chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID positive; COVID positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 at 11:00 as dose 1, single (Lot number: EN6204), in left arm, on 05Apr2021 at 11:00 as dose 2, single (Lot number: ER8737), in left arm and on 18Nov2021 at 16:00 as dose 3 (booster), single (Lot number: F63527) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16May2022 at 07:00, outcome "unknown", COVID-19 (medically significant) with onset 16May2022 at 07:00, outcome "recovering" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out
I developed tinnitus on or about March 1, 2021.  I never had it before.  I have read that this is a possible side effect of the vaccine.  It is a constant unrelenting buzzing in both ears.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-AUG-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unspecified demographics. Approximately on an unknown date in 2013 (reported as between 18-FEB-2013 and 11-JUN-2013), an unknown number of patients might have received RECOMBIVAX HB injection (dose, lot number and expiry date was unspecified) that had been improperly stored. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint was involved. The outcome of patients might received improperly stored RECOMBIVAX HB was unknown. No further information was provided. This is one of the several reports from the same source. Additional information has been requested.
A report was received from a health care professional on 11/18/03 concerning a 4 year old vaccinee of unknown gender who inadvertently received a sub-optimal dose of Fluvirin on 11/11/03. On 11/11/03 the vaccinee received 0.25ml Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/19/04: A follow up report was received from a health care professional indicating that the vaccinee received a sub-optimal dose of Fluvirin on 11/10/03 approximately. No follow up pending. All information received.
developed slight eye tearing and left ear pressure within 24 hours of vaccination. followed by left facial drooped. was seen in ER on day 3 after vaccination, diagnosed with Bells Palsy. treated with eye care and oral prednisone.
Polymyalgia rheumatica; decline in health; sick more or less; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: EW0161) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot number: ER2613), administration date: 30Mar2021, for Covid-19 Immunization, reaction(s): "Polymyalgia rheumatica", "decline in health". The following information was reported: ILLNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "sick more or less"; POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "decline in health". Therapeutic measures were taken as a result of polymyalgia rheumatica and included treatment with prednisone since Apr2022. Clinical course: The patient need to get into a vaccine study. She have been sick more or less since Apr2021. Patient was still sick. The patient see a relationship between the vaccine and decline in health. She have never been diagnosed with COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300043708 same patient, different vaccine dose number/event;
Extremely fussy/restless all nite 12/3 (vaccine given that afternoon), refused to nap 12/5, awoke 12/6 am "roasting" with fever, had seizure at 130PM, ER discharge 530PM, had 2nd seizure 830PM, different ER, admitted overnight for testing/fever reducing medication.
hurted so bad; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date, refer case US2021AMR241121).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received the 2nd shot and it hurted so bad but it was a breeze. Follow-up would not be possible as no contact details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241121:same reporter - 1st dose
Headache, Myalgia, NauseaVomiting, 1/5 lethargic. 1/6 severe lethargy, low grade fever, headache, muscle aches. 1/7 nausea, headache, muscle aches, lethargy. 1/8 headache. Narrative: 1/5 lethargy 1/6 severe lethargy, feeling sick, afternoon fever 37.2C up to midnight 38 C, headache, muscle aches. 1/7 nausea headache, muscle aches, lethargy. 1/8 headache. Instructed to call COVID result negative.
Got sick to stomach around 11:30 pm and began  vomiting violently for 2 hours.  woke up at 7:30 AM the next day and head was stuffy and had sudden loss of hearing  her good ear (right ear).
wanted to receive 3rd dose, second dose was administered in April 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 27-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 2nd dose in April 2021) and Engerix B (received 1st dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporters comment: Registered pharmacist reported that, there was a patient at the facility who wanted to receive 3rd dose of Engerix B but second dose was administered in April 2021.  It had been more than 6 months between doses and healthcare professional wanted to know how to proceed in this situation. Healthcare professional did not have neither lot number or expiration date of 2nd dose.  Additional supportive information: Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete vaccination schedule.
This last period (the first since being fully vaccinated) came three days early; I recently stopped breastfeeding; I recently stopped breastfeeding; I recently stopped breastfeeding; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 33-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 01Jun2021 at 12:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization (at the age of 33-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization. It was reported by the patient that her period has always been very regular. It has come on the Tuesday of the week expecting every month for the last 15 years with the exception of the months she was pregnant and breastfeeding. She stated that she recently stopped breastfeeding and her period came back, also on a Tuesday. The period following that was also very regular. This last period (the first since being fully vaccinated) came three days early on 18Jul2021. The patient underwent lab tests and procedures which included nasal swab (SARS-CoV-2 test): unknown on an unspecified date. The outcome of the events was unknown.   Information about lot and batch number was requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100921081 mother/baby
Patient had episode of syncope following immunization; Patient has a history(mother has the same history) of fainting after receiving vaccinations. Patient caught from falling forward during initial episode.Patient's legs were elevated at a seated position, though she seemed to worsen some (pale, reported chills, rash/redness/flushing on face). Assisted patient to move to a flat-lying position on waiting room floor with feet elevated and a cool compress. Called 911 who arrived to evaluate patient before she was transported home by a friend.
