chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored GARDASIL (lot # K008931, Exp date 04-MAR-2017, dose and route not reported). No adverse effects was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Nausea; Vomiting; Shortness of breath; Muscle aches; Extremely ill; Body aches; expired; This is a report from a contactable consumer based on the information received by Pfizer. (Manufacturer Report Number: UNT-2021-006444).   A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization; and treprostinil sodium (TYVASO, strength: 0.6, mg/ml), via resp inhalation (reported as via inhalation route) from 30Mar2021 (Batch/Lot Number: 2101912; Expiration Date: 31Jan2022) to an unspecified date, at 18-54 ug, four times a day (QID) for primary pulmonary arterial hypertension. Medical history included ongoing pulmonary arterial hypertension. Concomitant medications included riociguat (ADEMPAS), amlodipine besilate, rivaroxaban (XARELTO); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient began therapy with IH Tyvaso (treprostinil sodium, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A), on 30Mar2021 for primary pulmonary arterial hypertension. The current dose was reported as 18-54 ug (3-9 breaths), four times a day (QID) via inhalation (IH) route. On an unspecified date, the patient experienced nausea, vomiting, shortness of breath, muscle aches, extremely ill, and body aches. The patient was hospitalized in response to the events on an unspecified date. The outcome of events was unknown. On an unspecified date in 2021, the patient expired, and cause of death was not reported. The action taken in response to the events for treprostinil sodium was unknown. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed.  The reporter's assessment of the causal relationship between the events with the suspect product 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.  Case Comment/Senders Comment: The company has assessed the serious adverse event of death as not related to IH treprostinil and TD-300/A device. The event was likely due to progressive complications and life limiting nature of underlying PAH in this elderly patient.  Information about lot/batch number has been requested.; Sender's Comments: The information currently available is limited and does not allow a meaningful causality assessment for reported event of death (unknown cause); however, based solely on implied vaccine-event chronological association a causal relationship between this event and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The other reported events; Reported Cause(s) of Death: expired
Big red welt around the injection site; Big red welt around the injection site/ red stripe she has that goes down her arm; Lumps on the inside of the elbow; Warmness; Sore; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (Lumps on the inside of the elbow), URTICARIA (Big red welt around the injection site), VACCINATION SITE WARMTH (Warmness), VACCINATION SITE PAIN (Sore) and VACCINATION SITE ERYTHEMA (Big red welt around the injection site/ red stripe she has that goes down her arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LIMB MASS (Lumps on the inside of the elbow), VACCINATION SITE WARMTH (Warmness) and VACCINATION SITE PAIN (Sore). On 21-Jan-2021, the patient experienced URTICARIA (Big red welt around the injection site) and VACCINATION SITE ERYTHEMA (Big red welt around the injection site/ red stripe she has that goes down her arm). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. On 18-Jan-2021, LIMB MASS (Lumps on the inside of the elbow), VACCINATION SITE WARMTH (Warmness) and VACCINATION SITE PAIN (Sore) had resolved. At the time of the report, URTICARIA (Big red welt around the injection site) and VACCINATION SITE ERYTHEMA (Big red welt around the injection site/ red stripe she has that goes down her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided
red, swollen, blotchy, hot, tingling at injection site. said doctor told her she has a bacterial infection from vaccine and gave her "antibiotic and prednisone"
Burning and soreness in arm, then tingling from shoulder to wrist. This has gone on for a month. I've been taking Advill.
Diarrhea; Nausea; A spontaneous report was received from a 68 year-old female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed diarrhea and nausea.  The patient's medical history was not provided. Concomitant medications included vitamin D, multivitamin magnesium and zinc, pill for circulation, and muscle relaxer.  On 30-DEC-2020, prior to onset of the events, the patient received her dose of mRNA-1273 (lot#: unknown) intramuscularly in the left arm for the prophylaxis of COVID-19 infection.  On an unknown date, the patient developed diarrhea and nausea. Treatment included loperamide.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events, diarrhea and nausea, were resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Developed moderate to large (half dollar sized) red, fluid-filled lesions in (Rt) axillary area and down (Rt) side of anterior chest.  Has 20-50 lesions.  Child seen by Dr. MD on 6/21/10.  Dr. believed these lesions to be VARICELLA & prescribed BACITRACIN ointment to lesions.
