chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (Same reporter source, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient got sick in bed for 2 weeks. Further the reporter thought "I was going to die". The patient's laboratory data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
I have irregular heart beat that flutters and takes my breath away. At first it was just slight discomfort but the fluttering heart beat wasn't an issue until after my 2nd shot. Its been a month and it seems to grow more constant.
The day following the vaccine, patient developed SOB and a cough. Came to the ED on 4/13/2021 and was found to have new atrial flutter. Patient continues to be in atrial flutter, has received anti-arrhythmic and rate control medications
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient reported via telephone that after receiving the TDAP and Shingles vaccine on 10/27/22, the next day they had hives all over their body.  Per client, the hives were on their stomach, chest, throat, back, and hips. The patient also reported having hives around the location the shingles vaccine was administered, in the right deltoid.  Per client, these symptoms, started on Thursday 10/28/2022 and were still present on 11/01/2022 but were starting to subside.
This spontaneous report as received from a registered nurse refers to an unknown number of patients (age and gender were unknown). On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (lot # 1248AA, exp. date 01-AUG-2013) (dose and route not reported). It was reported that lot of VARIVAX (Merck) underwent multiple temperature excursions that was recently discovered after a review of freezer temperature data over the past two years. This lost of VARIVAX (Merck) exposed to -2.5C for a period of 956.5 hours. The excursion date range from 09-FEB-2012 to 06-MAY-2013. All the stock of the lot number was administered to an unknown number of patients. Last dose administered on 06-MAY-2013. This VARIVAX (Merck) lot number was not supported. The reporter stated that she believed that some of the VARIVAX (Merck) should have had stability information to support some of the excursions. No adverse events were reported. This is one of several reports from same source. Additional information has been requested.
G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/14/2023 HX OF ACUTE KIDNEY INJURY G47.33 ADULT OBSTRUCTIVE SLEEP APNEA 4/14/2023 GRAVES DISEASE
On May 6th at 10:30 I felt pain in chest on my left side. The pain went my left elbow. The pain got worse and I called my nurse hotline and advised me to go to the emergency room right away. I went to the emergency room, they checked my blood, check my heart to make sure I did not have any blood clots. I waited for a few hours for my results and the emergency room doctor said I did not have any signs of blood clots and my heart was doing great. The doctor said I have costochondritis. The pain and swollen has not went away anytime I have stress or pick something up too heavy.
Lump on the left side of her neck; Arms and back itch like crazy; Redness on her arm below injection site; Headache; Hypersensitivity reaction; Lumps in my neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Lump on the left side of her neck), PRURITUS (Arms and back itch like crazy), VACCINATION SITE ERYTHEMA (Redness on her arm below injection site), HEADACHE (Headache) and HYPERSENSITIVITY (Hypersensitivity reaction) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L30A and 029L20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: TETANUS VACCINE (Rash) in 1962. Concurrent medical conditions included Penicillin allergy (Rash) in July 1995, Cholesterol, Hypertension and Reflux esophagitis. Concomitant products included ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension, OMEPRAZOLE for Reflux esophagitis, CENTRUM FOR WOMEN for Supplementation therapy, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced NECK MASS (Lump on the left side of her neck), PRURITUS (Arms and back itch like crazy), VACCINATION SITE ERYTHEMA (Redness on her arm below injection site), HEADACHE (Headache), HYPERSENSITIVITY (Hypersensitivity reaction) and SWELLING (Lumps in my neck). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. In March 2021, PRURITUS (Arms and back itch like crazy), VACCINATION SITE ERYTHEMA (Redness on her arm below injection site), HEADACHE (Headache) and HYPERSENSITIVITY (Hypersensitivity reaction) had resolved, SWELLING (Lumps in my neck) had not resolved. At the time of the report, NECK MASS (Lump on the left side of her neck) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram neck: (Inconclusive) Specialist doctor did not find anything worrisome at this time.. On an unknown date, Ultrasound scan: Inconclusive and Inconclusive.         Patient reported that Doctor - regular doctor - wants that she has a future ultrasounds to check lumps as they still  there.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up was received and included information for Product tab 1st dose, Patient tab, race, ethnic group, height, weight, allergies, historical condition, concomitant medication, onset date, stop date, and outcome event.
Vision changes; Constant headaches, some are worse then the rest; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision changes) and HEADACHE (Constant headaches, some are worse then the rest) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (Constant headaches, some are worse then the rest). On 01-Apr-2021, the patient experienced VISUAL IMPAIRMENT (Vision changes). At the time of the report, VISUAL IMPAIRMENT (Vision changes) and HEADACHE (Constant headaches, some are worse then the rest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.   No treatment information was provided.
