chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.; immunocompromised individual received 0.25 ml as third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised individual received 0.25 ml as third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ETANERCEPT (ENBREL) for Immunocompromised.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 23-Sep-2021, the patient experienced UNDERDOSE (immunocompromised individual received 0.25 ml as third dose). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.). At the time of the report, UNDERDOSE (immunocompromised individual received 0.25 ml as third dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her first dose (0.5 ml) of Moderna COVID19 Vaccine on 03Mar2021 and second dose (0.5 ml) on 31Mar2021 and third dose (0.25 ml) on 23Sep2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient who received their first two doses and a third dose as a booster back before the guidelines were updated, at the time of reporting want to get the fourth dose. The pharmacist wanted to know if this fourth dose should be considered as the booster or the third dose. The pharmacist states that it was not really an error because the guidelines changed after the patient received their vaccines.  No treatment information provided.   This case was linked to MOD-2022-493745 (Patient Link).
chest pain, cephalgia, neck pain & swelling & erythema lt arm; chest pain began 2PM of 9JUL92 22 hrs p/Td;
I had the shot and still got shingles going on 4 was they're real bad/Suspect vaccination failure; I had the shot and still got shingles going on 4 was they're real bad; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles shot and still got shingles going on forth was they were really bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
arm only hurt a little; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (arm only hurt a little) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm only hurt a little). At the time of the report, PAIN IN EXTREMITY (arm only hurt a little) 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.   Reporter did not allow further contact
Chest pain such as tightness in chest, difficulty when breathing in hard, soreness in chest.
pt recv vax 28APR97 & 12MAY97 pt exp arthralgia which gradually abated;pt was last eval on 19MAY97 @ which time was treated w/non-steroidal anti-inflammatory med;
Daughter called and said her father was experiencing terrible body aches, headache, and chills.
First a cough that produced massive amount of mucus as I would have with a severe allergic reaction to mold.  Pain in my left arm that spread to my finger tips and upper back.  Both lasted all day.  Mucus and cough in to the next day (today).  On second day (today) severe pain in my left chest that started in the afternoon and by 6:30 pm spread to my left back.  Feels like massive muscle cramping.  Head aches on day one and the first half of day two. Head aches in spurts and lasted a short while but were intense.
ABOUT 5 MINUTES AFTER GETTING VACCINE LEFT ARM STARTED TO ITCH AND HIVES APPEARED PATIENT SAID SHE FELT FINE OTHER THAN ITCHING THEY DID NOT SPREAD TO OTHER AREAS WE PT TOOK BENADRYL AND WE OBSERVED HER IN WAITING AREA FOR 30 MINUTES HER HIVES WERE GETTING BETTER AND PT SAID FELT FINE AND WOULD CALL US IF ANYTHING ELSE OCCURED
he is having aches; discomfort; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he is having aches), DISCOMFORT (discomfort) and FATIGUE (fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced MYALGIA (he is having aches), DISCOMFORT (discomfort) and FATIGUE (fatigue). At the time of the report, MYALGIA (he is having aches), DISCOMFORT (discomfort) and FATIGUE (fatigue) outcome was unknown.            Concomitant medications includes Metoprolol, Atorvastatin, Quinapril, Lansoprazole, Solifenacin succinate, Sertraline, Baby Aspirin.  Treatment medications were not provided.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION 3/18/2023 -- RECURRENCE OF SAME SYMPTOMS
seizure-like effects; tried to speak but her brain could not process it; difficulty in speaking; having slurred speech/more episodes with her tongue and slurred speech episodes; This is a spontaneous report from a contactable nurse (reported for herself). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (lot number: not known) at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller is a 65-year-old retired nurse who took the 1st dose of the Pfizer COVID Vaccine. She experienced seizure-like effects after vaccination, in which she had difficulty in speaking, almost having slurred speech. She mentioned that she tried to speak but her brain could not process it. During the first onset, the medications prescribed to her seemed to not work, she had more episodes with her tongue and slurred speech episodes. She went from taking her medications once a day to now twice day, attributing to her regained ability to speak. She was recommended not to get the 2nd dose. She will be having an MRI and MRA and will follow up for 4 months. She is asking if this has been reported and if she should go get her 2nd dose. The outcome of all events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Currently pregnant. Got a large red splotch on my arm after my vaccine that continues to be sore.
Received Pfizer as first dose and Moderna for second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as first dose and Moderna for second dose) in a  patient of an unknown age and gender 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, 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 INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as first dose and Moderna for second dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received Pfizer as first dose and Moderna for second dose) had resolved.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Brain aneurysm (ruptured); This is a spontaneous report from a contactable consumer (patient's sister) via the Pfizer-sponsored program. A female patient of an unspecified age, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 20Mar2021, at a single dose, for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The sister reported that the patient received her first administration of the Pfizer Covid vaccine on the morning of 20Mar2021. In the early hours of 21Mar2021, the patient had a brain aneurysm (ruptured). The outcome of the event was unknown. Causality was reported as temporally related or possibly causal.   Information on the lot/batch number has been requested.
Pt experienced a burning sensation when vaccines were administered and has since experienced worsening pain in her arm and shoulder and is unable to lift her arm more than 45 degrees.
Loss of sensibility in the left side of the face; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Loss of sensibility in the left side of the face) 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 No adverse event (No relevant medical history provided).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced FACIAL PARALYSIS (Loss of sensibility in the left side of the face) (seriousness criterion medically significant). On 19-Mar-2021, FACIAL PARALYSIS (Loss of sensibility in the left side of the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.  This case concerns an adult female with a serious unexpected event of facial paralysis. Event onset 15 minutes after the first dose of mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an adult female with a serious unexpected event of facial paralysis. Event onset 15 minutes after the first dose of mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Right arm red, swollen, hot to touch from injection site to elbow. Patient was nausea and vomited Monday.
