chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per co-workers, patient reported "not feeling well" on 12/04/09.  12/29/09 Autopsy received. DOD 12/06/2009. Cause of Death: Long-term Sequelae of Spina Bifida. Additional information abstracted: Contributory - Associated Chronic and Acute Urinary Tract Infection. Summary of Autopsy Findings: I. Spina bifida - A. Large puckered lower lumbar scar. B. Chronic lower extremity atrophy with bilateral foot deformities. C. Indurated scars and large scarring - buttock and legs. D. Chronic and acute urinary tract infections. E. Posterior absence of corpus callosum. F. Ventriculoperitoneal shunt. G. Congested, dusky leptomeninges with associated cerebral edema.  II. Other findings - A. Moderate atherosclerotic coronary artery disease. B. Minimal to moderate cardiac hypertophy. C. Acute visceral adhesions. D. Old abdominal adhesions. E. Status-post cholecystectomy.
Disturbances to menstrual cycle, including the following side effects/symptoms:  very heavy periods, excessive blood clots, longer periods, painful ovulation with cramping.
mom states that pt was lethargic, hypotonic, slept for a total of 18 hrs; pt would wake up when stimulated, eat then return to sleep; no fever was detected; pt recvd APAP every 4 hrs during that time period;
Aprrox 90 min after Flu shot pt called in stating she was red in face arms and chest. No SOB but eyes slightly swollen. She drove herself to the ER locally.
Information has been received from a registered pharmacist concerning a 75 year old male patient with myelodysplastic syndrome who on 09-MAR-2011 was vaccinated on his left upper extremity with a dose of PNEUMOVAX 23 (Lot number 667690/1158Z, Exp. 26-JAN-2012). Concomitant therapy included Z-PAK, lovastatin (manufacturer unknown) and PROTONIX. The pharmacist reported that the patient received PNEUMOVAX 23 at his primary care physician's office and was reported to had tolerated it well. On 10-MAR-2011, the patient presented episodes of shaking, chills, two episodes of emesis and feeling some "what" disoriented for the next "2-3 days". It was reported that on 12-MAR-2011, the patient's daughter checked out on him and his temperature was 103.4 and he was "so weak he could not get out of bed". The patient told his daughter then that he had some left arm soreness, which the daughter looked at and later told emergency room personnel that "there was no obvious redness, swelling, or anything that looked abnormal". It was noted that the emergency room record report that the patient confirmed this statement. On 13-MAR-2011, the patient noted large bright red areas with swelling and worsening pain in left upper extremity. He went to an urgency care facility and he was sent to the hospital. The patient was admitted to the general medical unit with a diagnosis of cellulitis in his left upper extremity. The physician noted that he was concerned about the possibility of necrotizing fascitis. While inpatient, the patient received ZOSYN, 4.5g, IV and vancomycin, 1g, IV. The patient was discharged from the hospital on 17-MAR-2011. At the time of the report, the patient was recovering. Additional information has been requested.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On 14-AUG-2015, the patient was vaccinated with the first dose of GARDASIL (lot #, expiration date and route were not reported). On 28-JUL-2016, the patient received the second dose of GARDASIL (lot # M014929, expiration date 27-MAY-2017, route unknown), later than the recommended dosing schedule in the prescribing information. No adverse effects were reported. Additional information has been requested.
shivering; achy; feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 12:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 55 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, start date: 12Sep2023, stop date: 12Sep2023. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Primary immunization complete, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 04Oct2023 at 01:00, outcome "not recovered", described as "achy"; PYREXIA (non-serious) with onset 04Oct2023 at 01:00, outcome "not recovered", described as "feverish"; CHILLS (non-serious) with onset 04Oct2023 at 01:00, outcome "not recovered", described as "shivering". Therapeutic measures were not taken as a result of chills, pain, pyrexia.  Additional information: Patient awoke at 1:00 a.m. shivering, achy and feverish. Patient had no known allergy, no covid prior to vaccination and not covid tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Itchy and puffy spots of swelling in various spots on whole body, lasted from 24-48 hours after vaccination before subsiding.
9 pm (9 hours after shot) - sore/stiff - took Advil 600 mg 12pm - spiked a fever; Rigors; headache "Felt out of it. T - 101.2 at time - 1 AM - T 102.5 - chills, Rest of week - not feeling well; low grade fever 7/21/2020 - notified pharmacist  "FDA/Vaers  8/1/2020 - spoke with Dr
She had tingling fingers and palm without swelling. The tingling did not travel up or down her arm. She had not eaten that day and she said she had just finished cleaning her sister's salon where she was hand scrubbing the floor. She had no other complaints. She said that this started about 5 minutes after the injection and upon follow up in the afternoon she said the tingling had resolved.
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown ages and genders. On unknown dates, the patients were vaccinated with unspecified doses of improperly stored VAQTA (lot #M021124, expiry date: 02-FEB-2018, lot #L043209, expiry date: 17-SEP-2017, lot# L032749, expiry date: 04-NOV-2016) (route: intramuscular). The vaccine was stored at a temperature of 53.3 F for a time frame of 3 hours and 23 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Friday night Achy, dizzy, no strength and Head ache.  Saturday Internal fever. Sunday forehead and nose rash/redness.  Monday morning, Large red welt on right wrist approx siz of baseball. Redness in forehead and nose continued.    Treatments: rest and motrin 600 mg every 3 hours.
4MAY92 mom found pt face down, shaking, blue, not breathing, eyes rolled back-taken to hosp ER observed for 24 hrs & released; MD felt febrile seizure not due to vax; CXR showed pneumonia;
G62.0 DRUG INDUCED POLYNEUROPATHY 1/3/2023 ACUTE RESPIRATORY DISTRESS I20.8 STABLE ANGINA 1/3/2023 ACUTE RESPIRATORY DISTRESS J96.00 ACUTE RESPIRATORY FAILURE 9/28/2022 ACUTE RESPIRATORY DISTRESS
Migraine red Spots all over Itchy Tired Generally feel bad Tired Chills and pouring sweat Joint pain
Flu Like symptoms after the first primary dose for 3 days; A lot of Pain all over the body after the first primary dose for 3 days; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu Like symptoms after the first primary dose for 3 days) and PAIN (A lot of Pain all over the body after the first primary dose for 3 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu Like symptoms after the first primary dose for 3 days) and PAIN (A lot of Pain all over the body after the first primary dose for 3 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In July 2021, INFLUENZA LIKE ILLNESS (Flu Like symptoms after the first primary dose for 3 days) and PAIN (A lot of Pain all over the body after the first primary dose for 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided. The patient had received 2 primary doses of Moderna COVID-19 vaccine. The patient had dose 2 Primary monovalent dose on unknown date (Lot and Expiry Date: unknown). After the 2nd dose, she did not had any side effects.
Eruption began over contralateral  (Left) proximal arm on 30 June 04.  Subsequently spread to his back over the following 24hrs.  Eruption described as 1-3 mm  widely separated  pustular lesions. Patient is completely asymptomatic except for itching which has been easily controlled with Anti-histamines.  He has not missed any duty days and the physical findings are resolving.
Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No Adverse Event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 34th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but it was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
On 12/30 Immediately 1 hr post vaccination employee  could not speak correctly.  2.5 hours after vaccine experienced severe headache and called 911. Vital signs were stable  and did not go with EMS. 3 hours after 911 was called went to ED. MD in ED  wrote up summary as "severe migraine with trouble speaking". ED MD said "trouble speaking is a symptom of migraine". No evidence of stroke. Employee still has Headache as of 12/31/20. Employee was COVID positive on 12/1/2020.
Reports bald patch at back of head - onset one month after receiving MENACTRA, Flu and GARDASIL 2/11/08, condition has worsened over past 5 months - seen 9/25/08 for this condition. Treated - Triamcinolone - referred to Dermatologist.
Patient had a positive COVID test on 1/31/2022 and expired on 2/17/2022.
Patient received initial intramuscular typhoid (ViCP SP/G1541) and subcutaneous Yellow Fever (SP/UH139AA) vaccinations to left arm on 5/22/2012 at 0809 hours. Patient advised he left clinic and got haircut, then ate new sub sandwich (*turkey, ham, cheese) with sour cream onion potato chips and a diet coke. Approximately 15 minutes after eating he (about 60 minutes after vaccination) he began to note an itchy (1-2/10) red macular rash to bilateral axilla that spread over the next hour across his upper chest, neck, right eyelid (upper/lower lid) and tops of both hands (to webbing about index fingers) with red blotches (hives) to face (bilateral cheeks and chin). He had a rash to left shoulder around band-aid site. He denied any breathing difficulty, difficulty swallowing, chest pain, or oral swelling. He presented to medical at 0958 hours, now two hours after vaccination, with "facial erythema and urticarial lesions on chin and jaw, erythema to left shoulder". He was diagnosed with urticaria allergic reaction and treated with 0.3 mg epinephrine SQ and 50 mg of IM BENADRYL. Symptoms resolved over next hour and he was released with prescriptions for BENADRYL, EPIPEN and ZANTAC without further recurrence. Patient reported using same barber in past but was unsure about use of new soaps/lotions, detergents or chemicals in barber cleaning supplies. He also denied self use of (or new tubes of) new detergents, deodorants, shampoo, cologne, soaps, razor or shaving gel, or any travel, recent illness or exposure to anyone ill. He did not exercise day of vaccination. On 5/30/2012, he advised he had eaten same sub sandwich, chips and diet coke on 5/22/2012 and had used the same barber again without reactions. No new lotions, soaps, detergents, etc were reported by barber. A RAST test drawn 5/25/2012 for whole egg, yolk and white was negative, however gelatin RAST requested was not performed.
Pt received second booster of bivalent vaccine by mistake. guardians informed, possible side effects explained. Pt felt ok leaving a clinic.
pt recv vax 17OCT97 & starting on the day p/vax pt exp swelling, mild erythema, warmth of the lt deltoid area (inj site);sx which cont over a period of 5 days;responded to symptomatic therapy;
Pt fainted after receiving injection, fell and sustained laceration to chin. Received 6 sutures in clinic.
No additional AE/PQC was reported; she is above the recommended age of 45 for GARDASIL 9 and she received her first dose of GARDASIL 9 on 8/23/2021; This spontaneous report was received from a female patient of age above 45 years, who was referring to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-AUG-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, anatomical location, route of administration, lot # and expiration date were not reported) (Inappropriate age at vaccine administration). Her second dose is scheduled for 19-OCT-2021. No additional adverse event was reported.
I received my Covid -19 vaccine on 09/22/2022. On the morning of 11/13 I woke up with sniffles and the next I took a Covid -19 test and was positive. I was feeling lethargic with a slight fever. Symptoms of weakness still persisting.
Narrative:  COVID infection following COVID vaccine series 03/18, Pfizer, dose #1 04/08, Pfizer, dose #2 12/28 COVID swab, result: detected 12/28 pt cc: cough, headache, myalgias, dyspnea, exposure: wife/son/grandson 12/28 pt admit ED CC: shortness of breath, dizziness and general body aches DX: Covid infection los: 1 DAY 12/29 CXR Impression: No acute cardiopulmonary abnormality. Follow-up suggested for persistent or worsening symptoms.
Client states feeling hot inside (hot patches) at various ares of body and face. Areas would move from spot to spot. Felt like sunburn. See past Hx. Felt worse during the night and early AM. States better now (10/20/2009 4:30 PM). States discussed with MD and was advised seek medical attention if cont. or worsens. States plans to see MD this week for seasonal flu vaccine as advised by MD. Client states he will call if any further px.
