chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a fever of 100.1; I was not able to sleep last night; Body aches; I was throwing up; I had pain on the arm where they put the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).   A 49-year-old patient received bnt162b2 (BNT162B2), administration date 03Sep2021 (Lot number: FC3184, Expiration Date: 30Oct2021) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2021, outcome "unknown", described as "I had pain on the arm where they put the vaccine"; PYREXIA (non-serious) with onset 04Sep2021, outcome "unknown", described as "I have a fever of 100.1"; VOMITING (non-serious) with onset Sep2021, outcome "unknown", described as "I was throwing up"; INSOMNIA (non-serious) with onset 03Sep2021, outcome "unknown", described as "I was not able to sleep last night"; PAIN (non-serious) with onset Sep2021, outcome "unknown", described as "Body aches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter seriousness for all the events was Unspecified. NDC number and UPC number of COVID-19 Vaccine was unknown. Consumer stated, I am calling because I got the first dose of Pfizer vaccine yesterday around 05:30, 05:35, I was not able to sleep last night. I had pain on the arm where they put the vaccine and I have a fever of 100.1 today and I was throwing up and body aches. Consumer stated, this was my first shot, Yes and I was throwing up and I just want to know if that is normal. When informed about Pfizer Medical information Department, consumer stated, I will take the number. Consumer stated, I don't have email. Further probing could not be done as consumer was unwilling to complete the report. Thus limited information available over the call.  Follow-up attempts are completed. No further information is expected.
There wasn't adverse event, the patient was underage the approved age for the vaccine at that time.  The patient was 17 yo and 5 months when he received the Moderna vaccine.
eye feels irritated; squirted some of the VARIVAX in his eye.; Occupational exposure while preparing product for administration; This spontaneous report was received from a 49-year-old male physician reporting on himself.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. The physician reported that he had never had chicken pox, but he was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) in the past and received approximately 6 doses over the years because the results of his titers were always equivocal.   On 07-DEC-2022, while the physician was preparing a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, as prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); in combination with sterile diluent (strength, dose description, lot #, expiry date, route of administration, and indication were not provided), he inadvertently squirted some of the vaccine in his eye. He reported that his eye felt irritated (Eye irritation) and that after the exposure he immediately irrigated with an unspecified eye wash.   At the time of reporting, the patient had not recovered from the event of eye irritation and he did not receive any other medical treatment for his eye since it was flushed.   The causal relationship between the event of Eye irritation and varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent was not reported.
I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I was exposed Christmas I have been quaranting since 26Dec I have Pfizer vaccination completex2".  Clinical course: Patient stated that she need a home tester kit for Covid. She was exposed Christmas  she have been quaranting since 26Dec she had Pfizer vaccination complex but she had 3 children with her she need test asap.Her symptoms were mild but no tester was stressful due to onset exposure time and 10-14 days upon results were making her sicker. She was disabled fixed income and did not have money for kit.  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) : UM-PFIZER INC-PV202300036011 same patient/drug, different dose;
Cellulitis on (R) upper extremity - warm to touch - Ice packs to site - no antibiotic treatment treatment needed.
myalgia, arthralgia, headache, low grade fever that lasted for about 6 hrs.
Swelling and redness of arm in which vaccine was administered (right). Patient went to emergency room as precaution and received Cephalexin.
Prior to vaccination patient experienced dizziness and feeling "sick". Denies symptoms of active illness. Blood glucose level 280. Patient stated he would be more cautious and take his prescribed medications.
Developed rash all over body after receiving VARIVAX vaccine. Dermatologist stated eczema probably exacerbated condition.
71-year-old female with h/o COPD, CAD, HTN ,a.fib receved her 2nd dose of covid vaccine in may.  started with cough sob hence brought into ED. tested postive for covid
Pt recvd 3 doses of Engerix-B 4NOV90, 28NOV90, & 29APR91 & 6SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
Mild case of chickenpox with fever, URI symptoms , with 5 - 10 vesicles.
