chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; Injection site reaction of redness; Injection site reaction of warmth; Injection site reaction of soreness; This is a spontaneous report from a non-contactable pharmacist (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unknown route of administration in the left arm on 19Jan2021 at 16:30 (at the age of 26-years-old) as a single dose for Covid-19 immunization. Medical history included skin of upper arm is affected by mild eczema/atopic dermatitis, keratosis pilaris, hypertrophic scarring all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to latex which causes a rash/ swelling. The patient's concomitant medications were not reported (did have other medications in two weeks, unspecified). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Jan2021 reported as for first day, the patient experienced Injection site reaction of firmness beneath skin, swelling, redness, warmth, soreness and on the second day also experienced itchiness. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pain was not recovered; pruritus was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.     No follow-up attempts are possible. No further information is expected.
Vaccine given on 7/6/2021 which was day 35 in refrigeration . Vaccine was moved from freezer on June 1 2021 and was labeled in refrigerator as hitting the beyond use date on July 1. This was an oversight on monitoring. Pfizer was notified and patient notified  and counseled on next steps. No adverse events reported by patients prior to or after notification .
Initial report received on 08-DEC-2005 from a patient in USA. A 41-year-old female patient with a medical history of no known allergies, increased cholesterol and asthma woke up with pain and stiffness in her fingers and joints bilaterally, i.e. approximately 2 days after the influenza vaccine (Fluzone SV '2005-'2006), lot no.: U1804AA administration in the left deltoid on 11-Oct-2005. Also she had some pain in the inner side of her elbows. Additionally, she complained of a "travelling pain" in her lower back, wrist and achilles tendon area bilaterally. The laboratory tests performed at an unspecified time revealed mycoplasma pneumonia elevated. Pain continues to persist. Patient also stated that her left middle finger appears swollen at the joint at the time of the report. Outcome was not reported. Of note that, the patient was taking Lipitor and Zyrtec occasionally.
Felt 'light-headed', sat down on chair, turned pale, LOC, jerking movement of extremities for 5-10 seconds. Patient lay down on examining table, received blow-by O2, regained consciousness 5 minutes later.  Continued to be supine for the next 10 minutes.  Drank coconut juice (4oz). Vitals stable. Self-ambulate out of clinic without incident. Patient states that she had not eaten nor drink since previous night.
Sore left arm; lymph node on left side is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 17:00 (Lot number: FK5127) at the age of 11 years 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: PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 10:00, outcome "unknown", described as "Sore left arm"; LYMPHADENOPATHY (non-serious) with onset 06Nov2021 10:00, outcome "unknown", described as "lymph node on left side is swollen". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: Facility type vaccine other: Vaccination Clinic. No other vaccine taken in four weeks. No other medications taken in two weeks. No Covid prior vaccination. Not tested for Covid post vaccination. No Known allergies  No follow-up attempts are possible. No further information is expected.
HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal, Heart disease, unspecified and Stomach discomfort. Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure, ROSUVASTATIN for Cholesterol, CARVEDILOL for Heart disease, unspecified, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, PANTOPRAZOLE for Stomach discomfort.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown.  The vial was stored in the Refrigerator at the time of the excursion. The maximum or minimum temperatures reached between 2-8 Celsius degrees. The excursion duration was almost 24 to 30 hours. The vial are dropped into a specific container. There was no visual inspection noting any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all). The proposed desired use by date was 10-Dec-2021.   This case was linked to MOD-2021-408597, MOD-2021-408595, MOD-2021-408594, MOD-2021-408463 (Patient Link).
Patient needed the bivalent dose of Pfizer, but received regular Pfizer, no adverse event or occurrences needed/noted.
severe headache- took Maxalt, went away vomiting- began 12 hours after injection painful arm, especially when lifting arm up
Received the Pneumovax 20 Vaccine at approximately 10:20AM and at approximately 1:30 PM I felt like I was going to pass out while driving on the expressway. Experience some facial, tingling and tingling in my distal extremities thereafter continuing to the emergency room with what I thought to be high blood pressure ultimately was put on prednisone to counteract the immune response. It has been now six weeks since the vaccine, and I am still experiencing lightheadedness and a feeling of passing out on occasion it may have restarted reactive hypoglycemia, which I experienced maybe 40 years ago and have had under control ever since. Or this might have been caused by the prednisone which was a prescription for 320 mg over a period for 10 days with less and less each day.
