chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Golf ball size swelling to left of the right antecubital fossa; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7533) via an unspecified route of administration in the right arm on 07Apr2021 at 16:15 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, atrial fibrillation, overweight, smoker and allergy to PC (penicillin). Concomitant medications included naltrexone hydrochloride, bupropion hydrochloride (CONTRAVE), acetylsalicylic acid (ASA) and multivitamins (MANUFACTURER UNKNOWN) for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 the patient experienced golf ball size swelling to left of the right antecubital fossa. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event swelling to left of the right antecubital fossa was not recovered.  No follow-up attempts are needed. No further information is expected.
On 1/8/2021, at 8:00 PM, patient began to experience a low-grade fever, chills, body aches, muscle aches, cramps in arms and legs, nausea, fatigue and shivering.  At 4:00 AM on 1/9/2021, patient awoke with extreme fatigue, diminished eye-sight - describes as vision being "grey and mottled", and impairment of gait - stumbling when attempting to walk.  Patient was scheduled to work that morning and had to call off due to these symptoms she was experiencing.   **This was reported on 1/12/2021, at which time, the patient stated that she was currently experiencing a loss of taste and smell, and had tested positive for COVID-19 that morning.**
meningitis; coma; Initial information was received on 20-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case is linked to cases 2021SA352054, 2021SA352053 and 2021SA351848 (same reporter)  This case involves adult and unknown gender patient who experienced meningitis and coma while receiving INFLUENZA VACCINE.  Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious meningitis and coma (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant and life-threatening. The patient was hospitalized for these events.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for both events.  There will be no information available on the batch number for this case.; Sender's Comments: This poorly documented social media case concerns adult and unknown gender patient who suffered from meningitis and coma after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. However, the rationale or medical condition of the patient leading to consideration of the events as life-threatening or descriptions of the specific nature of events being life threatening was not provided. Based upon the reported information the role of the vaccine cannot be assessed.
Patient was injected with an empty steriled syringe that prepared to draw Pfizer vaccine. There was no vaccine injected to the patient's arm. The syringe was disposed in a sharp container. The patient was inform of the error in administration that she did not received the vaccine. The patient was skeptical about the situation and did not get the second dose. The error happened at 4:46pm on 9/8/2021. An error report was generated, policy was reviewed and strategies are implement to prevent future error.
5/1-itching, pain, swelling, redness at injection site tx-OTC IBU, BENADRYL. Lasted 3-4 days. 5/7-still red but no pain or itching. 2.5 inches long 1.5 inches wide.
pt recv vax 30APR96 & exp hives, itching, & soreness @ the inj site;tx DPH;sx began to resolve p/24 hr & were completely gone w/in 32hr;
2 1/2-3wk p/vax pt arrived @ ER;mom states pt vomited x 1 & quit breathing 4-5 seconds, pt also crying @ time;unsure of sequence of events;MD recommends DTAP for 3rd dose;9DEC96 on apnea monitor w/o complication;
Pt developed cellulitis in (L) deltoid, site of administration. Pt treated w/Keflex 500 mg po q 12 h x 5 days by treating physician. Course of ABX started on 9/16/2016.
Tingling at injection site began 30 min after injection, lasted 6 hours.  Developed a rash sige of an orange that is reddish/pinkish in color.  Does not itch or hurt and is flat that has lasted into the next day.  This was her first flu shot and was H1N1
Report A0359465A describes arthralgia in a 46 year old male who received Lyme disease vaccine recombinant OspA. The medical history included gastroesophageal reflux disease. The vaccinee did not have gout, psoriasis, Crohn's disease, or a history of Lyme disease. Concurrent medications were not specified. On 2/14/02, the vaccinee received his third injection of LYMErix. Approximately 12 hrs later, he presented to the ER with a rash that began on both shoulders, then spread over his entire trunk, arthralgia of the knees, and diarrhea. No joint swelling or warmth was noted on physical examination. No laboratory evaluations were performed. The vaccinee was treated with prednisone and released. The reporting physician stated that the adverse events were possibly related to LYMErix administration. As of 5/6/02, the outcome of the events were unknown. The adverse event "arthralgia" does not meet serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.
This spontaneous report as received from a other health professional refers to a 34 year old female patient. The patient's medical history included nausea and fatigue. On 28-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N013521 for prophylaxis. On 29-AUG-2017, 2 days after onset of therapy the patient experienced injection site joint pain, pyrexia, injection site erythema, injection site swelling and chills. The outcome of injection site joint pain, pyrexia, injection site erythema, injection site swelling and chills was reported as not recovered/not resolved.
Patient have not received second dose and more than 42 days after first dose have passed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient have not received second dose and more than 42 days after first dose have passed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient have not received second dose and more than 42 days after first dose have passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient have not received second dose and more than 42 days after first dose have passed) 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.   Concomitant medication was not provided.  Treatment information was not provided.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: ER2613), in right arm, on 16Apr2021 as dose 2, single (Lot number: EW0158), in right arm and on 10Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FH8028) at the age of 30 years for Covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient took Paxlovid from 13Jul2022 to 18Jul2022 for treatment of COVID-19. Rebound two days after testing negative and finishing a round of Paxlovid. No follow up attempts possible. No further information is required.
Extreme body aches, 103-degree fever-lasting 36 hours, low-grade fever and sweats lasting 12. more hours. Fatigue.
Within minutes of administration patient felt warm, hot, all throughout the body; the warmth spread to the face and face felt numb and tingling.  Symptoms resolved after observation and administration of water and orange juice
By midnight on the day I received the second dose of the shingles vaccine, I developed a fever and muscle aches. I spent most of the next day in bed, and the fever persisted for about 36 hours.  I found this strange because I had no side effects at all from my first dose.
Rash all over body (possibly pityriasis rosea) will not be able to confirm type of rash due to covid and doctor appointment back logs
pt recv vax 25JUL95 & MAY97 pt exp chickenpox disease;pt recovered;
pt recvd vax;exp induration, redness & swelling at inject site;see by MD;no addtl info avail at this time;not considered to be a valid case;
Pt returned to clinic 2 days after receiving IPV, DTaP left arm, MMR right arm. Complained of left arm redness, heat, swelling, itching. 12 cm x 12 cm red area. No symptoms of infection, tx with Keflex 375 mg TID for 7 days and Motrin.
patient reports being light headed. patient vitals are taken. patient shows hypotension. patient is monitored for an additional 15 minutes and vitals signs are taken again. vitals signs now normal and patient states improvement. patient is given the option to stay longer if need be and patient declines.
The patient walked in with his mother to receive a COVID-19 J&J vaccine on 5/1/2021 in the afternoon. The patient filled out the consent form and indicated his date of birth (16 years old). A Janssen vaccine was then administered and the patient was monitored for 15 minutes. The patient denied any signs or symptoms of complications and went home. On Monday morning, a pharmacy intern reviewed the consent forms to bill for the vaccines and noticed that the patient was not within the approved age range to receive the J&J vaccine and notified the pharmacy manager and the immunizing pharmacist. It was determined that there was an administration error, however, it was not associated with any adverse event(s).
Bodyaches, fatigue, chills, tenderness over site of injection, thirsty, shiver, sweats. ( hot and cold)
Rash that started in the antecubital day of vaccine and 3 days later covered in whelps
Palpitations, heart racing, muscle aches, severe fatigue, symptoms consistent with diagnostic criteria for POTS - Postural Orthostatic Tachycardia Syndrome
Fever of 103.7 and seizure Ambulance to hospital diagnosed with febrile seizure - gave Tylenol and Motrin
No adverse event noted. Parent was called as soon as the incident was discovered. Patient's mom called again this morning and she is reporting that patient is doing fine.
Higher heart rate; loss of appetite; Burning of skin all over; Fatigue; Joint pain; Headache; Injection site pain; Fever; Chills; Muscle pain; Feeling unwell; Lymph node swelling; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 14Mar2021 at 14:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included PASC (Post-acute Sequelae of COVID-19). Patient had no allergies to medications, food, or other products. Concomitant medications included celecoxib (CELEBREX) 200mg for 2 times a day and salbutamol (ALBUTEROL INHALER) as needed, both from unknown dates for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 29Mar2021, the patient underwent SARS-CoV-2 (nasal swab) and the result was negative. On 15Mar2021 at 00:00, the patient experienced joint pain, fatigue, burning of skin all over, headache, injection site pain, fever, chills, muscle pain, feeling unwell, lymph node swelling, loss of appetite and higher heart rate. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. . The clinical outcome of the events of joint pain, fatigue, burning of skin all over, headache, injection site pain, fever, chills, muscle pain, feeling unwell, lymph node swelling, loss of appetite, higher heart rate was recovered with sequelae on an unknown date.  No follow-up attempts are needed. No further information is expected.
