chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 4 year old patient who on 28-AUG-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot # 661444/0529X). On 23-NOV-2011 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot #670796/0781AA). The nurse mentioned that on 11-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 4 year old male patient with reactive airway disease, eczema and no illness at time of vaccination on 28-AUG-2008, was vaccinated SQ in the right leg with the first dose of VARIVAX (Merck) lot # 661444/0529Z) at 11:00 am. On 27-NOV-2011, the patient was vaccinated SQ in the left leg with the second dose of VARIVAX (Merck) (lot # 670796/0781AA) at 09:00 am. The nurse reported that the patient went to the clinic on 06-NOV-2012 with a rash described as "erythematous popular and vesicular rash, lesions in various stages and coalescing into patches on arms, leg and buttock, few on face, no lesions on trunk". The patient was diagnosed with varicella. On 20-JUN-2012 the patient recovered. The patient did not have any testing done. A lot check has been initiated. Additional information has been requested.
Infant was to receive PEDIARIX, HIB, PREVNAR and ROTARIX. Received PEDIARIX, KINRIX, PREVNAR and ROTARIX - no immed. problems. Parents notified mistake and Immunization Quality also notified. Parents to seek immed. attention if any problems noticed.
tired; coughing; Minor fever; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced tired, coughing, minor fever and headache on an unspecified date. The patient wanted to know if being tired, coughing, and minor fever are normal side effects after the COVID-19 vaccine dose. Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Lime sized swelling in armpit on side of most recently administered vaccine; Dose received: 3; This is a spontaneous report from a contactable reporter (Nurse). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 17Dec2021 at 10:00 (Lot number: unknown) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medications included: FLU, administered in left arm, taken for immunisation, start date: 03Dec2021, stop date: 03Dec2021; PROPRANOLOL ER; OMEPRAZOLE; VITAMIN D; VITAMIN C and TURMERIC. Past drug history included: Codeine, reaction: "Drug allergy", notes: known allergies: Codeine. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown, vaccine location: left arm), administration date: 07Jan2021, when the patient was 37 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: unknown, vaccine location: right arm), administration date: 27Jan2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 10:00, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious) with onset 18Dec2021 at 23:00, outcome "unknown", described as "Lime sized swelling in armpit on side of most recently administered vaccine". Therapeutic measures were not taken as a result of swelling.  Additional Information: Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt devel erythema, warmth, & swelling of the entire upper arm @ the site of inject p/receiving Td; Pt MD was consulted for another reason, felt had cellulitis;
COVID-19 Treatment; COVID-19 Treatment; Cough worsened; Sore throat; Stuffy nose; GI upset; Vomiting; Aggressive Cough; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (boster), single (Lot number: FF2589) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Con Willebrands Disease" (unspecified if ongoing); "PCOD" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX DM, start date: 23Jul2022. The following information was reported: COUGH (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Aggressive Cough"; ABDOMINAL DISCOMFORT (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "GI upset"; OROPHARYNGEAL PAIN (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Sore throat"; NASAL CONGESTION (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering", described as "Stuffy nose"; VOMITING (non-serious) with onset 22Jul2022 at 10:00, outcome "recovering"; COUGH (non-serious) with onset 23Jul2022, outcome "recovering", described as "Cough worsened"; DRUG INEFFECTIVE (medically significant) with onset 23Jul2022 at 12:00, outcome "unknown", COVID-19 (medically significant) with onset 23Jul2022 at 12:00, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Negative, notes: Started with an aggressive cough on 22July around 10:00, negative COVID antigen test; (23Jul2022) Positive, notes: Cough worsened on 23July, positive test taken at 12:00 this day. Therapeutic measures were taken as a result of covid-19, cough, cough, oropharyngeal pain, nasal congestion, abdominal discomfort, vomiting.  Clinical course: Patient received treatment with Paxlovid for the adverse events which was prescribed on 25July. Patient had no known allergies.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Stroke; Bad headache; Very tired; Right side of her body numb; A spontaneous report was received from a consumer, concerning a female patient (herself) of 64-years-old, who received Moderna's COVID-19 vaccine and experienced headache, tiredness, stroke/ Cerebrovascular accident and right side of her body numb/hypoaesthesia.   The patient's medical history included high blood pressure, migraine, high cholesterol, obesity, fusion of spine and neck surgery and numbness on the right side. Products known to have been used by the patient, within two weeks prior to the event included unspecified blood pressure medications.  On 18 Mar 2021, approximately four days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 006B21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 18 Jan 2021 night, the patient experienced a bad headache and was very tired. On 20-Mar-2021, the patient felt better and went for a walk. On 21 Mar 2021, Sunday, at 1:00 am the patient experienced stroke and was hospitalized subsequently. The event stroke was considered as medically significant and required hospitalization.  On 24 Mar 2021, the patient was discharged from hospital and she stated that the stroke had left her entire right side of the body numb.   Treatment for the events included atorvastatin, aspirin.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events headache, tiredness, stroke/cerebrovascular accident was considered as resolved/recovered on 24 Mar 2021. The outcome of the event right side of her body numb/hypoaesthesia was considered as not  recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ, lot # L008053, expiration date 30-NOV-2015 (dose and frequency were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Vaccine exposure via breastmilk; had a fever for a couple of days; a topical rash; This is a spontaneous report from a contactable consumer or other non-HCP (patient's father). A 7-months-old male patient (infant) while breastfeeding received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date 2021, the patient experienced Vaccine exposure via breastmilk, had a fever for a couple of days, and a topical rash. Caller stated, should mother get her second dose because of the infant's reaction. The outcome of the events was recovered on an unspecified date 2021.  Additional information: Caller states that after the mother received the first dose of the vaccine the seven month old breast fed male infant "a couple of days later he developed a fever and he had a full body rash it was like a topical rash so when you stretched the skin it would kind of disappear and he had that for a while".   Caller declines to complete a report. No further details captured, reported, or documented at this time.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (30Jul2021): This is a follow-up Spontaneous report from a contactable consumer. This consumer reported for a male patient which included: missed AE details.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100976062 Mother/baby case
I developed a ringing in my right ear. One night I just laid down and was like what the heck, high pitched squeal in my ear, I also have chronic fatigue. I do not feel rested , I am chronically tired .
I started feeling bad, dizzy, headache immediately after the injections. After normal meal, I went to sleep about 10:00. I woke up about 4:30 AM on 01/03/2019 lying on floor, with my left eye, forehead and eyebrow all bruised. I was lying on the floor, opposite direction of my bed pillow.
administration of DAPTACEL after expiration with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received via health professional. GMI Inquiry Number: 01271929  This case involves patient of unknown demographics to whom Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] administration after expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received suspect Daptacel vaccine after expiration at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (expired product administered) same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.     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.
Swelling of deltoid. Ice applied after 15 minutes. No further swelling noted.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 at 13:30 as dose 1, single (Lot number: EN6207), in left arm, on 11Apr2021 at 14:30 as dose 2, single (Lot number: ER8729), in left arm, on 25Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 15May2022 at 16:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Patient has no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jul2022 at 10:00, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid 5 days after taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid ( Lot number GA3595) started on 03Jul2022 and stopped on 07Jul2022, for the Treatment of COVID-19.   Follow-up attempts are completed. No further information is expected.
Was sitting in chair after the vaccine. 2-3 min after given pt fell to the floor from sitting position, mom opened door to alert us. Pt was awake and responsive, mom states that she did not think he passed out as when she knealed down he was looking at her. Pt stood up with help form mom and went and sat in chair again. Not pale, no increased RR. When asking pt how he felt he said good. Asked him if room was spinning and he said no. While asking him these his questions he kept closing his eyes or his eyes were rolling back. Lifted pt up onto exam table and had him lay down. He was responsive but did seem a little more tired. Asked him and he said he was a little sleepy. Asked him if he had felt that way before the vaccine and he said yes. Took BP and was on low side 89/58.  Pt laid down and monitored in office for 40 min. Recheck BP 30 min after was- 97/62. Pt was fully responsive although quiet, said he was still sleepy. Informed mom for next vaccine he will need to lay down while getting it and remain laying down the whole 30 min.