Soon after the injection of H1N1, patient felt faint and fell to the floor passed out, but came to very quickly. He had to lay down 10-15 mins before he felt better.
Vaccine administered 2/26/08.  Patient presented to clinic on 2/27/08 with area of redness and induration at site of Varicella #2 administration.  (Induration 5/8").  Also complained of itching.  On 2/28/08 size of induration had increased to 15/8" but less itch c/o.
Patient reported that he started having body ache, fatigue, loss of appetite same day he received the vaccine... 12/09 he was on the bathroom floor feeling he was about to pass out and very nauseous.. He feels very weak and shaky
Pt recvd vax 26FEB92 in AM c/o t102 oral @ 3PM chills, vomiting; mom called MD spoke to nurse stated probable bad rxn to shot according to MD; meds called in; illness resolved 27FEB92;
Information has been received from a register nurse concerning a 12 year old female patient with asthma who on 07-OCT-1998 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# not reported). On 02-JAN-2008, the patient was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (658999/1490U). Concomitant therapy included albuterol and FLOVENT. On 16-MAY-2010 the patient developed chickenpox. The patient was seen at the office today with a 3 day history of fever of 102F, rash that appeared yesterday, with approximately 50 to 100 lesions. The nurse said that no treatment was given just verbal precautions to parent to watch for infection. At the time of this report, the patient was recovering. Follow up information has been received from the nurse who reported that on 02-JAN-2008, the patient was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Merck) (658999/1490U) into the left arm. On 16-MAY-2010, the patient was seen in office after 3 days history of nausea, temperature 102F and rash that started on 18-MAY-2010. It was noted that the patient have approximately 50 scattered erythematous papules on the trunk, face and extremities, viral culture were performed and result was positive for varicella. There were no illnesses at time of vaccination. At the time of this report, the patient had recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with Merck vaccine strain. A lesion sample was collected on 19-MAY-2010. The sample was taken from upper chest. On 20-MAY-2010, the sample was sent to the laboratory. The herpes simplex/varicella zoster rapid culture was performed on 25-MAY-2010 and its result was "not isolated" VZV rapid culture was also performed on the same day with result "varicella zoster isolated". Additional information is not expected.
Student came to office and reported visual and tactile hallucinations of an "animal, like a cat" repeatedly running through visual field. When animal left his visual field he would feel scratching on his right back shoulder. Student reported this was happening multiple times about "every 5 minutes". School Nurse called his mom. She picked him up. Mom reported she would contact his doctor.
I experienced a breakthrough case of COVID-19 with the following symptoms: stuffy nose, sore arm, sore throat and a severe cough.
Swelling in upper lip. Took 50mg Benadryl. Seen in Emergency Department at 4:02 PM given 125 mg Solu Medrol IV, Zyrtec 10mg, p.o. with Pepcid 20mg
MUSCLE WEAKNESS, WEAKNESS IN USE OF THE ARM; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (unspecified manufacturer) on an unspecified date.  The patient subsequently received  covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, 1 in total, administered on 26-OCT-2021 as a booster for prophylactic vaccination on her left arm (dose series 2). No concomitant medications were reported.  On 02-NOV-2021, the patient experienced muscle weakness, weakness in use of the arm and pain at injection site. Patient stated that after about a week her arm pain and muscle weakness became progressively worse.  Patient stated that she had not taken any medication or treatment for this condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, and muscle weakness, weakness in use of the arm. This report was non-serious.
Headache, Myalgia & Fever  Narrative:  Fever, Headaches, Body aches ,cold sweats
PHANTOM SMELLS OF CIGARETTE SMOKE; GIVES A HEADS; 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, and batch number were not reported) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced phantom smells of cigarette smoke. On MAR-2021, the subject experienced gives a heads. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from phantom smells of cigarette smoke, and the outcome of gives a heads was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, since 08-DEC-2015, the patients were vaccinated with unspecified number of improperly stored doses of oral, ROTATEQ (lot # L008057, expiration date 01-DEC-2016) (strength was not reported) by oral route. There was no concomitant medication reported. The reporter stated that the oral, ROTATEQ, were exposed at 32 degrees F (also reported as 31 degrees F) during 2 hours 30 minutes. No adverse effect was reported and no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Dose #1 Moderna 01/25/2021 lot # 029K20A  Pt died in hospice care on 8/9/2021
NECK PAIN; TROUBLE IN MOVING; TINGLING SENSATION; SORENESS IN RIGHT ARM; CHILLS; WEAKNESS; FEVER; DIZZINESS; FEELING ACHY; FEELING FREEZING; DIARRHEA (3 LOOSE BOWEL MOVEMENT); This spontaneous report received from a patient concerned a 31 year old male. The patient's weight was 180 pounds, and height was 182 centimeters. The patient's concurrent conditions included non-smoker, and abstains from alcohol, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced feeling achy. On 10-APR-2021, the subject experienced feeling freezing. On 10-APR-2021, the subject experienced diarrhea (3 loose bowel movement). On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 F. On 13-APR-2021, the subject experienced neck pain. On 13-APR-2021, the subject experienced trouble in moving. On 13-APR-2021, the subject experienced tingling sensation. On 13-APR-2021, the subject experienced soreness in right arm. Laboratory data (dates unspecified) included: Pain scale (NR: not provided) 7/10. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling freezing, diarrhea (3 loose bowel movement), chills, and fever on 12-APR-2021, had not recovered from feeling achy, dizziness, weakness, neck pain, and soreness in right arm, and the outcome of tingling sensation and trouble in moving was not reported. This report was non-serious.