chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Live Followup received contains Significant information of Patient Information added
Sore left arm, headache, body aches, severe fatigue and loss of energy.  In bed for 2 full days.
New rash inflamed; New rash on front of whole arm which is inflammed and itchy; rash is hot to touch; Rash at injection site was inflammed and itchy; Rash at injection site was inflammed and itchy; Rash at injection site; Red circle at injection site about 5" across; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy), FEELING HOT (rash is hot to touch), VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy) and VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy) in a 42-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.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy), VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE ERYTHEMA (Red circle at injection site about 5" across) and VACCINATION SITE SWELLING (Vaccination site swelling). On 09-Mar-2021, the patient experienced INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy) and FEELING HOT (rash is hot to touch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. In March 2021, VACCINATION SITE PRURITUS (Rash at injection site was inflammed and itchy), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. At the time of the report, INFLAMMATION (New rash inflamed), RASH PRURITIC (New rash on front of whole arm which is inflammed and itchy), FEELING HOT (rash is hot to touch) and VACCINATION SITE ERYTHEMA (Red circle at injection site about 5" across) had not resolved and VACCINATION SITE INFLAMMATION (Rash at injection site was inflammed and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Development of fever 105 and maculopapular circular rash over site of vaccinations 7 days after immunizations.
Chills, body aches, nausea, vomiting, headache, dizzy
Fever; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 29Mar2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient  got a shot (COVID Vaccine) on 29Mar2021(yesterday) and started running a fever on same day (29Mar2021) . Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
mom called office describing rash that looks like chickenpox;seen in office dx confirmed & zovirax prescribed;
Day 3-6  Extremely painful blisters in mouth, on hard palate, small yellowish bumps/blisters. Resolved with warm salt water gargles. total time period 3-4 days
Developed acute shortness of breath and chest pressure after vaccine.  Developed 2 minutes after vaccine was provided. Did not report to nurse.
Body aches, chills, fever.  Started 14 hours after vaccine, and lasted 36 hours.  Used tylenol for symptoms.
Pain in bones; Nausea; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, BONE PAIN (Pain in bones), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: unknown (Positive) COVID Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-079694, MOD-2021-079062 (Patient Link).
It was sore at injection site.  Now shoulder is in pain and so is my arm muscle above elbow.  Hard to dress, sleep and drive.  I don?t have a doctor here and can?t afford one.  I am taking aspirin and applying an ice pack.
This spontaneous report was received from a registered nurse concerning an approximately 60 year old female patient who on 09-OCT-2012, was vaccinated with a dose of ZOSTAVAX (lot no. H011048, exp. 05-SEP-2013), 0.65 ml, subcutaneous. On an unknown date the patient developed an "outbreak" along her jaw line. The "outbreak" was itchy and painful. The "outbreak" resolved within a few days. These "outbreak" occurred repeatedly and lasted for a few days. No lab diagnostic tests were performed. Relationship between "outbreak" along the jaw itchy, painful and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Nausea, dizziness, states body feels like jelly, shaky.  No vision changes or shortness of breath.  Given oral Benadryl and oral Pepcid and discharged in stable condition after 2 hours.
8/9/02 mother notified son received Hep B on 8/5/02 at health dept in AM. Mother states son did not feel well by late afternoon and had temp 103.8. She gave him Tylenol for fever which came down to normal the next AM 8/6/02 and he was feeling better. Checking client's chart he also received Td on 8/5/02.
Fever, sweats noticed 3/8/06, redness and warmth feeling to injection site on 3/9/06.
Client states that on 11-26-14 she began to feel "run down" These symptoms progressed to fatigue, headache, nausea, light sensitivity, vision disturbances, stiff muscles, stiff neck for which she has taken Ibuprofen and that have since worsened. Client also reports having had a migraine on 12-7-14. Client states she was seen by her Dr. on 12-8-14 and had blood work done for anemia which yielded normal results.  Advised client that a VAERS report will be made and that she should return to her Dr. as her symptoms are worsening. Client states "My Dr. said they have done all they can do". Advised client to seek new Dr. if necessary as worsening neck stiffness and vision disturbances are concerning and need to be evaluated soon. Client states she was experiencing the above symptoms when evaluated by her Dr. Client verbalized understanding.