My arm is causing me a lot of pain./My left arm was hurting; Patient recived first vaccine on 28-Apr and second vaccine on 16-May; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is causing me a lot of pain./My left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recived first vaccine on 28-Apr and second vaccine on 16-May) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00K21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PAIN IN EXTREMITY (My arm is causing me a lot of pain./My left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recived first vaccine on 28-Apr and second vaccine on 16-May). On 16-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recived first vaccine on 28-Apr and second vaccine on 16-May) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm is causing me a lot of pain./My left arm was hurting) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number: 657617/0384U), on 20-SEP-2007 with the second dose (lot number: 658282/0929U) and 20-JAN-2008 with the third dose of Gardasil (lot number not provided). Concomitant therapy included VAQTA. It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day." It was also reported that this "also occurred after she had received her second dose of Gardasil, with her period only lasting a day." The patient's mother was reluctant and didn't schedule her for her third dose. The patient recovered. On an unspecified date the patient received her third dose. No further information is available. This is in follow up to report(s) previously submitted on 3/14/2008.  Informatino has been received from a physician concerning a 12 year old female who on 16-JUL-2007 was vaccinated with the first dose (lot number:  657617/0384U), on 20-SEP-2007 with the second dose:  lot number:  658282/0829U) and 20-JAN-2008 with the third dose of GARDASIL (lot number:  058563/1063U).  Concomitant therapy included VAQTA.  It was reported that the patient had "gotten her first period after receiving the vaccine, but it only had lasted for a day."  It was also reported that this "also occurred after she had received her second dose of GARDASIL, with her period only lasting a day."  The patient's mother was reluctant and didn't schedule her for her third dose.  The patient recovered.  On an unspecified date the patient received her third dose.  Follow-up information was received on 19-Mar-2008 the mom reports that child began first period after dose of 1 of GARDASIL for 1-2 days.  Then the second cycle for 1-2 days after 2nd dose of GARDASIL.  Mom held off for one month for dose 3 and child had third cycle at time that the third dose was to be received.  No further information is available.
Fever to 101 degrees, chills, headache, swelling, pain, warmth & redness to injection site in left arm.
Patient was administered with a dose that was expired.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 10th June 2022, the patient received Shingrix. On 10th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 60 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 3 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097903:Same Reporter US-GLAXOSMITHKLINE-US2022097905:Same Reporter US-GLAXOSMITHKLINE-US2022097908:Same Reporter US-GLAXOSMITHKLINE-US2022097898:Same Reporter
Information has been received from a physician concerning a 13 year old female who on 3/2/2006 was vaccinated with a dose of Varicella virus vaccine live (lot 647533/0638R). Several days later, on 3/18/2006, the patient was hospitalized. She had approximately 3 lesions on her neck. She had difficulty urinating and difficulty walking. Her legs were extremely weak. She had a tingling sensation in her legs and abdomen. The physician believed the patient had some form of myelitis. An MRI was done on the brain and spinal cord and was normal. The patient was discharged on 3/24/2006. The patient still had some weakness on her left side. It was reported that the patient recovered on 3/24/2006. No product quality complaint was involved. No other information was provided. Additional information has been requested.
This case was reported by a consumer and described the occurrence of paralysis in a 19 year old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subjects medical history included primary immune deficiency. Concurrent medications included antibiotics. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On an unspecified date in Nov 2005 the subject received a dose of Influenza virus vaccine. Approx nine hours later, on an unspecified date in Nov 2005, the subject experienced tiredness. During that night following receipt of influenza virus vaccine, the subject experienced muscle spasm at night, heart racing and a fluttering feeling in her muscles, such that she could not move. The subject went to the doctor the day after these events for IV immunoglobulin (for primary immune deficiency) not because of the reaction she had during the night. The doctor checked her out and she seemed fine. The events were considered disabling. At the time of reporting the events were resolved.
Extremely swollen and sore lymph node in left armpit. Began at 10:30 AM on May 5th - worsening throughout the day.
Day 1. No symptoms/Day 2.fast heart beat all day.foggy mind.sent message to physician/Day 3.fast heart beat all day.foggy mind.took 4 ibuprofen/Day 4.fast heart beat at random times throughout day.tiredness/Day 5.fast heart beat at random times throughout day.tiredness.recd message from physician with name of shot.recd 2nd message from physician about treating with tylenol, advil or could try benadryl.took half a benadryl, helped for a while. Took another half at bedtime and helped through night/Days 6-14,16,17.fast heart beat at random times throughout day.tiredness.took 4 ibuprofen 2 or 3 nights not consecutively and did not seem the help/Day 15.diarrhea.fast heart beat at random times throughout day.tiredness/Day 16-21 fast heart beat at random times throughout day.tiredness/Day 22(10/22/2021) fast heart beat at continuous throughout day.tiredness.took half of 25mg Benadryl.
I awoke yesterday with a red, swollen, warm, and itchy patch on the back of my arm, where the vaccine was administered, it was approx 1/1/2" x 1/1/8". Today, 10/24/09, It measure 1 3/4" x 1 1/4" and looks and feels the same, and it is very itchy.
