chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inappropriate schedule of vaccine administered; Our 17 year old son was vaccinated with Moderna; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021. The most recent information was received on 30-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Our 17 year old son was vaccinated with Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Our 17 year old son was vaccinated with Moderna). On 26-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 30-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Our 17 year old son was vaccinated with Moderna) had resolved. On 26-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received 30-JULY-2021. Updated reporter contact information, updated patient details, added new event of inappropriate schedule of vaccine, added dose 2 and batch numbers for both doses. Added statement into narrative no adverse events were noted.
Temp 102.0 evening of shot.  Now fever 101.  Both thighs hurt red and inflamed where shots were.  All 3 shots normal looking now.  Spit up x1.  C/O stomach ache - no emesis yet, cranky too.
Pt felt dizzy and light headed after receiving  Pfizer booster.  Pt vitals: BP 90/70, P56, 98% on room air, Glucose 90. Pt given water, ice pack, laid down with feet up. Approximately 10 minutes later patient reported feeling better and with assistance was moved from floor to chair. Vitals at 16:02 were 120/82, P59, 99% on room air. Pt remained in vaccination clinic until her mother arrived to pick her up. This nurse walked with patient to car. Pt reported feeling much better and mother assured this nurse that she would remain with patient all night.
sore arm, thirsty and really tired, light headed a few days after whenever I did anything strenuous
Patient was given Menveo and Bexero ahead of patients advised age. Patient is of 10 years of age.  No side effects on patient.
I had a fever over 102, severe body ache, severe fatigue and lightheadedness for up to 5-6 days. Then then severe fatigue and lightheadedness remained. It's still there off and on, even after a month. Along with that, I feel very low, sleepy, and depressed. This never happened before until I took the vaccine.
I ended up getting a rash over my complete body. It was very painful and itchy. The hospital told me to take Benadryl bit it didn't help, so I went to the Dermatologist.
sx-hives given DPH 1/3ts q 6hr 15MAY97;return visit 16MAY97 more hives, given Prelone syrup;2/3 tsp stat-then 1/3 tsp, 4-5x a day;hives gones 19MAY97;
NUMBNESS IN THE RIGHT ARM; HEAVY RIGHT ARM; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23/JUN/2021) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body aches. On 16-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4. On 18-MAY-2021, the subject experienced numbness in the right arm. On 18-MAY-2021, the subject experienced heavy right arm. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever on 17-MAY-2021, and had not recovered from body aches, numbness in the right arm, and heavy right arm. This report was non-serious.
Started shaking, hands shivering sideways not normal, got nauseous, vomited then got body aches that go along with the flu took TYLENOIL. By next day issues resolved. Today pt is fine.
Extreme very severe headache, swollen throat, extreme fatigue, bone crushing pain especially in hips and legs, muscle pain
I had the typical sore arm and achy feeling, but I also was nauseous.  I got up to use the bathroom in the middle of the night and passed out.  I fell and now have a huge bruise on my left thigh where I hit something hard, probably the toilet.  My whole left side of my thigh is tender and swollen where it is black and blue.
Severe Temperature 103.3 then 103.5. Gave TYLENOL...Called pediatrician on call service, was told to go to urgent care for evaluation. Went to Urgent Care, fever decreased to 101.9, with with complaints of severe headache. Headache resolved but then temperature increased back to 103.3. Was given MOTRIN. Was seen by Urgent Care pediatric physician and told that this was most likely a concurrent viral illness. Denied needing to report adverse reaction. Temperature decrease to 100.9 and was discharged home. Heart rate was between 150 and 130 during Urgent Care stay. Patient vomited at home in the middle of night with continued fever of a 102.8. Receive TYLENOL in the morning at 7 a.m. and eventually developed a fever of 104.5 with severe headache again. Vomited one more time. Received MOTRIN and TYLENOL for fever. Patient remain to have a temperature between 101 and one or two throughout the second day. On the third day temperature was 101.8 but feeling better. Nausea no vomiting. Approximately 80 hours after vaccination patient appears to no longer have fever.
- fever (100), chills, truncal rash, itchy, red - discontinued adalimumab  & methotrexate for 1 week and stayed home from work 1 week - rash c/w measles vaccine strain.
Information has been received from a nurse concerning an 18 year old female with pertinent medical history and drug reactions/allergies unspecified who on 28-DEC-2006 was vaccinated with Gardasil (yeast) (lot# not reported) injection. Concomitant therapy unspecified. On 01-Jan-2007, the patient passed out. Medical attention was sought. The patient later reported that she was experiencing light headedness and tingling in her hands and feet on 02-JAN-2007. The patient was referred to a cardiologist. The patient had a carotid ultrasound and echocardiogram performed on 05-JAN-2007 and 11-JAN-2007, respectively (results not reported). At the time of reporting, the tingling in her hands and feet persisted. No further information was available at the time of reporting. Additional information has been requested.
