chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on form arms; This is a spontaneous report from a contactable healthcare professional. A 40-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140), at the age of 39-year-old, via an unspecified route of administration on 23Dec2020 at 02:30 at a single dose on the right arm for Covid-19 immunization. Medical history included diabetic type 1. Concomitant medications included insulin aspart (NOVOLOG) and levothyroxine sodium (SYNTHROID).  The patient experienced rash on "form arms" on 28Dec2020 at 07:00. The patient received diphenhydramine hydrochloride (BENADRYL) as treatment for the event. Outcome of the event was recovering. The event was assessed as non-serious by the reporter.
Redness has spread to elbow, soreness,  extreme swelling, rash, arm is hot, hand swelling upset stomach.
6 hours in: feeling cold, muscle aches 7 hours in: extreme chills and nausea 8 hours in: extreme chills, muscle aches, feverish  13-14 hours: chills subside, muscle aches, hot/feverish 20 hours: muscle aches, fatigue
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified doses of ROTATEQ (lot # K001198, expiration date: 25-OCT-2015, oral; dose not reported) which were improperly stored from 05-SEP-2014 through 01-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came to the pharmacy to get a flu shot.  During the administration process, some portion of a vaccine leaked out of the syringe while it was injected. The needle that used to inject was found to be a defective one causing the leakage between the connection of the needle hub and the syringe tip. Patient was informed about the situation and reported no symptoms. He came back 2 days later to get revaccinated with a full dose of vaccine.
12/24/2021 presents to ED "for palpitations and newly diagnosed covid". PMHx of "atrial fibrillation on Xarelto, ESRD status post renal transplant, CHF, CAD, and ICD placement"
chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 24-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree) for five minutes. No previous temperature excursion was reported. The call was due to digital 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.
PROQUAD  administered after an excursion that occurred on 4/25/2022.; This spontaneous report was received from a medical assistant referring to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 25-APR-2022, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) vaccines experienced a temperature excursion for 1 hour and 12 minutes, at -2 degree Celsius (product storage error). The vaccines underwent a previous temperature excursion at -10 degree Celsius up to 8 degree Celsius (7.3C) for 2 hours and 37 minutes, and at -10 C up to 8 C (0.7 C) for 2 hours and 56 minutes.  On 27-APR-2022, the patient was vaccinated with the improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 ml, Lot number: U029319,  expiration date: 19-MAR-2023, (strength, vaccination scheme, frequency, route of administration, and anatomical location were not provided), for prophylaxis.   This is one of several reports received from  the same reporter.
About 12 hours after pneumonia shot, I began to get achy and had a fever of 101 degrees.
Patient developed a DVT in right leg, pain started one week after shot but also on long car ride
My 17 years old son got a first dose of COVID-19 Pfizer vaccine on 4/26/21 at 4:30 PM and next morning woke up with a bleeding from his nose. After applying pressure bleeding stopped.
headache/weird pain in her head; but it continued and got worse after first vaccine; horrible pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Feb2021 10:30 (Batch/Lot number: unknown) at the age of 75 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Trigeminal neuralgia" (ongoing); "before the first shot she had a headache because of facial pain but thinks the shot made it worse" (unspecified if ongoing); "before the first shot she had a headache because of facial pain but thinks the shot made it worse" (unspecified if ongoing); "Dry eyes" (ongoing); "High blood pressure" (ongoing); "heart to keep everything calm primarily heart pain due to stress" (ongoing); "heart to keep everything calm primarily heart pain due to stress" (ongoing); "bones" (ongoing); "to keep up my health" (ongoing). Concomitant medication(s) included: ATACAND taken for hypertension (ongoing); TOPROL taken for angina pectoris, stress (ongoing); VITAMIN D NOS taken for bone disorder (ongoing); FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL] taken for dry eye (ongoing); CENTRUM A TO ZINC taken for supplementation therapy (ongoing). The following information was reported: HEADACHE (non-serious) with onset 26Feb2021, outcome "recovering", described as "headache/weird pain in her head"; CONDITION AGGRAVATED (non-serious) with onset 26Feb2021, outcome "recovering", described as "but it continued and got worse after first vaccine"; PAIN (non-serious) with onset 26Feb2021, outcome "recovering", described as "horrible pain".  Additional information: The patient had no prior vaccination (within 4 weeks). The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. Clinical course: Patient stated before the first shot she had a headache because of facial pain but thinks the shot made it worse. Patient stated she was driving home and all of a sudden had a horrible pain and was wondering if the shot caused the pain. Patient stated she had been having a headache but it continued and got worse after first vaccine and immediately after she felt a weird pain in her head. Patient stated it was gradually decreasing between the first and second shot. The patient did not undergo any relevant tests. The adverse events did not require a visit to Emergency Room/Physician Office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports running a temperature of 102.5 with chills that started at about 1700 and lasted 10-12 hours. After temperature lowered to "low grade temp" and patient reported fatigue for 2-3 days. Also reported "lymph glands" swollen in right side of neck, right axillary area and tenderness  extending down right arm to elbow. Symptoms have resolved at this time.
