chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 31Oct2023 to 05Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300362883 Same patient, different product, different dose/event;
This case described the occurrence of "multiple sclerosis symptoms" in a female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received from the pt's spouse and has not been verified by a physician or other healthcare professional. On 6/24/03 the pt received an injection of Engerix B. "Early the next morning," on 6/25/03, the pt reportedly experienced a seizure and vomiting. The pt was taken to the local ER. The seizure and vomiting resolved. On 6/25/03, the pt also reportedly began to experience "multiple sclerosis symptoms" and "frequent" periods of nausea and fatigue. The pt was seen by a neurologist. As of 7/31/03, the "multiple sclerosis symptoms," fatigue, and nausea persisted. The pt's spouse considered all of the reported events to be probably related to Engerix B. He stated that the immunization schedule was discontinued; however, it was unclear if it was discontinued because of the events or because no further doses of vaccine were necessary. The reporter declined to provide additional information, and declined to grant authorization to manufacturer to contact the pt's neurologist. Therefore, no further info will be available. Seizure and "multiple sclerosis symptoms" are considered to be medically serious (OMIC).
Extremely dry mouth / unable to produce saliva for 6 days after vaccine. Lips chapped from dryness.
huge lump under the shot that came up on arm; feels like I have an abscess under there; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in 2021, as single dose for COVID-19 immunization. The patient stated that after receiving second dose of vaccine on 19Aug2021 she experienced huge lump under the shot that came up on arm and feels like she has an abscess under there. The reporter stated that her husband and she got their second dose of the Pfizer BioNTech covid vaccine yesterday on 18Aug2021 and she am having problems. When they got there, they were going to give her a dose of the Moderna, her husband witnessed it, so they went somewhere else and got the Pfizer dose. On next day she had a huge lump under the shot that came up on her arm and stated that it feels like she has an abscess under there. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Red facial rash/flush across nose and cheeks, lasted approximately 2 hours Insomnia
Patient reports that vaccine was not given in the deltoid muscle. However, I am sure I administered in her deltoid muscle. I went in on 90 degree angle (as supposed to for intramusclar shot) in the deltoid muscle.
Had first Pfizer vaccination on April 30 and second one on May 21,2021. First day after had  an episode of vertigo (eyes and head felt like it was rolling off). Never experienced this before. Was reclined in bed when this occurred. Lasted several minutes. Repeated a couple of times but has not happened since. About 2 weeks later, reported to doctor uncomfortable bloated feelings
Pt. had injection on 11-13-2011 and pain started 11-14-2011. Injection site felt a little hot but no real swelling. Pain radiating down into hand. Took Ibuprofen & NAPROSYN to rule out infection. Did not help. Dr. took X-ray came out normal. Pt told to make appt with hand surgeon. Was told he had infection in joint and got steroid shot. Also starting physical therapy for a few weeks.
Pain in the left arm from the fingers to the head. Chest pain and shortness of breath.
About 14 hours post vaccination I started feeling severe arm pain (I have high tolerance to pain and I would describe it 8 out of 10) for the first 12 hours.  I took some Tylenol and Advil and even Hydrocodone and it did nothing. It was really bad. It was hot to the touch, I have a huge band of redness on me it was worse than the first dose. I took some Benadryl to try to sleep through it.  I also have a swollen bulge under my arm (lymph node) and it lasted for about 6 days. The redness in my arm it is about 5 to 6 inches in diameter and it went away about 4- 5 days. It was a little itchy but no big deal. I also just remember I started with a fever the next morning after the pain started in the middle of the night 99.5F to 100.5 and it lasted for about 3 days.
Information has been received regarding a case in litigation for NUVARING (case #1402USA004226) from a physician concerning an approximately 24 year old female, gravida 1. In 2008, the patient was reported to have questionably received a pneumococcal vaccine (unspecified manufacturer) when she was pregnant. The patient subsequently had a spontaneous abortion. No further details of gestation at time of possible vaccination or at the time of the spontaneous abortion were provided. Upon internal review, spontaneous abortion was determined to be medically significant. Additional information is not expected.
First 15 days suicidal and depression. Spoke therapist . Also lots of joint pain and hard to move . Feels really stiff. Diarrhea all day since May 7th .
Approx. 15 minutes after receiving the vaccine the patient complained of feeling lightheaded, nausea, and dizziness.
pt recv vax 9NOV96 & 14 days later reported nausea, vomiting & diarrhea which left pt incapacitated;
tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 16Dec2020 14:00 (lot number: EH9899) at a single dose, then intramuscular at the left arm on 05Jan2021 16:00 (lot number: EK9231) at a single dose for COVID-19 immunization in the hospital. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medications included allopurinol and atorvastatin. The patient experienced left arm soreness and tachycardia with hr of 110-120 on 06Jan2021 16:30. No treatment was given in response to the events. The patient assessed the events as non-serious. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
Pt had nausea and dizziness approximately 12 hours after administration. Pt took her nausea medication.
