chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection at 9:10am. Ten minutes after injection, severe swelling in left arm. Informed nurse. She stated to remove watch band that was cutting into left arm - the swelling was normal. Ten minutes after noticed arm swelling. Pressure on left and front of side of throat with difficulty breathing. Informed nurse. We talked and she suggested I get out of the car walk around and take deep breaths. After doing so I informed nurse my breathing wasn't any better. She took me inside one of the buildings and found someone to use a pulse ox to test blood oxygen level. She said it was fine and I was good to go when 30 minutes was up. Husband drove me home, I laid down for a nap at 2:30 pm and got up at 4:45 pm. I woke several times during nap due to pain in lower left arm and upper left chest. When I got up I had difficulty breathing, talking and walking. I called on nurse. She asked questions and told me to call 911. My husband drove me to hospital in because it was faster than getting an ambulance. On the way to hospital swelling increased to left jaw and left ear.  At Hospital I was seen by many nurses, I received 2 Pepcid, a Benadryl shot and a steroid shot. Due to the location of pain they were concerned they were concerned that something was wrong with my heart or I was having a heart attack. They took blood tests and chest xrays and did an EKG. Then they had me wait for a long time then did another EKG because they didn't like the results of first EKG. No changes in EKG's.  They prescribed Pepcid 20 mg BID and Prednisone 2 20 mg tablets once a day. RX for Epi-pen 2 pack. Started with medications on Monday 4/12/21 morning and took for 5 days as prescribed. Also called primary care on 4/12/21 to inform them of situation. Also called hospital on 4/12/21 asking how to get records and get information
Case number PHEH2014US025006, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 25 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 18 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Shingles; Information has been received from a lawyer concerning a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant medications were not reported. On or about 23-OCT-2012, the patient was vaccinated as prescribed with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and/or zoster-related conditions (dose, strength, route of administration and lot number were not reported). On an unspecified date, the patient developed shingles and was treated in an hospital. According to reporter, as a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future.  At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).
TD given 5OCT-redness, pain devel gradually: redness lt shoulder (site of inj) & spread to lt trapezius; muscle soreness seen 12OCT
mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place/ "stupid" with brain fog that I called in; mild fatigue; mild intermittent headache; mild intermittent headache/ only mild joint ache in knees; This is a spontaneous report from a contactable other health care professional. A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 04Jan2021 11:30 at single dose at right arm for COVID-19 immunization.  Medical history included non-Hodgkins lymphoma from 1995, invasive ductal carcinoma 2009 with breast reconstruction; phrenic nerve paralysis left side; cardiomyopathy. Concomitant medications included beclometasone dipropionate (QVAR), and metoprolol. On 04Jan2021 15:30, noted starting around 4 hours after vaccine, the patient experienced mild fatigue, mild intermittent headache, mild intermittent ache in knee joints. The patient was unsure if they were vaccine related but became a little more intense as the evening went on (next 5 hours) but still overall were mild, but enough for the patient to determine they seemed related to the vaccine. Also noted about 6 hours after vaccine, on 04Jan2021 17:30, mild brain fog-feeling "stupid" and struggling with connections, like not picking up on humor immediately, trying to put things away in the wrong place. The patient went to bed about 8-9 hours after vaccine (8pm). The patient usually gets up at 4:45-5am. She was so tired the next morning and "stupid" with brain fog that she called in. She wasn't uncomfortable per se, no headache the next day, only mild joint ache in knees, fatigue and brain fog. No serious reactions. The outcome of the events was recovered on an unspecified date in Jan2021. The patient did not receive treatment for the events.   Information about lot/ batch number is requested.
Beginning approx 4 days post 3rd dose had diarrhea, then nausea.  Warm burning feeling of whole body,  dizziness, foggy mental status with loss of concentration began approx 1 week post 3rd dose.   Day 12 had feeling of faint, high to low blood presssure readings, heart palpatiions, facial numbness, headaches, reflux, twitching of muscles surrounding eyes, twitching of muscles in legs. Wend to ED day 12, EKG obtained, normal result, labs found  low potassium found. Day 14 potassium infusion when symptoms presented again at MD office.  Presented day  17 with heart palps and warm tingling in chest, dizziness.  EKG , ECHO and Ddimer for blood clots completed, all normal results.  24 holter monitor plaaced. At MD visit 24 hr Holter monitor switched to 14 day monitor.  MD felt possibly could be post viral syndrome from sinus congestion.  No palpitations  were noted while on 14 day monitor but dizziness and foggyness remained.   Day 27 due to airline travel, began taking mecllzine for dizziness and this seem to have helped.  Foggyness is also getting better.    Should mention with the foggyness, did have difficulty with word finding.  Also noted that vision  also disturbed as even with prescription reading glasses, items seemed more blurry.   Missed 1 full day of work and worked as was able to remotely for 2 business days (approx 5-6 hour per day).
