chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dull pain in buttocks/Pain when he was laying straight on bed; Tingling pain in buttocks; Hip pain; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL PAIN (Dull pain in buttocks/Pain when he was laying straight on bed), PARAESTHESIA (Tingling pain in buttocks) and ARTHRALGIA (Hip pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B and 041A2B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Lot : EM9810) on 05-Feb-2021 and Pfizer (Lot : EM6205) on 24-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Yes to medication allergies, but did not specify which and no food allergies.). Concomitant products included LISINOPRIL and SITAGLIPTIN PHOSPHATE (JANUVIA) for an unknown indication.   On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient experienced MUSCULOSKELETAL PAIN (Dull pain in buttocks/Pain when he was laying straight on bed), PARAESTHESIA (Tingling pain in buttocks) and ARTHRALGIA (Hip pain). The patient was treated with PARACETAMOL (TYLENOL) for Buttock pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL PAIN (Dull pain in buttocks/Pain when he was laying straight on bed), PARAESTHESIA (Tingling pain in buttocks) and ARTHRALGIA (Hip pain) outcome was unknown.            Other concomitant product used include Statins .  Patient states that he started experiencing this pain when he was laying straight on bed. He explains that the pain is so subtle that he can walk, bend and work even when it is a little uncomfortable when he lays down.
Fatigue     sxs started satuday. no otc meds taken. no exposure to covid-19.  ? Nasal Congestion ? Sore Throat ? Fever     100.4 F today.  ? Cough
2/25/17 - seizure lasting for around 3 min. Fell to the ground shaking, eyes rolled back, lips turned blue. 911 called - taken to Hospital ER.
Patient had a hard ball that was bluish and swollen immediately after vaccination. Swelling went down before patient left pharmacy.
This case was reported by a physician (the mother of the patient) and described the occurrence of systemic shot reaction in a 2-month-old male subject who was vaccinated with Diphtheria tetanus pertussis (A or W not know), manufacturer unspecified). Concurrent vaccination included tetanus toxoid vaccine (manufacturer unspecified) given on an unspecified date when the subject was an adolescent. On unspecified dates at 2, 4, and 6 months of age the subject received primary 1st dose, 2nd dose and 3rd dose of Diphtheria tetanus pertussis (A or W not known). The subject received booster doses (4th dose and 5h dose) of Diphtheria tetanus pertussis (A or W not known) in 1984 and 1987. At unspecified times after each vaccination with Diphtheria tetanus pertussis (A or W not known) the subject experienced systemic shot reaction with inconsolable crying, irritability, injection site induration, high-pitched crying and swelling injection site. Resolution of inconsolable crying, irritability and injection site induration was noted, but not specifically following each dose of Diphtheria tetanus pertussis (A or W not known) received. Attribution of these same events was indicated to be possible, but again, in relation to specific doses was not noted. Outcome of systemic shot reaction, high-pitched crying and swelling injection site and attribution of these events to vaccination with Diphtheria tetanus pertussis (A or W not known) was not specifically reported (unknown). It was reported that the subject is now 29 years old and the physician (mother) was wondering if her son (now grown) would still have reactions to Tdap if given. Similar events occurred in the subject's sister following vaccination with Diphtheria tetanus pertussis (A or W not known). For details on the sibling case, refer to linked case A0943976A.
Elevated heart rate, flushing of the face and ears, vomiting, trouble breathing, pulmonary edema
Crying, diarrhea increase sleeping, and vomiting. Bloody stool x one.
This spontaneous report as received from a nurse refers to a 6 months 24 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sore swollen lymph nodes in my underarm left side. Swollen sore lymph nodes groin both sides; This is a spontaneous report from a contactable Other-HCP (patient). A 58-year-old female started to receive dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: Ek573), via an unspecified route of administration on 11Jan2021 3:30 Pm in left arm, dose number: 1 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: En5318) on left arm, dose number: 2, on 02 Feb 2021 as single dose. The patient medical history included allergies to Penicillin. The concomitant medications included Estrogen (ESTRADIOL), medroxyprogesterone, venlafaxine, alpraz (ALPRAZOLAM) at an unspecified date at an unknown dose. The patient experienced Sore swollen lymph nodes in her underarm left side. Swollen sore lymph nodes groin both sides on 03Feb2021, 05:00 AM. The outcome of events was recovered.
Started hurting after vaccination (which I thought was natural after an injection) and at night felt very achy all over. Then my left shoulder hurt for a month (could not sleep on that side) so called Primary Doctor and they said go to where you received the shot.  Went to pharmacy to complain got no where so I went to Urgent Care 10/15/13. They took an exray of my shoulder and said there was no sign of infection. They gave me a prescription for steroids which I am taking this week.
