chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Dizziness, Dyspepsia, Feeling hot
Clinical narrative: Late in the evening after receiving the shot, I felt hot, and uncomfortable. The entire next day I felt dizzy, slow, hot, and later in the evening I had what felt like heartburn. A gripping in my chest. By morning of the second day I felt 100% again.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness
Clinical narrative: Late in the evening after receiving the shot, I felt hot, and uncomfortable. The entire next day I felt dizzy, slow, hot, and later in the evening I had what felt like heartburn. A gripping in my chest. By morning of the second day I felt 100% again.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: Blood Clot Left Leg
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood prolactin increased, Generalised tonic-clonic seizure, Ultrasound kidney normal, Vitamin B12 normal, X-ray normal
Clinical narrative: 5 days afterwards  i had a grandmal seizure  for unknown cause.  No history of seizures.  No symptoms prior to this event.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Adnexa uteri pain, Arthralgia, Asthenia, Bone pain
Clinical narrative: Immediately had Wrist pain, body felt off within 15 minutes,  within two hours fever, body aches, injection site pain, fatigue, headache, heart racing 125bpm, chest/heart ache, after 6 hours nausea, severe arm pain, after 18 hours vomiting, body weakness, shortness of breath, almost passed out, severe bone pain, muscle aches, chills, ovary pain, break-through period .  Feet hurt to walk on, severe weakness. Pain and fever did not go away with Tylenol or Advil. Fever lasted five days. Break-through period lasted 3.5 weeks. High blood pressure was marked a week after vaccine. Still have high heart rate, shortness of breath, high blood pressure, headache, fatigue, ovary pain, malaise, swollen abdomen 4 weeks later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Immediately had Wrist pain, body felt off within 15 minutes,  within two hours fever, body aches, injection site pain, fatigue, headache, heart racing 125bpm, chest/heart ache, after 6 hours nausea, severe arm pain, after 18 hours vomiting, body weakness, shortness of breath, almost passed out, severe bone pain, muscle aches, chills, ovary pain, break-through period .  Feet hurt to walk on, severe weakness. Pain and fever did not go away with Tylenol or Advil. Fever lasted five days. Break-through period lasted 3.5 weeks. High blood pressure was marked a week after vaccine. Still have high heart rate, shortness of breath, high blood pressure, headache, fatigue, ovary pain, malaise, swollen abdomen 4 weeks later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Injection site pain, Intermenstrual bleeding, Malaise
Clinical narrative: Immediately had Wrist pain, body felt off within 15 minutes,  within two hours fever, body aches, injection site pain, fatigue, headache, heart racing 125bpm, chest/heart ache, after 6 hours nausea, severe arm pain, after 18 hours vomiting, body weakness, shortness of breath, almost passed out, severe bone pain, muscle aches, chills, ovary pain, break-through period .  Feet hurt to walk on, severe weakness. Pain and fever did not go away with Tylenol or Advil. Fever lasted five days. Break-through period lasted 3.5 weeks. High blood pressure was marked a week after vaccine. Still have high heart rate, shortness of breath, high blood pressure, headache, fatigue, ovary pain, malaise, swollen abdomen 4 weeks later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Palpitations
Clinical narrative: Immediately had Wrist pain, body felt off within 15 minutes,  within two hours fever, body aches, injection site pain, fatigue, headache, heart racing 125bpm, chest/heart ache, after 6 hours nausea, severe arm pain, after 18 hours vomiting, body weakness, shortness of breath, almost passed out, severe bone pain, muscle aches, chills, ovary pain, break-through period .  