the patient experienced confusion/ the patient would say things that did not make sense; the patient experienced excruciating pain; the patient received an MRl of the shoulder because of a lesion ( described as an unknown physician believes it is inflamed; This spontaneous report was received from a patient's wife referring to her 83-year-old male husband. The patient's pertinent medical history included blood urine present, two tumors on the kidney (renal neoplasm), nephrectomy, adrenalectomy, splenectomy and vena cava was reconstructed (venous operation) and the organs were flushed. His concomitant medications and previous drug reactions were not provided.  On 02-MAR-2020 the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in his left arm as prophylaxis (concentration, number of dose administered, route of administration, lot number and expiration date were not reported). On the same date, 3 hours after the patient was received the vaccine he experienced excruciating pain (pain in extremity).   On 10-MAR-2020, the patient received pembrolizumab (KEYTRUDA) with (INLYTA) (for both therapies, strength, dose, frequency, route of administration, lot number and expiration date were not provided) for renal cell carcinoma. On 19-MAR-2020, the patient experienced confusion (also reported as he said things that did not make any sense) (confusional state). On an unspecified date in 2020, the patient received magnetic resonance imaging (MRI)  of the shoulder because of a unspecified lesion, the wife stated that, the physician believed that the shoulder was inflamed (arthritis). On 23-MAR-2020, the patient started daily treatment of prednisone for the inflamed shoulder. The patient sought medical attention.  The outcome of pain in extremity was reported as not recovered because she still had pain in his left arm., however the outcome of confusional state and arthritis was not reported.  The causality assessment between pembrolizumab (KEYTRUDA) and the events arthritis and confusional state was not reported and for the event pain in extremity was not related. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with the aforementioned events was not reported.  This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2003USA009835:
Patient was mistakenly given high dose flu vaccine instead of regular flu vaccine. State vaccine program was phoned and they contacted CDC. No treatment was needed. Patient was notified.
Pifzer monovalent covid vaccine was given instead of bivalent Pfizer covid vaccine.
Swollen and redness in the left arm at and below the injection site. Swelling and redness in the forearm also. This is the same side as when I had shingles in October. I have been taking Benadryl at night. I had the flu shot and my first Moderna shot on Dec. 12, 2021. I was part of the Novavax trial and received injections in February and March. I dropped out of the trial because I work for company and the Novavax is not recognized by the CDC as a valid vaccination so I got two doses of Moderna.
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EN6200 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 16Feb2021 at 14:45 (Age at vaccination was 74 years) as dose 2, single for covid-19 immunization. Medical history included knee arthroplasty on an unknown date. The patient was allergic to IV iodine. There were no concomitant medications. The patient did not have COVID-19 prior to vaccination. The patient did not take other vaccine within four weeks and other medication within two weeks. The patient also took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL8982 and expiration date was not reported) via an unspecified route of administration, administered in right arm on 26Jan2021 at 14:45 (Age at vaccination was 74 years) as dose 1, single for covid-19 immunization. On 16Feb2021 at 20:00 the patient experienced terrible joint pain and patient stated that 6 hours after 2nd vaccination I could hardly walk as knees giving way. The patient did not tested COVID post vaccination. Adverse event resulted in doctor or other healthcare professional office. Physical therapy was taken as therapeutic measures for the events. The outcome of both the events was recovering.  No follow-up attempts are possible. No further information is expected.
Patient was spoken to via a telephone appointment and reports that she had diarrhea that same day of her vaccine and reports fatigue and new onset SOB at rest x 1 day.  She is also c/o head tightness, back pain and BLE pain even at rest since she received her vaccine.  She denies swelling to injection site, fever, hives, n/v, diarrhea, abdominal pain
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 54 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 12-FEB-2014, the patient was vaccinated with MMR II (Lot number reported as J008882; expiry date, dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 and 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
9/2/2015, red and swollen arm, chills, cough, difficulty breathing, fever, sore throat, tarry stools, fast heartbeat. Body aches in chest area (left).
A few minutes after vaccination patient was dizzy, lightheaded, pale, and was sweating. 10 minutes into symptoms the patient had leg and abdominal cramps and was having difficulty with hand dexterity and making a fist by closing his hand. 20 minutes after onset, symptoms started to lessen and patient no longer felt on the brink of passing out. Patient continued to have cramps and discomfort and was in no way able to stand. 40 minutes after onset patient decided food might help and was able to eat a sandwich. Patient didn't leave for a full hour after vaccination
exposure to freezing temperatures; This case was reported by a pharmacist and described the occurrence of incorrect storage of drug in a 64-year-old male patient who received HBV (Engerix B) (batch number LR537, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number KN5VR, expiry date 16th April 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received Engerix B, Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The reporter called due to their discovery that patient was inadvertently administered the vaccines that were in the temperature excursion, which led to incorrect storage of drug. This patient was administered Boostrix and Engerix on the same day. The Medical Information agent informed pharmacist the vaccines should be discarded due to exposure to freezing temperatures 31.5 Fahrenheit for 13 hours. The reporter did not consent to follow up. This is 1 of 7 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021198147:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198144:same reporter US-GLAXOSMITHKLINE-US2021198142:same reporter US-GLAXOSMITHKLINE-US2021198139:same reporter US-GLAXOSMITHKLINE-US2021198149:same reporter
massive headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (massive headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (massive headache). At the time of the report, HEADACHE (massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-386528, MOD-2021-386972 (Patient Link).