101.5F temp over night; significant pain in the injected arm; muscle aches; headache; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration, administered in Arm Left on 06Mar2021 08:00 (age at vaccination 57-year-old) as 2nd dose, single for COVID-19 immunisation. Facility type for vaccination was other. The patient took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunisation. Medical history included known allergies to Ivp dye, chronic sinusitis, high cholesterol. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for Covid post vaccination. Concomitant medications in two weeks included rosuvastatin (ROSUVASTATIN), ezetimibe (ZETIA) and Thorne multivitamin. On 06Mar2021 21:00, the patient experienced 101.5 f temperature overnight, significant pain in the injected arm, muscle aches, headache. The patient underwent lab tests and procedures which included body temperature: 101.5 Fahrenheit on 06Mar2021 101.5F temp overnight. The patient did not receive any treatment. The outcome of events was not recovered.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Allergic reaction; This is a spontaneous report from a contactable nurse. The nurse reported events for herself and for her sister. This case refers to her sister. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in Dec2020 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date in Dec2020, 5 hours after receiving the vaccine. The patient was treated with antihistamine. The outcome of the event was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and strong temporal relationship there is reasonable possibility of causal association between the event hypersensitivity and the suspect drug 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.
I received my vaccine at 1300 on 8/26/21, at 1330 I began feeling dizzy, suddenly had a headache, and my mouth felt extremely dry. By 1700, I was experiencing abdominal pain as well. By 1900, I was lightheaded, experiencing chills, very sweaty, I had severe body pain, my teeth hurt, my face was swollen, I was extremely weak, had leg cramps, and began vomiting I?m addition to the symptoms I had developed earlier in the day. I also had some shortness of breath and wheezing upon inhalation. I took 1000 mg of Tylenol, 10 mg of Claritin, 25 mg of hydroxyzine, 2 puffs of an albuterol inhaler, drank lots of water, and tried a warm shower. Without any relief I went to urgent care and was elevated. I was informed I was having an anaphylactic reaction. An IV was immediately started, and the team pushed steroids and Pepcid. I was also given prednisone to start tomorrow and zofran to prevent any rebound reactions.
delayed reaction; WBC in blood; felt tired; diagnosed with Urinary tract infection; blood in urine; soreness in the arm lasted 24 hours; A regulatory authority report was received from a consumer regarding himself, a patient who is a 68-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness in the arm that lasted 24 hours, diagnosed with a urinary tract infection, blood in the urine, WBC in the blood, felt tired as a delayed response to the vaccine.  The patient's medical history was not explicitly provided, however the patient noted that he takes "blood pressure medication" and "Benign Prostatic Hypertrophy medication."  On 12 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, patient stated that he had soreness in the arm that lasted 24 hours. No treatment information was reported and event is considered recovered/resolved.   On 13 Jan 2021, after the mRNA-1273 vaccine was given, the patient was reported to have been diagnosed with a urinary tract infection and had blood in his urine.  On 15 January 2021, the patient reported that there were white blood cells in his urine and felt tired. He was questioning if this is a delayed reaction to the vaccine.  Treatment information included antibiotic for the urinary tract infection.  Action taken with mRNA-1273 was not reported.  The outcome of the events, soreness in arm for 24 hours is considered resolved as of 12 Jan 2021. The outcome of the events, urinary tract infection, blood in urine, white blood cells in urine, and feeling tired were not reported.; Reporter's Comments: The events of urinary tract infection, blood in the urine, WBC in the blood is more likely associated with the patient's suspected underlying condition of benign prostatic hypertrophy Hence assessed as unlikely related to mRNA-1273. Fatigue and muscle soreness are temporarily associated with mRNA-1273 use and consistent with the known safety profile of the vaccine. Thus, causal association cannot be excluded.
Chills and fever for two days. Nausea for 4 days. Red rash on arm which is swollen and hot.
Brief pain at injection site, tingling a bit later. Very sore arm the next day and for four days, now eight days later it is warm, hard and itchy.  It is not getting better. I am very worried.
On 11/11/09 at approx. 7:30, I experienced pain in the back of my head, rated a 10 on a scales of 1-10, it pulsating, I became hot, rapid heart beat, and nausea, I vomited within ten minutes, and the pain lasted until 4:00 am, and I continued vomiting, twice an hour until that time also. The pain was immediate, one minute I was fine, the next I was not. The very same thing happened two days later, Nov. 13, at 8:30 AM. I have not had Migraines before, This second episode I went to the Emergency room, Cat scan was negative. They gave me IV pain meds and something for the nausea. I spent 6 hours in the ER.
SHORTNESS OF BREATH; OUT OF BODY FEELING; EPIGASTRIC PAIN; POSSIBLE RHEUMATOID ARTHRITIS FLARE; STINGING IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 53-year-old not Hispanic or Latino white female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, gastroesophageal reflux disease (GERD), hashimoto's thyroiditis, possible sjogren's, penicillin allergy and sulfa drugs (sulfonamide) allergy, and other pre-existing medical conditions included opiates allergy causing rash.  The patient experienced drug allergy when treated with Azithromycin, Ciprofloxacin and Levofloxacin for an unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 in right deltoid for prophylactic vaccination.  Concomitant medications included Acetylsalicylic acid (Aspirin) to prevent blood clot, and Prednisone for an unknown indication.  On 09-APR-2021, the patient experienced stinging in the right arm for a few seconds while getting the vaccine shot, then pain in left arm, stomachache in the night, profound weakness in the legs, heaviness in both legs and both arms, shortness of breath, out of body feeling, severe pain in the epigastric area. It was reported that vaccine could have triggered a rheumatoid arthritis reaction in legs hands, feet and arms. The feeling of weakness and heaviness in the arms and legs were still on going, and the reaction with Aspirin occurred about 30 minutes ago but became better once she took a liquid antacid. The patient took the Aspirin to prevent clots because she was on prednisone, which was read on the news that blood clots may form after getting the vaccine. She attributed the heaviness of the arms and legs as a possible rheumatoid arthritis flare. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging in the right arm, and epigastric pain on an unspecified date in APR-2021, was recovering from out of body feeling, and had not recovered from shortness of breath, and possible rheumatoid arthritis flare. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421350-covid-19 vaccine ad26.cov2.s-possible rheumatoid arthritis flare. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Patient had extreme muscle and joint pain that evening,; Patient had extreme muscle and joint pain that evening,; unable to walk for an hour; spasms in hands, feet and legs; The next day the consumer experienced migraine 35 hours after injection.; Migraine accompanied by severe GI symptoms and vomiting, which concluded after 2 hours.; vomiting; This is a spontaneous report from a non-contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER8730, expiration date was not reported) via an unspecified route of administration, on 24Mar2021 (at the age of 64-years-old), at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced extreme muscle and joint pain at evening, unable to walk for an hour, spasms in hands, feet, and legs. These symptoms passed after one hour. It was also reported that the next day he experienced migraine (35 hours after injection), accompanied by severe GI (gastrointestinal) symptoms and vomiting, which concluded after 2 hours. The outcome of muscle and joint pain at evening, unable to walk for an hour, spasms in hands, feet, and legs were recovered on 24Mar2021 and all the other events were recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.
LOSS OF TASTE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, allergy to bactrim, alcohol use, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste on 17-MAR-2021. This report was non-serious.
vaccination site rash; vaccination site pruritus; Vaccination site swelling; vaccination site urticaria; flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (vaccination site rash), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE URTICARIA (vaccination site urticaria) and INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). On 31-Jan-2021, the patient experienced VACCINATION SITE RASH (vaccination site rash), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE URTICARIA (vaccination site urticaria). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Injection site rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (vaccination site rash), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE SWELLING (Vaccination site swelling), VACCINATION SITE URTICARIA (vaccination site urticaria) and INFLUENZA LIKE ILLNESS (flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.
Next day pt developed hives, parents brought to ER, ER provider advised parents hives were caused by flu vaccine. PCP not notified of reaction/incident until 12/7/11 at WCC.
had large bilateral PE; This is a spontaneous report from a contactable nurse. A 72-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 23Jan2021 (lot number EL1283) on Left arm at single dose for COVID-19 immunization. Facility type vaccine was at urgent care center. Medical history included hypertension. Concomitant medications were not reported. The patient had large bilateral PE (pulmonary embolism) several weeks after vaccine on 18Feb2021. The event resulted in emergency room visit, physician office visit and Hospitalization for 2 days. Serious criteria Life-threatening also reported for the event. The event was treatment with anticoagulation. The outcome of the event was resolved in 2021.; Sender's Comments: A causal relationship between the event "had large bilateral PE" and suspect product BNT162B2 is possible based on the information provided and a temporal association in this 72-year-old female patient with hypertension. This case will be reassessed should additional information become available.  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.
Patient received 1st dose of Moderna vaccine around 1445 on 4/6/2021 after waiting in the waiting area for about 13 min he got up and spoke to EMT stationed at the first aid and asked if 'he was supposed to be feeling this way' and then he had an episode of syncope - the EMT caught him and lowered him into chair. He was also very pale. EMS were called around 1516 patient's VS were BP 92/52, HR 42, R 10, 02 95%. When EMS arrived they attempted to do orthostatic BO his seated BP was still low (I don't have reading) and when they stood him up he got woozy again so they seated him. The decision was made for him to be taken to ER by EMS Transport. Patient denies any medical history or NKDA. Tr