chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.94 degrees Celsius for one hour. Data logger was involved. There were multiple previous excursions below 0 degrees Celsius reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA001976: US-009507513-1811USA001975: US-009507513-1811USA001977.
I started feeling extremely fatigued on 03/24/2021 and was unsure if I had a fever at that time. The cold-like symptoms, body aches, and the fatigue lasted about a day. I called the doctor and I went to see them on 03/25/2021. Doctor wasn't sure if it was related to COVID-19, something else or the vaccine. I was tested for COVID-19 then and it was negative.
Menactra was administered after being exposed to frozen temperatures several times, with a minimum of minus 1.25 Celsius, no AE; Initial information received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA203233, 2020SA203126 and 2020SA203423 (same reporter).  This case involves a 11 years old female patient who received a 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number not reported) via unknown route in the left arm for prophylactic vaccination on 03-Jul-2020 after being exposed to frozen temperatures several times, with a minimum of minus 1.25 Celsius (product storage error).  The patient's medical history, past medical treatment, past vaccination and family history were not provided. The patient did not receive any other medications or vaccines on that visit.  It was an actual medication error due to product storage error temperature too low.  It was reported that the refrigerator got too cold many times due to possible batteries issues and it happened on and off on several days.  At the time of reporting, no adverse event was reported.  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.  There will be no information available on lot number for this case.
pt recv vax 14NOV96 & 15NOV96 pt exp a rash;23NOV96 pt noticed the rash over entire upper body;pt also exp itching at the rash on an unspecified date;
Severe arm pit pain and tenderness on the side in which the injection was given. Lymph nodes feel swollen and it?s very difficult to place anything against it
No adverse event; monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    Concomitant medications details were not reported by the reporter.  Reportedly, patient received 0.5ml of the dark blue cap vaccine for 6-11 years old instead of the new Bivalent vaccine.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-657525 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow-up document contains updated patient demographics.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657525:Master case (Crosslink case with same reporter)
4 hrs after larger dose of flu vaccine, I started aching all over, got the chills, took hot bath & went to bed feeling miserable - somewhat better next day.
PATIENT SMALLPOX VACCINE AND HAS SWELLING, HEAT AND REDNESS TO ALL OF UPPER LEFT ARM. "FEELS LIKE A PULLED MUSCLE"
Patient with very mild swelling  lip and  itchy feeling of tongue. Given 37.5 mg Benadryl, all symptoms resolved.
Information has been received from a 64 year old female with hives with suldinac (WAES 0805USA06072) and horse serum who on an unspecified date was vaccinated with an unspecified pneumonia "shot" (manufacturer not reported). After she received the shot, the patient reported that her arm swelled up at the injection site. The patient also reported her experiences with zoster vaccine live (Oka/Merck) (WAES 0805USA03822). Additional information is not expected.
Booster on Friday, I had a slight scratchy throat. After the vaccine on the same day aches and pains, chills started. I was under my blanket and my arms felt cold. I changed into long sleeves. Sat & Sunday and Monday- fatigue, chill, stuffy congestive coughing, aches and pains. hips and everything hurts. Not much of the fever. Monday  - I saw the doctor, I worked at the hospital. Sent ER for covid test was positive. Tuesday texted doctor through my chart. Drug infusion/ IV therapy tomorrow. A Tuesday positive.
severe pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (severe pain at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (severe pain at the injection site). At the time of the report, VACCINATION SITE PAIN (severe pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
shingles; nerve damage; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 31-MAR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around May 2014, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles and nerve damage. As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
1150 Dtap, Hib, Prevnar, MMR and Varicella administered. 1210 developed facial rash, periorbital edema and erythema. 1225 administered Benadryl 37.5mg PO.
Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient who was vaccinated with a 0.5 ml fourth dose IPOL (Batch number: N28758 and expiry date: 14-Nov-2019) via intramuscular route in the left deltoid on 16-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. Concomitant medications included DTAP for Immunisation; MMR for Immunisation; and VARICELLA VACCINE for Immunisation on an unknown date. It was a case of potential medication error due to incorrect product storage because vaccine was "too long in transit" and 1 vaccine from a MDV was given. No reaction was reported. 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. Documents held by the sender: None.
Could hardly talk, could not take meds. Throat swelled. Throat better toward evening.  Woke on 10/18/2016 with lips and lower face swollen and hives begin-ning throughout body. To urgent care.
pt recvd vax;7dec fever 103 in eve of vax;12dec fever 103.5,rash from chest to butt x 2 days;16dec fever 104.5 highest,signs of joint pain;18dec maculopapular rash neck to buttocks;
Right eye swelled shut, hurt, itched, turned red, and had discharge. Swelling went down by itself starting the next morning.
Patient came to the ED with complaints of weakness, cough, and shortness of breath.  Patient was admitted to the hospital with Covid and treated with remdesivir.
Patient developed a itchy rash on his left wrist. Rash had multiple small blisters, looked like cold sore. Patient said rash was itchy, pink/red, with blisters, and partially responsive to topical steroid, tried antiviral cold-sore treatment on with resolution of blisters.  No other systemic symptoms.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis. Co-suspect products included fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder (batch number 7ZP6165, expiry date 31st March 2019) for product used for unknown indication and PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis.  Concomitant products included amlodipine, lisinopril, proair (nos) (Proair) and tiotropium bromide (Spiriva). On 1st December 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. In 2014, the patient started Advair Diskus (inhaled) 1 puff(s) twice daily (2 puff(s) daily). On 8th December 2017, the patient received PNEUMONIA SHOT. In January 2018, less than a year after receiving Influenza vaccine Quadrivalent 2017-2018 season and not applicable after starting Advair Diskus, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and pneumonia (serious criteria GSK medically significant). Advair Diskus was continued with no change. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and pneumonia were recovered/resolved. It was unknown if the reporter considered the vaccination failure, influenza and pneumonia to be related to Influenza vaccine Quadrivalent 2017-2018 season. It was unknown if the reporter considered the influenza and pneumonia to be related to Advair Diskus. Additional details were provided as follows: The age at vaccination was not reported. The wife of the patient was transferred from GSK PAP. This case was considered as suspected vaccination failure as the laboratory confirmation for influenza was not available at the time of reporting.
