chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Shingles vaccination. This is my second shot. I had a milder reaction with the first shot, but it is more severe with the second shot. Chills, aches and pains, 101 degree fever.  I am reporting these symptoms 36 hours following vaccination.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: large (~ 3x1.5 inc) area of redness and soreness with slight swelling. temperature  of the redness area is as the same as the other body parts. No fever noted. I recommend patient to apply cold compress and take ibuprofen as need for sore and swelling. If the redness spreading outward, fever, she need to go see doctor
Age: 47.0
Sex: U
Vaccine: PNC13
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain in right ventrolateral for over nine months. Felt like someone was consistently frogging me. In the beginning I could not lift my arm.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Grip strength decreased
Clinical narrative: patient stated he lost majority of his grip strength. He already has some condition that affects his grip to some degree, but after his second dose of shingrix, he stated he lost all grip strength in that one hand.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Dyspnoea, Hypertension, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Pain and tingling immediately, whole arm down to fingers Moderate swelling of upper arm  within first hours after shot Within 24 hours, some itching on torso, spreading to upper thighs by hour 30 Within 36 hours, some dry coughing with wheeze; possible throat constriction and a feeling of difficulty breathing Presented at hospital 12/21/2019 at 4 am with diff breathing, tachycardia, high BP Swelling of arm, throat constriction, itching etc. relieved within 30-60 minutes of receiving oral dose of Prednisone 60 mg Contiuned with four daily doses of Prednisone 40mg
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Tachycardia, Throat tightness
Clinical narrative: Pain and tingling immediately, whole arm down to fingers Moderate swelling of upper arm  within first hours after shot Within 24 hours, some itching on torso, spreading to upper thighs by hour 30 Within 36 hours, some dry coughing with wheeze; possible throat constriction and a feeling of difficulty breathing Presented at hospital 12/21/2019 at 4 am with diff breathing, tachycardia, high BP Swelling of arm, throat constriction, itching etc. relieved within 30-60 minutes of receiving oral dose of Prednisone 60 mg Contiuned with four daily doses of Prednisone 40mg
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: Pain and tingling immediately, whole arm down to fingers Moderate swelling of upper arm  within first hours after shot Within 24 hours, some itching on torso, spreading to upper thighs by hour 30 Within 36 hours, some dry coughing with wheeze; possible throat constriction and a feeling of difficulty breathing Presented at hospital 12/21/2019 at 4 am with diff breathing, tachycardia, high BP Swelling of arm, throat constriction, itching etc. relieved within 30-60 minutes of receiving oral dose of Prednisone 60 mg Contiuned with four daily doses of Prednisone 40mg
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Agitation, Arthralgia, Chapped lips, Dry skin, Dysphagia
Clinical narrative: 2/9/19 - complaining of being cold 2/13/19 - hands cold, right hand more than left; skin pale/white.  fatigue 2/16/19 - 101.9 temperature, severe headache, nausea, hallucinations, eyes hurt - right more than left, sensitive to light, drowsy, agitated, stiff neck 2/17/19 - sensitive to light, headache, eye pain improving, neck not stiff, nausea subsiding, low fever, fatigue, some hallucinations 2/18/19 - improving 2/20/19 - not cold anymore, dry, chapped skin, palpable lymph nodes on neck 2/23/19 - tenderness in parotid area, skin and lips extremely chapped and dry 2/24/19 - TMJ or parotid pain, tight jaw muscles, slight difficulty swallowing 2/25/19 - TMJ pain mostly right side, hands pale and mottled 2/27/19 - fatigue 3/3/19 - trouble sleeping, neck pain, sore jaw 3/5/19 - right wrist pain, right arm pain, right side jaw pain 3/6/19 - lips and face still dry, same pain in right arm, wrist, jaw 3/7-13/19 - right arm, wrist very painful, jaw pain both sides.  Symptoms began resolving by 3/13 3/13/19 to 2/8/20 - has had four or five debilitating migraine headaches with the usual migraine symptoms, which he has never had prior to MMR
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Eye pain, Fatigue, Feeling cold, Hallucination, Headache
Clinical narrative: 2/9/19 - complaining of being cold 2/13/19 - hands cold, right hand more than left; skin pale/white.  fatigue 2/16/19 - 101.9 temperature, severe headache, nausea, hallucinations, eyes hurt - right more than left, sensitive to light, drowsy, agitated, stiff neck 2/17/19 - sensitive to light, headache, eye pain improving, neck not stiff, nausea subsiding, low fever, fatigue, some hallucinations 2/18/19 - improving 2/20/19 - not cold anymore, dry, chapped skin, palpable lymph nodes on neck 2/23/19 - tenderness in parotid area, skin and lips extremely chapped and dry 2/24/19 - TMJ or parotid pain, tight jaw muscles, slight difficulty swallowing 2/25/19 - TMJ pain mostly right side, hands pale and mottled 2/27/19 - fatigue 3/3/19 - trouble sleeping, neck pain, sore jaw 3/5/19 - right wrist pain, right arm pain, right side jaw pain 3/6/19 - lips and face still dry, same pain in right arm, wrist, jaw 3/7-13/19 - right arm, wrist very painful, jaw pain both sides.  Symptoms began resolving by 3/13 3/13/19 to 2/8/20 - has had four or five debilitating migraine headaches with the usual migraine symptoms, which he has never had prior to MMR
