chrisvoncsefalvay/vaers-outcomes huggingface dataset:
prev dose administration date=01May2021, dose number=1/administration date=26Sep2021, dose number=2; gout flare ups in my right foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 12:00 (Lot number: EW0187) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN SODIUM; LEVOTHYROXIN; CLARITIN [LORATADINE]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0173, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01May2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "prev dose administration date=01May2021, dose number=1/administration date=26Sep2021, dose number=2"; GOUT (non-serious) with onset 2021, outcome "not recovered", described as "gout flare ups in my right foot". The event "gout flare ups in my right foot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility where the most recent COVID-19 vaccine was administered at Public Health Clinic/Veterans Administration facility. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient had been tested for COVID-19 since the vaccination. Patient had not diagnosed with COVID-19 prior to vaccination. Patient had received other medications the patient received within 2 weeks of vaccination was pravastatin sodium, levothyroxin, Claritin. After my 2nd shot, I started having gout flare ups in my right foot. It's been happening once a month. I didn't have any gout issues before the vaccination. Patient had not known allergies. Patient had other medical history was cholesterol, hypothyroid.  Follow-up attempts are completed. No further information is expected.
Chills, achíness in muscles and joints, fever (100-102.3) for about 24 hours. Achiness and low grade fever (99-100) for an additional 5 hours.
02/12/22 presents to ED for "nausea with vomiting". PMHx of " HTN, HLD, hypothyroidism"
Terrible headache for 2 full days (much worse than with her first two shots); This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Terrible headache for 2 full days (much worse than with her first two shots)) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 01-Apr-2021.    On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Terrible headache for 2 full days (much worse than with her first two shots)). On 18-Nov-2021, HEADACHE (Terrible headache for 2 full days (much worse than with her first two shots)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, Heart rate: 20-30 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient had terrible headache for 2 full days (much worse than with her first two shots) and an elevated heart rate by 20-30 bpm for 2 -3 days. No treatment medication reported.
Information has been received from a physician concerning a 10 year old female patient with asthma that does not require any chronic medications and a history of Kawasaki's disease in 1997 who on 28MAY1997 was vaccinated in the arm with a dose of varicella virus vaccine live. There were no concomitant vaccinations on that day. On 19APR2003 while on vacation in Cancun, the patient developed a red raised rash on her chest, spreading to her arms. There were over 60 lesions and lots of itching. On 22APR2003, the patient was seen by the physician and was treated with oral Benadryl. At the time of the report, the physician expects the rash will still be there. The reporter also mentioned two other patients had adverse experience following vaccination with varicella virus vaccine live. Additional information has been requested.
fluid in lungs; difficulty breathing; congestive heart failure; AFib; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 19Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that an 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9263), via an unspecified route of administration on 29Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included diabetes from 1991 and ongoing. Concomitant medications included insulin taken for diabetes, lisinopril, lovastatin, omeprazole (PRILOSEC), and piroxicam (PAXIL); all ongoing. The patient received first dose of bnt162b2 on 08Jan2021 for COVID-19 immunisation and experienced sugar out of control. On 29Jan2021, the patient experienced fluid in lungs, difficulty breathing, congestive heart failure and AFib (Atrial fibrillation). The events required a visit to the emergency room. The patient was hospitalized on an unspecified date for 5 days. The events required initiation of new medication/other treatment and procedure and many tests. The patient underwent x-rays on an unspecified date and showed fluid in lung. The patient had no other vaccinations within four weeks prior to the vaccine. Outcome of events was not recovered.
Received vaccine 1/31/2022 at 11AM.  2/1/2022- experienced chills and body aches begining around 4:30 PM.  2/2/2022- woke up around 6AM with Left axillary swelling and severe pain.  Called my Doctor?s office and was able to get a appointment for 2:40PM.  Doctor prescribed 40mg Prednisone daily x 5 days and 800mg Motrin for pain.  2/3 - Pain has lessened a little but has now spread to shoulder and neck.
