chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase MB, Chest X-ray, Chills, Computerised tomogram abdomen, Computerised tomogram head
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram neck, Computerised tomogram pelvis, Computerised tomogram thorax, Differential white blood cell count, Dizziness
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electromyogram normal, Fibrin D dimer, Full blood count, Headache
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Influenza A virus test, Influenza B virus test, Labyrinthitis
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Migraine
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Nausea, Nerve conduction studies normal, Neuralgia
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Photophobia, Prothrombin time
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Scan with contrast, Sleep disorder, Tinnitus, Troponin T
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, Vertigo, Vestibular migraine, Vomiting
Clinical narrative: Received 1st shot of Moderna vaccine on February 25th. On March 8th started to have headaches/migraines and took Ibuprofen, this headache lasted for 3 days. Received my second Moderna vaccine on March 24th. On March 25th had chills, fever 102-103, weakness on the left arm, whole body aches, and headache. This lasted for 24 hours. On April 8th started to have lower back pain, lower right leg pain, muscle pains and this continue on for weeks. Saw chiropractor and acupuncture to get some relief. On April 28th started having left arm and upper back left side stabbing pain, felt like needles pocking. On May 5th was coming down stairway, got really dizzy and almost fell to the ground. May 10th started to have have more back pain, couldnt sleep on back  due to pain and head started spinning, left arm pins and needles, numbness on left side from neck to tip of fingers on left arm. This continued and on May 12th got very dizzy, nausea, throwing up, headaches, ringing in the left ear, left side pain and numbness and ended up at ER. In the ER was given diagnosis of vertigo and migraine, Since then have seen Neurologist, ENT, PT, Audiologist, Neurosurgeon, and have been given diagnosis of tinnitus. vestibular migraine, labyrinthitis. Never had these symptoms before the vaccine. Currently on leave and not able to work or resume regular daily life. Have taken one week of steroids to decrease inflammation, taking nortripline to help with migraine and numbness/pins and needles from left neck side through left arm and fingers.  Suffer from migraines, sensitivity to light. nerve pain.  Have done a balance test, audiology test, emg and nerve conduction study-all came back normal.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Basal ganglia infarction, Cerebral calcification, Cerebrovascular accident, Computerised tomogram head abnormal, Lacunar infarction
Clinical narrative: Stroke - CVA (cerebral vascular accident) (HCC) on 05/21/2021; 6:00am 10 day Hospital stay, ongoing Rehabilitation / Physical and Occupational Therapy
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, White matter lesion
Clinical narrative: Stroke - CVA (cerebral vascular accident) (HCC) on 05/21/2021; 6:00am 10 day Hospital stay, ongoing Rehabilitation / Physical and Occupational Therapy
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache, Injection site pain
Clinical narrative: Weakness, dizziness and headache approximately 12 hours later. Injection site pain.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Hypoaesthesia oral, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Tingling immediately in my feet. It moved into my legs with periods of numbness. Mostly pins and needles feeling or as if there were droplets of water. After two weeks, it moved into the right side of my face. Teeth hurt and extreme sinus pressure. Some numbness in tongue. Legs, lower legs and feet and behind knees, continued to have pins and needles sensation for seven weeks. Some small itchy bumps on legs. Also dizziness occurring during the first two weeks after dose one. I have not received dose two. I have delayed it on my own without consultation from doctors.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, Rash, Rash pruritic, Toothache
Clinical narrative: Tingling immediately in my feet. It moved into my legs with periods of numbness. Mostly pins and needles feeling or as if there were droplets of water. After two weeks, it moved into the right side of my face. Teeth hurt and extreme sinus pressure. Some numbness in tongue. Legs, lower legs and feet and behind knees, continued to have pins and needles sensation for seven weeks. Some small itchy bumps on legs. Also dizziness occurring during the first two weeks after dose one. I have not received dose two. I have delayed it on my own without consultation from doctors.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Gait disturbance, Magnetic resonance imaging abnormal, Multiple sclerosis
Clinical narrative: New multiple sclerosis onset / new diagnosis on 6/4/21 that presented with gait instability and slurring of words. MRI showed enhancing and non enhancing lesions in multiple locations.  Hospitalization 6.4-6.7.21
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Blood test normal, Computerised tomogram normal, Ear discomfort, Ear pain
Clinical narrative: At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain and severe ringing in head. Increase in severe muscle weakness in arms and legs for 3 months  plus  high blood pressure weakness
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Hypertension, Influenza like illness, Muscular weakness, Tinnitus
Clinical narrative: At first warm flu like feeling followed by severe flu like feeling without fever. Ear pressure pain and severe ringing in head. Increase in severe muscle weakness in arms and legs for 3 months  plus  high blood pressure weakness
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Blood glucose increased, Blood thyroid stimulating hormone increased
Clinical narrative: April 23 2021 had blood work done and TSH levels where extremely high 157.42 out of range. Creatinine levels and Glucose were also high.  June 11 2021 second panel for thyroid was done and TSH levels were >150 out of range.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Euphoric mood, Feeling of relaxation, Pain in extremity, Somnolence
