chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Coughing; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and HEADACHE (Headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headaches cluster on 13-Apr-2021 and Coughing on 13-Apr-2021.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced COUGH (Coughing) and HEADACHE (Headaches). At the time of the report, COUGH (Coughing) and HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants and treatments were not reported. Treatment include bed rest. Patient undergone an unknown surgery.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received and contains significant information. Updated Non drug treatment and surgery.
After the next day when I woke up I started getting itchy and got worse and worse. I do have a picture of it. My back was all red, It only stayed in that area. I was going to physical therapy to use heat lamp for cirrhosis. I would never take another shot.
Information has been received from a physician concern a 3 month old patient who was vaccinated with RotaTeq vaccine (Lot not provided). Subsequently, the patient experienced Kawasaki disease and was hospitalized. Additional information has been requested. This is one of several reports from the same source.
Information has been received from a newspaper article concerning a 14 year old "very healthy, athletic" female with no previous reaction to shots who on an unspecified date was vaccinated with Gardasil.  The patient was concomitantly vaccinated with meningococcal vaccine (unspecified).  The patient immediately fainted and had a seizure.  The outcome was unknown.  Upon internal review, the patient's seizure was considered an other important medical event.  Additional information is not expected.
Information has been received from a physician concerning a female who was vaccinated with an unspecified dose of GARDASIL (lot# not reported) and was found to be positive for HPV.  Also another report was mentioned about a different patient who was vaccinated with an unspecified dose of GARDASIL (lot# not reported) and fainted in the elevator.  The patient's outcomes were note reported.  A phone call was placed on 08-APR-2008 to obtain patient identifiers.  Additional information has been requested.
little localized reaction; a little red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Previously administered products included for Drug use for unknown indication: Skelaxin and Influenza vaccine (Gets the flu shot every year). Past adverse reactions to the above products included Hives with Skelaxin; and No adverse event with Influenza vaccine. Concurrent medical conditions included Drug allergy (Allergy to Reglan), Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to phenothiazines (Compazine, Mellaril)), Drug allergy (Allergy to codeine), Drug allergy (Allergy to Flexeril), Drug allergy (Allergy to Flagyl), Drug allergy (Allergy to hydrocodone), Drug allergy (Allergy to oxycodone), Drug allergy (Allergy to Skelaxin (hives)), Drug allergy (Allergy to Dilaudid) and Drug allergy (Allergy to Imitrex).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-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 VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red). At the time of the report, VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red) outcome was unknown.            No concomitant medications were reported. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient had a question about ingredients in the vaccine. She received the first two series of Moderna vaccine and had no real problem. She had a little localized reaction, a little red, but no fever. The patient explained that she gets the flu shot every year, and she's never had a reaction.  No treatment medications was reported.   This case was linked to MOD-2022-654193, MOD-2022-654194 (Patient Link).
10/12/20 - initially swelling/warm to touch around injection site  10/14/20 - swelling expanded past injection site to elbow area
30 year old male received his 2nd dose Pfizer covid vaccine on 5/12/21. Client reported that 2 days after receiving the covid vaccine he developed a rash and itchiness that covered both of his arms. He took benadryl at home and stated that it did not have any effect. He denied shortness of breath, swelling, or chest pain. Client did not follow up with PCP or emergency care.  Client stated that the rash and itchiness lasted for 2-3 weeks and then resolved on its own.
Information has been received from a pharmacist concerning afemale with itchy scalp and itchy head who on 15-SEP-2007 was vaccinated with Zostavax (Lot # 657559/0462U) 0.65 ml dose. No information was provided with regard to the patient's medical history and concomitant therapy. On 16-SEP-2007 the patient developed an unspecified rash on her scalp and neck. The patient noted that the areas were itchy prior to the administration of the vaccine. The patient contacted the physician. The patient outcome was not reported. Additional information has been requested.
Uncontrollable sobbing, no appetite not, not wanting to be held, throwing objects, arching back, shivering fits (as if someone was walking over her grave) 8-10 times a day whilst awake continuing to date with same severity.
This spontaneous report has been received from a consumer, a male, 68 years old patient with drug reactions/allergies to KEFLEX with none pertinent medical history who was referring to himself. In approximately September 2012, reported as about a year ago, the patient was vaccinated with ZOSTAVAX (lot# not reported) injection (strength, dose, route not reported) one time. Concomitant therapies included prednisone (manufacturer unknown) and COLCRYS. It was reported that approximately in June 2013, reported as 3 months ago, the patient developed shingles and experienced rash to the right of the eye that was mildly painful and painful bumps in his head. Routine blood work was performed, no results provided. The patient sought medical attention by seeing the dermatologist every 3 months. It was reported that the patient was treated with valacyclovir hydrochloride but the shingles did not fully go away. The outcome of developed shingles, rash to the right of the eye and painful bumps in his  head was reported as recovering/resolving. The reporter did not assess the relatedness between the ZOSTAVAX and the adverse events. Additional information has been requested.
