chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022).    No concomitant product use was reported. The patient received full dose. The vial had not undergone any temperature excursions. No treatment information was provided.
Pt recvd 3rd dose in series of hep B vax on 07MAR91 titer indicated pt "not immune."
12/19/20  Pfizer covid vaccine 1/9/21 Pfizer covid vaccine 8/6/21 ill 8/8/21 + Covid PCR 8/17/21 potential to return to work
joint pain; body weakness; dizzy; sleepy; legs were painful; fever; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm), ASTHENIA (body weakness), DIZZINESS (dizzy), SOMNOLENCE (sleepy) and PAIN IN EXTREMITY (legs were painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm) and PYREXIA (fever). On 05-Feb-2021, the patient experienced ASTHENIA (body weakness), DIZZINESS (dizzy), SOMNOLENCE (sleepy) and PAIN IN EXTREMITY (legs were painful). On 06-Feb-2021, the patient experienced ARTHRALGIA (joint pain). At the time of the report, PAIN IN EXTREMITY (soreness on her arm), ASTHENIA (body weakness), DIZZINESS (dizzy), SOMNOLENCE (sleepy), PAIN IN EXTREMITY (legs were painful), ARTHRALGIA (joint pain) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5 weeks of migraines; inability to focus or think clearly; head, neck and back muscle pain.
Outbreak testing. Patient is fully vaccinated and had a positive PCR Covid test result (tested 9/1/2021; resulted 9/2/2021)
She woke up in the AM slightly congested and with a very mild cough. About 30 mins after the vaccine she had a mild fever and was throwing up (in the car ride on the way home). Once home, she took a nap and woke up about an hour later with a high fever and very lethargic, and coughing/croupy sounding. The cough progressed throughout the day and by that evening was very harsh and she was having difficulty breathing. We went to the ER and she was given steroid breathing treatment, ibuprofen and albuterol breathing treatment. She began to feel better and was breathing better afterwards. She was seen at her regular doctor the following morning and still had a mild croupy cough with no other symptoms. Her pediatrician states that she likely had a virus and it was not related to the vaccine. By the end of the second day she sounded and acted back to her normal self.
tested + for covid 10-08-2023 at Hosp    deceased 10-26-23
pt recvd vax & 11 days later devel a red, blotchy rash, mostly on the arms & legs, swelling of hands & feet, & swollen lymph nodes behind ears;pt subsequently recovered;
Erythematous, non-raised, blanching 9 cm x 9 cm area around vaccination site. No warmth to touch. Injection sites 1 cm apart. Redness started 1/25/18 and worsened 1/26/18. Advised on OTC BENADRYL and ibuprofen for pain. Denied any respiratory or GI sxs.
Began feeling poorly at 1:30pm as if physically drained; pain in every joint and large muscle group; excruciating light sensitivity/pain in eyes; approx 5:30pm upper back muscles in great pain; then pain in lower body including backs of thighs, scrotum, and anus; approx 6pm stiffness and pain shifted to fingers and toes; by 6:30pm entire body feels dull heaviness/pain/extreme fatigue.   Slept less than 2 hours, now 6:45pm.
Pt received vaccine at 11:20. At 1132 staff member asked RN to assess pt as he began slurring his words and mumbling. VS 97% RA, HR 92, temp 99.8, BP 168/92. Pt is conscious but unable to tell me his name or location. Skin is clammy, patient?s hands are shaky. Wife was notified that we are calling an ambulance for further assessment. Ambulance arrived at 11:48 and pt was taken out shortly before noon.
2hrs p/vax pt's leg swelled double in size became very red & extremely painful;had a high pitched cry, t104.2 & was not aware of surroundings;these effects lasted 3 days;
pain at the injection site; swelling / at the injection site; redness / at the injection site; injected arm was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site erythema and pain in arm. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received shingrix and experienced redness, swelling and pain at the injection site, which was resolved. The patient also mentioned that the injected arm was sore for about a week, and then resolved.  The reporter did not consent to follow up.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot # and expiration date not provided) as prescribed and/or administered by a health care provider at the physician office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by health care provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event shingles (Herpes zoster) was unknown. Causality assessment between the event and zoster vaccine live (ZOSTAVAX) was considered related.  {Additional information has been requested. / Additional information is not expected.}
Patient had vaccine ordered: pediarix (DTaP-IPV-Hep B).  Infanrix (DTaP) was given by staff.  No scanning for vaccines currently at location.  Family notified.
