chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 11:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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 74.42 for dose administered on 07-JAN-2021.  No concomitant medications were reported.  underwent temperature excursion 07-JAN-2021 with temperature 34 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-JAN-2021 and beyond use date for the vial was reported 27-JAN-2021. Product moved to clinic 07-JAN-2021.  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.
Arm soreness; 2 small itchy spots about the size of a flea bite or smaller on neck about two hours after and a larger sized itchy bite like spot on other side of neck about 8 hours later; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the right arm on 15Mar2021 at 12:00 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medical history included anemia, psoriasis, high cholesterol, dust allergy. Concomitant medications included vitamins. Allergies to medications, food, or other product reported as sensitive skin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 14:00, the patient experienced itchy rash (two small itchy spots about the size of a flea bite or smaller on neck about 2 hours later, and a larger sized itchy bite like spot on other side of neck about 8 hours later) and painful arm at 18:00. The patient did not receive treatment for the reported events. The clinical outcome of painful arm and of the itchy rash was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (gave him an empty vial or used syringe, so they revaccinated him) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (gave him an empty vial or used syringe, so they revaccinated him) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION ERROR (gave him an empty vial or used syringe, so they revaccinated him) and NO ADVERSE EVENT (No adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. 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. No treatment medication was provided.
Pt experienced itching the the afternoon post vax. The following day he received an IM shot of Benadryl. The pts reaction resolved one and a half days post vax.
A few minutes after receiving the Havrix immunization, the patient stated she was warm and her head did not feel right and that she was nauseated.  She  had put her head down and the started to vomit.  After about 4 minutes  she stated she felt better.
Information has been received from a medical assistant at a physician's office concerning a female patient who on an unspecified date was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot number not reported). Subsequently the patient experienced a knot/cyst at the injection site. The physician removed it surgically. X-ray and biopsy were performed (result not provided). At the time of the report, the patient was recovering. No further information is available.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 18-year-old female patient who received HAVRIX 1440 adult (batch number 4G7P2, expiry date 3rd October 2015). On 15th December 2014, the patient received the 2nd dose of HAVRIX 1440 adult. On an unknown date, the dose was an unknown dose. On 15th December 2014, an unknown time after receiving HAVRIX 1440 adult, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: On 6/13/14 this patient received their 1st dose of HAVRIX as the pediatric dose. On 12/15/14 the patient received the 2nd dose of HAVRIX as the adult dose when they should have been given the pediatric dose.
Possible cellulitis; left arm stiff; itchy redness on the area of injection; itchy redness on the area of injection; A spontaneous report was received from consumer concerning a 84-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy redness the injection site on her left arm, her left arm is stiff, and possible cellulitis.  The patient's medical history and concomitant product use were not provided.  On 28-Jan-2021, the patient received the first of two planned doses of mRNA-1273, (Lot number 007M20A), intramuscularly into her left arm for prophylaxis of Covid-19 infection.  On the morning of 05-Feb-2021 the patient noticed, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff. The patient was examined by her doctor that same day and was prescribed Doxycycline for a possible cellulitis.  No relevant laboratory tests were ordered.   Action taken with mRNA-1273 in response to the event  was not provided.  The outcome of the events, itchy redness, 4X6 inches in size, 4 inches below the injection site on her left arm and her left arm is stiff and possible cellulitis were unknown.; Reporter's Comments: This case concerns an 84-year-old female who experienced a serious unexpected event of cellulitis along with a NS unexpected events of stiffness and injection site pruritus and NS expected event of injection site erythema.  The events occurred 9 days after the first dose of mRNA-1273. Treatment included doxycycline. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 20JUN95 foster mom called 21JUN95 to report that pt had screamed & spit up for 8hr starting 6 hr p/vax; slept 10 hr & woke w/dry diaper; sat quietly x 3 hr; had a red pharynx;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 85-year-old male patient. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Patient came in for their second dose of Pfizer toddler primary dose series. I noticed the lot number for the first dose was a pediatric Pfizer lot number. Initially, I was not sure if it was a clerical error or an incorrect vaccine given. I notified the parent their child received pediatric Pfizer vaccine instead of toddler upon speaking to the pharmacist on duty on 6/26/2022. The pharmacist was not aware that there was a separate vial for toddler Pfizer vaccine (maroon color). The parent stated the child did not experience any side effects as a result of the first dose (pediatric dose: orange cap). Error discovered on 7/17/2022.
