chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt started to feel sick; ambulance was called by co-workers. Pt vomited x 3 in ambulance. Upon arrival at hospital, pt rec'd Benadryl po; said he felt better almost immediately. Pt observed, then dc'd.
Death NOS; Vaccine-vaccine interaction; This serious case was reported by a consumer and described the occurrence of unknown cause of death in a 85-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 18-OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: Death NOS) (serious criteria death, hospitalization and GSK medically significant) and vaccine-vaccine interaction (Verbatim: Vaccine-vaccine interaction) (serious criteria clinically significant/intervention required). The outcome of the vaccine-vaccine interaction was unknown. The reported cause of death was unknown.   The reporter considered the unknown cause of death and vaccine-vaccine interaction to be related to Arexvy.     The company considered the unknown cause of death and vaccine-vaccine interaction to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-NOV-2023 The reporter was caregiver. The reporter reported that Arexvy vaccine was killing people and GSK should stop advertising it on television. The patient was in hospital for death NOS. Reporter would report GSK to the authorities and to the FCC (Federal Communications Commission) for promoting a vaccine that was killing people. Reporter reported that GSK was killing people with its vaccines. God Almighty would punish all the employees working for GSK money hungry company and all would be punished very soon and everything that worked for company should be thrown in jail. The reporter did not consent to follow up.; Reported Cause(s) of Death: Unknown cause of death
Initially had flu like symptoms-myalgia, chills, fatigue. Now after  month had persistent right arm pain, soreness, fatigue (arm) and arm weakness.
Case number PHEH2014US014071 is an initial spontaneous report received from the medical assistant on 14 Jul 2014. This report refers to a 17 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13016) intramuscularly on 10 Jul 2014. It was reported that MENVEO was exposed at temperature of 31.8 degree F (-0.11 degree C) up to six hours on 10 Jul 2014. No adverse event reported after the maladministration.
Mother states that her daughter received the varicella vaccine in 1995 and came down with this disease on 1/1/01.
Two weeks after the booster I broke out in hives. I have not been able to get rid of them, they keep coming back. The hives are on my legs, hands, and stomach. I have tried a bunch of treatment and medications from the dermatologist and the allergist and nothing seems to be helping or stopping the hives. The dermatologist did some bloodwork and it did show some elevated levels with my thyroid not sure if that has anything to do with it but I am scheduled to see an endocrinologist.
Shingles  - rash on left side of trunk along a pattern with pain and sensitivity.
Eyes bloodshot, headache, achy-diff breathing-sinus swelling. Slept-hives on face, stiff neck. Tx Benadryl.
I started with rashes (red) on both ankles. then near arm pits.  They I started with very itchy eyes which turned to Pink Eye.  Addtionally I got very congested, trouble breathing, phelm production.  Tired or fatigued.  Got back enough and went to the doctor and receive a steroid shot, and eye drops.   I am still have issues still.
expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April; 4 patients administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) and PRODUCT STORAGE ERROR (expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients administered with expired vaccine) and PRODUCT STORAGE ERROR (expiration date 25Mar2022/The vial was taken freezer and placed in refrigerator on 7 April/ administered on 7 April) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was given booster dose. Concomitant medication list was not provided. The vial was taken from the freezer on the morning of 07-Apr-2022 and placed in the refrigerator for use on 07-Apr-2022. The vial did not undergo any temperature excursions. Treatment information was not provided.   This case was linked to MOD-2022-537851, MOD-2022-537863 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Live follow up received: updated reporter contact details, added patient demographics, added dose description of suspect product.
Patient had chills and fever of 103 in less than 24 hours; however, that was an expected side effect. What followed is being entered here as an adverse reaction. she has significant decreased vision by 1/22. (5 days after the injection). Was seen in ophthalmology on 1/27 and diagnosed with RIGHT NONARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY
Arm still bruised, on aspirin, a little  5x4 feeling malaise, no fever, after 3 or 3 days, symptoms stopped, but came back a little while later. Told pt to see doc.
