chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EXPIRED VACCINE USED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no illness at the time of vaccination, past history of similar event, patient had no adverse event after any previous vaccination, patient had no history of allergy to vaccine, drug, or food, patient had no family history of any disease (relevant to vaccination) or allergy. it was not confirmed by test, if event is covid-19 infection. patient have no allergies and history of history of drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: 11-JUN-2021) .5 ml, administered on 12-JUN-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced expired vaccine used. On 12-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine used and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210629340.
Complaint of intermittent sharp pain to entire left side pain level 5/10, nausea, redness at injection site and on lower left anterior arm.
Breakthrough case admission after 2 vaccines Moderna 2/24/21 Lot# 023M20A;  Moderna 3/24/21 Lot# 030A21A
Our son developed full blown chicken pox from the varicella vaccine. He developed pox all over her face, arms and trunk (over 100 pox). He had a high fever from 4 days. The fever was consistently at 103, and peaked at 104.5. Tylenol did take the fever down, but it would return 3-4 hours later.
developing COVID symptoms; developing COVID symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: EP6955), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Feb2017, stop date: 13Apr2022; ESCITALOPRAM, start date: 30Apr2020.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Apr2022, outcome "unknown" and all described as "developing COVID symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: rapid at-home test, which was positive again. I still have symptoms 4 days later, and continue to test positive; (14Apr2022) Positive; (19Apr2022) Negative, notes: at-home rapid test; (20Apr2022) Positive; (23Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had no known allergies. Patient had received other medications within two weeks. Adverse event- Started taking Paxlovid after developing COVID symptoms of a scratchy throat and cough, and after testing positive. Took the pills as prescribed twice a day, for the full five days of the course. Felt better within 3 days of taking Paxlovid, and tested negative on an at-home rapid test on days 5 and 6 after first testing positive and starting Paxlovid. 4 days later (day 9 after testing positive and starting Paxlovid), patient started developing a sore throat, cough, and congestion again, and took another rapid at home test, which was positive again. Patient still have symptoms 4 days later, and continue to test positive.  No follow-up attempts are possible. No further information is expected.
Initial slight elevation in fever. Body aches, muscle weakness within 24 hours, including muscles of torso, headache nausea, joint pain. Several days after injection I developed mouth sores which lasted approximately one week. I had severe muscle pain starting in thighs and hips and radiating down into calves. Very distinct feeling of edge of muscles of vastus medialis & vastus lateral is, and sartorius. My legs were very weak and I was unable to walk more than a block. Normally, I walk approx. 5 mi 3 x per week and exercise daily. I became very exercise intolerant and required long rests. My legs were hot and sore to the touch. I thought I might be developing rhabdo so had a phone visit with Dr. Physician order blood tests, including CPK to rule out rhabdomyosis. Tests were negative. Symptoms continued and I had a video visit with my PCP. He ordered send rate, electrolyte tests, etc. all within normal range. Now two months later, I finally can walk and exercise normally.
Patient admitted on 1/8/22 after being diagnosed with COVID on 12/27/21. Patient received two doses of Pfizer on 2/84/21 and 3/4/21, however was not boosted. Patient was transferred from hospital to another hospital for higher level of care on 1/12/22. Patient requested to be transferred to comfort care on 1/17/22.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in an unspecified numbers of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. During the conversation with the reporter, the reporter stated that, he had been talking with his friends and friends of friends, who said they had terrible symptoms with SHINGRIX. The reporter did not have specific demographics of the patients to report. The reporter did not have specific events reported on the other patients. This is 1 of 4 cases, reported by the same reporter.
The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-2022; Patient received expired dose after the 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 016M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose after the 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient received booster 2 dose. It was reported that the staff were not dating the boxes of vaccine when placed them in the fridge for storage. The vial was initially stored in the refrigerator on 11-Jan-2022. The dose administered more than 30 days after 11-Jan-2022 was not in accordance with the university. The vial did not undergo any temperature excursions. The patient had not reported adverse reaction to the HCP knowledge. No treatment information was reported.