5/22/18, noticed red blotching rash and pain at injection site. Rash and pain subsided on or about 5/26/18. 5/30/18, started experiencing flue like symptoms, weakness, joint pain, upset stomach, loss of appetite, no bowel movements. 6/2/18, taken to ER for sever gastrointestinal pain, treatment included, morphine, stool softeners and anti-cramping medication. 6/3/18, taken to ER by ambulance for possible stroke. Diagnosed with Bell's palsy, treated with anti-viral medication and steroids. Continued to experience sever gastrointestinal pain. 6/4/18, started losing strength in extremities, continue to experience sever gastrointestinal pain. 6/5/18, taken to ER, unable to walk, continued to experience dropping on left side of face due to Bell's Palsy, continued to experience sever gastrointestinal pain. Admitted to hospital for Gillian-Barre Syndrome. All previous listed issued tied back to the Gillian-Barre Syndrome (GBS). Treat with high-dose immunoglobulin therapy. In acute care from 6/6/18 thru 6/12/18. Moved to rehabilitation on 6/12/18 and discharged on 6/23/18. Extended out-patient rehabilitation currently continues. 6/30/18, severe pain in toe joints of right foot, x-ray confirmed diagnosis of gout by podiatrist on 7/5/18, advised treatment ice foot and TYLENOL for pain.
Tremors two weeks time. Adam's apple swollen for 4 months. I still have peaks in my heart to this day. Consulted at the hospital twice, they found nothing
Painful right axillary lymph node. This occurred with my first two injections as well, but I have now also developed tenderness (a stinging, burning pain) of my lateral right chest side wall underneath my right axilla and then tenderness of my lateral right breast. These areas of tenderness are also swollen. The lateral side of my right breast is mildly pink and edematous. The tissue beneath my right axilla is swollen.
Two weeks after shot my arm is very red around injection site, swollen, has a knot, itching, very hot
Headache; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 13Apr2021 at 08:30 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 23Mar2021 at 09:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, at 00:00 the patient experienced headache and exhaustion. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as the result of adverse events.  The clinical outcome of the events headache and exhaustion were recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
pt is 36yrs old and recieved the geriatric high dose flu vaccine for 65yrs or older
Chills without fever started 2 days after injection and lasted 1 day.  No treatment given.  AE resolved
pt recv vax; pt complained of slowness of speech, double vision, difficulty walking,unable swallow, occipital HA; neck pain
1st dose - soreness at injection site on left upper arm starting 12 hours after injection and lasted for 2 days; 7 days after injection: half dollar sized area 2-3 inches below injection site on left arm was red, itchy, swollen and hot to touch, symptoms faded over the next 5 days. 2nd dose - soreness at injection site on left upper arm almost immediately,  within 12 hours area very painful to touch, palm-sized area about 1 inch below injection site was red, itchy, swollen and hot to touch 72 hours post injection
DIZZINESS; CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and dizziness was not reported. This report was non-serious.
soreness on the left side of head, neck, arm and upper abdomen 2 days after vaccine
Redness and swelling from groin down past the knee on the same side vaccine was given.
Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient experienced excessive sweating; nausea but did not vomit; and also visual changes where for a brief moment his vision was blurred.  after elevating his legs and given some orange juice his vision normalized, also given a cool damp cloth to place on his forehead; which control his sweating. All vital signs were within normal limits and checked by nurse practitioner from .
severe joint pain; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer (Patient) reported that, a 48-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was unable to locate or read the details), dose 2 via an unspecified route of administration, administered in Arm Right on 13Mar2021 11:30 am (48-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome and hypertension from an unknown date and unknown if ongoing. The patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was unable to locate or read the details), dose 1 via an unspecified route of administration, administered in Arm Right on 20Feb2021 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included dexlansoprazole (DEXILANT) and venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported. No covid prior vaccination and covid not tested post vaccination. Approximately 3 weeks on 10Apr2021, after the 2nd vaccine patient began having severe joint pain that she have never had before. Her husband also has this. No treatment received. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021495434 same reporter/drug/event , different patient
Patient is 34 year old female who was admitted to us with Pulmonary Emboli with past medical hx of bipolar and schizoaffective disorder presented with right sided chest pain of one day. It is crampy and sharp pain, about 6/1o in intensity, radiate to left axillary region and left arm, worse with breathing with no reliving factor. Pt reports left arm and left lower extremity tingling and numbness of one day duration. States it started after she got first dose of moderna vaccine earlier on August 11, 2021. Endorsed generalized weakness, chills but denies cough, shortness of breath, orthopnea or bilateral leg swelling. Denies headache, weakness of upper or lower extremities, blurring of vision, difficulty of swallowing. Denies urine or bowel habit change.   On arrival to ER, pt was hypotensive 90s/60s otherwise stable, HR 80s and satting 98% on room air. Labs remarkable for mild hypokalemia, elevated d dimer 0.62. CTA showed  Few pulmonary emboli within the right upper and left upper lobes as well as involving the left lower lobe. MRI brain showed no acute intracranial process. Pt received 1L of NS and transferred to ICU.
felt really sick/ had not been that sick before in her life; Chest pain; Rash; moaning in her sleep; This is a spontaneous report from a contactable consumer (patient's coworker). A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient felt really sick and had not been that sick before in her life. She had chest pain, a rash on her legs, and her husband said that she was moaning in her sleep. The patient did not have a cough. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Heart rate high; Blood pressure high; bruise at the site of the vaccination; This is a spontaneous report from a contactable other health professional reporting for herself. A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 22Dec2020, 1-1.5 hours after vaccination, the patient experienced heart rate high with outcome of unknown , blood pressure high with outcome of unknown and bruise at the site of the vaccination with outcome of unknown. The patient underwent lab tests and procedures which included: blood pressure, high (22Dec2020); heart rate, high (22Dec2020). She returned to the emergency room (ER) of the hospital where she received the vaccine due to all the events. Therapeutic measures were taken as a result of heart rate high and blood pressure high and included treatment with a beta blocker. The patient was also prescribed with a blood pressure medicine from the ER physician. The events heart rate high and blood pressure high were considered medically significant.  The information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the Company considers the events heart rate high and blood pressure high are possibly related to vaccination with BNT162B2. 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.
rash woke him up in the middle of the night; rash spots are itchy and red; rash spots are itchy and red; rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms; rash on the right arm around injection site; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (rash woke him up in the middle of the night), RASH PRURITIC (rash spots are itchy and red), RASH ERYTHEMATOUS (rash spots are itchy and red), RASH (rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms) and INJECTION SITE RASH (rash on the right arm around injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced POOR QUALITY SLEEP (rash woke him up in the middle of the night), RASH PRURITIC (rash spots are itchy and red), RASH ERYTHEMATOUS (rash spots are itchy and red), RASH (rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms) and INJECTION SITE RASH (rash on the right arm around injection site). The patient was treated with HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) at a dose of UNK dosage form and DL- LACTIC ACID (EUCERIN DERMO PURIFYER) at a dose of UNK dosage form. At the time of the report, POOR QUALITY SLEEP (rash woke him up in the middle of the night), RASH PRURITIC (rash spots are itchy and red), RASH ERYTHEMATOUS (rash spots are itchy and red), RASH (rash all over the body and it comes and goes/rash on knees, elbow, shoulder, and arms) and INJECTION SITE RASH (rash on the right arm around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
MUSCLE ACHES, JOINT ACHES, CHILLS, FEVER, INJECTION SITE TENDERNESS, STOMACH UPSET, DIARRHEA