chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 77-year-old female patient who received SHINGRIX for prophylaxis.  On 30th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, feeling unwell, laziness, tiredness and fever. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell, laziness, tiredness and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell, laziness, tiredness and fever to be related to SHINGRIX. Additional details were reported as follows: The caller asked about the medicine causing certain flu like symptoms was that normal. The patient had not received second shot. The caller stated she doesn't remember all of her symptoms but remembers that she did not feel well. She said she was tired and laggy and was on the couch. She said she might have had a fever but was not sure. The permission was not granted to contact MD. MD information was asked but caller refused.
suspected vaccination failure; shingles on her left hip; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got shingles vaccine and sometime later got shingles on her left hip. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Headache, Myalgia, Fever, sore left arm and chills Narrative:
Initial unsolicited report received from other non health care professional (Office Staff) on 16 September 2016. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient experienced increased local reactions, itchy, swollen arm and warm to the touch. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. List of documents held by sender: none.
A report has been received from a Health Professional concerning a Male subject, who had been receiving FLUMIST (intranasal). Concomitant medications included EZETIMIBE. FLUMIST (intranasal) started on an unknown date. It was reported that the patient was inadvertently administered with FLUMIST at an age of 66 years which started on 07-Nov-2014. The outcome of the event of inadvertent administration to a 66 year old patient is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between inadvertent administration to a 68 year old patient and FLUMIST. Reporter and company physician assessed the event inadvertent administration to a 66 year old patient was not related to suspect FLUMIST.
After the 15 mins of waiting in the exam room the patient became dizzy, nausea and pale. Had the patient sit next to her father. Had a dr. come into the exam room to check on the patient. Pt received food and a drink and slowly felt better and color returned to normal.
Severe migraine type headache, burning feeling in feet and hands, cold/hot sweats, feverish, nausea, aches in body
Injection occured without incident per patient. Pain at injection site became a 7 out of 10 and lymph node became very swollen and was reported as a pain of 4 out of 10 the starting the next day (Wed 04-24-19). Patient reported normal range of motion of the arm with pain, extremely large and swollen lymph node in armpit (visibly enlarged), no fever, no tingling or numbness in arm or fingers, no redness at injection site or anywhere on arm/armpit, and no heat to injection site/lymph node. Patient took an ibuprofen but didn't get much relief and had appt with MD on 4-25-19 to check on reaction. Per patient account to pharmacy, MD was concerned with size of lymph node but wanted to wait to see if it would go down over next 2 weeks or develop heat to site/fever, redness, or continue to enlarge. If the reaction got worse would do a scan to help determine cause. MD was hoping reaction would decrease over next 1-2 weeks per patient. Patient was going to continue ibuprofen to help with swelling/pain. Patient's pain at injection site was decreased slightly 48 hours post injection with lymph node pain still had no change.
Information has been received from a nurse concerning a female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil.  Subsequently the patient experienced a lump underneath the injection site.  Unspecified medical attention was sought.  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) had resolved. Not applicable      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expired date was 07-NOV-2021. Concomitant medications were not reported. Treatment information was not reported.
Vaccine was administered to a 16 year old; A spontaneous report was received from a pharmacist concerning a 16 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) (PT: Product administered to patient of inappropriate age) with no associated adverse events.  The patient's medical history was not provided. No concomitant medications was reported.  On 17-Feb-2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 016M20A) via unknown route for prophylaxis of COVID-19 infection.  Treatment information was not applicable.  Action taken with mRNA-1273 was not provided..  The outcome of the event, vaccine was administered to a 16 year old, was recovered/resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age 16 year old for mRNA-1273 (Lot number: 016M20A) with no associated AEs reported.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Medium, Additional Details: She explained she has fainted in the past from vaccines. Received vaccine and shortly after said she wasn't feeling well. I went to grab her a wet paper towel. When I got back she had her head back and she was unresponsive, but breathing. she clenched the chair and had a sort of convulsion breifly. She came back to after about 2-3 minutes, shortly before the ambulance arrived and they looked at her. she decided not to go to the hospital.she drank some water & ate & said her husband would get her
This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A 12-year-old male patient, the doctor's son, received one dose of TRUMENBA (lot M13066, Expiry Date: Sep2016), intramuscular on 17Jan2016 at 0.5 ml single dose for prevention of meningococcal disease. The patient medical history and the patient's concomitant medications were not reported. The patient experienced muscle pain at site, headache and low grade fever on 17Jan2016. The outcome of the events was reported as recovered. The events were assessed as non-serious.
