chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is one case out of a cumulative total of 122 cases solicited from the database during the surveillance period from 01 January 2010 to 09 August 2012. These 122 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 09 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; received on 16 June 2009, 25 August 2009, 27 October 2009 and 05 November 2010 (lot numbers, routes and sites of administration not reported). The subject developed cough on 18 July 2012, approximately twenty months after the last dose and paroxysmal cough on 26 July 2012 with a whoop. Laboratory testing included positive PCR on 22 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 03 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Narrative:  Pt received covid vaccines on 12/20/21 & 01/16/2021. Pt was residing in health care rehab facility who transferred him to hospital on 6/7/2021. Pt died at hospital on same day admitted, 6/7/2021. Pt with large problem list in records system: Urinary incontinence A Decrease in appetite A Malnutrition A Seen by palliative care medicine service A CAD - Coronary artery disease A CHF - Congestive heart failure HFrEF 35% A Hyperlipidemia A AF - Atrial fibrillation A Femoral artery thrombosis Onset 05/27/2020 1. Right 2. S/p thromboebolectomy R SFA, popliteal, tibial arteries A Pleural effusion A Gout A Cardiomyopathy Ischemic A History of left cataract extraction A Glaucoma A OA - Osteoarthritis A Cardiac defibrillator in situ ( A Allergic rhinitis A Benign prostatic hypertrophy without outflow Appears death is unrelated to vaccinations.
Site: Bruising at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Additional Details: Pt coadministered Fluzone quad vaccine with Morderna COVID vaccine on 08/16/21. Mom called RX on 08/23/21 to notify the patient was hospitalized 2-3 days after receiving a shot and has a low blood pressure and anaphylactioid events. When the patient was admited to hospital, the only reason that doctor thinks is the coadministration of both Moderna and Fluzone vaccine at the same day. The pharmacist on duty apologized the mom and states it rarely occurs. Pt is still on process of recovering.
This case was reported by a pharmacist via sales rep and described the occurrence of nerve pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced nerve pain, fever, chills, headache and pain. On an unknown date, the outcome of the nerve pain, fever, chills, headache and pain were unknown. The reporter considered the nerve pain, fever, chills, headache and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter believes related to product. Initially had fever, chills day after 2nd dose the patient had pain, headache that had persisted for almost 2 weeks, pain spreads across top of head along a dermatome, got worse throughout the day and overnight. The reporter believes it to be nerve pain.
It started on 9/28/19, I felt a lump in my throat and I coughed up some phlegm. I thought it was just a cold or maybe I swallowed something, so I started drinking plenty of fluids and sucking on a peppermint. This didn't do the trick, to help me with the problem I was experiencing. I called my PA to ask a question of what to take over the counter that will help, but I have not heard back from his office as of yet.
a vein in his pimple popped out yesterday; smashing and splitting headache; loss of appetite; slept most of the day on and off; heart racing; severe shaking/chills; SEVERE BODY ACHES; highest fever of 101F; really bad nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea) and HEADACHE (smashing and splitting headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea), DECREASED APPETITE (loss of appetite), SOMNOLENCE (slept most of the day on and off) and PALPITATIONS (heart racing). On 13-Feb-2021, the patient experienced HEADACHE (smashing and splitting headache). On 16-Feb-2021, the patient experienced VASCULAR COMPRESSION (a vein in his pimple popped out yesterday). On 13-Feb-2021, CHILLS (severe shaking/chills), MYALGIA (SEVERE BODY ACHES), PYREXIA (highest fever of 101F), NAUSEA (really bad nausea), HEADACHE (smashing and splitting headache), DECREASED APPETITE (loss of appetite), SOMNOLENCE (slept most of the day on and off) and PALPITATIONS (heart racing) had resolved. At the time of the report, VASCULAR COMPRESSION (a vein in his pimple popped out yesterday) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided) and then with the second dose on 30-MAR-2015. No adverse effect was reported. Additional information has been requested.
DPaT right arm 4/23/03. On 4/25/03 redness, as big as a quarter on 4/29/03. Circular lesion, raised edges. Not itchy, not hurting. No fever.
This is a 65 year old male with a PMH/PSH as noted below, who developed a cough and SOB over the last few days. The patient had been to Dr. office for chemotherapy today and was sent in for a CT of chest due to expectoration of thick phlegm and cough. The patient denies any SOB, but has been tired and feeling weak the last few days. Patient gets frequent transfusions due to HX MDS with chronically low platelet counts around 5. Last transfusion noted as 12/11/21. patient did get 2 doses of Pfizer but could not get booster over concerns of interactions per his team. Patient is also in the Catastrophic Emergency Fund due to debris exposure. In the ED, patient was found to be Covid +. Saturations were good on RA.
doesn't feel good; her body is hurting/her left side hurts/her body hurts/it's like somebody hit her hard; headache; so weak; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date: unknown), via an unspecified route of administration on 06Jan2021 at 12:30 at a single dose for Covid-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine the day before (06Jan2021) and doesn't feel good in the morning, her body is hurting, and she has a headache. The patient is a CNA and she got the vaccine the day before at around 12:30 and she just got up in the morning, so weak, and her left side hurts. Her body hurts and she doesn't feel good too, reportedly "all the body hurts now, it's like somebody hit her hard". The patient asked if she can take Tylenol or pain medication. After receiving a verbal response, the patient added that she would take Tylenol and pain medication together and hopefully get some sleep. The patient then asked if headache and body ache are normal side effects of the vaccine. The outcome of the events was unknown.   Information about batch/lot number has been requested.
My heart began to pound rapidly; I felt breathless and lightheaded; I felt breathless and lightheaded; and also felt as though I might either vomit or lose control of my bowels; and also felt as though I might either vomit or lose control of my bowels; This is a spontaneous report from a contactable consumer (patient herself).   A 50 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left Arm on Aug2021 at 13:00 as a Dose number unknown, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included other medication sensitivities (nonallergic). The patient's concomitant medications within two weeks of vaccination was reported as none. The patient previously taken Reglan which caused her anaphylaxis. The patient had not received any other vaccine within four weeks prior to vaccination. The patient was not diagnosed for Covid prior vaccination. The patient was not tested for covid post vaccination. On 04Aug2021 at 13:00, the reporter stated that she received the shot and was directed to sit in another chair and wait 15 minutes. She got up and walked to the chair, sat down and within 60 seconds of sitting down her heart began to pound rapidly, she felt breathless and lightheaded and also felt as though she might either vomit or lose control of her bowels. From the time the symptoms began, they subsided within a minute or so. No treatment received for the resulted events. The outcome of the events was recovered on 04Aug2021.
his arm swollen; bleeding in the injection site; his arm hurting a lot; weakness; fever; chills; nausea; constant headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness) and PYREXIA (fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (constant headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (his arm swollen), VACCINATION SITE HAEMORRHAGE (bleeding in the injection site), PAIN IN EXTREMITY (his arm hurting a lot), ASTHENIA (weakness), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (constant headache) outcome was unknown.            No concomitant medication were reported 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-080260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant FU - Email address provided; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-080260:crosslinked
0213A21A -(The lot number is hard to read and it could be this number or the one above.) Wednesday, Thursday and Friday - I had headaches and I had extra fatigue (I already do have fatigue because I have insomnia). My arm soreness was on the other arm not on the one that I had an injection. Friday and up until yesterday, I had nausea. Saturday, I had headache and being tired. Sunday, I had chest pain (woke up with it) like a burning in my chest. My left arm, I felt a tingling down my arm to my legs - it almost felt like a blood clot was there in my arm. I had to put heat on and then ice. I couldn't extend arm because it hurt. Midnight on Monday, the burning and the chest pain was too much and I was getting worried. The only thing I have is asthma, otherwise I'm healthy. I went to ER - they gave a Cocktail of Lidocaine; Malex and something else to see if it would help with the burning in my chest.  Monday, I took Tylenol. Tuesday, the chest pains were more intense.  03:00 on Wednesday am - I went back to ER. They brought me to a full chest x-ray - front, side and back and a CAT SCAN and gave me another Cocktail and also put something in my IV. This time,  they sent me home with four different medicines. The meds are: Generic of Nexium; Aspirin low dose of 81 mg - bayers children - one a day; Generic version of Bentil Triacetin   - I take this when I want to be still; Generic version of Valium - they gave me four of these - and I have one left that I will take tonight so I can sleep. I am taking Vit D. I haven't taken Tylenol since getting on these. I try to stay hydrated.  I still have a really really funny feeling inside me. Last night, I was very restless and couldn't sleep. It makes me on borderline and dizzy and my heart starts palpitating. It's a scary feeling in my chest.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 31st January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 61 days after receiving SHINGRIX, the patient experienced shingles and pharmaceutical product complaint. On an unknown date, the outcome of the shingles and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient's doctor reached out to the pharmacy to report patient's adverse event. This case was associated with product complaint, as the patient felt that the lot was defective. The patient received SHINGRIX on left deltoid. The patient got a full blown case of shingles.
From 7:00 PM to 7:30 PM, resisted attempts to breastfeed or received very little in between constant bouts of screaming and crying.  From 7:30 PM to 8:30 PM, he slept.  At 8:30 PM, awoke with constant, hysterical, doubled-over screaming and crying.  Finally slept from 9:15 PM until 9:50 PM.  At 9:50 PM, awoke with more of same--screaming, crying and moaning, constantly until 12:00 midnight.  From 12:00 midnight until 12:30 AM, was finally able to breastfeed, with crying in between.  Finally went to sleep at 12:45 AM.
My COVID-19 Infection symptoms started on 03/18/2023 . I had a cough, fatigue, aches, chills, loss of taste , loss of smell, and sinus congestions. I did a home COVID-19 test on 03/19/2023 which was positive. I sent an email on 03/23/2023 to a PA at my work place. She suggested some over the counter medications such as Sudafed, Nasal Spray, and cold & Sinus medication. I still have  lingering cough and sinus congestions.
