chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 03-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Began my menstrual period. I have not had a period in over two years due to pregnancy, breast feeding, and birth control.
LEFT LEG NUMBNESS; LEFT FOOT FEELING OF WEIGHTLESSNESS; LEFT ARM AND HAND TINGLING; TONGUE NUMBNESS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included psoriasis, and non smoker. The patient was previously treated with apremilast for psoriasis; and experienced hives and local inflammatory response when treated with progesterone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 10:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced left arm and hand tingling. On 05-APR-2021, the subject experienced tongue numbness. On 05-APR-2021 11:45, the subject experienced left leg numbness. On 05-APR-2021 11:45, the subject experienced left foot feeling of weightlessness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left leg numbness, left foot feeling of weightlessness, and tongue numbness on 05-APR-2021, and was recovering from left arm and hand tingling. This report was non-serious.
Hyperactivity, Defiant, Angry, Trouble focusing. Was diagnosed with Aspergers one week after MMR Vaccination.
Joint pain; Soreness in the arm; Temperature went up to like 101 degrees/fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), lot number: EH9899, via an unspecified route of administration on 23Jan2021 as single dose for COVID-19 immunization.  Medical history included none.  There were no concomitant medications. The patient stated he had the COVID shot a week ago and as of now, he has no symptoms until the soreness in the arm but that was natural. The patient had joint pain starting yesterday, day before and today like it was his temperature, it went up to like 101 degrees. The patient was asking if that is normal. The patient stated the fever was today which is 29Jan2021 and still experiencing.  The patient took couple Tylenol. The outcome of the event fever was not recovered as of reporting time; while the other events was unknown.
Information has been received from a physician concerning an 18 month old female with no allergies or medical history and no history of chickenpox or recent exposure to chickenpox or herpes zoster who on 15-MAR-2006 was vaccinated with a 0.5 mL dose of Varivax. The lot number was unknown because the vaccine was administered by a different doctor's office. There was no concomitant medication. On 05-OCT-2006, the patient presented to the doctor's office with shingles or herpes zoster rash. The rash was on the left buttock and thigh of the child and she had no pain. No diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. Herpes zoster started on 05-OCT-2006 and was described as "left S1 dermatone-dozens of lesions and left sacrum running down lateral thigh-blisters and papules." The maximum temperature was 98.4. A direct fluorescent antibody was not done. There was no other systemic symptoms and the patient recovered.
-Large, red, painful rash that spread over right arm (most of the upper arm). Occurred within 24 hours per patient. Follow up reported a bacterial infection. Pt was given antibiotics.  - Right area only affected - Spread to lower arm - Went back to MD - Stayed on Keflex 500mg TID. - Patient said second MD thought it may have been allergy and not an infection.
The adverse event is that the Covid vaccine was administered too early in age. The patient is only 5 months and 2 weeks old, not a full 6 months of age, as instructed should be at time of administration.
Pt reported a flushing feeling, then tightness in her chest; given 50 mg of diphenhydramine, then 0.3 mg of epinephrine IM.  Pt's symptoms resolved.  No further incidents
Itchy painful bump within 1 hour of injection lasting until present time (1 week). Fatigue for 2 days.
2/25/21 swelling and redden around arm.  On 2/26/21 headache, body aches, chills and fever - 102.
developed chest pain with radiation into axilla, shoulder, scapula and down the arm; axilla discomfort; arm discomfort; Pain felt similar to sciatica; a full nagging pain and the muscles of my arm are fatigued from constant tension; a full nagging pain and the muscles of my arm are fatigued from constant tension; This is a spontaneous report from a contactable Nurse reported for herself. This 44-year-old female Nurse (patient) receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1685), via an unspecified route of administration on 22Dec2020 09:30 at single dose on left arm for Covid-19 immunisation. There was no known allergies, medical history nor concomitant medications. Prior to vaccination, it was not unknown if the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 4 days following the vaccination on 26Dec2020 18:00, the patient developed chest pain with radiation into axilla, shoulder, scapula and down the arm. The chest pain and axilla discomfort subsided but the arm discomfort continued and intensified. Pain felt similar to sciatica. The patient took ibuprofen and paracetamol (TYLENOL) also placed ice pack under her arm and on top of shoulder. The following day the patient started on a methylprednisolone (MEDROL) dose pack. The patient received minor relief with the steroids and NSAIDs after 2 days she took a gabapentin (NEURONTIN) which was given to me by a family member. The gabapentin had given the most benefit. On day 4, the patient continue to have a full nagging pain and the muscles of her arm are fatigued from constant tension. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.