Lost my sense of smell; Lost my sense of taste; This non-serious case was reported by a consumer and described the occurrence of loss of smell in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-APR-2023, the patient received the 1st dose of Shingrix. On 13-APR-2023, 4 hrs after receiving Shingrix, the patient experienced loss of smell (Verbatim: Lost my sense of smell) and taste loss (Verbatim: Lost my sense of taste). The outcome of the loss of smell and taste loss were not resolved.   It was unknown if the reporter considered the loss of smell and taste loss to be related to Shingrix.     It was unknown if the company considered the loss of smell and taste loss to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-APR-2023 The case was self reported by the patient. This case was submitted by public reporting reference via the online direct entry reporting system. The patient received first dose of Shingrix and stated that the patient lost sense of smell and taste (could not smell and taste) within 4 hours of administration.  The patient reported that symptoms were not treated. The reporter consenedt to follow up.
Covid symtpoms started 01/11/2022 and main symptoms were really runny nose and then a fever that got up to 100.9. I had a fever for 3 days and the runny nose lasted 5 days. I developed a cough and that started on the 3rd day and I was diagnosed. The cough was bad for a week and I've had chronic cough ever since. Tested positive on 01/11/2022 with a home test.
According to patient on 1/6/21 around 9:00 PM,, one week post 1st  dose Moderna injection, left arm injection site started to itch.  On the morning of 1/7/2021, patient noted site was red, warm and tender to touch.  Reported to RN and MD and observed  erythema approximately 1 " circle around injection site, warm to touch with slight swelling. Itching somewhat subsided.
No immediate side effects but the next day I began experiencing severe itching on palms and soles of feet in the middle of the night. Could not sleep - the itching was so severe I was taking a hair to scrub my feet. This continued for several days before I realized it started after receiving the vaccine. At that point I took Benadryl and the itching stopped. Before receiving the 2nd vaccine, I asked the doctor about this. But he dismissed as a common reaction and said just take Benadryl again.  This has now been ongoing for 7 months and counting. In the evenings or middle of the night, I experience severe itching on the palms of my hands and soles of feet.  I take Zyrtec and the itching stops - but this resurfaces every 2-3 days.  I have asked doctors about this during other routine visits (GP and Dermatologist) but none have any information or knowledge of this. I have only found 1 research study with similar symptoms.
102 FEVER WITHIN 4 HOURS OF RECEIVING VACCINES - SEEN AT EMERGENCY ROOM. ADDITIONAL TESTING DONE TO RULE OUT INFECTION.  TREATED WITH ANTIPYRETICS & RELEASED TO HOME.  FOLLOW UP WITH PCP IN 1 DAY.
Within 36 hours of the shot, I started having diarrhea and nausea and abdominal pain. The symptoms have progressively gotten worse over 2 1/2 weeks. They have not resolved since I?ve gotten the shot. I am still waiting to see my doctor.
pt began exp h/a, warmth & tenderness @ inj site about 1hr p/vax;h/a cont off & on next day;red, indurated area next day, very tender to touch (beginning about 1" below inj site & extending 2" down & 4" across);31OCT96 BP 115/70-76-T97;
Received PENTACEL, PREVNAR 13, ROTATEQ on 7/25/11 approx 230pm. Unrelenting vomiting began about 8pm. Refusing to feed and pallor and lethargy prompted ER visit. Was able to rehydrate p.o. there (failed home secondary refusal). Back to baseline by morning.
Received intranasal H1N1 on 10/31/09. Developed itchy rash over chest/abd, spread to face, arms, legs. Raised plaques on exam with erythema. Given BENADRYL, prednisolone.
Market area of erythema on left upper arm (7 1/2 x 8cm) warm, tender to touch. (Cellulitis).
Patient receive 5 vaccines on 3/12/13. 3 in right arm and 2 in left arm. On 3/14/13 patient present with 2 inch x 3.5 inch red, warm and swollen area on right arm. Patient treated with SINGULAIR 5mg x 21 days.
Positive for Covid post 2 weeks from last of Covid vaccine series. First Pfizer Vaccine 12/18/2020 IM Rt arm EH9899 @ 0730 Second Pfizer Vaccine 1/8/2021 IM Lt arm EL3246 @0730 3/14/2021 POC Antigen test Positive.  Followed with a PCR test at which confirmed Positive for Covid
Pt vaccinated w/Hep B vax (recomb); Subsequently following vax pt exp flu-like illness; No further details were provided;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 72.46.  No concomitant medications were reported.  On 17-Feb-2021, 5 vials were moved to clinic.  The vial was initially moved to the fridge on 11-Feb-2021 and proposed beyond use date was 10-Mar -2021. On the date of administration, at 08:00 A.M., the temperature recorded was 20 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 22 degree Fahrenheit has been reached by the vial. The vial was moved to clinic on 17-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment details were reported.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
ADMITTED 12-15-22 Hosp with shortness of breath.  HYPOXEMIA  met sepsis protocol.  Rocephin and azithromycin given, LATER VANCO AND ZOSYN..  ADMITTED TO ICU.   PMH OF PE.  + COVID 12-16-22.  GIVEN REMEDISIVIR, PO BARTICINIB AND STEROIDS.    COULDNT GET CTA DUE TO DESATTING  AND WAS GIVEN tx FOR SUSPECTED pe.      12-21-22  hr 150-190 AMIODARONE GIVEN DUE TO FAST HEART RATE, , GIVEN TOCILIZUMAB,  12-24-22  HAD A CODE BLUE : ASYSTOLE, PEA, V TACH AND DESPITE ACLS INTERVENTIONS , PASSED ON 12-24-22. DIAGNOSES INCLUDED:  COVID, RESP FAILURE, PNEUMONIA SEPSIS AFIB ELEVATED TROP I LEVEL ACUTE AND CHRONIC RESP FAILURE WITH HYPERCAPNIA
painful shots; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine (received on an known date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient had Shingles shot in the beginning of last year and those were some painful shots and with seriously tough side effects however, patient glad to have those. The patient mother and older sister both had Shingles in their 50s. The patient stated that compared to this shot, Covid vaccine was a breeze. The follow up would not be possible as no contact details were available. For tolerance to 2nd dose, refer case US2021AMR191192.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR191192:same reporter
A few days after getting my second dose, I started to develop a numb and sharp pain in my upper back . It started in the right but usually goes to the left side of my back too. It?s a pinching feeling too. When i wake up, there?s a painful pinch in my back.
I am an adult male, 59 years, very good health, lifetime athlete and workout routines, no ailments.  Nothing has changed in my routine, lifestyle, environment, bed, chair, etc. except for getting the vaccine.  2 days after the vaccine, I began to have nerve pain in my lower back.  The pain gradually built up to the point of complete debilitation.   I went from being able to run 5K to not being able to walk 100 yards.   I met with my doctor yesterday and he prescribed Prednisone 20 mg tabs which has helped significantly. It is important to note that I had a bout of shingles in September 2021.   I endured the pain which wasn't anywhere near this level of pain.   In addition, 800mg of Advil did nothing to stop the pain
Received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported. Treatment information was not provided.
Two infected teeth; 1st dose in Aug2021, 2nd not received; This case was reported by a nurse via call center representative and described the occurrence of tooth infection in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tooth infection and incomplete course of vaccination. On an unknown date, the outcome of the tooth infection was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the tooth infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's Comments: The reporter was wife of patient called stating her husband (patient) was at the dentist on the day of reporting and had two infected teeth and that they could had been infected for a month, but she did not know.  The reporter was stated that her husband was forgetful.  Nurse did not wish to provide any additional information, including her contact information.  The reason she called was asked if her husband could receive his 2nd dose of Shingrix tomorrow given his infected teeth. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Dizziness Immediately after receiving vaccine. Approx. 5 months later- Loss of consciousness causing a sprained left ankle and right knee, strained left shoulder.
UTI; respiratory distress; elevated BP; tachycardia; This is a spontaneous report from a contactable nurse received via Medical Information Team.  A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced urinary tract infection (UTI) (hospitalization) on an unspecified date; respiratory distress, elevated blood pressure (BP) and tachycardia, all on 15Jan2021.  The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 15Jan2021. The patient outcome of the events was unknown.  Information on the lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the respiratory distress, elevated blood pressure and tachycardia due to temporal relationship. Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event UTI, which may  likely represent intercurrent medical condition.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, EKG, arterial blood gas and physical examination, counteractive treatment measures and concomitant medications.   This case will be reassessed upon receipt of follow-up 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 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.
I experienced brain fog, dizziness, and severe muscle pain to the point my hands cramped up; my legs cramped badly. When I woke up the next day I was dizzy, still severe cramps, and needed a muscle relaxer and pain pill to rest.  The symptoms have slowly begun to improve as of 5 days later.  The dizziness has resolved, just minor muscle aches lingering. I did not have injection site pain. I had a phone consult with a nurse at the aforementioned clinic.