chrisvoncsefalvay/vaers-outcomes huggingface dataset:
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
I have had chronic pain in my left arm that some days I can barely lift it and others a pain in the whole arm down to the hand. It. I can't sleep on my left side and I am left handed so I use this side more which is hard with pain. It started the afternoon of the day I got my shot.
Pt described a "funny feeling" when she got vaccinated - called 10-26-12 to report this & tingling in arm radiating down to hand - has been to doctor & doctor says she feels we have hit a nerve - pt would like to hear from pharmacy.
A MILD 8 HOUR DELAYED BLAH FEELING REACTION; This spontaneous report received from a consumer concerned an elderly female of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on MAR-2021 for covid-19 prophylaxis.  The patient had no adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on DEC-2021 for covid-19 prophylaxis. Drug start period was 8 hours. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced a mild 8 hour delayed blah feeling reaction to the booster (Dose number in series 2).  Reporter stated that both him and the patient (elderly mother) had been initially vaccinated with J and J vaccine and also boosted with J and J vaccine. No adverse event experienced for first dose and patient experienced 8 hour delayed blah feeling reaction to the booster. So far neither of them had a positive or symptomatic covid infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a mild 8 hour delayed blah feeling reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220904494.
p/vax pt was warm to touch given APAP;mom stated very very warm;child given APAP still very warm given more APAP;while child sleeping started to breath heavy mom touched child who opened eyes & started shaking;fever
06/25/02 T99.4-99.7. 06/26/02AM decrease in appetite, very fussy, not consolable. 06/27/02 above sx worsened-taken to hospital. 06/28/02 Asymptomatic
had Covid twice, once in 2019 and one last year; had Covid twice, once in 2019 and one last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2019 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "had Covid twice, once in 2019 and one last year". Clinical course: Consumer stated, "she took the original 2 Pfizer shot when it first came out, took two of the boosters back about a year and a half ago. The every shot (Pfizer COVID-19 Vaccine) she had taken and she had Covid twice, once in 2019 and one last year.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300356951 Same patient/product, different dose/events;US-PFIZER INC-202300356952 different patient;
Patient called on 10/5/19 for a refill and stated she was unable to lift her arm above her head since Thursday night, a few hours after receiving her flu shot. Stated she had flu shots in the past but believed the young lady gave it to her too high in her arm, and pointed to a place just below the shoulder joint where the shot was administered. Patient complained of numbness in the arm and that she had kept it in a sling for Friday (10/4/19) since she had trouble moving the left arm.
patient took the shot every year for years and years. Delt with chronic bronchitis; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involved unknown demographic patient who took the shot every year for years and years. delt with chronic bronchitis (Bronchitis chronic), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who took the shot every year for years and years. delt with chronic bronchitis (Bronchitis chronic), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was patient took the shot every year for years and years. delt with chronic bronchitis.   It was not reported if the patient received a corrective treatment.  The outcome was reported as Unknown for patient took the shot every year for years and years. delt with chronic bronchitis.  There would be no information available on batch number for this case.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K003407 and expiry date: 06-MAR-2016) (dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. No product quality complaint (PQC) was filed. The outcome of incorrect product storage was unknown. This is one of the several reports of the same reporter. Additional information has been requested.
Patient received vaccine on 7/28/21 at clinic. Presented to ER on 7/31/21 after vomiting large amount of bright red blood 1 hour PTA.  She was admitted to ICU, required 8 units PRBSx, 3 units FFP, and 1 unit platelets with poor response in Hgb and Hct. Required pressors  up to maintain BP.  EGD revealed bleeding varices which were banded.  On ICU day 2 patient became increasingly acidotic and began to desaturate. Oxygenation improved with increased sedation and 2 additional units PRBC.  On ICU day 3 patient became hypertensive, pressors were stopped.  There was acute change in LOC with decreased responsiveness to painful stimuli and nonreactive pupils. Head CT showed severe diffuse cerebral edema c/w hypoxic brain injury.  Patient continued to deteriorate and decision made for compassionate extubation. Pateint  expired at 2110.
Rash around the injection site; Warm around the injection site; Injection site itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches). At the time of the report, VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Symptoms developed 16 hours after injection of the 2nd dose (booster). Symptoms included body aches, nausea, chills, fever, headache, chest tightness. All symptoms resolved within 24 hours with the exception of chest tightness which fully resolved 8 days after the shot.
Headache at 5pm 5/25 Abdominal cramps at 9 am on 5/26 Fever 100 degrees at 10 am on 5/26 Muscle weakness at 5:30pm 5/25 throughout 5/26 Light nausea 6pm 5/25 Heavy nausea 9 am 5/26
pt recvd vax 12SEP95 & 01OCT95 taken to ER w/fever of 104-105 & rash on face & chest;rash was pinkish & tended to appear one day & disappear the next;dx of viral reactive arthritis;exp photophobia 2-3 days p/being hosp devel neck pain
Rash all over the body; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 65-year-old male patient received pf-06928316 (ABRYSVO), on 30Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (prolonged hospitalization) with onset 30Aug2023, outcome "unknown", described as "Rash all over the body". It was unknown if therapeutic measures were taken as a result of rash. AE resulted in Prolongation of existing hospitalization (treatment received during existing hospitalization).  The information on the batch/lot number for pf-06928316, pf-06928316 has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of pf-06928316 in triggering the onset of rash all over the body cannot be fully excluded, considering the temporal relationship.  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
Patien reported development of an itchy rash over his entire body, including palm of hands, feet, genitalia, and scalp after receiving Pfizer COVID vaccine. In addition he reports swollen lymph nodes on the left side (same side as Oct. 5 vaccination). He said that since his second dose, he has developed sores, and has clear fluid "oozing" from the scalp lesions.   He received Pfizer COVID vaccine dose #1 on 14 Sep 2021. About two weeks later, he noticed the rash. It started on the back of his hands, forearms and palms and spread rapidly to the rest of his body. He received Pfizer COVID vaccine dose #2 on 5 Oct. 2021. He went to sick call on 12 Oct 2021 to report the rash. The documentation at the visit states patient reported development of an itchy rash over his entire body, including palm of hands, feet, genitalia, and scalp after receiving Pfizer COVID vaccine. In addition he reports swollen lymph nodes on the left side (same side as Oct. 5 vaccination). He said that since his second dose, he has developed sores, and has clear fluid "oozing" from the scalp lesions.   He received Pfizer COVID vaccine dose #1 on 14 Sep 2021. About two weeks later, he noticed the rash. It started on the back of his hands, forearms and palms and spread rapidly to the rest of his body. He received Pfizer COVID vaccine dose #2 on 5 Oct. 2021. He went to sick call on 12 Oct 2021 to report the rash. The documentation at the visit states patient had a maculopapular itchy rash on axilla, torso, hands, and scalp. Medrol dose pack, topical hydrocortisone cream prescribed, and Derm consult filed.   He reports biggest change since Oct. 12 is rash spread and persists despite Medrol and hydrocortisone.
This spontaneous report as received from a pharmacist via a company representative refers to a 55-65 years old female patient. On 01-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported, dose: 1 vaccination) intramuscularly for prevention of pneumonia. Concomitant medications were not provided. The pharmacist reported that the patient experienced "more than normal swelling" and an injection site reaction that was "warm to the touch" on 01-NOV-2014 after receiving a vaccination with PNEUMOVAX 23. Outcome of the events was not reported. Additional information has been requested.
After first dose mention of nausea for one week afterwards; This is a spontaneous report from a contactable consumer. A 33-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration on 02Feb2021 (Age at vaccination: 33 Years) as 1ST DOSE, SINGLE for covid-19 immunisation. Pregnant at the time of vaccination reported as unknown. The patient medical history was not reported. The patient concomitant medications were not reported. On 22Feb2021, the patient experienced nausea for one week afterwards after first dose. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The adverse event result in any of the following in Doctor or other healthcare professional office/clinic visit. It was unknown that treatment received for the adverse event. The clinical outcome of event was unknown.  Follow-up (25Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of query which included that: awareness date for report AER#. Response received as she overhead her casually telling another friend about having a bad reaction to the vaccine at dinner on 07Mar2021. As this was a group setting, she waited until the following day, Monday 08Mar2021 - at which point she had a solo phone conversation with her. At this point she provided the details she put in the event description and she communicated that it would be reported at work the following day, Tuesday 09Mar2021.   No follow-up attempts are needed. No further information is expected.
Generalized maculopapular rash on body, shotty post cervical nodes, low grade fever.
not sure when started but got just discoloration (like orange/rust) freckles predominantly on the palm of my left hand.
Tongue feels tingly and swollen. Felt hot then it went away. No shortness of breath, respirations even and unlabored.  Skin pink warm and dry. b/p 146/108 pulse 88  10:17 pulse 89 ps02 98% 10:35 reports no tingling and feels like there is no swelling of tongue.  b/p150/110.  Informed her blood pressure was high.  She stated she was ready to go home.  informed to seek medical attention for any further problems and to have her blood pressure monitored.
This medically confirmed spontaneous report (initial receipt 20-May-2011) concerns a 43 year old male patient with high cholesterol. Concomitant medications included simvastatin which he had been taking for a long time. The patient has no known drug allergies. On an unknown date, the patient received AFLURIA (batch: M53309). The reporter referred to the vaccine received as 'H1N1'. No other vaccines were administered at the time. On an unknown date, two weeks after getting the vaccine, the patient developed a rash on his trunk, then legs. The patient then started experiencing a general weakness and drowsiness during the day. In Feb-2011, the patient was diagnosed with severe, complex sleep apnea. The patient was cleared by cardiology and is currently being followed by neurology, where a brain tumor was ruled out. An antibody test is to be performed, since the issues may be caused by an autoimmune response related to the vaccine. The event outcome was not yet recovered.