Feet hurt to walk on, severe weakness. Pain and fever did not go away with Tylenol or Advil. Fever lasted five days. Break-through period lasted 3.5 weeks. High blood pressure was marked a week after vaccine. Still have high heart rate, shortness of breath, high blood pressure, headache, fatigue, ovary pain, malaise, swollen abdomen 4 weeks later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Immediately had Wrist pain, body felt off within 15 minutes,  within two hours fever, body aches, injection site pain, fatigue, headache, heart racing 125bpm, chest/heart ache, after 6 hours nausea, severe arm pain, after 18 hours vomiting, body weakness, shortness of breath, almost passed out, severe bone pain, muscle aches, chills, ovary pain, break-through period .  Feet hurt to walk on, severe weakness. Pain and fever did not go away with Tylenol or Advil. Fever lasted five days. Break-through period lasted 3.5 weeks. High blood pressure was marked a week after vaccine. Still have high heart rate, shortness of breath, high blood pressure, headache, fatigue, ovary pain, malaise, swollen abdomen 4 weeks later.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Induration, Intermenstrual bleeding, Lymphadenopathy, Sinus congestion
Clinical narrative: Started on the morning of 6/25/2021. I received my second dose of Pfizer COVID vaccination after my menstrual period ended and this morning when I woke up, I noticed that there was blood on the toilet paper. There was no blood in the urine and throughout the day, there continues to be an increase in the amount of blood left on my pad and tissue paper. Haven't had issues with spotting in the past and this is a new occurrence. Also feel that my left posterior auricular lymph node is harder and more swollen and left sinus is more congested.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Gait disturbance, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Sudden sharp pain in the right leg under the knee.  Making it difficult to walk and move.  Noticed three small bruises in the same area appeared around 1 hour after the pain started.  Also some swelling around the area.  And the area around the bruises is pale (white)  This happens today at 2:30 pm June 24  The vaccine was administered June 21 11:30 am
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Sudden sharp pain in the right leg under the knee.  Making it difficult to walk and move.  Noticed three small bruises in the same area appeared around 1 hour after the pain started.  Also some swelling around the area.  And the area around the bruises is pale (white)  This happens today at 2:30 pm June 24  The vaccine was administered June 21 11:30 am
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Contusion, Discomfort, Fatigue
Clinical narrative: Sudden sharp pain in the right leg under the knee.  Making it difficult to walk and move.  Noticed three small bruises in the same area appeared around 1 hour after the pain started.  Also some swelling around the area.  And the area around the bruises is pale (white)  This happens today at 2:30 pm June 24  The vaccine was administered June 21 11:30 am
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Pain assessment, Pain in extremity
Clinical narrative: Sudden sharp pain in the right leg under the knee.  Making it difficult to walk and move.  Noticed three small bruises in the same area appeared around 1 hour after the pain started.  Also some swelling around the area.  And the area around the bruises is pale (white)  This happens today at 2:30 pm June 24  The vaccine was administered June 21 11:30 am
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Mammogram abnormal, Ultrasound breast
Clinical narrative: Patient went for a routine mammogram screening and was noted to have R axilla lymphadenopathy- likely reactive lymph nodes
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Pain in extremity, Tinnitus
Clinical narrative: Sore arm, increased and loud heartbeat, shortness of breath, lightheaded, and tinnitus.
Age: 50.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Asthenia, Burning sensation, Dizziness, Erythema, Fatigue
Clinical narrative: Severe aches and pains, felt like my skin was on fire, horrible headache, exhaustion, and extreme pain in my arm.   I was very weak and dizzy.  The next day my arm was huge and had red welts all over it.  The doctor told me to take an antihistamine and ice it.  I was on back to back ibuprofin and tylenol, however it barely helped. Symptoms have lasted 17 hours so far.  If my arm is still sore, red, and huge I will go in tomorrow to urgent care.
