chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONSTANT TO BAD DIZZINESS (TO THE POINT WITH FEELS LIKE ROOM IS SPINNING); PAIN BEHIND EYES; MODERATE CONSTANT HEADACHE; NAUSEA; VOMITED 10 MINS AFTER FEELING NAUSEOUS; FEVER OF 102 CONSISTENTLY; FATIGUE; MUSCLE PAIN; LEFT ARM SORENESS; CHILLS BADLY; BODY ACHES EVERYWHERE; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, non alcohol user, cigarette smoker, bees allergy, and insect allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 12:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body aches everywhere. On 28-MAY-2021, the subject experienced left arm soreness. On 28-MAY-2021, the subject experienced chills badly. On 28-MAY-2021, the subject experienced fatigue. On 28-MAY-2021, the subject experienced muscle pain. On 28-MAY-2021, the subject experienced fever of 102 consistently. Laboratory data included: Body temperature (NR: not provided) 102 (units unspecified). On 29-MAY-2021, the subject experienced vomited 10 mins after feeling nauseous. On 29-MAY-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced constant to bad dizziness (to the point with feels like room is spinning). On 04-JUN-2021, the subject experienced pain behind eyes. On 04-JUN-2021, the subject experienced moderate constant headache. On 07-JUN-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches everywhere, chills badly, fatigue, muscle pain, and fever of 102 consistently on 31-MAY-2021, vomited 10 mins after feeling nauseous, and nausea on 29-MAY-2021, and left arm soreness on 02-JUN-2021, and had not recovered from constant to bad dizziness (to the point with feels like room is spinning), moderate constant headache, and pain behind eyes. This report was non-serious.
when i stretch i get pain in my arm; arm i got the vaccine is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (when i stretch i get pain in my arm) and VACCINATION SITE PAIN (arm i got the vaccine is still sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (when i stretch i get pain in my arm) and VACCINATION SITE PAIN (arm i got the vaccine is still sore). At the time of the report, PAIN IN EXTREMITY (when i stretch i get pain in my arm) and VACCINATION SITE PAIN (arm i got the vaccine is still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.
Fever and rash 10 days post MMR, Erythematous plague over trunk.
expired dose administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Fever over 100.5, chills/shivering, headache, neck and shoulder pain and stiffness
Information has been received from a pharmacist concerning a female patient with no pertinent medical history, who on 02-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). Other suspect therapies included TDAP, mfr unknown (vaccinated on the same day, 02-AUG-2012). No concomitant medications were reported. it was reported that, after receiving ZOSTAVAX (in 2012), the patient developed bilateral hives on her neck, on face, legs and trunk. It was also reported that, in 2012, the patient developed bilateral arm swelling and stiffness. The patient sought a medical attention. The patient's symptoms were treated with unspecified antihistamine and steroids. At the time of the report, the patient's outcome was not recovered. The relatedness for stiffness, bilateral arm swelling and hives was unknown for ZOSTAVAX and TDAP. Additional information has been requested.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had not resolved.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment information was reported.
Twelve hours post vaccine extreme chills, nausea and headache.  Seven months post vaccine ER admission with atrial fibrillation and hypertension.  ER admission lasted for 15 hours with discharge on beta-blocker and Non-STEMI diagnosis.  Chills, nausea and palpitations persisted for 60 days after ER discharge.
1/30/2022- Presented to ER, report of a fall 2 days ago-right rib pain, congestion and SOB. T-pp, HR 111, RR-30 and 02 96% on RA. Covid+, WBC-22.7, CRP-2.8. ALT-114, AST-269 and CK-4,822. Transaminitis. CT Thorax- pneumothorax and Moderate compressive atelectasis right lower lobe and acute fractures right thirs-10th ribs. Chest tube placed, small amount of blood accompanied a rush of air. Admit fall with hemopneumothorax and sepsis secondary to Covid pneumonia. Started cefepime, vancomycin, solumedrol, heparin and remedesvir.  1/31/2022- Added Bicarb for traumatic Rhabdo and Valium d/t presenting with tremors and DT symptoms.  On 4L via NC sat 96%. Afebrile. BP-161/99.  2/3/2022- Chest xray-persistent bibasilar opacities similar to original study. AST-71, ALT-59  and CK-254 are trending down.  Reports dyspnea. BP-88/54. Levophed started. ABG-7.501/35.0/258/4.3  02 sat 92%.  NRBM placed, 15L. upgrade in care to ICU. Clonidine started for hypertension. Dislodged chest tube overnight, replaced drained 700cc of blood from thorax. Chest ct- Large hemothorax, compressed  right lung with collapsed right middle lobe. Small Right pneumothorax noted. O2 titrated down to 5L via NC. 2/4/2022- Levophed titrated off. BP 114/60 and o2 stable on 4L NC. Rhabdo resolved CK now 48.  Chest x ray-improved right hydropneumothorax and right pulmonary infiltrate.  2/7/2022-Increase of WBC-17.6. Afebrile. Cultures Pending.  Chest x ray- new small apical pneumothorax. Bibasilar pulmonary infiltrates. Chest tube drainage minimal.  96% o2 sat on RA. 2/8/2022- Chest tube removed. 2/10/22-BP-120/75. Afebrile. Maintaining 02 on RA. WBC trendig downward 15.0.  AST-46 and ALT-40.  Covid  improved. Continue IV Rocephin   ABG- 7.501/35.0/258/4.3 o2 sat 92. Chest x ray- No significant change. D/C to home.
Spondylitis ankylosing aggravated; Stress; Fever; Chills; Fatigue; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program FACILITATED COLLECT, based on information received by Pfizer from, manufacturer control number: 21K-163-4065604-00.   Solicited report from the consumer of a 43 year old female with events of non-serious chills, fatigue, stress, fever and ankylosing spondylitis flare up with (HUMIRA). The patient received adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date and ongoing, at citrate free for ankylosing spondylitis. On 23Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech at age of 42-year-old, on 13Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech at age of 42-year-old, in 2021, patient received booster COVID-19 Vaccine manufactured by Pfizer BioNTech, all via intramuscular for COVID-19 vaccination. There was no reported medical history and concomitant medications. On unknown dates, the patient experienced stress and ankylosing spondylitis flare up. On 16Aug2021, the patient experienced chills, fatigue and fever. Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for adalimumab was dose not changed. The outcome of chills, fatigue and fever was unknown, the outcome of stress and ankylosing spondylitis flare up was not resolved.   Causality for adalimumab: The reporter's causality for the events of chills, fatigue and fever with (HUMIRA) was no reasonable possibility. The reporter's causality for the events of stress and ankylosing spondylitis flare up with adalimumab was a reasonable possibility. Tozinameran (PFIZER BIONTECH COVID-19 VACCINE) was also considered suspect.  The reporter's assessment of the causal relationship of the events with the suspect product PFIZER BIONTECH COVID-19 VACCINE was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Ankylosing spondylitis, chills, Fatigue, stress and pyrexia cannot be excluded.  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.
3/16/2021 - 6 PM lower left arm lite tingling, at 8 PM blood pressure dropped from 80 to 61 bpm (111/64), at 9 PM now left arm and left side of face lite tingling. 3/17/2021 - Still lower left arm and face has light tingling. 3/18/2021 - 3:40 AM felt nauseated. Took a Tum.  Now at 1:40PM the tingle is stronger on lower left arm and left side of face is slightly numb.
Heavy irregular menstrual flow; terrible cramping; irregular and heavy menses; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Nov2021 13:00 (Lot number: 330268D) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Elo14d, Location of injection: Arm Left, Vaccine Administration Time: 12:00, Route of Administration: Intramuscular), administration date: 12Dec2020, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "Heavy irregular menstrual flow", "irregular and heavy menses", "Terrible cramping"; Bnt162b2 (Dose Number: 2, Batch/Lot No: Eliz83, Location of injection: Arm Right, Vaccine Administration Time: 12:00, Route of Administration: Intramuscular), administration date: 12Jan2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "Heavy irregular menstrual flow", "irregular and heavy menses", "Terrible cramping". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "Heavy irregular menstrual flow"; DYSMENORRHOEA (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "terrible cramping"; MENSTRUATION IRREGULAR (non-serious) with onset 02Dec2021 16:00, outcome "not recovered", described as "irregular and heavy menses". The events "heavy irregular menstrual flow", "terrible cramping" and "irregular and heavy menses" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, dysmenorrhoea, menstruation irregular.  Additional Information: Heavy irregular menstrual flow after initial vaccines. Labs ultrasound biopsies came back negative. After about 7 months symptoms began to improve. Received her booster and symptoms are back. Terrible cramping, irregular and heavy menses.  No follow-up attempts are possible. No further information is expected.
Patient rec'd 2nd dose at 1217, had syncopal episode x 3  in observation area. Patient evaluated by Dr . We layed patient supine. Patient became more alert. Attempted to sit patient up after 10 minutes, had syncopal episode again. Patient c/o left arm and chest heaviness, left neck tightness, and left sided facial tingling. BP remained 130-150/60's and HR in the 60's. EMS was called at 1301. Transported to HH ED with belongings. Patient's mother notified.
Father received vaccinia vaccine prior to deployment. Patient developed two pustular lesions approximately 3/6/04. One under right arm; one in right diaper area.
Pt called saying she felt dizzy about 2 hours after Shingrix administered and wondered if it was from the vaccination. It can happen in roughly 1% of patients so I am documenting. I did follow up with a phone call to pt but had to leave a message.
Rash on chest that spread to stomach, shoulders, and around the neck over the 5 days following the injection. We went to the doctor on the 5th day and was prescribed a steroid cream.
Dealing with long term effect; Receieved both moderna and pfizer vaccine; Receieved both moderna and pfizer vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Dealing with long term effect), INTERCHANGE OF VACCINE PRODUCTS (Receieved both moderna and pfizer vaccine) and COVID-19 IMMUNISATION (Receieved both moderna and pfizer vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prophylactic 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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Dealing with long term effect), INTERCHANGE OF VACCINE PRODUCTS (Receieved both moderna and pfizer vaccine) and COVID-19 IMMUNISATION (Receieved both moderna and pfizer vaccine). At the time of the report, IMMUNISATION REACTION (Dealing with long term effect) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Receieved both moderna and pfizer vaccine) and COVID-19 IMMUNISATION (Receieved both moderna and pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Body aches; chills; headache; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non pregnant female she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 10Feb2021 at 09:15 (at the age of 49-years-old) as a single dose for covid-19 vaccination. Medical history included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 22Jan2021 at 09:15 as a single dose for covid-19 vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Allergies to medications, food, or other products included: Allergy to Penicillin, Amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19.  On 11Feb2021 at 08:30, the patient experienced body aches, chills, headache. Patient did not receive treatment for the adverse event. On an unknown date, the outcome of the events was recovered.   Information on the lot/batch number has been requested.
HEADACHE; NOSE BLEEDS; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 25-MAY-2021) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine besilate/olmesartan medoxomil for high blood pressure, and hydralazine for high blood pressure.  On 02-APR-2021, the subject experienced nose bleeds. On an unspecified date, the subject experienced headache. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nose bleeds and headache was not reported. This report was non-serious.
high pitched scream for 3-4 hrs duration same noc p/vax; lt thigh where DTP administered was red, lump there; lump originally size of grape, now 3mm diameter; no fever;
After 5 minutes of getting the Moderna shot , the patients body got stiff and he fell of the chair he was sitting . The patient got up 1 minute after all this happened stating that he was feeling fine although he looked pale on his face. Called 911 right away and an ambulance took the patient for more evaluation 10 minutes after .
Moderna COVID?19 Vaccine EUA:  Unexplained Cramping and Menstrual Blood Clot with no period to follow.
LMP per patient first week of March 2018. No pregnancy testing done prior to immunization. Ultrasound done on 4/2/2018 shows a 5 5/7 weeks pregnancy - making her 3 weeks and 5 days at the time of immunization. Her EDC is Nov 27, 2018.
Chills, Fever of 102, Aches, Headache, Fatigue, Confusion
Vaccines given on 8/02/06 mom calls on 8/14/06 kid away at camp, developed rash, itchy bumps, went to an ER (I have no info from ER).
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 11:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 11:38 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. On 28-Feb-2021, Excursion time was 09 AM and temperature was 27,excursion time was 1PM and temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43, 4 PM: 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pt expired vaccine TriHiBit (DTaP + HIB) parents have been left message to call clinic, no contact, will continue to contact or revaccinate at 18 month well check. 08/08/2005 spoke with mom. She will walk in for revaccination on or before 15 month.