chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.     The reporter's causality for the events of Skin plaque, Scab and Rash macular with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. No treatment medication were provided.   Reporter did not allow further contact This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels). At the time of the report, SKIN PLAQUE (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands), SCAB (Broken out in scabs and plaques with the exception on bottom of feet and the palms of the hands) and RASH MACULAR (Red spots were the size of nickels) outcome was unknown.      No concomitant medication information was provided.  Reporter did not allow further contact
105 Degree F fever; chills; uncontrollable shivering; A spontaneous report  was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 105 degree f fever, chills, uncontrollable shivering.  The patient's medical history was not provided. Concomitant medications reported were Extra Strength Tylenol for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first  dose of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) 105 degree f fever, chills, uncontrollable shivering.  Treatment details included Patient's doctor advised her to take Extra Strength Tylenol to decrease the patient's fever and or to, go to the Emergency Department. Fever continued for 24 hours after taking a few doses of, Tylenol Extra Strength..  Action taken with mRNA-1273 in response to the events was not reported.   the outcome of event(s), 105 degree f fever, chills, uncontrollable shivering was resolved.
Breakthrough case of Covid-19 starting on April 24, 2022.  Tested positive on April 25
Infant received vaccines on 11/18/02 in the late AM. Mother called us on 11/19/02 in AM stated infant started running temp of 103-105 on 11/18/02 in PM. Also had purple ring around eye. Alternating Tylenol + Advil. No physicians, Advised to go ER or Immediate Care
Case number PHEH2015US026910, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 35 years old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 24 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there had not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Pt. got a 102 temp on 7-24-08 & 7-25-08 called the paramedics and was evaluated.  Pt today still running low grade temp.
Flu-like symptoms: headache, achy body, extreme fatigue lasting 24 hrs Ibuprofen
Patient presented to the ED and was subsequently hospitalized on 4/26/2021, within 6 weeks of receiving COVID vaccination.
2 series shot is a doozy; This case was reported by a consumer and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date refer case US2021AMR178133).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. After received shingle shot patient was doozy, but so much better than contracting shingles. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178133:same reporter, same patient, 1st dose
A report was received from healthcare professional on 04 Dec 2006, concerning an unidentifiable vaccinee. The reporter stated that 6 or 7 employees experienced swollen tender arms, with difficulty elevating the arm for weeks after the vaccination. Further information will be requested. Follow up received from a healthcare professional on 05/Dec/2006, identified the vaccinee as a 32 year old. No details concerning the vaccinee's past medical history or concomitant medications were provided. The vaccinee was administered Fluvirin 0.5ml by intramuscular injection on an unspecified date, developed an acute painful arm for 3-4 weeks and was subsequently diagnosed as having brachial neuritis. The reporter considered the event to be serious, hospitalisation and disability/incapacity. The events are ongoing. Further information is requested.
02/13/2021 my reactions were as  expected-- headache for a couple of days,  swollen joints. 02/19/2021- I started getting a headache, full blown, I thought my head was going to explode. I had chills, I was very, very weak and within a couple of hours the vomiting started, and suddenly everything came up. It was projectile vomiting. I was just shooting vomit all over everything. I don't have migraines. Severe Headache, it was horrendous. Like my head was going to explode. I had to wear sunglasses. It was debilitating. I could not function, disoriented, chills. My son came and told me I had to go to the ER. We had a telehealth with my doctor and he said we had to get to the ER room immediately. He thought it could be a blood clot.   I could not sleep; the pain was intense. I felt this thing on the top of my head, on the very top of my skull, it went one direction, like 2 inches,  to another direction, I felt like liquid.   My son transported me to the Emergency Room. They put 2 bags of IV fluids.  They put me on a drip of morphine and it fixed it and I slept.  I was at the hospital for a little less than 24 hours. They sent me home with prescriptions, ant nausea medication, and a pain killer medication, that I never filled. I had a little bit of a headache the next day and it resolved. They did not find a clot.
Patient was given wrong dose. Patient should have received 0.25ml but received 0.5ml.
Expired Pediarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 08-APR-2023) for prophylaxis.   Previously administered products included Kinrix (has had previous dose of Kinrix ).   On 04-MAY-2023, the patient received Pediarix. On 04-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2023 The nurse reported that the patient received Pediarix vaccine, which was expired on April 08, 2023. The reported that the patient was being caught up on vaccines and has had received previous dose of Kinrix. The vaccine administration facility was same as primary reporter. Patient received a dose of Pediarix on May 04, 2023 which was expired on April 08, 2023, which led to expired vaccine used. The reporter consented to follow up.
Patient immediately started to experience blurred vision, said she felt nauseous, eyes were rolling towards the back of her head. She was coming in and out. Patient reported reduced hearing. Had difficulty keeping coherentthoughts. Felt weak and after 5-10 minutes the decision was made to call the ambulance as the patient's symptoms and general presentation were not resolving or getting better. EMS arrived and patient left pharmacy on stretcher and was taken to the hospital where further attention was provided but unknown to us here at the pharmacy. Will follow up with patient in two days.
No adverse symptoms reported; inadvertently administered a dose of PROQUAD (Lot: S022912, Exp: 01/19/2021) via the intramuscular route rather than the recommended subcutaneous route; This spontaneous report has been received from a nurse referring to a patient with unknown age and gender. The concomitant therapy included sterile diluent (DILUENT MRK). Information about current condition, medical history, and drug reactions/allergies was not provided.   On 26-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin(rHA)) (PROQUAD), lot# S022912, expiration date 19-JAN-2021 (strength, dose and frequency was not reported) as prophylaxis, inadvertently via the intramuscular route rather than the recommended subcutaneous route (incorrect route of product administration).  No adverse symptom was reported.
Chills began 9 hours (8:15 pm) after shot (shot at 11:20 am) and lasted for approx 8 hours(until 4 am)   Chills were accompanied by nausea and extreme headache.  Nausea lasted 9 am, and headache lasted until 11 pm (36 hours after shot).   No adverse effect with first shot.
This spontaneous report was received from a physician, via a company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 PK, lot # L002310, expiration date: 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 48 hours. The lowest recorded temperature was 34 Fahrenheit degrees (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Individual experienced acute adverse reaction approximately 20 minutes after dual administration of flucevax and comirnaty (biotech/pfizer) monovalent injections were administered. Flucevax quadrivalent PF injection was administered into left arm, biotech/pfizer) monovalent injection was administered in right arm.  Approximately 20 minutes post vaccination, individual experienced acute chest pain in the lower left  chest side, that rapidly intensified along with sharp pain in the left arm and complete numbness of his left arm.  Immediately went to ER for treatment as individual indicated he thought he may be having a heart attack.
Stiffness of the arm immediately following shot. Large moveable cyst on elbow. Doctor drained at some point, but cyst is still present. White watery discharge. Mildly painful to touch
Fever of 100.9 for 12 hours after administration of two Extra Strength TYLENOL every 6 hours, Shaking Chills, Numbness of upper legs, Nausea, Somnolence, Headache.
This spontaneous report was received from a licensed nurse practitioner, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 22-SEP-2017, the patient was vaccinated with an improperly store dose of GARDASIL 9 (strength, dose, route of administration, anatomical location were not reported), involving lot # N002720 with expiration date on 12-MAY-2019, or lot # N001533 with expiration date on 16-OCT-2019; for prophylaxis. The storage temperature was 32.54 degrees Fahrenheit (F) for a time frame of 25 minutes. There was no previous temperature excursion reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011217: US-009507513-1710USA011216: US-009507513-1710USA011218: US-009507513-1710USA002653.
Age 17 years 6 months at time of vaccination.  Under age 18 identified when mother brought patient for 2nd dose appointment.
Pallor, nausea, vomiting, faintness symptoms resolved in 10 min, pt was layed flat with cool compresses on forehead and neck.
sweating; felt like they were going to pass out / felt lightheaded; was inadvertently re-vaccinated with PNEUMOVAX23; This spontaneous report was received from a physician via a company representative and refers to an elderly (reported as over 65-year-old) patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, vaccine status could not be determined and the patient was inadvertently vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On the same date, the patient was sweating, felt lightheaded and felt like was going to pass out. The patient sought medical attention by calling the doctor and the doctor confirmed the patient had already received one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23).  The outcome of hyperhidrosis and dizziness and the relatedness between the events and the suspect therapy was not reported.
Major rash on both forearms and both legs, minor rash chest and stomach area...nose very stuffy with drainage in throat
This spontaneous report as received from a pharmacist via Market Research Company employee refers to unspecified number of patients of unknown age and gender. On an unknown date, the patiens were vaccinated with PNEUMOVAX 23 (dose, route, anatomical location and expiration date were not reported). The reporter stated that vaccination with PNEUMOVAX 23 was not enough and that the patients needed both vaccines-PNEUMOVAX 23 and PREVENAR. The reporter considered that both vaccines were necessary. The outcome of the event was unknown. The relatedness between the event and the therapy with PNEUMOVAX 23 was not provided. Additional information is not expected, as the reporter was not willing for him/her or her/his doctor to be contacted to discuss further.
