chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TEMPERATURE EXCURSION VIALS ADMINISTERED; POOR QUALITY PRODUCT ADMINISTERED; This spontaneous report received from a pharmacist concerned an 84 year old of unspecified 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: 1821286, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced temperature excursion vials administered. On 27-MAY-2021, the subject experienced poor quality product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the poor quality product administered and temperature excursion vials administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612503, 20210612311 and 20210612749.
unresponsive 3 times; major heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "unresponsive 3 times"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "major heart issues". Additional information: The patient stated, "I have questions about complications I had hours after the Pfizer booster shot- who do I need to contact. I had major heart issues leaving me unresponsive 3 times. I would like a contact or someone to reach out to me."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient vaccinated with Covid vaccine and was admitted to hospital with Covid symptoms.  She was admitted with right lower lobe pneumonia due to Covid.
Pt came to the COVID vaccination clinic today to receive her first dose of the Pfizer vaccine: EL3246. Pt states "I am very nervous about getting this".  Pt brought a co-worker with her for support. Pt has "MS and Anxiety". Pt received her vaccine without any difficulty. While sitting for her observation time after the vaccine she began having some "tingling of her tongue and face feels hot".  Pt denies any breathing difficulty. Pt states "I am not sure if this is from my anxiety or a reaction".  Pt is drinking water with honey. Gave her some fresh water and monitored.  Checked on her a couple minutes later. She was in the chair and then up to walk and was concerned "my legs are feeling tingly and a little cold".  When asked if she ever takes BENADRYL for her previous medication reactions Pt states "yes".  I asked her if she has someone who can drive her home and she made arrangements for her co-worker to take her. Gave Pt BENADRYL 25 mg po one for potential reaction symptoms at 15:05. Moved Pt to a quieter place to monitor and observe. Gave her a warm blanket and some juice. Vitals at 15:18:  BP= 116/68, HR=80 Resp rate 16-18.   Pt is alert, oriented and states "feeling a little better".  Tingling sensation is "leaving".  Pt denies any respiratory symptoms. Monitored by RN. Pt set up with telephone call with Employee Health Provider, PAC.  Determined this is most likely symptoms caused by her anxiety.  Pt left ambulatory with her co-worker and symptoms were resolved.
Chest pain; This is a spontaneous report from a contactable consumer (parent; patient's father). A 14-year-old male patient (son) received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 19Jul2021 18:00 (batch/lot number: FA6780 and expiration date: 01Sep2021) at the age of 14 years old, as DOSE 2, SINGLE for COVID-19 immunization. The Vaccination Facility Type where patient received the vaccine dose was reported as a grocery store. The patient had no medical and family history relevant to the reported adverse event. When the family first moved here, the patient had to take a lot of vaccinations, and he didn't have any reaction to any of them. There were no concomitant medications. There were no prior vaccinations within 4 weeks, and no additional vaccines were administered on same date of the Pfizer suspect. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 28Jun2021 (batch/lot number: EW0196 and expiration date: 30Sep2021) at the age of 14 years old, as DOSE 2, SINGLE for COVID-19 immunization. On 19Jul2021, the patient experienced chest pain. It was reported that the patient was alright for a while, and then he noticed chest pain in the middle of the night the same day of the second dose. They took his son to a clinic, and they just tried to read the heartbeat, and they couldn't quite read it; so, they sent him to the emergency room. They waited patiently for four or five hours next to the Exit in the Emergency room; and his son just got better. At the emergency room they read his heartbeat and that was that. Patient was sent home. No investigation assessments were performed. The patient's father further reported that they have a couple of emergency room bills and when he called them, they told him to call someone else to get reimbursement. The patient's father asked for information about how to seek reimbursement. He thought they could just file for it, but they were told since it is COVID related he should call. The father added, they got the bill after they got home; they were visiting another country; he called the bill office and said this was COVID related and they told him to call someone in (place name) but this was the first number he found to call. When asked to report, the father stated no, at this point everything was fine, then decided to report anyway. The patient recovered from the event chest pain on 19Jul2021.  Follow-up attempts are completed. No further information is expected.
abdominal aches and cramps gradually increasing in severity; walking and other core body movement provided temporary cessation of increasing severe pain;  the peak of severe pain was accompanied by a bowel movement, followed within about 5 minutes by body temperature increase, sweating, and profuse salivation such that saliva was swallowed every 2-3 seconds for a few minutes.   Treatment was a focus on breathing while practicing the turtle yoga position (forehead on floor with knees folded under abdomen) and then laying flat on back with one or both knees bent.  After 10-15 minutes of this treatment the symptoms (abdominal pain, high temp, profuse salivation) subsided.