Headache, muscle ache, nausea, injection site sore. Lasted 36 hours
rash at the injection site; slept a lot,; chills; nausea; fatigue; body aches; headache; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches) in a 78-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 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache) and MYALGIA (sore arm). On 22-Mar-2021, the patient experienced INJECTION SITE RASH (rash at the injection site). At the time of the report, SOMNOLENCE (slept a lot,), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headache), MYALGIA (sore arm) and INJECTION SITE RASH (rash at the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a physician concerning a 15 year old female who on 24-MAY-2007 was vaccinated intramuscularly with the first dose of Gardasil (lot # 655620/0171U). It was reported that about a day or two after receiving the vaccination, on approximately 25-MAY-2007, the patient developed blister formations around her mouth. Unspecified medical attention was sought. Subsequently, the patient recovered on an unspecified date. The physician was unsure whether or not therapy would be discontinued. Additional information has been requested.
Pt began running high fever, had a severe headache and muscle spasms.  Pt was seen at Muskogee Regional Medical Center by Drs. O'Reily and Cole.  Pt continuing to have extreme fatigue
Bleeding in the cough; Rashes; Cough; Tiredness; Muscle Pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 30-years-old, via an unspecified route of administration in left arm on 07Apr2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient had no COVID prior to vaccination, did not have any other vaccines in four weeks and no other medications in two weeks. The patient experienced rashes, cough, bleeding in cough, tiredness, and muscle pain on 09Apr2021 at 12:00. There was no treatment given in response to the events. The patient was not tested for COVID post vaccination. The outcome of the event was not recovered. Information about the lot/batch number has been requested.
LETHARGY; NAUSEA; CHILLS; FEVER; BODY ACHES; SWEATS; DIARRHEA; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 was not reported) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 19-MAR-2021, the subject experienced sore arm. On 20-MAR-2021, the subject experienced body aches. On 20-MAR-2021, the subject experienced sweats. On 20-MAR-2021, the subject experienced diarrhea. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102.8 F. Treatment medications included: paracetamol. On 21-MAR-2021, the subject experienced lethargy. On 21-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and lethargy on 22-MAR-2021, sweats, diarrhea, chills, fever, and nausea on 21-MAR-2021, and sore arm on 19-MAR-2021. This report was non-serious.
Information has been received from a health professional concerning a 9 year old female who on 17-SEP-1999, was vaccinated with a first 0.5 ml subcutaneous dose in the arm of varicella virus vaccine live (Oka/Merck) (lot # 629614/0286J). On 04-JAN-2008, the patient developed a rash with 50 to 100 lesions and fever to 102.8 degrees Fahrenheit. The patient sought medical attention via the phone. No laboratory or diagnostic studies were performed. The reporter indicated that on 24-JAN-2008, the patient had recovered. A product quality complaint was not reported. Follow up information from the health profession provided no additional information. This is one of 4 reports from the same source. Additional information has been requested.
At 10:30 AM had a flu vaccine on 10/26/07.  On 11/01/07 came to ER 10:16 AM with c/o persistent pain from site to wrist in L arm.  Doesn't radiate to thumb & little finger, c/o nausea with pain.  Pain 10/10 sharp.  Has also trapezius pain intermittently.  Came in with EP, had full workup.  Dilaudid x2, CT of chest, CXR.
This is a spontaneous report from a contactable consumer. A female patient (reporter's wife) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Mar2021 16:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. On 19Mar2021 the patient experienced tiredness, headaches, body pains, muscle aches and pains, chills, fever, nausea, and some vomiting, rapid heart beats, and on an unspecified date breathing problems, soreness in the arm. On 19Mar2021 the patient underwent lab tests and procedures which included Body temperature: high fever 100 or 101 (On high fever 100 or 101), heart beats: Rapid. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314398 same reporter/drug/event, diff patients
The patient was brought to a popup clinic for his second Pfizer COVID19 vaccine by his mother 7/14/21,  and a dose was administered that day.  On July 23rd 2021 it was discovered during data entry that the patient had received his first Pfizer COVID19 vaccine dose  7/6/21, 8 days prior to dose 2.   Both doses were recorded on the patient's vaccine card.   NP, notified the patient's mother, who reported she brought her son in for dose 2 on 7/14 because she thought it was time.   NP advised patient's mother per Dr and CDC guidelines that no further doses are recommended at this time, and to follow up with booster dose if and when it is recommended. in the future..
This spontaneous report as received from a the clinical research coordinator referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot number R002805 and expiration date 23-SEP-2019, or lot number R016790 and expiration date 20-APR-2020, for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8.2 degrees Celsius for 6 minutes. Previous temperature excursion of 11.5 degrees Celsius for 37 minutes There was no adverse effect reported. Sender's Comments: US-009507513-1903USA007501.
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ff2593) via an unspecified route of administration in the left arm on 21Nov2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The medical history included abnormal blood pressure. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified blood pressure medications within two weeks of vaccination. On 22Nov2021 at 10:15, the patient's left middle finger first joint with fingernail was swollen for two days. It was red and then turned purple and was sore to touch and was tender. The patient felt like she had slammed it in a car door but did not. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the reported events. The clinical outcome of the events left middle finger first joint with fingernail was swollen for two days then it was red and then turned to purple, sore to touch, tender were not resolved at the time of this report.