Acute "asthma like" attack day after receiving Hep A#1, MMR#2 No adverse reaction day of vaccines, no fever or rash or other reaction.
Red area RUE at injection site, site warm to touch (+) edema. Tx: Beandryl 25mg bid x 3d, Augmentin 875 bid x 5d.
Headache, Myalgia, Fever, NauseaVomiting, chills, lymph node swelling L armpit, injection site soreness, fatigue Narrative:
105.5 fever for a few hours then down to 103 up until 48 hours later. Had been taking Tylenol max dosage.   72 hours later onset of menstural period. Heavy, painful. Not expected.
Client is a physical therapist and was vaccinated on 12/31/2019 and 1/26/2020 with Moderna vaccines.  Became symptomatic for Covid and tested positive 9/10.  Symptoms: fatigue, nasal congestion, loss of taste and smell, feverish x 1 day.
Dose #2 was given 12 days after Dose #1.  Patient reported no adverse effects.
never had diabetes before believe diabetes is side effect of shot; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 27Aug2021 at 14:30 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. Medical history included high blood pressure and thyroid disorder. Concomitant medications included lisinopril, levothyroxine sodium (SYNTHROID) and cartilage, hyaluronic acid (MOVE FREE ULTRA), all taken for an unspecified indication, start and stop dates were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 05Aug2021 at 02:30 PM for COVID-19 immunisation. Two days after the second shot, on 29Aug2021 at 00:00 (also reported as 12:00 AM), the patient experienced severe dry mouth and extremely high sugar, never had diabetes before and believes diabetes was side effect of the shot. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and disability or permanent damage. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 03Aug2021. Therapeutic measures were taken as a result of all events (reported as 'Metforman'). The outcome of the event was not recovered.    The lot number for BNT162B2, was not provided and will be requested during follow-up.
Pt was vaccinated 3/20/07 in AM, later afternoon noted back heaviness. Symptoms worsened over night. Then experienced chills, nausea, vomited 5x on 3/21/07. Some arm pain. T102 on 3/22/07 - TX'd with APAP, SX TX
Tingling and redness at the injection site; Redness at injection site; Injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A e) for COVID-19 vaccination.     Concomitant products included SPIRONOLACTONE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), ALPRAZOLAM (XANAX), FLUOXETINE HYDROCHLORIDE (PROZAC) and PRAVASTATIN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore). At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling and redness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Injection site was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-350630 (Patient Link).
DVT in left leg 4 weeks after 2 nd doseRecurrent DVT in left leg 2 weeks after 3rd dose; Received dose 3; Received dose 3; This is a spontaneous report from a contactable physician (patient). This 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 06Jan2021 08:00 at age of 51-year-old as dose 2, single, dose 3 intramuscular, administered in Arm Left on 20Sep2021 13:00 at age of 51-year-old as dose 3 (booster), single for COVID-19 immunization.  Medical history included Factor V leiden, hypertension (HTN). No known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEC); lisinopril. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 18Dec2020 03:00 PM in Arm Left at age of 51-year-old as dose 1, single for Covid-19 immunization. The patient experienced DVT in left leg 4 weeks after 2nd dose Recurrent DVT in left leg 2 weeks after 3rd dose on 04Oct2021 08:00. The event resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included covid test: negative on 24Sep2021 (Nasal Swab).  Therapeutic measures were taken as a result of the event. The outcome of event DVT of legs was recovering, of other events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Deep vein thrombosis and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from an RN concerning a 70 year old female pt with allergies to escitalopram oxalate, serazone, statins and niacin who on 13JAN2004 was vaccinated IM with a second dose of pneumococcal 23v polysaccharide vaccine. There was no illness at the time of vaccination. Concomitant therapy included lisinopril, omeprazole, levothyroxine sodium, Topicort, Advil and chrondroitin sulfate sodium + glucosamine sulfate. Subsequently, the pt developed a local rxn that was very