Patient describes turning black and blue at the injection site. Below on the inside of her arm she developed a rash.
Positive COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced COVID-19 (Positive COVID-19). At the time of the report, COVID-19 (Positive COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On 19-Mar-2021, the patient experienced COVID- like symptoms such as coughing and low grade fever. Later, the patient had lost of taste and experienced loss of appetite.; Sender's Comments: Based on the mechanism of action of mRNA 1273 and etiology of event Covid 19, the event is unlikely related to the vaccine.
Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a non-health care professional (Manger of wellness center). This case involves a male patient (age unknown) who developed Gullian- Barre' Syndrome from receiving (flu shot) FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 09-Dec-2016, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI622AC, expiry date 30-jun-2017 via unknown route in unknown administration site. On an unknown date, the patient developed a serious Guillain-Barre syndrome with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diagnosis of Guillain-Barre syndrome. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diagnosis of Guillain-Barre syndrome. List of documents held by sender- none. Sender's Comments: This case concerns an adult patient who presented with Guillain-Barre syndrome after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. The time to onset is unknown. Moreover, there is no medical confirmation of the events, nor past history, clinical examination reports or lab tests reported that can rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Narrative:  72 y/o male with PMH of T2DM, obesity, HTN, chronic polycythemia vera followed by community hematologist has been having phlebotomy, chronic essential tremors, BPH, chronic vitamin D deficiency, possibly OSA currently on work-up as outpatient. Pt presented to ED on 05/21/22 w/ SOB, fatigue and cough. Pt positive for COVID 19 and admitted to hospital with acute hypoxic respiratory failure due to COVID PNA. Pt treated w/ remdesivir (05/22-05/27) and dexamethasone (05/22-06/01). Pt improved and discharged to Rehab on 06/03/22.
Epigastric Pain described as dull and achy that radiated to back.  Back constant and worsened by eating. Not improved with clear liquid diet and over the counter PPI therapy. Seen  in Emergency Department at health care facility on 10/19/2021 and Diagnosed with Gastritis. Abdominal Ultrasound Normal on 10/21/2021. Seen by Gastroenterology  on 10/22/2021 due to persistent pain not improved with Pantoprazole and Carafate. Upper Endoscopy on  Monday 10/25/2021 revealed Gastritis.    Biopsies pending.
5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared). At the time of the report, URTICARIA (5 from Moderna that had similar reaction hives the whales/In some cases had another similar reaction where they had the hives, the welts/The hives reappeared) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Case contains information of 1 of 5 patients reported.  Concomitant products were not reported.  It was reported that it was whether patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that a total of 12 patients on a study based on 7 from Pfizer and 5 from Moderna that had similar reaction hives the whales. And that they proceeded to get another vaccine. In some cases had another similar reaction where they had the hives, the welts. But they At the time when they had them they took an antihistamine and relieved it. It was just resolved simply by taking an antihistamine. The hives reappeared. They didn't have any respiratory problems. They didn't have any cardiac problems, which was good.   This case was linked to US-MODERNATX, INC.-MOD-2023-710371, US-MODERNATX, INC.-MOD-2023-710376, US-MODERNATX, INC.-MOD-2023-710383, US-MODERNATX, INC.-MOD-2023-710387 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710376:3 of 5 patient US-MODERNATX, INC.-MOD-2023-710371:2 of 5 patient US-MODERNATX, INC.-MOD-2023-710387:5 of 5 patient US-MODERNATX, INC.-MOD-2023-710383:4 of 5 patient
adult/ received a pediatric dose of Havrix.; adult/ received a pediatric dose of Havrix.; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HAV (Havrix pediatric) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th August 2021, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The nurse reported that adult patient received a pediatric dose of Havrix, which led to underdose and adult use of child product. The HCP (health care professional) consented to follow-up.
