chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had low platelets and had to have a platelet transfusion; This is a spontaneous report received from a contactable nurse. A 54-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Pfizer product), via an unspecified route of administration on right arm on 07Jan2021 at single dose for COVID-19 immunization in hospital. The patient's medical history included ongoing possibly has rheumatoid arthritis. No known allergies to medications, food, or other products. Concomitant medication included meloxicam (MOBIC) and multivitamin. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Pfizer product), intramuscularly on left arm on 17Dec2020 (54-year-old, Lot number: EH9899) at single dose for COVID-19 immunization. The patient did not diagnose with COVID-19 prior to vaccination. The patient did not test for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 11:00, the patient experienced low platelets and had to have a platelet transfusion. The patient visited doctor or other healthcare professional office/clinic and visited emergency room/department or urgent care due to the event. The event was considered as non-serious by the nurse. The outcome of the event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event low platelets requiring platelet transfusion with BNT162b2 can not be fully excluded. 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.
tested positive for COVID; migraine/ big headache, a migraine; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 20-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP6955, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 27Mar2021 at 10:00 (at the age of 20-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient did not administer additional vaccines on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) were none. Adverse events following prior vaccinations were none. Caller states she got a really big headache Monday night 29Mar2021, a migraine, and she took Advil 2 capsules and wasn't sure what dose, maybe 200 or 400 by mouth just that one time. States the migraine went away, she usually gets migraines, so it started around 18:00 and she took the Advil around 20:00 and then went to sleep at 10 and it was gone by the time she woke up the next morning. She tested positive for COVID on 05Apr2021. She wants to know if she could get her second dose which was scheduled for 17Apr2021. Informed caller that Pfizer was unable to make treatment recommendations. Spoke from attached document  could patient receive the vaccine with a prior or current COVID-19 diagnosis or not. Caller states she was calling to find out what could she do, should she reschedule her appointment or keep the appointment. Caller relays that she read the fact sheet and it didn't say anything about that. Caller states she was about 128-130 lbs. The adverse events did not require emergency room visit and physician office visit. The patient underwent lab test and procedure which includes COVID PCR test: Positive on 05Apr2021, weight: 128-130 lbs on an unspecified date. The outcome of the event tested positive for COVID was unknown and recovered on 30Mar2021 for the other event. Description of Product Complaint: Caller had the first dose Pfizer COVID 19 vaccine 27Mar2021 and tested COVID positive 05Apr2021. Caller does not have the NDC, expiry date or dose to provide. States she had the COVID PCR test done and that was positive.  No Follow-up attempts are needed. No further information is expected.
10/21/09 5 min after vaccine had pruritis and redness on chest. Given BENADRYL 25 mg Po x 2 then BENADRYL 25 IM x 1. Felt a little better 3:40 PM. At 3:50 PM c/o of feeling cold and throat closing. Brought to ED.
Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling; Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing; Head is Lumpy / head is swollen; The injection site hurts; Pain at the top of her head / Even when she moves her hair, it hurts / head is tender; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling), HYPOAESTHESIA (Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing), SWELLING (Head is Lumpy / head is swollen), VACCINATION SITE PAIN (The injection site hurts) and HEADACHE (Pain at the top of her head / Even when she moves her hair, it hurts / head is tender) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced HEADACHE (Pain at the top of her head / Even when she moves her hair, it hurts / head is tender). On 11-Sep-2021, the patient experienced PARAESTHESIA (Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling), HYPOAESTHESIA (Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing), SWELLING (Head is Lumpy / head is swollen) and VACCINATION SITE PAIN (The injection site hurts). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 mg. At the time of the report, PARAESTHESIA (Tingling sensation on her face / Forearm was tingling / Fingertips were  tingling), HYPOAESTHESIA (Numb Face, felt like she had a Novocain shot / Forearm was numb / Fingertips were numbing), SWELLING (Head is Lumpy / head is swollen), VACCINATION SITE PAIN (The injection site hurts) and HEADACHE (Pain at the top of her head / Even when she moves her hair, it hurts / head is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided by the reporter.
