chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The above named patient was seen in my office on February 7th, 2009 with a complaint, which I witnessed one bump on her shoulder area. Two days later on February 9th, 2009 patient was seen at facility and was diagnosed with having the Shingles. I am the Primary Care Physician and patient did receive vaccinations in my office. Documentation along with an adverse event reporting system form is included with this fax.
over 42 days, 1st dose 06/10/2021, 2nd dose 08/12/21
Itching a little on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching a little on the Injection Site) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoarthritis (Patient's pain management doctor allowed her to have Tylenol sometimes in addition to other meds. The patient stopped taking Tylenol prior to vaccination.).    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching a little on the Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Itching a little on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient admitted to hospital 5/4/2021 with confusion, acute hypoxic respiratory failure patient is s/p heart transplant on 3 immunosuppressive medications Fully vaccinated for COVID mid-March 2021
Redness (size of a one-dollar coin). Itchiness. Slight swelling.
Student fell off chair immediately after receiving H1N1 vaccine IM and hit head on bookcase.  Student eyes rolled back and did not respond for 3-5 seconds.  Color pale, pupils dilated but left pupil reacted sluggishly: weak pulse-92 and BP-82/50. First aid squad present and administered oxygen 8LPM via mask.  Student responsive and oriented but color remained pale and pulse weak.  Benadryl 25mg. given po as per standing order.  Transported via ambulance with first aid squad to Hospital.  Parents were notified and met student at hospital.  Medical Physician from Health Department notified.  Triage nurse from Hospital notified and report given on status of student.
No side effects reported at this time; 4 year old patient received GARDASIL 9 vaccine; This spontaneous report as received from a nurse refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 14-SEP-2020, the patient was vaccinated in error with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # S010729, expiration date 01-DEC-2021 (exact dose and route of administration were not reported) for prophylaxis. At the time of the report, no side effects were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
PT AWOKE MORNING FOLLOWING IMMUNIZATION. FELT SORE ACHY. WENT TO WORK. VERY BAD CHILLS/SHIVERS. PT TOOK OFF FOLLOWING DAY DUE TO SIDE EFFECT OF CHILLS AND ACHE. MUSCLES HURTS FROM SHIVERING.
started feeling sick; Coughing; Feel bad; not very good appetite; Fever/fever of 102°F and fluctuated to 100°F.; Feels kinda weak; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling sick), COUGH (Coughing), FEELING ABNORMAL (Feel bad), DECREASED APPETITE (not very good appetite) and PYREXIA (Fever/fever of 102°F and fluctuated to 100°F.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN, METFORMIN HYDROCHLORIDE, AMLODIPINE (AMLOPIN [AMLODIPINE]), METOPROLOL and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MALAISE (started feeling sick), COUGH (Coughing), FEELING ABNORMAL (Feel bad), DECREASED APPETITE (not very good appetite), PYREXIA (Fever/fever of 102°F and fluctuated to 100°F.) and ASTHENIA (Feels kinda weak). At the time of the report, MALAISE (started feeling sick), COUGH (Coughing), FEELING ABNORMAL (Feel bad), DECREASED APPETITE (not very good appetite), PYREXIA (Fever/fever of 102°F and fluctuated to 100°F.) and ASTHENIA (Feels kinda weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included mutinex DM dextromthorphan 16 mg, guaifenesin 1200 mg 2/day, acetaminophen and ibuprofen. the patient SARS-CoV-2 test report came back positive on 19-Feb-2021.
Patient was to receive MODERNA BIVALENT booster but received Moderna NON-BIVALENT booster.
Severe skin irritation apprx. 5 in in diameter. Excessive fluid drainage and sore lymph nodes under armpit with fever around 99.1 degrees.
Patient had erythema and slight swelling about 3 inches in diameter for approx 2 days.
SOB worsened throughout the day. Admitted to hospital with CHF, COVID, chronic thrombocytopenia, OSA.
PATIENT COMPLAINED OF HEADACHE AND DIZZINES. PATIENT WAS ADVISED TO REST AND EAT SOMETHING BY HER DOCTOR'S OFFICE. PATIENT WAS FINE ON 02/5/21.NO FURTHER TREATMENT WAS RECOMMENDED.
I started to notice hives on my forearms, face, stomach, and chest the day after I received my second vaccine.
Day after had a fever, chills, extremely tired and generally didn't feel good; arm was sore, warm, hard, and rashy; the following day had a headache that went away in the afternoon; took tylenol as was recommended at the time of the vaccine if I had any adverse symptoms ( I am usually an advil person )
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005237: US-009507513-2103USA005238: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Child had fever to 105 degrees F evening of the day received MENACTRA & DTaP. I examined patient next day & had no focal findings (injection site normal).