PT FAINTED FOR ABOUT 5 TO 10 SECONDS AND THEN SHE WAS OK. SHE WARNED US THAT SHE HAD FAINTED WITH A PAST VACCINE BECAUSE OF ANXIETY OF BEING STUCK WITH A NEEDLE. SHE LEFT THE PHARMACY FINE.
Within 12 hours I began having a radiating pain from the injection site up to my neck. Mild edema above my clavicle that is very painful to touch. Pain and edema has not decreased in 72 hours.
No additional AE; Inbound call from CMA who reports improperly stored MMR II was administered to 2 patients. See additional AE case 02429824 for additional patient. Excursion occurred 7/15/2023 and product was administered 7/17/2023.        ?    Names of vaccines in; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 15-JUL-2023, doses of vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # W039698, expiration date: 24-MAY-2024, underwent temperature excursion about 9 degrees Celsius (C) (14.0 C) during 30 hours. On 17-JUL-2023, the patient was vaccinated with this improperly stored vaccine which was reconstituted with diluent (not involved in temperature excursion), administered 0.5 mL, once (route of administration, anatomical location not provided) as prophylaxis. No adverse event was reported.      This is one of 2 cases reported by the same reporter.
On approximately 11/10/2000, the patient developed 10-15 chickenpox lesions in the diaper area and on the upper thighs that resolved in one week. No further information is expected.
Pt recvd 3 doses of Engerix-B vax 11APR91, 16MAY91 & 17OCT91 & 48 hrs p/3rd dose of vax exp inject site redness & a rash on face, that looked like hives;
arm swelled up and got hot; emotional and cries a lot; faint red spot the size of a baseball underneath where she was injected; fever of 99.7 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up and got hot), EMOTIONAL DISTRESS (emotional and cries a lot), VACCINATION SITE ERYTHEMA (faint red spot the size of a baseball underneath where she was injected) and PYREXIA (fever of 99.7 degrees Fahrenheit) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelled up and got hot), EMOTIONAL DISTRESS (emotional and cries a lot), VACCINATION SITE ERYTHEMA (faint red spot the size of a baseball underneath where she was injected) and PYREXIA (fever of 99.7 degrees Fahrenheit). At the time of the report, PERIPHERAL SWELLING (arm swelled up and got hot), EMOTIONAL DISTRESS (emotional and cries a lot), VACCINATION SITE ERYTHEMA (faint red spot the size of a baseball underneath where she was injected) and PYREXIA (fever of 99.7 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
Was having a mensural cycle every 22 days since I have received the booster/vaccine I have not had a cycle in the past year and I am not producing eggs and have been trying to start a family
Information has been received from a physician, via a company representative, concerning a 15 year old female student with a history of dizziness and syncope "in general," who on an unspecified date was vaccinated with the second dose of Gardasil (lot # not provided). Following the vaccination the patient was "fine," however, the next day, she had a seizure while at school. The physician reported that the student's condition had improved, though no other details were provided. Upon internal review, "the next day at school she had a seizure" was considered to be serious as an other important medical event. Additional information has been requested.
pt recvd vax;1sep95 devel blisters on lt thigh & 1 on rt thigh;
Approximately 10-15 minutes after administration the patient reported being "itchy everywhere." Upon examination there was erythema, warmth and inflammation at the site of injection on the right arm, soon followed by a rash all over the arm. The rash appeared as small red spots (non-raised). Vitals were WNL except for a slightly elevated BP. After approximately 5 minutes, the patient began to report difficulty breathing and chest tightness. At this time the patient received one epinephrine injection (via EPIPEN). After administration of epinephrine, the patient's symptoms resolved.  Approximately 45 minutes after epinephrine administration, patient received prednisone 50 mg PO x 1. She was discharged from the clinic with a short course of prednisone.