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Insomnia, Lip dry, Livedo reticularis, Lymphadenopathy, Migraine
Clinical narrative: 2/9/19 - complaining of being cold 2/13/19 - hands cold, right hand more than left; skin pale/white.  fatigue 2/16/19 - 101.9 temperature, severe headache, nausea, hallucinations, eyes hurt - right more than left, sensitive to light, drowsy, agitated, stiff neck 2/17/19 - sensitive to light, headache, eye pain improving, neck not stiff, nausea subsiding, low fever, fatigue, some hallucinations 2/18/19 - improving 2/20/19 - not cold anymore, dry, chapped skin, palpable lymph nodes on neck 2/23/19 - tenderness in parotid area, skin and lips extremely chapped and dry 2/24/19 - TMJ or parotid pain, tight jaw muscles, slight difficulty swallowing 2/25/19 - TMJ pain mostly right side, hands pale and mottled 2/27/19 - fatigue 3/3/19 - trouble sleeping, neck pain, sore jaw 3/5/19 - right wrist pain, right arm pain, right side jaw pain 3/6/19 - lips and face still dry, same pain in right arm, wrist, jaw 3/7-13/19 - right arm, wrist very painful, jaw pain both sides.  Symptoms began resolving by 3/13 3/13/19 to 2/8/20 - has had four or five debilitating migraine headaches with the usual migraine symptoms, which he has never had prior to MMR
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Muscle tightness, Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity
Clinical narrative: 2/9/19 - complaining of being cold 2/13/19 - hands cold, right hand more than left; skin pale/white.  fatigue 2/16/19 - 101.9 temperature, severe headache, nausea, hallucinations, eyes hurt - right more than left, sensitive to light, drowsy, agitated, stiff neck 2/17/19 - sensitive to light, headache, eye pain improving, neck not stiff, nausea subsiding, low fever, fatigue, some hallucinations 2/18/19 - improving 2/20/19 - not cold anymore, dry, chapped skin, palpable lymph nodes on neck 2/23/19 - tenderness in parotid area, skin and lips extremely chapped and dry 2/24/19 - TMJ or parotid pain, tight jaw muscles, slight difficulty swallowing 2/25/19 - TMJ pain mostly right side, hands pale and mottled 2/27/19 - fatigue 3/3/19 - trouble sleeping, neck pain, sore jaw 3/5/19 - right wrist pain, right arm pain, right side jaw pain 3/6/19 - lips and face still dry, same pain in right arm, wrist, jaw 3/7-13/19 - right arm, wrist very painful, jaw pain both sides.  Symptoms began resolving by 3/13 3/13/19 to 2/8/20 - has had four or five debilitating migraine headaches with the usual migraine symptoms, which he has never had prior to MMR
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Pain in jaw, Pallor, Peripheral coldness, Photophobia, Pyrexia
Clinical narrative: 2/9/19 - complaining of being cold 2/13/19 - hands cold, right hand more than left; skin pale/white.  fatigue 2/16/19 - 101.9 temperature, severe headache, nausea, hallucinations, eyes hurt - right more than left, sensitive to light, drowsy, agitated, stiff neck 2/17/19 - sensitive to light, headache, eye pain improving, neck not stiff, nausea subsiding, low fever, fatigue, some hallucinations 2/18/19 - improving 2/20/19 - not cold anymore, dry, chapped skin, palpable lymph nodes on neck 2/23/19 - tenderness in parotid area, skin and lips extremely chapped and dry 2/24/19 - TMJ or parotid pain, tight jaw muscles, slight difficulty swallowing 2/25/19 - TMJ pain mostly right side, hands pale and mottled 2/27/19 - fatigue 3/3/19 - trouble sleeping, neck pain, sore jaw 3/5/19 - right wrist pain, right arm pain, right side jaw pain 3/6/19 - lips and face still dry, same pain in right arm, wrist, jaw 3/7-13/19 - right arm, wrist very painful, jaw pain both sides.  Symptoms began resolving by 3/13 3/13/19 to 2/8/20 - has had four or five debilitating migraine headaches with the usual migraine symptoms, which he has never had prior to MMR
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Salivary gland pain, Skin fissures, Somnolence, Temporomandibular joint syndrome, Tenderness
Clinical narrative: 2/9/19 - complaining of being cold 2/13/19 - hands cold, right hand more than left; skin pale/white.  fatigue 2/16/19 - 101.9 temperature, severe headache, nausea, hallucinations, eyes hurt - right more than left, sensitive to light, drowsy, agitated, stiff neck 2/17/19 - sensitive to light, headache, eye pain improving, neck not stiff, nausea subsiding, low fever, fatigue, some hallucinations 2/18/19 - improving 2/20/19 - not cold anymore, dry, chapped skin, palpable lymph nodes on neck 2/23/19 - tenderness in parotid area, skin and lips extremely chapped and dry 2/24/19 - TMJ or parotid pain, tight jaw muscles, slight difficulty swallowing 2/25/19 - TMJ pain mostly right side, hands pale and mottled 2/27/19 - fatigue 3/3/19 - trouble sleeping, neck pain, sore jaw 3/5/19 - right wrist pain, right arm pain, right side jaw pain 3/6/19 - lips and face still dry, same pain in right arm, wrist, jaw 3/7-13/19 - right arm, wrist very painful, jaw pain both sides.  Symptoms began resolving by 3/13 3/13/19 to 2/8/20 - has had four or five debilitating migraine headaches with the usual migraine symptoms, which he has never had prior to MMR
