chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; Blurred vision in both eyes, but most in right eyes; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VISION BLURRED (Blurred vision in both eyes, but most in right eyes) and FATIGUE (Fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Dizziness), VISION BLURRED (Blurred vision in both eyes, but most in right eyes) and FATIGUE (Fatigue). At the time of the report, DIZZINESS (Dizziness), VISION BLURRED (Blurred vision in both eyes, but most in right eyes) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Lot number for box:C5449AA; expiry date: 07-Dec-2018; lot number for DTaP-IPV component: C5288AA; expiry date: 07-Dec-2018) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique since nurse at the hospital gave the PENTACEL vaccine but instead of giving the 2 components together she only gave the powder-ActHIB part and not the liquid part-DTaP-IPV component. It was not reported whether the patient experienced any adverse events following the reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Approximately 18 hours after shot, woke up with extreme chills; body shaking head to toe; fever of 100.5; Left arm very sore; it was swollen and very red; it was swollen and very red; it feels itchy; This is a spontaneous report from a contactable consumer. This 57-year-old female consumer(patient) reported that:A 57-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247)dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:45 asfor covid-19 immunisation .The patient medical history was not reported. The patient experienced approximately 18 hours after shot, woke up with extreme chills on 12Feb2021 01:00, body shaking head to toe on 12Feb2021 01:00 and, fever of 100.5 on 12Feb2021 01:00 and, left arm very sore and on 12Feb2021 01:00 and it was swollen and very red on 12Feb2021 01:00 and , it was swollen and very red on 12Feb2021 01:00 and, it feels itchy on 12Feb2021 01:00 and.The patient underwent lab tests and procedures which included body temperature: 100.5  on , body temperature: 101.9 and Approximately 18 hours after shot, woke up with extreme chills, body shaking head to toe and fever of 100.5 Took 600mg Ibuprofen, an hour later fever was 101.9, took 400mg Ibuprofen. Left arm very sore noticed that it was swollen and very red on Saturday. Swelling continued to get worse & redder & is still present today (Monday) & it feels itchy. Fever finally stopped Sunday evening. Every time the fever returned it took 1000 mg Ibuprofen and about 2 - 2-1/2 hours to go down and outcome of the events was not recovered.  No follow-up attempts are possible; information about lot number cannot be obtained.
Migraine headache affecting patient's gums/teeth/back of fracture vectebrate (muscles across the back (L) shoulder 1/4 of my (L) neck and straight down her (L) shoulder), hearing hurt, difficulty breathing.
The patient broke out with hives on 7/ 22/2021 associated with itching.  No breathing difficulty or wheezing. No fever, no body ache
Patient states day after vaccination noticed pain on right cheek and side of head.  Patent went on vacation where condition worsened.  Lesions developed and patient went to hospital for treatment.  No info on treatment received.  On 4/24/15 upon arriving home, patient sought medical care at an urgent care facility.  I was told Dr. prescribed Bactrim and Valtrex. On 4/27/2015 Patient was seen by her family care Dr.  Dr. prescribed Lyrica for nerve pain.  On 5/22/2015 I contacted Merck and reported reaction.  Case # 1-13874749883.
2/12/18 9:30 PM Patient woke up crying in his crib and was unable to settle himself to bed.I went in to get him out of the crib and rock him. When I picked him up out of his crib his body went rigid and straight, he screamed out until about 10:30 PM as if he were in pain. I administered Tylenol to help with pain. I nursed him. He went back to sleep. 2/13/18 He had increased irritability, fever of 100.3, and rash on his abdomen and back. Tylenol and Ibuprofen were administered throughout the day to manage his irritability and fever. 2/14/18  Fever continued ranging around 100.0 and rash spread on his abdomen and back. Pediatrician was contacted. Irritability continued. Slept through the night. 2/15/18  Pediatrician aware of symptoms. No fever this morning. Rash still present.
Brachial neuritis in right shoulder. Patient was seen by physician in corporate health and is currently receiving physical therapy.
Flu/cold/ allergy symptoms - home care liquids, rest, Aleve  and cold meds.
This is a 65y.o. female with significant past medical history of HTN, GERD, neuropathy, ETOH abuse, hypothyroid, and bipolar 1 disorder that presented to the hospital with chief complaint of LE swelling. She notes that she fell 2 weeks ago and did strike her head but did not seek medical evaluation. She has had increased confusion per her caregiver at the group home. She does complain of lower extremity and bilateral foot pain which has progressively worsened. She denies any fever, chills, chest pain, shortness of breath, cough, abdominal pain, nausea, vomiting, diarrhea, or constipation.   In the ED, vitals stable. COVID detected on swab. She was started on IV antibiotics with concern for LE cellulitis. Admitted for further evaluation and management.    Patient seen and examined only by the attending physician. NP only responsible for chart review given the patient's COVID positive status.