Loss of appetite; Severe headache; Nausea; vomiting; Chills; Fatigue; Pain at the site of the injection Left arm; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), HEADACHE (Severe headache), NAUSEA (Nausea), VOMITING (vomiting) and CHILLS (Chills) in a female patient of an unknown age 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.  Concomitant products included LISINOPRIL, OMEPRAZOLE and MELOXICAM for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of the injection Left arm). On 30-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite), HEADACHE (Severe headache), NAUSEA (Nausea), VOMITING (vomiting), CHILLS (Chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Loss of appetite), HEADACHE (Severe headache), NAUSEA (Nausea), VOMITING (vomiting), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at the site of the injection Left arm) outcome was unknown.        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.
4 month-old female who came for a routine physical exam and vaccines and developed a rash over the next 24 hours.  The rash was of rapid progression affecting mostly upper and lower extremities characterized by erythematous raised  wheals, flat topped and had tense edema.  Patient came back 24 hours after the beginning of symptoms.  She received BENADRYL and PREDNISOLONE and symptoms resolved in 1 day.
Pain at injection site, Chills and whole body muscle ache, feeling as though I had a fever and had been hit by a car
test result came back positive; test result came back positive; not feeling good after got the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer Covid Vaccine), dose 1 via an unspecified route of administration on 12Apr2021 (Lot Number: EN6202) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had been sick ever since, went to get test yesterday and result came back positive on an unspecified date, the patient was not feeling good after got the vaccine. The patient underwent lab tests and procedures which included SARS-CoV-2 test negative on 31Mar2021, SARS-CoV-2 test positive on unknown date. The outcome was unknown.  No follow-up attempts are needed. No further information is expected.
I had breathing issues the same day I had the first dose and aches and pain. I called my doctor and they said it was a reaction to the vaccine and they did not prescribe any medications since they told me there was nothing they can do for it. After the second dose I had a swollen eye lid.
Hoarseness  and  pain underneath  my right rib and  right should er, also when I  inhale I feel the pain in my right side. I did have mild fever the first 2 days with nauseness .
Patient developed pain in both knees and pain and swelling of calves about 36 hours after receiving the J&J COVID19 vaccine. His Allopurinol dose had been increased to 300 mg. daily a few days before that but no other change in health status. Now his left calf still feels a little swollen and he noticed  a bruise there without history of trauma.
The shot was administered right at the top of the arm, where the shoulder joint is.  I believe it was administered into the ligament instead of the muscle as it should have been.  Since the date of the shot, I have been taking 600 mg ibuprofen, 2-3 times daily to control pain.  I am unable to lift my arm sideways without pain.  This has lasted for two months already, and the pain is not subsiding.
sx noted after a small nodule, hot and warm, tenderness, no fever, arm pn on left arm
Rash erythema on site of vaccination, given IPV and DTaP at site LRI thigh. Patient was given Rx for BENADRYL & BACTRIM.
A report has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on 14-JAN-2015. The patient administered by expired FLUMIST Quadrivalent on 14-JAN-2015. The outcome of the event of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious.
Patient says she started experiencing anxiety and "facial numbness" 14 days post-vaccine. She presented to the emergency room on 9/13/21 (19 days post vaccination) with high blood pressure and was given ativan 1mg for anxiety which is a condition she had before vaccination. There was no diagnosis of bells palsy but that is what the patient believes she had and it presented 14 days after vaccination and is improving. She said the doctor did not agree with her self diagnosis and does not believe it was related to the vaccine but I am submitting this report based on the patient's version of events.
Within 24 hours of receiving DTaP, patient developed fever up to 102.5 and a large erythematous/raised area at injection site 7 inches.
Patient was scheduled for a vaccine at clinic today. Patient came and employee checked system. Employee couldn?t find patient in system and sent her over to get her 2nd vaccine. Patient didn?t have her CDC card. Patient was vaccinated after having 1st dose on 12/29/2021. Patient c/o dizziness, water was given and cold compress applied. Patient stated that she had HTN and Diabetes and haven?t had any medications since 2/2021. Patient was observed for 40 min and stated that she felt better. COVID clinic manager made aware. Patient felt better and left the clinic asymptomatic.
This spontaneous report as received from a medical assistant referred to a male patient of unknown age. The patient received his first dose of GARDASIL (0.5 ml, intramuscular, lot# unspecified) on an unspecified date 2 years ago (approximately in January 2011) and was in the office today, 31-JAN-2013, to receive the second dose of GARDASIL (lot#, dose/frequency and route were unspecified). No adverse effects reported. No treatment information was reported. The outcome of were unknown. Additional information has been requested.
Fever, cough, left arm pain, erythemia, swelling, s/p seasonal influenza vaccination. 3 days ago given GENADRYL 50mg IM x 1dose and EPINEHINRINE 0.3MG SC x 1dose w/ improvement in Sx. D/C w/ Rx for oral ABX and F/U in 2 days.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 03-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 02-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    The route of administration of suspect Moderna bivalent dose 1 and 2 was reported as BI. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Fever, chills, muscle/head/body aches, difficulty breathing, fatigue lasted for 3 1/2 to 4 days.