1st dose in 2021, not completed the series; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly around 2 years ago in 2021).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comments: The patient had not completed the vaccine series and adverse event (AE) was filed. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Approximately 7 hours after vaccination patient presented to emergency department, chief complaint chest pain and tightness, weakness, headache.  Patient was admitted for cardiac workup.  Cardiac enzymes and diagnostics were negative for cardiac event, symptoms resolved.  Patient was scheduled for discharge on 10/8 but reported a low grade fever so discharge was held for fever workup.  Fever workup was negative, patient was discharged without symptoms on 10/9.
C/O arm pain, erythema, swelling, and low grade fever.  Had N/V, dizziness, Headache over the weekend with temp. up to 101.   Foliculitis around outer erythematus area at injection site. Rx. for Keflex, Phenergan, and Pain med on Saturday.
Pt. came to pharmacy with his card of vaccine and it was laminated and he wanted a flu shot and the booster Pfizer so we checked and he had last shot on 3/29/21 he was due for the booster , we administer both shots and then his wife called and said he has dementia and he already got his booster from another pharmacy 10/01/21 and they didn't give him a card so he didn't know. He was alone when he came to the pharmacy  and with the dementia he didn't remember.
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:  Other Relevant History:
17JUL92 pt recvd vax & began to c/o headache while driving home from the clinic; t103 & 104 later in the afternoon; c/o of SOB;
Five minutes post vax, I became dizzy light headed, nauseous. My upper arms and chest area became chilled and I felt I was slipping away or about to faint. I recovered about 15 minutes later but this effect kept coming in waves for the next 4 hours, lasting aprox 15 minutes each. My stomach has been upset to date. Also nausea and inability to eat normally.
very sl swollen erythematous area on rt thigh;approx 4 inches in diameter;2 inches diameter in center of inflamed area sl hardened;parents reported inj site was less red & swollen on day 3;
ZOSTAVAX immunization administered by pharmacist on 12/1/2015 left arm on 61 year old male. Increasing soreness and redness. Increasing size of redness to greater than 7 mm on back of left arm. Tissue beyond turned ink. Sought medical care on 4th day. Cellulitis mostly likely diagnosis. KEFLEX rxed qid. 7 days later improved, however, redness of inflamed area has now reduced to 5 mm in diameter. Adjacent tissue is now normal.
Reaction locally spread to 2 other areas (macular erythematous lesion, small vesicle).
2 inch red area around injection, fever, aches, fatigue, headache Taking tylenol and ibuprofen
Developed a raised itchy rash all over my body prominent on hands, underside of arms, on thighs, hips, legs, top of feet.  The rash appeared day after shot and persisted for a week.  No other symptoms such as fever.  I felt fine otherwise.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 10-FEB-2016 the patient was vaccinated with a properly stored expired dose of M-M-R II (lot #K000738, expiry date 16-JAN-2016) intramuscularly. No concomitant medications were reported. No adverse effects were reported. The was no product quality complaint reported. The action taken with the therapy with M-M-R II was unknown. Additional information has been requested.
Localized site reaction, rash, pain. Clinic notified 10/19/17, child was examined by provider and mom was advised to watch the site and call the clinic if symptoms persist or worsen.
Patient called 11/19/2017. She said she woken up Friday (11/17/2017) to a very sore arm. She reported redness on that arm. She said the redness was not where she was injected but was on the left arm under the injection side. Patient alternated between warm and cold compresses and the swelling and redness did go down. By sunday she said it didn't hurt and it was almost back to normal. I recommended adding Benadryl and continuing the compress because they had helped.
