chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Bronchitis, Herpes simplex, Herpes zoster, Rash pruritic, Rash vesicular
Clinical narrative: This medically confirmed report (initial receipt 03-Apr-2015) concerns a 55 year old female patient who had a medical history of GBS (Guillain Barre Syndrome) in 2010 and allergies to sulfamethoxazole/trimethoprim and IV (intravenous) dye. On the 15-Oct-2014, the patient received an influenza vaccine (manufacturer and batch number not reported) and ZOSTAVAX (batch number not reported) 0.65mL via the subcutaneous route. On the 20-Oct-2014, since receiving the vaccine, the patient has experienced three to four vesicular rashes/shingles outbreaks. On the 20-Oct-2014, the first lesions appeared and resolved on an unspecified date. On the 20-Jan-2015, another lesion appeared and resolved on an unspecified date. The rash was cultured and tested on the 03-Feb-2015 and was diagnosed as HSV (Herpes Simplex Virus). On the 06-Feb-2015 another lesion appeared and she was diagnosed with bronchitis, both resolved on an unspecified date. On the 27-Feb-2015, another lesion appeared and she was diagnosed with bronchitis again and had not recovered from either illness. Treatment included Valacyclovir and doxycycline on unspecified date. She was assessed by a NP (nurse practitioner) on unspecified date. On the 19-Mar-2015, the patient had stated that she was having the fifth or sixth outbreak. New lesions appeared on her low back and right buttock which were very itchy and not painful. Outcome was not recovered.
Age: 55.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS, FLUX, VARZOS
Symptoms: Skin lesion
Clinical narrative: This medically confirmed report (initial receipt 03-Apr-2015) concerns a 55 year old female patient who had a medical history of GBS (Guillain Barre Syndrome) in 2010 and allergies to sulfamethoxazole/trimethoprim and IV (intravenous) dye. On the 15-Oct-2014, the patient received an influenza vaccine (manufacturer and batch number not reported) and ZOSTAVAX (batch number not reported) 0.65mL via the subcutaneous route. On the 20-Oct-2014, since receiving the vaccine, the patient has experienced three to four vesicular rashes/shingles outbreaks. On the 20-Oct-2014, the first lesions appeared and resolved on an unspecified date. On the 20-Jan-2015, another lesion appeared and resolved on an unspecified date. The rash was cultured and tested on the 03-Feb-2015 and was diagnosed as HSV (Herpes Simplex Virus). On the 06-Feb-2015 another lesion appeared and she was diagnosed with bronchitis, both resolved on an unspecified date. On the 27-Feb-2015, another lesion appeared and she was diagnosed with bronchitis again and had not recovered from either illness. Treatment included Valacyclovir and doxycycline on unspecified date. She was assessed by a NP (nurse practitioner) on unspecified date. On the 19-Mar-2015, the patient had stated that she was having the fifth or sixth outbreak. New lesions appeared on her low back and right buttock which were very itchy and not painful. Outcome was not recovered.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Blood test, Computerised tomogram, Dysphagia, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Mobility decreased, Nuclear magnetic resonance imaging
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Dizziness, Eating disorder, Gait disturbance, Guillain-Barre syndrome, Speech disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Asthenia, Back pain, Computerised tomogram normal, Constipation, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Dizziness postural, Dysgeusia, Dyspnoea, Eating disorder, Electrocardiogram normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Eyelid function disorder, Fall, Flank pain, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Immunoglobulin therapy, Injection site pain, Lacrimation increased, Loss of consciousness, Lumbar puncture abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Mobility decreased, Neck pain, Nuclear magnetic resonance imaging normal, Renal pain, Respiratory tract congestion
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 72.0
Sex: M
Vaccine: PNC13, PNC13, PNC13
Symptoms: Visual impairment, Walking aid user, Weight decreased
Clinical narrative: This is a spontaneous report from a contactable consumer (patient wife) via a non-clinical-study program. A 72 years old male patient received first single dose of PREVNAR 13 (lot L13518, expiry date Jul2016, NDC number: 0005-1971-02) on 01May2015, in left arm. No other vaccinations were given within four weeks prior. Medical history included ongoing high cholesterol, diagnosed about 10 years ago. The patient experienced in the past PERCOCET addiction. Concomitant medications included CRESTOR, at 1 DF daily for high cholesterol, TYLENOL with Codeine No. 3 2 DF, daily (2 at night) when he hurted and cyclobenzaprine hydrochloride 1 DF twice daily (one in the morning and one at 3 P.M.). The patient experienced pain at injection site on 01May2015 with unknown outcome. No redness was noted to arm. Since an unknown date the patient developed also weakness, walking like a drunk, trouble eating and drinking food falling out of mouth, 25 pounds lost, unable to close eyelids, eyes watering, congestion, constipation, lightheadedness when tying shoes, neck and back pain, kidney pain, felt like he had no taste buds, fell over and passed out, out of breath, vision problems, he could not go to bathroom and had no ambition to do anything. The patient had been receiving an unspecified stool softener for constipation. The neurologist