chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever(102F); Headache; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).   A 14-year-old male patient received bnt162b2 (BNT162B2), on an unknown date as dose 3 (booster), single (Lot number: unknown) at the age of 14 years for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: Unknown), for COVID-19 immunisation.  The following information was reported: PYREXIA (non-serious) with onset 25Apr2022, outcome "recovering", described as "Fever(102F)"; HEADACHE (non-serious) with onset 25Apr2022, outcome "recovering". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia and headache.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received TYLENOL as the treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from a registered nurse concerning her 12 year old son with no pertinent medical history, drug reactions or allergies who in September or October 2010, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot number not reported) and on 21-OCT-2011 was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that her son received the first dose of the vaccine without incident. The patient received the second dose of the vaccine from his pediatrician on 21-OCT-2011, and within 3 minutes of receiving the vaccine he grabbed his head and passed out. The registered nurse stated that her son began to fall, he hit his head on the wall and then had seizures. The seizures lasted about 15 seconds. The registered nurse reported that 911 was called, while still in the pediatricians office and while waiting for 911 to arrive they monitored her son's vital signs and he was hypotensive. They also monitored his blood sugar (result not reported) and oxygen was applied. The Registered nurse reported that 911 staff arrived and transported her son to the emergency room, while in the ER they inserted a hep-lock, provided fluids by mouth and observed her son. The registered nurse reported that the ER physician recommended an EEG but her husband who was a neurologist spoke to the physician in the ER and the EEG was not done. The registered nurse reported that several hours later her son was discharged home directly from the ER and he was not admitted to the hospital. Subsequently on 21-OCT-2011, the patient recovered from the events. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Low fever, fussy.  11/9/2013 - very fussy, higher fever, not eating, sleeping poorly, exhausted, cough, rash on chest and back.  11/10/2013 - lower fever, slightly less fussy, better sleeping but exhausted, rash worse.  11/11/2013 - rash spread to head, slept better, still coughing, no fever.
patient has trouble swallowing; Problem with her voice box/Her voice is very high; got sick to her stomach; fever of 100 degrees Farenheight; This spontaneous case was reported by a patient and describes the occurrence of DYSPHAGIA (patient has trouble swallowing), DYSPHONIA (Problem with her voice box/Her voice is very high), ABDOMINAL DISCOMFORT (got sick to her stomach) and PYREXIA (fever of 100 degrees Farenheight) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced DYSPHONIA (Problem with her voice box/Her voice is very high). On an unknown date, the patient experienced DYSPHAGIA (patient has trouble swallowing), ABDOMINAL DISCOMFORT (got sick to her stomach) and PYREXIA (fever of 100 degrees Farenheight). At the time of the report, DYSPHAGIA (patient has trouble swallowing) and DYSPHONIA (Problem with her voice box/Her voice is very high) outcome was unknown and ABDOMINAL DISCOMFORT (got sick to her stomach) and PYREXIA (fever of 100 degrees Farenheight) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 degrees Farenheight.         Concomitant medication of the patient was not reported.  The patient received the vaccine in her left arm shoulder deltoid muscle. The patient did not remember the date or month of administration, but she did remember that she received the Moderna COVID-19 vaccines in 2021.  Due to stomach sickness and fever, the patient drank water and stayed hydrated, and she got better. The patient did not visit a physician due to her voice problems. The patient reported that she first noticed the problem with her voice box after she went to a movie in December 2021 and laughed really hard at the movie.  The patient reported that her ex-husband also received the Moderna COVID-19 vaccine and reported no side effects and adverse events.  Treatment information for the events swallowing difficult and voice disturbance were not provided by the reporter.   This case was linked to MOD-2022-578403 (Patient Link).
Pt is very small, mother of the patient requested smaller dose of vaccine. Pt got 0.2ml vaccine
Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 062e21a) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).
pt recvd vax at 1:30pm;by 5:30pm was having shortness of breath,hard productive cough & heart was beating fast;sxs got worse & to hosp;testing revealed no trouble w/ heart;dph given & sxs subsided;
c/o intense pain 3 days after 2nd dose of Moderna on Lt arm. Pat discovered 2 masses, one at left axilla, and the other on left upper arm.  Will fu with oncologist in July, 2021.  Pat reported size of masses about size of a quarter, tender.   Told to observe, pat noticed decrease in swelling! nil reaction after 1st dose of Moderna.
Information has been received from a registered nurse concerning a 60 year old female with asthma who on Oct 8, 2002 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot# not reported). Four hours after vaccination the patient developed severe pain in her right upper arm. The pain started to abate six days after administration. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Lightheaded, fever (reached 102 degrees before taking Tylenol), extremely thirsty, fatigue, body aches. Very similar to the flu.