Patient got vaccine on 10/14 and noticed her arm where vaccine was given was breaking out on 10/15. On 10/16 it looked like the break out got bigger. Does not hurt
About 7 minutes after administration of Flu shot pt presented with hives on his face only. Treated with Benadryl 12.5/5 ml, 5ml PO now. Hives decreased within 10-20 minutes. Before admin of IZ, grandmother asked if egg allergy and stated no. When explained after reaction, Grandmother states she recalls now that patient gets hives when he eats eggs.
red rash all over the body; This is a spontaneous report from a contactable consumer reporting on behalf of the patient via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on Saturday (unspecified date). The patient experienced red rash all over the body on unspecified date. The reporter asked if the patient should go to the hospital. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Redness and swelling on the left arm around the deltoid area - Prescribed/ advised to take BENADRYL and ibuprofen. Reaction on the arm then got the KINRIX.
This spontaneous report as received from a consumer refers to her father of unknown age. The patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown) on an unknown date in 2012. No other co-suspects were reported. No concomitant medications were reported. "A few months later"(also reported as "A few days ago") the patient developed shingles. The patient had been on steroid medications for many years. The outcome of shingles was reported as not recovered/not resolved. Additional information is not expected.
Receive Influenza vaccine at 8am, noted hives on back at 4pm. Treated with Benadryl cream and hydrocortisone cream.
No adverse effects reported; one (1) dose of MMR II (lot unknown) with DILUENT was administered intramuscularly to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 30-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 1 dose, (lot# was not reported) intramuscularly for prophylaxis. The vaccine was reconstituted in sterile diluent. No adverse event was reported.
not feeling good; pulsating at the injection site/arm; when will his taste buds will be back or the smell.; when will his taste buds will be back or the smell.; fever; dizziness; muscle aches; nausea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, at 1st dose, single dose for COVID-19 immunization. Medical history included COVID in Oct2020. Concomitant medications were not reported. The patient had COVID back in the Oct2020 and after taking first dose of BNT162b2 he was experiencing all the symptoms which he experienced with the COVID-19: fever, dizziness, muscle aches, nausea, not feeling good, pulsating at the injection site/arm. He wanted to know about if he was contagious and when would his taste buds would be back or the smell. The patient had not recovered from when will his taste buds will be back or the smell, the outcome of the other events was unknown.   Follow-up attempts are completed. Information about lot/batch number cannot be obtained.
Head called to the room body stiffened and started to slide off chair.  Assisted to floor by RN and mother.  Some twitching "came to" and didn't know where she was (4 minutes).  Sat on floor, then up in chair, moved to private room, blood pressure 90/60 taken again 80/60 and complain of throat feeling funny, "full", clammy. Epi pen administered right thigh. Blood pressure remain at 80/50.  Transferred by mother to emergency room, walked to car by RN
4 yrs old patient receives on February 2, 2010 the following vaccines: MMR, DTaP, Varivax. These vaccines were administrated on his right arm. The patient presented on the 3rd of February 2010 the following reactions: rash, pain and swollen on the area administration. Also the patient presented fever. Patient was evaluated by his pediatric physician and begins to receive antibiotic treatment by mouth.
On October 11, 2021 I got my period 9 days early making it due on November 9th. Here it is December 9th and I am 30 days for my period.
T 102.2F, chills, night sweats, cough, congestion, head ache, myalgia, general malaise
Following injection of COVID19 Moderna vaccine in LA via IM Lot 043B21A, the patient states tingling in fingers.
It was reported that a pt (5 of 5) received an Imovax Rabies ID vaccination on 3/5/01. Reportedly, the pt developed a headache, sore muscles, nightmares, insomnia and a local reaction, lasting 2-4 days. Further information is requested. From telephone conversation on 4/6/01, it was reported that the pt recovered from this experience. From additional correspondence received on 4/18/01, the correct vaccination date (3/5/01) and the adverse event onset date (3/7/01) were provided. Additional pt, vaccine, responsible physician and vaccine administrator information was also provided. This case is closed.
Extreme chills, weakness, inability to stand, dizziness.  I get the seasonal flu shot every year. I do have the sore arm, that is normal. My eyes are watering so it?s hard to see. My ability for fine motor skills is a bit limited,
Patient was given an unauthorized COVID-19 for her age at the time of vaccination. The parent/guardian provided the incorrect date of birth 7/16/2016 which would have made her at least 5 years old at the time.
pt recv 3rd dose of vax 12JUN93; lab testing performed 27MAR95 revealed anti-HBs neg; a booster dose of vax was given 31MAR95; No further details were provided;
wrong covid vaccine was given to patent. Patient requested Pfizer and moderna was administered 0.3ml. Full dose of Pfizer was administered to left deltoid for completion of the series.
Swollen, red arm around injection site.  Redness size of baseball. No fever.
Complains of ache and soreness in the arm x9 days. Denies redness, swelling, or any knots at the injection site.
High fever 102-103, fatigue, lightheaded and nausea with headache.
