chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; still red; it has increased in size slightly and it's progressing down the shoulder, down towards the elbow; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6198, expiry date not reported) via an unspecified route of administration, administered in right arm on 22Feb2021 (at the age of 74 years old) as dose 2, single for covid-19 immunisation (for prevention of Covid-19 as reported). Medical history included thyroid (disorder) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (THYROXINE) taken for thyroid (disorder) at 25 ug, start and stop date were not reported; and tiotropium bromide (SPIRIVA) via respiratory inhalation at 2.5 ug, twice a day taken for an unspecified indication, start and stop date were not reported.  The patient had the first dose of bnt162b2 as covid-19 immunization (lot EL9269) on 01Feb2021 and had zero reaction, "no pain, no swelling, nothing". On 26Feb2021, patient had rash; still red; it has increased in size slightly and it's progressing down the shoulder, down towards the elbow. This was further reported as approximately four days later, patient did not know the exact time because patient did not noticed it, patient developed a rash, not around the injection site itself but below it, it started sort of a regular, squarish, rectangular, pattern. It was the still red and spread somewhat; does not itch, has no blisters, no pain for med site. Patient could not really tell if patient have any other symptoms at all. Patient was seeing family physician at the time of the report as he wanted to have a look at that. The rash, it was on the arm, but it has spread slightly since patient first discovered it and the rash was a small area about the size of 3 fingers wide and about 4 inches long and it has increased in size slightly and its progressing down the shoulder, down towards the elbow. Patient had laboratory tests for respiratory relief, chest, and lungs on an unknown date with unknown results. Patient stated that it was spreading, persisting and patient was going to see family doctor. At the time of the report, patient was not taking any medication for it. The outcome of the event was not recovered.    No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a 61-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included renal cell cancer. On 25th June 2018, the patient received SHINGRIX. On 28th June 2018, 3 days after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant), pain in arm, pain, heart rate increased, weakness and nausea. On an unknown date, the outcome of the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea were unknown. The reporter considered the atrial fibrillation, pain in arm, pain, heart rate increased, weakness and nausea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a healthcare professional (HCP) for himself. The patient received SHINGRIX in the left deltoid. The patient reported experiencing pain, his arm hurt, felt weak and nausea. The patient reported experiencing atrial fibrillation, clarified as a heart rate of 146. The patient's heart rate was usually 65. The symptoms were not considered life threating or disabling. No emergency room (ER) or doctor visit was required. The caller was unable to clarify if the pain was only in the patient's arm.  Lab Comments: The patient's heart rate was usually 65.
Redness, warmth and swelling at injection site. Hydrocortisone cream, ice and oral allergy medications.
On 3-26-02, pt called concerning TD and soreness of arm. Pt instructed to come for check. No redness and noted no warmth. Area swollen bigger than a fifty cent piece size. Instructed pt to call his family doctor. Pt called on 3-29-02 and stated he spoke to his doctor, who instructed him to use ice pack, Benadryl and Tylenol and not to get another TD. Pt stated that arm had been swollen approximately size of small apple. Now improving and thinks he will not have further problems.
vasovagal response: BP 70/40 with dizziness and diaphoresis. legs elevated, given PO fluids observed for 30 minutes
After approximately 5 days began developing rash and swelling at injection site, so-called "Covid Arm".  Swelling, some pain, and significant itching in a patch some 4 to 5 inches in extent.  Gave her some over-the-counter antihistamine (Claritin) and this helped to resolve the symptoms somewhat.  Redness had abated somewhat by the end of the day.  I am reluctant to give her too much of the antihistamine due to dizziness and increased lack of mental clarity (she suffers from Alzheimer's).  Being a military wife, she has had many vaccinations, but has never had a reaction like this before.
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-FEB-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 one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Client received a Moderna 06/2/2021. Reported hadn't had a dose prior but when submitting to the database the first dose of Moderna was reported.
