chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose administered more than 42 days post first shot; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 42 days post first shot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 42 days post first shot). On 18-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 42 days post first shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided. This is a case of Inappropriate Schedule of Vaccination concerning a 65-year-old female patient, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-377773 (Patient Link).; Sender's Comments: This is a case of Inappropriate Schedule of Vaccination concerning a 65-year-old female patient, with no relevant medical history, who experienced no other adverse events. The event occurred the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Mild, Systemic: Headache-Mild, Additional Details: patient presented at pharmacy 2 weeks post moderna booster vaccination. complained of a bruise that was still affecting her after the vaccination. pharmacist examined the bruise and it was about the size of a quarter, light yellow around the edges and darker in the middle, looks to be healing appropriately. patient wanted to know what happened which is why she presented to the pharmacy.
This spontaneous report was received from a 56 year old male patient regarding himself. The patient's medical history included appendicitis. Patient had no drug allergies. The patient reported that on 15-MAR-1995 someone may have broken into his house and gave him an injection of either VARIVAX (Merck) (lot #, expiry not reported) or a horse medication in his buttock. On 23-MAR-1995, the patient experienced intestine failure, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores. The patient sought medical attention-went to the emergency room for a day. The patient believed he had an undiagnosed condition as a result of this shot. The patient did not have a primary care physician. An Electron microscopy test was performed on the mouth sore: and results confirmed herpes simplex. Patient was given unspecified antibiotic for treatment. The outcome of intestine failure, herpes simplex, malabsorption problems, loose teeth, teeth grinding, lip peeling, ridges on his toenails, impotency, bladder pain and sores was reported as not recovered. Additional information has been requested.
C/o swelling of throat after receiving vaccine and Bicillin, no prior allergy history. Given BENADRYL and observation - return to division.
3/25/02 - body rash, high fever, watery eyes, 3/25/02 cough started
Pt was well before Fluzone injection was given. Within 1-2 hours, the pt developed urticaria. There were no other new exposures, allergens or any viral symptoms. The hives have continued for one day at this point. There was no mucous membrane involvement and no airway compromise.
CLIENT FAINTED AND LOST CONSCIOUSNESS SHORTLY AFTER RECEIVING BEXSERO VACCINE.  POSTURING OF UPPER EXREMETIES WAS NOTED. LOC LASTED APPROX 10-15 SECONDS. FELL INTO MOC ARMS, NO INJURY TO HEAD OR BODY. PLACED ON MAT IN SUPINE POSITION WITH FEET ELEVATED. RECOVERED QUICKLY, IN LESS THAN 15 MINUTES. APPARENTLY CLIENT HAS A HX OF SIMILAR SYNCOPAL EPISODES WITH MEDICAL PROCEDURES BUT DID NOT ADVISE THIS RN TODAY BEFORE ADMINISTERING VACCINE. FLUMIST GIVEN PRIOR TO BEXSERO; TOLERATED WELL WITHOUT INCIDENT.
No further adverse events; administration of expired doses of MMR-II and VARIVAX to the same patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 15-MAR-2022, the patient was vaccinated with expired doses of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # T006346 with expiration date 20-FEB-2022; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) 1 (units not provided), lot # T007235 with expiration date 27-FEB-2022; both for prophylaxis (strength, route of administration and anatomical location were not reported for the suspect vaccines). No further adverse events were reported.
Onset of papular slightly vesicular rash on L side upper body (neck/shoulder/upper chest) with two other smaller areas involved (R shoulder and below sternal notch) suggestive of viral eruption, onset 3-4 days after vaccination
This spontaneous report was received registered nurse regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (therapy type digital data logger) (lot # L040459, expiry date 06-APR-2017) dosing details and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 10.5 degrees C for a time frame of 2 hours and 33 minutes. It was reported that there were no previous temperature excursions. No other symptoms reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Severe low back pain/ back pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe low back pain/ back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Severe low back pain/ back pain). At the time of the report, BACK PAIN (Severe low back pain/ back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
presents with SOB; previously diagnosed with COVID PNA on 1/7/22 and was previously hospitalized and eventually discharged home but was profoundly weak and unable to get himself out of bed. transferred to Rehab where he was found to be progressively more hypoxemic requiring up to 10L NC. CXR demonstrated worsening bilateral opacities and antibiotics were initiated with cefepime. Pt transferred for higher level of care.  MAJOR EVENTS: 01/30 -- transferred to ICU, intubated  2/10/22 thoracentesis with removal of 1400cc bloody fluid 2/11/22 afib with RVR with rate control with diltiazem  2/13/22 clinical deterioration with increased vasopressor requirement, acute renal fialure             Family elected to transition to comfort care             Assistance from Palliative care
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. on  07-JUN-2016, the patient was inadvertently administered an expired dose of ZOATAVAX injection, lot # L006382, expiration date: 26-MAY-2016 (exact dose, dose number, route of administration and anatomical location were not reported). There were no adverse effects reported. Additional information has been requested.