19APR93 itching of wrist, bumps on arm, & trunk-welts under clothing area also hands; 20APR93 OK;
I started having a rash, when it didn't go away I saw a dermatologist. They gave me a cream, the rash still didn't go away. I went to a different doctor and said it was asystamic, than I went back to my dermatologist and she gave me prednisone. After, 10 days my breath was unstable after my rash was going away. Till now I am still having the same issue with my shortness of breath. On 06APR I felt like my breathing was going very low, I went to the emergency room and they sent me home after checking me and said I will be okay.
Diarreaha for 2 days, abdominal pain for 2 days, fever for 2 days.
SLIGHT PAIN IN THE ARM FOR THE FIRST TWO DAYS; SEVERE NERVE PAIN IN THE ARM AFTER TWO OR THREE WEEKS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 05-AUG-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced severe nerve pain in the arm after two or three weeks. On 09-APR-2021, the subject experienced slight pain in the arm for the first two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slight pain in the arm for the first two days on 11-APR-2021, and had not recovered from severe nerve pain in the arm after two or three weeks. This report was non-serious.
flu; Initial information was received on 20-Oct-2020 regarding an unsolicited valid non-serious social media case from patient via Social Media.  This case involves a patient of unknown demographics who had flu (influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  The patient reported of not having any trouble with the shot but then on an unknown date, patient had flu (influenza) later on the season, (unknown latency) following the administration of INFLUENZA VACCINE.   Details of laboratory data were not reported.  Corrective treatment was not reported.   The event outcome was unknown.  There will be no information available on the batch number for this case.
nerve pain in both legs; chills; burning sensation; fever/ elevated temperature; achy at the injection site and soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 2nd January 2020, 4 days after receiving Shingrix, the patient experienced fever. On 6th January 2020, the patient experienced burning sensation. On an unknown date, the patient experienced injection site pain, nerve pain and chills. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the nerve pain, fever, chills and burning sensation were unknown.   It was unknown if the reporter considered the injection site pain, nerve pain, fever, chills and burning sensation to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 57 or 58 years. The reporter stated that the patient experienced achiness and soreness at the injection site for 2-3 days following the vaccination. On the 4th day the patient had nerve pain presented in both legs and that night mild elevated temperature and chills presented. The patient also had burning sensation in lower back presented. The patient stated that it felt like the skin was burned but there was nothing visibly in the area.      Lab Comments: on an unknown date body temperature was recorded
Information has been received from a nurse concerning a 23 year old female who on 17-JUL-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast), 0.5 mL, IM. On 22-JUL-2008, the patient called the office to report common cold symptoms including a high fever and sore throat. At the time of reporting, the patient had not recovered. Additional information has been requested.
joints got really hurt; This is a spontaneous report from a Pfizer-sponsored program COVAX US SUPPORT. A contactable female consumer  reported for her sister that:       A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) ,dose 1 via an unspecified route of administration on an unspecified date as Dose 1, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.On an unspecified date reporter stated that her sister's joints got really hurt after receiving her COVID-19 shot. The outcome of event was unknown..  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
axillary lymphadenopathy Narrative:  experiencing axillary lymphadenopathy to arm with site of injection. mild pain 6/10 relieved by otc apap. states had previously with first dose of moderna vaccine (which resolved within 5-6 days post vaccine)
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered PEDVAXHIB (Lot # L042258, expiration date: 18-AUG-2018, dose, frequency and route were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pts left thigh swollen the size of a softball and red and bruised looking; pain to left thigh. Pt treated with Tylenol and cool bath.
High fever, shaking, dizzines, redness and swollen in area, difficulty breathing, paleness and weakness.
Migraine; Extreme fatigue; Extreme joint pain; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the right arm on 13May2021 at 12:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and sulfa allergy, both from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient reported receiving unspecified concomitant medications in two weeks. The patient previously received the first dose of BNT162B2 (lot number unknown) in the right arm on 23Apr2021 at 09:00 (at the age of 29-years-old) for COVID-19 immunisation. On 14May2021 at 01:00 the patient experienced migraine, extreme fatigue, extreme joint pain, nausea and lack of appetite. No treatment was received for the events. The clinical outcomes of migraine, extreme fatigue, extreme joint pain, nausea and lack of appetite were recovered in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
serious vertigo; exhausted everything I can do; This is a spontaneous report from contactable consumer. This contactable male consumer (Patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot number and expiration date were not reported) via an unspecified route of administration, as single dose for COVID-19 immunization.The patient experienced some serious vertigo as a side effect from the vaccine. He reports that he was exhausted everything which he can do and reports that he has seen his HCP who said she had no treatment or fix for him.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No additional AE reported; the patient moved and that caused the medication to squirt in the nurse's eye; the patient moved and that caused the medication to squirt in the nurse's eye; This spontaneous report has been received from a nurse and referring to a patient of unknown age and gender. The patient's medical history, current condition and concomitant medication were not provided.  On 16-FEB-2023, the nurse was administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) injection (lot number W028558, expiration date was reported as 06-MAR-2024; dose and route of administration were not reported) for prophylaxis to patient, and while the nurse was injecting the medication, patient moved and that caused the medication to squirt in the nurse's eye (product administration error, accidental underdose). Nurse stated that the patient received the full dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) before it squirted out into the nurse's eye. No further information was provided. No additional adverse event (AE) or product quality complaint (PQC) were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2302USA006030:MSD
felt totally wiped out/tired; weak; having chills; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 14Mar2021, outcome "recovering", described as "felt totally wiped out/tired"; ASTHENIA (non-serious) with onset 14Mar2021, outcome "recovering", described as "weak"; CHILLS (non-serious) with onset 14Mar2021, outcome "recovering", described as "having chills".  Additional information: Patient reported receiving the first Pfizer covid vaccine dose on Sunday afternoon and afterwards felt "totally wiped out, tired, weak and having chills". Patient also reported that the next day the tiredness and weakness continued and started to feel better. Patient was querying if it was normal and how long it was expected to last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increase in frequency and severity of periods.   I use to barely get it 2-3 times a year and very light, no cramping becuse I have IUD. After getting the Covid vaccine I get it monthly and it is the heaviest it?s ever been and I have a lot of cramping.    This has continued the last 6 months
As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain.  This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I'm still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don't know what else to do that is why im contacting the CDC for help. I'm in a extreme amount of pain and pounding headaches.  Please help
Day 1: couldn?t lift arm, beyond a ?little? sore  Day 2: arm pain and rash around injection site  Day 3:  menstrual  cycle starts 2 weeks early is incredibly painful  Day 5: localized skin rash around arm gets worse and body aches start, arm still in pain Day 10: sacral nerve pain begins rash around my neck appears. Body aches still present  Day 13 today: still on my menstrual cycle it is heavier and more painful that usual. Heavy bleeding for 10 days no end in sight still experiencing sacral nerve pain
Severe headache, chills, vomiting, exhaustion,  body rash, couldn't move left arm x 2 days
hsv-1 outbreak; sore arm redness and bruising at site; sore arm redness and bruising at site; sore arm redness and bruising at site; This is a spontaneous report from a contactable physician.  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1204), intramuscular into the left arm on 23Dec2020  at 18:00 as single dose for COVID-19 immunization.  Medical history included herpes simplex  1 (HSV1) from an unknown date.  The patient's concomitant medications were not reported. Prior to vaccination, the patient had not been diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19. There were no allergies to medications, food, or other products.   On 27Dec2020, patient experienced HSV-1 outbreak and sore arm redness and bruising at site. This was elaborated as 4- 5 days post vaccine, there was marked HSV-1 outbreak, different than typical outbreak and that was not responding to valacyclovir hydrochloride (VALTREX). There was also sore arm redness and bruising at site. The events were not serious.  Therapeutic measures were taken as a result of  the events as aforementioned (valacyclovir hydrochloride). The outcome of events, HSV-1 outbreak and sore arm redness and bruising at site was not recovered.