Initial report received on 17 February 2009 from another manufacturer as part of a study for which sanofi pasteur is not a sponsor. The following is verbatim per the report: "She is an 11-year-old female who presented to the urgent care clinic for worsening of left knee pain. Patient states that on November 13, Thursday night, she suffered trauma to her left knee/leg while wrestling with her brother. The following morning, she went to school, and was sent home with a temperature of 101. Patient was limping slightly. On November 15, Saturday morning, the patient presented to the ED with a fever of 104.7. In the ED, the patient received a lumbar puncture for concerns of meningitis. Patient was complaining of headache, nausea and dizziness. Patient was sent home from ED on Motrin, and encouraged p.o. intake. Patient continued to have left knee pain to the point she could not bear weight on it. She continued to have fevers, and came back to the ED on Sunday. The patient was examined, evaluated, and discharged home again. Patient continued to have symptoms that progressed overnight. Patient came to the urgent care clinic for worsening of left knee pain. The pain was sharp, located to bilateral joint line, tender to touch. It was 10 out of 10, nonradiating. It is worse with movement, worse on passive flexion and extension. Some relief has bee noted with application of [rest, ice, compression and elevation] (RICE). Mom states the left knee was swollen, warm to touch, and tender. In the urgent care clinic, patient was evaluated. Plain films were taken, and it was decided that the patient, for persistence of fevers x5 days and severe left knee pain, was concerns for septic arthritis. The subject was hospitalized from November 17 to November 26, 2008. Subject had methicillin resistant S. aureus bacteremia and osteomyelitis of her distal left femur. She underwent incision and drainage of her osteomyelitis in the left distal femur. She had a PIC line placed in the right arm for home antibiotic therapy which consisted of clindamycin 600 mg every 8 hours and gentamicin 340 mg every 24 hours. Subsequently because of rising creatinine levels, gentamicin was stopped and rifampin 300 mg twice a day was begun. The subject denied knee pain, fever or other complaints on her last follow-up visit on January 7, 2009. Her incision had healed well, she had normal range of motion of the left knee, CPR was undetectable and her sedimentation rate was 17." The subject had no past medical history and had not been taking any concomitant medications. The final diagnosis was determined to have been Methicillin resistant S. aureus osteomyelitis with bacteremia. The patient (ID number 1-08-03283) had received FLUZONE on 14 October 2008. The date of the SAE was reported as 17 November 2008. The event was considered by the investigator to be serious and unexpected, and not related to either FLUMIST or FLUZONE. The reporter for this case is the same as in case number 2009-00623.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypoglycemia since 05-Jan-2005. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Acid reflux (esophageal), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from an unknown date to 13-Jun-2021 for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 15-Sep-2020 and the estimated date of delivery was 19-Jun-2021. On 09-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The vaginal delivery occurred on 13-Jun-2021, which was reported as Full-term. For neonate 1, with an APGAR score of 8 at 1 minute. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, Ultrasound antenatal screen: inconclusive (Inconclusive) Single fetus implanted in uterus, regular heartbeat. On 07-Jan-2021, Prenatal screening test: inconclusive (Inconclusive) Fetus is female, no likelihood of genetic disorders detected.. On 10-Feb-2021, Ultrasound scan abnormal: normal (normal) Anatomy scan-No problems detected.. On 30-Mar-2021, Glucose tolerance test: normal (normal) No gestational diabetes..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient date of positive pregnancy was 17-OCT-2021.Patient received prenatal care during pregnancy from a local hospital. Number of fetus was 1.Patient had prior history of alcohol use 4 drinks/ weeks. and stop date is 17-OCT-2020. Treatment information was not provided.   This case was linked to MOD-2021-239414 (Parent-Child Link).   See case MOD-2021-239414 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up information received on 28-JUN-2021 contains significant information.Pregnancy details added. Medical history added. Lab data added. Patient's ethnicity added.
Sore Arm; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), HEADACHE (Headache) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm), HEADACHE (Headache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore Arm), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is taking concomitant medication , But not provided by Reporter.
shingrix was administered to an 8 month old baby today; shingrix was administered to an 8 month old baby today; This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 8-month-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2021, the patient received Shingrix. On 10th March 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were reported as follows: The shingrix was administered to an 8 month old patient, which led to inappropriate age at vaccine administration and wrong vaccine administration. No additional details were available at the time of reporting. The reporter was an License PR actioner Nurse in the practice requested to speak with GlaxoSmithKline medical information urgently. The reporter consented to follow up.  Note: The event wrong vaccine administered was captured conservatively in case because it seems that patient visit to received another vaccine but instead got shingrix. Clarification has been raised for same.   Follow up information was received from nurse on 21st April 2021: Patient's demographics details was reported. VAERS details was updated.
