chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The allergic reaction was even worse (after second dose); Reaction covered from her upper arm to her elbow; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (The allergic reaction was even worse (after second dose)) and VACCINATION COMPLICATION (Reaction covered from her upper arm to her elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Malaria. Concurrent medical conditions included Fruit allergy (Mango, Chia, Antibiotics, and many others).   On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CONDITION AGGRAVATED (The allergic reaction was even worse (after second dose)) and VACCINATION COMPLICATION (Reaction covered from her upper arm to her elbow). At the time of the report, CONDITION AGGRAVATED (The allergic reaction was even worse (after second dose)) and VACCINATION COMPLICATION (Reaction covered from her upper arm to her elbow) had resolved.            No concomitants are provided No treatments are provided   This case was linked to MOD-2021-213215 (Patient Link).
Fever; Chills; doesn't feel 100%, in bad shape; Tiredness; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), VACCINATION COMPLICATION (doesn't feel 100%, in bad shape), FATIGUE (Tiredness) and DIARRHOEA (Diarrhea) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), VACCINATION COMPLICATION (doesn't feel 100%, in bad shape), FATIGUE (Tiredness) and DIARRHOEA (Diarrhea). At the time of the report, PYREXIA (Fever), CHILLS (Chills), VACCINATION COMPLICATION (doesn't feel 100%, in bad shape), FATIGUE (Tiredness) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and Concomitant medications were not provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: form was attached; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
less than 24 hours have the vaccine, I experienced severe muscle aches, brain fog could not concentrate, mild nausea and headaches. Severe for 12 hours, less severe up until next day. Resolved around 24 hours or less, by the time I got up the next day.
experienced non stop numb lips since his first vaccine; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA ORAL (experienced non stop numb lips since his first vaccine) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (experienced non stop numb lips since his first vaccine). At the time of the report, HYPOAESTHESIA ORAL (experienced non stop numb lips since his first vaccine) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Patient did not report any other adverse reactions or side effects and also not having a Physician. No treatment information was provided by the reporter.   This case was linked to MOD-2022-573240 (Patient Link).
diarrhea; Recurring chills; dizziness; fatigue; joint ache; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8733) at the age of 69 years as dose 1, single and administered in arm left, administration date 14Apr2021 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ASPIRINE; VITAMIN D3; CENTRUM SILVER +50; TURMERIC CURCUMIN. The following information was reported: DIARRHOEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "diarrhea"; CHILLS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "Recurring chills"; DIZZINESS (non-serious) with onset 07Apr2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 07Apr2021, outcome "not recovered", described as "fatigue"; ARTHRALGIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "joint ache"; NAUSEA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "nausea". The events "diarrhea", "recurring chills", "dizziness", "fatigue", "joint ache" and "nausea" 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 diarrhoea, chills, dizziness, fatigue, arthralgia, nausea.  Follow-Up (03Dec2021):Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a adult male patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine. On an unknown date, less than a year after receiving Flu trivalent vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, Guillain Barre Syndrome (serious criteria hospitalization and GSK medically significant), monoplegia (serious criteria GSK medically significant), facial paralysis (serious criteria GSK medically significant), swallowing difficult and weakness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza, Guillain Barre Syndrome, monoplegia, facial paralysis, swallowing difficult and weakness were not reported. It was unknown if the reporter considered the vaccination failure, influenza, Guillain Barre Syndrome, monoplegia, facial paralysis, swallowing difficult and weakness to be related to Flu trivalent vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient was 60 years old at the time of reporting. In 2002, the patient received seasonal influenza vaccine (pharmacist did not know which Flu vaccine). In 2002, the patient was sick with flu, was weak, became paralyzed in the right leg, arm and face and had difficulty in swallowing. The patient was hospitalized and diagnosed with Guillain Barre Syndrome. This case has been considered as suspected vaccination failure case since the time to onset and laboratory test confirmation was unknown. No further information was provided. No consent to follow up required.
local redness, swelling, warm to touch approx 3" diameter;no fever;mom to ice area-call if no improvement;
due to non availability of the vaccine after the first shot, i was never able to get the second one within the prescribed time frame.  i contracted shingles as a result of the shot.
This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. The patient had no pertinent medical history or drug allergies. On 07-DEC-2012, the patient was vaccinated with first dose of GARDASIL (lot # 0477AA, expiry date 29-JUN-2013 given in the left arm). On 25-JUN-2013, the patient was vaccinated with second dose of 0.5 ml GARDASIL (lot # H020901, expiry date 05-JUL-2015 given in the left arm). Concomitant therapies included Prenatal vitamins (unspecified). The patient's last menstrual period was on 28-APR-2013 and Estimated Delivery Date of 02-FEB-2014. On 25-JUN-2013, the patient had blood work done which showed that the patient was pregnant and the urine pregnancy test was positive. The patient sought medical attention. Additional information has been requested.
