chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Wheezing
Clinical narrative: 63 year old patient presented to the clinic 3 days after PCV13 vaccine given today for acute sudden left shoulder pain. Patient was recently at the clinic OCT 31 2018 and he received PREVNAR vaccine on his left arm. That night he started feeling the injection area stiff and sore but then he developed a sharp 10/10 left shoulder pain with radiation to the left arm, no weakness of numbness, he is not able to lift his left arm about the head, limited to about less than 15 degree in abduction, he uses his right arm hand to help lift the left one. He denies lifting any heavy objects, denies trauma, denies any further injuries. He had pneumonia vaccine before and never had reaction to it. Denies swelling of the shoulder, redness, no other issues. Patient then presented a day later to the ER c/o itching, redness to face and neck, tongue swelling and wheezing. Pt stated s/sx began after he took his second dose of naproxen. Pt was prescribed naproxen for the pain and hydrocodone. Pt stated he took both medications last night, today only the naproxen, then the other s/sx began. Symptoms: Muscle pain; Treatment Drugs Used: Naproxen Dose: 500 Units: MG Freq: BID Route: PO
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13
Symptoms: Rash, Rash papular
Clinical narrative: Rash on back, discrete red papules on lower back.
Age: 1.0
Sex: M
Vaccine: HIBV, HPV4, MMR, PNC13, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pre drawn up vaccine previously done by another staff member, vaccine was noted with "Hep A, SV, time, date, lot # and ex #"! I needed a Hep A and it was placed in Hep A box. I used the vaccine on patient. No reaction at the time or after. I was entering lot #, it came up as HPV instead. I double checked in fridge and it was still HPV lot #. Assumed I gave HPV. We reported it to manager, provider and parent. Also CDC.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Swelling, Tenderness
Clinical narrative: Bruising, pain, swelling, tender.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Condition aggravated, Laboratory test, Loss of personal independence in daily activities, Polymyalgia rheumatica
Clinical narrative: This spontaneous report was received from a 71-year-old female patient via Pfizer reporting about herself. The patient's relevant medical history was not provided. The patient's historical vaccine included pneumococcal vaccine (pneumonia shot). The patient's concurrent condition included flu vaccination. The patient's concomitant medication included flu shot (influenza virus vaccine inactivated (unspecified)). On 03-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, lot # and expiry date unspecified) intramuscularly, for prophylaxis. On an unknown date in October 2018 (reported as "in days to a week"), the patient experienced pain in her joints that got worse. She started having chest pains and went to the emergency room where they got it under control. On 17-OCT-2018, she had a heart cath (catheterisation cardiac). On the same day (reported as "morning of the cath"), her joints made it hard for her to walk and she couldn't pick her arms up to comb her hair. On 18-OCT-2018, the patient had open heart surgery. It was reported that the patient was heavily sedated through the surgery. She was still in pain when she got home. The patient was taking pain medication continuously, but the pain did not stop. On an unknown date in October 2018, the patient felt like she had the flu. She couldn't eat, she lost 10 pounds. She reported it was that sick flu feeling where everything tastes terrible, she had dry mouth and was nauseated. On an unknown date in 2018, the patient was still weak and not thinking strong. On an unknown date in 2018, at one point she was anemic and her potassium was low at one time. On an unknown date in 2018, the patient received a shot of steroid as treatment. The patient reported that the steroid helped. The outcome of cardiac operation, chest pain, dysgeusia, dry mouth, catheterisation cardiac, limb discomfort, blood potassium decreased, anaemia, asthenia and nausea was unknown. The outcome of influenza like illness, weight decreased, gait disturbance and decreased appetite was reported as improved. The outcome of arthralgia was reported as not recovered and the pain was coming back worse. Causality assessment was not reported by the reporter. Upon internal review, cardiac operation was determined to be medically significant.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anaemia, Arthralgia, Asthenia, Blood potassium decreased, Cardiac operation