Pt had a rash start yesterday evening after she had gotten HepA vaccine and also eating. No new foods were tried. She has had the rash since last night. No meds given. Is pruritic, mom sees her itching it at times. No associated sx. No recent travel, no URI sx.  Rash and other nonspecific skin eruption noted.  The rash has not occurred previously.  The rash is widespread and diffuse in its location.  She describes the rash as red.  The rash is itching.  She denies any associated symptoms. Rash and other nonspecific skin eruptionpt with blanching macular rash, discussed use of Benadryl  monitor and if progresses RTC tomorrow ddx includes viral exanthem, allergic to component of Hep A vaccine or other source/restaurant food, or lower on ddx given interdiginous distribution and pruritius scabies
I started having symptoms of a cold on Saturday February 25, 20223. I felt fatigue the following Sunday. On Monday I started feeling chills, along with the other symptoms. Later in the day, I started to feel like it might be COVID -19, so I did a home test, and it was positive. I went to the urgent care and got tested again and it was positive. The doctor also tested me with a positive response, and he prescribed me Paxlovid. I also had a fever. I took my first pill that evening and I started feeling better the next day.  It took a couple days to regain my energy, but my symptoms were pretty mild.
Pt vaccinated for COVID vaccine, came to RN to schedule 2nd appointment. Pt reporting feeling lightheaded. RN told pt to sit in chair next to RN. Pt sat down and after 1 min he start to slide down the wall, moving the painting with his forehead. RN caught pt and assisted him to the ground. RN called for help and ordered a dynamap. RN assessed for breathing and a pulse. Pt breathing and with pulse. RN slightly provided sternal rub and called name. Pt unconscious for 15 seconds. Pt awoke and stated he felt disoriented. Vitals collected. After a couple 2 min pt reports knowing where he was. Pt was wheelchaired to urgent care.
Pt had syncope after administration of FLUZONE vaccine. Pt passed out approximately 30 sec then regained consciousness. Pt requested 911 called, paramedics checked vitals, had pt drink gatorade & left approximately 20 min after.
List all energy, felt very sick like the Flu was coming on.  Pain in knees and spine.  Lost my sense of Taste.
I become pregnant within 30 days of my 2nd vaccine (last menstrual period (LMP) was February 3rd and I ovulated  around February 18th). I then miscarried at 6 weeks and 1 day  (3/18/21). I found out I miscarried at 9 weeks and 2 days (4/9/21), but I had a "missed miscarriage" and the baby stopped growing with no heartbeat at 6 weeks and 1 day (3/18/21). My due date would have been November 10th 2021.
Very sore arm couldn't raise past shoulder, muscle aches - legs, arms, neck, and headache for 3 days beginning on 11/30/2020 until 12/2/2020 10pm.  Fever of 99.7 until 12/1/2020 8:00 am.  Shivering for 6 hours on 11/30/2020 at 5 pm until 11pm on 11/30/2020.
received an expired Moderna vaccine booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired Moderna vaccine booster dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 026B21A and 002C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired Moderna vaccine booster dose). On 18-Jan-2022, EXPIRED PRODUCT ADMINISTERED (received an expired Moderna vaccine booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
burning sensation; swollen tongue; allergy reaction; This is a solicited report based on information received by Pfizer from pharmaceutical company  (Manufacturer report number: CLO-2021-001324). A contactable 52-year-old female consumer reported that:   On 27Aug2021, this solicited report was received by biopharmaceutical(#) from a coustmer in the Country. A female patient, 52-years-old, had been treated with Rubraca (rucaparib) 500mg twice daily by mouth from an unspecified date in 2018 for malignant neoplasm of unspecified ovary. The patient's medical history was not reported. On an unspecified date, after the start of Rubraca, the patient was seen in the emergency room for an allergic reaction to the Pfizer COVID-19 Vaccine the patient experience the burning sensation and swollen tongue. Therapy with Rubraca was maintained. The outcome of the allergic reaction to Pfizer COVID-19 vaccine was unknown. Outcome attributed to adverse event: Other serious (Important medical events).  The patient assessed the causal relation between Rubraca and the allergic reaction as no related, providing the COVID-19 Vaccine to suggest an alternative casuality.  The adverse events in this Safety Report have been assessed against the he adverce event in the marketing authorisation  which is identical to the marketing authorisation . As a result, the listedness filled for the marketing authorisation  also captured the listed ness against the marketing authorisation .  Pharmaceutical Company comment: The serious event of allergy to vaccine is unlisted for Rubraca, as per the Safety Report, marketing authorisation, Regulatory Authority, and marketing authorisation . Considering the causality assessment provided by the patient, the causal relationship between Rubraca and Allergy to vaccine is assessed as not related. This single individual case report dose not change the benefit/ risk (BR) balance of this product. The company continues to monitor all adverse event and safety information individually and in aggregate on an ongoing basis.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current available information, a possible contributory role of BNT162B2 cannot be completely excluded for event swollen tongue, burning sensation, drug hypersensitivity due to temporal relationship.  However, current information is limited and does not allow a full medical assessment. 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.
Felt faint, skin clammy, BP 98/60, pale, pulse 76.  Cool packs placed on forehead and back of neck - laid down on exam table and rested.