bothersome for her, including temporary loss of the full use of the arm, pain, erythema and hardness. On 14JAN2004, the pt presented to the physician because of swelling and redness where she received the dose of pneumococcal 23v polysaccharide vaccine. Physician examination revealed erythema around the area where she had the shot, diffusely extending down into the biceps area and then around to the area in the deltoid. There was moderate tenderness and increased warmth, but no lymphangitic streaking and no adenopathy. Laboratory tests were not performed. The medical assessment was a local reaction to dose of pneumococcal 23v polysaccharide vaccine with possible cellulitis. The plan was to place the pt on Clarinex for the allergic component and a short term course of Cefzil. They planned to watch for gastrointestinal side effects including diarrhea. If the pt developed that, the mediation would be discontinued. If the pt developed redness going further up or down her arm, she would call. Coolness to the area seemed to feel better, so the pt was to use cool compresses. If swelling continued to be an issue, prednisone therapy would be considered. The pt was to update them in a few days if she was not improving. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned two other pts who developed local reactions post vaccinations with dose of pneumococcal 23v polysaccharide vaccine. It was noted that all the reactions came from the same lot number, but upon inspection the vaccine appears to be fine. Additional info is not expected.
pt vax hepta B. pt ex arthritis which resolved spontaneously in 3 weeks.
This case was reported by a consumer and described the occurrence of autism in a 12 month old male subject who was vaccinated with a hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. There was no concurrent medications. The reporter state that, on 24 August 2001, "the day her son was born," he received the 1st dose of hepatitis B vaccine (lot number not reported). On 24 August 2001, less than one day after vaccination with hepatitis B vaccine, the subject's "eyes became off track and he could not suck." The reporter also stated that, "when he was about 6 to 12 months old, he stopped making sounds. At 12 months (exact date not reported), he started experiencing symptoms of autism." The reporter state that the subject "received the usual childhood vaccines until age 2." The subject was seen at a physician's office. On an unspecified date in 2002, the subject was diagnosed with developmental delay and severe speech problems and slight autism. As of 03 February 2006, the subject is unable to control his bowel, is unable to be potty trained and drools." The events were considered to be disabling and to require clinically significant intervention (OMIC). The subject was treated with physical therapy and speech therapy. The reported stated that, "when the vaccines were stopped at 2 years of age, he improved."
Patient fainted moments after injecting Fluvirin IIV3 Trivalent vaccine. Recovered with stable vitals less than 2 minutes later. EMT personnel was dispatched as a precaution and found her to be normal and able to drive herself home.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 4/9/2021 and 4/30/2021. Presented to ED on 2/4/2022 with diarrhea and SOB after testing positive for COVID on 2/1. Admitted for acute hypoxemia respiratory failure due to Covid19. Transferred to the ICU 2/5/22, on the morning of 2/6/22 his condition worsened.  He required intubation and developed bradycardia followed by some ventricular arrhtythmias that required CPR.  Stat TTE demonstrated severe biventricular failure and coded several more times over the course of the morning and expired on 2/6/2022.
Information has been received from a licensed practical nurse (LPN) concerning patients who on an unspecified date were vaccinated by injection with the second dose of Gardasil. The nurse reported that after the patients received the second dose, the patients had experienced burning and muscle tightness. The burning and muscle tightness lasted for about five minutes and then it went away. There was no redness or swelling. The nurse said that they used a different arm from the first injection of Gardasil. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. In follow up it was reported by the LPN that at least 10 patients have experienced his muscle tightening and burning for 5 minutes with the second dose. These patients were mostly 18 years of age or older. Additional information is not expected.