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: LOCAL REACTION LEFT DELTOID:  SWELLING , REDNESS, WARMTH, PAIN WITH MOVEMNT
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Pain
Clinical narrative: LOCAL REACTION LEFT DELTOID:  SWELLING , REDNESS, WARMTH, PAIN WITH MOVEMNT
Age: 63.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Grip strength decreased, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient complaining about soreness in left arm that she received Shingrix in. Having general dul pain, but also having trouble lifting objects over her head and holding objects such as drink glasses with that hand. Patient has been experiencing this since the shot was given 12 days ago. There is no outward sign of bruise or redness.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Magnetic resonance imaging abnormal
Clinical narrative: Patient reports symptoms starting about 2 days after vaccine.  Left arm/shoulder feels like it was hit by a sledgehammer with numbness throughout arm and hand.  He cannot move his wrist and has limit range of motion for his elbow and shoulder.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Nerve injury, Pain in extremity, X-ray abnormal
Clinical narrative: Patient reports symptoms starting about 2 days after vaccine.  Left arm/shoulder feels like it was hit by a sledgehammer with numbness throughout arm and hand.  He cannot move his wrist and has limit range of motion for his elbow and shoulder.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in Deltoid muscles since shot & still to this day Limited range of motion Pain & soreness in arm Required outpatient Physical Therapy Still under P.T. care
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Lung assist device therapy, Respiratory distress
Clinical narrative: Patient was diagnosed with Influenza A  and had severe respiratory distress. Was placed on ECMO
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not experience an adverse event, but was given Prevnar when we should have given Pneumovax.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Nodule, Tenderness
Clinical narrative: Golf ball Hard knot 2 days after. After a month grape sized knot still present still very tinder to touch but not hot like infected.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Discomfort, Gingival swelling, Lip swelling, Pain, Rash
Clinical narrative: Per patient, approximately 15 to 20 minutes after administration of Flucelvax, he experienced a swelling in his lips and gums that resulted in significant pain and discomfort. The next day, patient woke up with red blotchy rash all over his body. Did not report to MD or RX until 2/9/20.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash macular
Clinical narrative: Per patient, approximately 15 to 20 minutes after administration of Flucelvax, he experienced a swelling in his lips and gums that resulted in significant pain and discomfort. The next day, patient woke up with red blotchy rash all over his body. Did not report to MD or RX until 2/9/20.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle soreness, flu like symptoms
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Anger, Insomnia, Screaming
Clinical narrative: Baby slept for 7 hours post vaccinations and woke up extremely angry. He screamed all night long into the next day. He became a very unhappy baby from that point on. He stopped sleeping 5-6 hours at night and would only sleep 1-2 hours combined. He was never content after that.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Muscular weakness, Myalgia
Clinical narrative: Next day had severe pain in muscles and some muscle weakness; this was not reported to me until 1/16-he does have some chronic back pain-but this was different
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Pain
Clinical narrative: Aching, weakness, tired, unable to do regular activities.  Spent most of the day in bed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient states she has a red circle about  the size of an egg under the deltoid muscle where the vaccine was given. She states it is slightly warm and sore. Began the day after vaccination. Recommended patient monitor size of redness on arm, apply ice, and follow up with us tomorrow. Will recommend doctor's visit/ follow up if redness or other side effects worsen.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Patient reports feeling shoulder pain, initially unsure if related to the vaccine. She describes the pain as sharp/stabbing when moving her arm above her head. It increases with movement, no pain at rest reported. She initially visited an urgent care facility where they prescribed a 2 week prednisone burst, during which the pain got better. After the steroid course the pain returned back to baseline.
