chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body feels like a oven.; Sick like is dying; Bad coughing; Really bad body aches; A fever of 102F° or 103F°; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Body feels like a oven.), ILLNESS (Sick like is dying), COUGH (Bad coughing), MYALGIA (Really bad body aches) and PYREXIA (A fever of 102F° or 103F°) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a and 037f21a) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced FEELING HOT (Body feels like a oven.), ILLNESS (Sick like is dying), COUGH (Bad coughing), MYALGIA (Really bad body aches) and PYREXIA (A fever of 102F° or 103F°). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING HOT (Body feels like a oven.), ILLNESS (Sick like is dying), COUGH (Bad coughing), MYALGIA (Really bad body aches) and PYREXIA (A fever of 102F° or 103F°) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Oct-2021, Body temperature: 102  or 103 (High) 102F° or 103F.         No concomitant information were reported by the reporter   This case was linked to MOD-2021-347166 (Patient Link).
Two hives in area where shot was given that was red, swollen area 3-4cm in length. Local reaction from Varivax. Benadryl 1 tsp tid for a few days. Shot was given in L thigh sub at 11:20am on 10/29/02.
1/21/2005 Patient had history of Crohn's Disease.  In remission for 1 year.  On no steroids.  Dr. felt patient should receive vaccine.  Patient works as an aid at hospital.  Frequently exposed to shingles.  Complaint of abdominal pain and possibly chicken pox.  No lesions.
given at pharmacy Pt received Shingrix 11/7, was achy and had chills 11/8.  On 11/10, had facial swelling & felt throat was tight.  He took Benadryl. Seen 11/11 - Rx Prednisone for periorbital swelling
Had an aortic valve procedure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: AORTIC VALVE DISEASE (medically significant) with onset 2021, outcome "unknown", described as "Had an aortic valve procedure". Therapeutic measures were taken as a result of aortic valve disease. The patient got the first dose of the Pfizer BioNtech covid-19 Vaccine on Mar2021 and the second dose on Apr2021 and had an aortic valve procedure 2 months ago and was currently on a blood thinner (Plavix 75mg 1 pill/day). The patient mentioned that during his first and second dose, he was not on a blood thinner.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
it brought on heart palpitations; This case was reported by a consumer via interactive digital media and described the occurrence of palpitation in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Flu vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received flu shot two years before the date of reporting and it brought on heart palpitations that did not fully subside for a full year. The reporter reported that some people's bodies could not tolerate some of the ingredients. Take a look at this vaccine excipient summary. This case has been linked with the case US2020AMR242083, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR242083:same reporter
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 2 / Vaccine brand other: Moderna; Vaccine dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in right arm and on 01Apr2021 as dose 2, single (Lot number: ER8732) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 03Dec2021 as dose 3 (booster), single (Lot number: O5OH22B), in right arm and on 01Oct2022 as dose 4 (booster), single (Lot number: H35763B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2021, outcome "unknown", described as "Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 2 / Vaccine brand other: Moderna; Vaccine dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID 19 treatment from 08Apr2023 to 13Apr2023.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA 12/13/2022 --  RECURRENCE OF SAME SYMPTOMS
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of GARDASIL (lot # J010668, expiration date 28-APR-2016, dose and frequency were unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
No adverse event; 6 Patients received the vaccine past the beyond used date; 6 Patients received the vaccine past the beyond used date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (6 Patients received the vaccine past the beyond used date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     It was unknown if patient had any allergy history or diseases.     On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (6 Patients received the vaccine past the beyond used date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (6 Patients received the vaccine past the beyond used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 Patients received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (6 Patients received the vaccine past the beyond used date).    Case included information of 3rd patient out of 6 reported patients.  No concomitant product reported by reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-705086 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705086:Master case
Vaccine administered at approximately 9am on 7/1/2019.  Patient's arm hurt & she developed a headache.  She went to her job as a caregiver at 8pm.  By 10pm, she was having chills and could not get warm.  She awoke again and was sweating, had body pain.  At 5:08am she called me (mother) and said she was in excrutiating pain, had a fever and felt that her heart was racing.  She stated she could not leave her elderly client until next caregiver came in at 8am.  At 8am, I (mother) called doctor's office about patient's symptoms.  They told me to bring her in right away.  We arrived between 8:30-9am.  Patient had a fever over 100 and her heart was racing. They did flu and strep swab and both were negative.  We were there