Two days following vaccination, on May 1 2021, the patient experienced fatigue, headache, and swollen lymph nodes in the armpits. This lasted until May 10 2021. The patient notified the pharmacist today at the time of her second dose of the side effects experience with her first dose.
covid vaccine breakthrough case  all Moderna dose 1  2/26/21  010a21a dose 2  3/26/21  017b21a dose 3  10/23/21  039d21a dose 4  4/21/22  066k21a
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 12-JUN-2015 the patient was inadvertently vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # L001326; expiration date: 13-JAN-2017) (dose and route not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Client attended a vaccine clinic and requested Pfizer vaccine.  Client completed the vaccine consent form indicating he had not had a previous Covid 19 vaccine and signed the form prior to administration.  RN administered Pfizer #1 to client.  Upon entry of completed vaccine into the Immunization Registry, RN noted that client had previously had a Johnson & Johnson Covid 19 vaccine on 04/01/2021.  RN emailed Department of Health Services Covid 19 Vaccine Team for consultation as to next steps.  Email was received back advising that client was complete for Covid vaccine series and that a VAERS Report should be submitted.  Client was called 07/01/2021 at 1018 and notified he had previously received a Johnson & Johnson vaccine, was complete for Covid 19 vaccine series and was not in need of receiving the second dose of Pfizer.  Client admitted he was aware he had received a Johnson & Johnson Covid 19 vaccine  in the past.  Client verbalized he was confused as to needing  the Pfizer vaccine and that it was "better to be protected".  Client was reassured that he was fully vaccinated with the previous Johnson & Johnson vaccine.
My arm swelled at injection site and turned red & feverish. Fever & chills over nite with vomiting by morning.
Legs were covered with hives and moved to arms. Went to doctor's office at 10:50 AM and the hives were disappearing. It's now 8:40 PM and she has more hives on arms and a couple appeared on her face.
1. Swollen lymphatic node (left armpit) sent me Sonomammography. It has been decreasing in size after a month and a half. 2. Irregularity with menstruation. I get off after the vaccine and after two weeks. 3. Triggering signs of lupus that was in remission several months prior to the vaccine. Increase inflammatory symptoms, hair loss and chemical alteration. Female doctor increased dose of drugs from routine.
Very sore at injection site and red for 4 days. Chills and entire body aches for 2 days. Could not get warm.
woke next morning w/difficulty breathing, eye/nose running;throat sore;appeared to have gen allerg sx;
patient felt unsteady/ faint Blood Pressure 82/50 Pulse 60/ mon No resp symptoms no rash  Patient placed supine for 10 -15 min. Improved and BP 114/80 No postural changes
This spontaneous report was received from a pharmacist, and refers to a 63 year old male patient. The patient did not have any medical history, concurrent conditions or drug reactions/allergies. On 02-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously in the arm (unspecified; dose was not reported), lot # L037791 with expiration date of 30-DEC-2016. The patient was not taking any concomitant medications. It was reported that the patient went to his home and fell asleep after the vaccination. Later, on an unspecified date in June 2016, when the patient awoke, the arm where he received the vaccine was "tingling and numb". Additionally, his arm felt heavy and was unable to move it below the wrist. Therefore, the patient called his pharmacist and was advised to go to the local emergency room (ER) of a hospital. However, the reporter did not know if the patient went to the ER. No intervention to prevent serious criteria was performed. No laboratory diagnostic studies were performed. No product quality complaint was involved. At the time of reporting, the outcome of all above mentioned events was unknown. Additionally, the relatedness between the events and the suspect therapy was not provided by the reporter. Additional information has been requested.
Patient had Moderna shot for 1st dose.  PT received Pfizer shot for 2nd dose
facial numbness; Itching/itching on arms and legs; Her mouth is also numb; driving her crazy; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732) via an unspecified route of administration, administered in Arm Left on 12Apr2021 at 08:00 (at the age of 54-year-old) as dose 2, single for COVID-19 immunisation. Patient's medical history (including any illness at time of vaccination) was none. Concomitant medication(s) included vitamin d nos (VITAMIN D) taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, NDC and expiry are not provided) via an unspecified route of administration, administered in Arm Left on 22Mar2021 (at the age of 54 years old) as single for COVID-19 immunisation. Additional vaccines administered on same date of the pfizer suspect was none. The patient experienced facial numbness, Itching/itching on arms and legs, her mouth is also numb, driving her crazy on 12Apr2021. Reported as, Her face from the forehead down to her lips are numb. Her mouth was also numb. She feels like she has been to the dentist. It was driving her crazy. She was also itching on her arms and legs. Numbness started about 45 minutes after the vaccine followed by itching around 11:00 am. Outcome of all the events were not recovered.  No follow-up attempts are needed. No further information expected.