Clinical narrative: Initially a sore arm for a few days, the next day felt a bit sleepy.  Third day feeling of euphoria and relief.  I hesitate to mention this because it may be unrelated but I swear my cell signal strength went up a bar as well.  The sore arm went away after a few days, I took a nap, but the euphoria and relief hasn't passed two months later. I'll learn to live with it.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Paralysis, Vision blurred
Clinical narrative: blurred vision, paralysis all over body. Time of occurrence was about 12:30 am 7/13/21. No treatment has been given since vaccine. Has had cuts in ligament on ankle (work related injury) the day before covid shot.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Days after the vaccine, inflammation and pain in the area of the puncture. It went away after 3-4 days. However, a week after the administration of the vaccine I woke up with significant inflammation with pain in the same area.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fear, Hormone level abnormal, Hot flush, Menopause
Clinical narrative: Hot flushes. Intense hot flushes every 20 mins for about 3 -4 weeks. Hormone levels were indicated pre-menopausal. Sonogram ordered.  Hormone levels returned to normal. Hot flushes went away.  But they were super intense for a while at all hours of day and night. Very scary
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound ovary
Clinical narrative: Hot flushes. Intense hot flushes every 20 mins for about 3 -4 weeks. Hormone levels were indicated pre-menopausal. Sonogram ordered.  Hormone levels returned to normal. Hot flushes went away.  But they were super intense for a while at all hours of day and night. Very scary
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Condition aggravated
Clinical narrative: Alopecia areata flared 3 weeks post vaccine after being dormant over 8.5 years. Half of eyebrow gone, needed 3 steroid injections in eyebrow to encourage hair regrowth.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: experiencing moderate injection site pain and erythema; experiencing moderate injection site pain and erythema; This spontaneous report has been received from a physician, concerning a 30-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-JUN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T025370 with expiration date 01-DEC-2022, intramuscularly in the right arm (dose and frequency were not provided) for prophylaxis.  On an unknown date in June 2021, the patient reported that was still experiencing moderate injection site pain and erythema (vaccination site pain and vaccination site erythema). The patient did not received treatment for the adverse events.  The outcome of vaccination site pain and vaccination site erythema was reported as not resolved at the reporting time. The reporter did not provide a causal relationship between the adverse events and the therapy. 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: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: RV5
Symptoms: Product temperature excursion issue
Clinical narrative: A rotateq vaccine was administered and it had temperature excursion; No additional AE reported; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided by the reporter.   On an unspecified date, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #T033812 and expiration reported as 29-DEC-2021 (strength, dose, frequency and route of administration were not reported).  It was informed that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) temperature excursion was at 47°F during 1 hour. There was no previous temperature excursion and the call was not made because a data logger. No additional adverse event was reported.; Sender's Comments:  US-009507513-2106USA004106:
Sex: U
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: No additional AEs; PROQUAD which was administered to a 37 year; PROQUAD which was administered to a 37 year The nurse states she does not know why PROQUAD was administered as the adult patient was needing the varicella vaccinations for graduate school; This spontaneous report was received from a registered nurse and refers to a 37 year old patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 12-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T010651, expiration date 22-SEP-2021 1.5 milliliter, for prophylaxis. The nurse states she did not know why measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)was administered as the adult patient was needing the varicella vaccinations for graduate school
Sex: F
Vaccine: PPV
Symptoms: Alpha 1 foetoprotein, Alpha 1 foetoprotein decreased, Condition aggravated, Hepatocellular carcinoma, Magnetic resonance imaging
Clinical narrative: (potentially related) intervening event in HCC reduction (unexpected benefit);   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 65-year-old female patient. No information regarding her medical history or concomitant therapy was provided. The patient's concurrent conditions included alcohol-associated cirrhosis. On an unknown date in December 2018, she was diagnosed with infiltrative 17 cm hepatocellular carcinoma (HCC) with occlusive portal vein tumor thrombus and serum alpha-fetoprotein (AFP) of 40 250 ng/mL. On an unknown date, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot#, expiry date were not reported) for prophylaxis. On an unspecified date in February 2019, she experienced spontaneous regression. On an unknown date in June 2019, (reported as: before treatment was initiated), she showed a spontaneous decrease in serum AFP to 250 ng/mL, prompting repeat magnetic resonance imaging (MRI). On an unspecified date in July 2019, the MRI surprisingly showed complete involution of both the primary tumor and the portal vein tumor thrombus. In October 2019, she reached a complete remission with no viable tumor. On an unspecified date in December 2019, she experienced the 1.5 cm HCC recurrence treated with transarterial chemoembolization (TACE) for a small area of suspected recurrence. In April 2020, the patient was asymptomatic with AFP  less than 2 ng/mL, in remission.   The authors of a published literature article considered unexpected therapeutic benefit to be possibly related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: PPV