Poison ivy like rash on his wrist (a few inches away from injection site). He has two other instances of rash in the same area; Case reference number US-BN-2022-004002 is a spontaneous case report initially received on 10-Oct-2022 from a consumer via agency (reference number: USBAV22-1671) and concerns a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with a first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at unknown dose, unknown route of administration, for monkeypox prophylaxis.  As reported, the patient was vaccinated against monkeypox two weeks ago and developed a poison ivy like rash on his wrist (a few inches away from injection site). He had two other instances of rash in the same area. He was not exposed to monkeypox.  At the time of this report, the event outcome was unknown.  The reporter did not provide seriousness criteria and a causality assessment.  No further information was provided.; Reporter's Comments: A male patient of unknown age experienced the non-serious event of rash, on an unspecified date following vaccination with the first dose of Jynneos, applied at an unknown dose, unknown route of administration, for monkeypox prophylaxis. Rash is listed per the agency but unlisted per the agency 2 for Jynneos. The patient's medical history and concomitant medications were not provided. Reportedly, the patient had not been exposed to monkeypox. Based on the known safety profile and the suggestive temporal relationship, the event of rash is assessed as related to Jynneos.; Sender's Comments: A male patient of unknown age experienced the non-serious event of rash, on an unspecified date following vaccination with the first dose of Jynneos, applied at an unknown dose, unknown route of administration, for monkeypox prophylaxis. Rash is listed per the agency but unlisted per the agency 2 for Jynneos. The patient's medical history and concomitant medications were not provided. Reportedly, the patient had not been exposed to monkeypox. Based on the known safety profile and the suggestive temporal relationship, the event of rash is assessed as related to Jynneos.
On 3/31/22 it was discovered that the patient has received two doses of Pneumovax 23. One dose was given on 12/5/20 and the other dose was given on 12/28/21. I have tried to reach out to the patient but the phone number says voicemail has not been set up. As far as we know there were no adverse events for receiving the same vaccine twice. We will update when we talk to the patient.
This spontaneous report as received from a consumer and a pharmacist who refers to herself, a 79 year old female patient with diabetes and PCN allergy. ON 31-JUL-2015, the patient was vaccinated with ZOSTAVAX, subcutaneous. Concomitant therapies included JANUVIA, glimepiride, PLAVIX, NITRO and COREG. The patient reported two days after receiving ZOSTAVAX, she developed a red rash on her right arm from the injection site to her elbow. The injection site had become swollen and site began running a low grade fever. (Specific temperature not provided). The patient has since visited a dermatologist and received a skin biopsy, although she has been diagnosed with "shingles" and was rather diagnosed with an allergic reaction. The patient was treated with prednisone and tetracycline (manufacturer and dose unspecified). The rash has since moved to both of her arms, both legs, upper thighs, and shin area. She also has a rash on her buttocks. The patient reported she was recovering from her allergic reaction and rash. The patient was also stated that her husband has visited the local hospital emergency room with a red rash across his chest. He husband was not admitted. Additional information has been requested.
pt recv vax 25OCT95 on 30OCT95 pt devel lymphadenopathy (one large node in lt clavicular area);pt's MD reportedly wanted to biopsy the node;pt felt it was getting smaller in size & softer than when it first appeared;
About 5 days after the vaccine, I had really severe chest pain. This lasted about 5 hours. It started in the morning around 7am. My husband is a first responder, and we were worried. It was a very severe crushing chest pain. I was almost falling to the ground with the pain. We called 911 and went to the hospital. They did a heart attach workup on me. I was told I might have had some inflammation of my heart. I went home and then started experiencing pain on my right side. It wrapped around my rib cage from the front to the back. It was worse pain than being in active labor. It started off as a dull pain that then turned to severe pain that felt like contractions, This would last for a few hours and it would return to a dull pain. It would come back all over again. I went to urgent care where they thought I pulled a muscle. This did not work. This was about a week after the vaccine. The pain was still really bad and kept me up at night. I went to my PCP and ER. They thought it could be a gallbladder issue. I had a cat scan, MRI done. Everything was negative. I was given hydrocodone because the pain was so bad. The pain causes 5 trips to the ER over the course of 4 months. I eventually saw my neurologist. He suggested I might have had an internal shingles response to the vaccine. The area by my rib cage turned numb. I have no feeling there. Because of this, my PCP and neurologist believe it was indeed a shingles reaction. After the second vaccine, I did not have any adverse events
This spontaneous report was received from a registered nurse refers to a 15 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with VARIVAX lot # M027347, 01-JUN-2018 and M-M-R II M032153 22-APR-2017. No adverse effects were reported. Additional information has been requested.
