chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received via a letter to the company from the mother (who is also a lawyer) and refers to her daughter of unspecified age. The mother stated her daughter was a previously healthy young lady and never had a gastrointestinal or autoimmune issue ever before in her life. On an unspecified date, her daughter was vaccinated with GARDASIL (lot number not provided). The mother stated she just discovered that her perfectly healthy daughter's immune system and gastrointestinal tract were injured by the GARDASIL vaccine. She stated GARDASIL was the catalyst to her daughter's ulcerative colitis - a case so severe that 2/3 of her colon was filled with bleeding ulcers. She stated "the doctor was afraid she would have to have her colon removed at the age of 22!" She also stated GARDASIL caused her daughter to have a seizure. The outcome of the events were unknown. The reporter stated that prior to filing a lawsuit, she was contacting the company to give the chance to seriously discuss a pre-suit settlement. Upon internal review, ulcerative colitis, 2/3 of her colon was filled with bleeding ulcers, and seizure were considered to be medically significant. Additional information has been requested.
History of present illness from office of 8/22/14: Concerned for possible reaction to PPV23 vaccine (given on 8/20/14). The arm was sore immediately after injections; reports that the R upper anterior biceps region became swollen and red 2 hours later. No fever or chills. Felt short of breath, hard to swallow- feels like throat is clogged. No hives/rash. No difficulty swallowing, facial edema, wheezing or stridor. Went to ER last night (report not available). Does have Rx with her for NORCO 5-325 and Clindamycin (from ER). POC: Advised not to fill Clindamycin or NORCO prescriptions. This does not appear to be cellulitis but instead a localized reaction to the injection. SOLU MEDROL injection today. Cold compressess the area. May take acetaminophen as directed. BENADRYL as directed for itching. Advised if develop shortness of breath, stridor, face, eyes, or mouth/tongue swelling or hives to go to ER. Hospital ED 8/21/14 (just before midnight to early morning): This is a 30 yr old...She states by the time she got home she noticed some localized redness around the area and seemed to progress by getting larger and larger and tracking further down the arm. Because she is having quite a bit of a burning sensation and the redness there, she was concerned and came to in for evaluation. She denies any itching, fever, chills. 8/28/14 @ 2:25 I called patient and asked how her arm is doing. She said that after that shot (SOLU MEDROL) her arm was better by the time she go home. The swelling and redness went away. The soreness lingered till the next day.
2125-patient reports she is not feeling well, while sitting in the waiting room. Patient reports she feels a warm sensation all over her body and epigastric discomfort. Vital were assessed. Denies chest pain, shortness of breath, difficulty breathing, dizziness.  Patient reports symptoms were not improving, patient sent to ER for evaluation at 2140. Report given to PA.  no medication given in clinic.   Patients airway is patent, alert and oriented to person, place, time. answering questions appropriately. walking on own.  Husband transported patient to hospital.
Pt received vax had that evening onset of chills, next morning T 103, & chills, aching, anorexia, lethargy, vomiting. Recovered
Shingles about 2 months after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles about 2 months after vaccination) in a male patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles about 2 months after vaccination). At the time of the report, HERPES ZOSTER (Shingles about 2 months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported  It was reported by reporter that her friend's husband was vaccinated with Moderna and developed shingles about 2 months after vaccination.
About 28 hours after booster I started having atrial tacycardia and my heart rate was in the 150's-160's. I took a rescue dose of Metoprolol of 50mg and started drinking LOTS of water which amounted to almost 1 gallon over 2 hours and my HR did not slow down or become more regular. Finally at 6pm I took another 25mg and my HR slowed to only in the 120's and became more regular but was still pounding in my chest. I was instructed by my cardiologist not to exceed 75mg of metoprolol in the past when this occured so finally at 8pm I went to the ER. All lab work ordered was normal but EKG was not. I stayed in atrial tacycardia for 10 HOURS before I converted back to sinus rhtym. I have NEVER in my life been in in that long!! It has only ever lasted 3 hours at the most so I can only attribute this to the booster since it was the day before. I have been having atrial tachycardia every day since and it is now 5 days later but only in 15-20 min runs but this is very stressfull and I get worried it is not going to stop again. I have an appoint ment with my cardiologist in a few weeks for an ecchocardogram and a 2 week halter monitor now.