finally diagnosed Guillain Barre Syndrome which patient said he thought was due to the vaccine. The patient was admitted to hospital on 04Jun2015 due to Guillain Barre Syndrome and was transferred from the hospital on 15Jun2015 to a rehabilitation facility and was just discharged from the rehabilitation facility on 08Jul2015. The patient was treated at the hospital for Guillain Barre Syndrome with IV drip of immunoglobulin for five days in a row at 4 P.M. The patient saw a cardiologist, a urologist and a neurologist while in the hospital. Lab data performed on unknown date showed: CT scan normal, EKG normal, MRI normal, spinal tap revealed Guillain Barre Syndrome. Patient had declined to have a prescription of PERCOCET, which he had in the hospital, because PERCOCET could be addicting. Guillain-Barre syndrome had not resolved at time of report. However, the patient has been able to eat soft foods and oatmeal. A physical therapist was coming to his house to reteach him how to eat. He was walking much better. He was using a walker in the rehab facility and now at home he was using a cane to help with balance. He still had neck and back pain. He thought his kidney pain was because of the lower back pain in the right flank which he had at night. He was still congested and constipated and thought this caused his kidney to hurt (right side of lower back at night). He could now close his eyelids, his eyes were still watering, his vision was improving. He still had some weakness. Lightheadedness was better. Taste buds were starting to come back. The patient stated that the doctor thought his events were related to the shot.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Patient received varicella vaccine 9/7/06 & 9/1/09 and was diagnosed with varicella 7/15/15.
Age: 5.0
Sex: F
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Patient received varicella vaccine 9/7/06 & 9/1/09 and was diagnosed with varicella 7/15/15.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Biopsy, Blood test, Erythema, Pyrexia, Skin necrosis
Clinical narrative: Started to develop necrotic ulcers, fever and redness. Eventually diagnosed as pyroderma gangrenosum as a result of immune response from flu vaccine.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Ultrasound scan
Clinical narrative: Started to develop necrotic ulcers, fever and redness. Eventually diagnosed as pyroderma gangrenosum as a result of immune response from flu vaccine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left upper arm, area of increased warmth erythema covering 2/3 of left upper arm surrounding site. Treatment: prednisone (pak). Injection dexamethasone 1 mg.
Age: 44.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Headache, Influenza like illness, Injection site nodule, Injection site rash, Mobility decreased
Clinical narrative: Swelling & tightness in arm, itching, rash dime size knot at injection site, muscle aches limited mobility of arm, headache flu like. Took Tylenol & Benadryl.
Age: 44.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Musculoskeletal stiffness, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: Swelling & tightness in arm, itching, rash dime size knot at injection site, muscle aches limited mobility of arm, headache flu like. Took Tylenol & Benadryl.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Erythema, Induration, Skin warm, Swelling
Clinical narrative: Swelling, redness, tenderness, hard under skin, warm, shortness of breath.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Swelling, redness, tenderness, hard under skin, warm, shortness of breath.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and unknown gender. Pertinent medical history and drug allergy were not reported. In September 2012, the patient received the first dose of GARDASIL (dose, route, lot# and expiration date were not reported). On 20-AUG-2013 and 04-OCT-2013, the patient received the second and third doses of GARDASIL respectively. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patient sought medical attention. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 month old patient of unknown gender. There was no information about pertinent medical history, drug reactions and allergies and concomitant medications provided. On 08-JUL-2015, the patient was vaccinated with the first dose of VARIVAX (lot#, expiration date, dose were not reported) and MMR II (lot#, expiration date, dose were not reported), both vaccines were given subcutaneously. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. No pertinent medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose, route, lot # and expiry date were not reported). No adverse effects were reported. Follow up information has been received from the licensed practical nurse on 09-JUN-2015. The nurse stated that the requested information for patient identifiers, lot number and expiration date and dates of vaccination were not readily available at time of contact. Follow-up information has been received from the licensed practical nurse on 24-JUN-2015. It was reported that 8 patients received improperly stored ZOSTAVAX (lot# K008880, expiry date 20-SEP-2015 (also reported as 09-SEP-2015)). Additional information is not expected as all the scheduled correspondence has been obtained. Product and narrative were updated. This is one of several reports from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. The reporter stated that between 28-APR-2015 and 30-JUN-2015 (exact dates of administration were not provided), the patients were vaccinated with improperly stored doses of GARDASIL, dose 0.5 ml, intramuscularly, lot # K005881, expiration date 14-JAN-2017 (strength was not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Ear swelling, Erythema, Pallor, Rash erythematous