Symptoms: Thrombosis
Clinical narrative: (potentially related) intervening event in HCC reduction (unexpected benefit);   This literature marketed report has been received from the authors of a published literature article, titled as stated above and refers to a 65-year-old female patient. No information regarding her medical history or concomitant therapy was provided. The patient's concurrent conditions included alcohol-associated cirrhosis. On an unknown date in December 2018, she was diagnosed with infiltrative 17 cm hepatocellular carcinoma (HCC) with occlusive portal vein tumor thrombus and serum alpha-fetoprotein (AFP) of 40 250 ng/mL. On an unknown date, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (formulation, strength, dose, frequency, route of administration, lot#, expiry date were not reported) for prophylaxis. On an unspecified date in February 2019, she experienced spontaneous regression. On an unknown date in June 2019, (reported as: before treatment was initiated), she showed a spontaneous decrease in serum AFP to 250 ng/mL, prompting repeat magnetic resonance imaging (MRI). On an unspecified date in July 2019, the MRI surprisingly showed complete involution of both the primary tumor and the portal vein tumor thrombus. In October 2019, she reached a complete remission with no viable tumor. On an unspecified date in December 2019, she experienced the 1.5 cm HCC recurrence treated with transarterial chemoembolization (TACE) for a small area of suspected recurrence. In April 2020, the patient was asymptomatic with AFP  less than 2 ng/mL, in remission.   The authors of a published literature article considered unexpected therapeutic benefit to be possibly related to Pneumococcal Vaccine, Polyvalent (23-valent)(manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: His prescriber gave him a prescription to receive GARDASIL 9 but he was 56 years old and he was not sure if he should used it since there was no safety or efficacy data available for his age.; No additional adverse event (AE) reported; This spontaneous report was received from a consumer referring to himself as a 56 year old male patient. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On an unknown date, the patient was prescribed HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported) as prophylaxis (product prescribing issue). The patient was unsure if he should be using HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since there was no safety or efficacy data available for his age. The patient stated there should be more information available to the public as to why people over 45 years old were not included in the clinical trials involving the suspect vaccine HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: he reported that on 02JUL2021 a patient was administered ROTATEQ that expired on 03JUN2021; no adverse event; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On 02-JUL-2021 the patient was vaccinated with an expired 2 ml dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis (lot number: 1684142  and expiration date: 03-JUN-2021) (vaccination scheme frequency were not reported). No adverse event was reported.
Age: 63.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Information as received from a lawyer and medical records and refers to a 63-year-old non-smoking female patient. Historical vaccinations inculded: tuberculine PPD, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (twice), influenza vaccine inact sag 3v(FLUVIRINE) and zoster vaccine live (ZOSTAVAX). On 06-OCT-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration were not reported) for prophylaxis. On 01-SEP-2016, the patient was vaccinated with a dose of pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) 0.5 milligram, in left deltoid, lot # M5t193, expiration date 02-MAY-2017 for prophylaxis. On 06-SEP-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration were not reported) for prophylaxis. On 06-SEP-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in 0.5 milligram right deltoid, lot # N011491, expiration date 04-NOV-2018 for prophylaxis. Concomitant therapies included influenza vaccine inact sag 3v(FLUVIRINE).; Sender's Comments:  US-009507513-2101USA000011:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No further information provided. No additional AE reported.; Caller stated the adult patient over 40 years old received the first dose of GARDASIL 9 in 2019. There was a gap between the first and second dose. Second and third doses were both administered sometime in 2021.; This spontaneous report has been received from an unspecified reporter (conflicting information as it was reported as physician and other) and refers to an adult patient of unknown gender reported as over 40-years-old. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On an unspecified date in 2019, 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) 0.5 milliliter (ml) for prophylaxis (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter).   On an unknown date in 2021 (also reported as "sometime in 2021"), the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter). It was reported that there was a gap between the first and the second dose (inappropriate schedule of product administration).  On an unspecified date in 2021 (also reported as "sometime in 2021"), the patient also received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency and route and anatomical site of administration were not provided; lot number and expiration date were unknown by the reporter). No additional adverse event (AE) was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms reported by the caller; Inappropriate schedule of vaccine administration; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 06-JUN-2021 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) (dose, frequency, route, lot # and expiration date not reported) for prophylaxis.    On 19-JUN-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637641, expiration date 16-FEB-2022) 0.5 mL intramuscularly (IM) (frequency not reported) (inappropriate schedule of product administration). No symptoms or additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637641; expirationdate: 16-FEB-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: 43.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Dizziness, Loss of consciousness, Nervousness