Age: 52.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Hypoaesthesia, Mobility decreased, Myalgia, Paraesthesia
Clinical narrative: patient is unable to lift their arm above their head.  patient experiences severe muscle pain when laying or sleeping on the arm. Patient experiences numbness and tingling in the arm.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Headache, Induration, Myalgia
Clinical narrative: She went to a walk in clinic for cellulitis of the left arm. The doctor told her it was 20cm x 20cm and indurated. She showed me the arm that had been injected, and there was a large red area.  She also experienced a low grade fever, muscle aches, and headache. The doctor sent her to the pharmacy with a prescription for Keflex.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: She went to a walk in clinic for cellulitis of the left arm. The doctor told her it was 20cm x 20cm and indurated. She showed me the arm that had been injected, and there was a large red area.  She also experienced a low grade fever, muscle aches, and headache. The doctor sent her to the pharmacy with a prescription for Keflex.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Pain, Pruritus
Clinical narrative: Patient says he began experiencing extreme body aches and fatigue the next day.  He also developed itchiness all over body.  He spent the next two days sleeping.
Age: 75.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash
Clinical narrative: After almost a week after the shot patient got a big rash on the arm where she got the shot. She two shots in 1 arm only. It was not painful she said but it's a big rash. I advised her to go see her doctor but she wanted to apply Calamine lotion which I said she can try. Told her to update me if anything changes or if she went to the doctor.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eructation, Influenza like illness, Pain, Upper respiratory tract congestion
Clinical narrative: About 12 hours after the shot I felt like I was getting the flu.  I had aches and pains and chills .  Luckily I hadn't eaten in hours so I felt full but did not feel nauseous.  Just kept burping.  I also had head congestion.  I went to bed before 8 PM and got up at 7 am.  11 hours sleep.  I still did not feel better until about noon the next day.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Nausea, Rash
Clinical narrative: Rash over arms, around breast and upper stomach, armpits, and injection site.  Rash lasted about 3 days.  Other effects were nausea and headache.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: large mildly erythematous area of skin over right deltoid the day after injection, mildly warm, non-tender, no  pain, patient complained of itchiness
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Fever, low grade achiness, 3 inch diameter red, raised sore area
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity, Vaccination site induration, Vaccination site nodule
Clinical narrative: G3P2 EDC 4/17/20 Arm became extremely sore even to very light touch, hard nodule one spot where vaccine was injected and nodule became larger over 2 days from pea sized to golf ball sized. Red area began dime sized and now baseball sized. Restrictive arm movement.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Dizziness, Dyspnoea, Exercise tolerance decreased, Fatigue
Clinical narrative: Feb 5: Soreness in arm. No other symptoms Evening of Feb 5: Significantly decreased endurance, fatigue Morning of Feb 6 through evening of Feb 6: Dizziness/motion sickness worsening as the day went on (feel like I need a dramamine), Worsened with concentration and fast movements. High resting heart rate, pounding heart in chest, body feeling hot/like it's on fire, sweating randomly throughout the day, occasional chills (however not the same as chills from a fever), winded easily/decreased endurance,  Overall, the evening was the worst. Had to leave normal activities to go home as heart rate was high, had dizziness, and difficulty doing normal daily tasks due to decreased endurance.  Woke up on Feb 7 completely fine.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Heart rate increased, Hyperhidrosis, Loss of personal independence in daily activities, Motion sickness
Clinical narrative: Feb 5: Soreness in arm. No other symptoms Evening of Feb 5: Significantly decreased endurance, fatigue Morning of Feb 6 through evening of Feb 6: Dizziness/motion sickness worsening as the day went on (feel like I need a dramamine), Worsened with concentration and fast movements. High resting heart rate, pounding heart in chest, body feeling hot/like it's on fire, sweating randomly throughout the day, occasional chills (however not the same as chills from a fever), winded easily/decreased endurance,  Overall, the evening was the worst. Had to leave normal activities to go home as heart rate was high, had dizziness, and difficulty doing normal daily tasks due to decreased endurance.  Woke up on Feb 7 completely fine.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Palpitations