vertigo; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. This female consumer reported receiving her first injection of covid-19 vaccine, manufacturer unknown. She looked at her vaccination card but did not see a manufacturer name but noticed it did have EL8982 on it. The patient experienced vertigo which started about 2-3 days ago on an unspecified date and was continuing. She was scheduled to receive her second dose of the covid-19 vaccine on Friday. She asked was it still OK for her to get the second shot? The patient said, she does not think her vertigo is due to the covid-19 vaccine. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Initial information received on 29-Mar-2019 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional by phone. This case involves a 19 years old female patient who died suddenly from meningitis, while received vaccine MENINGOCOCCAL VACCINE. The patient's past 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 MENINGOCOCCAL VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious meningitis (meningitis) (reported as serogroup A), following the administration of MENINGOCOCCAL VACCINE. This event was leading to death. It was reported that the patient had been given the meningococcal vaccine but still contracted the deadly disease. It was also a case of suspected vaccination failure. No lab data was reported. Final diagnosis was (fatal) died suddenly from meningitis. It was not reported if the patient received a corrective treatment. The Patient died on an unknown date from meningitis. It was unknown if an autopsy was done. Documents held by the sender: None.; Sender's Comments: This case corresponds to a poorly documented consumer report. Patient reportedly had received meningococcal vaccine for which the name and manufacturer were unknown. The patient died due to meningitis (reported as serogroup A) an unspecified amount of time after vaccination. Clinical details- such as latency from vaccination, medical history, clinical details surrounding the reported event, vaccination details, the name of the specific vaccine administered, and diagnostic work-up- are lacking to allow adequate medical assessment.; Reported Cause(s) of Death: Meningitis.
After Moderna Dose #1 Within one day of vaccination the person experienced extreme fatigue, muscle weakness, joint achiness, headache, and nausea.  She felt feverish and chilled but had no fever.  She noted nightmares , hard to focus, eye sensitivity, abdominal pain and about 10days after vaccination had an episode of thick saliva and drainage so that she had to sleep upright.  These symptoms progressed for about a week and then slowly resolve completely by about 3 weeks post vaccination.     After Moderna Dose #2  - RN spoke with client 1 week after dose #2. Within one day of vaccination she experiences intense fatigue, headache on day 2, light sensitivity, body aches in joints and muscles, her arm felt hot, swelling of her breasts, no appetite, and abdominal pain, She did NOT experience any rashes or itching or difficulty breathing.  Her symptoms were so incapacitating that she could not do any of her ADL's and could only relieve her pain by lying down in bed all day.  As soon as she tried to move around the intense joint pains returned and she had to lie down.  Normally she treats her arthritis with Colchicine as needed but received no relief.  After a few days she did try one dose of Allegra (antihistamine) with some relief.  Resting by lying down in bed for a week has been her only relief.  She did not indicate any allergies to PEG.
COVID arm.  Itchy red rash, sore and tender, swelling. Started 8 days after the shot when the initial tenderness had gone away after the first few days.
after the second das my whole body was achy and had a rash on my right foreman and it went up my arm and across my back it was really itchy and had a fever on and off for two weeks. I stopped oral chemo because of this and went to the doctor. I still have the pain in the back and the arm. I am extremely tired and cough more
Pt received initial Pfizer covid vaccine.  About 8 minutes after the injection, his wife stated he was not feeling well.  Upon assessment, pt was pale in color, a&Ox3, but sluggish to response.  Pt was immediately placed from chair to floor and legs were placed in trendelenberg after initial bp was 90/60.  Pt was weak but remained responsive. Pt was diaphoretic.  Cold compress to forehead.  No noted rash or hives, no difficulty speaking or respiratory distress. 0940- 90/60 0945 100/70 legs up on chair as he was supine on floor- pulse ox 93% 0955 110/70 97% sat; skin color returning to pink. 1000- 112/64 96% pulse 73 1010- 115/70 93% sat pulse 83 sitting up on floor 1012 bp 88/inaudible  In chair 1012- bp 90/64 on floor 95% sat 78 pulse Pt remained A&O throughout assessment and to point of transfer to ER   911 ems arrived at 10:25 and began assessment.   10:35 EMS elevated pt to sitting position , and placed on cart and escorted pt to ER with security also. Pt stating he is feeling better, color pink/yellow tone.