Clinical narrative: passed out; Dizziness; This spontaneous report was received from a 43-year-old male patient via other company Pfizer (2021855371). The patient's medical history and concomitant medications were not reported. It was reported that the patient was nervous about the vaccinations.  On an unknown date in August 2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. The patient had dizziness and he passed out when he got the vaccinations. The patient thought that this happened because "he was nervous about it".  The action taken with the suspect vaccines, the outcome of the events and the relatedness between the events and the suspect vaccines were not reported.  Upon internal review, the event of passed out was determined to be medically significant.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No other adverse event involved; Nurse calls and states an expired dose of PNEUMOVAX 23 PFS was inadvertently given to a patient; Information has been received from a registered nurse reporting on a 74-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 09-JUL-2021, the patient was vaccinated inadvertently with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot# S034299, expiry date 01-JUL-2021  (dose and route of administration were not reported). No other adverse event involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain
Clinical narrative: she has been having abdominal pain; This spontaneous report as received from a pharmacist refers to a non-pregnant 13-year-old female patient. There were no patient's concurrent conditions, medical history and concomitant therapies.    The patient had her 2nd injection with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly (strength, dose, lot number, expiration date were unknown) for prophylaxis (reported as "Cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58, Genital warts (condyloma acuminata) caused by HPV types 6 and 11, And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52,and 58: Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS), Cervical intraepithelial neoplasia (CIN) grade 1, Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3") on 15-JUN-2021. Since 22-JUN-2021, she had been having abdominal pain. It had been off and on since then. She gave it about 1-2 level of pain out of 10, sometimes her pain was 6-7. She was still having abdominal pain yesterday and into this morning." No treatment was given for the event. There were no laboratory/studies performed. The patient did not seek for medical attention.   At the time of reporting, the outcome of the event was considered to be not resolved. The causality was not provided.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza
Clinical narrative: FLU; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST.    On an unknown date, the patient experienced flu (preferred term: Influenza).     It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Product Role: Suspect
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pulmonary thrombosis
Clinical narrative: blood clot in the lungs; covid-19; This is a solicited report from a non-Pfizer sponsored program,  received from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb(manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-065486), license party for apixaban.  This 64-year-old male patient was involved in a patient support program. The patient (patient ID: redacted) received APIXABAN. The report describes a case of PULMONARY THROMBOSIS (blood clot in the lungs) and COVID-19. Co-suspect products included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started APIXABAN (unknown route), (unspecified dose and frequency). On an unknown date, the patient experienced PULMONARY THROMBOSIS (seriousness criteria hospitalization and medically significant) and COVID-19 (seriousness criterion hospitalization). The patient was treated with Surgery for Pulmonary thrombosis. The action taken with APIXABAN(Unknown) was unknown. At the time of the report, PULMONARY THROMBOSIS and COVID-19 outcome was unknown. Patient reported he got the Covid-19 shot and then got Covid-19, and got a blood clot. Patient was then sent to emergency and had surgery to get the blood clot taken out of his lungs. For APIXABAN(Unknown), the reporter did not provide any causality assessments. The primary reporter was the consumer. The indication of apixaban therapy was unknown.  Medical Evaluation Comment: This patient was hospitalized due to COVID 19 and Blood clot in lungs after receiving apixaban study therapy. Considering the anticoagulant nature of suspect therapy and the infective nature, mode of transmission and current pandemic situation due to COVID 19, a role of study therapy in the event COVID-19 is considered unlikely. Blood clot in lungs could be likely secondary to COVID-19 infection, hence not related to suspect therapy.  Causality assessment about apixaban for events 'thrombosis pulmonary, COVID-19' was not related as per Company (Bristol-Myers Squibb) and was not provided as per reporter.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. Conversely, the company does not attribute the reported events to study drug apixaban.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Unevaluable event
Clinical narrative: Miscarriage at 8 weeks pregnant; Unevaluable event; This case was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) (seriousness criterion medically significant). 14-May-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) and UNEVALUABLE EVENT (Unevaluable event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On  05/14/2021 and 05/17/2021 unknown lab tests were done ,results not provided. No Concomitant medications were  reported. No treatment information was provided.  This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.   Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.