Age: 50.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Severe aches and pains, felt like my skin was on fire, horrible headache, exhaustion, and extreme pain in my arm.   I was very weak and dizzy.  The next day my arm was huge and had red welts all over it.  The doctor told me to take an antihistamine and ice it.  I was on back to back ibuprofin and tylenol, however it barely helped. Symptoms have lasted 17 hours so far.  If my arm is still sore, red, and huge I will go in tomorrow to urgent care.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Genital ulceration
Clinical narrative: Genital ulcer
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain, heart beat around 100 for few hours.  Took Motrin.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Pronounced lower back pain and left leg pain, commencing second day after vaccination. Experienced both in milder form at the same interval after first vaccination.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Very fast heart beating and shortness of breath (maybe related to heart inflammation side effect)
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Chills, Cluster headache
Clinical narrative: No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot.  At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine.  As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup.  As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held.  As of June 25th max athletic output at 80% of capabilities prior to the vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Electrocardiogram normal, Fatigue, Headache, Myalgia
Clinical narrative: No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot.  At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine.  As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup.  As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held.  As of June 25th max athletic output at 80% of capabilities prior to the vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Urinary incontinence
Clinical narrative: No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot.  At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine.  As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup.  As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held.  As of June 25th max athletic output at 80% of capabilities prior to the vaccine.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Angina pectoris, Blood pressure decreased, Chest discomfort, Chills
Clinical narrative: About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling  very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dissociation, Dizziness, Dyspnoea, Feeling abnormal, Flushing
Clinical narrative: About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling  very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypotonia, Muscle tightness, Nausea
Clinical narrative: About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling  very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling  very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: High fever 103 and diarrhea for 3 days  Fatigue, strong headache, sensitivity to smell, sensitivity to light and nausea for 24 h Dizziness and brain fog for 1 week
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Parosmia, Photophobia, Pyrexia
Clinical narrative: High fever 103 and diarrhea for 3 days  Fatigue, strong headache, sensitivity to smell, sensitivity to light and nausea for 24 h Dizziness and brain fog for 1 week
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Menstruation irregular
Clinical narrative: 2d post receiving the second dose developed a nose bleed - lasted 10 minutes 2d post had headache all day 3d post started her menses (would not have been typically due at that time)
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect route of product administration, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 26-MAY-2021 the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (strength was not reported; dose: 0.5 milliliter, lot # was T019423 and expiration date was 02-DEC-2021) and varicella virus vaccine live (oka/merck)(VARIVAX) (strength was not reported; dose: 0.5 milliliter, lot # was S021320 and expiration date was 09-JUL-2021) via intramuscular for prophylaxis (wrong product administered; incorrect route of product administration). No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date and route were not reported)  for prophylaxis. On an unknown date post administration, the patient had two trips to Emergency Room (ill-defined disorder). At the time of the report, the outcome of ill-defined disorder was unknown.  The reporter considered ill-defined disorder to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The patient also mentioned that she seemed to have a reaction to every vaccine she got.
Sex: M
Vaccine: HIBV, PPV
Symptoms: Anti-platelet antibody positive, Blood immunoglobulin A decreased, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Coombs test negative
Clinical narrative: loss of protective titers; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 17-year-old male patient with germline heterozygous nonsense mutations in IKZF1 primarily affecting dimerization by haploinsufficiency, demonstrating reduced IKAROS expression. The patient was diagnosed at 9 years of age with immune thrombocytopenia (ITP). His concurrent conditions included mild leukopenia, thrombocytopenia and hypogammaglobulinemia. He did not have a history of recurrent or severe infections. His family history was remarkable for his father reporting one episode of pneumonia in adulthood, and pernicious anemia. On unspecified dates, the patient was receiving IgG replacement therapy. On an unknown date, the patient's laboratory results showed immunoglobulins IgG 1001 mg/dL, IgA 49 mg/dL (low result), IgM 14 mg/dL (low result), anti-platelet antibodies test was positive and Coombs test was negative.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)(dose, frequency, lot number and expiration date were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown)(dose, frequency, lot number and expiration date were not reported), both for prophylaxis.     On an unknown date, he experienced progressive loss of protective titers towards pneumococcal and Haemophilus influenzae b (Hib) antigens. The outcome of the event was unknown. The authors considered antibody test negative to be related to the suspect vaccines.  A copy of the published literature article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HIBV, PPV
Symptoms: Viral titre decreased