Clinical narrative: Feb 5: Soreness in arm. No other symptoms Evening of Feb 5: Significantly decreased endurance, fatigue Morning of Feb 6 through evening of Feb 6: Dizziness/motion sickness worsening as the day went on (feel like I need a dramamine), Worsened with concentration and fast movements. High resting heart rate, pounding heart in chest, body feeling hot/like it's on fire, sweating randomly throughout the day, occasional chills (however not the same as chills from a fever), winded easily/decreased endurance,  Overall, the evening was the worst. Had to leave normal activities to go home as heart rate was high, had dizziness, and difficulty doing normal daily tasks due to decreased endurance.  Woke up on Feb 7 completely fine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Gluten sensitivity, Hyperthermia, Somnolence
Clinical narrative: hyperthermia,  gluten fog, sleepy
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Immediate post-injection reaction, Palpitations
Clinical narrative: The patient reported that she was light headed immediately after receiving the vaccine. That evening and night, the patient said she felt her heart was pounding and reported that her blood pressure was elevated above 200. She noted the symptoms were present throughout the night and did not resolve until the morning the day after the vaccine. She had contacted her office that day and they advised that she should go to the ER/urgent care, but she declined.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Computerised tomogram neck, Electrocardiogram
Clinical narrative: not feeling well (malaise) and becoming nauseated; not feeling well (malaise) and becoming nauseated; Hit Head; he was not driving when he fell due to potential danger; was on floor and hit head; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 19 hrs after receiving Shingrix, the patient experienced nausea, fall, malaise, head injury and driving ability disturbed. The patient was treated with antiemetics and antinauseants (Anti-Nausea (Nos)). On an unknown date, the outcome of the nausea, fall and malaise were recovered/resolved and the outcome of the head injury and driving ability disturbed were unknown.   The reporter considered the nausea, fall, malaise, head injury and driving ability disturbed to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine approximately in early November 2019 around 3 pm in the afternoon. Next day at around 10 am the patient suddenly not feeling well malaise and becoming nauseated. The patient walking roughly 15 steps, and in approximately 15 seconds he was on floor and hit head. The patient's wife trying to get him up after calling for an ambulance. The patient in the ambulance he was given anti-nausea medicine, and upon arrival to the hospital he had head and neck CT scans, chest xrays, blood work, EKG, 2 bags of IV fluids and/ or IV anti-nausea medicine, and a flu test. There was no significant findings, a negative flu test, and doctors only reasoning of occurrence was from Shingrix vaccination the day before. The patient in hospital for approximately 4-5 hours, and once he arrived back home he felt good. The emergency visit required.  The follow up consent was granted.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Head injury, Impaired driving ability, Influenza virus test negative, Malaise
Clinical narrative: not feeling well (malaise) and becoming nauseated; not feeling well (malaise) and becoming nauseated; Hit Head; he was not driving when he fell due to potential danger; was on floor and hit head; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 19 hrs after receiving Shingrix, the patient experienced nausea, fall, malaise, head injury and driving ability disturbed. The patient was treated with antiemetics and antinauseants (Anti-Nausea (Nos)). On an unknown date, the outcome of the nausea, fall and malaise were recovered/resolved and the outcome of the head injury and driving ability disturbed were unknown.   The reporter considered the nausea, fall, malaise, head injury and driving ability disturbed to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine approximately in early November 2019 around 3 pm in the afternoon. Next day at around 10 am the patient suddenly not feeling well malaise and becoming nauseated. The patient walking roughly 15 steps, and in approximately 15 seconds he was on floor and hit head. The patient's wife trying to get him up after calling for an ambulance. The patient in the ambulance he was given anti-nausea medicine, and upon arrival to the hospital he had head and neck CT scans, chest xrays, blood work, EKG, 2 bags of IV fluids and/ or IV anti-nausea medicine, and a flu test. There was no significant findings, a negative flu test, and doctors only reasoning of occurrence was from Shingrix vaccination the day before. The patient in hospital for approximately 4-5 hours, and once he arrived back home he felt good. The emergency visit required.  The follow up consent was granted.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: not feeling well (malaise) and becoming nauseated; not feeling well (malaise) and becoming nauseated; Hit Head; he was not driving when he fell due to potential danger; was on floor and hit head; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 19 hrs after receiving Shingrix, the patient experienced nausea, fall, malaise, head injury and driving ability disturbed. The patient was treated with antiemetics and antinauseants (Anti-Nausea (Nos)). On an unknown date, the outcome of the nausea, fall and malaise were recovered/resolved and the outcome of the head injury and driving ability disturbed were unknown.   