Forehead began itching after the shot on 4/22/21. On April 23, 2021 noticed patchy rash all over forehead. Rash continuing on to April 24, 2021 all over forehead.
No Adverse Event, Patient was 17 and received a Moderna Vaccine instead of a Pfizer Vaccine
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2013, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) by a physician for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated in a rehabilitation center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
Information has been received from a consumer concerning her 10 month old daughter, who had no pertinent medical history or drug reactions/allergies and was vaccinated (route and site not reported) in July 2007 (exact date not reported) with PEDVAXHIB (OMPC) (lot # not given).  Concomitant therapy includes unspecified "heart medication".  In July 2007, post vaccination, the patient experienced "absence in both legs".  The patient did receive unspecified medical attention.  No lab diagnostics test were performed.  At the time of this report the patient had not recovered.  No additional information is expected.
Patient called a few days after receiving vaccine and reported a hot, swollen, painful upper arm (from injection site to elbow).
No adverse event or side effects noted on patient. Called patient mom and informed her of the incident. According to mom patient did not experience any side effects and do not wish to have a repeat dose.
Sore arm; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The initial case was missing the following minimum criteria. Upon receipt of follow-up information on [22Nov2021], this case now contains all required information to be considered valid.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 07Nov2021 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Nov2021, outcome "recovered" (Nov2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient age at time of vaccination: 8. Vaccination facility type: Workplace clinic. Vaccine administered at a facility: No. Prior vaccination: Unknown. Concomitant drugs: Unknown. Patient medical history: Unknown. Relevant tests: Unknown. Specific Relevant tests: Unknown. Seriousness Criteria: Not serious.  No follow-up attempts are possible. No further information is expected.
BODY ACHES; CHILLS; FEVER OF 100.2 F; INJECTION SITE SORENESS; NAUSEA; HEADACHES; This spontaneous report received from a patient concerned a 54 year old female. 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 not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever of 100.2 F. On APR-2021, the subject experienced injection site soreness. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 100.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever of 100.2 F, body aches, nausea, headaches, and chills, and the outcome of injection site soreness was not reported. This report was non-serious.
This spontaneous report was received from a other health professional refers to a 14 years old female patient who in 2012, during the spring was vaccinated with the first dose of GARDASIL (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The health care professional reported that on an unknown date in 2012, the patient became faint immediately after the GARDASIL dose. No treatment information was reported. At the time of the report, the patient had recovered with sequelae. It was unspecified if the patient sought medical attention. The relatedness for became faint immediately after dose was unknown for GARDASIL. Additional information has been requested.
My cheeks were red and hot.; My cheeks were red and hot.; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9263/expiration date: not provided), via an unspecified route of administration, on 23Jan2021 at 14:30 (at the age of 65 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included allergic reaction to almonds and brewers yeast in Sep2019, being pre-diabetic, and osteoporosis. The patient had allergies to codeine (all forms), almonds, brewers yeast, mold and dust. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included metformin, alendronate sodium (FOSAMAX), and multivitamin, other supplement. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 at 15:15, the patient experienced that her cheeks were red and hot. The clinical course was as follows: because of a prior significant allergic reaction (Sep2019 determined to be primarily almonds and to a lesser extent brewers yeast), she waited 30 min. and she didn't notice anything until she left the property and removed her mask. Her cheeks were red and hot. She had a diphenhydramine (BENADRYL) tablet (OTC) which within 30+ min reversed it. The outcome of the events cheeks were red and hot was recovered on an unspecified date in 2021. Since the vaccination, the patient had not been tested for COVID-19.
Hoarseness; burning and soreness in throat; burning and soreness in throat; inappropriate dose of vaccine administered; burning and soreness in lips; burning and soreness in lips; Backache; little dot on buccal mucosa in soft palate; This is a spontaneous report from a contactable physician.   A 73-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/lot number: 70865, Expiry Date: 31Dec2020) via an unspecified route of administration at 0.5 ml, single in the left deltoid on 23Jan2020 for immunisation. Medical history included ongoing diabetes mellitus (diagnosed several years ago), ongoing arthritis (has had for many years). There were no concomitant medications. The patient previously took Pneumovax 23 and Prevnar 13, both on unknown date for immunization without any adverse event. She had allergies to Ceftin, Ciprofloxacin, Dolobid, Fluconazole, Lasix, Levaquin, Macrobid, Metformin, Motrin and Sulfa drugs. The patient experienced burning and soreness in lips on 23Jan2020 with outcome of not recovered, backache on 23Jan2020 with outcome of recovered, little dot on buccal mucosa in soft palate in Jan2020 with outcome of recovered, hoarseness on 03Feb2020 with outcome of unknown, burning and soreness in throat on 23Jan2020 with outcome of not recovered. Therapeutic measures were taken as a result of little dot on buccal mucosa in soft palate.  The events were described as follows: After receiving the vaccine, about an hour and a half later she developed burning and soreness with her lips and throat. After 11 days she still has the same symptoms. She did not have a fever, angioedema or chills. She had a backache at that time as well. She developed a little dot on the buccal mucosa on 23Jan2020 or 24Jan2020. She applied Orajel to the dot. On 03Feb2020  she had hoarseness.
Memory loss, loss of fine motor skills, decreased reaction time,  balance issues/unsteadiness, extreme hot and cold flashes, elevated heart resting heart rate above 110 BPM   All on day of vaccination through the evening
Fever x 1 day of 103 degrees Fahrenheit for 1 day after DTaP, IPV  given, no other s/s of illness.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 15-JUN-2018, the patient was vaccinated with expired dose of (wistar ra 27-3) M-M-R II therapy type rHA, subcutaneously (lot# M029229 and expiry date 08-JUN-2018). No adverse effects were reported. There was no product quality compliant reported.
Patient has received the regular flu vaccine in years past with no problems. On the day of the vaccination she had a 3-4 inch around bright pink red & very hot to the touch circle on her arm. Then turned mottled looking then turned to bruising. The soreness extended all the way down the arm and into left hand for 4-5 days. Her arm was sore to the touch for 3 weeks total.
SOB; pain in right arm that radiated to right neck and shoulder; generalized itching; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; pain in right arm that radiated to right neck and shoulder; This is a spontaneous report from a contactable other healthcare professional (nurse, patient). A 45-year-old non pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration, administered in right arm on 19Mar2021 as dose 1, single (at the age of 45-years-old) for COVID 19 immunization (Hospital). Medical history included asthma and known allergies (both from an unknown date and unknown if ongoing) and COVID-19 (prior to vaccination) from an unknown date to unknown date. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had been tested for COVID-19, since the vaccination, via nasal swab and result was negative. On 19Mar2021 (began immediately after receiving injection), patient experienced generalized itching, shortness of breath (SOB), pain in right arm that radiated to right neck and shoulder. Events were reported to ED physician monitoring. Symptoms lasted for several days. Patient received no treatment for the events. The outcome of SOB was recovered on 23Apr2021, and rest of the events was recovered on an unspecified date in 2021.   No follow up attempts are needed. No further information is expected.
Sore arm; large blisters; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and BLISTER (large blisters) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and BLISTER (large blisters). At the time of the report, PAIN IN EXTREMITY (Sore arm) and BLISTER (large blisters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment information provided.
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Additional Details: Patient was bradycardic with HR of 46 > 1 minute
Pt. reports having chills, shaking, being nauseous, & having trouble breathing day of vaccine 10/26/10. He used an albuterol inhaler to help him breathe.
Initially pain with injection and taste in mouth. Arm pain worsened but improved w/ibuprofen. Mild fever 99.8. EXTREME weakness and fatigue, profuse diarrhea, poor appetite, feeling morose, intermittent runny nose, itchy eyes, mild congestion and mild rare coughing spells.  Please note- shot in first series was not painful- couldn't even feel shot. Only symptom after shot in 1st series was mild arm pain and mild fatigue for 2 days.
Body aches/Body pains; Chills; 99.9F temperature; Arm which received inoculation was sore; Severe headache; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0185) via an unspecified route of administration in the left arm on 25May2021 at 14:15(at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa and penicillin. Concomitant medications included gabapentin (GABAPENTINA), olanzapine (ZYPREXA), alprazolam (XANAX); all for an unspecified indication and unknown start date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation and also took novocaine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26May2021 at 03:41, the patient experienced severe headache and at 03:45, the patient experienced body aches, body pains, chills,99.9F temperature for 11 hours and arm which received inoculation was sore and unable to lift it due to severe pain and soreness. The patient did not receive any treatment for the events.  The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 26May2021 at 03:45, patient body temperature was measured and result was 99.9F. The clinical outcome of headache, body aches, body pains, chills, 99.9F temperature and arm which received inoculation was sore were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.