High fever 103 About 24 hours after vaccine  ES Tylenol 2 tablets q 4 hrs Ibuprofen 3 tablets q 6 hrs Cool/cold compress
On 8/24/18 pt noted 3 inch hot, firm, welts at both injection sites. These have been resolving with warm packs. On 8/26/18 at 4 am pt was noted to have fever of 102.7 and moderate headache. Mom administered ibuprofen for fever and headache. Fever reduced to about 100 and headache improved after second dose of ibuprofen. Yesterday, 8/26/18, fevers persisted around 100 and reduced to 99.8 with ibuprofen. 8/27/18 Today, fever is 100.8 and reduces to 99.8 with ibuprofen.
Brain stem stroke 5/12/2021 unable to swallow, blurred vision, left arm and left leg numbness, rough facial numbness.  G-tube had to be placed Lab, ct, mri
ACUTE NON ST ELEVATION MI 4/25/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt was 3 years old at time of administration. No adverse reaction reported. Pt is too young to receive vaccine, but was administered.
coughing; not feeling well; sneezing; running nose; tired; headache; nausea; muscle pain; cold like symptoms; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# not provided), via an unspecified route of administration on 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID vaccine on 06Jan2021 and second vaccine on 28Jan2021. She mentioned that she experienced reaction with both vaccines. After first vaccine she has swollen and tender lymph nodes, coughing, not feeling well, sneezing, running nose, tired, headache, nausea, muscle pain, cold like symptoms (AER 2021112057). With second dose, she had similar symptoms, but "not the swollen and tender lymph nodes, no chills or fever". She said she felt like she was going all over this again. Outcome of the events were unknown.   Information on the lot/batch number has been requested.
Pt recv vax on 10/9/98; @ 2 hr post vax pt exp fever (102-103), sleeping & eating less, crying a lot; tx=Tylenol
Initial report received from a health care professional on 23 November 2010. A 9-year-old female child received on 16 November 2010 at approximately 9:30 AM a 0.5 milliliter left deltoid intramuscular injection of FLUZONE SV, lot number U3744AA. The patient had no medical history and took no concomitant medications. She had no illness at the time of vaccination, no allergy to eggs and had no other vaccinations within 4 weeks of the FLUZONE. The patient had previously received in 2008 the flu vaccine and 2009-2010 the H1N1 vaccine. On the 17 November 2010 around 3:00 AM, the patient woke with hives and itching on the left arm injection site, trunk and legs. On 17 November 2010 the patient was taken to the Emergency Department (ED) where she received treatment with prednisone and BENADRYL. She was discharged from the ED with prescriptions for prednisone for 3 days, PEPCID for one week and diphenhydramine as needed. The patient returned to the ED on 18 November 2010 with itching and transient hives seen over body. She had no respiratory difficulty. The patient had started prednisone 10 milligrams (mg) on the 17 November 2010 and was given one dose in the AM on the 18 November 2010 as well as diphenhydramine. In the ED she had raised urticaria over entire body except for the face with some wheels in the form of hives which were widely distributed over the trunk and extremities. The patient was treated with 20 mg of prednisone, diphenhydramine and famotidine. She was discharged from the ED. On 22 November 2010 the patient was seen by her primary physician where her hives were noted as resolved. The physician was to speak with an allergist due to no clear etiology for the rash other the vaccine. The outcome was reported as recovered. Documents held by sender: None.
2/26/15 Removed band aid, area red, warm, swollen, hard area. Mother contacted MD administering TYLENOL and use of ice as needed. Monitoring for injection. Left deltoid area.