Fever (102) for over 48 hours; muscle aches; chills; headache; nausea; lethargy; joint pain; dry cough
Abdominal rash.  hydrocortisone not relieving.  recommended follow up with pcp
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history reported. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M024702 with expiration date 18-MAY-2018, (dose, route and anatomical location were not reported). The vaccine was exposed to temperatures between 6 F to 14 F (Fahrenheit) during 1 hour and 45 minutes. Additionally, previous temperature excursion was reported between 15F to 46F (Fahrenheit) during 6 hours. Digital data logger was filled. No adverse effects were reported. Lot number L007563 has been verified to be a valid lot number for sterile diluent.
Grandmother reported the child woke up on 10/18/2022 at 2:00 am with low grade fever, sick at stomach, and back hurting. Grandmother gave Tylenol then began alternating with Motrin.  She slept a lot. Grandmother watched child for little over 24 hours. Then she was fine.
Tenderness of the muscle and erythema over injection site and adjacent shoulder.  Persistent fever of 102 for two days.
This spontaneous report has been received from a pharmacy intern referring to a 50-year-old female patient. The patient's relevant concurrent conditions included coronary artery disease, asthma, arthritis, and a drug reaction/allergy to sulfa drugs. The patient did not have any concomitant therapies and her historical conditions were not reported. On 14-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot # M041510, expiration date 27-JUL-2017; dose, route of administration, and frequency were not reported) to prevent shingles which was reconstituted with a sterile water diluent (manufacturer unknown) (lot number and expiration date was not reported). On 18-APR-2017, the patient developed facial numbness. Subsequently, on an unknown date in April 2017, the patient developed shingles (Herpes zoster) that was confirmed by an unknown method. At the time of this report, the patient had not recovered from hypoaesthesia and the outcome of Herpes zoster was unknown. The varicella Zoster virus identification program (VZVIP) packet was sent. The causality assessment between hypoaesthesia and Herpes zoster with ZOSTAVAX was unknown. Additional information has been requested.
No additional AE; administered a separate dose of this Case's improperly stored GARDASIL 9 to Patient; This spontaneous report as received from a physician assistant and healthcare business professional refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-NOV-2021, the patient was vaccinated with a separate dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T025370, expiry date 01-DEC-2022 (exact dose, route and anatomical location of administration were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) on 04-NOV-2021 (53.0 degrees F for 3 hours and 30 minutes), on 11-NOV-2021 (59.7 degrees F for 6 hours), on 15-NOV-2021 (48.2 degrees F for 1 hour and 30 minutes), and on 19-NOV-2021 (57.3 F for 3 hours and 20 minutes). No additional adverse event details were provided (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA009160:
This spontaneous report as received from a nurse refers to an 8 year old female patient. Patient's medical history and concurrent condition was not reported. On 25-FEB-2010 the patient was vaccinated with dose 1 of M-M-R II dose: 0.5 ml (millilitres), subcutaneous, (in the past) and dose 2 on 10-DEC-2010. Patient's concomitant medication was reported as none. Approximately on an unknown date in 2014 (also reported as now has negative titers for MMR), the patient experienced negative titers for MMR and on an unknown date experienced leukemia (hospitalization and medically significant). The nurse stated that this patient was in remission from leukemia. The nurse did not know when the patient was diagnosed with leukemia. The nurse believed that the patient has been hospitalized at some point related to leukemia, but had no information about when or where the patient was hospitalized. The nurse stated that the patient received treatment for leukemia but did not know what treatments the patient received. Patient's laboratory results were unspecified by the reporter. The outcome of the events was unknown. Reporter's causality assessment was not provided. Upon internal review the event leukemia is considered to be medically significant. Additional information has been requested.
