chrisvoncsefalvay/vaers-outcomes huggingface dataset:
checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night; not feel well on 08APR2021; Chills after second dose; usual Shaking; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TREMOR (usual Shaking) and CHILLS (Chills after second dose). On 08-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night) (seriousness criterion medically significant) and MALAISE (not feel well on 08APR2021). At the time of the report, BLOOD PRESSURE INCREASED (checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night), TREMOR (usual Shaking), MALAISE (not feel well on 08APR2021) and CHILLS (Chills after second dose) outcome was unknown.            On 08Apr2021 evening, patient was not felt well. When she checked her blood pressure it was 193/115 mmHg. She had gone to the emergency room. She was prescribed with Atenolol 25mg and Amlodipine 5 mg as needed.  Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. Further information has been requested.   This case was linked to MOD-2021-019463 (E2B Linked Report).; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. Further information has been requested. MOD-2021-019463:First dose of vaccine case.
R09.02 HYPOXIA 4/18/2023 LUNG CANCER LEFT LUNG, UNSPECIFIED PART
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 18-year-old male patient received BNT162b2 (BNT162B2), on 24Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 24Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 17 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "heart murmur" (unspecified if ongoing), notes: other medical history: heart murmur; "known allergies: Peanuts" (unspecified if ongoing), notes: known allergies: Peanuts; "known allergies: tree nuts" (unspecified if ongoing), notes: known allergies: tree nuts. Concomitant medication(s) included: ALLEGRA taken for hypersensitivity; FLONASE [FLUTICASONE PROPIONATE] taken for hypersensitivity. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course included: The patient received Paxlovid for the treatment of COVID-19 from 7May2022 to 11 May2022. He tested negative on day 6 or so after going through all of Paxlovid but he was testing positive again on day 9. He felt completely fine from around day 3-8 but on day 9 he had a slight sore throat/shortness of breath. He may have started tested positive again earlier but didn't take a test between days 6 and 9. The adverse event started on 16MAy2022 at 8:45 AM. The patient was recovering. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills that lasted approximately 12 hours.  Then felt she had "skipping hearting rhythm."  Went to the hospital and was admitted on 12/08/2015 with fever and elevated white count.
Initial unsolicited valid non-serious case received from a physician via Sales Representative on 06-Aug-2018. This case involves a 15 years old male patient who experienced rash on both arms and legs, while he received vaccines MENACTRA and ADACEL. The patients past medical history, medical treatment, vaccination and family history were not provided. On an unknown date in 2011, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious rash on both arms and legs (rash), same day (in the evening) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Other relevant tests were not reported. Final diagnosis was rash on both arms and legs. It was not reported if the patient received a corrective treatment. On an unknown date, patient was recovered from event.
Sudden and rapid muscle loss. Extremely high CPK (6063) Fatigue Weakness  Blood work, Low dose CT, Abdominal Ultrasound, Chest Xray Next appointment is with a Rheumatologist  Discontinued Crestor 4/10/2021  No change in two months
3/27/03 Well child exam; 2 vaccines given. 3/27/03 Midnight; temp 105 and brief seizure tonic/clonic. Patient quickly recovered and seems fine.
PATIENT DEVELOPED A FEVER 1 DAY POST VACCINATION AND THEN DEVELOPED BELL'S PALSY.
This is a follow-up spontaneous report from a contactable consumer received from Pfizer sponsored program COVAX US support. A 40-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date Apr2021 (age at vaccination 40-year-old) as single dose, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history included ongoing adult ADHD (attention deficit hyperactivity disorder) he has had this for probably his entire life, but he was just diagnosed about a year ago. There were no concomitant medications. On 05Aug2021, the patient tested positive for the delta variant. It was reported that the reporter patient had their Pfizer COVID vaccines and then tested positive for the delta variant on 05Aug2021. The reporter stated that the patient got his second dose about 2 weeks after the reporter had hers. She confirms that patient got his last dose after she had her last dose which was on 28Mar2021.The patient underwent lab test and procedures which included sars-cov-2 test positive for delta variant on 05Aug2021. The clinical outcome for the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075459 Same reporter, drug, event for different patients.
