chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult male patient received BNT162b2 (BNT162B2), as dose number unknown, single for covid-19 immunization. The patient's relevant medical history included: "Chronic obstructive pulmonary disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19 which included oral Paxolovid, which was started on 31Mar2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
48 hours after receiving dose 2 of the Moderna vaccine, patient developed alterations in mental status - cannot recall the events. She was taken to the ED and was found to have a BP of  >200/130. Patient had a seizure in the ED - was intubated to protect airway. CT showed some decreased areas of attenuation in the bilateral occipital lobes and cerebellum. MRI showed vasogenic and cytotoxic edema in posterior temporal, parietal and BL occipital and BL cerebellar hemisphere which can be seen with PRES. Patient required inpatient treatment for her elevated BP and neurological evaluation. Was started on Norvasc and Keppra due to concern for PRES.  Discharged with follow up in cancer center and with neurology. Hospitalist and neuro teams thought PRES was likely due to her  chemo regimen, patient's oncology team though PRES may have been triggered by vaccine due to timing and her dose of Avastin.   Pt has extensive oncological history including ovarian cancer w/ metastatic breast cancer in L axilla. Pt recently started on cytoxan, Avastin, pembrolizumab. Also has malignant abdominal ascites.
it's been at least 20 weeks since I got my 1st dose; few minutes later my arm went numb/face went numb; it kind of scared me for getting the 2nd one; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (few minutes later my arm went numb/face went numb), FEAR OF INJECTION (it kind of scared me for getting the 2nd one) and PRODUCT DOSE OMISSION ISSUE (it's been at least 20 weeks since I got my 1st dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN (ZOCOR), VITAMIN B12 NOS, VITAMIN D [VITAMIN D NOS] and HYDROCODONE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HYPOAESTHESIA (few minutes later my arm went numb/face went numb) and FEAR OF INJECTION (it kind of scared me for getting the 2nd one). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been at least 20 weeks since I got my 1st dose). On 01-Apr-2021, HYPOAESTHESIA (few minutes later my arm went numb/face went numb) had resolved. At the time of the report, FEAR OF INJECTION (it kind of scared me for getting the 2nd one) and PRODUCT DOSE OMISSION ISSUE (it's been at least 20 weeks since I got my 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Chicken pox type rash first appearing on front of hips then massive outbreak in groin area down legs up midline to armpits. There are still spots on the top of his feet but they are not blisters. No fever, no real itchy feeling.
After the vaccine, he did experience the normal flu like symptoms. Then, he started experiencing chest pains  in January. It was a poking chest pain in the middle. He has never had to take aspirin for chest pain but does now. He was complaining of chest pains more often. He went to a cardiologist and did a stress test, EKG, and an electrocardiogram which was normal. He was told that his aortic arch is dilated.
Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle; Muscle pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle) and VACCINATION SITE PAIN (Muscle pain at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL, SIMVASTATIN, ZOLPIDEM TARTRATE (AMBIEN) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle) and VACCINATION SITE PAIN (Muscle pain at the injection site). On 10-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Injection 2 inches below the bicep muscle about 2 inches below the shoulder bone, in the middle part of the arm, he's unsure if it was in the muscle) had resolved. At the time of the report, VACCINATION SITE PAIN (Muscle pain at the injection site) had not resolved.            Treatment medication was not provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-019004 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received from the primary reporter: The reporter address was added.
Swollen lips, hives, swollen eyes. Received Prednisone and took for 10 days. Hives worsened over the 10 days. Have since diminished but have still have 6 weeks later. Took Benadryl and no relief.  Taking hydroxysine for itch.
Client was vaccinated with Pfizer Covid-19 vaccine, that has not been reconstituted. Error was caught, aware.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies or medical histories were not provided. On unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, lots#  M021365, M016238, M00611and M025565, expiration date 26-JAN-2018, 07-DEC-2017, 18-NOV-2017 and 06-NOV-2017 respectively (strength, dose and frequency were not reported) orally for prophylaxis. It was reported that the temperature excursion was for 20 minutes at 9 degrees Celsius, according to the data logger. There was no previous temperature excursions. No adverse effects were reported. No product quality (PQC) complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Guillan Barre Syndrome, ascending paralysis, was intubated for 3 1/2 weeks and required significant rehabilitation, still with residual sx
After waiting 15 minutes I was released and felt fine. About 3-5 minutes after leaving the site my tongue became numb and felt s=slightly swollen, throat became extremely dry, pulse rate increased from low 50 BPM to 100 BPM. Drove to a nearby store and stopped, felt a bit disoriented when trying to call my wife. Drank water and waited at a store for approximately 15 minutes until I felt better. This was about 40 minutes after the vaccine was administered. When driving home still some discomfort/numbing of the tongue and throat. Ate at 1:30 and symptoms had stopped.