pt recv vax 14APR99 lt deltoid & 15APR99 lt arm swollen w/induration & warmth;
Another terrible headache; worst headache of her life; weakness; walking around like she got hit by a truck; could not eat; felt awful all day; Chills; nausea; dry heaving; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaving), ASTHENIA (weakness), FEELING ABNORMAL (walking around like she got hit by a truck), DECREASED APPETITE (could not eat) and FEELING ABNORMAL (felt awful all day) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced RETCHING (dry heaving), FEELING ABNORMAL (felt awful all day) and NAUSEA (nausea). 04-Feb-2021, the patient experienced CHILLS (Chills). On 07-Feb-2021, the patient experienced DECREASED APPETITE (could not eat). On 08-Feb-2021, the patient experienced ASTHENIA (weakness). 08-Feb-2021, the patient experienced FEELING ABNORMAL (walking around like she got hit by a truck). On 09-Feb-2021, the patient experienced HEADACHE (worst headache of her life). On 10-Feb-2021, the patient experienced HEADACHE (Another terrible headache). At the time of the report, RETCHING (dry heaving), ASTHENIA (weakness), FEELING ABNORMAL (walking around like she got hit by a truck), DECREASED APPETITE (could not eat), FEELING ABNORMAL (felt awful all day), CHILLS (Chills), HEADACHE (worst headache of her life), NAUSEA (nausea) and HEADACHE (Another terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt c/o nauseated, upset stomach, cramping, dizzy, weak, sweating, chills, body aches. Took MOTRIN and laid down.
While in observation, patient reports being lightheaded and hot. Patient became diaphoretic and pale. Mother and patient state she does this after every injection. Ice pack, cold water, and snack provided. Pt feet propped on chair. Pt. waited additional 15 minutes and states she was feeling better and ready to go. ER/UC precautions given.
The day after the vaccine in the evening she became confused and her husband couldn't understand her so he took her to the emergency room and she doesn't remember anything after that.  She was in the hospital for 3 days.  She had no illness prior.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was discharged from hospital around 2/16/21 where he was evaluated for chest pain. He had paroxysmal afib and wide complex tachycardia. Other comorbidities include CAD w/ CABG, HTN, HLD. No mention in chart of circumstances surrounding death. Patient was 77.
Moderna Covid-19 Vaccine EUA Mild swelling and soreness for several days at the injection site.  No other symptoms.  Facility administering the vaccine insisted we report any side effect, even one this minor.
Starting the next day, it got worse over the next day or so. There was a red warm rash at the injection site and it started spreading down to right elbow. I went in to see the doctor at urgent care and was prescribed Keflex for 10 day. It went away. Around April, I developed a sore right ankle and went in to see a podiatrist on May 10, 2021 and was diagnosed to tendonitis. I was given a steroid injection. It's getting better but I am still not at 100%.
Systemic: Vaccine stored out of range-Mild, Additional Details: vVaccine stored out of range
03/14/2006 approximately 4:00PM patient returned to clinic with complaint of hives, shortness of breath, dizziness, anxiety.  Given 0.3mg epinephrine and oxygen.  Approximately 4:25PM transported to er via paramedics.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. Patient never had any health issue in past medical record and he claimed a very healthy physic history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 17-JUN-2021, the patient got COVID-19 test result positive. The patient experienced suspected clinical vaccination failure and suspected covid-19 infection. He stated that he did sports activities very regularly. He was closer to one of his friend with asymptomatic but COVID-19 positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000183485. The suspected product quality complaint has been confirmed to be non-voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210644973-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
felt like the left side of her body was numb; felt bad; blurred vision; dizziness; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 57-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiry date unknown) via an unspecified route of administration on 19Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 19Apr2021, the patient experienced difficult breathing, difficult to swallow, dizziness, headache, tachycardia, low blood pressure, redness in her face, felt shortness of breath and felt bad right after received the vaccination. 30 min after administration, the patient was admitted to the emergency room to manage the condition and was in observation for 3 hours and was diagnosed as anaphylactic reaction to the vaccine. After being released from the emergency room, the patient was experiencing blurred vision, tachycardia, continuous headache, felt like the left side of her body was numb, had nausea and dizziness. The patient was treated with benadryl and ondansetron in emergency room. Outcome of the events were reported as unknown.  Follow-up attempts are needed. Further information is expected.
Rash; Hives; Slight fever; This spontaneous case was received on 14-Nov-2022 from other healthcare professional (reference number: SEQW22-05776) with additional information received on 15-Nov-2022 (being processed together) and concerned a male patient of unknown age.  The patient's concurrent condition included flu. The patient's concomitant medications were not reported.  On 11-Nov-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 942444.  On the same date, after receiving Flucelvax Quadrivalent the patient experienced a rash and hives. The patient also had a slight fever.  On an unspecified date in Nov-2022, the patient visited a physicians office, the patient presented a rash and hives, and also had a slight fever. The physician stated that probably the patient was infected with flu at the time he received the vaccine.  Outcome of the events was unknown.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event of rash, hives and fever are assessed as possible related to Flucelvax Quadrivalent due to plausible temporal relationship.; Sender's Comments: The event of rash, hives and fever are assessed as possible related to Flucelvax Quadrivalent due to plausible temporal relationship.
Patient reported a red mark on the muscle a handful of days after vaccination was given. Pt then reported shoulder pain to her doctor who reportedly diagnosed it as a vaccine incorrectly given in the bursa of the shoulder. Patient was then prescribed Prednisone for the reaction.
My right arm/elbow/shoulder muscles/ligaments/joints have been inflamed/achy since 09/29/2021 and have not improved.  My ligaments in my elbow are stiff at times and it is painful to use. I have been trying to not use my arm to lift to heavy of objects as I feel I will damage it worse.
At about 6 pm I started having stomach cramps and diarrhea. The cramps worsened and by midnight the pain was at a nine. I was vomiting with intense force but nothing was coming up. My abdomen was bloated to the point where I couldn't stand upright and breathing was very painful. I was in that condition for about 12 hours before the swelling began to lessen. Now, 2 days later, I am still unable to eat and drink as normal and have moderate gastrointestinal discomfort with bloating.
really low energy; This is a spontaneous report from a contactable female consumer. This female consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date and unknown if ongoing tested positive for covid in July. The patient's concomitant medications were not reported. on an unspecified date the patient stated that she tested positive for covid in July she took the antibody test and had relaly high antibodies. After testing negative., she decided to get the first dose of the Pfizer covid vaccine had really low energy since getting the covid vaccine she was wondering if she can wait longer before getting the second dose of the vaccine the patient underwent lab tests and procedures which included antibody test: high antibodies, sars-cov-2 test: positive, sars-cov-2 test: negative. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Skin rash from 2017 to 01-Jan-2022 and COVID-19 (7 days) from 25-Mar-2021 to 01-Apr-2021. Concurrent medical conditions included Rheumatoid arthritis and Allergy to chemicals (Sulfur allergy). On 01-Sep-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired). On 01-Mar-2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant). In 2022, FATIGUE (Felt tired) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events of rheumatoid arthritis flare ups and felt tired with Humira (adalimumab) was no reasonable possibility. No treatment medication was provided. Company comment: This is a spontaneous case concerning a 47-year-old female patient with a relevant history of rheumatoid arthritis, who had the unexpected serious (medically significant) adverse event of special interest of Rheumatoid arthritis flare up, which occurred 1 month, 5 days after receiving the third dose of mRNA-1273 vaccine. The outcome was reported as not resolved. No diagnostic workup to support the diagnosis and treatment medication were provided. Underlying history of rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-642630 (Patient Link). Sender's Comments: This is a spontaneous case concerning a 47-year-old female patient with a relevant history of rheumatoid arthritis, who had the unexpected serious (medically significant) adverse event of special interest of Rheumatoid arthritis flare up, which occurred 1 month, 5 days after receiving the third dose of mRNA-1273 vaccine. The outcome was reported as not resolved. No diagnostic workup to support the diagnosis and treatment medication were provided. Underlying history of rheumatoid arthritis could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jan2021 as dose 1, single (Lot number: EK4176), in right arm, on 29Jan2021 as dose 2, single (Lot number: EL9262), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure-mild" (unspecified if ongoing), notes: high blood pressure-mild; "significant childhood asthma" (unspecified if ongoing), notes: significant childhood asthma; "kidney stones" (unspecified if ongoing), notes: kidney stones; "Elevated BMI" (unspecified if ongoing), notes: elevated BMI. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROTONIX [OMEPRAZOLE]; LEVOTHYROXINE; QNASL nasal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information expected.
Flu shot first week in October 10/98, by 10/12/98 huge infected mass forms on chest rather got flu symptoms immediately after shot. WBC doubled over night and WBC kept rising, RBC falling until dead 5 months later. March 10, 1999 cortizons injected to knee March 14, 1999 dead.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown demographics. The patients medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) lot # reported as L025206, expiration date: 07-JUL-2017 (dose and route were not provided), which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
devel total body red, maculopapular, pruritic rash 48hr p/vax;
This initial spontaneous case, was received on 21-Sep-2017 from a pharmacist, concerning a patient of an unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intravenous push, batch number, expiry date, anatomical location: not reported). It was reported that, AFLURIA QUADRIVALENT was given to a patient via IV (intravenous) push instead of IM route (explicitly coded as incorrect route of drug administration). The reporter assessed the events as non-serious.
This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose, lo#, expiration date and indication were not reported). No concomitant medications were reported. There was no adverse effects reported. Additional information has been requested.
Within an hour of the vaccine, her arm started to ache. No redness or tenderness to touch. Arm continued to be sore, was evaluated on 10-6-09. Vaccine was given by travel nurse.
Patient answered "No" to have you received any vaccinations in the past 2 weeks"  and did not disclose Td/Tdap vaccine that was administered on 3/14/2021 at the vaccination station.  When the patient proceeded to the station to register for a second dose appointment he indicated that he had recently had a Td/Tdap vaccine.