The reporter considered the nausea, fall, malaise, head injury and driving ability disturbed to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine approximately in early November 2019 around 3 pm in the afternoon. Next day at around 10 am the patient suddenly not feeling well malaise and becoming nauseated. The patient walking roughly 15 steps, and in approximately 15 seconds he was on floor and hit head. The patient's wife trying to get him up after calling for an ambulance. The patient in the ambulance he was given anti-nausea medicine, and upon arrival to the hospital he had head and neck CT scans, chest xrays, blood work, EKG, 2 bags of IV fluids and/ or IV anti-nausea medicine, and a flu test. There was no significant findings, a negative flu test, and doctors only reasoning of occurrence was from Shingrix vaccination the day before. The patient in hospital for approximately 4-5 hours, and once he arrived back home he felt good. The emergency visit required.  The follow up consent was granted.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: a case of varicella zoster virus vaccine-associated meningitis;   Information has been received from the authors in a published literature article title as stated above and refers to a 12-year old female. The patient's pertinent medical history, concurrent conditions, or drug reactions/allergies were not provided.  On an unspecified date in 2006, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength, route and anatomical location of administration, lot number and expiration date were not reported) as a varicella immunization. The patient was also vaccinated in 2009 with varicella virus vaccine live (Oka/Merck) (VARIVAX) (fully immunized).   On an unspecified date, the patient presented to an urgent care facility with 4 days of acute onset sharp right upper extremity pain and 1 day of rash over the right arm and shoulder.  At urgent care, she was diagnosed with shingles and sent home on a course of valacyclovir (dose and frequency not reported). It was stated that she tolerated one dose of valacyclovir that evening (exact date not provided), but subsequently developed fever to 100.2 grades Fahrenheit, severe headache, photophobia, nuchal rigidity, and mydriasis.  At that point, she presented to the emergency department where her exam revealed a tired-appearing but neurologically intact girl with photophobia and nuchal rigidity and a nonp-ruritic erythematous, blanching maculopapular rash in the C5-C6 dermatome distribution of the right upper extremity. On an unspecified date, her headache and mydriasis had resolved and she denied nausea, vomiting, abdominal pain or altered mental status  On an unknown date, a workup revealed cerebrospinal fluid (CSF) studies concerning for viral meningitis with lymphocytic pleocytosis (63) and elevated protein (units and results not reported). Blood cultures, CSF cultures, and urinalysis were sent, and empiric ceftriaxone and acyclovir were started at an unreported dose. On day 1 of admission, varicella zoster virus (VZV) was detected on meningitis/encephalitis PCR of cerebrospinal fluid; however, serum polymerase chain reaction (PCR) was negative for VZV. Ceftriaxone was discontinued after 48 hours of negative blood and CSF cultures and acyclovir was increased to1500 mg/m2/day.   The patient was discharged on day 4 of admission on a 14 day course of intravenous acyclovir. Following discharge, sequencing assay of the CSF revealed the vaccine strain of VZV as the etiology of her meningitis (herpes zoster meningitis). However, at the reporting time the outcome of the herpes zoster meningitis and was unknown.   The authors concluded that reactivation of vaccine-associated VZV is exceedingly rare in immunocompetent pediatric patients. But, the combination of a dermatomal rash with signs and symptoms of meningitis in a child should lead one to suspect this rare but important cause of meningitis.  Upon internal review, herpes zoster meningitis was considered medically significant.   A copy of the published article is attached as further documentation of the patient's experience.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Adnexa uteri pain, Arthralgia, Blood test, Fatigue, Gait disturbance