Nausea, vomiting, dry heaves, hot and cold flushing feelings.
For 5 days beginning day after vaccine, had extreme fatigue, light-headedness, and body aches.  Beginning a couple of weeks later, had intermittent episodes of racing heart while resting, the in May, had intense racing heart while resting (200 beats per minute) that wouldn?t stop.  Went to the ER.  Heart rate reduced.  After full cardiology workup, no issues found.
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) 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.   No concomitant medication provided. No treatment information mentioned.
Pt experienced a large, red, swollen local reaction on her right deltoid. Improved with the use of Benadryl.
Patient did not have any adverse events, however, she did receive the two immunizations 14 days apart rather than the recommended 28 days. She did not have her vaccine card with her and the dates were not verified prior to administration.
DID NOT SKIP A DAY BETWEEN FIRST AND SECOND DOSE; This spontaneous case report (PVX2019-2738) was received from a pharmacist on 05-Nov-2019. It described a female consumer who "did not skip a day between first and second dose" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took first and second dose of Vivotif on 04-Nov-2019 and 05-Nov-2019 respectively.  Action taken with Vivotif with respect reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "did not skip a day between first and second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not skip a day between first and second dose" was considered as not applicable.
Narrative: Patient presented to ED 6/1/22 with a chief complaint of weakness after receiving the Moderna COVID-19 booster two days prior. Patient reported that they "slid out of bed" and were unable to stand up. Possible that reaction was related to inflammatory response from COVID vaccine or resurgence of old neurologic symptoms unrelated to recent vaccination in setting of suspected UTI (patient has a history of stroke in 2012). Patient also has L sided weakness at baseline. Patient improved with supportive care and was discharged 6/2/22.
Woke up 8 hrs after injection having difficulty breathing - loud wheezing, chills, great discomfort. Sat up - the symptoms subsided in 2 hours, I was able to fall asleep after applying Vaporub to chest. ONLY respiratory issue and chills - nothing else. Next day feeling well now, just a little tired and achy (joints) but possibly to lack of sleep.  I decide to report it because I never had a bad reaction to any shot, have no asthma or other chronic breathing issues - this is the first time I experienced the wheezing/lack of breath.
Left leg 5cm inoculation reaction to the upper left thigh with moderate erythema.
Patient was talking to a friend about five minutes after receiving the vaccine and suddenly passed out and fell to the floor.  He was awake again in about a minute.  The patient was sweating, pale and a little disoriented for a couple minutes but started improving steadily until he was feeling his normal self again.  The EMS was called but the patient declined being taken to the hospital as he felt much better by the time they arrived.
No adverse event; Vaccine administered after beyond use date; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) in an 18-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication information was reported.  The vaccine was received at the clinic on 07-Jun-2022.  The vaccine beyond use date was reported as 07-Jul-2022.  No treatment information was provided.
Baseball sized warm, raised and red are on skin at site of injection with red, warm blotchy rash from cheeks on her face throughout entire body including her arms, buttocks, thighs, legs, ankles and feet. Rash mildly itchy. Sight of injection tender. Today marks day 3 of rash. Rash is not worsening at this time.
This form is to report the second dose of the vaccine shot was mistakenly administered to a person (info above) that was under the age of 18 y/o by me on 02/02/2021.  There were no adverse reactions, allergic reactions, or any symptoms other than mild soreness at the injection site, confirmed with the individual receiving the vaccine.   I was advised to administer the 2nd dose to the same person by Vaccine POD supervisors.  This action of administering 2nd dose to person under age 18 y/o was approved.  Pt had no symptoms during 15 minute observation.
