chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 26-JAN-2017, the patient was vaccinated with GARDASIL (lot #: K005881 with expiration date: 14-JAN-2017) (dose, dosage schedule and anatomical location were not reported) intramuscularly, for prophylaxis. The administered vaccine was expired. No adverse effects were reported. This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014428.
Patient reports pain originating posterior left leg behind knee (same side of TKA) with onset about 2 to 3 days after flu shot, worsening despite conservative therapy, seems to be traveling up posterior leg. Patient has trouble ambulating due to pain. No known history of guillain-barre or other side effects to vaccinations. Reports having x-rays performed by ortho (date = unknown) with normal joint and skeletal imaging. Patient denies any injuries around the time of the flu shot that may have contributed to ongoing pain.
Pfizer x 2. Tested positive for COVID 02/08/2022. Admitted to Hospital on 02/20/2022. Expired on 03/08/2022 while still hospitalized.
Physician ordered: Prevnar 13, Pedvax Hib, DTaP.  Child received: Prevnar 13,  Pedvax Hib,  Pentacel (DTaP-IPV-ActHib)
t103 by mouth @ 8PM APAP given; noticed fine rash next AM; 1230PM 9MAY95 to MD t101-rash; by 7PM rash more pronounced, eyes swollen (rash all over body); mom returned to urgent care; itchy rash-DPH MD said rash could be from fever or vax;
Severe headache, palpitations, chills, fever, body aches. Symptoms started on 10/15/2018. Rash started on 10/18/2018.
Pt test positive for COVID on 10/27/2021.  90 year old female with PMHx of afib, HTN, arthritis presented to ED complaining of one week duration of worsening cough with SOB, rhinorrhea.  Admission dx hypoxia, dyspnea, pneumonia due to COVID. D-dimer 510-499.  Treatment:  oxygen, decadron, Remdesivir held due to Bradycardia.  Discharged to home.
I felt a little tightness in my throat after waiting the 15 minutes after getting the vaccine. I went back home and used my inhaler without any relief. I called my doctor and they told me to go to the hospital. I went to the hospital, they gave me steroids and Benadryl. I was discharged the same day. My throat felt better two days after receiving the vaccine.
fever; body chills; bad headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "body chills"; HEADACHE (non-serious), outcome "unknown", described as "bad headache". Additional information: The reporter stated that she did work for Pfizer from 2001-2014. Caller states that Hopefully she had now experienced all the symptoms of all the shots and next time she won't have them.  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-202201193681 same patient, different dose/event;
We were at the store on Nov 8th and I got out there and I kept sneezing which was very odd. Next day I woke up well rested, but I felt like I had a cold just generally miserable that was Nov 9th. This night which was the 9th and 10th I had a horrible tome sleeping which consistence of difficulty's breathing and nonstop coughing. By November 10 friends of ours gave us COVID-19 test and it was positive. That same day I called my doctor and she said because I'm over 65 with asthma she prescribed me PAXLOVID on the 11th. I took the medication as she instructed, and it started working right away. The doctor said it would take five days. The first night I was able to sleep in my bed but the only issue that I am still having fatigue. I thought it was the rebound COVID-19 but its lingering fatigue.
11/7/13 - had FLUZONE high dose at 1pm. Came back in PM c/o soreness, nerve pain and difficulty raising arm. States has history of nerve pain in left arm. Instructed by MD to put ice on site.
Pt received Pfizer dose #1 on 03/10/2021. Pt returned for 2nd dose on 03/31/2021 and received Moderna in error
Information has been received from a physician concerning a 4 year old white male with no known drug allergies (NKDA) who on 22 January 2002, was vaccinated in the left arm with the first dose of varicella virus vaccine live (Oka/Merck) ( Lot #63127/1237L). Concomitant vaccinations administered on that same day included the fourth dose in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (P484-139). There was no other concomitant medications. The physician reported that in January 2006, the patient developed a mild chickenpox rash. No laboratory or diagnostic tests were performed as medical attention was not sought. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
22JAN94 started w/red, watery eyes & runny nose; 23JAN94 fever 101 all day, no appetite; 24JAN94 devel red rash 1st over abdo thin over entire body, eyes sensitive to light;
Pain in injection site started after a couple of hours, then I had body aches, muscle pain, chills, stomachs ache and fatigue and general malaise, lasting two days, either redness and bumpiness around the injection site. Then it became very itchy by the second day afterward and then I started getting a bumpy, itchy rash on the opposite arm.
Myalgia LABORED BREATH Narrative: EMPLOYEE USES NEBULIZER TREATMENT AT HOME AND WANTED TO LEAVE TO USE IT. INSTRUCTED TO MAKE SUPERVISOR AWARE OF LEAVE USAGE AND TOLD THAT IS BREATHING WORSENS TO CALL 911. EMPL. VOICED HIS UNDERSTANDING.
