chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Joint pain in both hands "mild" continuing; This is a spontaneous report from a contactable nurse (Patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 28Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included hypertension and breast cancer from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole, losartan potassium (LOSARTIN), hydrochlorothiazide. On 29Jan2021, the patient experienced injection site pain and joint pain in both hands "mild" continuing. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was not recovered.
Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Abdominal Pain-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Medium, Additional Details: Patient is still only currently dealing with rash/itchiness. She was seen by MD today and diagnosed with cellulitus. Patient is starting treatment today. She has had no reaction to previous year's flu vaccine of same brand, no previous reactions to Pfizer Covid-19 injection. Patient thinks this reaction was caused by her Pneumonia vaccination. This completed her Pneumonia vaccine series. All recieved same day.
Headache; Nausea; Severe pain in arms/legs (feels like arm was being broken in half); Severe pain in arms & legs (feels like my arm was being broken in half, could not walk on legs without shooting pain going up & down my legs),; Tiredness; Injection sight was burning; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 19:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), asthma, penicillin allergy and adhesive allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included norethisterone acetate (NORETHINDRONE) and metoprolol (MANUFACTURER UNKNOWN); both taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received erythromycin (MANUFACTURER UNKNOWN); amoxicillin, clavulanic acid (AUGMENTIN) and morphine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 16Apr2021 at 20:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 10:00, the patient experienced headache, nausea, severe pain in arms and legs (felt like her arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, severe pain in arms and legs (felt like arm was being broken in half, could not walk on legs without shooting pain going up and down legs), tiredness and injection site was burning was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a certified medical assistant concerning a 21 year old white female nonsmoker with a history of depression, no significant social history, no sexual activity, and no drug allergies, who on 20-NOV-2007 at 09:30 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil (Lot #659439/1267U).  Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), and ethinyl estradiol (+) etonogestrel (NUVARING).  On 20-NOV-2007 at 09:45 (also reported as about 10 minutes post vaccination) the patient felt lightheaded and nearly had a syncopal episode while sitting in the chair.  The patient never fell out of the chair and there was no injury.  The patient was "slow to come to" and felt fatigued.  The patient had a head cold followed by a cough and chest congestion that had developed over the past week.  The patient had no fever, chest pain, abdominal pain, shortness of breath.  The patient was taken to the emergency room where she was treated with normal saline 1000cc, 500cc/hour.  Laboratory diagnostics were performed (results located in laboratory section).  The patient was diagnosed with being near syncope and bronchitis.  It was reported that the patient was feeling better and was discharged to home.  The patient's condition was stable.  The patient was advised to follow up with physician.  On 20-NOV-2007 the patient recovered from the near syncopal episode, fatigue, and lightheaded/dizziness.  The outcome of bronchitis was unknown.  Additional information is not expected.
10/22/04: notified the rash in the area at chicken pox vaccine was injected and itching. Came to clinic today 10/25/04 to have his arm check. At upper right tricep region has slightly pin wheal 3cm in diameter and has several dried pin head papules on both arm. No other symptom. Advised to observe and can take Benadryl for itching. Rash disappear 4 days later and feeling fine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 21-DEC-2015, the patient was treated the same physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as acute zoster. The patient was prescribed Valtrex, Tramadol and Ibuprofen for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Causality assessment was related. Additional information has been requested.
Sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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.    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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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
Anaphylaxis about 15 minutes after the injections.  Chest pain, shortness of breath, hives, pain with swallowing.  She was given an EpiPen, put on oxygen, vital signs monitored and were stable.  Patient was transported to a local emergency room.  Recovered.  Referred to allergist for further evaluation
Skin disorder like Hives, very itchy. Larger red areas over back, wrist between legs, head,, legs. Pretty much all over body. Extremely itchy and warm to touch. Worsening after scratching.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported
Systemic: Autoimmune Disease (diagnosed by MD)-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Additional Details: Guillan Barre
No adverse effects reported; received improperly stored VARlVAX via the intramuscular route on 9/10/2019; received improperly stored VARlVAX via the intramuscular route on 9/10/2019; Information has been received from a medical assistant referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not provided. Concomitant therapies included sterile diluent. Sterile diluent was stored properly.  On 10-SEP-2019 the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX)(therapy type: digital data logger; batch/lot number R018144 and expiration date 25-JUN-2020; strength and dose were not provided) intramuscularly for prophylaxis (product storage error and incorrect route of product administration). The administered doses experienced a temperature excursion ranged from 6 degree Fahrenheit to 14 degree Fahrenheit for 8.75 hours (average 8.7 degree Fahrenheit). No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported.
