chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. The patient was treated by a physician for the onset of a rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
1. Sever hemi hyperesthesia R arm/chest/back which lasted about 72 hours. 2. Edema R arm & hand which lasted about 24 hours. 3. Fatigue which lasted about 1 week. 4. Pain & weakness in R shoulder which has not resolved.
Swelling of tongue, throat, face, eyes, nausea I dose from Epipen Swelling came down but then came back 911 was called- transported to  ER. Given a 2nd dose of Epinephrine en route which caused me to have an immediate heart attack
More than 36 hours of ... incapacity. Slept about 28 hours of the first 36 after the vaccine. Felt VERY washed out. ( I usually bicycle over 100 miles a week, so I am normally neither frail nor feeble)  Unlike previous Moderna Covid vaccinations - they have always been significant for me - I was not aware of a fever and I did not notice a lowered serum oxygen this time.
This case was reported by a healthcare professional (nurse) and described the occurrence of headache in a 50-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject's medical history included migraine. On 29 January 2013 at 17:00 the subject received a 0.5 ml dose of FLULAVAL (unknown details). On 29 January 2013, 3 hours after vaccination with FLULAVAL 2012-13, the subject experienced headache and nausea. The reporter described the headache and nausea as severe without vomiting. No diarrhea was reported per the reporter. The nurse stated that the subject contemplated going to the hospital but did not. On 30 January 2013, the events were resolved. The nurse stated that the subject reported being "75 percent" better by the next morning. The nurse stated that all events had resolved by noon the next day, 30 January 2013.
This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (two doses of the Moderna covid vaccine and it was the 2nd dose she got sick) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The patient's past medical history included Bladder infection (bladder infection at that time and ended up in the hospital for vomiting and she couldn't stop vomiting.) and Foot surgery (right foot was 6 weeks ago). Previously administered products included for Prophylaxis: Shingrix (Several years ago had some other shingles vaccine right arm); for Arthritis: Meloxicam. Past adverse reactions to the above products included No adverse event with Meloxicam ; and Shingles with Shingrix. Concurrent medical conditions included Arthritis (Takes Meloxicam for arthritis.). On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (two doses of the Moderna covid vaccine and it was the 2nd dose she got sick). At the time of the report, ILLNESS (two doses of the Moderna covid vaccine and it was the 2nd dose she got sick) outcome was unknown. Patient ethnicity was reported. No concomitant medications was provided by the reporter. Patient had two doses of the Moderna covid vaccine and it was the 2nd dose patient got sick on and does not know the dates, lots, expiry dates or NDC numbers to provide. Patient remembers they stuck her in the arm and it was very different because it is a different kind of medical care going through a drive through. Patient received Prevnar 20 vaccine on 14Jul2022 08:30am 1st dose administered to left arm and experienced some events such as soreness, feel nauseous, chills, vomiting. Patient had shingles with the 2nd covid vaccine but it was never clear if it was because of the vaccine or there was something else as patient had a bladder infection at that time. No treatment medications was provided by the reporter.
Vaccine was administered on (R) deltoid on 2/18/13. That night pt started with swelling , red & soreness, and painful. Sx still going on today.
tiny rash on left side of stomach, and small amount on inner left forearm, very itchy. and itching still continues. I used Benadryl spray on it.
2 1/2hrs p/vax high-pitch cry, screaming x 5hrs, didn't want to eat, swollen leg fr knee to hip; Tempra was given every 4 hrs;
Panic attacks, hallucinations, talking to himself, pounding, screaming, not be able to focus on anything, psychosis
Fever 100.2, headache, shivering, sore arm 9:00 pm Fever 102.0 headache, sore arm, 7:00am 3/7/21
This medically confirmed spontaneous report (initial receipt 18-May-2015) concerns a female patient. The patient had drug reactions/allergies to sulfa. On an unspecified date, the patient received unknown influenza virus vaccine (batch number not reported). On an unspecified date, the patient developed localised swelling at the injection site. The outcome was reported as recovered. Linked case: 2015051263 (same patient).