Clinical narrative: This spontaneous report from patient's mother refers to a 2 year old male patient. The patient was a premature baby. There was no history of drug allergies or reactions. On 02-JUL-2015 the patient was vaccinated with (Oka/Merck) VARIVAX lot # L006383 first dose, subcutaneous as routine vaccination. Concomitant medications were none. On 03-JUL-2015, within 24 hours of receiving the first dose of (Oka/Merck) VARIVAX, the patient experienced "itchy hive like rashes, that were red and swollen, big welts that sink in, turn into circle-like in area, with a clear center", that come and go all over his body. The hives started on his belly, moved to his upper back, bottom of his feet, near his eyes and ears. His ears were also swollen and red. He also experienced, within 24 hours of receiving (Oka/Merck) VARIVAX, difficulty breathing and was very pale. The patient sought medical attention and made an office visit and a visit to an unspecified urgent care center. The patient received BENADRYL as treatment in response to the events. The outcome of the events was reported was not resolved. Causality assessment was not provided. There was no product quality complaint involved. The lot check had been requested. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: This spontaneous report from patient's mother refers to a 2 year old male patient. The patient was a premature baby. There was no history of drug allergies or reactions. On 02-JUL-2015 the patient was vaccinated with (Oka/Merck) VARIVAX lot # L006383 first dose, subcutaneous as routine vaccination. Concomitant medications were none. On 03-JUL-2015, within 24 hours of receiving the first dose of (Oka/Merck) VARIVAX, the patient experienced "itchy hive like rashes, that were red and swollen, big welts that sink in, turn into circle-like in area, with a clear center", that come and go all over his body. The hives started on his belly, moved to his upper back, bottom of his feet, near his eyes and ears. His ears were also swollen and red. He also experienced, within 24 hours of receiving (Oka/Merck) VARIVAX, difficulty breathing and was very pale. The patient sought medical attention and made an office visit and a visit to an unspecified urgent care center. The patient received BENADRYL as treatment in response to the events. The outcome of the events was reported was not resolved. Causality assessment was not provided. There was no product quality complaint involved. The lot check had been requested. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. The reporter stated that between 28-APR-2015 and 30-JUN-2015 (exact dates of administration were not provided), the patients were vaccinated with improperly stored doses of PNEUMOVAX23, intramuscular (strength and dose were not provided), lot # K021577, expiration date 22-JUN-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (Merck), Lot number-L008356 and expiration date-01-SEP-2016, Lot number-K02336 and expiration date-20-MAY-2016 (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. No information regarding medical history and concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL lot # K005881 and expiry date of 14-JAN-2017 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date not provided) in her arm. Subsequently (exact dates not provided, reported as "a very long time ago"), the patient developed a little rash on her arm post vaccination. The patient sought medical attention and came into pharmacy. No treatment was needed. The rash resolved within 5 to 7 days on it's own, the patient's status was reported as fully recovered. The relatedness between vaccination site rash and ZOSTAVAX was not reported. Additional information is not expected, as the reporter did not want to be contacted regarding this event.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No concurrent condition, medical history or allergy/drug reactions were reported. On 07-JUL-2015, the patient was vaccinated with ZOSTAVAX (dose, route and lot number or batch number unspecified). No concomitant medication was reported. On 07-JUL-2015, the patient developed pruritus, warmth and a large area of redness at the injection site after receiving ZOSTAVAX. The patient sought medical attention - saw pharmacist in the pharmacy. The patient was treated with TYLENOL and ice pack was applied to the affected area. Lab tests were reported as unspecified. The outcome of injection site pruritus, warmth and redness was not recovered. There were no product quality complaints (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Oral herpes, Oral mucosal blistering
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 08-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX in her arm (strength reported as 19400 plaque-forming units (PFU); dose, frequency, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On 09-JUL-2015, the patient experienced "redness, pruritus and swelling down to the elbow of her arm", which occurred in the arm in which the patient received the ZOSTAVAX. The reported stated that the patient also developed a blister on the roof on her mouth and cold sores around her mouth after receiving ZOSTAVAX (on 09-JUL-2015). The patient sought medical attention (called the pharmacist on an unspecified date). No treatment was given for the events. The outcome of the events was unknown. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.