Two hours after shot left elbow severe pain progressed to my hand. Went to urgent care told it was a allergic reaction. Returned next day to urgent care with welts on and under left arm. Pain under left arm and redness. Patient comes in today for a new medical complaint. Pt just received her pneumonia shot x today and now has pain in her (L) elbow and has aches in her whole (L) arm.
06/06 I received a call that someone that we had meet was positive for COVID-19.  06/07 I had a scratchy throat and a runny nose. I did a home test, and it was negative.  06/08  Negative 06/09 Positive Home COVID-19 Test I contacted my doctor through the My Chart.  They forwarded my case to a COVID-19 team and they contacted me and gave me Paxlovid. I was also told to use over the counter for fever. I didn?t use anything but Tylenol for the low-grade fever.
Fever, weakness, anemia, bladder cancer, inflammation, kidney failure, diarrhea, nausea, dizziness, weight loss, lack of appetite, vision loss, AFIB, stomach pain, low blood counts
vomiting & diarrhea & fever 102 began 7hr p/vax;had extreme lethargy & couldn't even keep water down;MD saw pt 2 days later prescribed levsin;sx worsened, brought pt back next day;hosp x 3 days, on IV fluids because dehydrated;
Hospitalized 7/8/22-7/12/22 weakness, lethargy, fatigued, cough, dyspnea, afib, PNA, fever, hypoxia,
itchiness; ultimately developing hives; itchy tongue; swelling and tightness of my throat; swelling and tightness of my throat; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), URTICARIA (ultimately developing hives), TONGUE PRURITUS (itchy tongue), PHARYNGEAL SWELLING (swelling and tightness of my throat) and THROAT TIGHTNESS (swelling and tightness of my throat) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced PRURITUS (itchiness), URTICARIA (ultimately developing hives), TONGUE PRURITUS (itchy tongue), PHARYNGEAL SWELLING (swelling and tightness of my throat) and THROAT TIGHTNESS (swelling and tightness of my throat). At the time of the report, PRURITUS (itchiness), URTICARIA (ultimately developing hives), TONGUE PRURITUS (itchy tongue), PHARYNGEAL SWELLING (swelling and tightness of my throat) and THROAT TIGHTNESS (swelling and tightness of my throat) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.
constipation; Short term memory loss; Nausea; Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird; Throat started closing and tightening; Head feels foggy, loopy, funny when walking/brain fog; Dizzy; Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat started closing and tightening), FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog), DIZZINESS (Dizzy), HYPERTENSION (Hypertension) and CONSTIPATION (constipation) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy.    On 10-Mar-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat started closing and tightening), FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog), NAUSEA (Nausea) and HEADACHE (Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird). 10-Mar-2021, the patient experienced DIZZINESS (Dizzy) and HYPERTENSION (Hypertension). On an unknown date, the patient experienced CONSTIPATION (constipation) and AMNESIA (Short term memory loss). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK dosage form. At the time of the report, THROAT TIGHTNESS (Throat started closing and tightening), DIZZINESS (Dizzy), CONSTIPATION (constipation), AMNESIA (Short term memory loss), NAUSEA (Nausea) and HEADACHE (Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird) had not resolved and FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog) and HYPERTENSION (Hypertension) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2020, SARS-CoV-1 test: positive (Positive) positive. On 10-Mar-2021, Blood pressure measurement: 186/103 (High) elevated.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications also included Vitamins.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: Patient demographic details were updated, relevant history(food allergy)was added, added vaccine facility information and events ( Hypertension, dizziness, headache) On 10-Jun-2021: Lab data was added.
Expired Vaccine was adminstered on 05-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine was adminstered on 05-Apr-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine was adminstered on 05-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine was adminstered on 05-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  Patient received 2nd booster dose.  No treatment medications was provided by the reporter.
At the time of administration the vial was approximately 6-10 days past the 30 days window; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (At the time of administration the vial was approximately 6-10 days past the 30 days window) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (At the time of administration the vial was approximately 6-10 days past the 30 days window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (At the time of administration the vial was approximately 6-10 days past the 30 days window) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  7 patients received 2nd booster dose of moderna which was approximately 6-10 days past the 30-day expiration window. At the time of this report, no patient has contacted about any reactions.  No treatment medications were reported.  It was reported that isolated all vaccines with reported lot number and pulled from over inventory rotation.
Moderna COVID -19 Vaccine EUA. Approximately 7 hours after the injection I experienced chills, severe body aches, fever (101 F) and severe nausea. I took Tylenol extra strength at the onset of the symptoms and again 4 hours later. Fever broke around 3:00 a.m. but I still had body aches and loss of appetite for the rest of the day (Nov .4). Two days later, I am feeling better, but head still feels groggy.