chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jun2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); (unspecified if ongoing); "asthma moderate to severe" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "low thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Nov2022) Positive; (18Nov2022) Positive; (27Nov2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Original positive test date 18Nov and positive result confirmed at Urgent Care Clinic on 19Nov2022. Finished full 5 day medication course of Paxlovid from 19Nov2022 to 23Nov2022 as prescribed. Tested negative, with symptom abatement, on 27Nov2022. Full return of Covid 19 Symptoms on 29Nov2022 and a positive Covid 19 rapid antigen home test 30Nov2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Still feels tired; Felt "in and out of it"; Felt like she feels when she has a sulfa allergy/she does have multiple allergies including Sulfa, latex, apples, watermelon, carrots, and other food allergies; Light headed; Couldn't focus; Couldn't keep her eyelids open; Slept for two days straight; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Felt like she feels when she has a sulfa allergy/she does have multiple allergies including Sulfa, latex, apples, watermelon, carrots, and other food allergies), DIZZINESS (Light headed), DISTURBANCE IN ATTENTION (Couldn't focus), EYELID IRRITATION (Couldn't keep her eyelids open) and HYPERSOMNIA (Slept for two days straight) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug hypersensitivity (Sulfa), Fruit allergy (Apple), Fruit allergy (watermelon), Vegetable allergy (Carrots), Latex allergy and Food allergy (patient had other food allergies).    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced ALLERGY TO VACCINE (Felt like she feels when she has a sulfa allergy/she does have multiple allergies including Sulfa, latex, apples, watermelon, carrots, and other food allergies), DIZZINESS (Light headed), DISTURBANCE IN ATTENTION (Couldn't focus), EYELID IRRITATION (Couldn't keep her eyelids open) and HYPERSOMNIA (Slept for two days straight). On 17-Aug-2021, the patient experienced VACCINATION COMPLICATION (Felt "in and out of it"). On 19-Aug-2021, the patient experienced FATIGUE (Still feels tired). On 17-Aug-2021, EYELID IRRITATION (Couldn't keep her eyelids open) and HYPERSOMNIA (Slept for two days straight) had resolved. On 19-Aug-2021, DIZZINESS (Light headed) and DISTURBANCE IN ATTENTION (Couldn't focus) had resolved. At the time of the report, ALLERGY TO VACCINE (Felt like she feels when she has a sulfa allergy/she does have multiple allergies including Sulfa, latex, apples, watermelon, carrots, and other food allergies), VACCINATION COMPLICATION (Felt "in and out of it") and FATIGUE (Still feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Day 1 after the vaccination: very strong pain in the arm to the extent that I was unable to reach anything above a shoulder level (so much worse than the 1st shot), surprisingly little swelling though (so much better than the 1st shot). Increasing fatigue which maxed around 11am accompanied by  cold shivers and increased body temp . Fever picked at 5pm to 101.3F.  By 10pm fever and fatigue were gone! Day 2 after the vaccination: a red rash size 2 inch x 3 inch on the arm around the place of the injection, pain in the arm was nearly gone, no fever, no fatigue. Day 3 after the vaccination: red rash is gone. Back to normal.
This spontaneous report was received from a medical assistant and refers to a 9 week old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After my first dose I began to experience severe shin pain and calf cramping within a few days as well as noticeable swelling and bloating all over my body. The night of the day I got my 2nd dose I very suddenly became horribly ill. I ran a 103 degree fever, was very fatigued and nauseous, had severe muscle pain, and horrible chills. These symptoms counited for about 5 days after words, with the added effect of severe swelling in my lymph nodes under my arms and by my groin. After my vaccine, I also had changes to my period. My period is now shorter, lighter, and farther apart than it was before. However, I get horrible bloating about a week and a half before my period and it lasts until my period is over. The bloating is uncomfortable and is almost enough to make me change clothing sizes and is all over my body, legs, hands, arms, belly, face, etc.
Patient presented to the ED on 4/30/2021 for back pain with sciatica. Patient presented to the ED and was subsequently hospitalized on 5/1/2021 for fever of unknown cause. These visits are within 6 weeks of receiving COVID vaccination.
Inadvertently administered 0.3 cc of  Pfizer adult formulation instead of pediatric fizer
Vials of Pfizer COVID vaccine were stored in the refrigerator with a use-date expiration on 10/19 at 1:30pm.  On 10/19, approximately 2 hours after this, the patient was given their first dose of COVID vaccine with this vial. No harm detected.