Report  SOB while doing certain task such as washing dishes, body aches, numbness and tingling to entire body, chills, nose bleed, and Migraines (history of Migraines) began day 1 post vaccination. Treatment: Ibuprofen, Aleve, Advil with Mild improvement.  Outcome:  Advised to monitor symptoms and see primary care doctor if worsens or changes. Does not interfere with ADLs.
Pt had localized reaction on (L) deltoid arm 3 x 4 inch area with redness and slightly warm to touch, area was soft. No fever, no chills, no SOB, arm slightly tender.
16 year old patient recived first dose of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient recived first dose of Moderna Covid-19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031b21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient recived first dose of Moderna Covid-19 vaccine). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient recived first dose of Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: The follow up document was received and had significant information. Added patient demographics, batch number updated.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # 046A21A, with no associated AEs.
This case was reported by a nurse vial call center representative and described the occurrence of swollen eyes in a 63-year-old female patient who received FLUARIX QUADRIVALENT (batch number CD3TF, expiry date 30th June 2017). On 27th September 2016, the patient received FLUARIX QUADRIVALENT (intramuscular) 0.5 ml. On 27th September 2016, several hours after receiving FLUARIX QUADRIVALENT, the patient experienced swollen eyes, itchy eyes and burning in the eyes. The patient was treated with no-drug therapy (Cold Compress). On an unknown date, the outcome of the swollen eyes, itchy eyes and burning in eyes were recovering/resolving. The reporter considered the swollen eyes and burning in eyes to be possibly related to FLUARIX QUADRIVALENT . It was unknown if the reporter considered the itchy eyes to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received FLUARIX QUADRIVALENT on left deltoid. Beginning of the evening of the vaccinations, the patient experienced swelling an burning of the eyes for approximately 3 days after vaccination. The patient also experienced itchy eyes on the day of intentional vaccination for approximately 3 days after vaccination. The patient was also Health care professional and self-treated with alternating warm and cool compresses for comfort, and reported the event to employee health. Approximately 4 weeks after vaccination date, the symptoms returned.
ELEVATED BLOOD PRESSURE; NECK STIFFNESS; FUZZY HEAD; BUMP BELOW THE INJECTION SITE; PAIN IN ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported,1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the patient felt pain in the arm, stiffness in the neck 30 minutes after receiving the vaccine. She had a bump not where she got the shot but below the injection site and also had fuzzy head. She had elevated blood pressure (173/103) and her normal blood pressure was (118/75). It was reported that all the symptoms were still persisting. Laboratory data included: Blood pressure (NR: not provided) 173/103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in arm, neck stiffness, bump below the injection site, fuzzy head, and elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420595-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 at 12:00 as dose 3 (booster), single (Lot number: 301308A) at the age of 72 years, in right 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: "High cholesterol" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: LIPITOR, stop date: 17May2022; FOSAMAX, stop date: 02May2022. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Anti viral from 18May2022 to 23May2022.
Client reports swelling, redness, heat in upper part of Left arm after Pneumo vax 23.  Denied seeing PMD re: reaction. Client fully recovered per report and denies any lasting symptoms or effects.
Sudden weakness in legs ... so much that had to sit or would fall down because they wouldn't hold me. This has happened several times over the past few weeks but I did not know what it was.
c/o palpitation.  Client stated did not eat or take his blood pressure medication prior to taking COVID-19 vaccine today.  B/P 192/118, HR 74. 11:25am Patient stated that he was feeling much better when he gets home will have something to eat+take his medication.  Patient was informed by EMS if still has symptom to call or contact his doctor.  Understanding verbalized.
severe leg pain in the morning; She was unable to walk; white blood cell count was also very high; c reactive protein was 283; She was nauseous and unable to eat; She was nauseous and unable to eat; She has lost 17lbs; This is a spontaneous report from a contactable consumer reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 15:45 (at the age of 74-years-old) as 2nd dose, single for covid-19 immunization; and atorvastatin calcium, ezetimibe (STATIN EZ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The vaccine was administered at the hospital. The patient medical history was reported as none. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided), administered on left arm on 17Mar2021 03:30PM as 1st dose, single for covid-19 immunization. There were no concomitant medications. It was roughly 3 days after the second shot (10Apr2021) that the patient experienced severe leg pain in the morning. She was unable to walk for about an hour after waking up. Her physician did blood test and her c-reactive protein was 283. Her white blood cell count was also very high. She was nauseous and unable to eat. The extreme leg pain has since subsided but she still cannot eat. She has lost 17lbs. It has been a month of this and she's had every test known to man. The patient was hospitalized for 1 day due to severe leg pain, unable to walk and white blood cell count high on an unspecified date. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal swab): negative on 21Apr2021. The outcome of severe leg pain, unable to walk and white blood cell count high was not recovered; and unknown for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events  and the use of  BNT162B2 seems unlikely. The limited information available precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information.   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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Pt came in for a second dose of the Moderna primary series, and we gave her the Pfizer bivalent booster.  No adverse events, already reported to Pfizer safety department.
Rolled back eyes & tonic-clonic movements (seizure) followed by sleep, low grade fever;
Pt complained of a 3 inch hard area, that was warm to the touch and achiness at injection site.
PCR 18Apr2022 now positive; PCR 18Apr2022 now positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 41-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN5318), on 27Feb2021 as dose 2, single (Lot number: EN6202) and on 03Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 01Dec2021, stop date: 01Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "unknown" and all described as "PCR 18Apr2022 now positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) Inconclusive; (18Apr2022) Positive, notes: Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: PCR. other vaccine 4 weeks product includes Flu Sequiris. very mild ST 16Apr2022 and did Ag test 17Apr2022 inconclusive and PCR 18Apr2022 now positive. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19 and Since the vaccination, the patient been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Vaccination failure", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Presented to ED w/cough & hypoxia; admitted for COVID-19 pna,acute resp failure w/ hypoxia & sepsis; tx w/remdesivir, steroids, protonix, zinc
This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L039268 with expiry date 05-APR-2017, lot # M029599 with expiry date 10-DEC-2017 (dosing details unspecified) for prophylaxis. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was available.  Additional information has been requested.
We inadvertently immunized this patient with a Pfizer vaccination for their second dose instead of the intended vaccine, Moderna. Pt received their Moderna Dose 1 vaccine on 4/22/21 and mistakenly received Pfizer as a Dose 2 on 5/20/21.
I started to notice two days later I was feeling woozy, now I am dizzy all the time. When I sit still it's not that bad, walk and bending over makes it worse. It's really bad. I made an appointment for my doctor on May 4 2021.
After the second dose it was in the middle of the night. I woke up with a fever, I did not get out of the bed the whole day after. I was tired and could not get out of the bed. I called the doctor and they advised to take something to keep the fever down. I had the same symptoms with the 1st dose as well.
24 hours after the 2nd booster, walking real slowly home from the pharmacy; didn't feel right, felt cloudy,It was like he hit a brick wall; arm was hurting; fever at night at approximately 2:30AM; shoulder was hurting; This spontaneous case was reported by a patient and describes the occurrence of BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy), FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall), PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy) and FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall). 16-Jun-2022, the patient experienced PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting). At the time of the report, BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy), FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall), PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2022, Body temperature: 100.6 100.6 F, 99.9 99.9 F and 99.5 99.5 F.         No concomitant medications were reported. No treatment details were reported.
Left side facial swelling; chest thighs ness; elevated blood pressure; tingling; headache; fatigue; fever and chills; sore joints
Had nothing to eat or drink prior to the appointment, after the vaccine was doing errands with mom and had a wrap 1/ 2 hour after the visit, then developed nausea ,lightheaded, dizziness, and headache.Came home and rested