Patient was given Moderna Bivalent booster at time of visit as booster was required but was given incorrect one as it's only for 18+
After 2nd vax began having pains in upper arm, shoulder area. If pt sleeps on left side he has severe pain in area. This limits pt's mobility.
None - Phone from client 1 1/2 wks later stating she had a blood test & is early pregnant.
No adverse event.  Dr. was notified. Family is aware. Patient given wrong dose of Pfizer Biotech, patient given Pfizer Biotech 12 and up.
pt says on the 6th day she woke up w/ a headache and nauseated.  She started vomiting and took Medizine which seem to help.  On 4/11/21 she started having cramps in her stomachs like a spasm and SOB.  She went to hospital ER. They did blood work and Chest X-Ray which came back negative results.   She was told she did not have the same blood disorder as the other people who have had blood clots after taking the vax.  She was told she had blood in her urine but had no infection.  She will FU w/ PCP in June.  Pt says her only symptoms now are some nausea and still does not feel normal.
Pt came for Moderna Booster on 1/6/22. Pt reported to this writer RN both verbally and in writing on the COVID vaccine pre-screening form that she had received only one primary series Johnson and Johnson vaccine prior to coming to the booster clinic. THis writer verified one J&J dose on patients vaccine card that was given in April 2021. Moderna booster was administered on 1/6/22 by this writer based on information given to this writer by the patient.  When documenting administration on the booster into database, this writer observed that in addition to the Johnson and Johnson dose given in April of 2021 at a Pharmacy, pt also received a Pfizer vaccine in August 2021 at another Pharmacy. This writer called patient twice on 1/7/22 and once on 1/10/22  to ask if patient did indeed receive the Pfizer vaccine in August of 2021 or if this was a documentation error. Patient did not answer the phone. This writer emailed patient on 1/10/22. Patient responded to email on 1/11/22 and reported that she did get a Pfizer vaccine in addition to the Johnson and Johnson but lost that card.
Large local reaction with redness, tenderness measuring 13 by 15 cm with central area 4.5 cm which was redder and indurated - first noticed on day of immunization, worse the next day
This spontaneous report as received from a health professional refers to a female patient of unknown age. Approximately on an unknown date in September 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported) and at the same time was vaccinated with a dose of flu shot-influenza virus vaccine (manufacturer unknown) (lot number, expiry date, route and dose were not reported). Approximately on an unknown date in September 2012, the patient experienced fever of 100 plus, could not raise arm which was sore, redness and had nausea. The outcome of all the reported events was unknown. Additional information has been requested.
WEAK THE ENTIRE NEXT DAY. COULDN'T UNDERSTAND THINGS PEOPLE WERE SAYING TO HER REPORTED SHE FELT LIKE SHE WAS GOING TO DIE
Child came to get Seasonal Influenza vaccination and instead she got one dose of H1N1 injectable injection when she had already received one dose of H1N1 at School the day before 11/10/2009.
This spontaneous report was received from a medical assistant, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (dose, frequency and route were not reported) lot # M037770 with expiration date of 01-JUN-2019, for prophylaxis. The temperature of the GARDASIL 9 was between 47 °F and 77 °F for a time frame of 16 hours. No previous temperature excursion occurred, and no data logger was involved. No adverse effects were reported. This is one of three reports received from the same source.   Additional information has been requested.; Sender's Comments:  US-009507513-1705USA007816: US-009507513-1705USA007814:
hot to the touch; rose oval 6-7 inches; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (rose oval 6-7 inches) and VACCINATION SITE SWELLING (swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (rose oval 6-7 inches) and VACCINATION SITE SWELLING (swollen). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (rose oval 6-7 inches) and VACCINATION SITE SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use information was not provided  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant FU: TCR was received In that Second dose details provided, out come of event of first dose also provided.