vomiting; This spontaneous report was received from a pharmacist, who was also the patient's mother via company representative and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date , around 20:00 or 21:00, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. It was reported that by 03:00 he was vomiting. The outcome of the vomiting was unknown.    The causality assessment between the event and the suspect therapy was not provided.
Our Graduated Intern accidently mix & gave Shingrix vaccine instead of Arexvy (RSV) vaccine.  Intern did called patient to let her know about the incident, patient said she feel fine, she will self monitor for any side effects and will let us know.
Urticaria starting 10 days after Covid booster. Severe for about a week and have continued inconsistently for about a month
Date of Admission: 2/1/2022   Chief Complaint:  Chief Complaint Patient presents with ? Abdominal Pain     per pt " I just checked myself out, I have chest pain and abdominal pain" ? Chest Pain     Source of Information:  Patient   History of Present Illness:  This is a 64y.o. female is admitted from home with increasing back pain shortness of breath chest pain abdominal pain patient has the usual symptoms for many years was recently here in December patient found to have covert at this time very confusing history as to whether or not she was at hospital for the Covaderm not patient not sure if she received treatment there she states she was there for 2 days but states she left because she was not getting her pain medication as she wanted history of sepsis abuse alcoholic abuse smoking abuse patient has one kidney was born with only one kidney history of chronic pain syndrome drug-seeking behavior asthma heart disease recently had an episode of atrial fibrillation when she was here in December. Patient is totally noncompliant with the medication and following up with Dr. she frequently goes to emergency room emergency room until she gets what medication she wants she denies being exposed to anybody with Covid is not sure she received any treatment for Covid + not a good historian according to the family patient may of had recent GI bleed. Difficult to assess the patient because of her noncompliance. She has no known allergies. Slides family history of hypertension patient has a history of asthma. Chronic pulmonary disease chronic pain syndrome
Had seizure symptoms at 2:30 am the following day.  Husband woke to our dog whining.  I was very disoriented before it happened, I was freezing cold, aching, shooting pains, could hardly move or speak but got out the words, ?im not ok, I?m having a sever reaction? My husband said I then went into what he saw as a seizure.  Head throat, neck, back tensed- unconscious, unable to arrouse.  Lasted about a minute.  Where I lied unconscious and he didn?t think I was breathing.  30 seconds later I opened my eyes, but then had a similar but shorter episode 30 seconds and then was able to get me to come to.  He called 911, and they took me to hospital.  All vitals came back normal.  Blood pressure was on the low side.  I have no history of seizures.
ears sounds like talking like in a tin can like there was static in head; Ringing in the ears; This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: FA7485), intramuscularly in the right upper arm on 09Aug2021 at a single dose for covid-19 immunisation. Medical history included on a beta blocker for heart. Concomitant medications included atenolol (MANUAFCTURER UNKNOWN) taken for heart. The patient experienced ears sounds like talking like in a tin can like there was static in head and ringing in the ears on an unspecified date. The events were further described as: after receiving the vaccination dose one, last week, she has been experiencing an adverse effects of ringing in the ears. She described the side effects as better in the morning and almost gone awake when she wakes up but then it progressed throughout the day. She states that it was static like and sounded like she was talking into air or into a tin can and its all day long. She stated that she has been to her doctor and had a CAT scan and that everything came back normal on an unknown date. No therapeutic measures were taken as result of the events. The clinical outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Pressure in head, lips going numb Profusely sweating; colour drained from face and lips went white, as eyes started rolling back and heart was pounding.  Called Paramedics.  EKG?s showed heart stress.  Ambulance drive to ER.
dizziness; weakness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient non-pregnant received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13246), via an unspecified route of administration on 06Jan2021 13:00 at single dose in right arm for covid-19 immunization. Medical history included arthritis. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. The patient experienced dizziness, weakness, nausea, diarrhea on 07Jan2021. The patient was not received any treatment. The outcome of the events was not recovered.