2-3 weeks later severe pruritis, urticaria and dermatographia lasting almost 2 months later worse in the evening relieved by antihistamines
Redness and swelling and itching at injection site, about 1.5 inch diameter
Information has been received from the authors in a literature article concerning an unknown gender 18 years old patient with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) route, lot# and dose were unknown). In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Methods: Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, > 101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure had measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per Department of Public Health (DPH) guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 measles, mumps, and rubella (MMR) vaccines doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at HCA or at the facilities where patients presented. All positive samples from community laboratories were confirmed by health care agency (HCA), which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at HCA using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (Hl), and fusion (Fl). The DPH Viral and Rickettsial Disease laboratory performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirators. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmissions. Overall, 13 of 15 secondary cases had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR vaccine (manufacturer unknown). This is one of several reports received from the same reporter. Additional information has been requested.
chills all night and syncope; chills all night and syncope; This is a spontaneous report from a contactable other health professional (patient).  A 39-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Unknown), intramuscularly in the left arm (also reported as the right arm) on 22Dec2020 at 15:00 at 39-years-old at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as: other. Medical history included Penicillin allergy from an unknown date and unknown if ongoing.  Concomitant medications included estrogens conjugated (PREMARIN), progesterone (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified date to an unspecified date (all of which were received within two weeks of vaccination). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Dec2020 at 00:00, the patient experienced: chills all night and syncope. The event syncope was considered medically significant; and the event chills was non-serious. There was no treatment received due to the adverse events. It was reported that prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, chills all night and syncope, was recovering.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported event syncope. 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.
reporting large golf ball OR SOFTBALL SIZED WELT; hot to touch; swollen at the injection site; drunk/dizzy feeling; drunk/dizzy feeling; This case was reported by a physician via call center representative and described the occurrence of injection site wheal in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, less than a month after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness. On an unknown date, the outcome of the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness were unknown.   It was unknown if the reporter considered the injection site wheal, injection site warmth, injection site swelling, feeling drunk and dizziness to be related to Fluarix Quadrivalent 2019-2020 season.  Additional information received were as follows: The age at vaccination was not reported. The patient had large golf ball or softball sized welt, hot to touch, swollen, at the injection site, drunk and dizzy feeling, after vaccinated with Fluarix Quadrivalent 2019-2020 season. This case linked with US2019AMR181651, US2019AMR181432 and US2019AMR181652, reported by same reporter.
Extreme chills. Temperature dropped to 94 degrees F.. Followed by extreme fever. Temperature rose to 104 degrees. Body aches. Mental fog. Symptoms lasted 24 hours.
patient has passed out about 2 minutes after administration in the post vaccine waiting area.  Pharmacist administered Epi Pen as per protocol.  Emergency phone number was called and patient was taken to ER.  Patient did gain consciousness  few seconds after receiving epinephrine.  Paramedics reported low blood pressure and patient was taken for observation to a local hospital.  Bottom lip appeared blue in color but patient was aware of her condition and asked for pharmacy staff to call father.
Redness and swelling up to 5" in place of injection. Pain, fever 100.4.
This spontaneous report as received from a nurse manager via company representative refers to a 87 years old female patient. The patient did not have medical history and current conditions. On 12-OCT-2017 the patient was vaccinated with PNEUMOVAX 23 (unspecified dose and route of administration, lot # N011867, expiration date: 08-NOV-2017) for Pneumonia prevention. Concomitant therapies included FLUZONE. On 12-OCT-2017, the patient developed extreme swelling and pain. The patient, approximately two days after getting the vaccine, ended up going to an unknown Emergency Room (ER) as a result of the adverse events, however the patient was not hospitalized on her first ER visit because the ER sent the patient home. The patient's adverse reaction continued to persist so the patient went to the ER a second time on an unspecified date for an unknown duration and on the second visit to the ER, the patient was diagnosed with cellulitis. The patient was prescribed some antibiotics and steroids. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. Additional information has been requested.