VACCINATION ERROR; SORE FEELING IN HER ARM; stressed; depressed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (VACCINATION ERROR), PAIN IN EXTREMITY (SORE FEELING IN HER ARM), STRESS (stressed) and DEPRESSED MOOD (depressed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION ERROR (VACCINATION ERROR), PAIN IN EXTREMITY (SORE FEELING IN HER ARM), STRESS (stressed) and DEPRESSED MOOD (depressed). At the time of the report, VACCINATION ERROR (VACCINATION ERROR), PAIN IN EXTREMITY (SORE FEELING IN HER ARM), STRESS (stressed) and DEPRESSED MOOD (depressed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
830PM mom was holding pt & pt spit up & while mom wiped face noted pt was turning blue in the face, ear to ear; respirations were shallow, cry was weak, quieter, body was rigid; lasted 1 min, p/which color returned, resp & cry improved;
This case was reported by a consumer and described the occurrence of high fever in a 4-month-old female subject was vaccinated with Pediarix vaccine for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject's medical history included sinus allergy. The subject experienced a low grade fever following receipt of prior unspecified immunizations. Concurrent medications included Paracetamol (Tylenol). On 12 July 2004, the subject received the 1st dose of Pediarix. On 23 August 2004 the subject received 2nd dose of Pediarix. On an unspecified date in August 2004, less than one week after receipt of the 2nd dose of Pediarix, the subject experienced a high fever and was seen in an emergency room. The subject was treated with unspecified "medication to reduce the fever" and the fever resolved on an unspecified date. The vaccination course with Pediarix was discontinued. At an unspecified time following receipt of the 2nd dose of Pediarix, on an unspecified date, the subject's "overall development slowed down". On 14 November 2006, the subject was diagnosed with autism. The consumer reported that the events were considered disabling. At the time of initial reporting, 05 February 2007, the development delay and autism were ongoing.
Pt. states that after receiving the 3rd dose of Phizer 01/14/2022, started experiencing symptoms that evening of vertigo, nausea, and blurry vision lasting 4hrs. No noted Primary visit/communications.
Information has been received from a physician concerning a 78 year old female with a history of chickenpox as a child, rheumatoid arthritis, diabetes, hypertension and no drug reactions/allergies, who on 15-OCT-2007 (also reported as 09-OCT-2007) was vaccinated SC in the left deltoid with a first 0.65 mL (also reported as 0.5CC) dose of zoster vaccine live (Oka/Merck). Concomitant therapy included: prednisone 10 mg daily; methotrexate 10 mg weekly; lisinopril; Ditropan; Chromagen; aspirin;folic acid; Darvocet-N; Aleve; Prilosec; insulin. On 16-OCT-2007 (also reported as 10-OCT-2007), the following day the patient experienced a diffuse rash on the left anterior chest, left neck and left occiput. The rash did not occur at the site of the injection or elsewhere within 42 days of vaccination. The patient's maximum temperature was 99 degrees. The patient quantified her pain as a 10/10. A direct fluorescent antibody was not done. The patient was diagnosed with shingles. She was treated with Valtrex and Neurontin. The physician stated that the patient has typical shingles, localized and not disseminated at the time. No additional information was available. No lab diagnostics studies were performed. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested. Follow-up information has been received from the physician stating that his patient has been on methotrexate for about 10 years and was stable, so he did not think of her as an immunocompromised patient. However since she is immunocompromised, he was worrier that she might progress to a disseminated case and wanted to know how he should treat her. He asked if he was treating her effectively with Valtrex and Neurontin or should he be treating her as if she had a disseminated case. The physician stressed his concern for the patient. On 02-NOV-2007, the physician collected health Zoster lesions from the left side of the neck for PCR. The specimen arrived in the laboratory on 07-NOV-2007. The results indicated the VZV DNA was amplified. The VZV strain identification showed a Wild-type. The B-globin DNA was amplified. The interpretation was adequate specimen, wild type strain. A direct fluorescent antibody was not done.  A photo was not taken. The patient did not have a recent exposure to chickenpox or shingles. The patient's maximum pain level was a ten. The outcome was reported as recovered.
