chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm at injection site and very fatigued; Sore arm at injection site and very fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (pregnant) received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 11Mar2021 09:00 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Date of last menstrual period: 24Jul2020. The patient was 32 weeks pregnant at the time of exposure to bnt162b2; 31 weeks pregnant to anti-d immunoglobulin. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 21Apr2021. Concomitant medication(s) included: RHOGAM, administration date 04Mar2021; SYNTHROID. Past drug history included: Benadryl, reaction(s): "known allergies : Benadryl", notes: known allergies : Benadryl. Vaccination history included: Rhogam (other vaccine 4weeks : Rhogam), administration date: 04Mar2021. The following information was reported: VACCINATION SITE PAIN (non-serious), FATIGUE (non-serious) all with onset 12Mar2021 07:30, outcome "not recovered" and all described as "Sore arm at iprenatalsnjection site and very fatigued". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient received other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination synthroid .125, prenatals. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.
Two days after, my site was swollen, red, splotchy and hot. I took Benedryl and it felt a lot better the next day.
Started with arms and shoulder having redness and became itchy. It has been getting worse. She itch everywhere , swollen around elbows,
Received the second dose in the series on Wednesday 1/20/21.  The following day, he noticed some chest discomfort.  He then performed some-what of a self physical and was suspicious of pericarditis. Had an EKG pointing to pericarditis.  He then had an ECHO performed at the hospital that confirmed the diagnosis. Was then started on a course of colchicine to treat the pericarditis. It is important to know he contracted COVID earlier in the fall with a confirmed laboratory diagnosis on 11/13/20 which he was fully recovered from.  He was never hospitalized for the infection.
I had running nose, fatigue, and body aches that lasted for about 2 weeks. On Jan 20th, I tested positive for Covid-19.
Information has been received from a health professional concerning four patient who on 10/14/99 or 10/15/99 were vaccinated with one dose of Pneumococcal vaccine 23 Polyvalent. Subsequently the patients experienced high fevers, and hard red arms. The health care professional stated that "everything that was listed as an adverse experience in the prescribing information was experienced by the patients." The patients sought unspecified medical
about 7 hours after receiving the second covid shot, pt began experiencing severe restless legs. It was so bad she was unable to sleep. The restless leg last through till ~4 pm on 4-May-2021. After that pt got the chills.
Mild fever; Mild Cold; Mild swelling on face; Mild pain on swelling area of pain; Mild pain on swelling area of pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 43-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Ew0175) via an unspecified route of administration in left arm on 06May2021 13:00 as dose 2, single (at the age of 43-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The device timestamp was on 20Jun2021. Medical history included diabetes mellitus. The patient no known allergies. The patient did not have covid prior to vaccination. The concomitant medications included metformin, semaglutide (RYBELSUS), atorvastatin taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- Er8735) via an unspecified route of administration in left arm on 15Apr2021 18:00 as dose 1, single for COVID-19 immunization. The patient did not take other vaccine in four weeks. On 07Jun2021 at 13:00, the patient experienced mild fever, mild cold, mild swelling on face, mild pain on swelling area of pain. The patient did not test covid post vaccination. The therapeutic measures were not taken as a result of the adverse events. The outcome of the events was not recovered.  Follow-up (17Aug2021): Follow-up attempts are completed. No further information is expected.
This case has been considered invalid as there is no indication that the consumer experienced an event under BNT162B2. This case involves medical inquiry only. This is a spontaneous report from a contactable consumer (herself). A female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on an unspecified date, as single dose for Covid-19 immunisation. Medical history included sinusitis and concomitant medications were not reported.  He had first dose of the Pfizer BioNTech Covid-19 vaccine while she had a sinus infection. Or took the vaccine while she had a sinus infection. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (10May2021): Follow-up attempts completed. No further information expected. Follow-up (22Mar2021): This is a follow up-spontaneous report from a contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included that: I am fine. No one made or did anything wrong. I were worried that I think. But everything is good. To Pfizer, I do not know why I am receiving all of these papers. I called your company a while back when I received your vaccine, they were very professional and wonderful to me. I am fine was trying to find out if I did something wrong by not realizing I had a sinus problem. I thought I might have done some-thing wrong, I am fine the nurses were great. No need to worry. Thank you but everything is good no mistakes made. No follow-up attempts are possible. No further information is expected.
