chrisvoncsefalvay/vaers-outcomes huggingface dataset:
walking difficulty; Widespread Pain; Had muscle pain every day since then.; Had  fatigue every day since then.; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had  fatigue every day since then.) and ARTHRALGIA (Knee pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer on 18-Nov-2013. Concurrent medical conditions included Plastic sensitivity (Plastic Tape), Drug allergy (Betadyne), Fibromyalgia (Widespread pain and fatigue) since 05-Jan-2011 and Osteoarthritis (Joint inflammation and pain) since 12-Mar-2021. Concomitant products included ANASTROZOLE from 15-Jan-2018 to an unknown date for Breast cancer, BUPROPIONE from 01-Jan-2016 to an unknown date for Depression, VALSARTAN from 18-Nov-2019 to an unknown date and HYDROCHLOROTHIAZIDE from 06-Aug-2020 to an unknown date for Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had  fatigue every day since then.) and ARTHRALGIA (Knee pain). The patient was treated with GABAPENTIN (NEURONTIN) for Pain and Muscle pain, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had  fatigue every day since then.) and ARTHRALGIA (Knee pain) outcome was unknown.            She decide she will begin physical therapy on 28-Jul-2021 she will follow up with orthopedic surgeon and pain specialist on 28-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 and contain significant information. Reporter phone number, state, patient demographic, concomitant medication, treatment medications and event has been updated.
Complaint of itching and tingling around neck, ears, and face.  Felt as if had rapid heart rate and short of breath. Blood Pressure stable at 150/85 and 158/90 and Heartrate 66-80/min.   O2 Sat 88% when EMS arrived.  Epinephrine .5mg epinephrine administered and Benadryl 50 mg IM; O2 at 2 L NC. EMS called and transported to Medical Center.  Stable at time of departure with EMS at 9:34.  Reaction started within 15 minutes of receiving vaccine.
passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic condition". The consumer stated that he works in a long-term facility for elderly people.  This patient is of one the 8 patients at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 out of the 8 patients were long term residents and 3 were short term residents. 5 of them passed within a two-week period. The above patients' pulse oxygen saturation levels ranged 60-80%. Four of the above patients tested negative for Covid-19. The consumer asked with the Pfizer Covid-19 vaccine, how long the body continues to make the spike protein and how long after the inoculation is signaling set up. The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%; sars-cov-2 test: negative. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200376657 same reporter/drug, different event with similar event; Reported Cause(s) of Death: passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
FELT AWFUL AND  NOT GREAT; FELT LIKE FLU; SORE, ACHES ALL OVER; HIGH FEVER; INJECTION SITE PAIN; DIZZY; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin bees.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1848422, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAR-2021, the subject experienced dizzy. On 18-MAR-2021, the subject experienced injection site pain. On 19-MAR-2021, the subject experienced felt awful and not great. On 19-MAR-2021, the subject experienced felt like flu. On 19-MAR-2021, the subject experienced sore, aches all over. On 19-MAR-2021, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 18-MAR-2021, and felt like flu, sore aches all over, and high fever on 21-MAR-2021, and had not recovered from injection site pain, and felt awful and not great. This report was non-serious.
having menstruation/ period; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 06Mar2021 11:30 (Batch/Lot Number: en6199) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Mar2021 12:00 AM, Thought was done with period. Two days after first shot started a period/ menstruation/ period. The patient did not receive treatment for the AE. The outcome of the event was unknown.  Batch/lot number already provided
Lingering symptoms for 5 weeks since the first shot. Symptoms include - Chronic headache - Sore throat - Fever - Body Aches - Nasal congestion - Very tired all the time
I received my COVID-19 5th dose on 10/23/2022. My adverse event started on 11/26/2022 in the morning around 8:00AM. I had a scratchy throat, nasal congestions, headaches, fatigue and low grade fever. On 12/05/2022 I called my doctor and she prescribed me PAXLOVID for 5-6 days. I am also taking over the counter medications such as ibuprofen  and cough syrup as per needed.
Tinnitus in left ear. There is no treatment. After the second dose it lasted 24 hours, and I had an ENT doctor examine my ear. He found nothing to be wrong. After the booster, third dose, it has lasted for 2 days now. Both times the tinnitus occurred approximately 4 weeks after the vaccine. I have never experienced tinnitus prior to the vaccine.
19AUG96 mom phoned 840PM reporting fever, chills, diff breathing;advised to see PMD immed;20AUG96 spoke w/mom via phone still sick doesn't know yet dx but PMD states sx are not r/t vax recv viral, strep, mono;
Sore arm; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Medical history was not provided by reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and SIMVASTATIN for an unknown indication.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication  also included hydrate.   This case was linked to MOD-2021-293366 (Patient Link).
On day of vaccine I experienced a Heavy arm, a couple minutes after shot I felt dizzy then I felt better, went home, and that evening I had chills and fever, took TYLENOL, during the night I had fever and chills, next day I felt better. I continued to have fatigue for a couple months after I started having lots of anxiety and panic attacks, In July I had a very bad cough, I drove myself to the urgent care 07/17/2021. On July 18 I visited the same urgent care, they did some tests and transported me to the ER. The ER they did a covid test and I was also diagnosed with pneumonia. I have recovered from covid and pneumonia but I have not recovered from anxiety.