Clinical narrative: loss of protective titers; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 17-year-old male patient with germline heterozygous nonsense mutations in IKZF1 primarily affecting dimerization by haploinsufficiency, demonstrating reduced IKAROS expression. The patient was diagnosed at 9 years of age with immune thrombocytopenia (ITP). His concurrent conditions included mild leukopenia, thrombocytopenia and hypogammaglobulinemia. He did not have a history of recurrent or severe infections. His family history was remarkable for his father reporting one episode of pneumonia in adulthood, and pernicious anemia. On unspecified dates, the patient was receiving IgG replacement therapy. On an unknown date, the patient's laboratory results showed immunoglobulins IgG 1001 mg/dL, IgA 49 mg/dL (low result), IgM 14 mg/dL (low result), anti-platelet antibodies test was positive and Coombs test was negative.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)(dose, frequency, lot number and expiration date were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown)(dose, frequency, lot number and expiration date were not reported), both for prophylaxis.     On an unknown date, he experienced progressive loss of protective titers towards pneumococcal and Haemophilus influenzae b (Hib) antigens. The outcome of the event was unknown. The authors considered antibody test negative to be related to the suspect vaccines.  A copy of the published literature article is attached as further documentation of the patient's experience.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Incorrect product storage; no adverse event; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  It was reported by the medical assistant that on an unknown date, the administration of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032316 with expiration date on 22-SEP-2022) as prophylaxis. The temperature was -12.7 degree Celsius. Time frame: 0 hours, 13 minutes, 0 seconds. There was no previous temperature excursion and the call was not because of "data logger". No additional adverse events were reported, further details were not provided.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; a patient was inadvertently administered GARDASIL 9 today (14JUN2021) that was expired; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 14-JUN-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, formulation, concentration, vaccination scheme frequency, route of administration, anatomical site of vaccination were not reported; lot number R009615 has been verified to be valid, expiration date reported and validated as 07-DEC-2020) (expired product administered). No additional adverse events (AEs) reported.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: Customer reports that the finger flange has broken off and is separated from the barrel of the syringe; the patient did not experience any other AE; one of the GARDASIL 9 doses was administered to a patient before the defect was noticed; This spontaneous report was received from a consumer and refers to a 23-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 09-JUN-2021, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered into left deltoid, lot # T024831, expiration date 18-NOV-2022 (exact dose and route of administration were not provided) for prophylaxis. The reporter stated that finger flange had broken off and was separated from the barrel of the syringe (poor quality device used, syringe issue). It was reported that there was another dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) with the same issue from the same box and tray but it was not administered. No adverse event was reported (with an outcome reported as recovered). 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: T024831; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
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 78 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 14-OCT-2014, 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: U
Vaccine: HPV9
Symptoms: No adverse event, Poor quality product administered, Product distribution issue, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medication and drug reactions or allergies was not provided. On an unspecified date in April 2021, the reporter had a delivery of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that did not arrive for more than 5 days (product distribution issue), when the product was received it was supposed to be returned to the wholesaler, instead it was placed in the refrigerator. Information about the temperature storage or a time frame was unknown by the reporter. There wasn't a previous temperature excursion. On 15-JUN-2021, the patient was vaccinated with a bad dose  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe, 1 time dose as prophylaxis (lot number T026168 has been verified to be valid, expiration date reported and validated as 04-DEC-2022) (vaccination scheme frequency, route and anatomical location of administration were not provided) (product storage error) (poor quality product administered). No additional adverse events occurred. This is one of several reports received from the same reporter. 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: T026168; expirationdate: 04-DEC-2022; 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-009507513-2106USA005004: US-009507513-2106USA005005: US-009507513-2106USA005047: US-009507513-2106USA005081: US-009507513-2106USA005150:
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: No additional AEs reported; a patient received her first dose of GARDASIL 9 two years ago and did not receive the second or third dose recommended in the series; This spontaneous report was received from a pharmacy technician referring to a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies was not provided.    In June 2019 (reported as two years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. The patient did not receive the second or third dose recommended in the series (inappropriate schedule of product administration). No additional adverse event was reported.
Sex: F
Vaccine: HPV4
Symptoms: Anaphylactic reaction
Clinical narrative: reaction of anaphylaxis; This spontaneous report was received from a nurse practitioner referring to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  It was reported that the patient participated in a clinical trial for quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (dose, route of administration, lot #, expiration date were not reported). On an unknown date, the patient experienced reaction of anaphylaxis. The health care professional (HCP) was not sure if the event occurred during the trial. There was no additional adverse event details provided. The outcome of reaction of anaphylaxis was not reported.  Causal relationship between the event of reaction of anaphylaxis and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not provided.  Upon internal review, the event of reaction of anaphylaxis was considered medically significant.
Sex: U
Vaccine: VARCEL
Symptoms: Product dose omission issue
Clinical narrative: Missed dose for Varivax; No adverse event; This spontaneous report was received from a physician and refers to a 9 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  In August 2012, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route, lot number and expiration date were not reported) for prophylaxis. The patient did not receive the second dose of varicella virus vaccine live (oka/merck) (VARIVAX).