Moderate swelling of neck causing hoarseness, tenderness, and loss of voice lasting approximately 2 days. Slight swelling, pain, and redness of injection site that currently persists. Early onset (7 days) of menstruation with sudden heavy bleeding. Low-grade fever, nausea, fatigue, muscle aches, weakness, and generally not feeling well for approximately 4 days.
Within 10-15 min's developed hives at the injection sites. Resolved with ice and BENADRYL.
Joint pain; Unable to open my hand/to roll over in bed; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Joint pain) and MOBILITY DECREASED (Unable to open my hand/to roll over in bed) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (Joint pain) and MOBILITY DECREASED (Unable to open my hand/to roll over in bed). On 24-Feb-2021, ARTHRALGIA (Joint pain) and MOBILITY DECREASED (Unable to open my hand/to roll over in bed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was reported as steroid pack. Action taken with mRNA-1273 in response to the events was not reported.
developed sx of sore throat and congestion- tested positive on rapid test 10/14/22
On 05/19/2022 my adverse event started in the morning around 8:00AM. I had fever, runny nose, cough, sore stomach,  fatigue, diarrhea, chest pain, and headaches. I took ibuprofen as needed. I felt better for a few hours then the symptoms came back again. It was going for 3 days. I took zinc, fresh ginger root and other over the counter medications. I didn't  contact my doctor. I was alternating medications. I also took homeopathic medications. I drank plenty of fluids to keep myself hydrated. I wasn't able to walk around. I still have the lingering symptoms as of today 12/06/2022 such as tingling of my hands and feet, fatigue, joint pains, and brain fog. I get exhausted very quickly.
Patient's spouse called into the pharmacy at approximately 5:30 pm and reported that the patient was having arm pain, swelling, fever, nausea/vomiting, and fatigue. Pharmacist delivered cetirizine and TYLENOL to the patinet at 7pm to help with symptoms.
Severe menstrual cramps; Fever; Chills; Muscle/joint aches in legs; Muscle/joint aches in legs; Headache; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 11:15 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included isotretinoin (MANUFACTURER UNKNOWN); on an unknown date, for unknown indication and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 15:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 21:30, the patient experienced severe menstrual cramps, fever, chills, muscle/joint aches in legs, headache and tiredness. Since the vaccination, on 10Apr2021, the patient underwent nasal swab SARS-CoV-2 test and the result was negative. The clinical outcome of the events severe menstrual cramps, fever, chills, muscle/joint aches in legs, muscle/joint aches in legs, muscle/joint aches in legs, headache and tiredness was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax; exp fever & leg pain & warmth around inject site; tx w/ advil, ice to area;
This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix B immunization series. Past medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
immed p/vax pt fell on the floor, hit back of head;pt upper & lower extremities stiffened & eyes rolled back;
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. In 2012, patients were vaccinated with a dose of RECOMBIVAX HB (dose, route and lot number not reported) that was improperly stored. Nurse reported that RECOMBIVAX HB was exposed to temperature as low as -1C for several occasions from January of 2012 to July of 2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, patient's outcomes were unknown. This is one of several reports from the same source. Additional information has been requested.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 23 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220309972, 20220309987, 20220310590, 20220310548, 20220310306, 20220310363 and 20220309858.
It (Covid-19 vaccine) killed cytomegalovirus as unintended side effect; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EN3602) at the age of 55 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "heart transplant", start date: Jul2019 (unspecified if ongoing); "Cytomegalovirus", start date: Jun2020 (unspecified if ongoing). Concomitant medication(s) included: TACROLIMUS; MYCOPHENOLIC ACID; VALGANCICLOVIR. Past drug history included: Acyclovir, reaction(s): "didn't do anything.". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "It (Covid-19 vaccine) killed cytomegalovirus as unintended side effect". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was heart transplant recipient and her donor gave me Cytomegalovirus. She has had it for 10 months. She first diagnosed in June 2020. That was when the virus became a problem. When she got the Pfizer shot, it got rid of it. It killed cytomegalovirus as unintended side effect.  No follow-up attempts are possible. No further information is expected.