PATIENT DESCRIBED THAT SHE WAS DIAGNOSED WITH TONSILITIS THE MORNING AFTER COVID VACCINE. SHE EXPERIENCE SEVERE THROAT PAIN AND WAS NOT ABLE TO SWALLOW. SHE EXPRESSED CONCERN FOR SIDE EFFECTS WITH 2ND. SHE SAID SHE WAS TREATED AND Dx BY HER MD. MD DID NOT TELL HER SHE SHOULDNT GET HER 2ND DOSE.
Fast heart beat; Dizzy; Not feeling well; eyes were blurry; heart is pounding; laying in bed and does not usually do that.  He took off of work because he is not feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 07Sep2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: took his high blood pressure medication. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: FC3180, First dose. Injected in Left shoulder), administration date: 17Aug2021. The following information was reported: HEART RATE INCREASED (non-serious), outcome "recovering", described as "Fast heart beat"; DIZZINESS (non-serious), outcome "recovering", described as "Dizzy"; MALAISE (non-serious), outcome "not recovered", described as "Not feeling well"; VISION BLURRED (non-serious), outcome "recovering", described as "eyes were blurry"; PALPITATIONS (non-serious), outcome "unknown", described as "heart is pounding"; IMPAIRED QUALITY OF LIFE (non-serious), outcome "unknown", described as "laying in bed and does not usually do that. He took off of work because he is not feeling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling/ pain at injection site, flu-like symptoms: chills, aches, headache/dizziness, lethargy, nausea
Pt broke out with rash and blisters at site c/o itching to area applied Hydrocortisone cream to area.
Skin rash with tingling sensation and warm to touch at injection site , about 6 inches down from deltoid to bicep on left arm. Symptoms appeared about 12 hours after injection and duration has been approximately 48 hours but has not resolved yet.
Pain in R arm after receiving vaccine that has not gone away. Painful with any movement, but still has range of motion. Still on going.
Receiving immunizations, stood up and collapsed in syncopal episode. Did not loose consciousness but appeared to have muscular contractions/seizure in (R) arm for 15 seconds. Had seizures in the past but not connected w/immunization. No seizures or medication in several years. Mother called PCP during episode and was to take client to PCP when they left health dept.
Patient developed rashes on the extremities, face and trunk. It looks like varicella rashes.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EM9809), in left arm, on 28Feb2022 as dose 2, single (Lot number: EN6200), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hay fever" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2022) Negative; (02Dec2022) Positive, notes: symptoms back. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 22Nov2022 to 27Nov2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201350100 same reporter/patient, different dose number/event;
Chilled, then shivering, unable to get warm,  initially, within 9 hours of the vaccination fever of 102  with body aches, continues 48 hours - 3 days of missed work due to febrile without the use of antipyretics  for 24 hours to be allowed in hospital/work
Shoulder pain,  at least 6" x 6" plus radiating down to elbow.  Constant pain, started immediately from shot. Won't stop - won't go away. It was been 3 weeks and it is not getting better.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. Since from 25-FEB-2016 to 01-MAR-2016, these patients were vaccinated with improperly stored doses of ROTATEQ (lot#L037921 and expiry date 31-MAY-2017, lot#L020859 and expiry date 19-JAN-2017, lot#L026740 and expiry date 16-APR-2017) (strength, dosing details, anatomical location and route were unknown). These vaccine lots underwent temperature excursion from 25-FEB-2016 to 01-MAR-2016 and were exposed to the temperature of 10.3 degree Celsius for 108 hours. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
white blood cells increasing; This spontaneous case was reported by a pharmacist and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (white blood cells increasing) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Leukemia (has leukemia (cancer) since even before receiving Moderna vaccine.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (white blood cells increasing). At the time of the report, WHITE BLOOD CELL COUNT INCREASED (white blood cells increasing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: high (High) The latest blood work showed white blood cells increasing..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had not yet been started on Calquence treatment but was going to start it, because the patient's white blood cells are increasing. Concomitant medications were not provided by the reporter. Treatment information was not provided.