DIED; This spontaneous report received from a consumer via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. 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 administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 1 total administrated for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reported stated that, a family member died (date unspecified) after being fully vax (dose number in series was 1). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died of an unknown cause. This report was serious (Death).; Sender's Comments: V0: 20211266789-COVID-19 VACCINE AD26.COV2.S-died. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
The initial spontaneous case, was received from other health professional on 11-Oct-2017, concerning a female, patient of 3-year-old. It was reported that FLUVIRIN is an inactivated influenza virus vaccine indicted for active immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine. On 10-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch: 179701P, expiry date: on an unspecified date in May-2018, route of administration: intramuscular, anatomical location: left vastus lateralis). As the patient was below 4 years, considered as inappropriate age at vaccination. It was reported that, the patient did not experience any adverse event after the administration of the vaccine. The reporter considered the case as non-serious. Follow up received on 27-Oct-2017: The route of administration: intramuscular and anatomical location: left vastus lateralis were updated. New event (no adverse event) was added. It was reported that, the patient did not experience any adverse event after the administration of the vaccine. The narrative was amended accordingly.
This is from the second shot. The first shot was a little over 3 weeks prior. Nothing happened other than a slightly sore arm. The second vaccination was much worse. The day of, arm was just sore. I rubbed it, applied cold and warm compress, the nurse there said if I was in pain to take Tylenol or motrin, so thats what I did. The next day I couldn't move. A friend had to take my kids to school because I could not get off the sofa. I had a 103.8 fever, I couldn't see, my head was pounding, the room was spinning, and  couldn't swallow. I took Tylenol and drank a lot of water. I couldn't eat anything. It lasted all day and the next day I had the same all over body aches, headache, felt exhausted but no fever. Ever since then my period has been completely out of wack. I had it in June, but completely missed July, August was only here for 2 days and was very light, now I am in September and its also not here. I have taken multiple pregnancy tests and not pregnant, I also have my tubes tied. I have also have had recurring headaches, stomach pain, abdominal pain, abdominal burning, felt like my skin was on fire but no rash, my chest feels tight and I'm forgetting things. I've also been having terrible back pain and neck stiffness. I have never had any of these symptoms before. My doctor doesn't know what is the cause. They did blood work and just said its probably stress from moving from the states to overseas. But i was having these symptoms before I moved. No one is taking me seriously and im tired of having pain.
Muscles in left arm are sore. 6 months after vaccine I had fever for 4 days and cough that continued for over a week that developed into bronchitis.
Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) in a 78-year-old female patient 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, the patient experienced SOMNOLENCE (Sleepy). At the time of the report, SOMNOLENCE (Sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-020448, US-MODERNATX, INC.-MOD-2021-020515    Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020448:Same reporter, reporter herself US-MODERNATX, INC.-MOD-2021-020515:Same reporter, reporter's son
Initial unsolicited report received from a consumer on 21 October 2015. This case involves a male patient (age was not reported) who was vaccinated with a dose of FLUZONE (batch number, dose, dose in series, route and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced bruising and greenish/brown spot. Lab data and corrective treatments were not reported. The patient was recovering from events bruising and greenish/brown spot as they eventually faded after administration. List of documents held by sender: none.
Initial injection site reaction (swelling and redness) began in 24 hours and resolved after 3 days. A secondary injection site reaction (redness and itching with minor swelling) began 10 days after injection and was almost resolved by 15 days after injection.   Fatigue occurred 12 hours after injection and resolved in 3 days
Believed to contract a COVID 19 infection approximately 2 weeks after receiving the Moderna booster shot (around Nov.8, 2021).  Only symptom of infection was extreme fatigue, which last about a week.  Approximately 2-3 later, started developing several gastrointestinal issues including severe diarrhea, gas, bloating, nausea, decreased appetite, and mild loss of taste.  Additionally, experienced episodes of dizziness, disabling fatigue, headaches, increase in PVC heart contractions, night sweats, insomnia, and unexplained weight loss. All of these symptoms lasted off and on for about 2 months before I decided to see my Primary Care Physician for the gastrointestinal issues.  PCP did blood work.  Results showed I was a bit dehydrated but otherwise normal except the Anion Gap test.  Per the lab, the normal range for their test was 8.00-16.00 (mmol/l): my result was 2.0.  I have no history of heart disease other that high cholesterol.  Which has been monitored and uncontrol for at least 20 years. Colonoscopy was performed which no issues found to explain my symptoms.
Employee who is complaining of double vision since the morning after the vaccination. According to the employee symptoms are worsening. He also complains of "flushing" on raising in the a.m.
R upper an, red hot to touch and hard w/ pain immunization given right arm, DTaP, IM, IPO, IM, MMR, Antibiotics prescribed and advised ice to arm.