chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 23 month old Caucasian female patient with no allergies an no past medical history who on 08OCT2002 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live. Concomitant vaccination on 08OCT2003 included a first subcutaneous dose in the right arm of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. There was no illness at the time of vaccination. On 07OCT2003, the pt developed varicella lesions. On 08OCT2003, the pt was seen int he office with 40 scabbed lesions on her chest and back, as well as some vesicles. No treatment was required for the varicella lesions and no laboratory tests were performed. Subsequently, the pt recovered from varicella. It was also noted that the pt had sinusitis since 11SEP2003 with coughing and diaper rash, which "does not appear to be associated with varicella". On 11SEP2003, amoxicillin + cavulanate potassium (AUGMENTIN) was started and renewed on 01OCT2003 for the sinusitis. The pt was also treated with levalbuterol hydrochloride nebulizer (Xopenex) for the cough associated with the sinusitis. The pt was treated with nystatin cream three times a day for vulvitis, which was probably from the diaper rash. Subsequently, the symptoms of sinusisits, cough and diaper rash all improved. The reporter noted that there were no further problems and the pt recovered. On 21OCT2003, the pt was vaccinated in the left arm with a first intramuscular dose of influenza virus split virion 3v vaccine inactivated (Fluzone). A product quality complaint was not involved. Additional info is not expected.
Patient is a 15-year-old, male. Alert, oriented X4, clear speech, able to answer to questions. No known medical history. History of anaphylaxis twice in past, requiring the use of epinephrine. History of allergies to peanuts, animal hair, and grass. At 11:43 am, the patient received his first dose of Pfizer (lot number EW0185, expires on 08/2021) on left deltoid. Patient walked with a steady, balanced gait to EMT observation area. At 12:00 pm, patient's mother notified EMT that patient had blotchy redness in left hand. Lead RN responded immediately and assessed the patient. Upon observation, the patient had localized redness at the injection site, with erythema on the entirety of his back and hands. Patient was assisted patient to anti-gravity chair. Patient states he feels "tingling" at injection site. Patient denied SOB, itching, and dizziness. Patient remained A&Ox4 and talking to EMT. RN requested vitals Q5 minutes for 30 minutes while she drew up 1.0 mL of IM Benadryl. At 12:02 pm: BP of 108/70, HR 78, SPO2 98%. At 12:08 pm, the redness and rash on patient's arm and back had completely subsided. Patient denies feeling tingling sensation at injection site. At 12:10 pm: BP of 110/67, HR 75, SPO2 99%. Patient's mother declined use of IM Benadryl. Lead RN education patient and mother on signs and symptoms of anaphylaxis, and requested the patient stay for an additional 20 minutes for monitoring. RN disposed of 1.0 mL dose of Benadryl. At 12:18 pm: BP of 110/70, HR 79, SPO2 99%. At 12:26 pm: BP of 108/70, HR 82, SPO2 99%. At 12:37 pm: BP of 106/70, HR 85, SPO2 97%. Lead RN provided patient's mother with education concerning when to call 9-1-1, including worsening of symptoms and trouble breathing. Patient was instructed to follow up with PCP and allergist. At 12:40 pm, patient stood up from chair, denied lightheadedness and dizziness. Patient walked to car with steady, balanced gait. Patient's mother drove patient home.
injection site itching; injection site swelling; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes zoster.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). At the time of the report, VACCINATION SITE PRURITUS (injection site itching), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.            she recently got a Shingles shot No Concomitant medications were provided No treatment information provided   Reporter did not allow further contact
Discomfort; Patient stated her psoriasis got more severe; on Sun face was swollen on the left side, same side where she received the injection; low grade fever 99.5 degrees; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (Discomfort), PSORIASIS (Patient stated her psoriasis got more severe), SWELLING FACE (on Sun face was swollen on the left side, same side where she received the injection) and PYREXIA (low grade fever 99.5 degrees) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059a21a, 068h21a, 030b21a and 037a21b) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Patient was about to start taking biological drugs, an injection which affects her immune system, for a pre existent medical condition patient had, psoriasis, that would make her immunocompromised), Immunocompromised and Alcohol allergy (to rubbing alcohol, Patient can passed out for it).   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced DISCOMFORT (Discomfort), PSORIASIS (Patient stated her psoriasis got more severe), SWELLING FACE (on Sun face was swollen on the left side, same side where she received the injection) and PYREXIA (low grade fever 99.5 degrees). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort), PSORIASIS (Patient stated her psoriasis got more severe), SWELLING FACE (on Sun face was swollen on the left side, same side where she received the injection) and PYREXIA (low grade fever 99.5 degrees) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, Body temperature: 99.5 low grade fever 99.5 degrees.         Patient's height was reported as 5.8 without units. Patient had neither tested positive nor diagnosed with COVID. Patent did not receive any other vaccines within one month prior to Moderna COVID-19 vaccine. Patient received the 2nd booster injection on the left side. Patient has been taking a lot of regular, prescribed medications as concomitant medications. Patient states did not have any problems with the previous doses of the vaccine. Patient did not see any decrease on the swelling. AE caused patient to seek medical care, patient had to visit her physician. Patient never experienced a similar event in the past. Patient reported the status of symptoms were just the same (neither improved nor worsened). Treatment details included hot compresses, antibiotics and drank more water. Patient's HCP thought this was not related to the vaccine.