Clinical narrative: Pelvic Inflammatory Disease; Now I have Postural Orthostatic Tachycardia Syndrome; I had ovarian pain that made it miserable to walk; I also contracted HPV one year after receiving vaccination; I felt sick; fatigued; had a foggy memory; severe joint pain; flu-like symptoms; "I fainted after the first dose; This spontaneous report has been received from a non pregnant 19 year old female patient  with sulfa allergy (reported as "sulpha"), concerning herself. The patient had not medical history and was not taking any concomitant medications.      In May or June 2010,  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) intramuscularly in the left arm (lot number and expiration date were not reported) for prophylaxis.         In May or June 2010, after received the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the patient fainted (syncope). For two weeks afterwards, she felt sick (malaise), fatigued, she was in bed all the time, had a foggy memory(memory impairment), severe joint pain  (arthralgia), and flu-like symptoms. The patient received the other two doses of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on unspecified dates, and this happened every time after she received the vaccine.  One year after received the vaccination, in 2011, the patient contracted human papilloma viral infection (HPV).  On an unspecified date, the patient started to experience postural orthostatic tachycardia syndrome, pelvic inflammatory disease, and ovarian pain that made it miserable to walk.   The patient had visited multiple physicians for medical attention and unspecified blood tests had been performed (results not reported); however, the patient had not received any treatment for the adverse events. She stated "I need to be tested for lupus and rheumatoid arthritis"; however, not further information was provided.  At the reporting time, the patient was recovered from malaise, influenza like illness, arthralgia, memory impairment and fatigue; however, she had not recovered from pelvic inflammatory disease and postural orthostatic tachycardia syndrome. The outcome of syncope, ovarian pain and papilloma viral infection was unknown. .        Causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of faint and pelvic inflammatory disease were considered to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Influenza like illness, Malaise, Memory impairment, Papilloma viral infection, Pelvic inflammatory disease
Clinical narrative: Pelvic Inflammatory Disease; Now I have Postural Orthostatic Tachycardia Syndrome; I had ovarian pain that made it miserable to walk; I also contracted HPV one year after receiving vaccination; I felt sick; fatigued; had a foggy memory; severe joint pain; flu-like symptoms; "I fainted after the first dose; This spontaneous report has been received from a non pregnant 19 year old female patient  with sulfa allergy (reported as "sulpha"), concerning herself. The patient had not medical history and was not taking any concomitant medications.      In May or June 2010,  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) intramuscularly in the left arm (lot number and expiration date were not reported) for prophylaxis.         In May or June 2010, after received the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the patient fainted (syncope). For two weeks afterwards, she felt sick (malaise), fatigued, she was in bed all the time, had a foggy memory(memory impairment), severe joint pain  (arthralgia), and flu-like symptoms. The patient received the other two doses of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on unspecified dates, and this happened every time after she received the vaccine.  One year after received the vaccination, in 2011, the patient contracted human papilloma viral infection (HPV).  On an unspecified date, the patient started to experience postural orthostatic tachycardia syndrome, pelvic inflammatory disease, and ovarian pain that made it miserable to walk.   The patient had visited multiple physicians for medical attention and unspecified blood tests had been performed (results not reported); however, the patient had not received any treatment for the adverse events. She stated "I need to be tested for lupus and rheumatoid arthritis"; however, not further information was provided.  At the reporting time, the patient was recovered from malaise, influenza like illness, arthralgia, memory impairment and fatigue; however, she had not recovered from pelvic inflammatory disease and postural orthostatic tachycardia syndrome. The outcome of syncope, ovarian pain and papilloma viral infection was unknown. .        Causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of faint and pelvic inflammatory disease were considered to be medically significant.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Pelvic Inflammatory Disease; Now I have Postural Orthostatic Tachycardia Syndrome; I had ovarian pain that made it miserable to walk; I also contracted HPV one year after receiving vaccination; I felt sick; fatigued; had a foggy memory; severe joint pain; flu-like symptoms; "I fainted after the first dose; This spontaneous report has been received from a non pregnant 19 year old female patient  with sulfa allergy (reported as "sulpha"), concerning herself. The patient had not medical history and was not taking any concomitant medications.      In May or June 2010,  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) intramuscularly in the left arm (lot number and expiration date were not reported) for prophylaxis.         In May or June 2010, after received the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the patient fainted (syncope). For two weeks afterwards, she felt sick (malaise), fatigued, she was in bed all the time, had a foggy memory(memory impairment), severe joint pain  (arthralgia), and flu-like symptoms. The patient received the other two doses of of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on unspecified dates, and this happened every time after she received the vaccine.  