chrisvoncsefalvay/vaers-outcomes huggingface dataset:
o Pt presented for her N95 mask physical and new hire vaccines.   o Hx of anaphylaxis July 2020 (in hospital for 3 weeks) and November 2019 (intubated) with known triggering substances coconut and ketamine o Flu (had flu shots previously, no rxns) and Hep B #1 given today at ~6:50 am, immediately started to feel hot on R arm, and had a syncopal episode.  Was given a juice box after the syncopal episode.  Juice box was apple juice, didn't have any known coconut substance in it, but could be a contributing element.  (Juicebox was given to the paramedics to take with the patient.) o Pt started to feel hot, itchy around 7:00.  Was brought back to an exam room.  At the time was speaking clearly and was noted to have hives on arms and neck.   o While taking history, pt began to wheeze.  Benadryl given, shortly followed by a dose of epi and call to EMS.  Pt began tripoding with SoB and a 2nd dose of epi was given   Benadryl 50 mg given at 7:25 am Epi 0.3mL IM given at 7:38 am   Epi 0.3 mL IM given at 7:48   EMS arrived and pt had another syncopal episode.  Vitals at the time:  111/76, HR 122.  Provided report to EMS and pt was en route to ER.
Minor soreness in left arm and hard lump in injection area continues after 8 days. Red rash, circular area about 3-4 inch circle and is itchy. Rash developed 9 days after injection.
diagnosed with COVID-19; sars cov2 infection; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient. Other Case identifier(s): MOD22-016024 (Moderna).  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "diagnosed with COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "sars cov2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results, notes: he was diagnosed with Covid-19.  Clinical course was reported as, Update 23Jun2022, HCP reported that he was diagnosed with Covid-19 after receiving the Primary series of the Moderna Covid-19 vaccine and a Pfizer booster. Does not know he was diagnosed. He declined to provide further information at this time. As he is on vacation at his sons college orientation. HCP requested information needed to report via email. Pharmacist will email required safety information to (email withheld)   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
-Soreness at injection site.  -Tiredness -Angioedema on half of the arm  -Can not lift the arm up.
first dose of Engerix-b 20 mcg was given to a 18.5 yrs patient; first dose of Engerix-b 20 mcg was given to a 18.5 yrs patient; This case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a 18-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe (batch number ASKU, expiry date unknown) for prophylaxis.   On 9th June 2021, the patient received the 1st dose of Engerix B 20 mcg/mg and Engerix B Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follow: The 18.5 years patient received 1st dose of Engerix-B 20 mcg, which led to adult product administered to child and overdose. No vaccine details available. The reporter consented to follow up.
3/1/11 Positive pregnancy test in office sono in office confirmed pregnancy. EDC - 10/25/11 6 weeks LMP - 1/17/11 pregnancy precautions were advised.
Gross hematuria and proteinuria.  Gross hematuria was present for 3 days, but microscopic hematuria and proteinuria persisted.   IgA Nephropathy was diagnosed after biopsy 4 months after shot.  Treated with Losartan and fish oil.
pt recvd vax 17MAR93 & devel swollen lymph nodes in neck area w/scratchy, dry throat & soreness in both upper arms from shoulders to elbow on 26MAR93; on 30MAR94 felt flushed w/mild dizziness; 31MAR93 was seen in clinic; soreness in wrists;
This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received Shingrix (batch number AS9CM, expiry date 25th April 2020) for prophylaxis. On 31st May 2018 13:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 5 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be possibly related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient was well and had no history of issues with prior vaccinations. The patient experienced a rash under her armpit between her trunk and groin 5 days after receiving her first Shingrix vaccination. The rash resolved within 1 day with no treatment required.
No adverse reaction was observed or stated. Patient received JEV 0.5ml adult/adolescent dose instead of JEV 0.25ml for pediatrics under the age of 3.
SEVERE HEADACHE WITH RIGHT EAR HEARING LOSS AND NO SENSE OF TASTE OR SMELL ACCOMPANIED  BY  NAUSEA
Information has been received from a physician concerning children who were vaccinated with rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) at greater than 12 weeks of age. The reported noted that the series completed by 32 weeks of age in the infants. No symptoms were present. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt states that after receiving 3rd Anthrax shot, sudden loss of strength and grip in left hand. Pt states that while typing or holding on to anything for a prolonged period, it hurts.