I was fine on Friday after the injection. On Saturday morning I felt like a had the flu. On Sunday, I had a really bad headache at the top of my head that lasted until Thursday. Friday, the headache started to ease up but didn't go away. On Saturday, I started getting stabbing pains over my left ear that felt like an ice pick. I started having hearing loss in my left ear and pain in my left cheek and eye. I went to the ER where they did bloodwork and a CT scan. The doctor didn't see anything unusual and released me and told to schedule a follow up with my primary physician. I was unable to schedule a face-to-face appointment with my doctor, so I had a telehealth visit with her. By then, I was still having numbness in my face, intermittent hearing loss, and muscle pain in the back of my legs. She referred me to a neurologist and a ENT specialist, who hasn't been able to see me yet. Dr. performed a CTV which came back clear, but I still had the numbness in my face. He said the vaccine caused inflammation of my brain that was causing the face numbness and scheduled me for a MRI on October 20. The pain in the back of my legs is so severe that I can barely walk.
Place vaccine administered turned Bright Red and then Black and Blue. Member also had swelling and a lump the size of Baseball. Internally shoulder became extremely sore and could not raise arm above shoulder height. Member stated it felt like it was sore in the bone. Member did not come to work on 18 May 2004 because of soreness of arm shoulder area.
Migraine Headache; Body aches; Joint Pain; Chills; Night sweats; Anxiety; Fatigue; feeling as if heart is racing but when pulse was taken it was normal; This is a spontaneous report from a contactable nurse, who is also the patient.  A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231), via intramuscular route of administration in the right arm on 19Jan2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and the patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR), both from unknown dates, at unknown doses, for an unknown indications.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via intramuscular route of administration, in the right deltoid on 29Dec2020 for COVID-19 immunisation.  On 20Jan2021 at 06:00 the patient experienced migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal. The patient did not receive any treatment for the events. The clinical outcomes of the migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal  were recovered with sequelae (reported as "recovered with lasting effects") on an unknown date in Jan2021.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient was given the 2nd dose of Moderna 16 days early, Patient did not have any adverse reaction to the vaccine.
inflamed; hard; red patch in the arm (>2 inches); This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflamed), INDURATION (hard) and ERYTHEMA (red patch in the arm (>2 inches)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced INFLAMMATION (inflamed), INDURATION (hard) and ERYTHEMA (red patch in the arm (>2 inches)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLAMMATION (inflamed), INDURATION (hard) and ERYTHEMA (red patch in the arm (>2 inches)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product : Santrax
Patient called to report she had chills, fever, body aches, injection site was fire red and hot to the touch and hard.
Patient report that after 20 mins of the vaccine she had a serve headache and nausea...next day felt pain all over her chest and arm and develop lumps under her breast and on her left arm... bad cramping, light headed and dizzy,  heart was racing, chills and sweats
Adult patient received a pediatric dose; Adult patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a adult female patient who received HAV (Havrix pediatric) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2021, the patient received the 1st dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 1st December 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product 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 provided as follows: The age at vaccination was not reported. The nurse reported that an adult patient received a pediatric dose of Havrix for her first dose, which led to accidental underdose and adult use of a child product. The reporter did not consent to follow-up.
Severe headache and body aches,  Started about an hour after 2nd dose and is still going approx 28 hours later.
5/05/2022 I had a quick onset of a sore throat, congestion, runny nose, a little bit of cough and runny nose. I took the rapid antigen test the government sent me, and I was positive. I contacted my doctor immediately and left a message. The next day he prescribed Paxlovid which I am still on.   Today I am not feeling better.  The Paxlovid has a metallic taste in my mouth, it is making my appetite go away.
C/o (R) arm lesion x 1-2 days. Mom states lesions started right after vaccine was administered. Mom admits pt was fighting when vaccine was administered.
Day 1: Severe headache, fever/chills. Tylenol helped. Day 2: symptoms mild. Continuing Tylenol but needed less frequently. I am a 4th year medical student, thought maybe I had meningitis. Headache worse with neck movement.
Feeling dizzy; Felling shaky; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy) and NERVOUSNESS (Felling shaky) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety attack since January 2021.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Feeling dizzy) and NERVOUSNESS (Felling shaky). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy) and NERVOUSNESS (Felling shaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
8 days after vaccine experienced bullseye rash at site of innoculation appeared and lasted for 3 days.  Area was warm to touch, itchy, and sensitive.  Also experienced a sore arm for three days following the original shot.
pt recvd vax & devel indigestion, chest pain, gastristis & fatigue & elevated liver enzymes; lab evaluation showed pos for anti hbc; pt suffered from hepatitis c;
It was reported that a 39 year old female received a post exposure series of Rabies Imovax IM vax after her husband handled a rabid raccoon that was killed by a dog. The series was started on 9-29-1999, and the last dose was given on 10-27-1999. The pt also received Rabies Immune Globulin on 9-29-1999. Out of the  five Rabies vax's the pt developed adverse reaction after three. Post 2nd dose pt experienced malaise. Post third dose, the pt experienced malaise, headache, nausea, abdominal pain and diarrhea. Post fourth dose pt again experienced the same symptoms.