Clinical narrative: This spontaneous report was received from a 71-year-old female patient via Pfizer reporting about herself. The patient's relevant medical history was not provided. The patient's historical vaccine included pneumococcal vaccine (pneumonia shot). The patient's concurrent condition included flu vaccination. The patient's concomitant medication included flu shot (influenza virus vaccine inactivated (unspecified)). On 03-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, lot # and expiry date unspecified) intramuscularly, for prophylaxis. On an unknown date in October 2018 (reported as "in days to a week"), the patient experienced pain in her joints that got worse. She started having chest pains and went to the emergency room where they got it under control. On 17-OCT-2018, she had a heart cath (catheterisation cardiac). On the same day (reported as "morning of the cath"), her joints made it hard for her to walk and she couldn't pick her arms up to comb her hair. On 18-OCT-2018, the patient had open heart surgery. It was reported that the patient was heavily sedated through the surgery. She was still in pain when she got home. The patient was taking pain medication continuously, but the pain did not stop. On an unknown date in October 2018, the patient felt like she had the flu. She couldn't eat, she lost 10 pounds. She reported it was that sick flu feeling where everything tastes terrible, she had dry mouth and was nauseated. On an unknown date in 2018, the patient was still weak and not thinking strong. On an unknown date in 2018, at one point she was anemic and her potassium was low at one time. On an unknown date in 2018, the patient received a shot of steroid as treatment. The patient reported that the steroid helped. The outcome of cardiac operation, chest pain, dysgeusia, dry mouth, catheterisation cardiac, limb discomfort, blood potassium decreased, anaemia, asthenia and nausea was unknown. The outcome of influenza like illness, weight decreased, gait disturbance and decreased appetite was reported as improved. The outcome of arthralgia was reported as not recovered and the pain was coming back worse. Causality assessment was not reported by the reporter. Upon internal review, cardiac operation was determined to be medically significant.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Catheterisation cardiac, Chest pain, Decreased appetite, Dry mouth, Dysgeusia
Clinical narrative: This spontaneous report was received from a 71-year-old female patient via Pfizer reporting about herself. The patient's relevant medical history was not provided. The patient's historical vaccine included pneumococcal vaccine (pneumonia shot). The patient's concurrent condition included flu vaccination. The patient's concomitant medication included flu shot (influenza virus vaccine inactivated (unspecified)). On 03-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, lot # and expiry date unspecified) intramuscularly, for prophylaxis. On an unknown date in October 2018 (reported as "in days to a week"), the patient experienced pain in her joints that got worse. She started having chest pains and went to the emergency room where they got it under control. On 17-OCT-2018, she had a heart cath (catheterisation cardiac). On the same day (reported as "morning of the cath"), her joints made it hard for her to walk and she couldn't pick her arms up to comb her hair. On 18-OCT-2018, the patient had open heart surgery. It was reported that the patient was heavily sedated through the surgery. She was still in pain when she got home. The patient was taking pain medication continuously, but the pain did not stop. On an unknown date in October 2018, the patient felt like she had the flu. She couldn't eat, she lost 10 pounds. She reported it was that sick flu feeling where everything tastes terrible, she had dry mouth and was nauseated. On an unknown date in 2018, the patient was still weak and not thinking strong. On an unknown date in 2018, at one point she was anemic and her potassium was low at one time. On an unknown date in 2018, the patient received a shot of steroid as treatment. The patient reported that the steroid helped. The outcome of cardiac operation, chest pain, dysgeusia, dry mouth, catheterisation cardiac, limb discomfort, blood potassium decreased, anaemia, asthenia and nausea was unknown. The outcome of influenza like illness, weight decreased, gait disturbance and decreased appetite was reported as improved. The outcome of arthralgia was reported as not recovered and the pain was coming back worse. Causality assessment was not reported by the reporter. Upon internal review, cardiac operation was determined to be medically significant.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Gait disturbance, Influenza like illness, Limb discomfort, Loss of personal independence in daily activities, Mental impairment
Clinical narrative: This spontaneous report was received from a 71-year-old female patient via Pfizer reporting about herself. The patient's relevant medical history was not provided. The patient's historical vaccine included pneumococcal vaccine (pneumonia shot). The patient's concurrent condition included flu vaccination. The patient's concomitant medication included flu shot (influenza virus vaccine inactivated (unspecified)). On 03-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, lot # and expiry date unspecified) intramuscularly, for prophylaxis. On an unknown date in October 2018 (reported as "in days to a week"), the patient experienced pain in her joints that got worse. She started having chest pains and went to the emergency room where they got it under control. On 17-OCT-2018, she had a heart cath (catheterisation cardiac). On the same day (reported as "morning of the cath"), her joints made it hard for her to walk and she couldn't pick her arms up to comb her hair. On 18-OCT-2018, the patient had open heart surgery. It was reported that the patient was heavily sedated through the surgery. She was still in pain when she got home. The patient was taking pain medication continuously, but the pain did not stop. On an unknown date in October 