unconsolable crying;fever 103;vomiting;redness, swelling, steak @ inj site;
feeling little dizzy when she stand up fast; felt dizzy and couldn't even stand and could fall; itching in her left arm few days after the 2nd dose; Little red rash in her left arm after the 2nd dose; Little chilling after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (feeling little dizzy when she stand up fast), RASH ERYTHEMATOUS (Little red rash in her left arm after the 2nd dose), DIZZINESS (felt dizzy and couldn't even stand and could fall), PRURITUS (itching in her left arm few days after the 2nd dose) and CHILLS (Little chilling after the 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, CLOPIDOGREL, OMEPRAZOLE, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and ATORVASTATIN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced CHILLS (Little chilling after the 2nd dose). On 05-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Little red rash in her left arm after the 2nd dose) and PRURITUS (itching in her left arm few days after the 2nd dose). On 10-May-2021, the patient experienced DIZZINESS (felt dizzy and couldn't even stand and could fall). On 13-May-2021, the patient experienced DIZZINESS POSTURAL (feeling little dizzy when she stand up fast). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 02-Feb-2021, CHILLS (Little chilling after the 2nd dose) had resolved. On 06-Feb-2021, RASH ERYTHEMATOUS (Little red rash in her left arm after the 2nd dose) and PRURITUS (itching in her left arm few days after the 2nd dose) had resolved. On 12-May-2021, DIZZINESS (felt dizzy and couldn't even stand and could fall) had resolved. At the time of the report, DIZZINESS POSTURAL (feeling little dizzy when she stand up fast) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.
pt recv vax;exp allergic rxn marked by loss of strength in rt arm & swelling resulting in a partial loss of use of arm;devel yeast infect;exp n,back pain,trouble sleeping,loss of appetite & weight loss;
Itching was noted at the injection site five days post injection. On day seven, a raised rash/welt was noted at the site.
positive for covid./cough, congestion, and exhaustion; positive for covid./cough, congestion, and exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) at the age of 14 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. No COVID prior vaccination. The patient's relevant medical history and concomitant medications were not reported. It was unknown If there was other vaccine in four weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "not recovered" and all described as "positive for covid./cough, congestion, and exhaustion". The event "positive for covid./cough, congestion, and exhaustion" and "positive for covid./cough, congestion, and exhaustion" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: COVID test type post vaccination: Unknown,. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recv vax 28DEC95 & 21JAN96 devel 20 vesicular papular lesions on scalp, neck, back, arms, thighs & abd;also began to exp noc sweats & fatigue;
Whole leg swollen, red, hot to touch, reaction to Hib.  Benadryl, cold compress.
Headache,  fever, chills cold hands and feet, pain : teeth, stomach, back. extreme fatigue.
Painful and difficulty breathing. Persisted for 2 days before seeing a doctor. A CT scan showed acute segmental and subsegmental pulmonary emboli in the bilateral lower lobes, right middle lobe, and right upper lobe. Was administered a blood thinner (Xarelto) and continue to be prescribed the blood thinner.
Information has been received from a physician concerning a female who, "years ago", was vaccinated with a PNEUMOVAX 23 vaccine (manufacturer unknown).  Subsequently, the patient "broke out in hives and was rushed to the emergency room".  She has since recovered.  Additional information is not expected.
low grade temperature 100 F, chills and headache for approximately 8 hours. Afterwards  headache, nasal congestion and copious amount of  nasal mucous. Symptoms began to resolve after consuming Mucinex, cool menthol liquid, every 4 hours until completed one bottle. Head felt clear, continued to experience copious thick yellowish amounts of mucous and realized a loss of smell and taste. As of today, 4/30/21 I am continuing to experience loss of taste and smell.
Fever, muscle aches, severe sore throat, headache, Decreased/absent fetal movement.
On 12/18/00, the patient told his school nurse that he had an allergic reaction to the vaccinations that he had received on 12/16/00 at the Apache Junction Fire District monthly shot clinic. The school nurse contacted the Apache Junction Fire District that same day to advise them of the event. The school nurse stated that she could not completely understand the patient because he is spanish speaking. The nurse made contact with the patient's mother on 12/21/00, and asked if the patient had any problems with the vaccinations he received on 12/16/00. The mother stated that he had a full body rash and swelling to his face approximately 15 minutes later after receiving the shots. The mom stated that the rash and swelling lasted for 1 - 1/2 hours, but did not receive any treatment. The patient's mother also stated his symptoms subsided on their own.