Small lump on lower left leg; Same type of lump on upper left arm; Redness; Itching; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (Small lump on lower left leg), AXILLARY MASS (Same type of lump on upper left arm), ERYTHEMA (Redness) and PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Small lump on lower left leg), AXILLARY MASS (Same type of lump on upper left arm), ERYTHEMA (Redness) and PRURITUS (Itching). At the time of the report, SKIN MASS (Small lump on lower left leg), AXILLARY MASS (Same type of lump on upper left arm), ERYTHEMA (Redness) and PRURITUS (Itching) outcome was unknown.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 11:18 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 11:23 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.93 for dose administered on 03-MAR-2021 and 66.01 for dose administered on 31-Mar-2021.  Concomitant products were not provided.  On 03-Mar-2021 vials were moved to clinic. On 24-Feb-2021 the vaccines were moved to fridge. On 03-Mar-2021, the vial underwent the excursion. The vaccine beyond use date was reported as 26-Mar-2021.  On 31-Mar-2021 vials were moved to clinic. On 30-Mar-2021 the vaccines were moved to fridge. On 31-Mar-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 32. The vaccine beyond use date was reported as 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Mild
MODERNA 6-11 GIVEN AS BOOSTER DOSE AFTER PATIENT RECEIVED PRIMARY DOSE WITH PFIZER 5-11.
1 of 2 children vaxed the same day 6FEB95 from same lot# exp an adverse event; w/in 24hrs pt devel temp to 102.5 w/vomiting, localized swelling @ inj site & irritability;pt recovered;
Diffuse arthralgias beginning the day after the injection and lasting of one week.  Redness and pain at the injection site and distally along the arm.
Patient applying to EMS training.  Needed several vaccines.  Will be going to PCP for titers on a few.  He was given Hep B and Hep A vaccine series, both first doses.  Upon inventory a couple days later, was noted that patient was accidently given Pediatric dose of Hep A.  He was called, wife answered phone and the event was explained to her.  She verbalized good understanding by stating he can get his next dose in 1 month when he comes in for his next Hep B vaccine.
This spontaneous report as received from a registered nurse refers to an 4 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 were exposed to unspecified temperature excursion not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1404USA005558, 1404USA005559, 1404USA005560, 1404USA005561 and 1404USA005563) from the same source. Additional information has been requested.
she was given the Pfizer shot instead of the Moderna for her second shot. she came back to the pharmacy and also received her second Moderna shot
Fever, chills, arm pain (left) erythema 3 inches X 2 inches, tenderness.
Woke up this morning with rash covering my neck and down my chest, stomach and legs. Taking Benadryl but no improvement in symptoms
This case was reported by a pharmacist via call center representative and described the occurrence of generalized urticaria in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was unknown. It was unknown if the reporter considered the generalized urticaria to be related to SHINGRIX. Additional details were reported as follows: This case was received via website. The age at vaccination was not reported. The HCP (Healthcare Professional) reported that the patient's whole body broke out in hives after the dose of SHINGRIX. The HCP was in a corporate location and specific details were not accessible to her at the time of report. A VAERS report might have been filed by the administering site.
This spontaneous report as received from a 72 year old male consumer with no drug reactions/allergies refers to himself. The patient's pertinent medical history included 14 stents. The patient reported that he had accidentally received two unspecified doses of ZOSTAVAX on different dates. The patient was given the first dose of ZOSTAVAX on 09-DEC-2010 and he had no adverse experiences from it. On 11-SEP-2013 the patient was vaccinated with a second dose of ZOSTAVAX (dose, route and lot # unknown) because he and his physician had forgotten that he had the ZOSTAVAX injection. Three days later on 14-SEP-2013, the patient started to develop a rash on his arms and chest. The patient became very itchy. The patient then called his physician between the dates 15-SEP-2013 - 20-SEP-2013 and told him of the adverse experience. The physician gave him a prednisone shot. Then after 5 days, the itching came back. The physician gave him a higher dose of prednisone, but after 8 days or so the itching came back again. The patient was going to go see a 'skin/rash' doctor tomorrow. He could not remember the name of the physician he was going to go see tomorrow. There were no lab diagnostics performed. The outcome of very itchy and rash on his arm and chest was reported as not recovered. The relatedness between ZOSTAVAX and adverse events was not reported. Upon internal review rash on arms and chest and pruritus were considered to be medically significant events. Additional information has been requested.
Patient begain feeling ill after a short time and temp. was 104.7 at Midnight. Grandmother was giving pt. Motrin and Tylenol alternating every 2 hours. Fever was reduced slightly and she put him in cool bath which reduced temp. to 102 This continued until 10/21/10 at noon. He also c/o headache and pain in throat and poor appetite.
administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administration error because he received the Moderna bivalent booster dose instead of the first dose of primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       No concomitant medications was reported. It was reported that patient should go back to receive the first dose of primary series but mentioned there are some risks when it happens. No treatment drug details was reported.   Reporter did not allow further contact