the next two days I was very very pale and very very fatigued; After taking the first covid shot I developed a rash, not hives but a rash on my arms, some of my; I was completely wiped out/the next two days I was very very pale and very very fatigued; This spontaneous case was reported by a nurse and describes the occurrence of PALLOR (the next two days I was very very pale and very very fatigued), RASH (After taking the first covid shot I developed a rash, not hives but a rash on my arms, some of my) and FATIGUE (I was completely wiped out/the next two days I was very very pale and very very fatigued) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALLOR (the next two days I was very very pale and very very fatigued), RASH (After taking the first covid shot I developed a rash, not hives but a rash on my arms, some of my) and FATIGUE (I was completely wiped out/the next two days I was very very pale and very very fatigued). At the time of the report, PALLOR (the next two days I was very very pale and very very fatigued), RASH (After taking the first covid shot I developed a rash, not hives but a rash on my arms, some of my) and FATIGUE (I was completely wiped out/the next two days I was very very pale and very very fatigued) outcome was unknown.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed a small blood clot in my right lung. Initial symptoms started on Mon. 6/7/21. Felt like indigestion. Started early afternoon. Did not take anything that day (may have had some tea). Next day slight increase in symptoms. Took acid-indigestion medicine early afternoon followed by muscle relaxant followed by one (1) Aleve Muscle and Back pain tablet (these were all taken hours apart). Note: I work from home; shift ends at 2am. Symptoms did not subside but increased by that evening. By end of shift, was experiencing intense pain in chest area that hurt whether sitting, standing, bending over, laying down or moving. included shortness of breath. Tried to sleep and eventually got up around 7am on 6/9/21 and decided to go to nearest ER. Managed to get dressed and took Uber to ER. Was admitted to ER as soon as I arrived. Received ECG, blood pressure test, chest x-ray, covid test, chest MRI scan (w/ and w/o contrast), ultra sound of the legs, TTC w/ doppler and color, and various blood tests. The testing revealed the small blood clot in my right lung. Was admitted into the hospital and given Eliquis (oral, tablets) for that day and next and prescribed prescription for initially one month. I informed my cardiologist, my primary doctor and  neurologist of what was happening. Was eventually given a prescription by primary doctor for three (3) month supply of Eliquis and referral to hematologist by attending physician at ER and cardiologist to find out if I was susceptible to blood clots as there is not a known history of this in my family. Returned to the ER two times afterwards (6/18 - not admitted and 6/23 - admitted) for additional pain and shortness of breath. Was given an ECG, blood tests, blood pressure test, chest x-rays for both. Was given a chest CAT scan on the 6/23 visit. It was discovered during this visit that the blood clot had dissolved. On 6/24, was given a stress test by my cardiologist (he is affiliated with this hospital). Passed. Saw Hematologist in 8/2021; returned for results on 9/13/21. No propensity was found for blood clots. Conclusion - clot resulted from vaccine. Informed that I could stop taking Eliquis at end of month.  I did return to the ER just recently (11/10/21) due to the same/similar symptoms that I experienced back in June 2021 (heaviness in chest area). Similar test given (ECG, blood pressure, blood tests, chest x-ray, and chest MRI (w/ and w/o contrast). Also received pain meds and muscle relaxant (given before MRI in case this was muscle related). Results indicated no new blood clots, some small cysts in right lung.
her large toenail fell off; abdominal pain; back pain; high fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ONYCHOLYSIS (her large toenail fell off), ABDOMINAL PAIN (abdominal pain), BACK PAIN (back pain) and PYREXIA (high fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ONYCHOLYSIS (her large toenail fell off), ABDOMINAL PAIN (abdominal pain), BACK PAIN (back pain) and PYREXIA (high fever). At the time of the report, ONYCHOLYSIS (her large toenail fell off), ABDOMINAL PAIN (abdominal pain), BACK PAIN (back pain) and PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. HCP reported the patient was diagnosed with COVID-19 in the past and recovered. No treatment medications were reported.   Reporter did not allow further contact
At injection site- Large (approx 4 inches across at the widest point) raised, red, hot, painful area. This worsened over the course of 3 days, then gradually diminished, and was completely gone by 5. On trunk and extremities- rash consisting of small raised, red bumps. This worsened over the course of 1 day, then gradually resolved, resolved by day 3. Low grade fever, lethargy, and cold symptoms appeared 1 day after injection, resolved by day 4.
Began feeling raised area in perineum evening of 12/18/06. Diagnosed by OB/GYN office with Shingles on 12/11/06. Prescribed Valtrex 1 gm TID for 7 days.
Moderna COVID-19 Vaccine   Client received Moderna vaccine as a 17 year old--vaccine not approved for indivudals younger than 18 years old
I was recently diagnosed with Mosiac Lung disease and I've been in a Lupus and RA flare 1 week after booster.
Information has been received from a registered nurse concerning a 37 year old female with no known allergies or past medical history who was vaccinated SC with a first and second dose of Varivax (lot# 652557/1024R) on 16-JUN-2006 and 20-JUL-2006 respectively. There was no concomitant medication. On 21-JUL-2006 the patient developed a breakthrough rash on her genitalia, confirmed to be chickenpox by "lab work". The patient was being treated with VALTREX. At the time of the report, the rash with open vesicles was continuing. There was no product quality complaint involved. Additional information has been requested.
