chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of currently 1 year age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX with lot # L034368, expiry date 08-SEP-2017; dose, route of administration and anatomical location not reported). The doses of (Oka/Merck) VARIVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptom were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
Pneumonia; Sickness; Flu; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a non-contactable consumer (patient), based on the information received by Pfizer from Company (manufacturer control number: 21K-163-4149382-00).   A 61-year-old female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via intramuscular on an unspecified date in 2021 (at the age of 61-years-old) at dose number unknown, single for COVID-19 immunisation; and ibrutinib (IMBRUVICA) tablet via oral from 07Apr2021 and ongoing at 420 mg, once daily for CLL (chronic lymphocytic leukaemia). Medical history includes ongoing CLL (chronic lymphocytic leukaemia). The patient has no known allergies. The patient's concomitant medications were not reported. On Oct2021, the patient experienced pneumonia. On an unspecified date in 2021, the patient experienced sickness and flu. The action taken in response to the events for ibrutinib was dose not changed. Outcome of the events was recovering. Causality for ibrutinib (IMBRUVICA): The reporter's causality for the events pneumonia and flu was not provided. The reporters causality for the event sickness with ibrutinib (IMBRUVICA) was no reasonable possibility.                                                                                                                                                                                                           The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events pneumonia, illness and influenza and the suspect drug BNT162B2 cannot be 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.
Patient has asthma and tried to resolve continuous Shortness of breath started 9/13/21 using inhaler, without success. Patient visited ER 9/20/21 and admitted 9/21/21.
Further vaccine site details not recorded.  28 yo healthy male experienced severe local erythema, edema and ecchymosis at injection site left upper arm after receipt of Tdap #2, anthrax #5 and IPV #9.  Initially no immediate reaction. By evening he developed increasing pain followed be edema, warmth, erythema and ecchymosis but diminishment of pain. Local inflammation symptoms peaked day two and are improved today on day3. He has some pain with lateral motion but is otherwise performing usual activities other than weight  No systemic symptoms otherwise feels well. Symptoms limited to affected area on upper arm.. He reports a similar reaction 24  February 2020 which vaccine receipt included IPV #8 (lot #P1f541M)  and anthrax #4 (#300031A) JEV #2 (JEV18C74E) and  IIV #10 (P100139893, SKB).  This event was characterized by more erythema and edema but no ecchymosis.
9:26am BP 108/74, P 82, O2 99%. Presented self at observation sitting in car, talking on phone with complaint of left neck discomfort which she stated was a continuation from last night.  Skin W/D.  9:38an Stated feeling better, c/o "just being anxious."  Advised if symptoms return, call 911 or get to a medical facility.  Allowed to leave observation.
Patient phoned on 10-9-14 - complained of redness and swelling at site of injection. Complaints of headache starting on 10-7-14. Phoned PMD was told to take ADVIL and use hydrocortisone cream at site. Patient stated when called on 10-9-14 that she had a reaction to a flu shot in the past at site, but not as much redness or swelling.
The patient was given 0.1 ml of Pfizer instead of the correct dosage of 0.3ml. This was a vaccinator error and was caught by our pharmacist on site 3/12/2021.
patient lost consciousness and did not regain it. ems services took the patient to a local hospital. complained of burning at injection site
Received 2nd Covid vaccine on March 31. May 8th approximately, I developed slurred speech. My speech has progressively gotten worse. I can no longer talk clearly.  My family cannot understand me when i speak. I have been to 3 different neurologists and they are thinking it may be ALS but not yet confirmed.  I have no family history of ALS or other speech impairment. I have to go for a swallow study in August and speech therapy as well as follow up with nuerologist in October.
Stroke symoton inckuding fiund brain bloid clot loss of peripheral vussion left side numbness side of face habds fibger tips confusion
Fever of 99.3-99.8; No energy; Feeling severe aches; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in right arm on 17Mar2021 at 16:45 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. The patient medical history included uterine cancer in 2010, low thyroid and overweight. Concomitant medications included unspecified medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in left arm on 24Feb2021 at 16:30 (at the age of 45-year-old)), as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 09:00, the patient woke up feeling severe aches and no energy. The patient literally did not move for hours and very little as possible and also had a fever of 99.3-99.8 (body temperature with unspecified unit) through the day and night. The patient did not receive any treatment for events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events feeling severe aches, fever and no energy were recovered on 19Mar2021 (next day the patient felt fine again.).   No follow-up attempts are needed. No further information is expected.
Patient states they developed a low grade fever for the two days after the vaccine (06/20 & 06/21). Patient then began to develop a rash the third day (06/22). They used hydrocortisone cream to help with this. I spoke with them about possibly using benadryl if needed and following up with their PCP to determine further need for care. As of today (06/23/20) patient still has rash.
Started with migraine, fever, chills after three hours of injection, night two same, night three same, four night histamine levels were high and developed hives on back and chest area, fever, five night same, sixth night shortness of breath, fever, seventh night shortness breath, fever. Night eight same, tenth day went to urgent care x-ray lung had fluid and pneumonia . 12 day blood pressure was 80/50 and admitted in ER.