diagnosed with Ulcerative Colitis; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 18-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "unknown", described as "diagnosed with Ulcerative Colitis ". Therapeutic measures were taken as a result of colitis ulcerative. It was reported that patient was diagnosed with Ulcerative Colitis and was on Prednisone. The physician had a quick question about Trumenba. He was asking if it was safe for a patient to be on prednisone and to be due for Trumenba, or should they delay the second dose. He also asked if there were contraindications.  The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.; Sender's Comments: The association between the event ulcerative colitis with TRUMENBA can not be fully excluded based on the available information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received expired vaccine as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine as a 1st dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine as a 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine as a 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
HUNGRY; VERY ANXIOUS; FEELING UNSAFE TO WALK BY HERSELF; FEELING TRAPPED; BAD HEADACHE; FEELING TIRED; SORE ARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bipolar, no alcohol use, cigarette smoker and too stressed to take care of herself. The patient experienced drug abuse when treated with metamfetamine, and drug allergy when treated with lisinopril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included lorazepam for bipolar disorder. On 02-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced very anxious. On 08-APR-2021, the subject experienced feeling unsafe to walk by herself. On 08-APR-2021, the subject experienced feeling trapped. On 08-APR-2021, the subject experienced bad headache. On 08-APR-2021, the subject experienced feeling tired. On an unspecified date, the subject experienced hungry. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very anxious, and feeling unsafe to walk by herself on 09-APR-2021, and feeling trapped, and sore arm on APR-2021, and was recovering from feeling tired, bad headache, and hungry. This report was non-serious.
fever, cough, malaise, fatigue,  flu like sxs resulting in 2 missed days of employment
within 30 seconds from vaccine parient became very light headed cold and clamy.  and passed out blood pressure was very low 82/54. patient was awaken and immedietly started asking lots of questions stating that it felt like a dream a 2nd bp was taken and was 100/78.  3minutes later patient passed out again with what appeared to look like seizures..  Patient was lied on the ground a vitals continuously watched ambulance was called.  Patients vitals were stabilizing and was decided to move patient out of way when having patient to walk patients pressure once again dropped patient was sent to er for further evaluation. It was later passed on to us by patient that er statred that patient has such a low tolerance for pain that this caused this occurance as the same thing happened the next day when patient got out of bed and arm hurt from the vaccine.  Patient passed out.
Patient presented with vomiting symptoms, fever, general weakness, high blood sugar, and loss of appetite. COVID19-IgG and IgM test were ordered and both were positive. PCR testing was also performed, with positive result. Case was consulted with the Infectious Disease clinician, who also recommended treatment with Bamlanivimab. Patient has not shared that he had recently traveled 7 days prior and that her grandchildren had also tested positive for COVID-19.
This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A 12-month-old patient of an unspecified ethnicity and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration, in the right thigh, on an unspecified date in 2016, as single dose for routine vaccination.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced dime sized knot that occurred post injection.  The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  Therapeutic measures were taken as a result of dime sized knot that occurred post injection and included warm packs and the administrating office monitored the event; office also told the parent that if it persists to call back and the parent made no call back to the office.  The outcome of dime sized knot that occurred post injection was unknown.
Patient was given an expired dose of medication. Patient did not have any adverse reactions to the dose. Patient and mother are aware that this happened and that the patient will need to come back for another vaccine.
This spontaneous report as received from a male consumer refers to himself. Patient medical history and current condition was not reported. Approximately on 02-MAR-2015 (reported as a week ago on Monday) the patient was vaccinated with ZOSTAVAX one time vaccine injection. Other co-suspects were not reported. On an unknown date the patient experienced trouble sleeping, reported as he got 4 hours sleep the previous night and was hyper active. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (The Pharmacist call about the administration of expired moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last Oct 20,2021 to Nov 29,2021.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported
Day after shot, progressively felt sicker and more sore throught the day. Had a slight fever at 4 pm. By 630 pm at a 102 fever. Very high blood sugars that I couldn't manage for the day. Night sweats and fever over night but fever broke by morning. Felt off on the third day. On the fourth day woke up with a locked neck which never happens and felt ill, tired, sore, had a cough and mild vertigo for next 4-5 days.
Tingling sensations in my nose. On the 23rd and 24th, sick with fever, extreme fatigue, had a headache, cough and a runny nose and shortness of breath (that was really bad, it was really hard just to walk around the house; I couldn't function). I lost my sense of taste. I had blood in my stool. I went to urgent care locally, on the following Wednesday (the 27th). Negative COVID-19 tests, my husband tested positive with COVID-19 the Monday before I tested and he had blood in his stool, too. Doctor thinks I had COVID-19 like my husband did. My son was diagnosed with COVID-19 but had a negative test result too. I can't taste anything and my sense of smell is off. I was treated with medication like I had COVID-19, they gave me a steroid (which I couldn't take, it messes with my heart) and a Z-pack and started to do my inhalers as I needed. I feel much better now than I did but not all the way. Note: I got a Flu shot (October 12, 2021 04:45 pm at the local health department)