Developed nausea, vomiting, body aching, generalized of feeling of malaise X 10 days;
Tinnitus in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10May2021 at 08:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included micrographically oriented histographic surgery (Mohs surgery on face). The patient previously received silicone (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. The patient took unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left  arm on 17Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021, the patient experienced tinnitus in right ear. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse event. The clinical outcome of the event tinnitus in right ear was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # M042857 with expiration date on 21-OCT-2018 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Administered doses of the vaccine experienced temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 hours. There were previous temperature excursions: -14 degrees Celsius to -10 degrees Celsius for 12 hours and -9 degrees Celsius to 8 degrees Celsius for 1 hour 30 minutes. Digital data logger was involved in recording the excursions. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007864.
pt recv vax 5OCT98 & devel a fever & an inj site rxn characterized by redness, swelling, warmth, itching, pain & a huge knot;tx w/cortisone cream & recovered p/1wk;
This is a spontaneous report received from a contactable reporter(s) (Physician). A 79-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 at 14:35 as dose 1, single (Lot number: EL3246), in left deltoid and on 19Feb2021 at 15:29 as dose 2, single (Lot number: EL9261) at the age of 78 years, in right deltoid, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "Left leg Ischemia" (ongoing), notes: Left leg ischemia; "Prostate" (unspecified if ongoing), notes: Prostate; "Congestive heart failure" (ongoing); "Prostate cancer", start date: Mar2011 (ongoing); "Left leg Ischemia", start date: 09Aug2021, stop date: 11Aug2021, notes: Left leg ischemia. Concomitant medication(s) included: PLAVIX oral taken for peripheral ischaemia, start date: 07Sep2021 (ongoing); LIPITOR oral taken for peripheral ischaemia, start date: 07Sep2021 (ongoing); ELIQUIS oral taken for peripheral ischaemia, start date: 07Sep2021 (ongoing); HYTRIN oral taken for prostate cancer. Vaccination history included: fluval quad (Name: FLUVAL QUAD (2021-2022), Manufacturer: ID Biomedical, Batch/ Lo: 33D9, Route: Intramuscular, Anatomical site of injection: Left arm), administration date: 07Oct2021. The following information was reported: PERIPHERAL ISCHAEMIA (non-serious) with onset 09Aug2021, outcome "not recovered", described as "left leg ischemia"; PROSTATE CANCER (medically significant), outcome "not recovered". Clinical Course: Pertinent details: 3 stents implanted in left leg arteries, Congestive heart failure was ongoing. No follow-up attempts are possible. No further information was expected. Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Prostate cancer which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.
For six weeks I was very sick. Starting feel off, weak and sissy. Fever for over two weeks. I went to the doctors 4 times that first week. Every time I went they said it must be Covid. They tested me and sent me home over an hour drive each way? all tests were negative, I have never had the COVID-19 virus. After several blood tests, testing for everything they could think of they were able to determine blood clots were likely and some sort of infection. D-Dimer showed positive, while blood cells were through the roof, my liver enzymes were high as well, EKG showed irregularity. So after a month of all these tests. CT scan, Chest X-ray, Ultrasounds and nuclear lung perfusion scan and visit with the hematologist we finally had some answers. Now I have thousands in co-insurance and deductible to pay, as well as being out of work running my small business for almost two months
Patient presented to emergency department on 10/18/2021 with complaints of palpitations. He was diagnosed with COVID-19 infection on 10/12/2021 with minimal symptoms. He was found to be in atrial fibrillation with rapid ventricular response and was treated accordingly. He did not requirement treatment for his COVID-19 infection during admission.
Pt. felt dizzy and lightheaded and slumped out of observation chair.  Pt. was arousable, but sluggish in response.  No SOB, LOC, or rashes noted.  Pt. placed supine in trendelenberg position.  Paramedics arrived @ 0853 and transport to hospital was declined by pt.  Pt. continued to be observed and stated she felt 100% better and called lyft to drive her home @  0925.  Pt. was advised to call an acquaintance to drive her home but she was unable to find anyone and chose to call lyft.
After receiving his 1 dose of the shot, patient did not wait as requested for 15 minutes. He went to the gas station next to the pharmacy , and while he was about to pump for gas he had a seizure attack. Patient came to the pharmacy to inform me of the incident. Patient sustained minor cuts and bruises on his chin, leg and hands. I was able to dress his cut by applying band aid after wiping with alcohol wipes. I did follow up with patient today and he's doing well.
13 year old received Pfizer Pediatric for 5-11 year olds. Discussed with parent and child that she will receive Pfizer for 12+ year olds for second dose in 21 days. They acknowledged.