Patient received the Moderna COVID-19 vaccine for vaccination #1 and received the Pfizer COVID-19 vaccine in error for vaccination #2
Patient did not have an adverse event, just reporting due to giving the vaccine IM instead of subcutaneously. RN called the CDC after this occurred and per their recommendations, no dose needs to be repeated since it is a live vaccine and will replicate anyways. Patient was given this 3rd dose varicella due to not having immunity after 2 doses.
This spontaneous report as received from a physician via a company representative refers to a 26 year old female patient with no pertinent medical history. Physician reported that the patient was administered on an unknown date in 2011 with the first dose of GARDASIL (dose, route, lot number and expiration date not reported). Then the patient was administered with a second dose of GARDASIL (dose, route, lot number and expiration date were not reported) on an unspecified date. Later the patient was administered with a third dose of GARDASIL (dose, route, lot number and expiration date were not reported) in April 2012. The physician reported that the patient experienced constipation on an unspecified date after the first dose of GARDASIL and seizures, headaches, nausea, fatigue and autoimmune issues on an unspecified dates after the administration of unspecified doses in the GARDASIL series. The patient present status was reported as not recovered. The patient considered the events as disabling. Upon internal review the seizures were considered to be medically significant. Additional information has been requested.
cold; Runny nose; sore throat; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NASOPHARYNGITIS (cold), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm). At the time of the report, NASOPHARYNGITIS (cold), RHINORRHOEA (Runny nose), OROPHARYNGEAL PAIN (sore throat) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that he has never had a cold in the winter before.No concomitant medications were reported.No treatment information was provided.
Diarrhea; This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unknown.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional stated the that patient experienced diarrhea after first dose of Shingrix.  The patient was not able to leave the house.
This case was reported by a physician and described the occurrence of rash in an 8 week old pt who received DTAP (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the pt received Infanrix. At an unknown time post-immunization, the pt experienced a "big" rash on a leg, "severe" lethargy and a fever of 101 to 102 degrees Fahrenheit. The pt was seen by the physician on 05/23/03. The physician prescribed cold compress, paracetamol and applications of ice. The outcomes of the events were unknown. The reporting physician considered the events were probably related to vaccination with Infanrix Lot # DTPA574A2.
Patient received the vaccine around 11:05 AM. He stayed seated for about 5 minutes and then proceeded to stand up with his mother to pick up a prescription at the counter after receiving the vaccine. Around 11:13 AM, the patient fell  on his back near the pharmacy, and made impact on his head. Paramedics shopping at the store arrived within 2 minutes. The patient was in and out of consciousness, opening and closing his mouth and overall appearing confused. Cold water was poured over his head and vitals were taken. The child began to regain consciousness and was disoriented, asking "is this real? what happened?" Upon stabilization over the course of the next 10 minutes, the child was put on oxygen and still appeared confused prior to transportation to another healthcare facility for further evaluation.
Onset of red raised rash 1730, on 10/14/2016. On Monday patient had 10X17cm red raised rash with visible blistering on chest, left upper arm and bilateral arm bends. Patients took Benadryl with no relief. Pt was seen at ER following night for increased size in rash. Pt then saw dermatology the following Wednesday where a biopsy was completed showing chemical reaction dermatitis.
Td given 6/28/05. 6/29/05 Employee called with flu-like symptoms, no energy, feels terrible, aching all over into legs. 7/5/05 Employee reports rash on both arms and legs. Seen by local doctor.
24 hours after 2nd dose of shingles shot. All my muscles & joints had sharp pain. 48 hours still very painful. Knee replacement is most painful, unable to bend knee. 72 hrs still swollen knees & Leg pain
Brain Fog, Dreamlike State, Memory Loss, Very Dizzy/Vertigo for about 5 minutes 2 times, in addition to typical reactions of low grade fever, fatigue, nausea, lack of appetite , nasal congestion. No Treatment except rest and Ibuprofen and Benadryl (1/2 tablet) 3/30 evening. Resolved in 4 days, lessening each day.
Groggy & temperature of 103.2.  Had given Advil an hour earlier for pain.  Called pediatrician and they said to take him to the ER.  Temperature was 103.5 when we got there.  His heart rate jumped up to over 220.
Pfizer vaccines on 4/8/21, 4/29/21 COVID positive by PCR on 1/5/22. admit to hospital 1/5/22 d/t SOB, weakness; diagnosis of acute COVID-19 pneumonia, PE
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Aug2021 as dose 1, single (Lot number: EW0167) and on 04Sep2021 as dose 2, single (Lot number: FC3182) at the age of 36 years for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19. Outcome of the events was unknown.