Myalgia, Fever,  LETHARGY, SITE DISCOMFORT AND ITCHING BOTH DOSES Narrative:  Other Relevant History:
Friday 3/5: Fever 101.4, headache, nausea, loss of appetite, sore arm, redness and swelling at injection site  Saturday 3/6: Fever 100.4, headache, nausea, loss of appetite, sore arm, redness and swelling at injection site  Sunday 3/7: Headache, nausea, loss of appetite, sore arm, redness and swelling at injection site
GENERALIZED ITCHING; SKIN FEELS FUNNY; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced generalized itching, and skin feels funny. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized itching, and skin feels funny. This report was non-serious.
RARE BLOOD CLOTTING DISORDER; This spontaneous report was received concerning 4 adult female(18-48 years) patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown exp: unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date within one to three weeks of vaccination, the patient experienced rare blood clotting disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rare blood clotting disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210530468;-covid-19 vaccine ad26.cov2.s- Rare blood clots. This event is considered Un assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
After the shot was miserable over the next week fever temperature aches. Then about three weeks later developed ringing in my ears which continues to this day unabated
This spontaneous report was received from a nurse, who referred to an unknown number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. The patients were administered improperly stored doses of PROQUAD recombinant human albumin (rHA) (dose, route of administration and anatomical location were not reported) as prophylaxis on the following dates: with lot# M002053 and expiration date of 11-JUL-2017 on 03-JUN-2016, 06-JUN-2016, 09-JUN-2016 and 13-JUN-2016; with lot# M011664 and expiration date of 08-SEP-2017 on 19-JUL-2016, 20-JUL-2016, 30-AUG-2016, 01-SEP-2016 and 12-SEP-2016; with lot# M012986 and expiration date of 12-SEP-2017 on 20-JUL-2016, 21-JUL-2016, 26-JUL-2016, 28-JUL-2016, 23-AUG-2016 and 29-AUG-2016; with lot# M021731 and expiration date of 29-OCT-2017 on 01-SEP-2016, 06-SEP-2016 and 08-SEP-2016; with lot# M046943 and expiration date of 27-MAY-2018 on 06-JUN-2017. It was reported that the vaccines were reconstituted with sterile diluent (DILUENT MRK) that was always stored properly with no temperature excursions. The doses of vaccine with lot# M002053 and expiration date: 11-JUL-2017 were stored at the following temperatures: on 02-JUN-2016 at -14.3 degrees Fahrenheit (F) for 8 hours, on 06-JUN-2016 at -14.6F for 7 hours, on 09-JUN-2016 at -14.1F for 8hours, on 13-JUN-2016 at -14.8F for 8 hours, on 20-JUN-2016 at -14.F for 8 hours and on 28-JUN-2016 at -3.4F at 8 hours; with lot# M011664 and expiration date: 08-SEP-2017 were stored at the following temperatures: on 19-JUL-2016 at -12.1C for 8 hours, on 20-JUL-2016 at -9.0C for 8 hours, on 30-AUG-2016 at 5.2F for 8 hours, on 01-SEP-2016 at 5.2F for 8 hours and on 12-SEP-216 at 5.2F twice for 1 hour and 7 hours; with lot# M012986 and expiration date: 12-SEP-2017 were stored at the following temperatures: on 20-JUL-2016 at -9.0 degrees Celsius (C) for 8 hours, on 21-JUL-2016 at 9F for 8hours, on 26-JUL-2016 at 7.5F for 8 hours, on 28-JUL-2016 at 6.3F for 8 hours, on 23-AUG-2016 at 5.8F for 8 hours and on 29-AUG-2016 at 9.2F for 8 hours; lot# M021731 and expiration date: 29-OCT-2017 were stored on 01-SEP-2016, 06-SEP-2016 and 08-SEP-2016 at 5.2F for 8 hours and lot# M046943 and expiration date: 27-MAY-2018 were stored on 06-JUN-2017 at 17.1F for 8 hours. All temperature excursions were detected by a data logger. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006147: US-009507513-1706USA006148: US-009507513-1706USA006150: US-009507513-1706USA006151: US-009507513-1706USA006146: US-009507513-1706USA006149: