLING (Swollen arm), NECK PAIN (Neck ache) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported. Pharmacist reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022 No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662860, US-MODERNATX, INC.-MOD-2022-662875 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871:Patient 9 US-MODERNATX, INC.-MOD-2022-662860:Patient 3 US-MODERNATX, INC.-MOD-2022-662875:Patient 11
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Nausea-Mild
Rashes started appearing on upper chest around the shoulder blade around third days after the second dose after the body ache and other side effect subsided.  The rashes are only slightly itchy. There is a shine to the rashes near the bone are but not where the flesh is. Used topical ointment once but there was not change.
multiple watery diarrheal stools per day, low grade fever  X 10  days (still ongoing)
Pt given injection in the superior anterior portion of right deltoid. Pt heard crunching sound. Pain has gradually worsened.
On Mon 01/3/06 10:00 found injection site red ring and pale flesh colored center.
nausea, vomiting, diarrhea, for 2 days. Did have pain and tingling in her arm that lasted several hours
Headache, vomiting, chest pain  2/9/09 Received PCP medical records. FINAL DX: none provided Records reveal patient experienced migraine HA, nausea & emesis.  Records are difficult to follow but it appears patient had exercise induced asthma on day of HPV #2, otherwise in good health.  No further records available. Will attempt to obtain Lot#s
Pt coughed up blood about 24 hours after getting vaccine.  Blood from nose blowing as well as in mucous/phlegm . Also report of headache afterwards
patient had worse flu ever after receiving the flu shot; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a patient (age and gender not reported) who experienced worse flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination  On an unknown date, the patient developed non-serious worse flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Detail: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign The Race for 200M, it was assumed that consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was not reported.  There will be no information available on batch number for this case.
I began experiencing primarily joint pain throughout my body, accompanied by some muscle pain as well. This began approximately 22 hours after vaccination, and became worse as it progressed, peaking approximately 27 hours post-vaccine. I took a hot shower, used an electric massager on joints and muscles, and went to bed early. When I awoke at 6:30 a.m. the next day, I was completely back to normal.
A female patient, whose age, medical history included allergic to monosodium glutamate, thimerosal, demerol, morphine, stadol, versed, intravenous contrast dye and concomitant medications were not reported, had received a dose of influenza USP trival a-b sub virion vaccine (flu vaccine) (lot number, route and site of vaccination were not reported), on an unspecified date in 2012. On an unspecified date in 2012, after receiving vaccine the patient experienced abdominal pian, diarrhea, and vomiting that lasted 2 to 3 days. patient had flu vaccine this year but did not receive a flu vaccine that had a preservative. She did not experience any abdominal pain, diarrhea after this year's flu vaccine. She only had hard knot and inflammation at site for this year's flu vaccine. Thein she stated she did throw up once today 25 November 2013, but thinks that was related to her "sensitive stomach" and the food she ate at a restaurant last night. At the time of this report the outcome of adverse event were recovered. Documents held by sender: none.
Red and warm patch on left bicep. Onset 3 days after receiving vaccine Reported heartburn and mild tiredness/muscle aches after receiving vaccine
Baby became very pale, white lips 3 brief seizures (2) hospitalizations - for decrease appetite, increase irritability poor eye contact, loss of verbal coo / 8 only - on day 4 after event - resolving symptoms. Seen in ER awake, alert, PE WNL. labs negative. CSF negative. Blood culture leukocytosis. MRI normal. EEG normal.  5/25/07-no DC summary only progress note available for short stay. received progress note Impression. new onset seizure times three without recurrence. question abnormal behavior, not seen here.
This spontaneous report as received from a pharmacists refers to an unspecified patient of unknown age and gender. No information on concurrent conditions and medical history was reported. No previous drug reactions or allergies were reported. On 29-SEP-2015, the patient were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route and frequency were not reported) lot # K021444 with an expiry date of 17-SEP-2016. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Swollen at injection site at right deltoid muscle. Rash present with urticaria on right upper arm and right facial cheek.
Patient reports that approximately 2 weeks after receiving the flu shot that she began to have pain in her shoulder/arm. She said that she did not have any stiffness or soreness immediately or within a few days after getting the immunization. She now reports having pain that sometimes radiates down the inside of her arm to her elbow. If she puts pressure her deltoid she feels pain and sometimes has difficulty lifting her arm. She reports never having a had a bad reaction to the flu shot before. I instructed her to reach out to her primary care provider.
Patient Received a dose of Monovalent Moderna when they were scheduled to receive the Bivalent Booster.  Patient Had no adverse reaction to this vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:40 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 79.67 No concomitant medications were reported.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Swollen lymph nodes, fever for three days, body aches covering entire body and joints, fatigue, headache. All events lasted for three days
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at that time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was reported.
Fever on Tuesday (no temp taken, felt hot), Per MD. Stated forhead and also a rash on diaper line. Fever, Rash, on body, face, trunk and extremeties. No SOB, HA, NV.
erythematous mildly pruritic rash  2 x 4 cm at site injection occurring two days after Moderna vaccine dose 2
RESIDENT HAD ALREADY RECEIVED A PFIZER BIVALENT BOOSTER  IN OCTOBER 2022 BUT DUE TO BOOKKEEPING ERROR SHE WAS ADMINISTERD A MODERNA BIVALENT BOOSTER  TODAY 1/6/2023
Nausea , diahrea , fatigue , muscle fatigue , high  fever , extreme back ache in lower back caused me to collapse to the ground when walking . Could not get up. Had to have help to get up lost all ability to move . Sick for a week extremely bad did not go to work could not afford to go to dr I don?t have  insurance .  I am still weak and not well .
After getting the vaccine I started to have a high-pitched ringing in my ears, more strongly in the left.
Palpitations; Running nose; Extreme injection site pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), RHINORRHOEA (Running nose), VACCINATION SITE PAIN (Extreme injection site pain) and FATIGUE (Fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations), RHINORRHOEA (Running nose), VACCINATION SITE PAIN (Extreme injection site pain) and FATIGUE (Fatigue). At the time of the report, PALPITATIONS (Palpitations), RHINORRHOEA (Running nose), VACCINATION SITE PAIN (Extreme injection site pain) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: TCR form - added email
patient was administered an expired Havrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 22nd September 2022, the patient received Havrix. On 22nd September 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 22-SEP-2022 Reporter's comment: Medical Assistant (MA) had called to inquire if any information was available. Medical Assistant (MA) had reported that a patient was administered an expired Havrix dose on 22nd September 2022.  Reporter was unable to provide any patient details. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Patient received a flu shot on 12/11/2018 in the morning to the left deltoid and that night  he had some mild swelling and redness to the site. Next day (12/12/2018) morning his arm was  moderately swollen and red and painful. Mom called and sopke to the MA, who told her to give  Benadryl and do a warm compress. The swelling had not improved and we saw him at the clinic.  He has a low grade temperature. Plan: Benadryl every 4 hours Prednisolone as directed (gave first dose in office) Warm compress to arm Push fluids Motrin as needed for pain and fever F/u prn Medications  prednisolone solution, oral 15 mg/5 mL Dispense: 44 (forty-four) milliliter Take 11 mL by mouth once a day for 4 days He was feeling much better by Friday 12/14/2018.
Receive a cortisone shot on his wrist for his inflammation; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called in because he received his first shot of the vaccine last 21Jan2021 and about to receive his second shot on 11Feb2021. He was asking if it's okay to receive a cortisone shot on his wrist for his inflammation before taking the second shot. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
patient reported rash and pain in chest, torso and back areas.  Instructed patient to see doctor.
Chills, nausea, vomiting, body aches, headache, fatigue for 48 hours
Patient complained of itching all over, coughing, dizziness and chest pain. Happened about 7 minutes after her first dose of the Pfizer vaccine.  Vital signs were within normal range while evaluating her. EMS was called but patient refused to go to the hospital.  She stayed for a hour, while constantly being evaluated.
Patient was given the Pfizer vaccine at a drive through clinic. While waiting for a reaction - about 15 to 20 minutes the patient developed a flush feeling and thickness of the tongue. Patient was given an epi pen shot to her left thigh and felt better within minutes. Patient refused to be transported to the hospital for evaluation.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to an exact T not recorded but noted a equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estiamted total time out of range of 10.5 hours. On 12-JUN-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
during post vaccination observation period- began feeling faint and weak. Notified clinic personnel and was moved to a private exam room.  Then began nauseated and felt like heart was racing.  VS taken and O2 sat within normal limits. Patient was observed for 30 minutes, no medicines or labs were done
This spontaneous report was received from a pharmacist and refers to a 17-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 29-MAY-2017, the patient was vaccinated intramuscularly with an expired dose of GARDASIL 9 (lot # M014929, expiration date: 27-MAY-2017; exact dose was not reported). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Patient was given booster shot about 30 mins after expiration time. No adverse reactions while patient was in clinic