chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GARDASIL 9 causes postural orthostatic tachycardia syndrome; This spontaneous report was received from a physician via a company representative regarding unspecified patients of an unknown age and gender seen on social media. Details on pertinent medical history, concomitant medications and previously drug reactions or allergies were unknown by the reporter.  It was reported that parents of unspecified patients told the physician that they have seen on social media that HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) caused postural orthostatic tachycardia syndrome.  Therefore, it was reported that on unknown dates, unspecified patients could have potentially been vaccinated with HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) injection (INJ), intramuscularly to prevent certain human papilloma virus (HPV) related cancers (prophylaxis) (strength, dose, dose number, and frequency were not reported; lot number, and expiration date were unknown by the reporter), and then the patients were diagnosed with postural orthostatic tachycardia syndrome, however the physician reported that was unaware of any patients being administered HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and then being diagnosed with the aforementioned event. The event was not reported as a cancer event, or if it was related to a congenital anomaly. Furthermore, it was unknown by the reporter if treatment was given for the event, or if laboratory diagnostics or studies were performed to the patient.  It was not reported if the patients continued with the schedule of the suspect therapy. At the time of this report, outcome of the event postural orthostatic tachycardia syndrome was reported as unknown.  The parents of the unspecified patients considered the aforementioned event postural orthostatic tachycardia syndrome to be causally related to HPV RL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9), however the reporter did not provide a causality assessment between the event and the suspect therapy.  This is a non-valid case due to lack of patient identifier.
Swelling - extreme left anterior thigh, site of DTaP; No hx bleeding @ site after vaccine.
Over 5 hours progressively worsening symptoms of allergic reaction in order: Fatigue Itchy throat Chest tightness Cough Wheezing Shortness of breath Took 2 benadryl which did not improve symptoms and then went to the ER at ~8:30 pm. Given IV fluids, pepcid, and dexamethasone which resolved symptoms and was discharged around 11:30pm.
I had bizarre night terrors or nightmares. Zombies were chasing me and my family and I remember a constant black bile substance that was ubiquitous in my environment. I awoke suddenly at 6:45 AM.
The next day got a nose bleed that lasted for 2 days.; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 at 10:00 (at the age of 78 years) in right arm at single dose for covid-19 immunisation.  No other vaccine given in four weeks. No covid prior vaccination and no covid tested post vaccination. Not Known allergies. Medical history included Heart trouble, cancer (cancer survivor), high blood pressure, Alzheimer, bleeding ulcer, chronic obstructive pulmonary disease.  Concomitant medication included lisinopril, isosorbide mononitrate, metoprolol tartrate.  On 06Feb2021 at 16:00 the patient experienced a nose bleed that lasted for 2 days.  No treatment was given. The event was non-serious with outcome of resolved. Information on the lot/batch number has been requested.
Treatment of COVID-19/testing  positive with symptoms; Treatment of COVID-19/testing  positive with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 17:00 as dose 1, single (Lot number: El3246), in left arm, on 16Feb2021 at 12:00 as dose 2, single (Lot number: En6201), in left arm and on 03Nov2021 at 14:00 as dose 3 (booster), single (Lot number: Ff2593) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jan2022, stop date: 21Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19/testing  positive with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Apr2022) positive; (29Apr2022) negative; (09May2022) positive, notes: tested positive home test and also at urgent care rapid test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course included the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. First day of testing  positive with symptoms 21Apr2022. Finished 5 day of PAXLOVID on Tuesday morning 26Apr2022 and tested negative on 29Apr2022 and 20. on 09May2022 same symptoms returned and tested positive home test and also at urgent care rapid test.
Dose administered after 30-day Use By Date; No adverse event; administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy and Drug allergy.    On 23-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Feb-2023 at 10:21 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (administered the Moderna bivalent vaccine yesterday on 23Feb2023 and the Use by date was 22Feb2023.) to be related and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    Concomitant medications details were not reported by the reporter.  Reportedly, 6 veterans administered the Moderna bivalent vaccine on 23-Feb-2023 and the use by date was 22-Feb-2023. Vial size was reported as 2.5 ml. Vial did not undergo any temperature excursion.  On 27-FEB-2023, Case  MOD-2023-712565 became invalid as it was confirmed that there is no single identifiable patient.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow up received contains non significant information. On 01-Mar-2023: Significant follow up appended_ patient and product details and narrative part updated
headache-numbness on left side of my face lip to my eye brow shot site of arm hurt  all for 2 days.