Pt stated she couldn't move (L) arm well or raise above head since flu vaccination 3 wks ago. Pt contacted PMD-was told to take ibuprofen which has helped sx improve.
Bexsero in patient over 25 y/o; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The pharmacist reported that a patient received the Bexsero vaccine over the age of 25 year old. The reporter consented to follow up. Additional Supportive Information: The patient received dose of Bexsero at inappropriate age, which led to inappropriate age at vaccine administration.
DIZZY; SEVERE BODY ACHES; VOMITING; HEART WAS POUNDING OUT OF CHEST; WALKING DIAGONAL COULD NOT WALK STRAIGHT; FREEZING; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was previously treated with influenza vaccine for prophylactic vaccination. 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 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive, and COVID-19 antigen test (NR: not provided) Negative. On 02-APR-2021, the subject experienced dizzy. On 02-APR-2021, the subject experienced severe body aches. On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced heart was pounding out of chest. On 02-APR-2021, the subject experienced walking diagonal could not walk straight. On 02-APR-2021, the subject experienced freezing. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 02-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 03-APR-2021, and severe body aches, vomiting, heart was pounding out of chest, chills, fever, and nausea on 02-APR-2021, and the outcome of freezing and walking diagonal could not walk straight was not reported. This report was non-serious. This report was associated with a product quality compliant : 90000176248.
welts, erythema at pain & inj site-lt deltoid; afeb-alert-oriented x 3
Regular - Arm pain.  Adverse - Abdominal pain / pressure, green stools, dizziness, fast heartbeat, anxiousness, irritation, body hyper alert, triggered.
Swelling and hardness at injection site, redness with circle ~4 inches diameter, and itching.
This spontaneous report was received from an office manager and refers to a 23 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 06-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
I was test positive 01/04/2022 for COVID 19. I was sick for three days and I had a high fever 102, body aches, server fatigue, GI tract issues and shortness of breathe. Day 4/5 I broke out with hives on my entire body. It lasted until the end of January, 2022, I still get the hives under my arm pits. I also still have a cough and shortness of breathe, nothing really major. I did go to the ER at Hospital for the hives. They medication prednisone and Pepcid Histamine. My PCP gave me cough syrup promethazine w/codeine, prednisone, azithromycin, benzonatate 200mg, albuterol inhaler 8.5 grams. The f/u 01/01/2022 he gave me methylprednisolone 4mg, and doxepin 25 mgs
a bad side affect from covid19 vaccine-body on fire with RA; a bad side affect from covid19 vaccine-body on fire with RA; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), BURNING SENSATION (non-serious), outcome "unknown" and all described as "a bad side affect from covid19 vaccine-body on fire with RA".  Additional information: It was reported, the patient had developed a bad side affect from covid19 vaccine-body on fire with RA.  The lot number for bnt162b2 was not provided and will be requested during follow up.
At 1218 upon arrival to the car, pt complained of "itchy throat, racing heart, flushed face and not feeling well." Reassurance provided. Stated she had eaten and could drink fluids. 911 called. Vital signs obtained: 120 heart rate, 140/60 BP, 112 heart rate, 120/62 BP. Pt denied any previous types of reactions and/or anxiety concerns. Cool cloth to forehead, deep breaths encouraged.  EMS on site at 1230 to evaluate.  Pt was awake and breathing at time EMS arrived.
p/vax pt fell asleep in car on trip home;seen by MD well child check up;woke up screaming;warm & sweaty;had sz;eyes rolled ;
Patient complained of abrupt onset of dizziness after 1st dose of pfizer vaccine, BP 169/109 P75 RR22, 02 saturation 100%, lungs clear, no dyspnea, no cyanosis, heart sounds normal, last ate at 1030am. Pt off her bystolic med for 5 days her cardiologist is aware. 2nd reading BP 155/109, pt called cardiologist office was instructed to pick up meds and restart today. Pt asymptomatic as long as she doesn't stand, declined ER eval as suggested by RN.
Vaccine given from vial outside of 6 hour storage window; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced expired product administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, a vial containing mRNA-1273 was punctured and stored refrigerated for over six hours.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection from the vial that had been punctured over six hours ago, and the patient experienced expired product administered.  Action taken with mRNA-1273 in response to the event was not reported.  The event, expired product administered, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a patient of unknown age and gender.  The patient's medical history is not provided. This report refers to a case of out of specification product use for mRNA-1273 on an unknown date.