Patient with 2 Moderna vaccinations, last dose 04/01/21, who admitted with incidental COVID finding upon presurgical/admission testing.  Patient/family elected comfort care during admission and he subsequently died.  Hospice provider discharge note below:  "Pt admitted 1/3/22 for R hip fx, found to also have COVID and developed AF w/RVR d/t sepsis of unknown origin. Family elected comfort measures only on 1/16/22, and pt passed from his primary illness on 1/16/22. "
body aches; fever of 100.5; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and PYREXIA (fever of 100.5) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FUROSEMIDE, URSODIOL, AMLODIPINE BESILATE (NORVASC) and TACROLIMUS (PROGRAF) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (body aches) and PYREXIA (fever of 100.5). At the time of the report, PAIN (body aches) and PYREXIA (fever of 100.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Pyrexia: 100.5 (High) 100.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported.
Patient went unresponsive and bradycardic post vaccine. Regained responsive within 30 seconds.
Patient is a 21 year old female who is 12 weeks pregnant with PMH of ADD, migraine, UTI and Covid 19 infection in August 2021. Patient was admitted 12/19-12/20/21 for c/o nausea and constipation. During that admission patient had a negative rapid covid test but a positive PCR, was seen by a HCF and cleared. Patient is vaccinated. AS per Dr (NAME) patient has no fever or systemic symptoms of covid 19, the IgG ALONE is positive and the IgM is negative, suggesting remote, recovered infection and pregnancy releated vomiting and dehydration. Patient was also found to have a UTI and discharged on Keflex. As per patient she has had c/o nausea and vomiting for approximately 1 1/2 months and has lost 15lbs. Patient was discharged yesterday but she has had persistent vomiting and felt like she was going to pass out. Patient was due to follow up with her obgyn tomorrow however patient called her doctor and was referred to the ED. Patient denies chest pain and shortness of breath.
Information was received from a certificated medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-OCT-2016, the patient was administered an expired dose of ZOSTAVAX (lot # L024999, expired on 06-OCT-2016; dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Pt has a history of diabetes and cirrhosis and presented to outlying hospital with lethargy and confusion from nursing home.  Pt admitted for COVID-19 pneumonia, acute respiratory failure, and acute metabolic encephalopathy.
Patient is fully vaccinated. A 76-year-old female patient presented with shortness of breath secondary to COVID diagnosis 2 days ago. She states that she does have a nonproductive cough without fever, chills, nausea, vomiting, diarrhea, or chest pain at this time and currently on 4 L of nasal cannula. DX: Hypoxemia requiring supplemental oxygen, Pneumonia due to COVID-19 virus. CXR Stable chest without acute pulmonary or pleural abnormality. Treatment remesivir, lasix. hydroxychloroquine 200 MG  Elevated troponins. Discharged stable
allergic reaction to the Adacel; inflammation and redness and pain at the injection site; felt like she had a fever last night; Initial information received on 20-Jun-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 51 years old female patient who experienced vaccination site inflammation, fever and drug hypersensitivity while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (This was not her first dose.).  The patient's past vaccination(s) included Adacel. The patient's past medical history, medical treatment(s) and family history were not provided.  No other concomitant vaccines were taken.   On 18-Jun-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C5609AA via intramuscular route in the left deltoid.  On an unknown date, The patient developed a non-serious inflammation and redness and pain at the injection site (vaccination site inflammation) and allergic reaction to Adacel following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 19-Jun-2019, The patient felt like she had a fever last night (pyrexia) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  No lab test reported.  Final diagnosis was  vaccination site inflammation, fever and drug hypersensitivity .   The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]).  The patient outcome is reported as Unknown for the events.
Experienced arm pain at injection site starting about 12 hrs after shot.  About 24 hrs later, felt armpit pain on same side so likely swollen lymph nodes?  Took ibuprofen evening of 4/9 with some relief.  Now have dull pain left breast area/armpit a week later.