Felt bad; Temperature has been 101.6°F; Sick; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), ILLNESS (Sick) and PYREXIA (Temperature has been 101.6°F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 032B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included Dialysis. Concurrent medical conditions included Immune system disorder.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Oct-2021, the patient experienced FEELING ABNORMAL (Felt bad) and PYREXIA (Temperature has been 101.6°F). In October 2021, the patient experienced ILLNESS (Sick). At the time of the report, FEELING ABNORMAL (Felt bad), ILLNESS (Sick) and PYREXIA (Temperature has been 101.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Oct-2021, Body temperature: 101.6°f (High) since 6am.         No concomitant medication information was mentioned by reporter  Patient take around 40 medications for several heath conditions, including immune diseases.  Treatment medication was not reported.  Patient states they were recently in the hospital to have their bladder removed (10Sep2021), and had an infection with a bacteria from taking a lot of antibiotics.  Company Comment: This case concerns a 63-year-old female patient with no relevant medical history, who experienced the serious unexpected event of bladder disorder. The event occurred 176 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-356595 (Patient Link).
Shingles vaccine rec'd in January, the tech jammed the needle in my arm.  I just know that my arm kept hurting and when I finally looked at it, my arm was black, I cannot lay on my left side because the pain it too intense.  The pain is in my arm and not in my joint so I don't think its arthritis, I just don't know.
pt recv vax 16OCT95 & that evening devel a sore throat & fever;w/in 48hr devel laryngitis, chills & congestion;fever & chills have subsided;other sx are subsiding;
fever; chills; This is a spontaneous report from a Pfizer-sponsored. A contactable Male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number not reported), via unknown route of administration as a single dose on 02Apr2021 for covid 19 immunisation. The patient historical vaccine included first dose of BNT162B2 the vaccine on 12MAR2021. Medical history and concomitant medications were not reported. On 02Apr2021, patient reported having fever and chills after receiving second dose. The patient said that the vaccination provider told him that he can take Tylenol.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient reported hives on feet/hands/extremities that appeared 5-7 days after receiving vaccine.
heart racing; heart skipping; dizziness; rise in blood pressure to 170; Pulse in the 70 S/erratic heart rhythm; erratic heart rythm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm) and PALPITATIONS (heart racing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Allergy NOS since an unknown date. Concurrent medical conditions included Anaphylactic reaction (2 out of the three allergies are listed as anaphylactic). Concomitant products included CEFALEXIN (CEPHALEXIN AMEL), THIAMINE HYDROCHLORIDE (HYDROCHLORIDE B1), ATORVASTATIN CALCIUM (LIPITOR), PANTOPRAZOLE, FAMOTIDINE (PEPCID AC), CLOPIDOGREL BISULFATE (PLAVIX), DOXEPIN HYDROCHLORIDE (SILENOR), ATENOLOL (TENORMIN) and METFORMIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm) and HEART RATE IRREGULAR (heart skipping). On an unknown date, the patient experienced PALPITATIONS (heart racing). At the time of the report, DIZZINESS (dizziness), HYPERTENSION (rise in blood pressure to 170), PULSE ABNORMAL (Pulse in the 70 S/erratic heart rhythm), HEART RATE ABNORMAL (erratic heart rythm), PALPITATIONS (heart racing) and HEART RATE IRREGULAR (heart skipping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170 (High) 170. On an unknown date, Heart rate: 70 (Low) 70.         Information about treatment was not provided. Action taken with the mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021,the patient confirmed the first dose events and second dose related events given.
Rash; Rash, progressing to allergic hives on trunk, legs, arms within the 3 days after my second COVID shot; Also, extreme fatigue; Increase of existing tinnitus; This is a spontaneous report from a contactable pharmacist, the patient. A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 13:30 (at the age of 66-year-old) as a single dose for COVID-19 immunization. Medical history included seasonal and environmental allergies, increased cholesterol, dust allergy, pollen allergy, bee sting allergy and egg yolks allergy. Concomitant medications included montelukast sodium (SINGULAIR) , rosuvastatin calcium (CRESTOR) , zeaxanthin (LUTEIN) and vitamin d nos (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 65-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 02Apr2021, the patient experienced rash, progressing to allergic hives on trunk, legs, arms within the 3 days after the second COVID shot. The patient also experienced extreme fatigue and increase of existing tinnitus on 02Apr2021.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of  the events which included treatment with diphenhydramine (BENADRYL) 50 mg every 4 hours from an unknown date. The clinical outcome of the events rash, progressing to allergic hives on trunk, legs, arms within the 3 days after the second COVID shot, extreme fatigue and increase of existing tinnitus was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
pt recvd vax; fever of 104 on 29nov95; onset of gen sz on 30nov95;dilatin & phenobarb infusions,intubation for post itcal apnea;sz occured over 4 1/2 hr period;febrile sz x 3 at 9mo;szs associated w/ fever;