This case was reported by a healthcare professional and described the occurrence of dizziness in a 12-year-old female subject who was vaccinated with CERVARIX, (GlaxoSmithKline), (non-gsk) GARDASIL. On 20 November 2010 the subject received 1st dose of CERVARIX (0.5 ml, unknown, unknown arm) and 1st dose of GARDASIL (unknown). On 20 November 2010, less than one day after vaccination with CERVARIX and GARDASIL, the subject experienced dizziness and unintentional overdose. The subject accidentally received CERVARIX and GARDASIL at the same time instead of CERVARIX and MENACTRA. She felt dizzy for 15 minutes but was fine after that. At the time of reporting the dizziness was resolved.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patient experienced medication error.
autoimmune disorder, is nerve related; This case was reported by a consumer via interactive digital media and described the occurrence of autoimmune disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced autoimmune disorder (serious criteria GSK medically significant). On an unknown date, the outcome of the autoimmune disorder was not recovered/not resolved.   The reporter considered the autoimmune disorder to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 01-MAR-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The reporter reported that good luck to anyone who gets the Shingles shots. The patient now had nerve related autoimmune disorder from shingles vaccinations. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Patient called two days after flu shot complaining that her arm was sore. RPh told her to take Ibuprofen and ice area. Ptn went to Dr. later that day - Dr gave Rx for antibiotic and pain medication and told ptn she had a hematoma at injection site.
Received vaccine 6/4/16. On 6/5/16 noted redness, which increased by 6/6/16 14 x 7 cm. Treated with AUGMENTIN 875 1 po BID. ALLEGRA 180 mg 1 po daily. Cellulitis/Medicine Review.
COVID19 vaccine given beyond use date.  There were no side effects or symptoms.  There was no treatment given.
raging headache; brain fog; terribly fatigued; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 14:30 (Lot number: EN6208) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Reynaud's syndrome" (unspecified if ongoing); "hx of DVT" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1; lot number ER8733;vaccine location: Left arm; administration time=02:30 PM), administration date: 11Mar2021, when the patient was 44 years old, for Covid-19 immunisation, reaction(s): "nauseous". The following information was reported: HEADACHE (non-serious) with onset 04Apr2021, outcome "recovered" (Apr2021), described as "raging headache"; FEELING ABNORMAL (non-serious) with onset 04Apr2021, outcome "recovered" (Apr2021), described as "brain fog"; FATIGUE (non-serious) with onset 04Apr2021, outcome "recovered" (Apr2021), described as "terribly fatigued". Therapeutic measures were not taken as a result of headache, feeling abnormal, fatigue. Additional information: After 2nd vaccination developed a raging headache, brain fog and was terribly fatigued on the 3rd day after shot, with increasing fatigue, brain fog and headache on the 4th day after shot. It took another 2 days for patient to feel 100% better again.No covid prior vaccination. No covid tested post vaccination. No known allergies.No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021488734 same patient/drug, diff dose/event
Pregnant patient received the first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 17-Aug-2021. On 24-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 24-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Feeling dizzy; Heart racing; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy), PALPITATIONS (Heart racing) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DIZZINESS (Feeling dizzy), PALPITATIONS (Heart racing) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Feeling dizzy), PALPITATIONS (Heart racing) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Patient received the Pfizer vaccine on 4/4 then the moderna vaccine on 5/2
Patient fainted while sitting in his chair briefly. Patient was with his grandmother and she alerted pharmacy personnel. Patient reported feeling nauseated and tingling in his arms and hands. The pharmacy called 911 and patient was assessed and allowed to go home about 45 minutes later.
Narrative: 91 yo patient died on 6/1/2021. Pt had received covid vaccines on 1/3/2021 & 2/10/2021. No information available on circumstances of pt's death. Likely not related to the vaccinations given pt's age and long time frame between date of death & vaccination dates,
Resident received first dose of COVID vaccine on 2/1/21. Son decided to hold off on 2nd dose as the resident previously had COVID in December 2020. Resident then received second dose on 6/25/21 and a third/booster dose on 7/16/21. The third dose was administered prior to the recommended interval. No adverse effects noted to resident.
At 4 AM the following day I woke up with a severe headache and fever. I attempted to take 2 extra strength Tylenol which seemed to trigger cyclic  vomiting every 15-20 minutes for approximately 4 hours. After this, I vomited  once an hour for another 4 hours. I was finally able to sip water and sleep after this. I also took my first temperature once feeling better and it was 99.9F. My normal temp is in the 97s and I?m sure it was much higher during the vomiting.  My fever broke approximately 12 hours after the first symptoms. Headache lasted approximately 36 hours and resolved the next day, although a milder one did come back off and on for a couple more days.  I did not have much pain in the arm I received the injection in.
Patient received vaccine on 9/25/22 and on 10/31/22 still having arm pain. Patient states gradually getting better.
Patient called around 3:30 p.m. to report her side effects. All side effects were within expected range, except she also said it "may be difficult to breathe."   This started a couple of hours ago. Other expected side effects included: headache, body aches, chills, fever, and sore arm.  She said she took some Advil for her headache, which helped. She was reminded that all other reported side effects were to be expected and may last for up to a few days. She was told she may continue to take the oral pain reliever and use a cold compress for local side effects, but she was advised to seek medical attention if she is having difficulty breathing.
