chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned 4 patients of unspecified age, sex, race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, 4 patients experienced suspected immunological vaccine failure. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) negative. As per reporter "4 out of 5 patients who received the Janssen COVID-19 vaccine tested negative for antibodies in a small study group. Reporter complained about the vaccine stating that they do not believe in its efficacy. Since the reporter had a perceived lack of effect (LOE) based on their expectation from the product and the timing is unclear (no information on when the antibody test was done after the vaccine administration)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193783.; Sender's Comments: V0: 20210934975-COVID-19 VACCINE AD26.COV2.S - Suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Muscle aches in arm of shot, increasing each day. On the 5th day the pain was serious and limitation of arm movement. My fingers and finger tips numbness. The 6th day required Emergency Room Care with a follow-up with Family Doctor. Three weeks after shot I am still having pain, muscle aches and numbness in fingers.
Systemic: Fainting / Unresponsive-Severe, Systemic: Sweating-Severe, Systemic: Nausea-Severe
Started having the same problems I had after the 1st and 2nd dose, this time the reactions were a little milder; Within hours after vaccine started getting arm pain, sweating; started feely achy and began urinating blood; For the next 2 days I stayed in bed and had a fever, chills and lower back pain where my kidneys are; Also started to have a ringing in my ears; After first day in bed I started having severe joint pain, it got progressively worse with time; I couldn't close my hand all the way, not able to hold onto anything; The joint pain slowly got a little better; Returned to work, though ringing in my ears never subsided; The next month I got a really heavy period for 2 weeks.
Temperature 103 that night, down with Tylenol. Aches all over, chills. Could hardly stand up.
Bladder weakness noticed a week later, brought it up at her wellness visit beginning of October. The pediatrician wasn't sure if it was behavioral or maybe wasn't emptying bladder completely. She thought it most likely wasn't residual weakness from previous GBS because she had been fine the past year and a half. Parents noticed hand weakness and cramping in November. Parents noticed increase hand weakness and decline, requested OT referral from pediatrician. Over Christmas break, parents noticed leg weakness and this continued into January. Scheduled follow-up with neurologist at first available appointment. **Asked daughter if she started having trouble with her hands in school in October, she said yes. (We know it was October because her teacher quit first week of November and we used this as a reference. We asked her if her hands hurt or she was having trouble in writing when he was still her teacher or after he left which she responded when he was her teacher still). She was admitted the day of her neurology appointment for tests and treatment. She was given 4 days of IVIG treatment and officially diagnosed with CIDP.
Information has been received from a physician referring to a 65-70 year old female patient who was enrolled in market research. Historical condition and concurrent condition were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiration date and dose unspecified, route: injection). The concomitant medication was unknown. In approximately 2014 (1-1.5 year ago), the physician mentioned the patient complained of having some body aches and a fever a few days after receiving the vaccine. The outcome of the events was reported as resolved with sequelae. The causality between the events and ZOSTAVAX was not provided. Additional information is not expected because the physician would not given consent to provide contact information.
Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 21-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 21-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 21-Jul-2022).    No concomitant medication was reported by reporter.  Total 35 vials were affected. Vial was initially stored in refrigerator on 04-Jun-2022 and did not undergo temperature excursion. Manufacture code for the lot was MOD. Patient was administered with half dose.  No treatment medication was reported by reporter.
A report has been received from a Health Professional concerning a 16 year old, Female subject, who had been receiving Nasal FLUMIST, (intranasal). FLUMIST started on 16-Jan-2014. We inadvertently gave expired FLUMIST which started on 16-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter. Follow-up of insignificant information received by Astra Zeneca/MedImmune on 05-Feb-2014: Initial received date and form completed date changed to 03-Feb-2014. Corrected report: Reporter tab updated.
A few minutes after the shot was administered while sitting in the waiting area I started to feel heat at the injection site. The heat and tingling feeling spread across my back, my chest and up my neck. I instantly thought I was going to throw up or pass out. I alerted the volunteers and a nurse provided a bottle of water. I drank most of the water and felt well enough to drive home after 15 minutes. Felt a little nauseous but no other side effects or symptoms after this event.
Patient came for Pfizer bivalent booster, was given Pfizer monovalent instead. Discovered after patient left. Pt was informed as soon as discovered
Within minutes and almost instantaneously, as the shot was being injected, my arm tingled.  Then it moved to my mouth  and tongue.  The roof of my mouth, and tongue became numb.  I needed to think really hard how to swallow.  It was like I could not figure out how to work that muscle.  I took benadryl, to ease symptoms.  It helped but did not take it away.  Next day, mouth and tongue still numb, and my ears, eyes, nose and throat were itchy.  My external skin was also itchy.  My doctor put me on a steroid pack. 4 days later, I am doing much better still not 100% percent myself, but very close to being back to normal. Still have slight sensation in tongue.
Raised area approximately 1" x 3" hard to the touch.  Initially red, then Discolored as a bruise would appear...... also on L forearm what appear as dots (like a hive) multiple and itchy. This rash resolved after 2 days, using hydrocortisone cream, then returned on 2.25.21. Some relief but still a visible rash.
Patient felt dizzy after couple of minutes of receiving the vaccine.; This is a spontaneous report from a non-contactable consumer (patient). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0185), via an unspecified route of administration at right arm on 19May2021 (at the age of 12-year-old) as unknown, single for COVID-19 immunisation. Medical history included allergies: Cashews. Patient other medical history was none. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021, patient felt dizzy after couple of minutes of receiving the vaccine. Treatment was not received for the adverse event. Due to event Doctor or other healthcare professional office/clinic visit. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the event was recovered in May2021.  No follow-up attempts are possible. No further information is expected.
Fever, chills, aches in bones Narrative: employee states: The evening of second vaccination she had a fever of 102.4 F and then developed chills, and aches in joints and bones which resolved.
Fever; dizziness; upset stomach; This is a spontaneous report from a Non-contactable consumer. A female Patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route on Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced fever, dizziness, and upset stomach on unspecified date. Patient underwent lab tests and procedures which included body temperature. The outcome of the events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021196645 same reporter/SD/AE, different patient
Chills, fever, lack of energy, flu like symptoms, aching, soreness at injection site, swelling at injection site
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 27-JUN-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ 2 ML, 10 unit dose tube, which had the lot # K022995, with expiration date 22-JUL-2016, orally (dose and dosage number were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursion of 24 hours. The highest recorded temperature was 47 F (8.333333333 Celsius degrees), the lowest temperature was not reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: AFTER 5-10 MINS GIVEN THE VACCINE @6;50PM, THE PT FELT DIZZY/FAINTED FOR 2-3 MINS. RPH MADE SURE HE DIDNT FELL OR HIT HIS HEAD. TECH CALLED 911. PARAMEDIC TOOK BP 134/86, BS 78, OSAT 99. PULSE 69. 9/9/21 CALLED PT TO FOLLOW UP/OK. PT STATED HE WAS BEING WATCHED FOR 20MINS IN THE AMBULANCE AND SENT HOME
Hives on neck, chest, arms, and legs approximately 2-3 weeks after Moderna injection. Currently still ongoing.
Ogie Stoops is a 42 y.o. male patient of Physician No with no significant PMH who presented to the Hospital with sob and HA. Diagnosed with COVID-19 pneumonia   Covid-19 Pneumonia Acute hypoxic respiratory failure - resolved Date of onset of symptoms: 2/13 Symptoms present on admission: sob and cough Date of covid positive test: 2/16/23 Vaccination status: vaccinated Imaging: CXR (2/16) no acute findings Oxygen requirements on admission: 2 liters with ambulation, increased to 6L overnight Current oxygen requirements: back to room air Medical therapy: Received Decadron and remdesivir Consultants following: N/A Anticipated special isolation end date: 2/23 Discharge home with Decadron   COPD suspected CT chest shows extensive bronchitis, likely chronic In setting of smoking Will discharge with Spiriva, Symbicort, rescue inhaler Needs PFTs outpatient   OSA suspected Continue pulse ox when sleeping UM c/s for PCP referral and will need OP sleep study   Lung nodule Seen on CT - 2 right middle lobe nodules <1cm Follow up CT in 12 months   Tobacco use d/o Advised cessation ~5 min spent Ordered NRT
persistent numbness and tingling in feet and legs that started right after vaccination and is still present. Neuropathy is preventing activities of daily living. Pt is also struggling with chronic fatigue since 2nd J&J covid vaccine
Temperature 102.7 throughout the first night and 101.8 the second night.  Aches & pains, bad headache.  Feel much better today 1-8-21.