7 days after vaccination a 5x3cm rash developed at the vaccination site. Itching, red and swollen skin. Lasted for 3 days and went away with OTC Benadryl and Hydrocortisone Creme.
she had soreness; Bivalent on 10Apr2023 which was past its beyond-use date of 04Apr2023; Bivalent on 10Apr2023 which was past its beyond-use date of 04Apr2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID:.  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Apr2023 as dose number unknown (booster), 0.3 ml single (Lot number: GJ3270) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VARIVAX II taken for immunisation, on 10Apr2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 10Apr2023, outcome "unknown" and all described as "Bivalent on 10Apr2023 which was past its beyond-use date of 04Apr2023"; PAIN (non-serious), outcome "unknown", described as "she had soreness". The patient underwent the following laboratory tests and procedures: Tuberculosis: Negative, notes: She was tested for TB which was negative in the week prior.  Additional information: A Pharmacist was calling to get additional information because there was a potential that they have given an expired Pfizer Covid-19 Bivalent Vaccine to a patient, Caller was trying to verify any recommendation afterwards if the patient supposed to get a repeat dose or if it was okay for the patient to get the expired Pfizer Covid-19 Bivalent Vaccine.  Beyond use date (BUD) was 04Apr and it was given on 10Apr, 6 days later. The patient received the Pfizer COVID Vaccine grey cap, bivalent on 10Apr2023 the vaccine beyond use date was on 04Apr2023 administered between 5.15-5.30pm. So, the vaccine was given passed its beyond use date. patient said she had soreness and that was it, she is fine.   Follow-up (11Apr2023 and 12Apr2023): This is a spontaneous follow-up report from a contactable Pharmacist.  Updated information included: Primary reporter (full address, alternative email address added). Patient age at vaccination, name and date of birth added. Other medical history added. Lab tests added. Concomitant drug 'Varivax' added. BNT162b2 Lot number, Dose description, anatomical location added. Event Soreness added.  No follow-up attempts are possible. No further information is expected.
itching, swelling, redness at site of injection. swelling/redness about 5inches in diameter
Developed a cold sore; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old female patient received bnt162b2 (BNT162B2, Batch/lot # EY1685, or EJ1685) at single dose in the left arm on 21Dec2020 for covid-19 immunisation, through her work as workings in a high risk area.  Medical history included oral herpes (It is in the same spot as she has previous had other cold sores).  There were no concomitant medications.  The patient experienced developed a cold sore (oral herpes) on 22Dec2020 since receiving the vaccine. She started to notice on 22Dec2020 night. She was unsure that night if it was a cold sore, but she was sure on 23Dec2020. She thought it was a chapped lip, but it was not a chapped lip this morning. It was painful. It was in the same spot as she has previous had other cold sores. The cold sore was the 3rd one of her entire life. The vaccine outcome of cold sore was not recovered and worsened. Reporter assessed the event cold sore as not serious. She is wondering if she can take Valtrex, an anti-viral, to help with it, asking if Valtrex will interact with her vaccination. She was also scheduled out 17 days for her 2nd dose, and wants to make sure that is okay and this interval appropriate.
hives at the injection site; fever (100.1°F); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1°F)) 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 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1°F)). At the time of the report, VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1°F)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Edema, Fever, chills, local swelling, heat, erythema. L arm injection site and surrounding tissue with erythema, swelling, L axillary lymph nodes are enlarged and tender. Severe pain upper left arm. Tdap injection 9/2/08. 9/22/08-records received for DOS 9/6/08-presented to ED with C/O fever and pain and swelling at injection site of Tdap left upper extremity. Very painful axilla. Left upper extremity macular, warm erythema. DX hypersensitivity vs. cellulitis left upper extremity. Probably cellulitis possible abscess.