PERSISTENT RASH AT INJECTION SITE 14 MONTHS LATER, DELAYED HYPERSENSITIVITY REACTION
Two days post vax pts leg was swollen from the knee up to the top; area blotchy, red and warm to touch. Pt developed a fever of 100.1, which was reduced with Tylenol. Pt was seen in ER and advised to five Tylenol, Benadryl and Keflex. Swelling reduced gradually.
Information has been received from an LPN concerning a 21 year old female patient with allergies to sulfa and AMOXIL who on 02-APR-2007 and 12-JUN-2007 was vaccinated IM in upper arm with her first and second doses of Gardasil, lot #653736/0014U for both doses. No other medications or vaccines were administered on these days. After both doses the next morning both hands were hot and itchy, slightly swollen, burning sensation of palms, sensitive to heat, blotchy rash from wrist to middle of the forearm (not hives). This lasted approximately one day and resolved with no treatment on either occasion, however the reporter indicated that medical attention was sought. It was also noted that the blotchy rash resolved within 24 hours. The patient requested the third dose. The HCP will probably pre-medicate with BENADRYL and observe. Follow up information has been received concerning the student who on 2-APR-2007 at 2:30 p.m was vaccinated in left deltoid with her first dose of GARDISIL, lot # 65373G/0014U: and on 12-JUN-2007 at 4:00 p.m was vaccinated in left deltoid with her second dose of GARDISIL, lot # 653736/0014U. The nurse stated that the patient's reactions happened post injection #1 and injection #2, both approximately 24 hours post injection. She also stated that that the patient's reaction after dose 1 started on 03-APR-2007 at 2:30 p.m. The patient requested the third dose. The HCP will probably pre-medicate with BENADRYL and observe. Additonal information is not expected.
Hepatitis B surface antigen positive; Literature Report:.  This literature marketed report has been received from the authors of the published article, titled as stated above and refers to a 59 year old female patient. On 30-JUN-2018, Hepatitis B surface antibody (Hep Bs Ag) was negative and hepatitis B surface antibody (anti-hep Bs) was 3.3. On 11-JUL-2018, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route and lot # not reported).       On 14-JUL-2018, the patient presented to the ED for gastrooesophageal reflux disease with atypical chest pain. The patient was found to be Hep Bs Ag positive. A blood work was performed a month later the vaccination on 09-AUG-2018, and it showed low surface antibody titer and no antigen al all: Hep Bs Ag was negative, anti-hep Bs was 3.5, hepatitis B core antibody was negative, hepatitis B e antigen was negative and Hep B Viral DNA was not detected  The outcome of Hep Bs Ag positive was considered to be recovered.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports received from the same article (MARRS 2003USA003205).; Sender's Comments:  US-009507513-2003USA003205:
4 days of high fever over 103 that will not come down even with Tylenol.  Have been to the doctor and covid and flu tests are negative. Body aches, fatigue, diarrhea.
45 min p/vax pt awoke screaming, skin bright red, body stiff w/back arching; had apnea episode-did not require CPR; resumed screaming x 20 min EMT's were called but episode had subsided by time arrived; seen by MD next AM & dx rxn to vax;
I had COVID in November and I just got my first shot and I have all side affect of covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I had COVID in November and I just got my first shot and I have all side affect of covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (in November).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (I had COVID in November and I just got my first shot and I have all side affect of covid). At the time of the report, SUSPECTED COVID-19 (I had COVID in November and I just got my first shot and I have all side affect of covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Pain in her arm (the arm progressively got better over the last several weeks) severe leg pain (mostly at night) in both legs (mostly the calves / shins), insomnia, nightmares, headaches (including seeing flashes of color).
nausea, tingling light headed ness. 24 after injection-  Rash started on lower extremities. no itching.  migraine. nausea, dizziness. positive D Dimer. Shortness of breath Treatment: IV fluids, Reglan. IV Tylenol. Covid test- negative. Na 121.
12/31/20 body ached, chills, fever, fatigue, sore throat 1/1/21 reported tongue/throat swelling- relieved with Benadryl and Allegra
new onset of R-sided facial drooping, slurred speech, and confusion. VS: 98.7, 120 (apical), 22, 90/68, pulse ox 85% on room air.  She was medicated with routine ASA and PRN Clonazepam.  Pulse ox improved to 90%.  .  New orders received to send to ER via 911 for eval.
BLOOD CLOTS IN THE BRAIN; EXTRAORDINARY PAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported,1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient had clots in the brain. The patient was flown to the hospital and had been in Intensive Care Unit (ICU) for the past 2 weeks from the report.  The patient underwent multiple procedures for it, and was in extraordinary pain. The patient was currently receiving plasmapheresis. The number of days of hospitalization was not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in the brain, and extraordinary pain. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0:  This female patient of unspecified age and ethnicity was reported to have been admitted in ICU for clots in the brain after an unspecified duration of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient underwent multiple unspecified procedures and currently undergoing plasmapheresis.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Woke in the middle of the night every hour screaming for two nights. No problems during the day.
Severe Migraine with major Aura. Severe for 24 hours then minor for an additional 48 hours.