chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt cried unconsolably for 3 1/2 hrs beginning immediately p/vax recvd; mom gave APAP 2 hrs p/shot recvd; pt recvd vax 315PM & started crying 330PM & did not subside until 7PM;
Patient started with slight cough while waiting 15 minutes. Patient then walked to make next appointment and started wheezing and having trouble breathing. Patient given Epinephrine 0.3 mg IM and Benadryl 50 mg IM, and sent to ER for further evaluation and treatment.
Information has been received from a physician concerning a 12 year old female patient who on July 15, 1995 was vaccinated with varicella virus vaccine live. On Jan 24, 2006 the patient experienced breakthrough varicella with less than 24 lesions on the face and torso. symptomatic care was given. Unspecified medical attention was sought but no labs were done. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with no drug reactions/allergies or pertinent medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot # and route were not reported). No other co-suspects were reported. Concomitant medications included: LIPITOR. The pharmacist stated the patient reported "having tingling nerve sensations in her cheek and lips after receiving ZOSTAVAX. "The patient mentioned that it felt like her lips were getting bigger". The patient sought medical attention by contacting pharmacist. At the time of reporting, the patient was not recovered. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021 at 9:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:36 AM, 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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. Concomitant products were not provided. The age of patient was provided as 77.91. On 11-Jan-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 2 vials were sent to clinic. Vaccine BUD date was 04-Feb-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 Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
My right side since the morning of 03/14/2022 is numb, especially my mouth area, the corner, and jaw area, and I have a severe headache that started the 03/15/2022.
Non-sensical calling out, restless and difficult to redirect. Rash1/15 reported.
Pain under his left armpit started the next day after vaccine administration. Pain started to radiate down his left forearm 2 days after vaccination per pt. No swelling, edema or pain at the injection site.  Supportive care implemented. Ibuprofen started.
ACUTE NON ST ELEVATION MI ACUTE DVT OF RIGHT POPLITEAL VEIN 12/5/2022 &  11/16/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.) outcome was unknown. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). No concomitant medications information was reported. Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint no. added.
Swelling, redness to right arm from deltoid to elbow and to shoulder area with redness to deltoid and pinpoint rash to upper arm area.
1yo male experienced a rash p/vax w/dose of MMR in approx Oct 76; Vaccinated w/2nd dose of MMR experienced rash & fever (WAES 90050019); No further details were provided;
Back surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "emphysema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SPINAL OPERATION (medically significant), outcome "unknown", described as "Back surgery". Therapeutic measures were taken as a result of spinal operation. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from an health care worker at the physician's office concerning a 7 year old male who on 25-JUL-2001, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included: a fourth dose of Hib conj vaccine (OMPC) (manufacturer unspecified), a third dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), and a first dose of Prevnar. There was no reported illness at the time of the vaccinations. On 07-January 2008, the patient was diagnosed with chicken pox. It was indicated that unspecified blood work was performed (results not reported). On 07-JAN-2008, a specimen was obtained from a "superficial site" for VZV by PCR. The specimen was collected and processed at a local hospital. The PCR results for the specimen from the "superficial site" identified VZV DNA was detected. On an unspecified date, the patient had recovered. Additional information has been requested.
Continuous severe headache, body ache, swollen lymph nodes, low grade fever (97.7 F)
patient reports on 1/25/2021 - Within 2 hours after returning home from receiving vaccine she had a severe headache and fever, unknown exact temp, nausea and vomiting. Fever stopped on 1/20/21 per patient. She reports her eyes seemed blurry for several days, like haziness. States she felt like her heart was racing for a few days beginning on 1/18/21. She did have a routine doctors apt on 1/22/21 and her physician completed bloodwork, unsure of labs or results. Her physician said that she should report her symptoms after the vaccine. She also had swelling and redness to her left upper arm all the way down to her elbow area after the vaccine.
On 8-30-22 while organizing the fridge, I discovered that our box of Pneumovax-23 had expired in June of 2022. I checked our computer to see if any patients had been given that vaccine since then, and unfortunately, this patient had. The first step I took was to call Merck product support and ask for any safety and efficacy data I could relay to the patient. They said as long as the product was still in the fridge during that month period there weren't safety concerns, but that the CDC did recommend revaccination in the event of an accidental expired product administration. I have called the patient and explained what happened and let the patient know that we called the manufacturer and confirmed from the manufacturer that there weren't any safety concerns, but I did say that the CDC did recommend revaccination. She was very understanding and although surprised at first didn't seem upset at all.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 5-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. Concurrent medical conditions included fish allergy and allergic to dogs (and gelatin). On 9th November 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On 9th November 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: The caller was the mother of the patient who received flu shot on Friday. The caller was unsure of name of the flu shot and lot number was not available. The caller reported that the patient broke out in a rash after receiving the injection. The reporter gave consent to follow up.
