chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse / illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from headache. This report was non-serious.
sore arm; overnight headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and HEADACHE (overnight headache) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm) and HEADACHE (overnight headache). At the time of the report, MYALGIA (sore arm) and HEADACHE (overnight headache) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Loss of taste; Back pain; neck pain; Fatigue; Headaches; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history was reported as The patient had allergy to penicillins.  The patient did not receive other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 08:00 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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 09:00 the patient experienced loss of taste, back and neck pain, fatigue, headaches and nausea. The events resulted in emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 28Apr2021 and on 03May2021, the patient underwent COVID-19 PCR tests (nasal swab) and the results were negative. The clinical outcome of the events loss of taste, back and neck pain, fatigue, headaches and nausea were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated treatment received as no and medical history data.
feeling "sick" and she ran to the bathroom; she could not breathe; headache; chills; fever; felt like cotton balls were shoved in her mouth and it felt like someone put their hand on throat and started squeezing; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included allergy to shellfish, asthma and she did have covid last year in 2020 and the pharmacist told her that she would probably react more strongly to the first dose in regard to symptoms. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced 20 minutes after receiving her first dose she started feeling "sick" and she ran to the bathroom, felt like cotton balls were shoved in her mouth and it felt like someone put their hand on throat and started squeezing, she has had experiences like this before when she could not breathe so she knew what was happening. She quickly took 2 Benadryl and used her rescue inhaler and had her husband drive her to the urgent care. However, the Benadryl and rescue inhaler did resolve her symptoms. She also reports 22 hours later she started to experience the "expected side effects" including; headache, chills and fever. The events were reported as non-serious. Therapeutic measures were taken for the events. Outcome of the events feeling "sick" and she ran to the bathroom, she could not breathe, felt like cotton balls were shoved in her mouth and it felt like someone put their hand on throat and started squeezing was recovered and headache, chills, fever was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 6/12/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE  ACUTE NON ST ELEVATION MI 6/1/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE  HYPOTENSION 6/14/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE  ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 6/12/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ACUTE NON ST ELEVATION MI 6/1/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  HYPOTENSION 6/14/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA  ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 6/12/2021 CHF, STAGE C, UNSPECIFIED  ACUTE NON ST ELEVATION MI 6/1/2021 CHF, STAGE C, UNSPECIFIED  HYPOTENSION 6/14/2021 CHF, STAGE C, UNSPECIFIED  ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE 6/12/2021 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY  ACUTE NON ST ELEVATION MI 6/1/2021 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY  HYPOTENSION 6/14/2021 HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 72 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor was Product Quality Complaint (PQC) involved. This is one of several cases received from the same reporter. Additional information has been requested.
Pt had series in 10/98 and last series in 6/99. After receiving last vaccine scheduled, extreme skin swelling and rash.
I was on vacation between 3/16/2022 and 3/22/2022. On 3/21/2022, I took a PCR test, and the result was negative. On 3/22/2022, I flew back home, and I wore a mask during the entire flight. On the evening of 3/23/2022, I had flu-like symptoms. I took an at-home COVID test on 3/24/2022, and the result was positive; I had a breakthrough case. I called my doctor that day, and he prescribed me a 5-day supply of a Merck medication whose name I forget. I never developed a fever, though I did have a cough. The doctor prescribed me some capsules to treat the cough, and I took them for 3 days until my cough improved. I took another at-home COVID test on 4/2/2022, and the result was negative.
Patient received lower dose than what is recommended for dose 2 of the primary COVID vaccine series for her age.  She received the Moderna Bivalent Booster vaccine for 6mon-5yrs.  It is recommended that she receive the Moderna Bivalent vaccine for 6mon and older (Primary series).  Therefore, the patient received a lower dose than recommended.
Seriousness criteria other medically significant (OMIC) and persistent or significant disability incapacity. Initial report received on 9/28/06 from the pts spouse. A 53 year old male pt, with a medical history of allergies, received a right deltoid injection of Adacel, lot number unk, on an unspecified day in Aug 2006. One week post vaccination, the pt developed viral syndrome, lung congestion, wheezing, night sweats, dizziness and was clammy. He was unable to work due to fatigue. The pt was examined by a physician over several visits. Testing for tuberculosis and mononucleosis was neg. He was treated with steroids, albuterol and antibiotics (trade names and routes of administration not reported). At the time of this report, the pt had not recovered.
Numbness and tingling of hands and feet, autonomic dysfunction, facial flushing, diagnosed with Small Fiber Neuropathy in Jan 2022.
Inflamation on the left side of the neck; Pain at the injection site; Swelling; Pain in the axillary; Swelling in the axillary nodes; Chills; Pain in the arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY, INFLAMMATION, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, and AXILLARY PAIN in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OJ20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM for Prophylaxis.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced PAIN IN EXTREMITY, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, AXILLARY PAIN, LYMPHADENOPATHY, and CHILLS. On 28-Dec-2020, the patient experienced INFLAMMATION. At the time of the report, PAIN IN EXTREMITY, INFLAMMATION, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, AXILLARY PAIN, LYMPHADENOPATHY, and CHILLS 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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a pharmacist concerning an unspecified number of patients of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-JUN-2018, the unspecified patients were inadvertently vaccinated with an expired properly stored dose of PNEUMOVAX 23 injection, lot # M037669, expiry date: 09-MAY-2018 for prophylaxis (strength, dose, route, anatomical location and dosage schedule were not provided) (expired product administered). No adverse effects were reported. No product quality complaint (PQC) was reported. Upon receipt of follow-up information received on 07-SEP-2018 it was determined that this case is now valid because the registered pharmacist confirmed that two patients received the vaccines on 02-JUN-2018 (MARRS: 1809USA006237). On 02-JUN-2018, a 66 year old patient was inadvertently vaccinated with an expired properly stored dose of PNEUMOVAX 23. Sender's Comments: US-009507513-1809USA006237.
Patient was 17 at the time of injection.  It was noted when patient was scheduled for his second dose.  No issues from his first dose from what we are aware of.  Patient was seen at one of our COVID clinics.  Patient is coming back today 5/24 for his second dose per the CDC guidelines for children under 17 who have received Moderna before their 18th birthday.
Teeth chattering/ Chills; Headache; Tiredness; Muscle pain; Joint pain; 101 fever; Sweating; Soreness in the arm; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 13:00 (at the age of 55-year-old) at a single dose for COVID-19 immunisation. Patient medical history included thyroid and blood pressure from years and it was still ongoing. Concomitant medications included ongoing levothyroxine sodium (LEVOXYL) for thyroid and ongoing lisinopril for blood pressure. The patient did not receive any other vaccines within four weeks prior to the first date of vaccination. Patient historical vaccine included first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267) via an unspecified route of administration, administered in left arm on 14Feb2021 at 13:00 at a single dose for COVID-19 immunisation. On an unspecified date in 2021, the patient experienced headache, tiredness, chills/teeth chattering, muscle pain, joint pain, 101 fever, sweating and soreness in the arm. The outcome of the events was unknown.  Information on the lot/batch number already available. Other information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild
Approximately one hour after receiving vaccine patient noted onset fatigue and lightheadedness. Approximately six hours after receiving vaccine he noted onset of back spasms (upper greater than lower) and chest tightness which he felt caused him to feel shortness of breath. He reports feeling anxious, skin crawling, hot and cold flashes, racing heart rate, and sweating. These symptoms lasted for several hours and slowly resolved without treatment. He denies cutaneous, laryngeal, and GI symptoms.
patient passed out after receiving the flu shot and covid booster. we moved her to the floor and bent her knees, and she started to come to
Patient developed spots on left arm. Clinic revisit showed patient had redness and swelling of left upper arm that was warm to the touch.
pt recv vax 17MAY95 & 14MAY97 pt devel four lesions on scalp & around hairline, seven on face, three on neck, eight on trunk, thirteen on back & buttocks, one on foot, & two on lt leg;pt recovered;
Narrative: an error occurred while dispensing the Moderna bivalent booster 10/5/22 at the vaccine clinic, he was given half a dose of the vaccine which is 0.25 ml instead of 0.5 ml.
Dose schedule was interrupted / The patient received first dose of GARDASIL 9 on 12/12/2020 and the patient is in the pharmacy now to get the second dose but did not get the dose yet.; This spontaneous report was received from a pharmacist referring to a patient of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 12-DEC-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot number, and expiration date was not reported) for prophylaxis.  The reporter mentioned that the patient's hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose schedule was interrupted and that on 07-JUN-2021, also reported as "now", the patient was in the pharmacy to get the second dose but did not get the dose yet. No product quality complaint and no further information was available.