Severe nausea persistent to today?s date, headache, diarrhea, mild fever
CHILLS; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
A non-serious spontaneous report of administration to infant under 2 years old has been received from a Nurse Practitioner concerning a nine-month-old female, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. During the week of 10-Oct-2008 through 13-Oct-2008, FLUMIST was administered to four infants under two years old, including this patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
My arm got a hard knot at the injection site, turned red (about a 4 inch circle) with "fever"
PATIENT WAS DIZZY WHEN DRIVING HOME FROM FLU SHOT, PULLED INTO lot got out of car, passed out and Broke his jaw
Pt received vaccine on 1/12/13 and still has a significant welt that she feels has not really gotten any smaller since the time of vaccination. Redness & induration.
This spontaneous report was received from a medical assistant, regarding a 79 year old female patient. The patient's drug reaction allergies included erythromycin and cefuroxime. No concomitant medication or pertinent medical history were provided. On 23-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly in the left arm, lot # R018735 with expiration date 06-APR-2020, for prophylaxis (strength, dose and frequency were not provided). On 24-OCT-2018, the patient was experiencing redness (erythema) and swelling which extended from the left inner arm to the elbow(swelling of vaccinated limb), an unspecified lump on the inner arm (limb mass) and the injection site area was hot (vaccination site warmth). On 25-OCT-2018, the patient was examined by physician and treated with oral doxycycline. At the reporting time, the outcome of limb mass, vaccination site warmth, extensive swelling of vaccinated limb and erythema was resolving as upon examination patient stated that her arm had improved (also reported as not recovered). The reporter requested a lot checked. No laboratory studies were performed. The reported did not assess the relatedness between PNEUMOVAX 23 and the aforementioned events.
Herpes zoster rash on left posterior neck, vesicles in various eruptive stages, with erythema.
Flu shot was given to me at Pharmacy on a Friday evening. Early Sunday morning I was woken with ringing in my ear and numbness on right side of face and could not hear out of right ear.. Wife took me to clinic and they said I only had redness and prescribed drops. Later in the week I went to my doctor and said the same. I called ENT and requested to see doctor with out referral. I was injected with a steroid in the ear and up to mow I can not hear out of right ear.
warmth to the area; evolved into a larger rash; swelling to the area; Serum sickness-like reaction; joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warmth to the area), RASH (evolved into a larger rash), VACCINATION SITE SWELLING (swelling to the area), SERUM SICKNESS (Serum sickness-like reaction) and ARTHRALGIA (joint pain) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warmth to the area), RASH (evolved into a larger rash), VACCINATION SITE SWELLING (swelling to the area), SERUM SICKNESS (Serum sickness-like reaction) and ARTHRALGIA (joint pain). At the time of the report, VACCINATION SITE WARMTH (warmth to the area), RASH (evolved into a larger rash), VACCINATION SITE SWELLING (swelling to the area), SERUM SICKNESS (Serum sickness-like reaction) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and Concomitant medications were not provided.
pt recvd vax & devel vaginal yeast infect the first & only case ever exp;treated w/over the counter monistat & recovered on 8MAR94;pt recvd 3rd dose of vax w/no adverse effects;
Slight cough for 2weeks; Floundering; Fever; Aching feeling; Difficulty breathing; Chest sore feeling; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling) and DYSPNOEA (Difficulty breathing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling), DYSPNOEA (Difficulty breathing) and CHEST PAIN (Chest sore feeling). At the time of the report, COUGH (Slight cough for 2weeks), UNEVALUABLE EVENT (Floundering), PYREXIA (Fever), MYALGIA (Aching feeling), DYSPNOEA (Difficulty breathing) and CHEST PAIN (Chest sore feeling) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
diarrhea; dry cough; headache; muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (dry cough), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (chills) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (dry cough), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea), COUGH (dry cough), HEADACHE (headache), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details were not reporter by the reporter. Treatment details was not was reported by the reporter.