Severe reaction lasted 8 days.  This is day 9 and still in pain, but not as bad.  Wrote doctor msg twice, on day 3 and 8.  Symptoms started when I laid down that night.  Extreme pain in arm and entire abdominal wall.  Lasted into next day and could not get out of bed.  Day 3 muscles were still like rigor mortis.  No stretching, magnesium, or Epsom salts helped.  Upper back went out.  Day 4-now, lower back went out.  Can not sit, stand, lay down, get up with out extreme pain.  Trouble walking/ stiff.  Exhausted.
Began having chills about 7 hours after the injection. On the early afternoon of 4/8.   Developed excruciating headache (very similar to when I had Covid previously in Sept. 2020), all over body aches, ringing in my ears and temp. 101.  Unable to sleep during the night and excessively thirsty.  Was essentially bedridden for 36 hours when headaches and body aches subsided on Saturday morning (4/10)  Have only had a few brief headaches and some exhaustion since Sat. Morning.  Of note, I have been donating convalescent plasma and platelets since my  illness in September, 2020.  On March  28 (approaching 7 months after my illness) I was still positive for Covid Antibodies prior to the vaccine.
Elevated fatigue, joint pain and muscle fatigue within days of vaccine, escalating  for a few weeks before waning somewhat.  Developed Reynaud's Syndrome episodes which lasted for 2-3 weeks, starting 3 weeks after vaccine.   Mild to moderate intermittent muscle fatigue and joint pain persists.
This spontaneous report as received from a registered nurse refers to a 15 year old female patient. On 13-MAR-2013, the patient was vaccinated with a first dose of GARDASIL (lot number, expiry date, route and dose were not reported). Approximately on an unknown date in March 2013, the patient developed stomach pain. the patient sought medical attention and no treatment was provided. Laboratory test performed was none. The event stomach pain was reported as not recovered/not resolved. This is one of the report received from the same reporter. Additional information has been requested.
pt recvd MMR vax on 8NOV88 & 31JAN91 pt devel temp, vomiting, & a cough; pt was found to have coarse, bilateral breath sounds; On 4FEB91 a rash appeared but pt was found to be neg for koplik's spots; 5FEB91 dx measles;
No additional AE; was improperly stored and administered/ BELOW 36 Farenheit degrees/ ABOVE 47 Farenheit degrees; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 07-DEC-2020, the patient was vaccinated with incorrectly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T011167 with expiration date on 27-MAY-2022 (route of administration was unknown) for prophylaxis. The vaccine underwent an excursion of 35.7 degrees Fahrenheit for 1 hour and 30 minutes and 64.36 degrees Fahrenheit for 3 hours. Digital data logger was involved. No adverse event was reported.
Received email from Public Health Nurse that patient had passed away on 3-16-21.  The coroner did not believe it was associated with the vaccine, just reporting the death.  Requested VAERS form still be filled out.
Area where the Jynneos vaccine was administered was very red, swollen about 4 inches wide, with a hart knot under the skin. Very tiny red dots everywhere around it.
Colitis antibiotics 10 days. Covid onset 7/22/2022  Given IV 7/25/2022 getting better but still lung congestion as of today
Shortly after I received the flu shot, I began having a stiffness and soreness in my neck that will not go away - after many doctor consultations where no one can determine the cause, the only event that coincides with my pain is my flu shot.