I have TERRIBLE pain in my left armpit. Has been going on for two days. The pain radiates and is a bit swollen as well.
Chills, joint pain, back ache, red injection site and pain down right arm, headache; all of above lasted 48 hours. Right arm pain lasted for 7 days. Slept for 2 days sporadically. Continued prescribed meds. Drank water and did not eat.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On unknown dates, those patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot # L048236 with expiry date: 31-MAR-2018; lot# L033343 with expiry date: 13-SEP-2017 and lot# L040458 with expiry date: 04-FEB-2018; strength, dose, route and site of administration were unspecified). The administered vaccines underwent the temperature excursion at 25 degree Fahrenheit for 11 hours and at 50 degree Fahrenheit for 3 hours 26 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Caller is starting to get a stomach ache; This is spontaneous report received from a consumer via Pfizer-sponsored program Pfizer First Connect. A contactable female patient (Consumer) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took famotidine. It was reported that, the patient (caller) received first dose this morning, 2 days before vaccination she stopped taking Famotidine. The patient said that before she took the COVID vaccine this morning on 09Feb2021, about 5 hours ago, she did not take her Famotidine. It had been about four hours since the vaccine and the patient wanted to know if it was okay to take Famotidine. The patient started to get a stomach ache without medication on 09Feb2021. She remembered one pharmacist telling her that the Famotidine/Antacid hinders in the absorption of medications you can take. That was the reason she did not take it. She wanted to make sure that the vaccine would be absorbed completely by her body. Not taking her medication was voluntary on her part. She was afraid that it would hinder any absorption of the vaccine. She was calling to see if she can resume taking her medication. "She wants/needs to take it now". She was calling to see if it would affect the absorption of the vaccine. She was wondering can she resume it. From what she knew, the vaccine was absorbed by the muscle and not the stomach, she asked if that was true. She read that part, and the nurse who injected her said that the vaccine was absorbed by the muscle in the body, not directly from the stomach. She was not in the medical field, but her assumption was that since both medications were absorbed differently, there would be no interaction. The patient clarified that the Famotidine was a prescription. The outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
It was reported that a 48 year old male patient received his Fluzone vaccination in his left deltoid on 11/06/01. pain in left auxilla and chest started right away and has lasted 5-6 days. Patient has swelling of the left auxillar and chest area as well as his left hand. Patient has been diagnosed with carpel tunnel in his left hand so the numbness and tingling may be the result of that. Further information is requested.
This spontaneous report as received from a pharmacist refers to a 44 year old female patient. On 19-SEP-2014 the patient was vaccinated an expired dose of PNEUMOVAX23 (lot # J009827, expiration date: 10-AUG-2014, dose, units, frequency, route of administration, anatomical location were not reported). No adverse experience had been observed or reported.  Additional information has been requested.
Went for a MRI on her pelvis and during the MRI her body got very hot. Before the MRI a couple days after the vaccine she was getting hot and cold flashes, headaches and tiredness. During the MRI her whole body she felt like it was burning a hole in her. She had to stop the MRI. 3 days after the MRI she was still burning up and was cold. When she get hot flashes they are very painful.
big painful lump under her armpit; having some pain in the armpit/it was still quite painful; swelling; This is a spontaneous report from a contactable physician (patient). A 39-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 06Oct2021 as dose 3 (booster), single for COVID-19 immunisation. Family medical history included breast cancer. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single and via an unspecified route of administration on an unspecified date as dose 2, single both doses for COVID-19 immunization. She had third shot, she had it 10 months after having the other doses. Caller was a physician she was calling to report an adverse reaction for herself who received the Pfizer Covid vaccine 2 days ago on 06Oct2021 and noticed then last night on Oct2021 discovered a big painful lump under her armpit. She was wondering if Pfizer had any directions on this. She just wanted to know if Pfizer has any data on how quickly this may go away. She was worried, oh my God do she need to get a mammogram, because she do have a strong family history of breast cancer, she was talking to another colleague, and she said it just hit her, she got the vaccine on wednesday (06Oct2021) and in Oct2021 the swelling, was pretty big she could feel the lump, it was quite tender, and was in the same armpit of the arm she took the vaccine and exactly 24 hours after she took the vaccine it started, 24-36 hours after, so she would like to know how long does it take to resolve. she could feel it and was painful, it was still quite painful. Response received includes in general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response.3. Seriousness of the events was non serious. The outcome of the events was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
On 10/30/08 started to develop a large oval induration on the left deltoid that was warm to the touch that progressed into an infection; physician diagnosed cellulitis.  Has a dime size 1/4" hole on her left deltoid muscle.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2008, the patient was inoculated (by an unspecified healthcare professional person) with ZOSTAVAX at a family practice office, recommended for routine adult health maintenance for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, she was treated (by an unspecified healthcare professional) at the family practice office for a blistering vesicular outbreak and decreased immune symptoms which was then 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 outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Reddness, inflammation and  rash on site of injection about 3-4 inches in diameter
This case was reported by a healthcare professional and described the occurrence of rash on trunk in a 35-year-old female subject who was vaccinated with ENGERIX B. On 21 August 2008, the subject received the 2nd dose of ENGERIX B. On 21 August 2008, 6 to 7 hours after vaccination with ENEGERIX B, the subject experienced a rash on her trunk, arms, and legs. The subject was treated with Benadryl and ZYRTEC. At the time of reporting, the outcome of the events was unspecified. The reporting nurse stated that the subject did not experience any events following the 1st dose of ENGERIX B. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B.
tested positive for COVID 19; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (tested positive for COVID 19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (tested positive for COVID 19). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (tested positive for COVID 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided  Treatment medication was not provided
Nurse 1 was pulling out needle from vial after dilution for Pfizer COVID 19 Vaccine (5-11 y/o) and Nurse 2 noticed the syringe that Nurse 1 used to dilute was a 5 cc syringe not a 3 cc syringe. Therefore, the vaccine was diluted with 1.6 mL NS not 1.3 mL. One vial had previously been diluted with the same syringe in the morning session and 10 vaccines were given. Parents of the children who received the vaccine in AM session will be called and notified. Provider, Supervisor and Nurse Manager were notified. Pfizer and CDPH COVID Call Centers were called/consulted; both gave the CDC resources/instructions (COVID-19 Vaccine-Administration Errors and Deviations) that states, for this diluent error/deviations ?do not repeat the 1st dose? and they recommended that children receive their second dose as scheduled. Second vial was wasted with 10 doses.
She was in the hospital; Greater than 35 days since the patient received her first Moderna Covid-19 vaccine; Swelling in right arm injection site area; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (She was in the hospital) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swelling in right arm injection site area). On an unknown date, the patient experienced HOSPITALISATION (She was in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her first Moderna Covid-19 vaccine). At the time of the report, HOSPITALISATION (She was in the hospital), PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her first Moderna Covid-19 vaccine) and VACCINATION SITE SWELLING (Swelling in right arm injection site area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information about the event hospitalization has been requested.  This report refers to a case of product dose omission for mRNA-1273, lot # 037B21A.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information about the event hospitalization has been requested.  This report refers to a case of product dose omission for mRNA-1273, lot # 037B21A.
Covid positive 4/19/2021, off balance, weak/tired, trouble hearing, cannot taste, cough, runny nose, reports not short of breath but breathing heavy, fever comes and goes,
Woke up the next morning with swelling to eyes and itching. Stated she had some increase in SOB. She was seen and treated with Steroids. She started felling better on the afternoon of 10/06/18.
Pfizer Covid-BioNTech 0.2ml dosage was given without reconstitution
No Antibodies detected (lack of efficacy); This spontaneous case was reported by a pharmacist and describes the occurrence of ANTIBODY TEST NEGATIVE (No Antibodies detected (lack of efficacy)) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (No Antibodies detected (lack of efficacy)). At the time of the report, ANTIBODY TEST NEGATIVE (No Antibodies detected (lack of efficacy)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.