Patient fell out of bed 5-10 minutes after receiving vaccine.  Patient treated by staff at facility and per staff patient has a history of falling.
I'm having a reaction. It's near the injection site / It's a large red; It's a large red and a sore spot; plus the headache; painful rash; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 58-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st February 2020, the patient received the 2nd dose of Shingles vaccine. In February 2020, less than a week after receiving Shingles vaccine, the patient experienced erythema, pain, headache and painful rash. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the erythema, pain, headache and painful rash were not recovered/not resolved.   It was unknown if the reporter considered the erythema, pain, headache and painful rash to be related to Shingles vaccine.  Additional details were received as follows: The patient stated that after vaccination experienced large red and sore spot near the injection site but over to the side and to the right. The patient also had headache. The patient asked what to do with Advil as Advil was touching the pain.
p/vax pt devel inj site rxn by redness; swelling; warmth & pain; tx w/APAP & ice
Pt crying constantly for the last 2hrs & inconsolable; well prior to immun; On PE exam cry harsh but not piercing, mildy feb @ 99.2R HEENT unremarkable chest clear, heart reg; mild swelling & erythema about rt mid thigh; vomited;
Patient reports over the phone that she experienced pain at the injection site immediately after vaccine was administered. It was completed around 9:50 am on 4/12/21. She reports she also has muscle aches, nausea, and vomiting today (day 1 after vaccine). Patient reports only just recently taking off her bandage from yesterday a couple hours ago. She called with concern because she noticed she has an indention in her skin at the site of the injection. Patient reports it is about the size of a quarter. No treatment completed at this time. Patient called to report these symptoms over the phone, and nurse recommended she report to her primary health care provider so they could take a closer look at her administration site in person.
Diagnosed on March 15. 2022 with Myasthenia Gravis.
pain at Injection site; swelling at Injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2T7, expiry date 15th November 2021) for prophylaxis.   On 14th October 2019, the patient received Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient contacted the pharmacy over the weekend stating that she still had pain and swelling at the injection site.
Pt vaccinated with DTP/OPV developed apparent abscess 5 days after immunization; Treated with amoxicillin - resolving
Dose administered after more than 30 days of storage in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days of storage in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.   It was reported that the vials were stored in the fridge since 22-Dec-2021.   No treatment information was reported.
Irritability x 2 hrs; Seen in ER 26hrs p/immun; Had a full sepsis worked, all cultures negative; Seen in clinic 2 days p/visit to ER, had URI;
The patient developed a red, warm, sore area on the left arm about 4-6 inches below the site of injection.
Treatment of COVID-19; Treatment of COVID-19; Interchange of Vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jun2023 (as reported) as dose 4 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HIV" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Migraine medications" (unspecified if ongoing), notes: Known allergies: Migraine medications, e.g. maxalt, tetanus anti-toxin. Concomitant medication(s) included: ATORVASTATIN, stop date: 12Sep2023. Past drug history included: Maxalt for Migraine, reaction(s): "Allergies: maxalt"; Tetanus anti-toxin, reaction(s): "Allergies: tetanus anti-toxin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Jun2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included: Paxlovid.
Received DTaP on 07 Aug 2015 afternoon and had fever of 100.1 orally and increased red welt to right upper arm. Hot to touch. Softball size. Pt. went to urgent care.
he has had a rash from injection site on the outside of his arm to his elbo; This spontaneous case was reported by a consumer and describes the occurrence of RASH (he has had a rash from injection site on the outside of his arm to his elbo) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included DIAZEPAM, TRAZODONE, GABAPENTIN, CARVEDILOL, NITROGLYCERIN, ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ), HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]), LISINOPRIL, MELATONIN and SALBUTAMOL (SALBUTEROL) for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced RASH (he has had a rash from injection site on the outside of his arm to his elbo). At the time of the report, RASH (he has had a rash from injection site on the outside of his arm to his elbo) outcome was unknown.            patient took blood thinner and glaucoma drops as concomitant medications The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
pt brought to hosp with SOB and confusion; admitted; tested positive for COVID; COVID pneumonia, acute sepsis, respiratory failure; O2 supplementation; given dexamethasone, ABX, Vit C; mental status worsened; multiorgan failure worsened; transitioned to comfort care and pt passed away in the hosp