Dizziness, headache, intramuscular pain where the vaccine was given, shortness of breath and listlessness in the body
I tolerated the vaccination injection well. Had the normal chills, fever, malaise, body aches in 24 hours. Symptoms subsided within 48 hours. Then 7 days after the injection I developed back pain on the right side around T5-T7, right paraspinal muscles, and right scapula. This pain has been persistent since that time. I have had to adjust to pain in these ways: waking me up MANY nights for several hours at a time over the last year, taking  Ibuprofen or Tylenol most days, using  OTC pain patches, tried a cyclobenzaprine, carry massage balls in my car/beside my bed/in house/when I go out to eat, heating pad at my home and office, bought a massage gun,  saw a therapeutic massage therapist, and have seen my doctor about the pain. I did not have pain prior to this injection. My life now revolves around managing this pain.
Patient came to office for administration of 3rd Hepatitis B vaccine. Was given 1 ml. of Tubersol (Mantoux)in error. This was administered IM. Center for Disease Conrol, physician & patient notified immediately.
Sometime during the early hours of the morning, Patient started A-Fib and threw a brain-blood clot/stroke.  Surgery was performed to remove blood clot. A bleed then occurred in the area of the clot. Medication given to control A-fib.  Hospitalization/Acute Rehab/Out-patient OT/PT/Speech therapy bi-weekly.  Currently has little language and requires full-time assistance.
Per database, patient received 2 doses of Pfizer COVID vaccines and was subsequently admitted to our hospital on 11/25/2021 and diagnosed with COVID-19
Patient said that her arm was in pain two days after she received the flu shot. She experienced nausea and numbness in her left arm on 10/03/2010 and went to the local ER where they gave her pain medication and had her put ice on the arm.
Beginning feeling tingle on the tonged, 10-20 sec. Soreness at the inj site. 2hrs later tired.  Little nausea. 1/14/21 bad nausea, cold hot sweats, flu like symptoms. Nasal congestion and fatigue. Symptoms are trickling in not all at once.
Myocarditis; chest pain, sharp-pains in heart, shortness of breath. Prescribed Colcrys
This study case was received from the investigator in a trial on 10 March 2014. A 26-year-old male subject, with no reported medical history, received an injection of ACAM2000 (lot not reported) on 15 January 2014. On 28 January 2014, i.e. 13 days post-vaccination, the subject was diagnosed with other and unspecified acute myocarditis. The highest recorded Troponin I on 27 January 2014 was 0.56 ng/mL. Additional diagnostic testing on 27 January 2014 included ECG, which was reported as abnormal, and echocardiogram, reported as normal. MRI of the brain, spinal cord, and heart, and lumbar puncture were not performed. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
patient had complaint of throat tightness.  No Dyspnea. Chest Clear.  O2 sat at 100%.  BP 148/92, Pulse =72, all normal.  Patient was observed for an additional 45 mins and was dismissed after saying she felt normal.  No medication administered
Herpes simplex outbreaks; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had herpes simplex at the time of reporting. The patent wanted to ask that can Shingrix cause herpes simplex outbreaks. The follow up would not be possible as contact details were not provided.; Sender's Comments:  US-GSK-US2022AMR123057:Same reporter - deleted
Pt devel severe abdominal pain & generalized malaise a day p/ recving 2nd dose of Hep B. Sxs spontaneously over a period of hours.
Pt recv vax on 11/1/95; on 5/11/99 pt exp chicken pox
1st night: mild cough, sneezing, runny nose, tiredness, sore arm and shoulder. - Slept all day. 2nd day: sneezing, runny nose, sore arm.
6hrs following vaccine; Lightheaded, Nausea, Fatigue, Headache.  Symptoms subsided within 48hrs.  On 24 Feb 2021, in the afternoon, acute onset of tinnitus, both ears, began.  Continues since onset without improvement or change.
Pt recvd 2 Engerix-B vax, 1st given MAR91 & 2nd given APR91; Had lab screen done for surgery planned wk of 1JUL91 to reconnect fallopian tubes; Lab screen revealed pt to be HBSAG post & HBSAB; concerned about exposing pts to Hep B;
Patient signed up for Covid Pifzer bivalent updated booster. Her vaccine was processed in the computer with her insurance. She was given the bivalent booster and pharmacist noticed after the vaccine was given, that she had already received the bivalent booster in the beginning of September 2022. This was then her 4th booster and her 2nd bivalent booster, which is not approved. I had her wait for at least 15 minutes after the vaccine and she felt fine upon leaving. I checked in with her in the afternoon and at 7 PM the same day and she felt fine, no adverse effets.
Moderna COVID-19 Vaccine EUA  Moderate redness and itching at injection site - ongoing