asthma-using ventolin inhaler since JAN;sinus congestion;seen 6JAN;
11/28/21 ED note: "Patient is 63-year-old female history of diabetes, hypertension, hyperlipidemia presents with abdominal pain, emesis.  She reports intermittent abdominal pain for the past 3 days.  She reports episodes of emesis tonight.  She denies diarrhea, constipation, melena, medic hematochezia.  She denies fever, chills, chest pain, shortness of breath. Reports sugars have been elevated at home. "11/29/21 resident's note: '63 y.o. year-old female with history of T2DM, HTN, HLD, and Gout who presented with elevated blood sugars and DKA. Patient is sitting up in the bedside chair saturating 99% on RA. Spoke to patient over the phone. She is feeling better than yesterday and is ambulating well in her room. She endorses increased frequency in urination and pain with urination. She denies HA, CP, SOB, N/V, diarrhea, or leg pain. PCR was positive for COVID 19 upon admission, but asymptomatic". 11/29/21 ID's note: "Acute COVID 19 infection in vaccinated patient w/ Moderna, s/p booster 11/2/21 - mild sx for 3 days, possible household exposure 21. Decompensated IDDM w/ DKA - has not taken her insulin for the past 3 days 3. AKI - likely from dehydration 4. Chr pancreatitis 5. Multiple comorbidities including CHF s/ p AICD, gout, HTN, DM etc. mAbs w/ casi/imde 600 mg/600 mg iv x1 since pt w/ multiple comorbidities, and at risk for progression Discussed with patient re: investigational use of casirivimab/imdevimab, explained the rationale of blocking SARS-CoV2 at the onset of disease and the benefits observed with less progression of disease and need for hospitalization; also explained the risk of infusion allergic reactions and the need for monitoring. Pt agreed to proceed"  .
Covid monitoring documentation. PT admitted 12/20/21 documented to have positive covid. PT received Moderna 7/28/21 Lot 050C21A for dose 1. Dose 2 was Moderna given on 8/26/21 Lot 017A21A.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 20-MAY-2013, the M-M-R II vials in the physician's office were improperly stored at 48F for 16 hours. On 21-MAY-2013 one of these M-M-R II HSAS (lot# H010136, exp. 17-MAY-2014) was subcutaneously administered to the patient. No known adverse effects. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Within 5 minutes of received 2nd dose of Pfizer Covid-19 vaccine, patient became very dizzy and fainted.  We layed her down and elevated her feet and she immediately regained consciousness. The patient was assessed by paramedics and they did not transport her to the emergency room and instructed her to drink lots of water over the next 24 hours.
24 hours after 2nd shot, I developed a lump at injection site.  As well as redness, hot, stinging, pain, arm pain, swelling.  Writhing 48 hours the lump decreased in size but the redness is now the size of a grapefruit.  Very painful.  Arm itching, red, pain.
PATIENT STATES: Nasal dryness,hoarseness, fatigue, colorless urine
received only the adjuvant component; received only the adjuvant component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-Apr-2022 Reporter's comments: Health care professional reported that one unknown patient out of a group of three possible people most likely received only the adjuvant component of Shingrix. It was unknown which one of the three patients only received the adjuvant component. The reporter did not consent to follow-up. Additional Supportive Information: The patient received only adjuvant component of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Vaccine for flu administered 11/12/08 AM. That night his mother noted a tiny area of frontal hair loss. Continues to fall out now = 22mm X 10 mm bald (alopecia) patch. Treatment = refer to derm, Beclomethasone foam.
my arm became swollen in a 2-3 inch area surrounding the injection site. The same area was also red and mildly tender to the touch; my arm became swollen in a 2-3 inch area surrounding the injection site. The same area was also red and mildly tender to the touch; The same area was also red and mildly tender to the touch; This is a spontaneous report from a contactable Other Health Professional, the patient.  A 28-year-old non-pregnant female patient received the second dose of BNT162B2 (COMIRNATY Formulation: Solution for injection, Lot number: EL3246) via intramuscular route on arm right on 25Jan2021 11:00 (Age at vaccination: 28 Years) at a single dose for COVID-19 immunization at Hospital. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications included: Bactrim, Doxycycline and penicillin. Concomitant medication was not reported. The patient had not received any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (COMIRNATY Formulation: Solution for injection, Lot number: ELD140) via unspecified route on arm left on 04Jan2021 14:30 at a single dose for COVID-19 immunization. On 2-3 days) after receiving the vaccine on 27Jan2021 12:00 AM, her arm became swollen in a 2-3 inch area surrounding the injection site. The same area was also red and mildly tender to the touch. The swelling and redness was something she never experienced with any other IM injections. The red spot is still there. It doesn't bother her at all, but she just wanted to report it for data purposes. Patient didn't received treatment for the events. Outcome of events is not recovered.  The events was considered as non-serious.  Follow-up attempts are completed. No further information is expected.