Fever arm pain, swollen arm pit, nausea, appetite loss, fatigue, itching  Narrative: employee states: after 2nd vaccination: evening of 5/3/21 moderate right arm pain; took motrin and Tylenol 5/4/21 awoke around 0500 with moderate arm pain, right armpit swollen- possibly lymph node, and fever took Tylenol and motrin and used ice pact at site. also experienced nausea, loss of appetite, and fatigue 5/5/21 mild discomfort at site, mild discomfort arm pit, fatigue, some itching at sire- applied topical hydrocortisone
Began as area of induration approx 3 cm in diameter, which was tender and itched mildly. 1/31 5:00 pm more intense itching and area of induration measured 14 cm in diameter. Area noted to have erythematous blotches as well. 2/1  5:00 pm. Diffuse pinpoint rash in area of induration. No increase. In size continued itching.  2/2 8:00 am induration and erythema and rash resolved.
Tiredness/severe tiredness and fatigue; feeling wiped out; Patient experienced side effects 5 days later after the third dose; Patient experienced side effects 5 days later after the third dose; This is a spontaneous report from a contactable consumer or other non hcp.   A 67-years-old male patient received bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 17Aug2021 11:00 (Batch/Lot Number: EW0172) as dose 3, single for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, Diagnosed five years ago Type 2. There were no concomitant medications. It was reported that, Patient experienced side effects 5 days later after the third dose, the booster, of the Pfizer COVID-19 Vaccine, the patient experienced patient experienced side effects 5 days later after the third on 17Aug2021 with outcome of unknown, tiredness/severe tiredness and fatigue, feeling wiped out on 24Aug2021 16:00 with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test negative on. Spoke from press release from 25Aug2021 "PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION TO U.S. FDA FOR BOOSTER DOSE OF COMIRNATY® IN INDIVIDUALS 16 AND OLDER" The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was similar to or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data for COMIRNATY Follow up(25Aug2021): This is a follow up spontaneous report from a contactable consumer reported information included. Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Started feeling hot, pain down both arms, shaking, extreme weakness, headache. Approximately 1 day later noticed bruising at injection site. Six days later still feel weak & slight headache & dizziness.
This case was reported by a nurse via sales rep and described the occurrence of rash in an unspecified number of adult patients who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced rash and dizziness. On an unknown date, the outcome of the rash and dizziness were unknown. The reporter considered the rash and dizziness to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not applicable. This case was reported by field representative on behalf of health care professional. The field representative received email from the health care professional stating that, multiple patients experienced rash and dizziness after receiving FLULAVAL. No patient-specific details were provided for the individual patients therefore it was filled under one report.
In May 2022, my 6-year-old child and I both received a  Pfizer covid shot (my 3rd, his 1st). About 5-11 months later, he started complaining of knee pain. By June he was limping and his knee was swollen. In June 2023, my child was diagnosed with juvenile arthritis. It was found in both knees and both ankles by ultrasound in July 2023. I was diagnosed with Graves disease in August 2023. Both are autoimmune conditions that developed around the same time as each other.
Red spot (erythema) and rash to left leg at injection site, reported to MD 2 weeks after vaccination, treated with mupirocin 2% ointment.
Information had been received on 15-MAR-2017 from a medical assistant who reported that a 20 year old female patient received her first dose of GARDASIL 9 0.5ml (unspecified lot#/expiration date) on 15-SEP-2016 and then a second dose of GARDASIL 9 (lot# L036301, expiration 20-DEC-2017) via the intramuscular route in her left deltoid on 15-NOV-2016. The medical assistant stated that an unspecified time after the patient received the second dose of GARDASIL 9, she developed a "large lump that feels like fluid underneath the skin" at the injection site where the second dose of GARDASIL 9 was administered. The medical assistant stated the patient came into the office today, 15-MAR-2017, to receive the third dose of GARDASIL 9 but the third dose was not administered due to the lump. The medical assistant stated that the patient was being referred to an unspecified surgeon due to the lump. Patient's present status was not recovered. No further information was provided. Additional information has been requested.
INDIVIDUAL RECEIVED VACCINE PAST THE BEYOND USE DATE. MAY OR MAY NOT BE WITHIN THE 14 DAY STABILITY DATE (OFF LABEL). INDIVIDUAL MAY CHOOSE TO BE REVACCINATED. NO ADVERSE EVENTS REPORTED.
She reported stomach upset with the first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "She reported stomach upset with the first dose".  Additional information: The patient had pre-existing medical issues with her back and shoulders. Her stomach was upset after getting the first dose of Covid vaccine and mentions with the second dose she had less of reaction but did not specify.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lots of snot; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Lots of snot), PYREXIA (Fever) and VOMITING (Vomiting) in a 19-year-old patient of an unknown gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Lots of snot), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, RHINORRHOEA (Lots of snot), PYREXIA (Fever) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) fever.   Action taken with mRNA-1273 in response to the events was not applicable.     No concomitant medication reported. No treatment information provided.