As the RN, I did not reconstitute the bottle of 5-11 year old pfizer COVID vaccine prior to giving the shot. Father is aware, my MD is aware. Patient received 0.03 mcg too much. RN
7/9/2009 Associate reports cold sx , no fever.  7/17/2009 Associate received Tdap vaccine.  8/26/2009 Associate reported:  8/1/2009 onset of hands and feet tingling. 8/3/2009 numbness to rectal/perineal area and legs tingling. 8/4/2009 treated in Hospital ED, CT of head negative, discharged on Xanax.  8/5/2009 leg weakness to point of having to lift her legs with her hands to get out of her car.  8/6/2009 fell at home, went back to ED and was admitted with diagnosis of Guillain Barre Syndrome.  Hospitalized from 8/6 - 8/11/2009 and transferred to Hospital 8/11- 8/19/2009.  Reports paralysis from waist down while hospitalized.  8/26/2009 is now walking with a walker, receiving physical/ occupational therapy by home health agency. 10/19/09 ICD Codes:  357.0, 599.0, 782.0, 305.1, 260.9, 041.4.
9X11cm 2cm below injection. Red, indurated tender and warm to touch. No fever, no chills. Rx KEFLEX x10 days. After second dose of antibiotic, it improved dramatically.
Red, hot and sore to touch the area. The area is about the size of a silver dollar.
The date of immunization and 2 to 3 days following arm was very sore.  This was second  in series of two and first immunization left arm extremely sore also, so thought nothing of it.  In November, I  woke up and left arm was hurting.  Looked in mirror in bathroom and there was a huge dent in my arm with swelling above and pain.  Today 02/05/2020 the site looks bigger and deeper.  Dent in arm can be seen by others.  I showed to nurses at Health Department, regular doctor, and OBGYN and all concurred it was from immunization.  Muscle and tissue damage occured.
Patient called into our office on 11/27/2017 to report that she began having symptoms on 11/22/2017, approx. 4 hrs after receiving the vaccine. Patient reported "feeling the pressure of the medication going all through her body at time of injection", however pt did not mention this during visit. She stated that approx. 4 hrs after receiving vaccination that she experienced paralysis in her shoulders and neck that required her to have her granddaughter open the door for her and to help her turn in bed that night. Pt states that these symptoms, along with chills and elevated temp although she denies taking temp with thermometer, lasted for about 36 hrs. She denies any other symptoms past the 36 hrs.
left tongue deviation; right radial numbness in the right arm/left facial numbness/numbness in feet; left facial tremors; weakness in legs; This is a spontaneous report from a contactable physician's assistant in Emergency Medicine. This physician's assistant reported similar events for three patients. This is the third of three reports.  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), 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 after receiving the vaccine, the patient experienced right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs. The clinical outcomes of the right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.          Amendment: This follow-up report is being submitted to amend previously reported information: to correct the patient initials and patient information.  Follow-up (01Apr2021): New information received from the same physician's assistant includes: reporter occupation updated.   Follow-up (05Apr2021): This is a follow-up report to notify that the case 2021290853 and case 2021372580 are duplicates.  All subsequent follow-up information will be reported under manufacturer report number 2021372580.; Sender's Comments: As there is limited information in the case provided for tongue paralysis the causal association between the event and the suspect vaccine 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.,Linked Report(s) : US-PFIZER INC-2021154431 Same reporter/product, different patient, similar events;US-PFIZER INC-2021372512 same reporter, product, and event; different patient
This is a spontaneous report from a contactable consumer or other non-healthcare professional, (patient). A female patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, in Apr 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date in Apr 2021, patient experienced a feeling of flush/hot face and shoulder; and fatigue. Patient was unable to sleep. She said she felt flushed - like a red face/face felt hot. Patient felt hot spots on different parts of her body and it had been about two weeks. Patient still felt flushed. The outcome of felt hot spots on different parts of her body: not recovered. The outcome of the other events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
This is a spontaneous report from a contactable medical assistant communicated to a Pfizer sales representative. The medical assistant reported similar events for two patients. This is the first of two reports.  A patient of unknown age, gender and race/ethnicity received a single dose of PREVNAR 13 for immunization on an unknown date at the physician office. Medical history and concomitant medications were not reported. On an unknown date, the patient had allergic reaction, arms were extremely swollen; it was really large and they were hot to the touch and very painful for the patient. Treatment was provided. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017210408 different patient, same product, same event.
received FLUZONE HIGH DOSE QUADRIVALENT and some medication trickled down the consumers arm with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 73 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and some medication trickled down the consumers arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient was intended to received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ918AC and expiry date: 30-Jun-2023) via intramuscular route in the arm nos for prophylactic vaccination.  On 11-Oct-2022, (latency: same day) the patient received fluzone high dose quadrivalent and some medication trickled down the consumers arm with no reported adverse event (incorrect dose administered).  It was reported, a consumer received FLUZONE HIGH DOSE QUADRIVALENT and some medication trickled down the consumer's arm. Consumer came back in the store concerned about not getting the full dose. Less than recommended dose was administered.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was 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.
1 day old newborn received 1st hepatitis B vaccine. Subsequently after 32 hours developed an elevated temperature up to 101.5 rectally. Admitted to the NICU for suspected sepsis. Received IV ampicillin and Gentamicin. 2/17/06 Received medical records which revealed patient experienced fever, hyperthermia & sepsis/ss
Client States that he got Adacel, Hep B, Typhoid, and Yellow fever on 3/1/07. He developed a fever of 100 24 hours after the immunization night sweats, headache which lasted for 1/2 day. He did not see a Dr.
About 5 - 10 minutes after receiving vaccine patient complained of dizziness while walking, then fainted. She did not lose consciousness and got up right away, appeared very pale. Patient sat down for 15 minutes and color in skin returned. Guardians took her home afterwards.
2 weeks to the day patient recevied the vaccine he passed away in his sleep, heart stopped. Myrocarditis found in autopsy Date of Death- 05/25/2021
Patient has a severe dark red rash on three-fourths of her upper left arm. It lasted approximately one week and it was very sore.
Case went to hospital with ongoing vomiting and fatigue. Tested positive upon admission. No other COVID symptoms were reported.
12 year old received the Moderna Covid 19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna Covid 19 Vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna Covid 19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna Covid 19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Myalgia, headache, sore left arm, sore throat within an hour, sent home to rest Narrative:
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company (Pfizer) concerned a 37 year old male of unspecified ethnic origin. Initial information was processed along with the additional information received on 05-SEP-2022. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies nor other medical history at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 35 years old. No concomitant medications were reported. The patient additionally received a non-company suspect vaccine included: tozinameran (Pfizer) (Dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on NOV-2021 for covid-19 prophylaxis. The covid test had rebounded after finishing the Paxlovid treatment and remained positive for a week (confirmed clinical vaccination failure) (Dose number in series 1).  Mild cold like symptoms also occurred after the treatment (confirmed covid-19 infection) (Dose number in series 2). The patient received Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered on 10-AUG-2022 to 14-AUG-2022 for covid-19 treatment.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tozinameran was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000249245.; Sender's Comments: V0: 20220904972-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
The patient had an injection in both legs, both legs are red with large knot in each leg. Cool compresses to the areas and Tylenol for pain or fever.
Persistent disequilibrium commencing after vaccination. Was noticeable for two weeks after vaccination. Symptoms have subsided significantly since, although I (the patient) still don't feel as 100% as I was before the vaccine. I would randomly feel an immediate need to sit down when standing, and experienced significant vertigo when trying to go up and down stairs.
EMPLOYEE STATES THAT HIS LEGS BECAME TINGLY AND NUMB FEELING, DIZZY,RIGHT SIDE OF NECK BEGAN TO HURT, HEARING IN RIGHT EAR WAS MAKING A BUZZING SOUND. BLURRED VISION, BREATHING WAS SLIGHTLY ALTERED FROM EMPLOYEES NORMAL PATTERN, HOT AND SWEATY, DONOR FELT LIKE HE COULD PASS OUT. CENTER PHYSICIAN WAS NOTIFIED OF POSSIBLE REACTION AND SIGNS AND SYMPTOMS THAT WERE BEING EXPERIENCED, CENTER PHYSICIAN ADVISED CENTER TO CALL EMS. EMS CALLED AND EVALUATED EMPLOYEE AT CENTER. EMPLOYEE DECLINED TRANSPORT TO HOSPITAL FOR TREATMENT. EMPLOYEE STATES THAT HE IS FEELING BETTER AND THAT EMS STATES HE WAS HAVING A SEVERE ANXIETY ATTACK. EMS STATES PULSE WAS IN THE 180'S
Jansen Covid 19 vaccine  Headache increased in intensity by midnight got worse with no relief through the night with Tylenol or ibuprofen.  Fever of 100 and chills. Extreme tiredness through Thursday with nausea and diarrhea. Fever has subsided on Friday still have extreme tiredness and dizziness . I tested positive for Covid 19 on 1/14/21
Patient came to the clinic with a red, swollen area with blister like area in the middle of the area that was swollen. Parent stated that patient was unable to walk. Patient was sent to the local emergency room at Hospital
Donor received TDAP post plasma donation. Donor waited 15min and felt fine. Donor went to shop about 10min later and developed tunnel vision, was nauseated, pale, light headed and had a 2-3min episode of LOC. Donor then took bus to transfer station and developed the same symptoms followed by another 2-3min LOC. Later that evening while preparing for bed donor had the same symptoms again with another 2-3min LOC. Donor had had a routine amount of food and fluid before donating. Donor has never had a reaction to donating like this before. Donor has been a regular donor for about the last year. That evening donor slept well and awoke the next morning with no further symptoms except a temperature of 99.2 for two more days. Donor had no prior reactions to TDAP like this. Donor states she sometimes gets a little light headed post donation, but eating something fixes that.
c/o itchiness over body, hard to swallow, apprehensive & nauseous, resp distress; pt devel acute resp distress w/poor air exchange required Epi & DPH repeatedly to prevent complete resp arrest;