2018, the patient felt like she had the flu. She couldn't eat, she lost 10 pounds. She reported it was that sick flu feeling where everything tastes terrible, she had dry mouth and was nauseated. On an unknown date in 2018, the patient was still weak and not thinking strong. On an unknown date in 2018, at one point she was anemic and her potassium was low at one time. On an unknown date in 2018, the patient received a shot of steroid as treatment. The patient reported that the steroid helped. The outcome of cardiac operation, chest pain, dysgeusia, dry mouth, catheterisation cardiac, limb discomfort, blood potassium decreased, anaemia, asthenia and nausea was unknown. The outcome of influenza like illness, weight decreased, gait disturbance and decreased appetite was reported as improved. The outcome of arthralgia was reported as not recovered and the pain was coming back worse. Causality assessment was not reported by the reporter. Upon internal review, cardiac operation was determined to be medically significant.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Nausea, Taste disorder, Weight decreased
Clinical narrative: This spontaneous report was received from a 71-year-old female patient via Pfizer reporting about herself. The patient's relevant medical history was not provided. The patient's historical vaccine included pneumococcal vaccine (pneumonia shot). The patient's concurrent condition included flu vaccination. The patient's concomitant medication included flu shot (influenza virus vaccine inactivated (unspecified)). On 03-OCT-2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, lot # and expiry date unspecified) intramuscularly, for prophylaxis. On an unknown date in October 2018 (reported as "in days to a week"), the patient experienced pain in her joints that got worse. She started having chest pains and went to the emergency room where they got it under control. On 17-OCT-2018, she had a heart cath (catheterisation cardiac). On the same day (reported as "morning of the cath"), her joints made it hard for her to walk and she couldn't pick her arms up to comb her hair. On 18-OCT-2018, the patient had open heart surgery. It was reported that the patient was heavily sedated through the surgery. She was still in pain when she got home. The patient was taking pain medication continuously, but the pain did not stop. On an unknown date in October 2018, the patient felt like she had the flu. She couldn't eat, she lost 10 pounds. She reported it was that sick flu feeling where everything tastes terrible, she had dry mouth and was nauseated. On an unknown date in 2018, the patient was still weak and not thinking strong. On an unknown date in 2018, at one point she was anemic and her potassium was low at one time. On an unknown date in 2018, the patient received a shot of steroid as treatment. The patient reported that the steroid helped. The outcome of cardiac operation, chest pain, dysgeusia, dry mouth, catheterisation cardiac, limb discomfort, blood potassium decreased, anaemia, asthenia and nausea was unknown. The outcome of influenza like illness, weight decreased, gait disturbance and decreased appetite was reported as improved. The outcome of arthralgia was reported as not recovered and the pain was coming back worse. Causality assessment was not reported by the reporter. Upon internal review, cardiac operation was determined to be medically significant.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Erythema, Feeling hot, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Sjogren's syndrome in a 53-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. Concurrent medical conditions included autoimmune thyroid disorder and psoriatic arthritis. On 4th March 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 4th March 2019, 8 hrs after receiving SHINGRIX, the patient experienced Sjogren's syndrome (serious criteria GSK medically significant), fever, general body pain, tiredness and groggy. On 6th March 2019, the patient experienced injection site erythema and localized erythema. On 7th March 2019, the patient experienced facial swelling and injection site swelling. In March 2019, the outcome of the facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness and groggy were recovered/resolved. On an unknown date, the outcome of the Sjogren's syndrome and localized erythema were unknown. It was unknown if the reporter considered the sjogren's syndrome, facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness, groggy and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced red spots on her arm, one at the injection site and another at different site, that had merged together. On the day of reporting, her face, on the opposite side as the injection had swollen. The patient was being tested for Sjogren's syndrome. On the day of reporting, she experienced swelling in the face and was lessening or going away. The arm at the injection site was still red and swollen and feverish and a pretty good size 4 inches long and 2 & 1/2 inches wide. It was maintained and very defined. The pharmacist asked if she had any pains in the joints and patient described experienced all over body aches, feeling tired, groggy and had a low grade fever and felt like she did not want to get out of bed.