UrticariaPruritus induration sameday onset of flat,puritic, warm induration of 10x8 cm which continues at day 9.
Later noticed a cough that has not gone away; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Later noticed a cough that has not gone away) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced COUGH (Later noticed a cough that has not gone away). At the time of the report, COUGH (Later noticed a cough that has not gone away) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (rebound day 5/positive covid) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Drug allergy. On 16-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (rebound day 5/positive covid). At the time of the report, COVID-19 (rebound day 5/positive covid) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date was reported as 26-May-2022. Company comment: This spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 248 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 12, 2022, patient was started on Paxlovid treatment regimen, on May 21, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 248 days after administration of third dose of mRNA-1273, there was no information provided regarding the initial two doses. On May 12, 2022, patient was started on Paxlovid treatment regimen, on May 21, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The child has developed fever 2 days after vaccination, followed by whole body rash 8 day later.
Fever (101.9), myalgias, nausea, anorexia, headache x24 hours
Patient reports: pain and swelling in left leg below knee and calf tender to touch. Patient is currently admitted into hospital for treatment.
vaccination given at 0756am symptom onset 0759 episodic chest pain, light headedness, nausea, flushing, inclusive of chest pressure rated at 2/10 lasting minutes in duration- intermittent, intermittent light headedness  0812 136/69 hr 61 o2 sat 98 on room air.  0820 rapid response called 0822 132/79 hr 54 o2sat 98 on room air. 0827 127/76 hr 54 o2sat 98 on room air. 0832 pt wheeled to ED with RRT.
Approximately 2 weeks after shot, I began to have opthalmic shingles.    This happened again after shot number 2.   On that shot it reoccurring two more times.  I was treated in total for 3 bouts of shingles for 30 days of aniltiviral treatments to combat opthalmoc shingles during the vaccination period.
SOB, sensation of throat closing, tingling in the arms, evaluated by EMS, transported to nearest ER
Dose 1-Hives on left arm around injection site one week after injection.  Dose 2-Hives all over back within 2 hours of injection (Benadryl taken), migraine type headache, achy all over, low grade fever with sweats and chills, foggy thinking, tired.
Fever of 101.7; severe headache; body aches; chills/sweats; extreme fatigue; extreme pain at injection site - all developed within 5-6 hours of recieving vaccination. All syptoms lasted approximately 24 hours, causing missed work. (Used Tylenol to help with fever and pain)  The second day, fever, body aches, chills/sweats subsided but extreme fatigue and arm pain lingered for the next 3-4 days.
2 X 2 cm area on right arm red and warm to touch. Benadryl given and cold compress.
High Fever, Chills, Aches, Headache, Dizziness, Weakness, Fatigue.  Took Aleve, bedrest, drank water, went to sleep. Stayed home from work due to dizziness, still had low fever, tired.
no adverse effect; reconstitued with expired sterile diluent; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Information about patient's concurrent condition, concomitant medication, drug allergy/reaction, medical history was not reported.  On 09-OCT-2019, the patient was administered with a dose of expired sterile diluent(STERILE DILUENT), (lot # N015479, expiry date: 23-JUL-2019) which was reconstituted with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, frequency, route, anatomical location was not reported) for prophylaxis (expired product administered). No adverse event was reported. No product quality complaint was involved.
UNCONTROLLED VOMITING; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mitral valve prolapse, and cat hair allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered to right arm on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced uncontrolled vomiting. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, and uncontrolled vomiting. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Starting approximately 4 hours after vaccination patient experienced fatigue. Starting approximately 25 hours after vaccination patient began experiencing chills. By hour 27 patient was running a fever (measured at 101.5 F at hour 30 after vaccination). Symptoms resolved by approximately hour 38 after vaccination.