Case completed primary Covid vaccine seires in March 2021, then was hospitalized for Covid in March 2022. Hospitalized at:  Hospital.   Pneumonia due to COVID-19 virus Assessment & Plan Receiving Remdesivir and decadron per protocol; no significant dyspnea/cough observed but he does have a new oxygen need (did not require oxygen his most recent hospitalization); fluid overload on admission CXR possibly obscuring underlying infectious process; continue supportive oxygen; full code confirmed by patient - Positive covid test: 3/17 - 5 days of remdesivir last day 3/21 - 10 days of decadron last day 3/26   Acute respiratory failure with hypoxemia  Assessment & Plan Ex-smoker per report. Due to copd noncompliant with chronic or intermittent o2 and due to covid pneumonia plus fluid overload at admission. Resolved.
Information has been received from a physician concerning a 19 year old female patient who on 25-APR-2011 was vaccinated with the first dose of GARDASIL (Lot number not reported) and on the same day the patient experienced headache, nausea and blurry vision. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Follow up information has been received from a licensed practical nurse reporting that the 19 year old female patient with drug allergy to BETADINE, codeine and nonsteroidal anti-inflammatory drug (NSAID's) and no illness at time of vaccination, on 25-APR-2011 was vaccinated in her left deltoid, with the first dose of GARDASIL (Lot number 0057AA) at 10:00 a.m. and on the same day at 13:30 (also reported around 12:39 p.m) the patient experienced headache, nausea and blurry vision. No lab diagnostics studies were performed. It was reported that on an unspecified date the patient recovered. No further information is available.
off balance; Weak legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (off balance) and ASTHENIA (Weak legs) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Patient is on medications for blood pressure). Concomitant products included HYDRALAZINE and DILTIAZEM HYDROCHLORIDE (CARTIA XT) for Blood pressure, ROPINIROLE and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Restless legs, VITAMINS [UMBRELLA TERM] for an unknown indication.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Jan-2021, the patient experienced BALANCE DISORDER (off balance) and ASTHENIA (Weak legs). On 14-Jan-2021, BALANCE DISORDER (off balance) and ASTHENIA (Weak legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.; 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.
2 days p/shot began having nausea, vomiting, h/a & flushed face; no temp over 100-had sore throat that day; sx are better today but still has some flushing of the face & sl upset stomach; did not have to see MD;
Case previously recorded as MA2009-4318. Initial case report received from a health case professional via agency, on 11 NOV 2009. A 2 year-old male patient was vaccinated with 0.5 mL once of S-OIV FLUVIRIN (batch no. 102125P1) i.m. on 11 NOV 2009. No adverse events were reported. Agency reference no.: NA09-007978.
pt recv vax 24AUG98 & 2hr p/vax pt exp severe shakes, fever 101.4, blanched skin & vomiting;pt sought unspecified medical attention & supportive measures were employed for fever;
Patient reported an episode which she is classifying as a "petit mal seizure." She says she had sweating, chills, pallor and tremors throughout the body but did not lose consciousness, it lasted about 30 minutes in total.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 19-NOV-2013 the patient was vaccinated with a 0.65 ml expired dose of ZOSTAVAX (lot # H013946, expiry date: 25-OCT-2013) (Subcutaneous in patient's right arm). No adverse effect reported. Additional information has been requested.
Few hours after vaccination patient became dizzy, 3 episodes of vomiting and developed local reaction at both sites. At follow up vomiting resolved local reaction at site of MENACTRA (right arm) is improved, but site of Men B (left arm) was still slightly indurated on 8/14/18.
Experienced chills and slight fever 6 hours after the injection which continued for 4 hours.
Pt presents with c/o redness and swelling at SHINGRIX injection site on left shoulder. Denies pain/SOB/CP/dyspnea/tightening of airway/lightheadedness/fatigue. Pt reports reaction appeared 1 day after receiving SHINGRIX vaccine. Pt has been applying a warm compress. Denies decrease in size. Denies spreading or enlarging of symptoms. Pt is A and O x4.  No signs of acute distress.  Afebrile. Circular erythematic edema on left deltoid circumferencing vaccine injection site. Center is more firm than perimeter. Distinct borders. Measuring about 3.5 inches x 3.5 inches. No excessive warmth or drainage.