RUE cellulitis, pain, fever, tachycardia. Redness/pain at site w/ worse progression. Vanc and Zosyn given upon presentation to ER. D/C home with po Clindamycin.  7/21/09 MR received for DOS 3/19-21/2009 with D/C DX:  Cellulitis.   Pt admiited for RUE immunization site cellulitis, presenting with pain, swelling and erythema of the injection site, fever, H/A, eukocytosis, hypotension and tachycardia. Tx with abx and IVF for dehydration and some metabolic acidosis.  ICD9: 038.9, 584.9, 682.3, 733.49, 255.0, 276.1, 995.92, 174.9, E948.8, 276.51, 710.0, E932.0, 583.81, 272.2, V58.65, V43.64
Frequent and severe asthma attacks often requiring multiple doses of albuterol to control. Usually two-five times every day since 7/6/18. Previous asthma attacks would occur only once every few months and not severely.
No adverse reaction occured. DT was administered instead of DTAP. Was advised by coordinator to complete VAERS form.
Patient experienced flushed cheeks within 15 minutes of receiving the vaccine but she was very nervous about getting it and didn't have any other side effects;.  She was fine a few minutes after her flushed cheeks and reported no other adverse effects.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored VAQTA (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
HEADACHE; FEVER; NAUSEOUS; DIZZY; PAIN IN ARM; This spontaneous report received from a patient via  concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, dizzy, nauseous and pain in arm was not reported. This report was non-serious.
Vomiting and vasovegal syncope lasting <15 seconds. Pt's father reports hx of vasovagal events with venipuncture and vaccines. Event most likely due to receiving shot not the vaccine. This was her final HPV vaccine.
Moderna booster dose, 0.25 ml. administered to a 6 year old male.  Child was kept for observation for 60 minutes.  No noted adverse reactions or immediate side effects.
10-15 minutes after vaccination patient complained of dizziness, blurred vision, and shortness of breath.  Patient states she felt slightly short of breath walking into the clinic prior to vaccination but did not mention symptoms to staff.  Patient was evaluated by clinic medical director and EMS staff.  No objective signs of local or systemic reaction, only patient's subjective statements.  Patient was transported to Hospital for further evaluation.
DEPRESSION; ANXIETY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On AUG-2021, the patient experienced flu like symptoms. On an unspecified date, the patient experienced depression, and anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from depression, and anxiety, and the outcome of flu like symptoms was not reported. This report was non-serious.
About 6 days (3/23) after getting the vaccine, my left arm started to develop rashes, it was itchy and a bit painful and got worse during the day, it was also accompanied with a sneezing and runny nose almost throughout the day. Today (3/24), the rash spread out even more
Within several minutes of the injection in the left deltoid (as I was pulling into the staged observation area) I developed mild puritis in the area of my inner right antecubital area.  During the 15 minute observation period it did not worsen, therefore I discounted the itch and did not report it at that time with the intention to observe the area.  About an hour and a half later the itch was persistent so I removed my jacket sleeve and viewed the area which was now an evident rash about the size of my palm.  I took Benadryl 50mg at bedtime and the rash appeared to be improving upon wakening this morning.  I did not have any other accompanying symptoms.
My left arm feels like it's rubbing against something, stinging as if a bee stung me. My throat is feeling dry.  I feel drained and tired. I wake up with the pain on my arm.
The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via regulatory authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310353, 2020SA310335, 2020SA310460, 2020SA310462, 2020SA310354, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559 and 2020SA277871 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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
Fatigue; joint pain; muscle pain; Some chest pain/tightness.; Some chest pain/tightness.; This is a spontaneous report from a contactable consumer (patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 15Sep2021 at 16:00 (Batch/Lot Number: FD8448) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none known. No known allergies. Concomitant medication(s) included vitamin d nos (Vitamin D 5000IU daily) taken for an unspecified indication, start and stop date were not reported. No other vaccine in fourweeks. On 22Sep2021, at 16:00, the patient experienced fatigue, muscle and joint pain. Mostly muscle pain in his legs. Some chest pain/tightness. Office exam with X-ray and lab work. On 06Oct2021 16:00, patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in right arm (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for covid-19 immunisation. No covid prior vaccination and not tested post vaccination The patient underwent lab tests and procedures which included investigation: unknown results and x-ray: unknown results on unknown dates. Therapeutic measures were taken as a result of all the events. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from nurse practitioner refers to a 5 years old male patient. The patient was vaccinated with a dose of expired MMR II (lot # 667246/0907Z, exp. date 09-JUL-2012) on 16-JUL-2012. If the patient sought medical attention or not was unknown. No adverse reactions reported. Additional information has been requested.
Narrative: Pt new to our system, reports a h/o throat swelling and rash after covid vaccine.
The patient made two visits to primary Dr. with swollen feet and ankles.  Visits were a few weeks apart.  Dr had Lab done the second visit and didn't see anything  The next month Right foot was continuing to be swollen and had pain on bottom of foot.
Extreme nausea; Vomiting; Stomach pain; Ringing in ears; Fever; Extreme muscle fatigue; Still sick; This is a spontaneous report from a contactable consumer, the patient. A 40-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 right arm on 01Apr2021 at 08:15 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, 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 02Apr2021 at 15:00, the patient experienced extreme nausea, vomiting, stomach pain, ringing in ears, fever, extreme muscle fatigue and still sick 5 days later. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcomes of the events extreme nausea, vomiting, stomach pain, ringing in ears, fever, extreme muscle fatigue and still sick 5 days later were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received J&J vaccine on 3/19/21. Unknown lot number. COVID positive on 1/14/22. Presented to ER on 2/10/22. who was admitted for acute sigmoid diverticulitis with abscess on 2/10/22 and is status post percutaneous drain placement. No treatment for COVID19 during this admission. Discharged on 3/1/22
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026L20A) for COVID-19 immunization. No medical history provided. Concomitant products included Lexapro and Wellbutrin. On Jan 8, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 8, 2021, patient experienced pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. This case linked to MOD-2021-132216 (patient link).
pt recvd vax 28JUL devel big knot on rt deltoid 2AUG93; legal guardian states knot is the size of hand; legal guardian states pt sometimes seems SOB; pt has lot of allergies;
This is an instance of COVID-19 breakthrough disease after which death occurred.   The individual was vaccinated with the Pfizer product on 02/01/2021 and 02/22/2021. They became symptomatic for COVID-19 disease on 12/13/2021 and tested positive for COVID-19 via antigen test on 12/17/2021. The individual was admitted to hospital on 12/26/2021 for unresponsiveness and confusion. They died later the same day.
Information has been received from a healthcare worker referring to unspecified amount of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. From 24-NOV-2015 to 11-DEC-2015, the patients were vaccinated with doses of improperly stored GARDASIL 9 (incorrect product storage) (lot # L023230, expiration date 28-JUL-2017, dose and route were not provided), which were exposed to 51.3 Fahrenheit (F) for 288.83 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not wish to be contacted.
Initial report received from a consumer (who is also the patient) on 24 October 2013. A 58 years old female patients whose medical history included ongoing genital herpes, allergy to ampicillin, and sulfa drugs cause nausea and concomitant medication was not reported, had received a dose of FLUZONE (lot # UH898AA, route was intramuscular and site of vaccination was right deltoid) on 16 October 2013. Patient reported that seven days after vaccination, she began having hives at different locations on her body, which were red, raised and itchy. Also reported 24 hours after vaccination she had soreness at the right deltoid for two days, began feeling like a cold was coming on and felt very tired. She was seen by a physician and who prescribed prednisone, CLARITIN in the AM and BENADRYL in the PM. She also stated that as a child, she was allergic to eggs. But as an adult, eats eggs often. She also reported that in 2009 she had Novartis Influenza product, lot # 960364P, and experienced the same reaction. She was treated with DEPOMEDROL shot. In 2010 she received a Novartis Influenza product, lot # 111815P1, with no reaction. In 2011 she received FLUZONE lot # UH454AB, with no reaction. In 2012 she received FLUZONE lot # UH719AD and had the same reaction of hives occurring 7 days after the vaccination. Vaccinated on 24 October 2012 and hives occurred on 30 October 12. Events were not recovered at the time of report. List of documents held by sender: none.
Prt tested + 1/31/21; GOC comfort focused and no hospitalization. Pt  passed away on 2/16/21.
No side effects were reported/ No additional AE; HCP reporting that VARIVAX was administered after it experienced a supported temperature excursion. No side effects were reported. No additional information provided. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/e; This spontaneous report was received from a Nurse Practitioner and refers to a 15-year-old patient.  The patient's medical history, concurrent conditions were not provided. Concomitant medications included sterile diluent (manufacturer unknown).   On 11-OCT-2023, the patient was vaccinated with a improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, at a dose of  0.5 ml, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) following a temperature excursion of minus 9 degree Celsius for 4 hours, 30 minutes (Improper storage of product in use). No side effects were reported.