My muscles were extremely sore over the course of one to two weeks. Every day a new muscle group was very sore. It started at my shoulders then worked down my body with a new muscle group every days even my knee ankle and wrist joints were sore. My upper back muscles remained sore for the full two weeks. Also, my abdominal region and intestines were affected. I had intense constipation, which relates to the muscle tension felt throughout the week. the constipation has been going on for a few weeks now even to the second dose.
fever, arm pain, erythema, swelling 8x10cm, body aches;tx pred;
9/19/2022 that evening I had a sore itchy arm, but no other side effects. I did not feel sick. I had a headache, but I have a lot of allergies, so I could not tell if it was that or something else. On 9/28/2022 that evening, when I was getting ready for bed, I started to sneeze a lot. I was blowing my nose a lot, my ears, throat and roof of my mouth were itchy. I was feeling bad. I had congestion, sore throat and a headache. On 9/29/2022 I took a COVID-19 home test and it was positive. It was a very bright red. On 9/29/2022 I called my doctor in the morning, she was booked. That evening someone from urgent care called me and prescribed me paxlovid. I started taking it on 9/29/2022 and I took my last set of pills on 10/4/2022. On 10/4/2022 I took another COVID-19 home test and it was positive, faintly red. I am still coughing. I feel breathless when I do absolutely minimum, and I have diarrhea. Now my son is sick.
very strong headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (very strong headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (very strong headache). At the time of the report, HEADACHE (very strong headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.   Reporter did not allow further contact
This is a spontaneous report from a contactable consumer reporting for herself and enrolled in a Pfizer-sponsored program (XELSOURCE); this report regards an event part of the medical history of the patient. A 77 years old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name not reported) on 13Oct2015, in left shoulder, at single dose, for immunization. Medical history and concomitant medications were not reported. Since an unspecified date the vaccine paralyzed her left arm for about 8 months. Her left shoulder was 90% destroyed. She believed that it was what caused the rheumatoid to begin with. She had an X-ray of the shot going into the bursis on an unspecified date. She even asked about draining of the bursis for testing. They said that pneumoccal was not a live virus, but she thought it was a diminished form of a live virus. She knew it was a foreign substance going into a sealed sack. For 4-5 months she did physical therapy 3 times a day. She had diminished movement in the arm, but it was not causing horrible pain like her feet; she still cannot put on a bra. The final outcome of the events was unknown at the time of report. Information on the batch number has been requested. Pfizer is Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
dizziness; feeling unwell; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MALAISE (feeling unwell), CHILLS (chills) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostatic disorder NOS. Concomitant products included METFORMIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), MALAISE (feeling unwell), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), MALAISE (feeling unwell), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included unspecified medication for prostatic disease. Treatment information was not provided.
Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis from 17-May-2021 to 27-May-2021 and Bronchitis from 17-May-2021 to 27-May-2021. Concurrent medical conditions included Allergy to arthropod sting, Latex allergy (allergy to Latex and Doxycycline), Drug allergy (Allergy to Biaxin), Hypertension since 04-Jun-2018, Depression since 04-Dec-2017 and Hyperlipidemia since 04-Dec-2017. Concomitant products included DICLOFENAC from 03-Mar-2019 to an unknown date for Chronic pain, SIMVASTATIN from 04-Dec-2017 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from 01-Mar-2020 to an unknown date for Hyperlipidemia, METOPROLOL from 01-Mar-2020 to an unknown date for Hypertension, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from 04-Dec-2017 to an unknown date for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Open vial, that was open for more than 12 hours, a dose was administered from it to a patient / Discovered later that Moderna was withdrawn from punctured vial that was greater than 8 hrs open) had resolved.        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.   Patient reported that she is allergic to TD and viozz. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received on 30 Jul 2021 contains patient demographics added, medical history, concomitant medication were added.
Upper arm pain, mild; muscular discomfort, mild; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 20Jan2021 at 13:45 (at the age of 47-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Jan2021 at 13:45, the patient experienced upper arm pain, mild with associated muscular discomfort, mild. No treatment was provided for the events upper arm pain and muscular discomfort. The outcome of the events upper arm pain and muscular discomfort was recovering. Since the vaccination, the patient has not been tested for COVID-19.
*fever/chills - started hrs after injection. lasted about 1 full day.  *body aches - lasting for over 24 hour *chest rashes - this was boarder line severe.  lasted only about 10-12 hrs but was itching, red, sore and almost blisterie. if i hadn't been so tired i would have been at the urgent care.   *extreme fatigue - lingering for 3 days
Patient had a flu shot on 10-12-2007. On the day, she was fine. Next day she had pain on her left arm. On 10-14-07 pain to wrist, said she could barely move her arm.
Patient was in clinic on 12/11/2021 with concerns about a stiff left arm along with a rash on the site where she received a covid-19 booster (left deltoid). She states she has been able to move her left arm above her head. The rash appeared the next day along with body aches and fatigue. She also reports sore throat, congestion, and cough present for 2 days. Unsure if the URI symptoms are related to the vaccine or something else.  Vaccinated for influenza.
Nurse administered a Varicella vaccine with the expiration of 07/10/2015.