Vaccines were given to the wrong patient, no adverse effects have been noted so far on patient to date.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9264), in right arm, on 18Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hep C" (unspecified if ongoing), notes: Other medical history: had Hep C until 2017, cured; "Known allergies: Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: sulphur drugs, reaction(s): "Known allergies: sulphur drugs".  The following information was reported: VACCINATION FAILURE (medically significant) with onset Sep2022, outcome "unknown", COVID-19 (medically significant) with onset Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative at home; (unspecified date) Positive, notes: then positive at a clinic; (unspecified date) Positive, notes: indication: Treatment of COVID-19; (unspecified date) Negative, notes: (rapid & PCR) the negative at home; (unspecified date) Negative, notes: (rapid & PCR) the negative at home; (11Sep2022) Negative, notes: negative on a rapid yesterday at a different clinic (11Sep22); (12Sep2022) Positive, notes: then positive again today at a different clinic (rapid 12Sep22). Therapeutic measures were taken as a result of vaccination failure, covid-19.
GARDASIL (1 dose) on an unspecified date in 2016, and GARDASIL 9 (2 doses total) on unspecified dates in both 2018 and 2019; No adverse effects were reported; GARDASIL (1 dose) on an unspecified date in 2016, and GARDASIL 9 (2 doses total) on unspecified dates in both 2018 and 2019; Information has been received from a physician refers to a 21 years old male patient. There was no information about the patient's concomitant therapies, concurrent conditions, medical history drug reactions/allergies provided.  The patient received the following schedule of the human papillomavirus (HPV) vaccine: quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (1 dose) on an unspecified date in 2016, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (2 doses total) on unspecified dates in both 2018 and 2019 (inappropriate schedule of product administration, interchange of vaccine products). Strength, rout, lot# and expiration date for all products were not provided. No adverse effects were reported.
Depression, sadness, lack of motivation. It started 3 days after recieving the 2nd dose. It still lingers 7 days after.  No treatment. I have been dealing with it without medical attention by working out, resting, prayer, meditation and family.
Pt was found lying on cement at base of steps.  Recovery RNcalled outside to the back.  Patient was alert & oriented.  Stated that he fell and landed on the cement walkway.  Complained of left food pain and said he heard a crack when he fell.  911 was called per patient's request.  Was able to talk inside with assistance and Vitals obtained (stable).  Noted swelling in posterior back of ankle, pain with palpitation.  Ice was applied.  911 arrived and taken to hospital
weak as new born kitten; fever chills; headache; can not lift arm; Initial information received on 20-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via Social Media.  This case involves Adult patient (unknown gender) who reportedly was weak as new born kitten (asthenia), had fever chills (pyrexia), headache and can not lift arm (mobility decreased) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.  On an unknown date, the patient received a booster dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event weak as new born kitten (asthenia), fever chills (pyrexia), headache and can not lift arm (mobility decreased) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "Got my booster yesterday with reaction to go along with it very sick had to call in sick my two part time jobs. weak as new born kitten fever chills head ache can not lift arm. I am afraid to get another shot. I need a Prolia shot in December. to much poison for my body."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.  There will be no information on the batch number for this case.
FEVER; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a other, 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 08:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 27-FEB-2021, Laboratory data included: Multipathogen PCR test (NR: not provided) NEGATIVE. On 08-MAR-2021, the patient experienced fever, chills. headache. Laboratory data included: Body temperature (NR: not provided) 102-104 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and headache. This report was non-serious.  .
feeling sl unwell 19OCT AM;1030AM 19OCT noted red itchy, sl edematous area inside both wrists;rash progressed up forearms;lt side upper lip swollen by 330PM;scattered areas of hives started DPH;swollen face & urticaria w/mild angio ed
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 14-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059).  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Persistent heart stabbing pain that lasted for four days, short of breath, numbness, headaches, skin rush that persisted for about 2 weeks; prolonged joint pain (hip, knees, ankles) that continue for over a year now.
Administered with the vaccine which has been stored in the refrigerator for more than 30 days; Stored in the refrigerator for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Stored in the refrigerator for more than 30 days) had resolved.        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.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-265450 (Patient Link).
Student developed redness and swelling to left arm that start 11/8.  Pain present at the site.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unkonwn age and gender. Since 16-SEP-2014 the patients had been vaccinated with improperly stored GARDASIL, (dose, route, lot number and expiration dates not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.