Patient called 10/19/23 and reported her arm being red, sore and swollen. Patient went to the doctor and was diagnosed with cellulitis and antibiotic and Medrol dose pack were prescribed.
LUMP ON COLLARBONE THAT EXTENDS INTO NECK MUSCLE; SWELLING; SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a male 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: Unk) dose was not reported, administered on 11-MAR-2021 08:40 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On MAR-2021, the subject experienced lump on collarbone that extends into neck muscle. On MAR-2021, the subject experienced swelling. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on MAR-2021, had not recovered from sore arm, and the outcome of lump on collarbone that extends into neck muscle and swelling was not reported. This report was non-serious.
Immediately after vaccine caller experienced a flushing feeling; Later that day she felt nauseated and fatigue.; Later that day she felt nauseated and fatigue.; I felt a strange feeling from my chest; She thought was her second Pfizer Covid vaccine. However, the gentleman that gave her the shot told her she was receiving the Astra Zeneca vaccine, but on her vaccination card it says Pfizer EN6199; She thought was her second Pfizer Covid vaccine. However, the gentleman that gave her the shot told her she was receiving the Astra Zeneca vaccine, but on her vaccination card it says Pfizer EN6199; This is a spontaneous report from a contactable consumer (patient) reported for herself. Report from a Pfizer-sponsored program. This report was not related to a study or programme. A 77-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/lot number: EN6199, expiry date: 30Jun2021), via an unknown route of administration on 16Feb2021 (at the age of 77-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The caller calling about the Covid-19 Vaccine and said that the first shot she received was the Pfizer vaccine on 16Feb2021. Immediately after vaccine caller experienced a flushing feeling. Later that day she felt nauseated and fatigue. Caller also stated "I felt a strange feeling from my chest up". The second one was administered on 09Mar2021. States she did not experience adverse events following second dose. She thought her second shot was Pfizer Covid vaccine. However, the gentleman that gave her the shot told her she was receiving the Astra Zeneca vaccine, but on her vaccination card it said Pfizer EN6199 and he did not sign his name. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
she had a slight headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN531B) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number- EN531B, Expiration Date- UNKNOWN, Anatomical Location- may have received in left arm by injection), administration date: 04Feb2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "she had a slight headache". Additional information: Vaccination facility type was reported as Pharmacy/drug store. Patient did not receive the vaccine at a facility. Patient has diabetes, rheumatoid arthritis, and breathing issues. Patient called about the Pfizer Covid Vaccine. Stated that she has had all 3 doses. She had the booster on the 04Nov2021, last Thursday. The paper did not say this was one of the common side effects, so she wanted to know if it could still be a side effect of the vaccine. First dose, she had no side effects. Second dose, she had a slight headache for about a week. Patient received the second dose on 25Feb2021 may have received in left arm (as reported).  The adverse events did not result in the emergency room or physician office visit. She got the flu shot 34 days before the third booster dose.   No follow-up attempts are needed. No further information is expected.
Admitted for COVID-19 pna; tx w/abx, steroids, zinc; pt needed intubation; despite aggressive tx, pt didn ot improve and subsequently expired.
Nausea and vomiting within 1 hr of shot-went home from work slept and nurse called next day-pt stated she was fine.
Flare of all EGPA symptoms, , tight throat, phlegm in throat, abnormal liver function tests,
Started 6-28-05 at 6:30PM Noticed swollen, red and warm to touch area on lt . Area hard approximately 2 1/2 "
11/25 /21 Thanksgiving Day  heart palpitations & pressure.  Chest pains  Shortness of breath.  Fatigue  Upset stomach Nausea
red spot on the chest @ 5PM the same day;had 2 dose of HBV prev;
TOTS posterioral tachycardia syndrome. My heart was racing in my sleep. My smart watch said my pulse was 196. My blood pressure was fine. I went to the ER. It lasted until about 4:00PM.
headache; tingling to tongue lips and mouth; bp (blood pressure) 160/90; P107 (Pulse) RR (respiratory rate) 18; P107 (Pulse) RR (respiratory rate) 18; This is a spontaneous report from a contactable nurse. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 33-year-old, intramuscular, administered in left arm on 13May2021 10:00 (Lot Number: ew0183) as 1st dose single for COVID-19 immunisation. The patient has no medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. On 13May2021 at 10:00, shortly after her Pfizer vaccine she developed a headache and tingling to tongue lips and mouth. No swelling noted no hives noted. The patient was given 25mg PO (oral) diphenhydramine (BENADRYL) for the headache and tingling to tongue lips and mouth per protocol and EMS (Emergency Medical Services) called. Patient was speaking in full sentences. The patient's VSS (vital signs stable), BP (blood pressure) 160/90, P (pulse) 107, RR (respiratory rate) 18, RA (respiratory) 99% all on 13May2021. The patient was in no acute distress and reports tingling not getting worse. Patient was transported to HMH (health level) ED (emergency department) for evaluation. The events resulted in Emergency room/department or urgent care. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.