myocarditis within 48 hours of second dose; This is a spontaneous report received from a contactable reporter (Physician). A 12-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, 30 ug single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Single; Comirnaty 10ug; Lot Number: Unknown) for COVID-19 immunization. Prior to vaccination, it was unknown if the patient had COVID-19. Post vaccination, it was unknown if the patient had COVID-19 or tested for COVID-19. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis within 48 hours of second dose". It was unknown if therapeutic measures were taken as a result of myocarditis.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the compatible temporal association and the vaccine's known safety profile, the company considers the reported event myocarditis is possibly related to the vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
SEVERE PAIN IN ARM WHERE INJECTION WAS GIVEN PAIN SO BAD I CAN NOT USE IT OR SLEEP OR GET RELIEF, IT HAS BEEN 16 SIXTEEN DAYS AND THE PAIN HAS NOT LET UP. MY WIFE HAS THE SAME PROBLEM, SHE GOT THE SAME VACCINE TWO DAYS BEFORE I GOT MINE.
Pt was vaccinated on 07/29/2021 with the J and J  COVID-19 vaccine. Pt left a message on the health district's voicemail over weekend( 07/31-08/01/2021)  stating she had developed a rash and wondered if this could be related to vaccination . Pt was called  on Monday. Pt reports a "spidery rash" that resolved the following day. Pt denies any shortness of breath, chest pain and headache. Referred pt to medical provider for follow-up and EUA Fact sheet for more information.
She had recieved her dose, she fainted while she was seated, vitals were normal incident occured at around 8:37 am.
Day 8, became very fatigued, swollen neck glands and becoming worse today with complaint of headache. Tylenol prn since 6/8/01; refer to PMD.
Patient received dose #2 of Pfizer COVID-19 vaccine. Injection was given too high (left bursae area). Patient reporting neck pain and stiffness yesterday.
Pt had swelling, pain, and redness at the injection site that occurred approximately 24 hours after the injection
The day it happened I was on my treadmill and felt a tightening in my chest so I stopped. I knew what the symptoms meant so I went to the ER and when I got there they ran all the usual tests and determined I had blockage in my LAD which is the widow maker artery. It was about 30-40% blocked. The cardiologist prescribed many heart medications and sent me home the next day. A week later I had another attack but was different symptoms it woke me up around 3:30AM. I had severe compression and I called the ambulance that time and they ended up putting two stints in. Scan for blood clots which was normal, ultrasound (heart muscle was strong), many blood tests checking for elevated heart enzymes which was mildly elevated. I now take statins, blood pressure medications, and aspirin, and Brilinta.
AT 17:40 -PATIENT STATES SHE HAS SMALL AREA RASH AND ITCH ON RIGHT ARM. NO APPARENT DISTRESS. AT 17:50 LEFT ARM NOW ITCHES, BUT STILL NO LIPS, TONGUE OR THROAT DIFFICULTIES. AT 18:00 RASH AND ITCH HAS NOT INCREASED. PATIENT HAS BENADRYL AND ZANTAC AT HOME INSTRUCTIONS GIVEN. PATIENT REFUSED TO GO BY DCH ER, BUT WILL STOP AT ER OR MEDCENTER NORTH IF WORSENS BEFORE SHE GOES HOME. NO APPARENT DISTRESS UPON DISCHARGE
This spontaneous report was received from a 55 year old female patient regarding herself. Approximately on an unknown date in 1993 (reported as 20 years ago), the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On an unknown date in 1993 (reported as 20 years ago), the patient experienced generalized arthritis symptoms especially in her legs. The symptoms lasted about 3 weeks and then subsided. The outcome of generalized arthritis symptoms especially in her legs was recovered (reported as subsided). It was unknown if patient sought medical attention. Additional information is not expected.
ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE PULMONARY EMBOLISM ALLERGIC REACTION, INIT 1/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient received vaccine from multi dose vial. Person administering vaccine gave 0.6 mL instead of 0.3 mL - equivalent to double the dose.
pt recv 25JUL96 & w/in 48hr of vax pt exp sore throat, fever to 102.3, cough, bronchospasm, malaise;tx proventil inhaler & biaxin;sx cont;