This case is from a cluster of 11 cases received from a same reporter with same vaccine lot number 2012-10136, 2012-10137, 2012-10138, 2012-10139, 2012-10092, 2012-10141, 2012-10142, 2012-10143, 2012-10144 and 2012-10145. Initial report received from healthcare professional on 18 October 2012. A patient (age, gender, date of birth were not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE, batch number: UH717AC (route and anatomical site of administration were not reported) on 11 October 2012. It was reported that on an unspecified date, after receiving FLUZONE, the patient experienced red bump and skin hot to touch. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Pain and swelling at arm injection site. Pain and swelling under arm on right arm where received injection. Burning pain sensation.
About 30 minutes after receiving the vaccine the patient started to have tingling and numbness in the left side of his face. He said even his left eyelid was affected. No droopiness or signs of a stroke. It could have felt like a dull headache, but with more of a numb feeling than actual pain. He worked outside in the yard the rest of the afternoon. He said that the feeling continued until Monday, 04/12/21 around the noon time. He has no continued side effects at this time.
This spontaneous report has been received from a physician referring to a patient of unknown age and gender. No concurrent or historical condition was reported. On 01-JUL-2015 the patient was vaccinated with improperly stored dose of VAQTA, dose, route, frequency, Lot number and anatomical location were unknown. No adverse event was reported. This is one of several cases received from the same source. Additional information has been requested.
Information has been received from Pfizer, Inc and was assigned manufacturer report Number 2010107176 for PREVNAR. A 12 month old female patient was vaccinated with a dose of MMR II (lot number not provided) on an unspecified date. Concomitant therapy included two more vaccines and a dose of PREVNAR. The patient's mother reported that her daughter had a reaction to the vaccines. Upon further testing it was decided that the patient had a reaction to the gelatin in MMR II. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This was originally reported by a consumer. No further information is available.
got covid after receiving 1st dose of vaccine; got covid after receiving 1st dose of vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced had COVID-19 on an unknown date after receiving the first dose of vaccine. The clinical outcome of the event COVID-19 was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Fainted twice; Fell on the floor; Feels out of sorts; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Fainted twice) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 24-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. In October 2022, the patient experienced MALAISE (Feels out of sorts). On 25-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced SYNCOPE (Fainted twice) (seriousness criterion medically significant) and FALL (Fell on the floor). At the time of the report, SYNCOPE (Fainted twice), FALL (Fell on the floor) and MALAISE (Feels out of sorts) outcome was unknown.            The patient was not taking any medications for any conditions. Patient received first dose on 22-Mar-2021 with Lot number 939903 and second dose on 21-Apr-2021. Patient got the Moderna booster and the flu shot at the same time. Patient got the high dose flu shot. Patient says she was told to really hydrate and take it easy. Patient felt great last night. Patient was not really dizzy but just feels out of sorts.  Patient put ice on her forehead and toes.  No treatment medication was reported.  Company comment: This is a spontaneous case concerning a 70-year-old female patient with no reported medical history, who experienced the expected serious (medically significant) event of syncope among other non-serious events. The event occurred 2 days after the third dose of mRNA-1273.222 vaccine. It is reported that patient took Flu vaccine at the same time. Patient reported that she fainted twice. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old female patient with no reported medical history, who experienced the expected serious (medically significant) event of syncope among other non-serious events. The event occurred 2 days after the third dose of mRNA-1273.222 vaccine. It is reported that patient took Flu vaccine at the same time. Patient reported that she fainted twice. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of event was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
2-3 hr post vax pt drowsy, less alert, limp & t100.4;MD rx APAP for fever 38hr p/vax;pt awaken from sleeping & started high pitched inconsolable crying x45min;mom states pt not same x 2wk p/vax;change in rate of breathing, shallow or rapid
Pain in left breast and painful swelling. Physical exam from primary care doctor in May 20. Gyno- May 25. June 8- mammogram, 9cm of cancer across left breast. All previous mammograms were healthy, no issues.