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: error that occurred at my organization involving the administration of PROQUAD (MMR V) vaccine to a 17 year old patient; No additional AE; This spontaneous report was received from an educator via company representative referring to a 17-year-old patient of unkno gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On an unknown date, at the reporter's organization the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). Other suspect therapies included sterile diluent (dose, route of administration, anatomical location, lot number and expiration date were not reported) (product administered to patient of inappropriate age).   It was also mentioned that the clinic leadership and provider were not sure what follow up was needed or if there were any health concerned, they should be aware of due to this error. No additional adverse events were reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Chest X-ray, Chest pain, Echocardiogram, Full blood count
Clinical narrative: Myocarditis; Heart rate increased; Chest pain; Inflammation; This case was received via VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and INFLAMMATION (Inflammation) (seriousness criterion hospitalization). 26-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate increased) (seriousness criterion hospitalization). The patient was treated with COLCHICINE for Inflammation, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Angiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Chest X-ray: not provided (Inconclusive) Not provided. On 26-Feb-2021, Echocardiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Heart rate: increased (Inconclusive) Increased. On 26-Feb-2021, Lipids: not provided (Inconclusive) Not provided. On 26-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 26-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 26-Feb-2021, Urine analysis: not provided (Inconclusive) Not provided. On 27-Feb-2021, Full blood count: not provided (Inconclusive) Not provided. On 27-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 27-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 01-Mar-2021, Echocardiogram: not provided (Inconclusive) Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Patient received treatment to Lower Heart rate and Inflammation.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Inflammation, Lipids, Metabolic function test
Clinical narrative: Myocarditis; Heart rate increased; Chest pain; Inflammation; This case was received via VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and INFLAMMATION (Inflammation) (seriousness criterion hospitalization). 26-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate increased) (seriousness criterion hospitalization). The patient was treated with COLCHICINE for Inflammation, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Angiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Chest X-ray: not provided (Inconclusive) Not provided. On 26-Feb-2021, Echocardiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Heart rate: increased (Inconclusive) Increased. On 26-Feb-2021, Lipids: not provided (Inconclusive) Not provided. On 26-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 26-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 26-Feb-2021, Urine analysis: not provided (Inconclusive) Not provided. On 27-Feb-2021, Full blood count: not provided (Inconclusive) Not provided. On 27-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 27-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 01-Mar-2021, Echocardiogram: not provided (Inconclusive) Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Patient received treatment to Lower Heart rate and Inflammation.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin, Urine analysis
Clinical narrative: Myocarditis; Heart rate increased; Chest pain; Inflammation; This case was received via VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and INFLAMMATION (Inflammation) (seriousness criterion hospitalization). 26-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate increased) (seriousness criterion hospitalization). The patient was treated with COLCHICINE for Inflammation, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Angiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Chest X-ray: not provided (Inconclusive) Not provided. On 26-Feb-2021, Echocardiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Heart rate: increased (Inconclusive) Increased. On 26-Feb-2021, Lipids: not provided (Inconclusive) Not provided. On 26-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 26-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 26-Feb-2021, Urine analysis: not provided (Inconclusive) Not provided. On 27-Feb-2021, Full blood count: not provided (Inconclusive) Not provided. On 27-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 27-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 01-Mar-2021, Echocardiogram: not provided (Inconclusive) Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Patient received treatment to Lower Heart rate and Inflammation.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dysarthria, Lethargy
Clinical narrative: Death; Dysarthria; Lethargy; This case was received via FDA VAERS (Reference number: 1358542) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), DYSARTHRIA (Dysarthria) and LETHARGY (Lethargy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (History of multiple back surgeries including a rod placement.).    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DEATH (Death) (seriousness criteria death and medically significant), DYSARTHRIA (Dysarthria) (seriousness criterion death) and LETHARGY (Lethargy) (seriousness criterion death). The patient died on 27-May-2021. The cause of death was not reported. An autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported. On 27 May 2021, autopsy was performed. As per the spouse, the autopsy results were pending.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.Very limited information regarding the events have been provided at this time.; Reported Cause(s) of Death: Unknown cause of death