I received the Pfizer shot in my left arm. The arm was sore at the shot location for 3 days...On the fourth day around 1:30 in the morning I woke up in a cold sweat and I felt my heart racing and also  uneven heart beat. My blood pressure was up to 150/100. Over the next 20 hours this condition subsided and finally went away completely after 20 hours or so.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 at 17:30 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 09May2022 at 10:30 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Lot number: 025J20-2A), in left arm and on 04Feb2021 as dose 2, single (Lot number: 042L20A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Type 2 DM" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.
pt presented with shortness of breath 11 days later, found to have hbg of 6.0 with abnormal RBC morphology sent for transfusion, + direct Ab to her blood type (A+) hbg rose to 9.9 one week later, then eventually to 12
it was very painful; slept about 3 hours; 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.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain and sleep excessive. On an unknown date, the outcome of the pain and sleep excessive were unknown.   It was unknown if the reporter considered the pain and sleep excessive to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had a Shingle shot this week and the patient thought it hit a bone as it was very painful.  The patient came home and slept about 3 hours. Additional Supportive Information: Follow-up would not possible as no contact details were available.
28APR97 dx erythema mult rash;22APR97 some erythema @ inj site;no induration;redness extends 1 inch in circumference;no rashes noted anywhere also on body;MD notified;
Joint Pain/right elbow consistent pain/pain in left elbow and both knees/pain in right knee; tennis elbow; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the right arm, on 05Jan2021 09:30 (Bath/lot number: EL0140), at age 53 years old, as dose 1, single, for COVID-19 immunisation, at a hospital. The patient was not pregnant at the time of vaccination. Relevant medical history included sinus issues from an unknown date, not reported if ongoing or not, and ongoing menopause from an unknown date. The patient has no known allergies. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. There were no concomitant medications in two weeks. The patient did not receive any other vaccines in four weeks. On 06Jan2021, the patient experienced joint pain. It started out primarily with consistent pain in right elbow, and some pain in left elbow and both knees. Then the patient had right elbow pain which has not gone away and consistent pain in right knee. The event resulted to physician's office visit. The patient was told that it could be tennis elbow or menopause symptoms. The patient received unspecified treatment for the events. The patient then received the second dose of PFIZER-BIONTECH COVID-19 VACCINE on 27Jan2021 (Batch/lot number: EL3248), administered in the right arm. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
rt arm erythema & pain @ site of inject 3cm of intense erythema w/orange peel character surrounded by 10x 5 cm light erythema-diffusely tender; initial nausea, fever/chills which improved prior to visit; ? arthus rxn;
Dose was diluted incorrectly with 2.0mL of diluent instead of 1.8mL
I administered the vaccine and the patient left the booth to sit in the waiting area.  About a minute later, someone called that he had passed out.  I found him in the chair, and his mother was holding him and trying to wake him up.  He woke up briefly but then passed out again.  She again tried to wake him up but he was still only semi-conscious.  We took his blood pressure and it and his pulse were very low.  He kept saying that he felt like he was going to pass out again.  A few minutes later we took his BP again and it was still low.  His mother and I at that point decided to call for an ambulance.  By the time they arrived, the patient was feeling better and his blood pressure had gone up slightly, so he decided not to go to the hospital.
Tues PM 8/18/09 left arm red swollen with heat and "rash" at injection site with itching at site of injection.  Mom denies other symptoms and symptoms improved with BENADRYL.
Information has been received from a physician concerning a female who "a week ago" on approximately 12-OCT-2009 was vaccinated with a dose of PNEUMOVAX 23 at the hospital. Concomitant therapy included influenza virus vaccine (unspecified) in the other arm. The patient had a big knot in the shoulder that was red, swollen and a lot of pain in the arm which PNEUMOVAX 23 was given (which arm was unknown). The patient visited office for medical attention. At the time of the report, the patient was recovering. Follow up information has been received from a 33 year old female patient with seasonal allergies and asthma, who on 16-OCT-2009 (previously reported as 14-OCT-2009) at 10:15 am was vaccinated with a first dose of PNEUMOVAX 23 (lot # 662785/1124X) in the left upper arm. There was no illness at the time of vaccination. On 16-OCT-2009, in the PM, the patient had extreme left arm pain at site, left arm swelling at site approximately the diameter of a softball with raised areas that looked like "Vienna sausages". The patient was unable to move her arm for 3 days. The patient had fever of 102F that decreased in 2 to 3 days. She had joint ache, hips were the worst area. There were no labs and diagnostic tests performed. The patient did not seek medical attention. At the time of the report, the patient recovered. It was noted that the symptoms had gone by 6 days. No further information is available.
He also contracted COVID-19 in JUL2023. Asymptomatic; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (He also contracted COVID-19 in JUL2023. Asymptomatic) in a 24-month-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   In November 2022, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2022, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In July 2023, the patient experienced COVID-19 (He also contracted COVID-19 in JUL2023. Asymptomatic). At the time of the report, COVID-19 (He also contracted COVID-19 in JUL2023. Asymptomatic) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Patient did not took any medications or treatments.   This case was linked to US-MODERNATX, INC.-MOD-2023-737999 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737999:1 Year old Child case