10X6 CM RAINES ERYTHMATOUS RASH LEFT DELTOID.  APPEARED ON 3/19/2009 WITH MILD ITCHING.  RECEIVED TD LEFT DELTOID ON 3/10/2009.
This spontaneous report as received from a licensed practical nurse refers to a 4 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JAN-2016, the patient was vaccinated with the first dose of ROTATEQ (orally, lot # reported as L000433; dose and expiration date were not reported) that had experienced a temperature excursion. On 14-MAR-2016, the patient was vaccinated with the second dose of ROTATEQ (orally, lot # reported as L000433; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
CALF WAS ENLARGED/CALF SWELLING; EDEMA OF ANKLES; CALF PAINS; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 127 pounds, and height was 172.72 centimeters. The patient's past medical history included: respiratory issues, and other pre-existing medical conditions included: Patient was previously on a steroid breather to help with his breathing. The patient experienced drug allergy when treated with chloramphenicol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ibuprofen for drug used for unknown indication, losartan for drug used for unknown indication, and morniflumate for drug used for unknown indication. On an unspecified date, the patient experienced calf was enlarged/calf swelling, edema of ankles, and calf pains. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Clots did not show up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from calf pains, had not recovered from calf was enlarged/calf swelling, and the outcome of edema of ankles was not reported. This report was non-serious. This case, involving the same patient is linked to 20211122674.
Within 24 hours of vaccination, the site became red, swollen, and warm to touch measuring 8 cm in size. Site was also painful.
Patient developed URI sx  - runny nose nasal congestion and low grade fever on date of event, but also developed erythema nodosum rash.
Squamous Cell Carcinoma of the V2 nerve, extending to Meckel's Cave. Possible "skip" lesion. Third dose (booster) received on 10/08/21 and by 11/06/21 my husband experienced pain and numbness around the left eye, visual distortion upon looking downward, nausea, constipation, loss of appetite and general malaise. By mid-November, a new nodule appeared below site of previous excision. He was seen in 12/2021 by doctors multiple times. No proper explanation for severity of his symptoms and ~30+ lb weight loss was provided. By 01/20/22, my husband lost motor control of his left eye (w/diplopia). On 01/26/22, nodule at temple surgically removed.
Large localized reaction 10 x 1.5cm erythematous/ indurated 2 days after received vaccine-Benadryl/ Keflex started.
24 Hour period - tired, some arm muscle discomfort, lack of appetite, lethargic, nausea with  dry heaves. Next morning no sympyons.
was feeling tired; Body ache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a month after receiving Shingrix, the patient experienced tiredness and general body pain. On an unknown date, the outcome of the tiredness and general body pain were recovered/resolved.   It was unknown if the reporter considered the tiredness and general body pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received the 1st dose of Shingrix experienced tiredness and body ache which was recovered till the time of reporting. The reporter stated this reaction last for 2 days after the vaccination date. The batch number and expiration date were unknown. The reporter did not consented to follow up. This case was linked with case US2020206848 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206848:same reporter
Face and chest became bright red; felt very hot; sinus pressure increased; blood pressure was up 155/94; pulse rate up; This is a spontaneous report received from a contactable consumer (the patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL 9261), via an unspecified route of administration in the left arm on 21Jan2021 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, indoor and outdoor allergies, and allergies to latex and contrast. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient previously took and had allergies to: amoxicillin/ clavulanic acid (AUGMENTIN), sulfamethoxazole/ trimethoprim (BACTRIM), levofloxacin (LEVAQUIN), and gabapentin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Within 5 minutes of receiving the dose on 21Jan2021, at 15:45 (as reported), the patient's face and chest became bright red, felt very hot, sinus pressure increased. The EMT's took her blood pressure- was up 155/94, and her pulse rate was up (21Jan2021, 15:45 (as reported)). Her temperature and blood sugar were within normal limits (21Jan2021). The patient did not receive any treatment for the events. The clinical outcome of face and chest became bright red, felt very hot, sinus pressure increased, blood pressure was up 155/94, and pulse rate up was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pulmonary thrombosis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved. It was unknown if the reporter considered the muscle pain to be related to SHINGRIX. Additional information was reported as follows: The patient's age at vaccination was 73 years. After vaccination with the first dose of SHINGRIX, the patient experienced muscle pain in her neck which was severe for about a week and then subsided but the pain never really went completely went away. This case was linked to case US2018GSK198908 (2nd dose), reported by the same reporter for the same patient.
Itching at and around injection site and a hive off to the side of injection site - after running in place for 5 minutes.