Heart races faster/heart was racing a little faster; Cramps in the toes; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart races faster/heart was racing a little faster) and MUSCLE SPASMS (Cramps in the toes) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Breathing difficult (Could not breath very well on 2020 doesn't know if got COVID, but results were always negative.) in 2020.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart races faster/heart was racing a little faster) and MUSCLE SPASMS (Cramps in the toes). At the time of the report, PALPITATIONS (Heart races faster/heart was racing a little faster) and MUSCLE SPASMS (Cramps in the toes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: negative (Negative) got a test it came negative..         The patient also stated that could not breath very well on 2020 doesn't know if got COVID, may have it been hypochondria or may I have it. By the time I got a test it came negative. The patient also said my respiratory has not been the same and said that uses a couple of inhalers every day.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: follow-up received on 02-NOV-2021 contains Third dose was added.
Acted fussy-in afternoon - then unresponsive & pale & fussy - got better the next day & now is fine.
On 2-8-11 I shovelled snow 20 minutes in 11 degree temperature. I stopped, sat in my living room chair and felt vibrations from irregular heart beat. I went to my intern Dr whose assistant took an EKG and told me to go to hospital emergency. Put in hospital at 2:10 PM 2/8/11. Seen by a heart specialist and released after a night of intravenous feeding and medication on 2/9.
Pt had a seizure the following day after vaccines were given, last approx. 1-2 min, pt was afebrile on onset of seizure activity. She was evaled at Hospital ER. She became siff and starting shaking, eye directed upwards. Mother called 911 and pt was transported to ER.
Body aches. Joint aches. Sore arm. Runny nose. Headache. Burning eyes.
Red rash, swelling, itching and soreness of right arm from injection site to above (R) elbow after PNEUMOVAX (L) administration. Pt received PNEUMOVAX injection on 10/15/08 at about 5pm. Pt developed and experienced soreness, itching and rash at 10pm that night. Reported reaction 10/17/08
Pt had pneumonia 4/1/16 and was given PNEUMOVAX 6/8/16 but within a month diagnosed another pneumonia which the ER blamed on the vaccine.
Pt started losing feeling/ strength in feet and within 24 hrs loss of feeling/ strength in whole body. Pt is currently in hospital getting plasma transfusions for Guillain-Barre syndrome.
Patient started to feel dizzy and nauseous 30 minutes after vaccination.  Had left sided chest pain.  Was taken to ER by EMS.
pt recv vax 11OCT96 & devel redness, swelling & pain @ inj site;pt has recovered;
Dull headache for several days. Excruciating abdominal cramping off and on for almost a week. Arm soreness appeared about a week later severe enough to keep me from sleeping on that side of my body.  Lasted about a week.        At the same time,   large bruises appeared on the "shot arm" from the shoulder down almost to my elbow. Soreness in my right calf developed after four weeks and still comes at times.
Gastroesophageal reflux disease; fever; chills; stomach issues; numbness, elbow and thigh; constipation; severe stomach distension; This case was reported by a consumer and described the occurrence of gastroesophageal reflux disease in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness, constipation and distended stomach. On an unknown date, the outcome of the gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness and constipation were unknown and the outcome of the distended stomach was not recovered/not resolved.   It was unknown if the reporter considered the gastroesophageal reflux disease, fever, chills, gastrointestinal disorder, numbness, constipation and distended stomach to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced fever, chills, stomach issues, numbness, constipation, severe stomach distention, numbness in elbow and thigh as well as GERD symptoms. The patient had none of these issues before taking the vaccine. It's almost a year later and not one doctor can help the patient with his/her severe stomach distention and I had spent countless monies on seeing almost every doctor on Island. The reporter consented to follow-up.
This spontaneous report was received from a nurse, referring to a currently 62 year old female patient. The patient's medical history, concomitant medicationsand concurrent conditions were not disclosed. On an unknown date, the patient was vaccinated with  a dose of PNEUMOVAX 23 single 0.5ml dose (anatomical injection site, route of administration, and indication not disclosed), lot # R022249 and expiration date 16-APR-2020. It was reported that this vaccine had been on a temperature excursion, and was stored at or above 32 °F up to 35 °F (0°C to 1°C) (32.5F) during 8 hours; but it was also noted that there had not been a previous temperature excursion. At the time of this report, there were no adverse events reported. Digital data logger was involved. This was one of two cases received from the same reporter. Sender's Comments: US-009507513-1812USA008691.