Information has been received from a nurse practitioner via a company representative referring to a 16 year old female patient. Concomitant therapy included MENACTRA. On an unknown date the patient was vaccinated with GARDASIL 9 dose 2, intramuscularly (dose unknown). 24 hours after the vaccination, the patient developed bells palsy. The patient called to the office to seek medical attention. It was unknown if treatment was given for the event. At the report time, the patient was recovering from the event. Upon internal review, bells palsy was considered as medically significant. Additional information has been requested.
BODY ACHES; EXPIRED VACCINE ADMINISTERED; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry date: 13-MAR-2021) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced expired vaccine administered. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and expired vaccine administered was not reported. This report was non-serious.
1 of 2 pts who devel a 12 x 15 cm induration below deltoid mins p/vax; florid red response, however no urticaria was present; uncertain if this was an allergic react or a hyperimune response;
Severe Vertigo, for the first 12 hours after onset. Dizziness still 2 days later.
At approximately 5PM on 02/08/11 (the day of the vaccine) severe fatigue set in and within two hours of that, a headache and other flulike symptoms including nausea, vomiting, sweats, chills, body aches and fever appeared.  The injection site was extremely sore to the point of not being able to lay on that side or use my arm for the first 24 hours or so before getting better.  I also experienced an unusual tightness on the sides of the neck and periodic tightness in the chest. The symptoms (with the exception of the arm, which felt better after 24 hours, but is still itchy, with a 4 inch round light red circle) continued to worsen for approximately the first 36 hours or so after the vaccine and then slowly began to lessen.  The last time I vomited was approximately 3 am on 02/10/21,  I took my temperature later that morning and it was around 101.  I was unable to eat until 02/10/21 and had half of a small papaya and continued to drink water as tolerated.  2/11/21 was the first day I was able to get out of bed without vomiting, fever and headache.  Still feeling weak, with some minor nausea, but no vomiting.  The condition has improved since 02/08/21 and appears to be continuing to improve.
Information has been received from a physician concerning a 25 year old male with post traumatic splenectomy and no other medical history who on 7/12/05 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml), in the right buttock. Concomitant therapy included amoxicillin (+) clavulanate potassium. Subsequently the patient had a severe reaction to the pneumococcal 23v polysaccharide vaccine vaccination. On 7/13/05 the patient experienced temperature of 103 F, a white blood count of 23000 and what looked to be cellulitis reaction at the injection site. The symptoms all developed within 24 hours of the vaccine so possibly a hypersensitivity reaction. The patient was admitted to the hospital and given IV broad spectrum antibiotics for the fever and chills. The patient was in the hospital for 4 days for fever and chills. The diagnosis was not made initially as the patient was recovering from a trauma at the time. Additional information has been requested. (OMIC)
Plaintiff was treated by a healthcare provider for shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unknown date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions (prophylaxis).         On an unknown date, the patient was treated by a healthcare provider for shingles. The event caused patient's hospitalized. The outcome of the event was unknown. The relationship between zoster vaccine live (ZOSTAVAX) and the event was considered as related by the reporter.   As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, Patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.
No additional information provided.; GARDASIL 9 has been administered to the patient after the excursion oc; This spontaneous report was received from a nurse prescriber and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 06-APR-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #T036444, expiration date: 09-APR-2023 (vaccination schedule, site and route of administration were not provided) for prophylaxis (product storage error). A temperature excursion evaluation was not performed at the time of reporting. The complete cumulative time and temperature details are unknown until the reporter returns the multiple excursion form that was submitted to her. No additional information provided (no adverse event).  This is one of several reports received from the same reporter.
Approximately 4 hours post vax, the patient developed a fever. The fever persisted and patient was taken to ER. Fever was 103F and patient was diagnosed with otitis media.
Patient woke up with swollen lips and face and rashes throughout body. Patient contacted the doctor and was instructed to take antihistamines. Patient didn't want to take Benadryl due to drowsiness, so I recommended Zyrtec instead, but should also take a Benadryl at bedtime. Patient did not have any problems breathing. She was instructed to contact her doctor or seek medical attention if the symptoms did not improve or got worse.