Information has been received through the pregnancy registry for VARIVAX (Oka/Merck) from a physician's assistant concerning a 34 year old female, who in May 2007, vaccinated with a dose of VARIVAX (Oka/Merck). In May 2007, two weeks after the vaccination the patient became pregnant. Medical attention was sought. It was noted that the patient was exposed to shingles in July 2007 and went on to have an elevated IgM. Follow up information was received from the physician's assistant which reported that the patient delivered in February, 2008. The patient had no problems with the delivery and the baby had no problems either. At the time of the report, the baby was normal and healthy. Additional information is not expected.
PATIENT STARTED EXPERIENCING EXCRUTIATING ARM/ MUSCLE PAIN, THAT EXTENDED ACROSS HER CHEST MAKING IT PAINFUL FOR HER TO RAISE UP HER ARM OR MOVE IT. SHE DEVELOPED A HUGE KNOT THAT WAS RED AND SWOLLEN. I SAW HER 24 HOURS AFTER HER DOSE AND SHE WAS STILL IN PAIN.
Rash began on right hand (shot administered on left shoulder). First noticed around 8am. Rash began spreading to right forearm and left hand. Took 2 benadryl around 12pm. By 6pm, rash was on both hands/wrist, both forearms, right upper arm, and a few spots on my neck. Took 2 benadryl at 7:00pm and 2 benadryl at 11:00pm.
The pt showed in decrease of appetite, increased fussiness, crying, poor sleeping. Despite this she had gained weight. Exam normal. Local reaction on thigh.
I had my first TIA 9 days after 2nd Pfizer vaccine shot, otherwise no prior strokes of any kind.; First dose: 6-MAY-2021; Second dose: 18-JUN-2021; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient, not pregnant, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jun2021 (Lot Number: EW0181) at vaccination age of 54 years, as dose 2, single for covid-19 immunisation.  Previously the patient received the first dose of bnt162b2, administered in Arm Right on 06May2021 at 09:00 AM (Lot Number: EW0173) for covid-19 immunisation. No other vaccine in four weeks. The patient previously took Compazine and experienced allergy. Medical history included Borderline Blood pressure high and PreDiabetic. No covid prior vaccination. Concomitant medications included metformin, hctz, losartan, colecalciferol (VIT D), ascorbic acid (VIT C), zinc, all taken for an unspecified indication, start and stop date were not reported.   On 27Jun2021 05:30 the patient experienced her first TIA 9 days after 2nd Pfizer vaccine shot, otherwise no prior strokes of any kind. The patient was hospitalized for 2 days and the outcome of the event was recovered with sequelae. Therapeutic measures were taken as a result of the event.  Event treatment included: Mri, Ct, Echo, Swalliw Test, PT. The patient received bnt162b2 first dose: 6May2021 and second dose: 18Jun2021, resulting in inappropriate schedule of product administration. The patient underwent lab tests and procedures which included sars-cov-2 test (Rapid and Reg): negative on 03Oct2021 Nasal Swab.
Left deltoid swelling and redness. No limitation of movement. No fever. No significant tenderness.
Sore arm; Swollen injection site and halo formation; This is a spontaneous report from a non-contactable consumer reported for herself. A 30-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on 20Jan2021 11:15 on right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at workplace clinic. Medical history and concomitant medications were not reported. The patient experienced sore arm within 20 minutes from vaccination on 20Jan2021 11:30, swollen injection site and halo formation at 18h on 20Jan2021. Soreness subsided after 72h. No treatment was received for the events. The outcome of the events were resolving.  No follow-up attempts are possible. No further information is expected.
No additional AE details provided; Improperly stored administered PROQUAD 9.6 C for 80 min; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 28-JUN-2021, the patient was vaccinated with an expired measles, mumps, rubella, and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot #T021301, expiration date 19-DEC-2021 (formulation, strength, exact dose, anatomical location, and route of administration were not reported) for prophylaxis (product storage error). The temperature excursion was reported as 9.6 degrees Celsius (C) for 80 minutes. There was no previous temperature excursion. It was unknown if a digital data logger was involved in capturing the temperature. No additional adverse event details provided (no adverse event). The outcome of the event was unknown.  This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-108USA006155.
Chest pain - numbness both arms - difficulty breathing - increased anxiety.  ER on 4/16/03.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient called to report a band of redness around her arm below where she received immunization. she also said it was warm to the touch and quite painful. advised pt to contact md in case it was cellulitis.  rx later came over for keflex
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-DEC-2015 at 12:58, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
On 1/20/21 I received the vaccination. The next day I felt achy but not in distress.  On Saturday 1/23/21 I woke up with hives on my left arm and chest and a swelling on my left eye.  I took benadryl which had no effect. The next day the hives had progressed to blisters, my hand swelled  and my eye had almost swollen shut.  I contacted my health care advisers and they prescribed predinosne.  This reversed the reaction and the wounds are healing.  I have pictures of how I looked.