Patient received vaccination earlier than recommended date. Patient 1st dose administered 11/07/2021. Parent scheduled child for 11/20/2021 and received second dose. Patient was supposed to receive second dose on 11/28/2021. Father accompanied child. was advised for 15 minute observation. Child feels fine, no signs or symptoms of adverse reaction. All questions and concerns addressed. Fathers telephone number. Parent and child left facility after 30 minute observation (extra 15 minutes as precaution). Thanks.
Patient developed generalized malaise and localized urticarial rash affecting proximal 1/2 of vaccinated upper extremity still present one week post- vaccination.
Painful bumps in left armpit and back of arm lasting several days. Also experienced burning sensation in elbow for about a day. Pain from the bumps raidiated down the back of the arm and also into the left pectoral muscle.
Narrative: Patient states he had pain in injection site for one day. He also reports that his bladder control has worsened after receiving the vaccine, but this has been an ongoing problem. He has an appt with private provider regarding this issue within the next week.  Other Relevant Hx: Symptoms: & injection site reaction, bladder control Treatment:
The day after his vaccine, body aches, fever, inconsolable, and I did reach out to his doctors office and they instructed to give him Tylenol and to make sure to stick to the scheduled doses. After the prescriptions he was starting to calm down, stopped shaking, and he was able to go to sleep. His fever did not go down however and in the middle of the night he vomited and did not wake up due to it. Because his fever was still maintaining low grade, we did not go to our telehealth appointment. It took about 2.5 days for the fever to go away and he was eating bland food for a few days. He no longer has any of the symptoms anymore.
Injection was very painful and felt immediately as if it was improperly administered causing my arm to go limp (so to speak)  right away. The pain was so intense that I became extremely lightheaded almost to the point of fainting. Within 15 minutes following the vaccination, I started experiencing excruciating arm pain at the injection site . The pain has persisted for the past month with little to no relief, I now have limited range of motion and cannot make certain movements with my arm.
I started noticing 2 days after, I had a high temperature or around 100.5. I had for 6 weeks, been between 99.5-100.5 so I wasn't sure if it was due to the vaccine. I felt very weak and tired. I would try eating but would need to rest. I had a feeling of impending doom. When things got really bad, I went to an urgent care. They took blood and did tests but nothing showed up. My blood pressure was a little high. I was upped on my blood pressure medication. I had a little bit of candida in my urine, so I started drinking more water and having cranberry stuff. A few weeks after that visit I started feeling better. It took like 2 months to recover. I honestly felt like I was going to die. I did my best to move because due to my dysautonomia I need to move. I would have to lie down for 20-30 mins, I felt like I was 100 years old. Of all the tests they did, nothing came back. My diabetes got worse, where I am now on insulin. I had COVID in 2020.
Patient reported that after receiving the injection he developed a non itchy rash to right deltoid, that was localized to the deltoid area. Resolved after a few days.
Had his first shot of Pfizer vaccine and he had a bad accident; This is a spontaneous report from a Pfizer-sponsored program  from a contactable consumer (patient's spouse). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on an unknown date (at the age of 27-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient had his first shot of Pfizer vaccine and he had a bad accident and was hospitalized. The patient missed the second dose because of hospitalization and wanted to know if it was safe to schedule the second dose as soon as possible. The outcome of the event accident was unknown.  Information on the lot/batch number has been requested.
Within 24 hours post vax, the pt experienced headache, severe low back pain, black floaters in her left eye, dizziness, injection site pain, and elevated blood pressure. An ER visit was required. She was treated with Naprosyn, ice packs, and acupressure with tennis balls.
Vertigo; Left hand felt tingly; Difficult to inhale; Distraught; Stated sharp stabbing pain in lower lung area; Losing control; Crying with pain; BP 140/100; Pulse 132.
See attached biopsy report for reference. The differential diagnosis includes urticaria, or some forms of drug reaction or viral exanthem.