Felt extremely light headed and was about to faint.  Very shaky all over my body. Headache that lasted for five days. Fever for 3 days.  Rapid heart beat (like I was on a lot of prednisone)   With the second dose of the vaccine I had all of the above but a horrible pain on my upper right side of my chest muscle. Took almost a month for that to go away  3rd dose of vaccine booster shot I did not have the chest muscle pain but I had the same reaction as the first dose
Injection site pain and redness (approximately 3? x 3?). Reaction began within approximately 4-6 hours of the injection. The following symptoms began approximately 12 hours after the vaccine was administered and continued for 3 days, Low-grade Fever, Flu-like aches, Fatigue.
Moderna COVID-19 Vaccine EUA Palpable patchy erythema with mild tenderness around injection site, onset 8 days after injection.  As of the day of reporting, not significantly changed
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 10-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Patient fainted 5 minutes after receiving vaccine.  He regained consciousness immediately and paramedics were called.  Patient reported having breakfast at 5am and did not have lunch yet.  The paramedics said he was ok to go  home. I followed up with a phone call to the patient a few hours later and he said he felt better after having lunch and resting.
Patient reported tingling in her arm right after the covid vaccine, patient also received a flu vaccine in the same arm immediately after the covid vaccine. She described no issues in range of motion of her shoulder, just a tingling sensation similar to when one's arm has that "falling asleep" feeling
Patient presented with a rash coving the whole upper part of her arm and it is warm to the touch. She also stated she has tingling in her arm when she touches the rash.
Stroke, treated at hospital with blood thinners.  Outcomes - 85% within a year.  Patient has memory and speech issues.  Facial paralysis on right side.
Information has been received from a nurse practitioner (NP), via a company representative, concerning a 17 year old female patient, who on 12-SEP-2007 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot # not reported).  On 03-OCT-2007, "3 weeks after vaccine," the patient required a blood transfusion (no details provided).  She was hospitalized for an unknown period of time.  At the time of this report, the patient had recovered from the event (date and duration not reported).  The NP considered the event to be serious as an other important medical event.  Additional information has been requested.  3/25/08 Reviewed hospital medical records of 10/18-10/20/2007. FINAL DX: severe anemia; dizziness/weakness; transfused 3U PRBCs; hematemesis, presumed UGI bleed; melena, improved; pertussis, improving; pulmonary edema, improved. Records reveal patient experienced fatigue, dizziness, weakness, upper abdominal pain.  Seen in student health clinic for pmh on 10/12.  Dx at health clinic: whooping cough.  Tx w/antibiotics.  10/13 post-tussive HA, felt faint, DOE, muscle aches, heart pounding, difficult ambulation.  10/15 developed black hard, tarry stool.  Vomiting again on 10/17, but no blood noted.  Gastric lavage in ER was clear.  Tx w/O2, IVF, antiulcer meds & #U PRBCs.  Improved & d/c to home w/peds GI f/u.  Seen in GI clinic 10/30 & was stable; antiulcer med d/c; hemoccult cards provided to collect; consider enteroscopy for any further GI bleeding.
Experiencing serious heart arrhythmia; This spontaneous case was reported by a non-health professional and describes the occurrence of ARRHYTHMIA (Experiencing serious heart arrhythmia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Experiencing serious heart arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Experiencing serious heart arrhythmia) outcome was unknown.            No concomitant medication information was reported. The patient had both COVID-19 vaccines and boosters and was experiencing serious heart arrhythmia. After that the patient went into cardioversion for treatment.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history and with vaccine history of receiving Covid-19 vaccines and boosters. However, product details and batch number was not provided. Patient experienced the unexpected serious (medically significant) AESI event of arrhythmia (experiencing serious heart arrhythmia). The event occurrence was unknown with respect to the unspecified product and dose number of administered Covid-19 vaccine. It was reported that the patient underwent cardioversion for treatment. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history and with vaccine history of receiving Covid-19 vaccines and boosters. However, product details and batch number was not provided. Patient experienced the unexpected serious (medically significant) AESI event of arrhythmia (experiencing serious heart arrhythmia). The event occurrence was unknown with respect to the unspecified product and dose number of administered Covid-19 vaccine. It was reported that the patient underwent cardioversion for treatment. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I began having irregular heart palpitations making it difficult to sleep of function normal. It is worst when laying of at night and has been going on for three days now.