DECREASED APPETITE; TIREDNESS; TASTE PECULIAR(FUNNY TASTE IN MOUTH); CHILLS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma allergies- used nasal-spray acid reflux- on nexium 20 mg twice daily chronic coughuse, alcoholic, covid-19 infection, and non smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 14:00 for prophylactic vaccination. Concomitant medications included esomeprazole magnesium for stomach -acid reflux. On DEC-2020, Laboratory data included: COVID-19 (NR: not provided) positive (units unspecified). On 11-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced decreased appetite. On 12-MAR-2021, the subject experienced tiredness. On 12-MAR-2021, the subject experienced taste peculiar (funny taste in mouth). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, decreased appetite, tiredness, and taste peculiar(funny taste in mouth). This report was non-serious.
on the evening  following the vax pt devel t104, vomiting, fussiness;
Chronic Spontaneous Urticaria - Non responsive to Histamine I & II, High dose Prednisone over 30 days 40 mg with 4  week taper X2, Several visits to Primary Care, Urgent Care, Allergist/Asthma/Immunologists, Dermatologists with NO RESULTS  NO PREVIOUS HISTORY BEFORE THIS VACCINE
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 20-AUG-2014, the patients were vaccinated with a dose LIQUID PEDVAXHIB (lot number J014280, Expiry date 15-SEP-2016, dose and route were not reported) that was improperly stored at 48F for 39 minutes. Concomitant medications were not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Body aches and fatigue after 6 hours. By 8 hours severe headache and fever followed, persisting overnight. Accompanied by nausea, dizziness. Sickest I've probably ever felt, but then resolved completely by 9am next day.
Received standard Moderna two dose regimen in early 2021 with no adverse reaction. Received the booster on December 3, 2021 with no adverse reaction. Approximately 10 days after receiving the booster, a spontaneous, itchy rash broke out on the neck and inside wrists of both arms. This continued for 4 days before seeing the primary care doctor who prescribed Zyrtec, Pepcid, and Prednisone for 5 days. It has been 3 weeks so far, and the rashes come back if the antihistamines are discontinued.
Information has been received from a resident physician in her 20's with no pertinent medical history, who in approximately September 2008 (also reported as August 2008) was vaccinated intramuscularly with the first dose (reported as 0.5mg dose) of GARDASIL (Lot # not reported). On an unspecified dates, she was vaccinated with the second and third doses (reported as 0.5mg doses) of GARDASIL (Lot # not reported). There were no concomitant medications. The physician reported that on August 2008, she experienced a lymphadenopathy while receiving a dose of GARDASIL. She stated that she had lymph nodes under her arms as well as neck pain and was hospitalized. A biopsy was performed and her condition was determined to be benign. Also a CBC test and Monostat tests were performed (result not provided). At the time of the report, the patient had not recovered. Additional information has been requested.
Severe rash started on the back of my knees. Stomach, underarm, legs lower back and top of feet. Unbearable itch.  Caused me to lose time off work and visits to 5 different dr?s with no solution.
1st Vaccine - Uncontrollable shaking of body, feeling like an electrical current running through body,  very weak and chills went on for nearly 3 hours.  Went to ER. After being checked out - all vitals normal, given IV fluids - went home.  Sensation of electrical current through body went on for nearly 2 weeks lessening each day.   2nd Vaccine - severe migraine that lasted all of first night after vaccine, following day chills, migraine and fever of 102.6.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there was no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the state at this time. It was also reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
localized redness swelling pain and induration started 24 hours after injection raised itchy rash at its worse 48-72 hours after administration has improved on its own.
fever onset on 14DEC92; temp could not be controlled w/APAP; temp would noly dec for a couple of hrs; & then inc again emesis x 2 or more in last 24 hrs;
Information has been received regarding a case in litigation concerning a male patient who was vaccinated sometime during the period from June 1998 through December 1999 with a dose of hepatitis B virus vaccine. Reportedly the patient was subjected to very high doses of mercury contained in thimerosal-containing vaccines administered during the first 2 years of life and was therefore poisoned by the cumulative doses of thimerosal. Subsequently, it has been alleged that as a result of mercury in the thimerosal-containing vaccines that the patient received as an infant, he now suffers and in the future will continue to suffer from the toxic neurological effects of mercury poisoning. Upon internal review, the toxic neurological effects of mercury poisoning were considered to be other important medical events (OMIC). Additional information is expected.
Swelling and pain in peripheral joints, knees, wrists, MCP and IP joints of the hands. Metatarsal joints in the feet, lasted 4-5 days. Pain with work, ADL.