High fever (101.0 F). Bad aches in bones, muscles, and intestines for two days. Rash on deltoid of my left arm. Took until mid-day Wednesday for the effects to clear up.
administered an IV push of fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) (batch number fd723, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd October 2021, the patient received Fluarix Tetra (intrvenous push) and Fluarix Tetra Pre-Filled Syringe Device. On 2nd October 2021, unknown after receiving Fluarix Tetra and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an intravenous push of Fluarix quadrivalent, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
1826: Pt reported feeling like her heart was racing. R hand tremors noted. Pt reported history of SVT with first dose of some new medications. Pt reports intermittent SVT and PVCs post ablasion. HR 136, regular rhythm. 1828: 176/101 (119), HR 108, Resp 22, 99% on room air Pt reports feeling like her HR is returning back to normal, hand tremors continue. Reports mild shortness of breath, which is typical with her SVT episodes. 1831: 151/82 (98), HR 81, regular rhythm, Resp 12, 98% on room air. Denies any worsening or any additional symptoms. Hand tremor no longer present. 1839: 151/104 (113), HR 76, regular rhythm, Resp 10, 98% on room air. Pt reports headache and mild nausea that is typical with her SVT episodes. Pt appears relaxed sitting in chair. 1845: HR 78, regular rhythm. Pt remaining in monitoring area for 15 additional minutes. No s/s further distress. Pt calling husband to take her home. 1905: BP 157/91 (107), HR 87, regular rhythm, 98% on room air, Resp 14 Pt c/o numbness to L arm with some L chest tightness. Reports this sometimes happens with her SVT episodes. 1907: No further chest tightness or L arm numbness. Pt reports feeling anxious. Does not want to go to the ED for further monitoring. Continues to report that her symptoms feel typical after her SVT episodes with some additional nausea. 1910: 132/112 (117), HR 78, regular rhythm. Pt reports improvement of symptoms. Pt relaxed in chair. Instructed pt to stop and call 911 if she has any concerning symptoms after leaving clinic including difficulty breathing or HR abnormalities.
Thursday morning I woke up and my eyes were crusted over and difficult to open. At around 9:30 am I had uncontrollable unexpected diarrhea that I just oozed out of my bottom didnt even have time to get to the bathroom! The symptoms stopped . The pharmacy suggested I report incident
Awoke with fever, sweating, muscle twitching, headache. Taken to the ED where evaluation showed orthostatic hypotension which was only partially improved with IVF. Evaluated by neurologist. Seen 5/4 with continuing symptoms and begun on FLORINEF.
Hot flashes throughout the day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes throughout the day) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (Hot flashes throughout the day). At the time of the report, HOT FLUSH (Hot flashes throughout the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medications was provided     Reporter did not allow further contact
chills; fatigue; deep muscle aching in both arms; fever ranged between 100-101 F; This is a spontaneous report from a contactable nurse (patient).  A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration at left arm on 08Jan2021 at 09:30 at single dose for COVID-19 immunization. The patient medical history included seasonal allergy from an unknown date and unknown if ongoing and COVID-19 from Oct2020 (as reported: "I had been diagnosed with COVID-19 on 21Oct2020 with symptoms onset on 15Oct2020") to an unknown date.  The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY), aspirin, calcium/cholecalciferol (CALCIUM + D3), docusate.  The patient previously took COMPAZINE and BACTRIM DS and experienced allergies.  The patient reported that on 08Jan2021 at 21:00 developed chills, fatigue, deep muscle aching in both arms and fever ranged between 100- 101 F.  On 09Jan2021 at 09:00 he felt fine, until approximately 17:00 and again developed chills, muscle aching and fatigue. On 10Jan2021 at 08:30 all symptoms were gone and never returned.  The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 21Oct2020. The patient outcome of the events was recovered on 10Jan2021 at 08:30.
Pain for 4 or 5 days in left  leg (that leg also has varicose veins), some swelling and tender to the touch . Fifth day became raised and warm to the touch, so went to Urgent Care  Diagnosis:   Occlusive and nonocclusive thrombus within a superficial vein underlying the region of concern
Approx. 2 hours, post vax, parent noted infant's upper body was shaking. Parent took infant's temperature which was 99.3F (ax). Parent called health dept and was advised to take child to the ER. After bringing infant to ER at 14:25, the child was seen by PAC. After presenting at the hospital, the infant developed a macular papular rash on face, neck, chest and upper back. He was treated with po liquid Benadryl at the hospital. The parent followed with a repeat dose of po liquid Benadryl at 23:00. The child was rechecked on 1/3/02 at the hospital. Temperature was 98.4F. Rash clearing and child is active and playing. Note: no shaking noted on hospital visit of 1/2/02.
15 YEAR OLD MALE RECEIVED ONE DOSE OF THE PFIZER VACCINE. NO ADVERSE EFFECTS HAVE BEEN REPORTED.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
On the 4th day I had extreme vertigo, the surroundings were spinning and I needed to go to the ER.  I was given Meclizine and Zofran in the hospital. I have had outpatient physical therapy for vestibular rehab.
localized reaction of redness, swelling of over the size of a golf ball and pain; Localized reaction of redness, swelling of over the size of a golf ball and pain; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a 74 years old male patient who experienced localized reaction of redness, swelling of over the size of a golf ball and pain (Inflammation and vaccination site reaction), while he received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history, past medical treatment, vaccination and family history were not provided.  The patient did not receive other vaccine concomitantly.  On 21-Oct-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, lot UJ483AB, expiration date 30-Jun-2021) via an intramuscular route in the right deltoid for prophylactic vaccination.  On 26-Oct-2020, the patient developed non-serious localized reaction of redness, swelling of over the size of a golf ball and pain (Inflammation and vaccination site reaction), 5 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.   The patient was held on observation, no breathing or any other issues were reported, so he was discharged the same day of the vaccine.    Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome for the events was unknown.