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Sjogren's syndrome in a 53-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. Concurrent medical conditions included autoimmune thyroid disorder and psoriatic arthritis. On 4th March 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 4th March 2019, 8 hrs after receiving SHINGRIX, the patient experienced Sjogren's syndrome (serious criteria GSK medically significant), fever, general body pain, tiredness and groggy. On 6th March 2019, the patient experienced injection site erythema and localized erythema. On 7th March 2019, the patient experienced facial swelling and injection site swelling. In March 2019, the outcome of the facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness and groggy were recovered/resolved. On an unknown date, the outcome of the Sjogren's syndrome and localized erythema were unknown. It was unknown if the reporter considered the sjogren's syndrome, facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness, groggy and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced red spots on her arm, one at the injection site and another at different site, that had merged together. On the day of reporting, her face, on the opposite side as the injection had swollen. The patient was being tested for Sjogren's syndrome. On the day of reporting, she experienced swelling in the face and was lessening or going away. The arm at the injection site was still red and swollen and feverish and a pretty good size 4 inches long and 2 & 1/2 inches wide. It was maintained and very defined. The pharmacist asked if she had any pains in the joints and patient described experienced all over body aches, feeling tired, groggy and had a low grade fever and felt like she did not want to get out of bed.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Sjogren's syndrome in a 53-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. Concurrent medical conditions included autoimmune thyroid disorder and psoriatic arthritis. On 4th March 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 4th March 2019, 8 hrs after receiving SHINGRIX, the patient experienced Sjogren's syndrome (serious criteria GSK medically significant), fever, general body pain, tiredness and groggy. On 6th March 2019, the patient experienced injection site erythema and localized erythema. On 7th March 2019, the patient experienced facial swelling and injection site swelling. In March 2019, the outcome of the facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness and groggy were recovered/resolved. On an unknown date, the outcome of the Sjogren's syndrome and localized erythema were unknown. It was unknown if the reporter considered the sjogren's syndrome, facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness, groggy and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced red spots on her arm, one at the injection site and another at different site, that had merged together. On the day of reporting, her face, on the opposite side as the injection had swollen. The patient was being tested for Sjogren's syndrome. On the day of reporting, she experienced swelling in the face and was lessening or going away. The arm at the injection site was still red and swollen and feverish and a pretty good size 4 inches long and 2 & 1/2 inches wide. It was maintained and very defined. The pharmacist asked if she had any pains in the joints and patient described experienced all over body aches, feeling tired, groggy and had a low grade fever and felt like she did not want to get out of bed.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Pain, Pyrexia, Sjogren's syndrome, Somnolence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Sjogren's syndrome in a 53-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. Concurrent medical conditions included autoimmune thyroid disorder and psoriatic arthritis. On 4th March 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 4th March 2019, 8 hrs after receiving SHINGRIX, the patient experienced Sjogren's syndrome (serious criteria GSK medically significant), fever, general body pain, tiredness and groggy. On 6th March 2019, the patient experienced injection site erythema and localized erythema. On 7th March 2019, the patient experienced facial swelling and injection site swelling. In March 2019, the outcome of the facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness and groggy were recovered/resolved. On an unknown date, the outcome of the Sjogren's syndrome and localized erythema were unknown. It was unknown if the reporter considered the sjogren's syndrome, facial swelling, injection site erythema, injection site swelling, fever, general body pain, tiredness, groggy and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on an unknown arm. The patient experienced red spots on her arm, one at the injection site and another at different site, that had merged together. On the day of reporting, her face, on the opposite side as the injection had swollen. The patient was being tested for Sjogren's syndrome. On the day of reporting, she experienced swelling in the face and was lessening or going away. The arm at the injection site was still red and swollen and feverish and a pretty good size 4 inches long and 2 & 1/2 inches wide. It was maintained and very defined. The pharmacist asked if she had any pains in the joints and patient described experienced all over body aches, feeling tired, groggy and had a low grade fever and felt like she did not want to get out of bed.