Hospitalized for COVID-19, hypoxemia 1/20/22-1/23/22. Treated with vancomycin, Flagyl, and cefepime IV. Expired 01/23/22 before hospice transfer.
Severe body aches 04/02-04/03 Headache and Dizziness upon standing 4/3/21-current
Body and joint pain; lump under armpit; chest pain; heart racing; Body and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FC3180) via an unspecified route of administration in arm left on 01Aug2021 10:30 dose 2, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included asthma, allergies: shellfish, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took iodine and experienced allergy. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FA7485) via an unspecified route of administration in arm left on 11Jul2021 12:00 dose 1, single for COVID-19 immunisation. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and covid was tested post vaccination. On 02Aug2021 at 02:00 PM, the patient experienced lump under armpit, had chest pain and heart racing, body and joint pain. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 real time PCR test resulted as negative on 31Jul2021 nasal swab. The clinical outcome of the events was not resolved.  No follow attempts are possible; no further information is expected
I am extremely concerned and fearful; My circulatory side effects are worsening; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEAR (non-serious), outcome "unknown", described as "I am extremely concerned and fearful"; CARDIOVASCULAR DISORDER (non-serious), outcome "not recovered", described as "My circulatory side effects are worsening".  Additional information: The patient would like to please speak with someone about severe side effects that patient have and continue to have after Pfizer CoV2 vaccine. The patient circulatory side effects are worsening and was extremely concerned and fearful. The side effects are worsening, and the patient need resolution.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 27-year-old patient who received Hepatitis B vaccine (batch number NT9X3) for prophylaxis.   On 27-FEB-2023, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Pt had vaccine at 4:54 pm and started to feel sick with fever and chills at 8pm. Pt arrived at our unit with temp 38 degrees C and chills.
I got the vaccine at 2:30 and that night I went to bed and had chills, headache, fatigue and ear ringing. Everything lasted about 16 hours except the ear ringing. The ringing in one ear is so constant and sound like a pulsating fan while the other ear sounds like constant humming.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown dates the unspecified patients were vaccinated with an improperly stored dose of ROTATEQ (incorrect product storage) (lot # L013204, expiry date 28-JAN-2017) (Lot # L026067, expiry date 13-SEP-2017) (Lot # L029617, 19-MAY-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that these vaccines were exposed to a temperature of 53 degrees Fahrenheit, for a time frame of 3 hours and 15 minutes. It was also reported that these vaccines were administered. No adverse effect was reported. No product quality complaint was reported. The action taken with the therapy with ROTATEQ was unknown. The outcome of the event was unknown. It was reported that this case was reported due to a data logger. This case is related to case numbers 1603USA006320 and 1603USA006319 via same reporter link. Additional information has been requested.
it's been more than 6 months since you got the first dose, you should get the second dose as; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date more than 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This case was reported by patient herself/himself. The age at vaccination was not applicable for this report. Till the time of reporting patient had not yet received second dose of Shingrix which led to incomplete course of vaccination. The reporter asked if the second dose was given 8 months after the first dose does it rendered the procedure invalid. The reporter also asked the vaccine still effective if the second dose was received after 6 months.
Narrative: 76 yo male patient with hx of T2DM, Afib, HRrEF who presented with worsened hypoxia and dyspnea. Had a fever last week Patient fully vaccinated with Pfizer vaccine in March of 2021. Date of onset of symptoms determined to be around 8/26-27. Patient required 2-3L of supplemental oxygen and was initiated on Remdesivir and Dexamethasone.
History of fever, weakness the night of receiving vaccines. Had URTI symptoms. Lightheaded. No weakness in legs or extremities. Lasted 3-4 days.
GREEN MUCOUSY DISCHARGE IN URINE; SWEATING; CHILLS; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. 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 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-AUG-2021, the patient experienced green mucousy discharge in urine.  On 25-AUG-2021, the patient experienced sweating. On 25-AUG-2021, the patient experienced chills. On 25-AUG-2021, the patient experienced fever. On 25-AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, sweating, green mucousy discharge in urine, and chills. This report was non-serious.
Right leg swollen, red area with rash mother will give child Ibuprofen for pain, BENADRYL for rash & place hot packs or ice pack on area.