28MAY92 swollen glands-neck; generalized aching, dec appetite, h/a (entire head) x 4 days; sx inc in severity x 4 days; fever 101 x 4 days;
Two days after administration, site was still the size of a baseball, red and puffy, and very warm to touch. Site is sore and I am unable to lay on that arm without extreme pain.
Woke up at 3am with strong chills, chills lasted for an hour or two.  Experiencing fatigue since then.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine was mislabeled with the frozen expiration date rather than the refrigerated expiration date , which was unknown at the time of administration. Vaccine expired at time of administration
Debilitating pressure and pain in my head,  face and neck.   Severe migraines for 6 months. dizzy, extreme pain and numbness in left side of my face. Extreme sensitive to light and sound, motion sickness and nauseous.
still has a rash today; hives on her outer thigh area, hives recurred 2 days later; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), URTICARIA (hives on her outer thigh area, hives recurred 2 days later) and RASH (still has a rash today) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), DENOSUMAB (PROLIA) and SPIRONOLACTONE for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Jan-2021, the patient experienced URTICARIA (hives on her outer thigh area, hives recurred 2 days later). On 04-Feb-2021, the patient experienced RASH (still has a rash today). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), URTICARIA (hives on her outer thigh area, hives recurred 2 days later) and RASH (still has a rash today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications spironolactone, atorvastatin, Effexor, Prolia injections.
On day on injection, experienced numbness on left side of lips and lower face.  On day 6 (4/30/2021), woke up with a large red rash at injection site.
BIG red swollen bump that has formed on my left arm at the injection site. It is also itchy. I was expecting this, but not to be this bad. It's been growing bigger, and more swollen as the day has gone on.
Received the 1st dose of the vaccine on Dec. 23rd. On the morning of Jan. 4th woke up and had a red ring around the injection site on my arm. The skin was slightly warm to the touch but no other symptoms. The red ring disappeared within 48 hours.
Information has been received from a health professional concerning a 33 year old female who on 09-NOV-2007 while preparing a dose of ZOSTAVAX (Oka/Merck) (lot# 658209/1085U), she pulled back on the syringe and the solution splashed in her eyes.  It was reported that she flushed her eyes for ten minutes.  It was reported that she sought medical attention in the physician's office.  As of this report it was reported that her eyes are less red than they had been and that she feels fine.  At the time of this report the patient was recovering.  There were no laboratory or diagnostic tests performed.  A product quality complaint was not reported.  Additional information was not available.  Additional information has been requested.
I began having COVID symptoms on 12/29/2021. I got a positive result on a PCR test on 1/3/2022. This was a breakthrough case.
INTENSE DEPRESSIVE FEELINGS; STOMACH CRAMPS; STOMACH BLOATING; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included drug titration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diazepam. On 06-APR-2021, the subject experienced intense depressive feelings. On 06-APR-2021, the subject experienced stomach cramps. On 06-APR-2021, the subject experienced stomach bloating. On 06-APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intense depressive feelings, stomach cramps, stomach bloating, and soreness at injection site. This report was non-serious.
patient was given YF VAX intramuscularly instead of subcutaneously; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who was given yellow fever vaccine [YF-VAX] intramuscularly instead of subcutaneously.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine (lot number, expiry date, form, route, administration site: unknown) for immunization.   On an unknown date the patient was given yellow fever vaccine intramuscularly instead of subcutaneously (incorrect route of product administration) (latency: same day).   Action taken was not applicable.  At time of reporting, the outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
During that call, he mentioned that two dermatologist would like for him to get the GARDASIL 9 vaccine but he cannot afford it and it is not covered by his insurance since he is over the age of 45; No additional adverse event reported; This spontaneous report was received from a consumer and refers to a male patient over 45-year-old concerning himself.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.    On an unknown date, two dermatologist told the patient to get  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, , administered for skin papilloma (reported as "warts) (strength, dose description, lot #, expiry date, and route of administration were not provided) (product prescribing issue), but he cannot afford it and it is not covered by his insurance. At the time of reporting, the patient had not received any vaccine and no adverse event was reported.
Rash over most of my body - came 4 days after H1N1 shot. 1st appeared under arms.