Severe sore throat about 8 hours after receiving vaccine. The next morning sore throat was only on the left side but was also sore to the touch outside.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EP6955), via an unspecified route of administration in the left arm on 21Mar2021 at 13:30 (at the age of 65-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included vitamin D (MANUFUTURER UNKNOWN), calcium (MANUFUTURER UNKNOWN), multivitamin (MANUFUTURER UNKNOWN), omega 3 (MANUFUTURER UNKNOWN), super B (MANUFUCTURER UNKNOWN); all from unknown dates for unspecified indications. The patient had no known allergies to medications, food, and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 21Mar2021 at 20:30, the patient experienced severe sore throat, 8 hours after receiving the vaccine. The next morning sore throat was only on the left side but was also sore to touch outside. Therapeutic measures were taken as a result of sore throat and included treatment with Aleve. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore throat was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
I didn't get my period for two months, starting in June.  My first dose was given on 3/12 and the second on 4/09 I had an endometrial biopsy, ultrasound and CA125 blood test to rule out any OBGYN -related illnesses. After my period returned to normal, I began experiencing pain upon urination, gas relief, and bowel movements for the five days of my fertile window during my menstrual cycle. This has continued for four months. Each month the pain lessens, but still exists.
Patient developed a nose bleed about 10 minutes into his 15 minutes monitoring phase.  Mild to moderate bleeding from left nare.  Clotting obtained.  Monitoring continued for an extra 10-12 minutes.  Left vaccination site with family members.
Swollen left shoulder and collar bone. Swollen lymph node in left collar bone. Hurt to touch and more. Persisted 9/29/21-10/1/2021.
Tremors after first primary shot/Tremors never went away after first shot; Nervous system was affected after first primary shot; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors after first primary shot/Tremors never went away after first shot) and NERVOUS SYSTEM DISORDER (Nervous system was affected after first primary shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391-2A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PIROXICAM (PAXIL [PIROXICAM]) and ATORVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced TREMOR (Tremors after first primary shot/Tremors never went away after first shot) and NERVOUS SYSTEM DISORDER (Nervous system was affected after first primary shot). The patient was treated with PRIMIDONE for Tremor, at an unspecified dose and frequency. At the time of the report, TREMOR (Tremors after first primary shot/Tremors never went away after first shot) had not resolved and NERVOUS SYSTEM DISORDER (Nervous system was affected after first primary shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that the Tremors never went away.HCP prescribed primidone for tremors but that did not help to patient.   This case was linked to MOD-2022-572262, MOD-2022-572224, MOD-2022-572261 (Patient Link).
3Jul95 pt vax 1st dose varicella virus vax live SC. 19Dec97 & 20Dect97 pt devel 74-84 lesions & afebrile. ICT ok and no CLO's. Approx 27Dec97 pt recovered.
suspected vaccination failure; the second time was light easier; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient stated that, before receiving Shingles vaccine, shingles case was not good. After receiving Shingles vaccine, the patient got shingles. The patient stated that, Shingles vaccine helped. Shingles was light, easier and not as painful. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation of shingles were not provided. For the toleance of 1st dose, refer linked case US2021AMR192426. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR192426:1st dose, same patient same reporter US-GLAXOSMITHKLINE-US2021AMR192711:Original Case : US2021AMR179087
Information has been received from an office manager concerning a 66 year old female patient with no known drug allergies who on 06-OCT-2009 was vaccinated intramuscularly into her right arm with a 0.5ml PNEUMOVAX 23 (lot number 663888/0627Y). Concomitant therapy included alendronate sodium (+) cholecalciferol (MSD), LEVOXYL, aspirin and chondroitin sulfate sodium (+) glucosamine sulfate. On 06-OCT-2009, after received the vaccination the patient experienced erythema and swelling at the injection site. She was treated with anti-inflammatory and cold compresses. The patient had sought medical attention via phone. No laboratory diagnostic studies were performed. On 08-OCT-2009 the patient recovered. Follow up information was received from the office manager concerning a 66 year old female patient with no illness at time of vaccination and no drug allergies who in the morning of 06-OCT-2009 morning was vaccinated intramuscularly into her right deltoid with a first dose of PNEUMOVAX 23 (lot number 663888/0627Y). In that day afternoon, the patient experienced adverse effects (as previously reported). On 08-OCT-2009 the patient recovered. This is one of several reports received from the same source. Additional information is not expected.