I woke up and I had double vision, loss of balance and muscle control and coordination and was numb and tingly sensation over my body.
Extreme swelling of upper arm, Fever, Body aches, headache (resolved)  FATIGUE is the most concerning - has become chronic now -it is overwhelming and never went away!
This spontaneous report as received from a female patient of unknown age refers to herself. No concurrent conditions or medical history were provided. The patient was vaccinated with three doses of M-M-R II injection (strength, dose, route of administration, lot# and expiry date unspecified for all) on unspecified dates. No concomitant medications were reported. On an unknown date, the patient had the titers drawn and it showed that she was not immune. It was also stated she was breastfeeding at the time of report. The outcome of the events was unknown. The relatedness between the events and M-M-R II was not reported. Additional information is not expected as there is no patient and physician's contact information and we could not do follow up with them.
Dizziness, headache, heart palpitation, tiered, diarrhea.
Fever, chills, cold sweat, nausea and vomiting, muscle aches, headaches
all joints swollen by Friday p/vax; unable to hold a pencil, difficulty in walking; couldn't swim 23SEp93; seen by MD 24SEp93; seen again 1OCT; sore throat;
Lower blood pressure than his normal values which are high; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Lower blood pressure than his normal values which are high) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertensive. Concomitant products included GABAPENTIN and METFORMIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Lower blood pressure than his normal values which are high). At the time of the report, BLOOD PRESSURE FLUCTUATION (Lower blood pressure than his normal values which are high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: low (Low) Lower than normal values.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had not been taking his high blood pressure medication for the last 7 days (Losartan, Lisinopril and 1 more).  Treatment information was not provided.
Flu shot 9/17/15. Started feeling bad next day 18th. My wife put herself on a liquid diet, as she sometimes does, for her Crohn's. Our Dr got sick so he sent us to a Dr that we did not know on 9/22. She was told to stay on broth and Jello-no substantial food for about 5 days. I am patient's husband filling out this report. I called an ambulance, she was very sick 9/23. My wife was operated on 9/24 gallbladder removed. Surgeon told us it was gangrenous. Given antibiotics-later developed yeast infection. White blood count went up-taken off antibiotics given fluconazole for yeast-white blood count stabilized. Some speculated that the flu shot exacerbated my wife's Crohn's disease-others dissed that idea.
Patient called in and stated over the course of "a few days" both his arms and his neck swelled and later he developed sores all over both arms. It is now 3 weeks later and symptoms have resolved.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339657-00 (AbbVie).  A 77 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single, intramuscular, administration date 08Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  Additional Information: Solicited report from the RA by a consumer of an elderly female with an event of non-serious COVID with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Covid. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira(Adalimumab): The reporter's causality for the event(s) of COVID was not provided as Reaction: Covid-19 (Covid-19). Causality for Covid-19 (Covid-19), Causality as per reporter (Drug/Vaccine): Not Reported. Drug: Pfizer BioNTech Covid-19 Vaccine(Tozinameran)(Tozinameran), Unknown, Unknown. Causality for Covid-19 (Covid-19), Causality as per reporter (Drug/Vaccine): Possible. Did event abate after stopping drug reported as N/A. Concomitant Drugs and Dates of Administration (Exclude those used to treat event): Concomitant Drugs Not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Patient hospitalized for bacteremia, severe sepsis with acute organ dysfunction within 6 weeks of receiving covid vaccination.
4/1/2021 odd tickling cough, brief.  Biked anyway, 60 min hard ride.  But just in case started 81mg ASA qd. 4/2 odd tickling cough brief. Biked anyway, 60 min, good hard ride.  not feeling ill, no fever, cough did not continue, not productive, no URI symptoms.  Cough was different. 4/3 woke with pain upon taking  a deep breath HR in high 40's (normal 60 +-)  Like the pain of breathing after aspirating a lot of pool water.  This pain was only on deep breathing; a second 'radiating?' pain was more of a constant ache in region of R scapula or supra scapular region, no tenderness to palpation.  Had GB out Feb 2020.
# days post vaccination employee developed headaches, vertigo, Nausea and vomiting.  Employee did go the hospital for care.  Still feeling bad today and following up with primary care MD.