Sore arm and pain in arm; This is a spontaneous report from a contactable male consumer (patient) reported for himself. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unspecified), via unspecified route, administered in left arm on 09Apr2021 at 10:00am (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes cancer, Caller clarified that he had had chemo, radiation and 5 surgeries with sarcoidosis of lungs in 2007-2008. Concomitant medications were not reported.  On 09Apr2021 10:00 am, after the vaccination, the patient experienced sore arm and pain in arm. The reporter assessed the event as non-serious. Caller clarified that the pain was just from the needle. He did not have any discomfort where he had symptoms. Caller also states he lost his card, and he wants it back, He stated that he can go back to his vaccine site, but they are talking about closing the massive vaccination sites. He does not know if it is closed yet. He heard them say they are starting to close the sites as they have them at the drugs stores now. The caller also said everybody he knows that took other vaccines were halfway sick, but he took Pfizer, and he did not feel anything except for pain in his arm. He heard other things besides Pfizer that people were getting sick a little bit, but not him. The outcome of the event pain was recovered/resolved on an unspecified date.  No follow-up attempts possible. No further information expected.
7 1/2cm (3") area of erythema R proximal arm where Prevnar was given. No tenderness, a little warm.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine has been administered to patients post excursion.; Moderna COVID-19 vaccine has been administered to patients post excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine has been administered to patients post excursion.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine has been administered to patients post excursion.).    No concomitant medications were reported.  It was reported that there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.  No treatment medications were reported.  This case contains information for the 51th of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791, US-MODERNATX, INC.-MOD-2022-680489 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case US-MODERNATX, INC.-MOD-2022-680489:Master Case
diaphoretic, leg tremors, fatigued, short of breath, dizziness, chest pressure and weakness, which  occurred 10 minutes after injection. Patient went to the emergency department within the Medical Center. Patient had an EKG and blood work.  Patients symptoms were worse on exertion. She is followed by pulmonology and has been taking prednisone 40mg daily for the past  and Bactrim for prophylaxis. Patient had respiration rate in the 30s, and was saturating well on 3L oxygen which is her baseline. EKG was normal.  Patient tested negative for COVID-19 on 3/10/21. Patient was admitted to general medicine floor.
Pt called health service reporting severe H/A 45 minutes after injection. Shortly thereafter experienced bilat. lower ext. weakness. Advised to go to ER for evaluation and treatment.
Severe aches and joint pain, headaches, congestion, cough, sore throat, in bed for 4 days unable to work or function
leaking occurred when she was administering the vaccine/the leak was more than a few drops and felt to be about half of the vaccine with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 72 years old female patient and it was reported leaking occurred when she was administering the vaccine/the leak was more than a few drops and felt to be about half of the vaccine with no reported adverse event , while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a  dose of 0.7 ml , once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , with an unknown formulation and strength, (lot: UJ875AD ; expiry date: not reported) via intramuscular route in the left arm for immunization. No concomitant vaccination taken  The reporter stated that on 26-Sep-2022 the leaking occurred when she was administering the vaccine and the leak was more than a few drops and felt to be about half of the vaccine with no reported adverse event (accidental exposure to product) (latency: same day). There was no crack or visible problem with the prefilled vaccine. The caller stated that she tightened the needle but possibly not enough. Some leaked out where the needle attaches to the syringe. Some of the vaccine was administered to the patient, but some leaked out.  The vaccine started to leak after the pharmacist began to administer the vaccine to the patient. Part of the vaccine went into the patient's arm and part of the vaccine leaked out  Action taken : not applicable.  Outcome: unknown   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 the 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.
After my 2nd dose on 3/10/2021 I was awaken at 11:40 pm gasping for air. I called 911 because I was having such a hard time. I managed to get my rescue inhaler and get 3 puffs into me. That eased my breathing so at that point I told 911 I would call if I needed them. I stayed up and used my inhaler 3 more times. On the 11th of March I was in so much pain. It was like my body was one massive pain ball. On the 12th of March I could not move my wrists. They were very painful and stiff. I tried everything I knew over the course of a few days but when it got bad I called the doctor. She gave me some Prednisone to help the inflammation. A few days later I started with a cough, wheezing, and green and yellow sputum coming from my lungs. I called the doctor who gave me a Prednisone dose pack, a ZPac and some Mucinex. I did it for 5 days but with very little relief. I called the doctor and told her I was in pain and just not doing well. She then ordered some blood work. She then put me on some Prednisone daily and gave me a nebulizer treatment. I have been SOB since the 11th of March and it hasn't gotten much better.   About a week later I wasn't any better so she increased the Prednisone, gave me Amoxiclave and more nebulizer treatments.  Since then I have had shortness of breath, bilateral lower leg swelling and pain through out my entire body. She has since changed me to Lasix 10 mg one in morning and once at night. I have gained 35 pounds which makes this even worse.
This case was reported by a consumer via sales rep and described the occurrence of shingles in a 59-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date without any adverse events). On 6th September 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2018, 7 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with Valtrex. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to Shingrix. Additional details were provided as follows: This case was reported by husband to patient's friend of family. The age at vaccination was not reported. The patient received Shingrix in the left arm. Approximately 7 days later the patient developed dry rash on lower back right side (smaller than 4 into 6 note card). On 20th September 2018, the patient saw dermatologist and told it was shingles. No lot number was available. The reporter did not agree to be contacted for follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not provided, but was captured adult as per vaccine indication. The pharmacist said that they had been giving SHINGRIX vaccine and in general they had observed more soreness at the injection site than what they normally see with the flu shot (US2018GSK160732). No particular patient's information was associated with this report. This case has been linked with case US2018158125 and US2018GSK160732 reported by the same reporter.