Sex: U
Vaccine: MMR, MMR
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent, historical conditions and concomitant medications were not provided. On 11-MAR-2019, the patient was vaccinated with M-M-R II intramuscular (dose, strength, frequency, lot number and expiration date were not provided) for prophylaxis. On the same date, the patient experienced incorrect route of product administration.   The outcome of incorrect route of product administration was unknown at the time of this report.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood aluminium increased, Eating disorder, Eczema, Emotional distress, Lethargy
Clinical narrative: The patient developed a measles rash, fever of 102.5, became lethargic and inconsolable for two days. Patient had been eating solid foods (non purée foods) since 8 months old. He would no longer eat solid foods after his vaccines and did not eat solids for almost a year after.  He also developed eczema patches on his left hand.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Measles, Neurotransmitter level altered, Pyrexia, Rash
Clinical narrative: The patient developed a measles rash, fever of 102.5, became lethargic and inconsolable for two days. Patient had been eating solid foods (non purée foods) since 8 months old. He would no longer eat solid foods after his vaccines and did not eat solids for almost a year after.  He also developed eczema patches on his left hand.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever 99.7 F, malaise, moderate right arm pain, moderate body aches from scalp to feet. Txt: home treatment, tepid bath with epsom salts, acetaminophen.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, Balance disorder, CSF protein increased, Gait disturbance, Grip strength decreased
Clinical narrative: Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Paraesthesia
Clinical narrative: Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Walking aid user, Weight decreased
Clinical narrative: Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Asthenia, CSF protein increased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Lumbar puncture abnormal, Paraesthesia
Clinical narrative: Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH, ANTH
Symptoms: Paraesthesia, Walking aid user, Weight decreased
Clinical narrative: Patient received vaccine on 26 Feb. Patient noticed paresthesia in his 4th and 5th toe the day after.  Symptoms gradually got worse every day since then. He can hardly walk. He is having cramps throughout his body, especially when he turns with his upper body. This occurs anywhere from mid-section to the whole back. It is all over his chest as well. On Sunday he had a normal MRI Brain and C-spine. They thought is could be Guillain -Barre syndrome. He is weak as well. It started as a little weak in his legs, really noticed it when his hand grip was decreased. It is worse and now involves his entire body. He has no strength: lifting a book bag, using utencils, writing, fine motor tasks, walking. Everything is difficult. He wobbles when he walks. No pain. His calves constantly feel like they are in knots. He is ambulating with a cane currently. He has lost 10 pounds in 2 weeks. No diplopia. No bulbar symptoms. No bowel/ bladder incontinence. Balance is off. No tick exposures. No rashes.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse referring to an 18 months old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (product use issue). No adverse symptoms were reported.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Foetal disorder, Prenatal screening test, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician referring to a 26 year old female patient. The patient's medical history included sickle cell trait, migraines and history of pregnancy related hypertension. The gravida reported as 4, para reported as 2 and elective termination reported as 1. Information about concomitant medication and drug reactions/allergies was not provided. The patient became pregnant and the last menstrual period (LMP) was reported as 20-SEP-2018 and estimated due date (EDD) was auto-calculated on 27-JUN-2019. On 15-OCT-2018, the patient was vaccinated with 1 dose of GARDASIL 9 (lot # reported as R0003557 was an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); strength, dose detail, route, and expiration date were not reported) for prophylaxis (exposure during pregnancy). Initial exposure to GARDASIL 9 was at 3 weeks. The patient took prenatal vitamin daily from 20-NOV-2018. The patient performed ultrasound on 27-NOV-2018, result was EDD was 11-APR-2019, dating not consistent with LMP. The patient performed cell free fetal (cff) deoxyribonucleic acid (DNA) on 05-DEC-2018, result was positive of trisomy18. The patient took aspirin (ASA) daily from 05-DEC-2018. The patient performed Maternal Serum Alpha Fetoprotein (MSAFP) on 18-DEC-2018, result was less than 1:5000.  The pregnancy outcome was outcome pending. The fetal outcome was unknown. The causality of the event was not provided.
Age: 43.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a 43 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided. Approximately on 06-FEB-2019 (reported as "two weeks ago"), the patient was vaccinated with PROQUAD subcutaneously (dose, vaccination site, lot# and expiration date were not provided), for prophylaxis due to the measles outbreak in her area and her being worried she might get sick. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: This spontaneous report was received from a nurse practitioner via a field employee referring to a 12 years and 4 months old patient of unknown gender. Information about pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot#N026814 with expiration date 15-JUL-2020, dose detail and route were not reported) for prophylaxis. On the same date, an unspecified amount of time after received GARDASIL 9, the patient experienced fever, vomiting and lethargy. The outcome of events and the causality assessments between the events and GARDASIL 9 were not reported.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting projectile
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 2 months old female patient. The patient had no pertinent medical history, concomitant medication or drug reactions/allergies. On 21-FEB-2019, the patient's mother was breastfeeding the patient "just minutes" prior to the patient receiving a dose of ROTATEQ (lot # N030152 with expiration date 01-SEP-2019; strength and dose detail) orally for prophylaxis. On the same day, the patient "projectile" vomited "right after receiving" the dose of ROTATEQ. No treatment was givent to the patient. The patient didn't perform any labdiagnostics/studies. The outcome of vomiting projectile was reported as recovered on 21-FEB-2019. The causality between the event and ROTATEQ was not provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a office manager referring to an unspecified number of patients of unknown ages and unknown genders. Information of concomitant medication, concurrent condition, pertinent medical history and drug reactions/allergies was not provided. On unspecified dates, the patients was administered improperly stored GARDASIL 9 (lot# N021571 with expiration date 29-APR-2020, lot #M037770 with expiration date 01-JUN-2019; strength, dose detail and route were not reported) (product storage error) for prophylaxis. The GARDASIL 9 were exposed to temperature excursion of 47 fahrenheit degree to 77 fahrenheit degree (also reported as 55 fahrenheit degree) for 7 hours and 10 minutes and previous temperature excursion of 47 fahrenheit degree to 77 fahrenheit degree for 14 hours and 20 minutes. No adverse effects was reported. Data logger was involved. This case was determined to be non-valid as no patient identifier.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 21-FEB-2019, the patient was vaccinated with one improperly stored dose of VARIVAX, lot # R023502, expiry date: 16-AUG-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of vaccine was reconstituted with improperly stored sterile diluent, lot # R034106, expiry date: 22-JUN-2021 (dose, route of administration, anatomical location and indication were not provided). The reporter did not know temperature and time frame of excursion. There was no previous temperature excursion. It was not reported if digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1903USA005458: US-009507513-1903USA005457: US-009507513-1903USA005459.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Myalgia, Vitamin D decreased, Vitamin D deficiency
Clinical narrative: This spontaneous report was received from a nurse practitioner via a voicemail and refers to a 14 years old, female patient. No information was provided regarding the patient's concurrent conditions, medical history, concomitant therapies or drugs and allergies reactions. On 02-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L026602 and expiration date of 19-OCT-2017, for unknown indication (strength, route of administration, dose and anatomical site of injection were not provided). On 06-OCT-2017, the patient was vaccinated with the second dose of GARDASIL 9 lot # N019923 and expiration date of 28-APR-2019 for unknown indication (strength, route of administration, dose and anatomical site of injection were not provided). In January 2019, the patient started complained of joint pain (arthralgia) and muscle pain (myalgia) which the patient claimed to be related to GARDASIL 9. On an unspecified date, the patient went to visit an orthopedic doctor and a blood test was performed and showed vitamin D deficient (vitamin D deficiency). The patient sought medical attention, but  was unknown if the patient received any treatment for the adverse events. No product quality complained  was involved. The outcome for the events myalgia and arthralgia was reported as recovering. The outcome of vitamin D deficiency was not reported. The causality assessment between GARDASIL 9 and the events arthralgia and myalgia was reported as related; regarding vitamin D deficiency was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 01-MAR-2019, the patient received an improperly stored dose of ROTATEQ vaccine vial (lot # R016790, expiry date was 20-APR-2020) (route of administration, strength, dose, frequency, dose number were not reported) which was administered after temperature excursion (product storage error) for prophylaxis. No symptoms were reported (no adverse event). The vaccine was exposed to 47.3 degree Fahrenheit (degrees F) for time frame of 18 minutes. There were no previous temperature excursions reported. The call was because of a data logger. No product quality complaint was involved. No additional information has been reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 01-MAR-2019, the patient was vaccinated with one dose of improperly stored ROTATEQ (strength, dose and route were not reported, lot # R021390, expiration date 23-MAY-2020, therapy type digital data logger) and one dose of improperly stored LIQUID PEDVAXHIB (strength, dose and route were not reported, lot # R021077, expiration date 11-JUN-2021, therapy type digital data logger) for prophylaxis (product storage error). The vaccines experienced temperature excursion at 47.8 Fahrenheit degrees for 36 minutes. There was no previous temperature excursion. No adverse effects were reported. A data logger was involved.; Sender's Comments: US-009507513-1903USA002774:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 01-MAR-2019, the patient was vaccinated with one dose of improperly stored ROTATEQ (strength, dose and route were not reported, lot # R021069, expiration date 23-MAY-2020, therapy type digital data logger) and one dose of improperly stored LIQUID PEDVAXHIB (strength, dose and route were not reported, lot # R021077, expiration date 11-JUN-2021, therapy type digital data logger) for prophylaxis (product storage error). The vaccines experienced temperature excursion at 47.8 Fahrenheit degrees for 36 minutes. There was no previous temperature excursion. No adverse effects were reported. A data logger was involved. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA002750:
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacy student concerning a female patient of currently 35-years-old. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On unknown dates, also reported "as a child", the patient was administered a two-dose series of M-M-R II subcutaneously (strength, dose, frequency, lot number and expiry date were not reported). The patient was entering a healthcare field and was required to have titers drawn on an unknown date, which showed she was negative for immunity to measles, mumps and rubella. Therefore, she received treatment (unspecified) for the event. Subsequently, on 06-MAR-2019, the patient was vaccinated with M-M-R II dose 3, subcutaneously (strength, dose, frequency, lot number and expiry date were not reported) for prevention of measles/mumps/rubella and with sterile diluent(MERCK STERILE DILUENT) (strength, dose, route, frequency, lot number, expiry date and indication were not reported). The outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown.       The causality assessment between suspect therapies and the aforementioned events was not provided.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from physician via Pfizer regarding a 12 months old infant of unknown gender. Information on pertinent medical history and concomitant medications were not reported. On an unknown date, the patient received VARIVAX, lot# R021504 with expiry date of 26-JUL-2020, for prophylaxis (dosage schedule was not reported). It was reported that the patient had received his varicella and hepatitis vaccines. He had received two of those (Extra dose administered and Inappropriate schedule of product administration). Varicella or varivax.