Stroke like symptoms; aphasia; This is a spontaneous report received from contactable nurse. The reporter is the patient.  A 59 year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FF2590), on 12Oct2021, when the patient was 59 years, as single dose for covid-19 immunisation. Relevant medical history included diabetes and high blood pressure (HBP), and  COVID prior to vaccination from unspecified dates. The patient took unspecified concomitant medications. Vaccination history included first dose of BNT162B2  (Lot number: 301308A), on  19Sep2021, when the patient was 59 years old, for covid-19 immunization. On 13Oct2021, the patient experienced stroke like symptoms and aphasia, which were serious as they were  life-threatening, and involved hospitalization. The patient was noted as desperately in need of insight.  The events  were evaluated at the physician office visit and emergency room visit. The patient underwent laboratory tests and procedures, which included unknown results from a COVID test, post vaccination.  Clinical details were as follows: Stroke like symptoms-aphasia-then total incapacity occurred. The patient was currently hospitalized, and noted as "desperately in need of insight ". The events involved hospitalization, and were life-threatening illness. There was no immediate risk of death from the event, and the patient was noted as hospitalized for 31 days. The patient had not recovered and treatment involved unspecified multiple interventions. The clinical outcome of stroke like symptoms and aphasia was not recovered.
immunocompromised patient received booster for third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster for third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus and Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster for third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster for third dose) outcome was unknown.            No concomitant medications details were reported.  The patient stated that his wife had two Moderna vaccines and first Moderna booster. He noticed that there was a third Moderna shot for immunocompromised. He was wondering that she should forego her second booster and get the Moderna immunocompromised shot.  No treatment medications details were reported.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. Current conditions and other relevant medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous injection, dose, strength, route, anatomical location, lot # and expiration date not reported). Concomitant therapies were not reported. The reporter stated that on an unknown date, the patient developed shingles after receiving the ZOSTAVAX. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Small lump at the injection site; This spontaneous case reported by a pharmacist and initially received on 20-Sep-2018, concerns a 54-year-old, adult, female patient.  The patient's medical history and concomitant medications were unknown.   On 20-Sep-2018, the patient was administered Afluria Quadrivalent [Influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: YF37606 (as reported), expiry date: 11-Jun-2019] for protection against seasonal influenza. The reported batch number (YF37606), does not match Seqirus batch numbers, however, because the reporter named Seqirus product YF37606' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. However, the query regarding the batch number has been raised.   On the same day right after administration of the vaccine, the patient developed a small lump at the injection site. Patient did not undergo any treatment for the event.  At the time of this report, the patient was recovering from the event.  The reporter assessed this case as non-serious.; Reporter's Comments: A 54-year-old female patient developed an injection site lump on the same day after vaccination with suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event as related considering site-specific reaction (injection site) and due to plausible temporal relationship between event and suspect vaccine.
Contracted Covid. First sign was a fever. relocated to a hotel to quarantine. Body aches and pain first 2 - 3 days, coughing. then noticed bright red blood in mucus being coughed up lasted for approxmitaly 3 - 5 days then changed to a dark color like black and lasted another 4 - 5 days before clearing up.
Only the adjuvant was given; Only the adjuvant was given; This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7C4B3, expiry date 14th November 2022) for prophylaxis.   On 17th August 2021, the patient received Shingrix. On 17th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient received only the adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021182200, US2021182201 reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182200:Same reporter US-GLAXOSMITHKLINE-US2021182201:Same reporter
Possible esophageal spasms.   Day of vaccine / went to bed early. Next day,  mild tired reaction such that I stayed home from the office but was capable/functional to still work (remotely). Just past the 24 hour mark - after briefly realizing I was starting to feel better - pains in my sides that then became sudden, incredibly severe pain in center chest. Steady pain that became even more severe every couple minutes just like a contraction. Could barely speak during these moments. Hunched over went to hospital. Couldn?t even look up to see full room. I had an EKG. Normal. From start to finish the severe bout lasted less than two hours. Then just felt fine, like it never happened. Hospital treated with stomach medicine but by the time the medicine was administered the severe pain had subsided and I already felt ok. Gastro doctor post hospital was not concerned I have a medical issue, rather thought possible vaccine connection.  Given this unusual and rather severe pain experience 25 hours post booster, I wanted to report it in case seeing elsewhere or helpful to log in
red raised hot swollen area involving entire rt hip w/rt groin region w/gen itching, pain, & fatigue;