Fever, runny nose, chills and COLD SORE.duration.... 4 days
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Arm had swelling around inejection site, area was hard, patient states her doctor may want to perform a sonogram on area
Low grade temperature (99.1 degree F); Tiredness; This is a spontaneous report from a contactable healthcare professional (patient himself). A 26-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 15:45 at single dose for covid-19 immunization. The patient was vaccinated in the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 14:15, the patient experienced low grade temperature (99.1 degree F) and tiredness. No treatment was received for the adverse events. The outcome of the events was recovered on 22Jan2021 (time unknown). The case has been considered non-serious.
Woke up sweating; Nauseous which worsened; Abdominal discomfort which worsened; abdominal pain which was more of the liver area; Left Arm Discomfort; Sore arm; Insomnia; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 08Mar2021 15:50 (Lot number: EN6198) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Diphtheria tetanus vaccine, administration date: 2015, when the patient was 56 years old, for immunisation, reaction(s): "sore arm"; Polio vaccine, administration date: 2015, when the patient was 56 years old, for immunisation, reaction(s): "sore arm". The following information was reported: LIMB DISCOMFORT (non-serious) with onset 08Mar2021 19:00, outcome "recovered" (10Mar2021), described as "Left Arm Discomfort"; PAIN IN EXTREMITY (non-serious) with onset 08Mar2021 19:00, outcome "recovered" (10Mar2021), described as "Sore arm"; ABDOMINAL DISCOMFORT (non-serious) with onset 10Mar2021, outcome "not recovered", described as "Abdominal discomfort which worsened"; PERIHEPATIC DISCOMFORT (non-serious) with onset 10Mar2021, outcome "not recovered", described as "abdominal pain which was more of the liver area"; NAUSEA (non-serious) with onset 21Mar2021, outcome "not recovered", described as "Nauseous which worsened"; HYPERHIDROSIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "Woke up sweating"; INSOMNIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Insomnia". The events "abdominal discomfort which worsened" and "abdominal pain which was more of the liver area" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb discomfort, pain in extremity, abdominal discomfort, perihepatic discomfort, nausea, hyperhidrosis, insomnia. Additional information: Clinical course: The patient went to see her gynecologist on 22Mar2021 because she thought, the abdominal discomfort/abdominal pain may be caused by a yeast infection. The patient was tested for UTI and infection but came out normal (has no results from that). The gynecologist thought that the area where the patient was having pain was more of the liver area. The patient also woke up sweating in the morning. Also had intermittent nausea. Insomnia (slept five hours last night and the night before that, only two hours). The patient used Monistat as treatment for abdominal discomfort/ abdominal pain because she thought it was due to a yeast infection (but doctor said there was no evidence of it existing anymore). Ibuprofen, paracetamol (TYLENOL) with codeine were used as treatment for the rest of the events.  No follow-up attempts are possible. No further information is expected.
I have been diagnosed with Graves' Disease. My symptoms were increased heartrate, sweating, and fatigue. I was prescribed 2 medications atenolol, and methimazole. I am feeling better with medication at this time, but still deal with some of the symptoms.
tingling front of tongue and lips; Numbness front of tongue and lips; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling front of tongue and lips) and HYPOAESTHESIA ORAL (Numbness front of tongue and lips) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Asthma (allergy induced Asthma).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling front of tongue and lips) and HYPOAESTHESIA ORAL (Numbness front of tongue and lips). On 05-Mar-2021, PARAESTHESIA ORAL (tingling front of tongue and lips) and HYPOAESTHESIA ORAL (Numbness front of tongue and lips) had resolved.            Patient reported that she takes allergy shots for pollen allergy.  No treatment information was provided.
patient and his wife took first dose of Pfizer Covid vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19  infection/COVID-19 test positive; patient and his wife took first dose of Pfizer Covid vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19  infection/COVID-19 test positive; This is a spontaneous report from a contactable consumer received from a Pfizer-sponsored program. A 79-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient and his wife took first dose of Pfizer COVID vaccine on 12Mar2021 and 2 weeks later both of them contracted COVID-19 infection/ COVID-19 test positive on an unspecified date in Mar2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
died from clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: THROMBOSIS (death, medically significant), outcome "fatal", described as "died from clots". The patient date of death was unknown. Reported cause of death: "died from clots". It was not reported if an autopsy was performed.  Clinical course: The reporter had 3 clients died from clotting (also reported as died from clots).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112854 same reporter, drug and event, different patient;US-PFIZER INC-202300112855 same reporter, drug and event, different patient;; Reported Cause(s) of Death: died from clots
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 29-AUG-2016, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # M011116, expiration date: 17-JUN-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 1.8 degree Celsius for 7 minutes, 1.9 degree Celsius for 7 minutes and 1.0 degree Celsius for 35 minutes, respectively. The temperature excursion was captured using digital data logger. No prior excursions were reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.