First dose: arm of course hurt and itched; First dose: arm of course hurt and itched; This is a spontaneous report from a contactable consumer. This consumer Female (patient) reported.  A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK2176), via an unspecified route of administration on 14Jan2021 (at the age of 63-years-old) as dose, 1 single for covid-19 immunisation. The patient medical history included Alzheimer's from an unknown date and unknown if ongoing, cognitive issues from an unknown date and unknown if ongoing, Stroke (she had a stroke last year and Part of her throat is half paralyzed and even her voice dropped) from an unknown date and unknown if ongoing and COPD (chronic obstructive pulmonary disease) from an unknown date and unknown if ongoing, she also has COPD, so she had a problem breathing. The patient concomitant medications were not reported. On an unspecified date on 2021, the patient experienced first dose: arm of course hurt and itched. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Multiple emesis since 1:00 AM, also complaining of bilateral leg pain-from the knees down.
Large swelling at injection site 2 days post vaccination with pain radiating up arm to breast. Informed patient to go to urgent care.
Localized swelling, redness, streaking, nausea, very tender, upper arm, chills, low grade fever, headache.
Fever, Nausea, Hives, Not able to swallow, Chest Tightness, Hot to the touch, Dizziness, Swelling 12/11/2009 ED records for 12/1/2009, patient with c/o's red itchy rash, facial swelling,  SOB, heart racing, tx'd with IV Solu-Medrol and Benadryl, DC DX Allergic reaction
This spontaneous report as received from the consumer refers to a female patient of unknown age with hypertension. The patient's medical history included anxiety. Sometime in 2013, the patient was vaccinated with ZOSTAVAX vial, 0.65 milliliter (ml) of single dose subcutaneous (lot number was not reported). On 28-APR-2015, the patient was presented with symptoms of pain in the head, pain behind her ear and up the right of her head along with reddish colored rash. The patient went to see the physician assistant where she was diagnosed as shingles on unspecified date in 2015. The patient also reported that the shingles were also very close to her eyes she was referred to an unspecified physician for follow up on unspecified date. The patient sought for the medical attention and visited the physician and was not hospitalized. The outcome of herpes zoster was reported as not recovered/not resolved. The causality was not reported. No additional adverse event information was provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Caregiver tested positive for COVID19 4/11/21 after receiving Pfizer vaccine 12/28/20 and 1/19/21
One day post vax pt developed an itchy rash which spread from trunk to face. Pt was treated with hydrocortisone cream, Tavist and an injection of Depo-Medrol. Havrix was discontinued.
7SEP-11SEP pt exp fatigue, sl stomach discomfort, nausea; no treatment resolved; 17SEP severe athritic pain, inflammation in hands; seen by MD; 22SEP loss of appetite, fatigue, fever, pain (rt side), arthritic pain, muscle pain;
This spontaneous report as received from a medical assistant refers to a 19 years old female patient. The patient was vaccinated with the first and third dose of VARIVAX (lot# and exp. date were unspecified) in unspecified pediatrician's office on 25-JAN-1996 and 01-JUL-2011. It is a pregnancy registry products No other co-suspects were reported. No concomitant medications were reported. Varicella antibody titers on 10-APR-2012 were low at 0.59 (positive is >1.10). A booster dose of VARIVAX (lot#671128/1060AA exp.05-JUL-2013) was given on 13-APR-2012. Varicella antibody titers on 10-APR-2012 were low at 0.88. The patient had sought medical attention via office visit. No treatment information was reported. At the report time the patient still had low antibody titers. Additional information has been requested.
PT EXP PAIN AND STINGING AT SOI AFTER INJECTION OF ENGERIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 11Jan90 PT EXP SIMILAR PAIN AT SOI.
symptoms: acute chest pain, headache, stiff neck, pain at the injection site treatment: morphine (bolus), IV heparin (bolus plus drip), tylenol, asprin, IV fluids diagnosis: myocarditis and pericarditis