Seriousness criteria other medically significant (OMIC). Initial report received on 1/9/06 from the pt. A 64 year old male pt, with no concurrent illnesses, know allergies, or reported medical history, but who was taking Atacand, had received a right deltoid dose of Influenza vaccine, lot number unk, in either Nov or Dec 2005. The route of administration was not reported. Twenty four hours post immunization, the pt developed a reddened area that scabbed and then turned red (site not reported). He was recently evaluated by a dermatologist who diagnosed him with skin cancer. He also recently had a biopsy done. The result of the biopsy was not reported. Diagnostics performed and treatments received were not reported. At the time of this report, the pts recovery status was unk.
SORE ARM; TWITCHING OF ARM/MINOR TWITCHING ALL OVER THE BODY(FEET, LEGS, BACK); This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 112 pounds, and height was 60.5 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced twitching of arm/minor twitching all over the body (feet, legs, back). On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and had not recovered from twitching of arm/minor twitching all over the body(feet, legs, back). This report was non-serious.
My son got his 2 month vaccines yesterday in the exception of the Hep B vaccine. All of his stools are now green, with mucous and streaks of blood in them. He has had a fever since the vaccine 100.3F. I'm a breastfeeding mom and only introduced formula to his diet less than 2 weeks ago. He has formula (Instant Similac Advance) only once or twice a day (2-8ounces/day). I've only had Almond milk this week and so it's highly unlikely my little one has a milk allergy as the doctor suggested when I returned to report the reaction today.
administered only the adjuvant; administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administered only the adjuvant part of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up. The reporter did not want follow up as it did not happen at her pharmacy and she had no other details.
Patient is a 86 y.o. male who presents today with weakness . pmh dm2, htn, cad, afib anticoagulated with Eliquis. Presented to ed with dtr ( not currently present) . Hx obtained from medical record. Noted wife and primary care provider of patient ill at home dx with covid x7 days ago. Both ill for extended time frame for several weeks prior. Dtr brought in due to progressive generalized weakness and fatigue. Notes now unable to stand or get to bathroom. Notes of urinating on self in chair due to inability to get to br . He denies cough or sputum production . Denies shortness of breath. No co chest pian , dizziness . Denies n,v, no diarrhea or constipation ,no melena or hematochezia . States one week ago thinks he had food poisoning with n,v, and some diarrhea though all now improved. States since then has progressively become weak . Denies focal weakness , numbness or tingling .    In ed cxr with no infiltrate, was not hypoxic and continued on room air. Found to be at baseline renal function of creat near 2.00. anemia also noted appearing chronic with stable hemoglobin . Glucose elevated at 246 . Notes was unable to stand in ed .
This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had problems with her heart. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced heart palpitations that come and go. Laboratory data (dates unspecified) included: EKG (NR: not provided) Not reported, and Lab test (NR: not provided) not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations that come and go on NOV-2021. This report was non-serious.
This spontaneous report was received from a health care worker (certified medical assistant) refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. The reporter stated that, the patient was inadvertently vaccinated with an expired dose of MMR II lot # K005574, expiry date 17-APR-2016 on 23-APR-2016 (dose, strength, vaccination site, route unspecified). No adverse effects were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Headache, sore throat, productive cough, fever, chills, body aches, sinus congestion, post nasal drainage, chest congestion, itchy eyes, ear fullness.
16SEP92 fainted when MMR given c/o foot hurting; nausea; BP 80/46 then 110/68, pulse 60 then 88; initially pale then color returned; 17SEP92 running fever 100-101, foot pain; c/o h/a, stiff neck, vomited x 1, t102.6, no eating or drinking;
Patient received expired vaccine with beyond use date of 8/14/23.  Vaccine was given on 8/16/23 around 10:30am but should have been discarded 58hrs prior.
pt has ahd arm related pain since a few days after her vaccine was administered and it is not getting better
WRONG ROUTE OF ADMINISTRATION; OFF LABEL USE; NO ADVERSE EVENT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 15:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021 15:00, the subject experienced wrong route of administration. On 01-APR-2021 15:00, the subject experienced off label use. On 01-APR-2021 15:00, the subject experienced no adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong route of administration, off label use and no adverse event was not reported. This report was non-serious.
Information has been received from a certified medical assistant concerning a male patient (age unknown) who was vaccinated on an unspecified date with a dose of Pneumovax 23 (655289/0958F). Subsequently, on an unspecified date, the patient developed injection site redness and swelling and experienced a decreased range of motion of the arm. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint involved. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the agency and was released. Additional information has been requested.