Janssen COVID-19 Vaccine EUA - chills for several hours, headache next morning till now
A Pediatric 5-11 year dose Pfizer mRNA COVID-19 vaccine product was inadvertently administered for a second dose in a 2-dose series.
high temp x 4 days w/transient hematuria 4 days p/vax;
Patient reported tingling after receiving flu shot.  At 2:00 pm later that day, patient called pharmacy to report that swelling was occurring  "halfway down to her elbow" that was also accompanied with red, itchy bumps.  Pharmacist re-checked to see if there was any latex contained in the bandage used or the Flublok syringe, but there was none.  No other obvious allergen was identified from vaccination supplies.  Pharmacist counseled patient to mark the border of the swelling so that patient could track if the area continued to increase in size and to report to an urgent care if swell continued.  Recommended use of hydrocortisone cream to manage swelling and itching.
Rubbery legs; Unable to move legs; Weakness; Fever; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB DISCOMFORT (Rubbery legs), MUSCULAR WEAKNESS (Unable to move legs), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Headache) in a 65-year-old female patient 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 LIMB DISCOMFORT (Rubbery legs), MUSCULAR WEAKNESS (Unable to move legs), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, LIMB DISCOMFORT (Rubbery legs), MUSCULAR WEAKNESS (Unable to move legs), ASTHENIA (Weakness), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        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 products and treatment medication were reported.
Onset 7.5 hours after vaccination (2nd dose of Pfizer).  Felt sick "in the head." Vision was off leading to nausea.  Peripheral vision was good.  Central vision was blurry, difficult to focus, eventually could see near objects but not far.  Symptoms lasted approximately 30 minutes.  Patient had hydrated as recommended by the administrator.  Shortly after symptom onset, she decided to take an aspirin and go outside for a walk.  She continued to have the vision issues into the walk.  After 30 minutes, symptoms improved and vision gradually returned to normal.
A report was received from a health care professional on 12/12/03 concerning a 15 month old male vaccinee who inadvertently received Fluvirin on 12/10/03. On 12/10/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Pt said she experienced severe swelling after getting the shot on her arm. Swelling has gone down but still feeling itching. Told her to apply coco butter and rub ice pack.
This non-serious medically confirmed spontaneous report (initial receipt 03-OCT-2014) concerns a female patient (nurse). On 03-OCT-2014, the patient received AFLURIA (batch number not provided). On 03-OCT-2014, the vaccine was withdrawn into the syringe. During the administration, the needle came off the syringe and the serum sprayed into the administering nurse's eye. The nurse went into the restroom to flush out her eye. Her eyes seemed fine and there was not a problem at the time of reporting. Outcome was unknown.  Linked to TC-1165 (patient report).
Pt was given Shingrix via a 5/8" syringe rather than a 1" syringe. Pt experienced redness and swelling at the site of injection (left deltoid).
Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99% of "normal sid; This is a spontaneous report from a contactable consumer (patient). A 35 years old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route, administered in Arm Left on 15Jun2021 at 14:30 (age of 35 years old at vaccination) as 1st dose, single for COVID-19 immunization. The patient's medical history included Covid-19. The patient's concomitant medications included Vitamin (unspecified). Vaccination facility was reported as Pharmacy or drug store. Prior to vaccination the patient was diagnosed with Covid-19. The patient had not received any other vaccine prior 4 weeks to Covid-19 vaccine. On 15Jun2021 at 16:30, the patient experienced Extreme: shortness of breath, difficulty breathing, rapid heartbeat, dizziness, muscle aches, joint pain, exhaustion, chest pain. Very much like the actual virus felt. All on top of 99 percent of "normal side effects". Since vaccination the patient was not tested for Covid-19 infection. The patient had not received any treatment medications for the resulted events. The outcome of the events was not recovered.
Pt. experienced nausea and dizziness, and cardiac symptoms at 10:40 am.  Meclizine and Zofran given at camp clinic. Pt. did not experience any relief and that night was taken to Hospital.