This spontaneous report was received from a female patient of unknown age, reporting on herself. No medical history or concurrent conditions were reported. On an unknown date, approximately in 2012 reported as "three or four years ago", the patient was vaccinated with the first dose of GARDASIL via intramuscular (strength and lot number were not reported), the patient did not continue with the second and third dose. Concomitant medication was not reported. The patient reported that on unknown date, reported as "now" she was experiencing unspecified symptoms of genital warts and unspecified HPV diseases. The outcome of unspecified symptoms of genital warts and unspecified HPV diseases was unknown and the causality assessment was not provided. Additional information is not expected, since reporter details were not provided.
Recurrent nose bleeds. I?ve never had them in my life i have now been getting them every single day sometimes 2-3 times a day
Dermal swelled in lips, cheeks and under eyes  Oral prednisone for 4 days and anti histamines. I?m having more trouble now with breathing/ shortness of breath, chest pain, and headache. Undergoing treatment as of today for this part.
arm pain at injection site; arm pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Jan2021 17:30 (Lot number: EL3247) at the age of 74 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "shingles" (unspecified if ongoing), notes: She had shingles prior when she was 42; "She assumes she must have had COVID /antibodies present in May 2020, when she was tested", start date: May2020 (unspecified if ongoing); "chicken pox" (unspecified if ongoing), notes: She had the chicken pox when she was young; "she needs a magnifying glass/She always has her glasses to read with" (unspecified if ongoing); "she had slight mitral regurgitation", start date: Apr2019 (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 15Jan2021, outcome "recovered" (Jan2021) and all described as "arm pain at injection site". The patient underwent the following laboratory tests and procedures: cardiac stress test: (Apr2019) she had slight mitral regurgitation; sars-cov-2 antibody test: (May2020) antibodies present in may 2020, when she was teste. Additional information: Patient had no other medical conditions. She was healthy at the time of the report. No family medical history. She started shrinking before she got the vaccine. It was years before. She assumed she must have had COVID and did not know, she had the antibodies present in May 2020, when she was tested. When looking up an address, she stated she needs a magnifying glass.  She needed this before the vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other vaccines administered on same date of the Pfizer vaccination. No relevant tests were performed.  No follow-up attempts are possible. No further information is expected.
Supposed to get the second / shot in March or February 2020 / COVID hit and he never did; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (also experienced arm hurt and felt flu like after receiving 1st dose in November 2019, refer case US2021079438) and Flu vaccine with an associated reaction of influenza like illness (received within 3 to 4 weeks of 1st dose of Shingrix in 2019, refer case US2021AMR080271). Concomitant products included COVID-19 VACCINE.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not applicable to this report. The patient stated that he was supposed to get the 2nd dose of Shingrix in March or February 2020, but then COVID hit and he never received. The patient refused to provide any private information and did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR080271:Same reporter. US-GLAXOSMITHKLINE-US2021079438:Same reporter.
12/12/2022, I woke up with a headache and achy. I had chills during the night. The worst thing was the dry cough. My husband was COVID-19 positive. I had fatigue. I did a COVID-19 home test and it immediately came up positive. I called the doctor's office and she prescribed MUCINEX. She prescribed PAXLOVID and I started that on Tuesday.
pt reportedly recv vax & 2JUN95; 4JUN95 pt found in bed limp, grey nonresponsive taken to ER; improved ABGs nl sent home;
Fever 103F x 4 days Generalized erythematous maculopapular skin rash Koplik spots, cracked lips, mild dehydration
By 1pm patient had a bit of a headache that went away. About 6pm, patient started with chills, shaking, and cold.  Contacted doctor and recommended use of Tylenol and Ibuprofen. Took temperature around 7 and had about 102.8; fever stayed up all night and used Tylenol and Ibuprofen.  On Wednesday, slept all day and had fever of 101 all day, achy, eyeballs hurt because of headache.   Fever was gone after 2 days but headache persist and eyes hurt when moving.  Patient has not reach out to doctor again since out of town. Patient has received same vaccine in the past with no problems. Patient did not contact vaccine provider at any point.  Patient still taking Tylenol.
pt recvd vax & 5 miins p/vax rt leg started looking red, blotchy; immed followed by lt leg becoming blotchy (red) which then progressed to both legs appeared bright red, swollen & warm to touch, pt cried uncontrolably;