chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.) 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 04-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.). At the time of the report, PRODUCT ADMINISTRATION ERROR (Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   As reported Pharmacist gave two doses of the Moderna COVID 19 vaccine to two patients after the vial was opened for more than 12 hours. Concomitant medications were not reported. Treatment information was not reported.
I got mine, 3 years later, got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years 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 patient self-reported this case. The age at vaccination was not reported. The patient got the shingles shot and 3 years later got shingles. The Shingles were not too bad. After that, the patient had to get 2 more shots. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197180:same reporter
Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom; Left foot was broken; Had fallen on her foot, fell; Mild aches; Bed was soaked with diarrhea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Bed was soaked with diarrhea after second dose). 02-Apr-2021, the patient experienced MYALGIA (Mild aches). On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) (seriousness criterion medically significant) and FOOT FRACTURE (Left foot was broken). 19-Apr-2021, the patient experienced FALL (Had fallen on her foot, fell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom), FOOT FRACTURE (Left foot was broken), DIARRHOEA (Bed was soaked with diarrhea after second dose), FALL (Had fallen on her foot, fell) and MYALGIA (Mild aches) outcome was unknown.            Concomitant product use was unknown. The patient reported that the day after her second shot, she woke up and her bed was soaked with diarrhea. She has no memory of this, but on 19Apr2021, she woke up on the floor in the bathroom. She stated that she had fallen on her foot, and her left foot was broken. She also reported she had mild aches on 02Apr2021. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-162182 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Feeling faint, nauseous, chills, for 2 hrs. Called EMS
After receiving the pfizer covid vaccine pt c/o having an itchy throat and c/o dizziness.  Pt was placed supine on cot and vs obtained. VSS on RA.  Color pink throughout.  Pt continued to c/o itchy throat and then stated her lips where becoming numb.  Epi 0.3 mg given via auto-injector per protocol.   Ambulance called.  Arrived within 6 minutes and took pt to the hospital for further evaluation.
Arm hurts where shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurts where shot was given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (Arm hurts where shot was given). At the time of the report, VACCINATION SITE PAIN (Arm hurts where shot was given) had not resolved.            No concomitant medications provided.  Treatment information was not provided    The action taken with mRNA-1273 with the events was considered as not applicable  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Appointment date for second vaccination will be 48 days out; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment date for second vaccination will be 48 days out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment date for second vaccination will be 48 days out). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Appointment date for second vaccination will be 48 days out) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment details was not provided.   The patient stated that she was not able to get a call back for the second vaccination appointment until the 29th Mar 2021 and got the date on 15 Apr 2021. The patient also reports that the first vaccination was done at a mass injection site.
As soon as I received the Pfizer booster I was immediately sick. I was suffering severe headaches, dizziness etc. I followed up 5 days later with my ENT and expressed what I was feeling. He assured me that it had nothing to do with my sinuses, etc. The headaches did not go away and 7 weeks later I suffered a hemorrhagic stroke. On February 27, 2022 my left side went completely numb and I was rushed to the hospital and put into a CT scan where I heard the techs talking about my serious bleed. That was the last thing I remember until mid April. I was sedated and in an induced coma. A bolt was placed in my head and then a drain to try to relieve the pressure. I have been in extensive rehabilitation since April 1, 2022 but I have not regained any function of my left side and I am in a wheelchair. My wife and children take care of me on a daily basis.  I have had several CT scans and MRI's as well as having been seen by many Neurologists and Neuosurgeons looking for answers. Before Feb 27, I was in great shape. I exercised, ate right and never once ever had High BP until the day I was given the Pfizer booster injection.