One year after received the vaccination, in 2011, the patient contracted human papilloma viral infection (HPV).  On an unspecified date, the patient started to experience postural orthostatic tachycardia syndrome, pelvic inflammatory disease, and ovarian pain that made it miserable to walk.   The patient had visited multiple physicians for medical attention and unspecified blood tests had been performed (results not reported); however, the patient had not received any treatment for the adverse events. She stated "I need to be tested for lupus and rheumatoid arthritis"; however, not further information was provided.  At the reporting time, the patient was recovered from malaise, influenza like illness, arthralgia, memory impairment and fatigue; however, she had not recovered from pelvic inflammatory disease and postural orthostatic tachycardia syndrome. The outcome of syncope, ovarian pain and papilloma viral infection was unknown. .        Causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of faint and pelvic inflammatory disease were considered to be medically significant.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous report was received from a lawyer and a currently 67 year old male patient regarding a case in litigation on 31-JAN-2020. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On an unspecified date in 2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for shingles. Pt claimed damages as a result of the injuries to himself, loss of consortium, loss of services and economic losses. At the reporting time, the outcome of shingles was unknown. The reporters considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles developed on his right eye; the patient developed shingles on his forehead; This spontaneous report was received from a 70-year-old male patient referring to himself. The patient's pertinent medical history included shingles. The patient did not have any drug reactions/allergies and concomitant medications. On 23-AUG-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, anatomical location, route, lot and expiration dates were not reported) for prophylaxis. The other suspect product included sterile diluent (STERILE DILUENT). On 30-AUG-2016, the patient developed shingles on his forehead (herpes zoster). On the same day, the patient was examined by his physician and received unspecified treatment. On 01-SEP-2016, the shingles developed on patient's right eye (ophthalmic herpes zoster). On the same day, the patient returned to his doctor and received unspecified treatment. Approximately on 27-SEP-2016 (reported as 4 weeks after the outbreak (30-AUG-2016)), the patient was recovered from the events. The causality assessment was not provided.  Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 16-DEC-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered an outbreak of shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles (herpes zoster) was considered not recovered. The event was considered related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered to be disabling.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: seizure; This spontaneous social media report was received from a patient's mother referring a 20-year-old female patient. The patient's pertinent medical history, concurrent conditions, allergies/drug reactions and concomitant medications were not reported. On an unknown date (reported as when the patient was 12-year-old), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dosing schedule, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, immediately after vaccination the patient experienced seizure. The outcome of the event was unknown. The causality assessment between the event and suspect therapy was not reported.  Upon internal review, the event seizure was determined to be medically significant.  This is one of the two reports.; Sender's Comments:  US-009507513-2002USA002370:
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Blepharospasm, Muscle twitching
Clinical narrative: twitching of one eye and one limb; This spontaneous report was received from a healthcare worker (patient's mother) via a company representative, regarding her 18-year-old son.  Information on patient's medical history, drug allergies/reactions and concomitant medication were unknown by reporter. The patient current condition included attention deficit disorder.  On an unknown date, the patient was vaccinated with one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, route, anatomical location, lot# and expiration date were unknown by reporter) for prophylaxis (It was unknown if the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   On an unspecified date, within one month of receiving the vaccine, the patient began experiencing twitching of one eye and one limb (muscle twitching). It was unknown if the patient received any treatment. At the time of report, the patient did not recover from the event. Causality assessment for the event with respect to the therapy was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 19-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad outbreak of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles to be disability.