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old female patient who was vaccinated with a 0.5 ml first dose of ACT-HIB lot UI820AAA; expiry date: 18-Nov-2018 in the left thigh on 29-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DAPTACEL for Immunisation; HEPATITIS B VACCINE for Immunisation; and PREVNAR for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown whether the patient experienced any adverse reactions or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Nausea, limited range of motion in the administrated arm, weakness in the arm. Pt was give a MEDROL dose pak and we assumed that this was appropriate as we did not hear back from pt.
Baby now 15 months old and "6 months ahead in development" per pedi. Pt developed preeclampsia and was induced 3 weeks early with vaginal delivery of 5# 12 oz girl with meconium. Apgars not known, but cried right away. Went to NICU for hours because small for gestational age and meconium. She has had a healthy infancy. On 10 Feb she received PCN IM, HepA HepB (TWINRIX), Adenovirus. She also had gas exposure for training.
This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional via a sales representative regarding an unspecified number of patients who experienced apnea. The reporting healthcare professional stated that she obtained this information from an unknown journal. The patient received a dose on an unspecified date. The patient experienced apnea. Outcome was unknown. No additional information was available at the time of this report.
Localized rash to injection site followed by hives outbreak over entire body 3 hours after onset.
blisters in mouth on 2/26 then shingles rash on neck on 3/3 after neck rash patient went to PCP and was prescribed acyclovir
Sick; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles 2 years ago it was so painful). Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on unknown date, refer case US2021AMR195152).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles 2 years ago and it was so painful, and stated nothing works it had to run it was course. The patient got the shingles vaccine and got a little sick but still worth getting it. The patient mentioned that took vaccine and did not regret it. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195152:same reporter,same patient
Patient was told to sit and wait for 15 minutes in waiting area but his mother called him over to the pharmacy to schedule his 2nd dose appointment. As he stood there, he fainted in front of the pharmacy. Pharmacy staff rushed over and provided care and store management was notified. He sat until he felt fine and was provided water and snacks. He left after ~20mins.
About a month after I got the vaccine, and this is the only vaccine I got a little reaction to. I had a temperature and chills for 4-5 hours and then I was fine. And a month later I got horrible diarrhea and after I did everything I could for it, I finally went to the doctor. She did some tests for it and they're all negative. Next, since I've been out of town, it's continuing. I don't have a terrible stomachache but it's not convenient. My stomach area isn't painful, but it isn't great either. If I take the anti-diarrhea stuff too, it seems to help a little.
pt recvd vax;exp local redness swelling 4 hrs p/ vax, high pitched crying unconsolable x 1 1/2; fever 101.5; unconsolable crying x 4 1/2 hr when pt called;
severe left leg calf pain started on March 5, within 24  hours of recieving dose #2 of Moderna vaccine . Went to Hospital  on Saturday evening with worsening pain. I have been admitted to the hospital.
This case was reported by a consumer via interactive digital media and described the occurrence of psoriasis in a patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced psoriasis. On an unknown date, the outcome of the psoriasis was unknown. It was unknown if the reporter considered the psoriasis to be related to dTpa vaccine. Additional information received as follows: The age at vaccination was not reported. The patient reported that vaccine gave his/her psoriasis, an autoimmune disease. It was much more than just skin issues. The vaccine was combined with the Tetanus vaccine. The patient would never get a vaccine again.
Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION SITE SWELLING (Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (Round swollen mass in her arm where she received the injection it was about the size of a quarter but it got bigger, now it's like a plum) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.   Reporter did not allow further contact
I think I have COVID right now/COVID + possible after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I think I have COVID right now/COVID + possible after vaccination) 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 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 SUSPECTED COVID-19 (I think I have COVID right now/COVID + possible after vaccination). At the time of the report, SUSPECTED COVID-19 (I think I have COVID right now/COVID + possible after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.  Company comment: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Suspected COVID-19. Time to onset from vaccination with a dose of of mRNA-1273 vaccine was not reported, as event and vaccination dates are not available. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, non-serious and AESI of Suspected COVID-19. Time to onset from vaccination with a dose of of mRNA-1273 vaccine was not reported, as event and vaccination dates are not available. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
I experienced irregular menstrual cycle for 5 months, fever, sore arm and pain in my left arm.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received SHINGRIX (batch number G2ZF2, expiry date 22nd March 2021) for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and pain. On an unknown date, the outcome of the injection site erythema and pain were recovering/resolving. It was unknown if the reporter considered the injection site erythema and pain to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient experienced redness at the injection site, which was 2.5 inches in diameter. The pain and redness were not worsened and it had gone down slightly this past weekend. The reporter had given consent for follow up.
Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not applicable      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 49th out of 100 patients.  No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Patient received COVID vaccination and was waiting his 15 minutes in the waiting room, a few minutes after injection, his GF called me over because the patient passed out. As I approach, patient was coming to as he was peeing himself. Patient reported that he felt lightheaded and then did not realize what happened. Gave patient some water and took his blood pressure. His DBP was a little low around 49. Had the patient sit there for another 15 minutes and took blood pressure again and it was 104/60.
Rash on arm that was injected; ongoing  fatigued; lasted 24 hours