Co-lead nurse sent a medical consult to the clinical lead nurse for client who received his first dose of Pfizer on 7.14.21, EW0191 exp. 8.31.21. He reported he had lightheaded and fever for one day after his first dose. He said he had lightheaded prior to getting his first dose Pfizer COVID vaccine. Today (8.4.21), he ate and hydrated himself before coming to get his second dose Pfizer COVID vaccine and reported to the vaccinating nurse he started having the lightheaded 30 minutes before he sat at her table. He denied shortness of breath or any other anaphylaxis signs and symptoms after receiving his first dose Pfizer COVID vaccine. He denied following up with his primary care doctor for the lightheaded. He reported no known allergies or chronic illnesses. Clinical lead nurse sent the medical consult to the medical doctor due to his elevated blood pressure (BP). Vaccinating nurse took client's vitals at 3:45 PM, BP 159/108, Heart Rate (HR) 107, oxygen saturation rate (O2) 98% and at 4:00 PM, BP 136/101, HR 94, O2 99%. Client told lead nurse he cannot wait for the medical consult result but made an appointment for 8.5.21, Thursday at 1:00 PM for his second Pfizer COVID vaccine if approved at the public health center vaccination site. Co-lead nurse called client to let him know he is approved for his second dose Pfizer COVID vaccine after received a text medical consult from clinical lead nurse that she received from a medical doctor. Co-lead nurse only left a message for client to call back since unsure if the cell number client left was client's correct cell number. Since client didn't call back after co-lead nurse left him a message on 8.4.21 and he did not return to the POD for his second Pfizer COVID vaccine, co-lead nurse called client again and left him a message that he is approved for his second Pfizer COVID vaccine on 8.10.21.
Nausea; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (Nausea) and FATIGUE (fatigue) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was reported.     On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021 at 11:00 AM, the patient experienced NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, NAUSEA (Nausea) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Initiative, email from reporter asking for patient identifiers.
No Additional AEs; Caller reported a 30 year old patient received a pediatric dose of Hepatitis B.; Caller reported a 30 year old patient received a pediatric dose of Hepatitis B. HCP was told this was the patient's first dose of Hepatitis B but she states the state immunization records show patient received Hepatitis B Vaccine; immunization records show patient received Hepatitis B Vaccine in May 2000 (0.5 ml) and April 2002 (0.5 ml).; This spontaneous report was received from a medical assistant and refers to a 30-year-old patient. No information on patient's medical history, current condition and concomitant medications was provided.      On 12-MAY-2023 the patient was vaccinated with 0.5 milliliter hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # W016731 and expiration date 03-DEC-2024, intramuscularly for prophylaxis.  Other suspect therapies included and hepatitis b vaccine rhbsag (yeast) (HEPLISAV B). The reporter didn't know if it was hepatitis b vaccine rhbsag (yeast) (HEPLISAV B) or hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (product administered to patient of inappropriate age, inappropriate schedule of product administration and no adverse event). Health care professional reported that the state immunization records show that in MAY-2000 and APR-2002, patient received 0.5 milliliter of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (inappropriate schedule of product administration).
Low grade fever, chills, fatigue, swelling at injection site, injection site sore and warm to touch, body aches, joint pain, headaches
Pain in arm; Red patch around the injection site; Soreness; A spontaneous report was received from a consumer who was also a 62-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, red patch around the injection site and difficulty moving her arm.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 07 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 011J20A) for prophylaxis of COVID-19 infection.    On 07 Jan 2021, after being given the mRNA-1273 vaccine, the patient experienced soreness. Treatment for this event was two Tylenol 325mg Capsules.  On 08 Jan 2021, she reports having a red patch around the injection site and having difficulty in moving her arm.  Treatment included was Motrin on this morning. It was also noted that an ice pack was applied, but time not specified.  Treatment for these symptoms were reported as the following: Ice pack applied, Motrin taken but not reported when   Action taken with mRNA-1273 was not reported.  The outcome of the events, experienced soreness, red patch around the injection site and difficulty moving  her arm, was not reported.; Reporter's Comments: Based on a strong temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded.  Injection site erythema and Injection site pain are consistent with the known safety profile of the vaccine
3 days after the first dose I developed a blood clot in my right calf, never had one before, no trauma, i am very active; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first received first dose of bnt162b2 (Pfizer, Formulation: Solution for injection, Lot Number: EP 7534b) via an unspecified route of administration, administered in left arm on 13Mar2021 11:00 at a single dose for covid-19 immunization. Medical history and known allergies were none. Concomitant medication included rivaroxaban (XARELTO). The patient developed a blood clot in his right calf 3 days after the first dose, never had one before, no trauma, he was very active on 16Mar2021 07:00. No covid vaccination was taken prior. No covid tested post vaccination. Blood thinner for the clot was given as the treatment. The outcome of the event was not recovered.
Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; Large, warm, itchy red rash/spot at vaccination site, about 3 inches across.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 05Mar2021 at 11:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, eczema and known allergies to dust, cat, dog, pollen, grass and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and vitamins nos (DAILY MULTIVITAMIN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 17:00, the patient experienced large, warm, itchy red rash/spot at vaccination site, about 3 inches across. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large, warm, itchy red rash/spot at vaccination site, about 3 inches across were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Rash inside both elbows on forearm, and on stomach.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 01Apr2021 at 16:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation and also received influenza vaccine (MANUFACTURER UNKNOWN) in Aug2020 and experienced rash. Concomitant medications included biotin (MANUFACTURER UNKNOWN), cyanocobalamin (B 12), ergocalciferol (VITAMIN D), sambucus nigra (ELDERBERRY) and ascorbic acid, eucalyptus globulus oil, echinacea purpurea (ECHINACEA), all from unknown dates for unspecified indications. On 24Apr2021 at 04:00, the patient experienced rash inside both elbows, on forearm, and on stomach. Could not confirm it was from the vaccine, but had a similar reaction to the flu shot in Aug2020. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and was reported as going to allergist. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash inside both elbows, on forearm, and on stomach was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sudden siren sound in ears. High pitched. Constant whistle, like a tea pot, siren or dog whistle. It does not stop ever.
At the time of the booster shot I informed the pharmacist that my arm was tingling and he stated it was because he just gave me the pneumonia shot in the same arm and it will go away and i did question him about giving me the covid shot on the inner part of my arm close to my shoulder as 4:00 pm that day neared my arm completely went numb and i lost use of my arm and with a history of pulmonary embolism my doctors ordered that i go to the outpatient department for an extremity venous study to rule out any blood clots caused by the injection(s) and put on a steroid to help with the inflammation  i am still having issues with tingling and numbness in my left arm and currently. under treatment by pain management.
Bell,s Palsy 02/27/2021  Shot given 02/11/2021 2/20  Start of very sore scalp, sore throat, left ear ache, stiff neck/knotted up muscles. No Fever. 2/25 Rapid Covid test, Negative.   PCR taken, result Negative. Rapid Strep test, Negative . Throat culture for other possible bacteria taken, result  Negative. Diagnosis possible viral infection. No visible inflammation of the throat or inner ear. No Fever.
NO ADVERSE EVENTS OCCURED. NOTHING UNUSUAL OBSERVED NOR REPORTED BY THE PATIENT. PATIENT RECEIVED A PFEIZER SHOT AS A FIRST CV-19 SHOT. PATIENT FORGOT HER CDC CARD ADN WAS GIVEN A MODERNA SHOT INSTEAD OF HER SECOND PFEIZER.
1-2 hrs p/inject pt screamed for 7-8 hrs, non-stop; it was a high pitch scream, like never heard; both legs were red swollen & hot;
There were NO adverse patient reactions. Continually refrigerated Moderna vaccine was given past, recommended 12 hours of opening multi dose vial.
Seen on 6FEB91 @ 1050AM for f/u check; was on a cardiac/apnea monitor; exam was unremarkable; pt recvd vax; 2AM 7FEB92 pt @ ER w/mom because of cardiac monitor going off; HR to high 60's-low 70's, t92-93R; hospitalized x 5 days & given ATB;
After 5 minutes, felt a sensation sweep over my body, then felt fast heart rate and light headed/dizzy for about 3 hours. Ended after 3 hours.  Then, 6 days later, on 4/6, I felt numbness on the left side of my face and admitted myself to the ER. Numbness went away after 24 hours.
Big red rash at the injection site; It was painful; developed big red rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Big red rash at the injection site), VACCINATION SITE PAIN (It was painful) and VACCINATION SITE ERYTHEMA (developed big red rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H2HA) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE RASH (Big red rash at the injection site), VACCINATION SITE PAIN (It was painful) and VACCINATION SITE ERYTHEMA (developed big red rash at the injection site). At the time of the report, VACCINATION SITE RASH (Big red rash at the injection site), VACCINATION SITE PAIN (It was painful) and VACCINATION SITE ERYTHEMA (developed big red rash at the injection site) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.
Left leg swollen from knee to upper thigh, swollen twice the size of the other leg. Told to use ice paks and Motrin. Lots of pain and leg warm to touch. Child couldn't walk on leg. 08/02/01, the child was doing better, swelling gone down and the child was walking. They are to continue using ice paks and Motrin.