chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next day after injection, patient felt soreness and tenderness on left arm. On the second day, there's redness, bumps, rashes and swelling around the injection site. Per patient, she only had triple antibiotic and applied it on affected area and helped with the itching a little bit. I advised patient to take BENADRYL and apply hydrocortisone cream. I left a message to follow up with patient to see how if it's getting better.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Additional Details: Blood Pressure 139/88 at 12:23p
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-JAN-2015, the patient was inoculated with ZOSTAVAX at a pharmacy 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 03-JAN-2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as shingles. She was prescribed acyclovir topical ointment and tablet for management of her painful symptoms and chronic pain. On or about 05-JAN-2015, the patient sought treatment from an ophthalmologist for a blistering vesicular outbreak which was diagnosed as herpes zoster keratoconjunctivitis. On or about 13-APR-2016, she sought further treatment from a physician's assistant for another vesicular outbreak which was diagnosed as shingles. She was prescribed acyclovir and NORCO 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. Upon internal review, herpes zoster keratoconjunctivitis was considered to be medically significant. Additional information has been requested.
Within first hour - Pain at injection site radiating up to the ear, and down the arm, tingling down the arm and into the first three fingers of left hand.  Four hours after the shot - onset of intense stomach pain and nausea, continued for next 6 hours. Seven hours after the shot - low grade fever, chills and shivers. 18 hours after the shot - still 99 F fever, body aches.
pt recv vax 11SEP97 & 22SEP97 pt devel blood in urine & a dec platelet count & was hosp for 5 days;22SEP97 pt platelet count was 9, WBC count 2.8, protein 2;
Very tired and lethargic. Arm hurt very bad and patient got a rash at the site.
Narrative:  67 yo male with PMH: HTN, OSA, social anxiety disorder, neuroleptic-induced parkinsonism, bipolar, obesity, and arthritis tested positive for covid19 on 9/2/2021. On 9/11/2021, he was admitted due to fogginess, increased falls. In addition, patient had cough and dyspnea on 8/29/2021 and tested positive for covid on 9/2/2021. Family felt that since 8/29/2021, he's had more fogginess and difficulty ambulating and has had 2 falls. During the hospital course, he did not require treatment for covid. It was found that his imbalance was due to polypharmacy (benzo and overuse of OTC robitussin).
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported, lot # L035505 with expiration date 16-DEC-2016). Concomitant medications were not reported. On an unknown date the patient experienced injection site swelling and redness that was warm to the touch, headache, and "generalized achiness". Outcome of the events was unknown. The causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
I started to smell burnt bacon and coffee; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 13May2021(at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history included Adhd and stress. Concomitant medications included adhd medication and stress medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 14May2021 the patient started to smell burnt bacon and coffee. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event started to smell burnt bacon and coffee was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fatigue; This is a spontaneous report from a contactable consumer (patient's wife). An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left upper arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included COVID from 22Nov2020 to an unknown date and coronary artery disease from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced fatigue (fatigue) (non-serious) on an unspecified date with outcome of unknown. The patient's wife read that would test positive for 90 days after. She and her husband had their first vaccine on Tuesday, 12Jan2021. She read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 months from diagnoses. The patient has experienced fatigue, slept all day yesterday. The patient had an appointment yesterday but canceled it, it was for blood work but he wasn't feeling up to it. The facility where the most recent COVID-19 vaccine was administered was in an independent living center. The vaccine was not administered at a Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No emergency room or physician office visit done. The outcome of the event was unknown.  Information about lot/batch number has been requested.
3 inches by 2 inches rash left leg where injections were given 24 hours after immunization. Rash gradually worsen. Multiple raised papules on both legs on injection site.
tested positive for coronavirus; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for coronavirus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Reporter stated that the patient got over COVID, and had an antibody infusion.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for coronavirus). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for coronavirus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Coronavirus test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         No concomitant medications details were reported.  It was reported home test came back with a positive result as well.  No treatment information details were reported.  Company comment:This case concerns a male patient of an unknown age with a past medical history of Covid-19, who experienced the non serious event of Sars-Cov-test positive. On unknown dates the patient received the first and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, Coronavirus test: positive (Positive) Positive.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of an unknown age with a past medical history of Covid-19, who experienced the non serious event of Sars-Cov-test positive. On unknown dates the patient received the first and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, Coronavirus test: positive (Positive) Positive.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
I got vaccinated at 11:03 a.m. and left the site 15 minutes later I had no adverse reactions at first my first reaction was at 4:15 in the afternoon which was a really bad headache by the time I got off from work that evening my head was hurting really bad. I got real bad chills to the point where my teeth were chattering I was very cold I was nauseous I had pain all over my body. My left arm was hurting really bad the pain would not go away. I call not sleep because my tongue was swelling overnight so I stayed awake to make sure that my throat would not close up and I had diarrhea really bad.
This spontaneous reprot as received from a healthcare professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-APR-2015, the patient was vaccinated with a dose of GARDASIL lot # k006960 (expiration date, dose, route and site of administrations were not provided) that was exposed to temperatures outside of the recommended range for 63 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Dose given too soon from previous dose.  #1 dose was given on 1/13/2022.
Itching; Pain shouting from her shoulder to her back and to her leg; Pain shouting from her shoulder to her back and to her leg; pain shouting from her shoulder to her back and to her leg; This case was reported by a other health professional via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus, shoulder pain, back pain and leg pain. On an unknown date, the outcome of the pruritus, shoulder pain, back pain and leg pain were unknown.   It was unknown if the reporter considered the pruritus, shoulder pain, back pain and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physical therapist reported that the patient experienced itching and pain shouting from her shoulder to her back and to her leg.  The reporter did not consent to follow up. For tolerance after 2nd dose of Shingrix, refer case US2020AMR032820.
On 5/30/2023, I began getting a sore throat. That evening, I developed a fever and started having cold-like symptoms that included sneezing, runny nose, cough, and headache. The fever was around 103 at night. The cold-like symptoms and the fever lasted for about two days. On 5/31/2023, I took a home antigen test and got a positive result. On 6/1/2023, I had a telehealth visit with my doctor, who prescribed PAXLOVID. She advised me to cease taking ranolazine and rosuvastatin while I took the PAXLOVID and suggested that I wait two days after finishing the PAXLOVID before I resumed taking them. I still have some congestion, runny nose, cough, and fever, but I feel that they are progressively getting better. Whenever I have a fever at night, the temperature is now lower and is usually around 100.
Vulvar/genital pain developed about 2 days after the second dose of the vaccine, and bilateral apthous vulvar ulcers  (Lipschutz ulcers) were noted by the third day after the vaccine.  They worsened over the next few days, causing extreme pain, especially with voiding, requiring bladder catheterization.  They were resolved within 3 weeks.
Developed papulovesicular lesions.  Did not seek care.  Itching.  Lesions disappearing after a few days.
fever commencing with heavy shuddering... temperature reaching 103 degrees... not receding for 48 hours... treated with Tylenol very 5 hours... ongoing headache
I had and eye infection and I went to the eye doctor on May 26, 2021 and they stated that I had a really bad sinus infection. I then went home and I started coughing and couldn't stop. I was feeling really bad, like I was going to pass out. I went to the urgent care and they said to get some cough medicine and then two days later I went back and they said I had Pneumonia in my right lung. They ran a series of tests, Covid 19, flu test, chest x-ray. Than they took my oxygen level and it was very low, so they said to go to the ER. I then went there and they ran the same test and immediately admitted me to the hospital July 6, 2021 and they said that I had double pneumonia in both lungs. They treated me with antibiotics and other meds. I got discharged on July 9, 2021. I was sent home with antibiotics and oxygen and I am still on the oxygen. I saw a cardiologists this week and I am waiting to see a pulmonologist.
Shortness of breath; body fatigue; low grade fever; 57 year old male patient received Fluzone High-Dose; 57 year old male patient received Fluzone High-Dose; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a physician and nurse via Sales Representative.  This case was linked to cases 2019SA280604 and 2019SA280605 (same reporter).  This case involves a 57 years old male patient who experienced shortness of breath (dyspnoea), body fatigue (fatigue) and low grade fever (pyrexia), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious shortness of breath (dyspnoea), body fatigue (fatigue) and low grade fever (pyrexia) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was reported that an ambulance took him to the hospital. Hospital personnel told patient his symptoms were due to his flu shot.  It was also a case of Inappropriate age at vaccine administration and overdose.  Other relevant tests not reported.  Final diagnosis was low grade fever, body fatigue and shortness of breath.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for low grade fever, body fatigue and shortness of breath.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
vertigo on 1/26/2021. Swelling, redness and pain at site on 1/31/2021
Patient called to say next day woke up w/ 2 inch red, hard knot where shot was & said it itches too. I told her to use ice & BENADRYL if worsens to call her Dr.
got the vaccine, five days later got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's comment: The patient's relative reported this case via interactive digital media. The patient received dose of Shingles vaccine and five days later he got shingles. The reporter stated that he/she had almost over shingles (no shot) on his/her right hip area and they hadn't been bad at all. The reporter also stated that he/she must be lucky because everybody that has had them states how bad they hurt. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID-acidic mouth; burnt tongue sensation; scratchy throat; mild cold symptoms; cough/ dry hacking cough; Congestion/Nasal stuffiness; joint stiffness; low grade fever; limited taste and smell; limited taste and smell; fatigues; This is a spontaneous report from a contactable consumer or other non-HCP. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) intramuscularly on 28Jan2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) intramuscularly on 18Feb2021 as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination. Vaccination facility type was reported as Pharmacy or Drug Store. It was unknown if patient received any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced break-through COVID-19, COVID/PCR (nasal swab) test with result as positive (COVID-19), breakthrough covid-acidic mouth, burnt tongue sensation, scratchy throat, mild cold symptoms, stuffy nose, cough/dry hacking cough, congestion, joint stiffness, low grade fever, limited taste and smell, fatigue on 15Aug2021 20:00. Patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Sars Cov-2 PCR Test Nasal Test (reported as polymerase chain reaction (Nasal Swab)) with result as positive on an unspecified date in Aug2021. The outcome of events was resolved on an unspecified date in Aug2021.  Follow-up (26Aug2021): Follow-up attempts are completed. No further information is expected.
Pt developed a temperature over 102 for 36 hrs with frequent chills and a sensation or organs shaking. She had 4 days of bed rest and sleep and 7 days of fatigue.
Admit for COVID infection. Fully vaccinated. Remained on RA. Improved quickly and discharged home.
Myalgia, NauseaVomiting, Pain, Redness and swelling at injection Site, fatigue, chills Narrative:
Patient began developing nerve like pain in his right leg, joint pain, right foot numbness.  Went on to develop balance disturbances and intermittent episodes of altered mental status as well as twitching of the trunk.
Patient experienced soreness, redness over a large area of right shoulder over 6 days. Induration.
Complaints of increase pain to knees/hips,, extreme swelling  in lower extremities, Nausea, sweating, dizziness, increase SOB
16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose; Received their 1st dose of Pfizer and came in today and got the Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Received their 1st dose of Pfizer and came in today and got the Moderna) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Received their 1st dose of Pfizer and came in today and got the Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Received their 1st dose of Pfizer and came in today and got the Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
I had a fever, muscle pain, joint pain and serve fatigue that been going on since my vaccine. I spoke with my doctor. He did blood work and increased my thyroid medicine.
Pt came into office today (8/5/04) re: lt upper arm being sl. swollen, hot to touch with reddness measuring about the size of a lemon.  The onset of the site were after immunizations given o (8/3/04).  Doctor prescribed Atarax 10mg TIDx1week with warm compresses TID and f/up if site worsen or persist
5/15/2007 child came for well child examination. Child received Varicella vaccine today. 5/17/07 Doctor's progress notes read as follows: swelling at injection site after varicella vaccine. P.E: 10x4cm area of induration and erythema L arm at injection site. Plans report react -benadryl - rech prn Note: sibling came in same day 5/17/2007 for same findings: reaction to varicella vaccine given 5/15/2007
On the two hour ride home, my arm would ache then be fine.  I was cranky, not myself, going to bed, I woke several times as I rolled over onto my right arm.  When I awoke early, I was swollen from Head to Toes, my eyes were slits, my bracelets and rings were swollen into my skin, and my toes and ankles were large. AND I was grouchy about everything.  As the day went on I was just mad about everything,  I began to drink lots of water and tried to exercise to get the swelling down.   About noon, my eyes and face began to ease, but my body didn't ease till about 2pm, as my rings and bracelets were movable  then. I am still swollen and still angry and it is Friday.
Patient stated that she noticed lumps around armpits, and she thinks its related to the vaccine. She got the vaccine on 4/30/2021 and she noticed lumps in June 2021 about 2 months later. She hasn't talked to a doctor about it because she doesn't have a primary physician. I advised her to see a doctor.