chrisvoncsefalvay/vaers-outcomes huggingface dataset:
-saw white spots in eyes a minute or so after receiving the shot -arm extremely sore for a few days after -first day menstrual cycle heavy. Never experienced day 1 of cycle like that in my life. Also, hormones were off on home ovulation kit. -arm continues to be sore for 28 days - on day 22, arm below elbow begins to tingle and become weak. Rash around breasts occurs. Spreads to belly, arms, chest, and groin area. Hives in the area come and go. Glands felt tender and swollen. -Visit to ER 4/23/2021. Discharge paperwork diagnosed as Paresthesia. Tingling lessens. Weakness still present. -Visit Doctor 4/26/2021. Told all symptoms are Covid-19 vaccine symptoms.  -Rash around breasts, arm tenderness at injection site still present, hand weakness in injection arm present and tingle not as prevalent  *I am breastfeeding an infant, but no other illness is present that I am aware of at this time
I had an allergic reaction -about 2 hours afterwards,  it made me break out in hives. My physician gave me a shot of Benadryl and it was better the next day. Even if it was an allergic reaction - he said he'd advise me to take another one if a booster is needed.
Injection site redness and swelling, "hot and itching about 4 inches" no treatment by patient, receding by 4 days, self-limiting.
AMI onsite Paramedics were approached by a 28 y/o female stating she was about to ?pass? out as she was kneeling approx. 10 mins after receiving the vaccination which was administered at 16:54. Pt was caught prior to losing consciousness for approx. 30 seconds post vaccination and presenting with sz like activity consisting of decorticate posturing and pupils dilated @6mm. Pt was carried onto available cot via two man carry where pt regained consciousness, coax4 of 4 GCS 15. Pt stated she felt lethargic and was diaphoretic and feeling nauseated, no emesis. Pt was placed left lateral and was placed on oxygen via N/C @2lpm while EMS responded. Pt denies allergies but states being hypersensitive to Augmentin, no meds taken, no prior medical hx but states she?s had similar episodes since the age of 17 being reported as sz like but never diagnosed and denies having a neurologist. Pt also stated that this was the worst episode. While awaiting EMS, pts nausea and diaphoresis had subsided but stated feeling ?heavy?. HEENT-unremarkable, Pupils now equal and reactive, neck-supple ,equal chest rise with clear equal lung sounds ,abd non tender, FROM to extremities x4 with equal weak strength. Upon EMS arrival, report was provided, EOR.
5 days after the shot I noticed small metal objects are sticking to my arm like a magnet.  As long as a metal item is not too large it sticks.  Dimes, craft blade, paperclips, small magnets.  Doesn't stick on other arm, only sticks in spot of injection site. Called Health Department and they don't believe it.  Tried calling my doctor and left a message.  I'm planning on visiting a doctor.
blood in stools; increased stools; increased bowel movements; flare; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4119659-00 (AbbVie).  A 17 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Dec2021 (Batch/Lot number: unknown) at the age of 17 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "blood in stools"; FREQUENT BOWEL MOVEMENTS (non-serious), outcome "unknown", described as "increased stools"; FREQUENT BOWEL MOVEMENTS (non-serious), outcome "unknown", described as "increased bowel movements"; CONDITION AGGRAVATED (non-serious) with onset 13Dec2021, outcome "recovered" (2021), described as "flare". The action taken for adalimumab was unknown.  The reporter considered "blood in stools", "increased stools", "increased bowel movements" and "flare" related to bnt162b2. It was unknown if patient was enrolled in a covid-19 vaccine Trial. Primary reporters contact for lot number information was not available. On an unknown date the HUMIRA LEVEL was Low. Patient demographics, event information, reporter opinion of causality, concomitant drug information, laboratory/diagnostic procedures and narrative description updated. The event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "increased bowel movements" was added. Causality for adalimumab (HUMIRA)- The reporter's causality for the event(s) of flare unknown onset with adalimumab (HUMIRA) was a reasonable possibility. The reporter's causality for the event(s) of increased stools, blood in stools, , low and increased bowel movements was not provided. The reporter's causality for the event(s) of flare onset 13Dec2021 with adalimumab (HUMIRA) was no reasonable possibility.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. 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.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age (who was a sister of one of the physician's patient). The patient's pertinent medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, route and dosage not reported). On an unknown date 6 weeks after administration of vaccine, the patient developed shingles. No demographics were provided for the patient, who was not affiliated with the physician's practice. No further details were noted. The outcome of the event was unknown. The causality assessment was not provided. Additional information has been requested.
Improper storage of product in use; No adverse event; This spontaneous report was received from an office manager referring to a 14-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 10-OCT-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Shingles - Rash on chest, side and back (pain/tenderness, redness, oozing in rash area), shooting/sharp nerve pain in surrounding areas, low grade fever
A 9 month old child was administered Boostrix in error; A 9 month old child was administered Boostrix in error; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 9-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient was administered Boostrix in error which led to wrong vaccine administration and inappropriate age at vaccine administration. The reporter asked for recommendations that should be followed up on. The Healthcare provider's office refused to provide any additional details or any demographic information.  The reporter claimed that the physician would call back later to report the incident. The reporter did not consent to follow-up.
Pt states felt like her throat was itchy and obstruction. Pt states is allergic to sudafed and it felt the same.  Benadryl provided x2 doses at 25mg each.  After the first dose pt had no relief, after the second dose pt states felt relief. VS obtained x3. Pt was observed 30 min after the last dose of Benadryl. After the 30 min pt states felt better and felt back to normal.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old male patient who experienced pneumococcal meningitis, renal failure and hemolytic uremic syndrome. The patient received the second dose on 24-Sep-2008. The patient experienced pneumococcal meningitis and renal failure on 03-Nov-2008 and was hospitalized. These events were considered life-threatening. In Feb-2009 the nephrologist sent follow-up information to the patient's physician indicating the diagnosis of hemolytic uremic syndrome. The patient recovered from the pneumococcal meningitis and recovering from the renal failure. The outcome of the hemolytic uremic syndrome is unknown and no additional information was available at the time of this report.
Antibody developed enhancement caused my mother to not only have no protection from the virus she passed in above average time from major symptoms to death.
This is a spontaneous report from a contactable consumer (mother) via a Pfizer sales representative. A female patient (age unknown) received a dose of PREVNAR 7 on an unknown date. It was reported that, it was unknown if patient received PREVNAR 7 or PREVNAR 13. Relevant medical history and concomitant medications were not provided. On an unknown date, after receiving the vaccination, the patient experienced a hard lump (site not specified). Therapeutic measures taken as a result of the event were unknown. The patient recovered from the event on an unknown date. Follow-Up (08DEC2011) Follow-up attempts completed. No further information expected.
Next day hurt at injection site. Red swollen part lower than injection site. About 3 inches lower. Duration 5 days (+). Still red & swollen. Pt. will let me know when resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 24-JAN-1992 and on 20-SEP-1997, the patient was vaccinated respectively with the first and second dose of M-M-R II therapy type: HSA (dose, strength, route of administration, lot# and expiry date were not reported). Since an unknown date, the patient "was no longer immune". The outcome of the event and the relatedness between the event and M-M-R II was not reported. Additional information has been requested.
Right upper ext. with swelling, redness, and warm to touch. Tenderness noted to touch. States that RUE is pruritic.
Pt. states that after receiving the 3rd dose of Moderna 11/04/2021, started experiencing symptoms 30minutes later of hip and lower back pain. Experiencing hip "popping and snapping", hot flashes, face flashing, brain fog, and dry cough. No noted Primary visit/communications.
About a month later patient present to clinic with concerning new tinnitus, and worsening hearing loss. The tinnitus is ongoing and very disrupting to her everyday life.
Tdap given 4-15-14 (R) deltoid. To clinic 4-24-14 with (R) arm pain, swelling, redness, warm to touch and hardening of area. PA-C assessed and believes is an abscess. Referred to Urgent Care.
Breakthrough COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Breakthrough COVID-19 infection) in a male 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) (unknown route) 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 COVID-19 (Breakthrough COVID-19 infection) (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 (Breakthrough COVID-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported.  Treatment included monoclonal antibodies.  Patient received first two Moderna COVID-19 vaccinations and had caught breakthrough COVID-19 case. Patient was in Emergency Room and admitted to hospital as a result of COVID-19 infection.  Company comment: This case concerns a patient of unknown age and gender who experienced the unlisted, serious event of COVID-19 infection (hospitalization). The reporter/patient reports both doses of mRNA-1273 given but there is no information on timing so re-challenge in unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender who experienced the unlisted, serious event of COVID-19 infection (hospitalization). The reporter/patient reports both doses of mRNA-1273 given but there is no information on timing so re-challenge in unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Swelling and numbness in the right cheek/jaw area. Started 1/11/21 around 5pm. The patient notified us on 1/12/21 at 1545. He said that the swelling was "starting to go down, and seems like it is a little better."  The patient reports he had a similar reaction to ace inhibitors last year, but on the opposite side of his face. He was advised to seek medical treatment if it gets worse or if he has any issues with breathing. Patient verbalized understanding.
pt recv vax 10JUN96;10JUN96 in garden playing-seemed warm began trembling-blue scalp called amb adm x 1 days spinal tap done;
felt a little itching around the injection site; she was itching from head to toe; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 43-year-old female patient (not pregnant) received her first dose of bnt162b2 (BNT162B2, also reported as COVID 19, brand Pfizer, lot EL1284), intramuscularly in the left arm on 06Jan2021 15:45 at single dose, for Covid-19 immunisation. She received the vaccine in a hospital. Medical history included allergy to lima beans, grapes, cucumbers, celery, melons, kiwi. No other vaccine in four weeks. No Covid and Covid test prior to vaccination. Concomitant medications included propranolol, escitalopram, spironolactone, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, ferrous fumarate, norethisterone acetate (LARIN FE), biotin and sambucus nigra fruit (ELDERBERRY [SAMBUCUS NIGRA FRUIT]). The patient previously took CEFTIN (ceftriaxone) and sulfa and had drug allergy. The patient informed that once she got the shot (06Jan2021), she felt a little itching around the injection site a few minutes later. Later on that evening, she was itching from head to toe without any swelling or rash. No treatment was given. The patient recovered from the events.
PT C/O (L) ARM TINGLING AND BEING NUMB AND PROBLEMS WITH HER (L) LEG NOT ACTING RIGHT JUST THROUGH THE NIGHT. WAS BETTER IN THE MORNING.
Itching, swelling and heat in a 6 inch radius around the injection site lasting for more than a month after injection.
DIARRHEA; VOMITING; SEVERE BACK PAIN; MUSCLE ACHE; This spontaneous report received from a patient 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, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 15:45 to left arm for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 05-APR-2021, the subject experienced diarrhea. On 05-APR-2021, the subject experienced vomiting. On 05-APR-2021, the subject experienced severe back pain. On 05-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 06-APR-2021 08:30, and had not recovered from severe back pain, and muscle ache. This report was non-serious.
G47.33 OBSTRUCTIVE SLEEP APNEA 2/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I26.99 ACUTE PULMONARY EMBOLISM 2/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I82.409 ACUTE DVT, UNSPECIFIED VEIN 2/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I95.9 HYPOTENSION 2/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.00 ACUTE RESPIRATORY FAILURE 2/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/19/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC R09.02 HYPOXIA 2/17/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC G47.33 OBSTRUCTIVE SLEEP APNEA 2/19/2022 HYPERCAPNIA I26.99 ACUTE PULMONARY EMBOLISM 2/19/2022 HYPERCAPNIA I82.409 ACUTE DVT, UNSPECIFIED VEIN 2/19/2022 HYPERCAPNIA I95.9 HYPOTENSION 2/19/2022 HYPERCAPNIA J96.00 ACUTE RESPIRATORY FAILURE 2/19/2022 HYPERCAPNIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2022 HYPERCAPNIA J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/19/2022 HYPERCAPNIA J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/19/2022 HYPERCAPNIA R09.02 HYPOXIA 2/17/2022 HYPERCAPNIA G47.33 OBSTRUCTIVE SLEEP APNEA 2/19/2022 CANCER METASTATIC TO BILAT LUNGS I26.99 ACUTE PULMONARY EMBOLISM 2/19/2022 CANCER METASTATIC TO BILAT LUNGS I82.409 ACUTE DVT, UNSPECIFIED VEIN 2/19/2022 CANCER METASTATIC TO BILAT LUNGS I95.9 HYPOTENSION 2/19/2022 CANCER METASTATIC TO BILAT LUNGS J96.00 ACUTE RESPIRATORY FAILURE 2/19/2022 CANCER METASTATIC TO BILAT LUNGS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2022 CANCER METASTATIC TO BILAT LUNGS J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/19/2022 CANCER METASTATIC TO BILAT LUNGS J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 2/19/2022 CANCER METASTATIC TO BILAT LUNGS R09.02 HYPOXIA 2/17/2022 CANCER METASTATIC TO BILAT LUNGS
muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18Feb2021 15:30 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stomach" (unspecified if ongoing), notes: Stomach; "Blood pressure" (unspecified if ongoing), notes: Blood pressure; "Cholesterol" (unspecified if ongoing), notes: Cholesterol. Concomitant medication(s) included: NORTRIPTYLINE taken for abdominal discomfort; LISINOPRIL taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (First Dose), administration date: 28Jan2021, for Covid-19 immunisation, reaction(s): "Back pain"; Bnt162b2 (First Dose), administration date: 29Jan2021, for Covid-19 immunisation, reaction(s): "Pain in arm". The following information was reported: MYALGIA (non-serious) with onset 19Feb2021, outcome "unknown", described as "muscle ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations (within 4 weeks).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt got shingrix injection complained of week confused following day, several days hot swollen painful itching
stiffness in her both shoulders ,hip, neck,hand; Pain in hand; stiffness in her both shoulders ,hip, neck,hand; Pain in neck; 1-2 week after 1st dose, she started with pain in both shoulders,pain in hip; Doctor diagnosed her with polymyalgia Rheumatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included FAMOTIDINE (PEPCID AC), LOSARTAN, CALCIUM, ERGOCALCIFEROL (CALCIUM 600+VIT D), COLECALCIFEROL (VITAMIN D3), PANCREATIN (CREON), IPRATROPIUM BROMIDE, LOPERAMIDE HYDROCHLORIDE (IMODIUM) and CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip). The patient was treated with IBUPROFEN at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; MELOXICAM at a dose of UNK dosage form; CELECOXIB (CELEBREX) at a dose of UNK dosage form and METHYLPREDNISOLONE at a dose of UNK dosage form. At the time of the report, POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica), MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory was given.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.