Moderna COVID-19 Vaccine EUA. Patient reported lightheadedness, flushing, and chest "heaviness".  Patient vs stable WNL and transient lightheadedness. Persistent chest "heaviness". Patient transferred to ED for further evaluation via ambulance.
itchy rash; A spontaneous case was received from a customer who is a female patient (unkown age) that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy rashes on her neck.  The patients' medical history is reported as allergy to antibiotics and cold medications. No relevant concomitant medications were reported.  On 24-Dec-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) unkown route and location for prophylaxis of COVID-19 infection.  On 25-Dec-2020, the patient developed itchy rashes on her neck and  called in to inquire if she should visit her physician immediately or wait until the next day to visit her doctor.   The action taken with mRNA-1273 in response to the adverse event was not reported. No treatment information was provided.  The outcome of this event is unknown.; Reporter'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.
Patient received her second dose of Moderna from an expired vial; Patient received her second dose of Moderna on 20/Aug/2021 (day 61); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of Moderna from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose of Moderna on 20/Aug/2021 (day 61)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of Moderna from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose of Moderna on 20/Aug/2021 (day 61)). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of Moderna from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose of Moderna on 20/Aug/2021 (day 61)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
pt recv vax & immed began to cry;face became flushed, all arms & legs flushed;no temp;lungs clear;high pitched, cont cry;given epi;pt became quite mottled, t37.5 p/epi;pt observed in office x 3hr;
Starting 12/17/2021, I developed itching that traveled all over my body at different times. It would be on my arm then go away and come back on another part of my body. By 12/18/2021, I was getting small hives, and I was treating with Benadryl and hydrocortisone cream. I ended up going to urgent care because it was just getting worse. They gave me a weeks worth of prednisone and then told me to follow up with my PCP. The prednisone helped a little bit but did not stop the episode. Then my PCP switched me to Zyrtec and had me take 3-4 pills in a day. This started helping the event. I am down now to 1 pill a day and the hives are gone. However, I still get dermographia (marks on the skin that appear randomly) and itching but they're getting better slightly. I spoke with an immunologist over telehealth and he definitely thought this was a reaction to the vaccine because he is getting reports of this almost daily. He said it will eventually go away but will likely persist through springtime. He said he felt like it would not happen again after the next shot but I'm unsure why.
3mins post vaccination, pt c/o flushing/sweating Vitals: 12:45 100/65. 65, 100%, 98.2F -- > 12:58 107/57, 66, 100%, 98.3F Pt stable and released from the vaccination site
This spontaneous report was received from a physician via a company representative and refers to a 77 year old male patient. The patient did not have any concurrent conditions, pertinent medical history or drug reactions or allergies. On 04-FEB-2013, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (lot number, expiry date and dose were not reported) for prophylaxis. Concomitant therapies included aspirin (manufacturer unknown), esomeprazole sodium (NEXIUM), omega-3 acids, vitamins (unspecified), albuterol sulfate (VENTOLIN), simvastatin (manufacturer unknown), amitriptyline hydrochloride (manufacturer unknown), metformin, lisinopril (manufacturer unknown) and hydrochlorothiazide. On 02-DEC-2016, the patient sought medical attention and was diagnosed with shingles (herpes zoster.) Later, on 06-FEB-2017, the patient was diagnosed with post herpetic neuralgia.  In addition, it was reported that the patient was scheduled to see an unspecified anesthesiologist in March 2017 to receive an "spinal pain block", for an unspecified reason (adverse event.) It was also stated that the patient received an unspecified treatment for the reported events. No product quality complaint (PQC) was involved. At the reporting time, the outcome the events was reported as not recovered. The reporter did not provide a causality assessment between the events and the ZOSTAVAX. Additional information is not expected, because the reporting physician did not allow further follow up contact.
Patient called to report that the area of her arm that she was given the vaccine has turned pink. She was given the vaccine 15 days ago and had no redness/pink in the area until today. She stated that the only symptoms she had after the vaccine initially were low grade fever, site soreness.  Patient states the pink area on her arm does not hurt or itch. It feels slightly warm to the touch. We advised the patient to report the reaction through V-safe, to take oral Benadryl, apply a cold compress, and take Tylenol or Ibuprofen if needed. She was also told to inform our staff or her primary care provider if her symptoms worsen or do not resolve within a few days.
Flu shot Nov 2012. Insomnia starting night of injection lasting approximately 14 months, severe vertigo lasting past 2 years, better but not gone. Costing 20,000$ medical bills and 100,000$ in pain.
No adverse effects reported; Longer than recommended interval between dosing; This spontaneous report was received from a pharmacist referring to a 15 years old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.     In 2017 (reported as three years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On 09-NOV-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. This was longer than recommended interval (inappropriate schedule of product administration). No adverse effects reported.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date, unspecified number of patients were vaccinated with doses of RECOMBIVAX HB (dose, route of administration, anatomical location and lot# was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reporter is not willing to be contacted.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: days after tested negative for 2 days; (unspecified date) Negative, notes: days after tested negative for 2 days; (02Oct2022) Positive, notes: Then tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in two weeks. Patient received Paxlovid as COVID 19 Treatment from 23Sep2022 to 28Sep2022. Completed Paxlovid and two days after tested negative for two days. Then tested positive and symptoms reappeared Sinus, Cough, Headache, Tiredness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.