"hands and body shaken; felt onstantly thirsty; terrible chills; severe joint pain; nausea; fatigue; slide headache; sore arm; little soreness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR ("hands and body shaken), DEHYDRATION (felt onstantly thirsty), VACCINATION SITE PAIN (little soreness in injection site), FATIGUE (fatigue) and HEADACHE (slide headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included LISINOPRIL, SIMVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (little soreness in injection site). On 16-Apr-2021, the patient experienced FATIGUE (fatigue), HEADACHE (slide headache) and ARTHRALGIA (sore arm). On 17-Apr-2021, the patient experienced TREMOR ("hands and body shaken), CHILLS (terrible chills), ARTHRALGIA (severe joint pain) and NAUSEA (nausea). 17-Apr-2021, the patient experienced DEHYDRATION (felt onstantly thirsty). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 20-Mar-2021, VACCINATION SITE PAIN (little soreness in injection site) had resolved. On 17-Apr-2021, FATIGUE (fatigue), HEADACHE (slide headache) and ARTHRALGIA (sore arm) had resolved. On 18-Apr-2021, TREMOR ("hands and body shaken), DEHYDRATION (felt onstantly thirsty), CHILLS (terrible chills), ARTHRALGIA (severe joint pain) and NAUSEA (nausea) had resolved.            The action taken with the drug was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080446 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080446:FIRST DOSE
Administered  Rotavirus vaccine IM instead of PO as specified by manufacturer. No adverse effects were reported by parent.
By report, pt became difficult to arouse about 7 hrs after shot. It lasted about 6 hrs. He was seen in a local ER but reportedly recovered spontaneously and completely.
Received varicella vaccine 9 days ago has a rash on right thigh size of a dime which has grown to size of quarter in two days sensitive to touch. Prescribed mupirocin topical cream for rash.
This spontaneous report as received from a physician refers to a 82 year old female patient was graves disease, thyroid ablation, penicillin allergy and sulfa allergy. In approximately 2003, about 8 to 10 years ago, the patient was vaccinated with ZOSTAVAX (Lot number, dose and route was not provided) during "a research study that was being conducted". Concomitant therapies included thyroxine. In approximately February 2012, about 18 months ago, the patient had a "minor"outbreak of shingles "along one dermatome on the left rib" and the rash covered an area "about 3 centimeters long and 1 centimeter wide". No laboratory tests were performed. The physician reported that for this first outbreak of shingles no treatment was given and is "cleared up" very wuickly within 2 days. The physician reported that currently in 2013, the patient was having another outbreak of shingles. The patient sought medical attention; she went to an unspecified physician who prescribed acyclovir (manufacturer unknown). At the time of the report, the other shingles outbreak was recovering. Additional information has been requested.
Fatigued; Lightheadedness; Sweating; Mild fever-like symptoms; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 12Apr2021 at 09:45 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included constipation predominant irritable bowel syndrome (IBS-C). Concomitant medication included PSYLLIUM fiber capsules started on an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 22Mar2021 at 11:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 04:00, the patient woke up with mild fever-like symptoms, sweating and lightheadedness. The patient fell back asleep at 05:00 and woke up at 07:30 without symptoms, just fatigued. Therapeutic measures were not taken as a result of these events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lightheadedness, sweating, mild fever-like symptoms and fatigued was recovered on 13Apr2021.   No follow-up attempts are needed. No further information is expected.
headache and fatigue at 3:30pm day of dose; 3:00am the next day vasovagal syncope, shaking, nausea, EXTREME weakness/fatigue, stomach pains
Reporter is a retired pharmacist stating that his sister (the patient) received the PNEUMOVAX 23 vaccine approximately 2 weeks ago and is still having arm soreness today. Reporter states the patient had the PNEUMOVAX 23 vaccine administered in her ri; This spontaneous report was received from a retired Pharmacist and refers to a 79-year-old female.  The patient's medical history included  unspecified cholesterol issues, unspecified blood pressure issues, and not known surgeries. The patient's concurrent conditions were not reported. Concomitant medications included influenza vaccine (INFLUENZA VACCINE, reported as FLU SHOT). The patient has taken (unspecified) cholesterol medication in the past; however, the patient may not be on the medication any longer. The patient may also be on an (unspecified) blood pressure medication.  The reporter stated that his sister (the patient) received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered intramuscularly for prophylaxis (reported as pneumococcal disease) (strength, dose, lot #, and expiry date were not provided) in her right arm on 19-SEP-2022 (reported as approximately 2 weeks ago) and was still having arm soreness on 03-OCT-2022 (reported as today). On the same day, she had the influenza vaccine (INFLUENZA VACCINE, reported as FLU SHOT) administered in her left arm (strength, dose, route of administration, indication, lot #, and expiry date were not provided) .   The reporter advised his sister (the patient) to take ibuprofen for the soreness and advised her to report the soreness to her treating HCP. She started taking ibuprofen on 01-OCT-2022 (reported as 2 days ago) and was afraid to take more than 400 mg of ibuprofen per day.     The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2210USA006645: