chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Chills, Mobility decreased, Myalgia
Clinical narrative: Fever and chills, muscle pain began after 12 hours and lasted until 72 hours after injection. Used ibuprofen to control symptoms, but was confined to bed for two days. Noticable hair loss began on day 4. I have lost about 30-40% of my hair and it is still falling out 17 days later! My scalp is now showing through my hair! Also, joint pain in my fingers began about the same time and continued for about one week. (This is no longer a problem.). My only guess is that I received the vaccine too soon after recovering from Covid-19. I was sick with Covid symptoms from June 28-July 11th
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever and chills, muscle pain began after 12 hours and lasted until 72 hours after injection. Used ibuprofen to control symptoms, but was confined to bed for two days. Noticable hair loss began on day 4. I have lost about 30-40% of my hair and it is still falling out 17 days later! My scalp is now showing through my hair! Also, joint pain in my fingers began about the same time and continued for about one week. (This is no longer a problem.). My only guess is that I received the vaccine too soon after recovering from Covid-19. I was sick with Covid symptoms from June 28-July 11th
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: muscles aches, chills, severe headache,  dizziness, nauseous,  sore throat
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: muscles aches, chills, severe headache,  dizziness, nauseous,  sore throat
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Insomnia, Pain, Product administered at inappropriate site
Clinical narrative: The nurse administered the shot into the shoulder joint area  rather than the muscle. The shot was given above the deltoid and off center toward the back of the arm. There was intense pain upon administration. Pain continued through the evening, and it wasn't possible to sleep for much of the night. Pain during the day is less intense than at night. Lifting arm to change clothes or reach is extremely painful still at one week from injection. Pain radiates down to elbow and around to back. Sleeping is difficult as very few positions are pain free for the arm and turning is excruciating.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Sleep disorder
Clinical narrative: The nurse administered the shot into the shoulder joint area  rather than the muscle. The shot was given above the deltoid and off center toward the back of the arm. There was intense pain upon administration. Pain continued through the evening, and it wasn't possible to sleep for much of the night. Pain during the day is less intense than at night. Lifting arm to change clothes or reach is extremely painful still at one week from injection. Pain radiates down to elbow and around to back. Sleeping is difficult as very few positions are pain free for the arm and turning is excruciating.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Elbow swollen 3x normal size within a 10 minute period. Hot and painful to the touch. Red rash reaction between half of bicep and halfway down forearm
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Erythema, Joint swelling, Peripheral swelling, Pruritus
Clinical narrative: Elbow swollen 3x normal size within a 10 minute period. Hot and painful to the touch. Red rash reaction between half of bicep and halfway down forearm
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: Elbow swollen 3x normal size within a 10 minute period. Hot and painful to the touch. Red rash reaction between half of bicep and halfway down forearm
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Aldolase decreased, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Myocarditis, Rhabdomyolysis
Clinical narrative: Rhabdomyolisis and Myocarditis
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Electrocardiogram PR segment depression, Electrocardiogram ST segment elevation, Pericarditis
Clinical narrative: Pericarditis demonstrated within 15 mins of vaccine
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: chest pain, shortness of breath, body aches, fatigue and malaise
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Pain
Clinical narrative: chest pain, shortness of breath, body aches, fatigue and malaise
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Amylase, Arthralgia, Blood test, C-reactive protein, Dengue virus test
Clinical narrative: Reaction occurred 3 days after vaccination. presenting high fever, pain muscle, accelerated heart rate, very severe pain in joints, rash and very red eyes.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fibrin D dimer, Heart rate increased, Lipase
Clinical narrative: Reaction occurred 3 days after vaccination. presenting high fever, pain muscle, accelerated heart rate, very severe pain in joints, rash and very red eyes.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ocular hyperaemia, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Reaction occurred 3 days after vaccination. presenting high fever, pain muscle, accelerated heart rate, very severe pain in joints, rash and very red eyes.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Serum ferritin, Troponin I
Clinical narrative: Reaction occurred 3 days after vaccination. presenting high fever, pain muscle, accelerated heart rate, very severe pain in joints, rash and very red eyes.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Rash, Urticaria
Clinical narrative: Urticaria and rash to trunk within 2 hours of receiving injection. Rash continued to spread throughout trunk and to extremities over the following 3 days; even with continued use of regular daily antihistamines and added oral diphenhydramine and topic hydrocortisone 1%.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling
Clinical narrative: Patient had severe swelling and redness to joint of left knee the following day after vaccine.    It then worsened to include swelling to both knees and ankles although the left knee remained the most swollen, red and painful.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Palatal disorder, Stomatitis, Throat lesion
Clinical narrative: Progressively severe oral stomatitis. Multiple lesions of varying sizes developed over about 5-7 days, up to at least 12 at one time.;  scattered throughout the mouth, throat, & on soft palate. Treated by both my MD & 12 days later by my dentist. RX from each of "Magic Mouthwash" to swish & swallow. Contents of each very similar...visc lidocaine, antibiotic, & steroid combination. Lesions healing &  recurring over 3-4 weeks. Resolved after about 5 weeks.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Echocardiogram, Electrocardiogram, Magnetic resonance imaging, Seizure
Clinical narrative: 2 Seizures and a Stroke due to a blood clot that split into two
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 2 Seizures and a Stroke due to a blood clot that split into two
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Disorientation, Head discomfort, Headache
Clinical narrative: Immediately after received shot  I became disoriented and had severe headache. I had to sit down. About 20 minutes after I had pain in back of my neck in area of lymph nods and under arms. That lasted for less than 1 week, but headache never stopped. I have never experienced this type of pain, its located in the lower part in back of my head, feels like stabbing pain and pressure, almost like heavy head. Past two days the stabbing pain is stronger and I can not sleep. I also have pain in the back of my right knee for 2 weeks and joints on my left hand are enlarged and hurt.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Joint swelling, Lymph node pain, Neck pain, Sleep disorder
Clinical narrative: Immediately after received shot  I became disoriented and had severe headache. I had to sit down. About 20 minutes after I had pain in back of my neck in area of lymph nods and under arms. That lasted for less than 1 week, but headache never stopped. I have never experienced this type of pain, its located in the lower part in back of my head, feels like stabbing pain and pressure, almost like heavy head. Past two days the stabbing pain is stronger and I can not sleep. I also have pain in the back of my right knee for 2 weeks and joints on my left hand are enlarged and hurt.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain
Clinical narrative: Pain in armpit. No sense of lumps, but slight pain raising the arm and putting some pressure on the armpit.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Migraine, Nausea, Vomiting
Clinical narrative: Severe blinding Headache, Nauseous, vomiting,tiredness
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, International normalised ratio increased
Clinical narrative: INR went very high. 5.6 and Warfarin dose had to be suspended for two days. I also started to have blood in my urine.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: About 2 hours after vaccination site was very sore (similar to Anthrax shot), about 6 hours after shot slight fever and chills/sweating started, along with fatigue and headache. Symptoms persisted for approx. 48 hours and receded.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: About 2 hours after vaccination site was very sore (similar to Anthrax shot), about 6 hours after shot slight fever and chills/sweating started, along with fatigue and headache. Symptoms persisted for approx. 48 hours and receded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, COVID-19, COVID-19 pneumonia, Intensive care
Clinical narrative: COVID positive on 9/13/21 despite being fully vaccinated. Now with acute respiratory failure due to covid pneumonia requiring ICU admission and BIPAP. Still in process of being treated. Receiving decadron (requiring increased ARDS dosing due to progressively worsening respriatory status) and remdesivir. Received dose of tocilizumab 800 mg IV today.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: COVID positive on 9/13/21 despite being fully vaccinated. Now with acute respiratory failure due to covid pneumonia requiring ICU admission and BIPAP. Still in process of being treated. Receiving decadron (requiring increased ARDS dosing due to progressively worsening respriatory status) and remdesivir. Received dose of tocilizumab 800 mg IV today.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Thrombosis
Clinical narrative: Previously normal period. First period after vaccine with significantly increased and painful cramping not relieved by otc pain medication. Large clots present. I do not normally have any clots
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Feeling abnormal, Hypoaesthesia, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: Diagnosed with scoliosis and  this year 2021 due to back pain and lower lumbar nerve damage from previous knee surgeries on both knees in past years. Got my first dose of Pfizer and felt okay throughout the day until bedtime and woke up the next day in pain.Could NOT feel my back or left arm. It was Stiff, tiggling and  Hot/burning feeling all on my upper left side of my body. Felt half dead.   No OTC medicine fixed this. I suffered for days.  I am due for my next dose to keep my job, BUT i will NOT put myself through this again. I request exemption due to this and WILL NOT harm my body while still under-going my scoliosis process.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, X-ray
Clinical narrative: Diagnosed with scoliosis and  this year 2021 due to back pain and lower lumbar nerve damage from previous knee surgeries on both knees in past years. Got my first dose of Pfizer and felt okay throughout the day until bedtime and woke up the next day in pain.Could NOT feel my back or left arm. It was Stiff, tiggling and  Hot/burning feeling all on my upper left side of my body. Felt half dead.   No OTC medicine fixed this. I suffered for days.  I am due for my next dose to keep my job, BUT i will NOT put myself through this again. I request exemption due to this and WILL NOT harm my body while still under-going my scoliosis process.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis allergic
Clinical narrative: Allergic  Conjunctivitis in both eyes
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Full blood count, Superficial vein thrombosis, Thrombosis, Ultrasound Doppler
Clinical narrative: Blood clots left arm (1 superficial and 1 DVT)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Blood clots left arm (1 superficial and 1 DVT)
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: I have a red raised,feverish big heart shape rash at an below my injection site. 6 days later my arm is burning and hot to the touch.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia, Rash
Clinical narrative: Body aches, fever, headache, body rash, dizziness.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: Severe muscle soreness spread from left arm injection site throughout the entire body,  Subsided 3 days later and was normal 5 days post injection.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiovascular evaluation, Electrocardiogram, Heart rate, Hypertension
Clinical narrative: TACHYCARDIA; VERY HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04321A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient experienced tachycardia. On 14-APR-2021, the patient experienced very high blood pressure. Laboratory data included: Blood pressure (NR: not provided) very high, Electrocardiogram (NR: not provided) tachycardia, Lab test (NR: not provided) negative, and Pulse rate (NR: not provided) 130 {beats}/min. Laboratory data (dates unspecified) included: Cardiovascular evaluation (NR: not provided) not reported, and Lab test (NR: not provided) not reported. Treatment medications (dates unspecified) included: metoprolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and very high blood pressure. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test, Tachycardia
Clinical narrative: TACHYCARDIA; VERY HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04321A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the patient experienced tachycardia. On 14-APR-2021, the patient experienced very high blood pressure. Laboratory data included: Blood pressure (NR: not provided) very high, Electrocardiogram (NR: not provided) tachycardia, Lab test (NR: not provided) negative, and Pulse rate (NR: not provided) 130 {beats}/min. Laboratory data (dates unspecified) included: Cardiovascular evaluation (NR: not provided) not reported, and Lab test (NR: not provided) not reported. Treatment medications (dates unspecified) included: metoprolol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and very high blood pressure. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia, Joint swelling, Peripheral swelling, Rash
Clinical narrative: Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Mild numbness and redness in hands; Mild numbness and redness in hands; rash in veins; This is an Initial (PRD/SRD 07Apr2021) and Follow-up (PRD 07Apr2021/SRD 09Apr2021) spontaneous report from a contactable reporter (patient, self-reported). A 64-year-old female patient (age at vaccination:64 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7533 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 09:45 AM, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: PAA165969 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 05Mar2021 at 07:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Hashimoto's disease, hypotiroidism, arterial hypertension, and allergies to medications, food, or other products: Penicilina. Concomitant medications included levothyroxine and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Apr2021 at 17:30, the patient experienced swelling in face, hands and ankles and mild numbness and redness in hands and rash in veins. The patient did not receive treatment for the adverse event. No lab data was available. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Swelling in face, hands and ankles.; Mild numbness and redness in hands; Mild numbness and redness in hands; rash in veins; This is an Initial (PRD/SRD 07Apr2021) and Follow-up (PRD 07Apr2021/SRD 09Apr2021) spontaneous report from a contactable reporter (patient, self-reported). A 64-year-old female patient (age at vaccination:64 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EP7533 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 05Apr2021 at 09:45 AM, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: PAA165969 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 05Mar2021 at 07:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Hashimoto's disease, hypotiroidism, arterial hypertension, and allergies to medications, food, or other products: Penicilina. Concomitant medications included levothyroxine and lisinopril. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 05Apr2021 at 17:30, the patient experienced swelling in face, hands and ankles and mild numbness and redness in hands and rash in veins. The patient did not receive treatment for the adverse event. No lab data was available. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am) had not resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Ongoing sleep problems. Taking Zyrtec and is helping a tiny bit. Melatonin is not working. Waking up for 20-30 minutes a couple times a night with fitful sleep until I finally get up around 6-630 am.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diaphragmatic paralysis, Dyspnoea, Pyrexia
Clinical narrative: fever; chills; Paralyzed right diaphragm and breathing difficulty; Paralyzed right diaphragm and breathing difficulty; This spontaneous case was reported by a consumer and describes the occurrence of DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) (seriousness criterion medically significant) and DYSPNOEA (Paralyzed right diaphragm and breathing difficulty). On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, DIAPHRAGMATIC PARALYSIS (Paralyzed right diaphragm and breathing difficulty) and DYSPNOEA (Paralyzed right diaphragm and breathing difficulty) had not resolved and PYREXIA (fever) and CHILLS (chills) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab data included Xrays, CT scans, MRI's and pulmonary function test. No results provided.  No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter  Company comment: The case concerns a 65-year-old female patient with concurrent medical history of asthma who, presented with unexpected event of paralyzed right diaphragm and breathing difficulty 14 days after receiving the second dose of mRNA 1273 vaccine.  The patient was not responsive to use of inhalers for underlying disease and no result of diagnostic tests performed (X-ray, CT scan, MRI) were provided. Rechallenge was not applicable, as the event only occurred after the last dose. Causality assessment for the event was not provided by the reported. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: The case concerns a 65-year-old female patient with concurrent medical history of asthma who, presented with unexpected event of paralyzed right diaphragm and breathing difficulty 14 days after receiving the second dose of mRNA 1273 vaccine.  The patient was not responsive to use of inhalers for underlying disease and no result of diagnostic tests performed (X-ray, CT scan, MRI) were provided. Rechallenge was not applicable, as the event only occurred after the last dose. Causality assessment for the event was not provided by the reported. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Lymphadenopathy
Clinical narrative: Swollen lymph nodes and a hard knot close to breast; Swollen lymph nodes and a hard knot close to breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to morphine).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast). At the time of the report, BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No additional adverse events reported; administered RECOMBIVAX HB that had undergone a temperature excursion; This spontaneous report was received from a nurse, referring to 12 years old female patient. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 19-AUG-2021, the patients was administered hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, dose, route were not reported; lot# S005808 has been verified to be a valid lot number for hepatitis b vaccine (recombinant), expiration date 02-NOV-2021) for prophylaxis that had undergone a temperature excursion. No additional adverse events were reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: S005808; expirationdate: 02-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA006895: US-009507513-2108USA007014:
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: no adverse event; expired vaccine administered; This spontaneous report was received from a registered nurse and refers to a 13-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapy was not reported.   On 26-AUG-2021, the patient was vaccinated with expired varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dose, route of administration were not reported) lot # S024367, expiry date 06-AUG-2021; as prophylaxis. No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Colonoscopy, Smear cervix abnormal
Clinical narrative: Abnormal pap smears; This spontaneous report was received from a company representative concerning to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    Prior to her the vaccine, she never had any issues with her pap smears.  In approximately 2011 (reported as 10 years ago), the patient was vaccinated with a dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose route, frequency, lot# and the expiration date)  for Human Papillomavirus (HPV) prevention.        After receiving the vaccine (unknown date), she started having abnormal pap smears, year after year. The friend had to repeat pap smears numerous times and even had to perform a colonoscopy (unknown results). She sought medical attention.  At the time of reporting, the outcome of smear cervix abnormal was unknown.   The reporter considered smear cervix abnormal to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9), reported as "the friend blames hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for giving her abnormal pap smears".
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a currently 81-years-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 01-JAN-2011, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles (herpes zoster) and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: Shingles and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of the events was unknown.   The reporter considered the events of shingles and other zoster-related conditions (ill-defined disorder) to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain upper, Asthma, Condition aggravated, Gastrooesophageal reflux disease, Immediate post-injection reaction
Clinical narrative: extremely sick; her lungs and stomach started hurting; her lungs and stomach started hurting; asthma flare up; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; she reported having pain all over all the time due to the vaccine; still having daily migraines; problems with sciatica; GERD; This spontaneous report was received from a female patient of unknown age. The patient's concurrent conditions included asthma. Her medical history and concomitant medications were not reported.  On 17-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported).  Since she received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine on that date, she had been extremely sick. Immediately after the vaccine was administered, she became extremely ill. Her lungs and stomach started hurting and that her asthma flared up. She was not able to speak loudly due to trauma to her throat from all the health issues she had had since the vaccine being administered. She also was having pain all over all the time due to the vaccine. She had to call an ambulance on 01-SEP-2021 (also reported as the last Wednesday) and was rush to the hospital. She was not admitted but was sent home on medication. Her primary physician though she was given the Coronavirus disease (COVlD) vaccine instead of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine, however, she called the pharmacy were she got the vaccine and they reported that it was the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that she had received. She was no longer able to stay on the phone to provide more information due to be extremely sick. She reported it has been going on 3 weeks now. After that, on an unknown date in 2021, she experienced and still having daily migraines, problems with sciatica, gastroesophageal reflux disease (GERD), asthma, had not driven in a month and missing out on too much. Caller stated her daily life changed. She had doctor appointments that she had to cancel if no one was there to take her because she could not drive.  The outcome of illness, pain, speech sound disorder, oropharyngeal discomfort, asthma aggravated, abdominal pain upper and pulmonary pain was unknown. The outcome of migraine, gastrooesophageal reflux disease and sciatica was not resolved.  The reporter considered the pain to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal assessment between all the other events and the suspect therapy was not provided.
Sex: F
Vaccine: PPV
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Malaise, Migraine, Oropharyngeal discomfort
Clinical narrative: extremely sick; her lungs and stomach started hurting; her lungs and stomach started hurting; asthma flare up; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; she reported having pain all over all the time due to the vaccine; still having daily migraines; problems with sciatica; GERD; This spontaneous report was received from a female patient of unknown age. The patient's concurrent conditions included asthma. Her medical history and concomitant medications were not reported.  On 17-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported).  Since she received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine on that date, she had been extremely sick. Immediately after the vaccine was administered, she became extremely ill. Her lungs and stomach started hurting and that her asthma flared up. She was not able to speak loudly due to trauma to her throat from all the health issues she had had since the vaccine being administered. She also was having pain all over all the time due to the vaccine. She had to call an ambulance on 01-SEP-2021 (also reported as the last Wednesday) and was rush to the hospital. She was not admitted but was sent home on medication. Her primary physician though she was given the Coronavirus disease (COVlD) vaccine instead of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine, however, she called the pharmacy were she got the vaccine and they reported that it was the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that she had received. She was no longer able to stay on the phone to provide more information due to be extremely sick. She reported it has been going on 3 weeks now. After that, on an unknown date in 2021, she experienced and still having daily migraines, problems with sciatica, gastroesophageal reflux disease (GERD), asthma, had not driven in a month and missing out on too much. Caller stated her daily life changed. She had doctor appointments that she had to cancel if no one was there to take her because she could not drive.  The outcome of illness, pain, speech sound disorder, oropharyngeal discomfort, asthma aggravated, abdominal pain upper and pulmonary pain was unknown. The outcome of migraine, gastrooesophageal reflux disease and sciatica was not resolved.  The reporter considered the pain to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal assessment between all the other events and the suspect therapy was not provided.
Sex: F
Vaccine: PPV
Symptoms: Pain, Pulmonary pain, Sciatica, Speech sound disorder
Clinical narrative: extremely sick; her lungs and stomach started hurting; her lungs and stomach started hurting; asthma flare up; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; she reported having pain all over all the time due to the vaccine; still having daily migraines; problems with sciatica; GERD; This spontaneous report was received from a female patient of unknown age. The patient's concurrent conditions included asthma. Her medical history and concomitant medications were not reported.  On 17-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported).  Since she received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine on that date, she had been extremely sick. Immediately after the vaccine was administered, she became extremely ill. Her lungs and stomach started hurting and that her asthma flared up. She was not able to speak loudly due to trauma to her throat from all the health issues she had had since the vaccine being administered. She also was having pain all over all the time due to the vaccine. She had to call an ambulance on 01-SEP-2021 (also reported as the last Wednesday) and was rush to the hospital. She was not admitted but was sent home on medication. Her primary physician though she was given the Coronavirus disease (COVlD) vaccine instead of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine, however, she called the pharmacy were she got the vaccine and they reported that it was the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that she had received. She was no longer able to stay on the phone to provide more information due to be extremely sick. She reported it has been going on 3 weeks now. After that, on an unknown date in 2021, she experienced and still having daily migraines, problems with sciatica, gastroesophageal reflux disease (GERD), asthma, had not driven in a month and missing out on too much. Caller stated her daily life changed. She had doctor appointments that she had to cancel if no one was there to take her because she could not drive.  The outcome of illness, pain, speech sound disorder, oropharyngeal discomfort, asthma aggravated, abdominal pain upper and pulmonary pain was unknown. The outcome of migraine, gastrooesophageal reflux disease and sciatica was not resolved.  The reporter considered the pain to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal assessment between all the other events and the suspect therapy was not provided.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX vaccine was administered 16JUL2021 following a supported temperature excursion on 28JUN2021; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 4-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions, or allergies was provided.  On 28-JUN-2021, a temperature excursion involving varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T038830 has been verified to be valid, expiration date reported and established as 17-NOV-2022) occurred. The vaccine was improperly stored at a temperature of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 16-JUL-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, administered dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported)  as prophylaxis (product storage error).
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX was administered 27AUG2021 following a supported temperature excursion; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 5-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, previous drug reactions, or allergies was provided.  On 28-JUN-2021, a temperature excursion involving varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T038830 has been verified to be valid, expiration date reported and validated as 17-NOV-2022) occurred. The vaccine was improperly stored at a temperature of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion.  On 27-AUG-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, administered dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) as prophylaxis (product storage error).  This is one of several reports received from the same reporter.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: Patient had the first two doses of GARDASIL 9 and now she is 46 years old; Patient had the first two doses of GARDASIL 9 and now she is 46 years old; This spontaneous report was received from a registered nurse, referring to a 46 year old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not reported.  On unknown dates (reported as when the patient was 45 years old), the patient received the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, anatomical location, lot #, and expiration date were not reported) for prophylaxis. At the time of the report (stated by the patient as now), the patient was 46 years old (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error).
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received his first administration of GARDASIL 9 at the age of 26 and has not received the rest of recommended doses; No additional adverse events reported; This spontaneous report was received from a pharmacy intern, referring to a 32 year old male patient. The patient's medical history, concurent conditions, and concomitant medications were not reported.  On an unknown date (reported as at the age of 26), the patient was vaccinated with the first and only hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, anatomical location, lot #, and expiration date were not provided) for prophylaxis. At the time of the report, the patient had not received the rest of the recommended doses (Inappropriate schedule of product administration). No additional adverse events were reported.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No other AE; The patient inadvertently received a dose of VARlVAX on 9/14/2021.; a dose of VARlVAX on 7/30/2021./ The patient inadvertently received a dose of VARlVAX on 9/14/2021.; This spontaneous report was received from a pharmacist and refers to a 15-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 30-JUL-2021, the patient received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-SEP-2021, the patient came to the office and was scheduled to receive a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). On that day the patient inadvertently received a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, exact dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No other adverse event was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria, Vaccination complication
Clinical narrative: broke out in hives; patient had a reaction to it after receiving the vaccine a few years ago; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, the patient broke out in hives (urticaria) and had a reaction (vaccination complication).      The outcome of urticaria and vaccination complication was unknown. The causal relationship between the vaccine and urticaria was not reported, while the causality with vaccine complication was related.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; vaccine was administered after the expiration date; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 15-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, ot number S025610, expiration date 18-AUG-2021 (route of administration not provided) for prophylaxis (expired product administered). No adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion for PROQUAD/vaccines that were administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 11-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) 0.5 mL subcutaneously (SQ) (lot number T016990 has been verified to be valid, expiration date reported and established as 11-NOV-2021) as prophylaxis.  The vaccine was exposed to a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.3°F) during a time frame of 37 minutes (product storage error).   Aditionally, it was reported that other doses of the vaccine experienced temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (9.9°F) during a time frame of 2 hours, 11 minutes, and 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.6°F) during a time frame of 59 minutes.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: a temperature excursion for PROQUAD/Information obtained for vaccines that were administered to patients; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 25-JUL-2021, there was a previous temperature excursion between 6 to 14 degrees Fahrenheit (7.3 degrees Fahrenheit) for 37 minutes that was not reported.   On 19-AUG-2021, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (0.5mL subcutaneous (SQ) x 1 dose, lot # T016990, expiration date 11-NOV-2021) for prophylaxis (product storage error).