Hoarseness; swelling in his left leg; This case was reported by a physician via call center representative and described the occurrence of hoarseness in a 6-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number 2579B, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR-13 VACCINE) for prophylaxis.   Concurrent medical conditions included respiratory syncytial virus infection.   On 3rd January 2022, the patient received the 1st dose of FluLaval Tetra 2021-2022 season (intramuscular) .5 ml, Flulaval Tetra Pre-Filled Syringe Device, the 3rd dose of Pediarix (intramuscular) .5 ml, Pediarix Pre-Filled Syringe Device, the 3rd dose of Hiberix (intramuscular) .5 ml and PREVNAR-13 VACCINE (intramuscular). On 3rd January 2022, less than a day after receiving FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced hoarseness and swelling of legs. On an unknown date, the outcome of the hoarseness and swelling of legs were recovered/resolved.   It was unknown if the reporter considered the hoarseness and swelling of legs to be related to FluLaval Tetra 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a pediatrician that was reporting adverse events for 2 different patients who were brothers and received 4 vaccines as part of their 6 month old vaccination series. The patient received his first dose of Flulaval and Pediarix in his right thigh. The patient received his Hiberix and the Prevnar-13 vaccine in his left thigh The reporter did not get the lot number /expiration date for the Pediarix or the Hiberix vaccine administered. The doctor reported that the patient experienced hoarseness within 24 hours of taking the vaccines and she suggested that the Flulaval was the potential suspect vaccine to cause this adverse events since this was the only new vaccine to the patient.  Although, the physician also reported that the patient was recovering from a case of RSV.  The physician reported the patient's mom stated that her son experienced swelling in his left leg. Doctor reported all side effects are currently resolved. The reporter did not get consent because healthcare professional was reporter, not patient. The case has been linked to US2022002798, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002798:same reporter
Intense projectile vomiting, thick mucous, one time, some difficulty breathing w/ thick mucous, soothed by grandmother.
Enlarged lymph nodes, unspecified (R59.9) Suspected reactive lymphadenopathy due to recent Covid-19 vaccine. Rest, no increased activity. Warm compresses and analgesics for pain. Avoid strenuous activity for next 1-2 weeks depending on symptoms. Monitor, symptoms should improve or resolve in 1-2 weeks.  Take Tylenol as needed for pain management.  RTC in 2 weeks or sooner if needed.
Back pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on 01May2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) for unknown indication on unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 10Apr2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 02May2021, the patient experienced back pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event back pain was recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt got shot on 10/25/2017. His wife called in the afternoon and said that pt is complaining about shivering, Headache and left hand shaking (where he got Flu shot ). But she did give him Ibuprofen just few mins ago. We recommended her to see dr. I Called back after 2 hrs to check and his wife said that he is feeling much better now so did not see a dr. Also they do not have any primary physician. But he is much better. Pt also Informed to his dr (who does treatment of his MS). I just spoke with him today again and he said that he is completely ok now.
The first one was 2 weeks before the second; body feels on fire at night/Body feels like it is on fire; joints hurting/Joints are hurting; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) intramuscular, administered in Arm Left on 12Mar2021 14:00 (at the age of 73-years-old) as dose 2, single for COVID-19 immunization. Medical history included diabetic heart disease and low kidney function from an unknown date and unknown if ongoing. There were no concomitant medications. No investigation assessment was performed. On an unspecified date, the first one was 2 weeks before the second. On 13Mar2021 22:00, the body feels on fire at night/body feels like it is on fire and joints hurting/joints are hurting. No relevant test reported. No emergency room or physician's office required. The outcome of the event the first one was 2 weeks before the second was unknown. The outcome of the events body feels on fire at night/body feels like it is on fire and joints hurting/joints are hurting was not recovered.  Follow-up attempts completed. No further information is expected.
PATIENT DEVELOPED ITCHING, REDDNESS,SWELLING AND JOINT PAIN OF LEFT LOWER EXTREMITY THE DAY AFTER RECEIVING COVID 19 VACCINE.  SHE WAS SEEN BY HER PCP ON 2/8/21 AND VENOUS DOPPLER WAS ORDERED.
Initially, I only had pain at the injection site. About 10 hours later I started to become fatigued and have chills. This is around the time that I went to bed. All through the night I was running a fever of about 101.4 degrees Fahrenheit oh, and my pulse is racing at about 108 beats per minute. I can feel my head pulsating and towards morning a headache came on. I did not take any medication and was just waiting for the fever to pass.
08/24/22 presents to ED for "fatigue, not eating". PMHx of "anemia, Hep C, lymphoma, HTN"
Fever to 102 degrees F, subsided with MOTRIN. Fever and chills. Onset 11-13-09,  exact time unk. Fever decreased with MOTRIN to 98.6. Week prior to 10-31, child was sick with flu-like sxs.
Severe pain in the left deltoid area that has lasted for months. Was seen by Urgent Care, doctor and Physical Therapy.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff)   This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193;.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
pt recvd vax & did not show reaction until today became red-swollen sore-spread down arm;