chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Nuclear magnetic resonance imaging brain, Post herpetic neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of post herpetic neuralgia in a 75-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced post herpetic neuralgia, headache and drug dose administration interval too long. On an unknown date, the outcome of the post herpetic neuralgia, headache and drug dose administration interval too long were unknown. It was unknown if the reporter considered the post herpetic neuralgia and headache to be related to SHINGRIX. Additional details were reported as follows: About 3 weeks from the date of reporting, the patient developed pain in his head when he tilts it. The patient was diagnosed one week ago with post herpetic neuralgia in his scalp. The patient stated he never had anybody rash. The patient was also late getting his second dose, which led to lengthening of the vaccination schedule. The healthcare professional did not have the lot number or expiry date with him.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Post herpetic neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of post herpetic neuralgia in a 75-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced post herpetic neuralgia, headache and drug dose administration interval too long. On an unknown date, the outcome of the post herpetic neuralgia, headache and drug dose administration interval too long were unknown. It was unknown if the reporter considered the post herpetic neuralgia and headache to be related to SHINGRIX. Additional details were reported as follows: About 3 weeks from the date of reporting, the patient developed pain in his head when he tilts it. The patient was diagnosed one week ago with post herpetic neuralgia in his scalp. The patient stated he never had anybody rash. The patient was also late getting his second dose, which led to lengthening of the vaccination schedule. The healthcare professional did not have the lot number or expiry date with him.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of post herpetic neuralgia in a 75-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced post herpetic neuralgia, headache and drug dose administration interval too long. On an unknown date, the outcome of the post herpetic neuralgia, headache and drug dose administration interval too long were unknown. It was unknown if the reporter considered the post herpetic neuralgia and headache to be related to SHINGRIX. Additional details were reported as follows: About 3 weeks from the date of reporting, the patient developed pain in his head when he tilts it. The patient was diagnosed one week ago with post herpetic neuralgia in his scalp. The patient stated he never had anybody rash. The patient was also late getting his second dose, which led to lengthening of the vaccination schedule. The healthcare professional did not have the lot number or expiry date with him.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 52-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX. On 30th September 2018, 9 days after receiving SHINGRIX, the patient experienced herpes zoster and rash. On an unknown date, the outcome of the herpes zoster and rash were recovering/resolving. It was unknown if the reporter considered the herpes zoster and rash to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX in the left deltoid. The rash appeared on the patient's right side of body.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 52-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 21st September 2018, the patient received the 1st dose of SHINGRIX. On 30th September 2018, 9 days after receiving SHINGRIX, the patient experienced herpes zoster and rash. On an unknown date, the outcome of the herpes zoster and rash were recovering/resolving. It was unknown if the reporter considered the herpes zoster and rash to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX in the left deltoid. The rash appeared on the patient's right side of body.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Chills, Lethargy, Night sweats, Oropharyngeal pain
Clinical narrative: After the flu shot was administered, within 2 to 3 hours later, I developed a severe sore throat with tightening in my throat, stomach cramps after I ate at 8 pm, and developed chills and body aches about 10 pm and could barely move. I had to have help getting into bed. In the middle of the night I had a sweating attack that lasted 1/2 hour to 1 hour. Was able to get back to sleep but still had the sore throat and very dry mouth. In the morning my throat was still sore and the roof of my mouth hurt. My head was clear but my body was aching. I stayed home the whole day and rested. By Wednesday I was back to normal.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Stomatitis, Throat tightness
Clinical narrative: After the flu shot was administered, within 2 to 3 hours later, I developed a severe sore throat with tightening in my throat, stomach cramps after I ate at 8 pm, and developed chills and body aches about 10 pm and could barely move. I had to have help getting into bed. In the middle of the night I had a sweating attack that lasted 1/2 hour to 1 hour. Was able to get back to sleep but still had the sore throat and very dry mouth. In the morning my throat was still sore and the roof of my mouth hurt. My head was clear but my body was aching. I stayed home the whole day and rested. By Wednesday I was back to normal.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Bed rest, Chills, Dry mouth, Hypokinesia
Clinical narrative: After the flu shot was administered, within 2 to 3 hours later, I developed a severe sore throat with tightening in my throat, stomach cramps after I ate at 8 pm, and developed chills and body aches about 10 pm and could barely move. I had to have help getting into bed. In the middle of the night I had a sweating attack that lasted 1/2 hour to 1 hour. Was able to get back to sleep but still had the sore throat and very dry mouth. In the morning my throat was still sore and the roof of my mouth hurt. My head was clear but my body was aching. I stayed home the whole day and rested. By Wednesday I was back to normal.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Night sweats, Oropharyngeal pain, Pain, Throat tightness
Clinical narrative: After the flu shot was administered, within 2 to 3 hours later, I developed a severe sore throat with tightening in my throat, stomach cramps after I ate at 8 pm, and developed chills and body aches about 10 pm and could barely move. I had to have help getting into bed. In the middle of the night I had a sweating attack that lasted 1/2 hour to 1 hour. Was able to get back to sleep but still had the sore throat and very dry mouth. In the morning my throat was still sore and the roof of my mouth hurt. My head was clear but my body was aching. I stayed home the whole day and rested. By Wednesday I was back to normal.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Inflammation, Yellow skin
Clinical narrative: I found out about the adverse event on Friday night, October 5, 2018 after the patient filed a complaint. She stated that her arm was inflamed and had a yellowish color around the bottom rim of inflammation on her arm. She was given the shot on Tuesday, October 2, 2018 and I believe she started having a reaction later that day. She came in with her husband on Thursday, October 4, 2018 as he was getting a PREVNAR shot and flu shot. She showed my staff pharmacist her arm as they were leaving. My staff pharmacist stated that she did not think it was a typical reaction and urged the patient to see her doctor. My pharmacist told me it looked like inflammation with liquid. I believe the patient was either seen by her doctor later that day or the following day. She stated that the doctor believed that I did not clean the area very well and therefore introduced bacteria, thereby causing an infection. She said she was given an antibiotic and steroid and told to finish the course before it turned into MRSA. I'm unsure what lab tests or cultures were done, if any. I am also unsure which medications she was given as we did not fill the prescriptions at my pharmacy. The PNEUMOVAX was the only prescription on her profile after checking. I did apologize for what she experienced and told her it was the first time anyone has had a reaction since I had been giving immunizations starting 2009. I also told her I would file a report and follow up. I contacted later that evening, our third party who handles claims. After speaking in further detail on Monday, October 8, with the rep they said they would follow up with the patient and handle any claims she may have. I was also told not to contact the patient further as they would be the one to follow up.
Age: 34.0
Sex: M
Vaccine: ANTH, FLUC4
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: The morning following administration, I discovered localized swelling at the injection site, approximately 2cm protrusion from nominal skin level, approximately 15cm diameter circular area. Area was abnormally firm to the touch, and abnormally warm to the touch. The symptoms began to subside after 48 hours, and were completely subsided after 7 days. This is the first instance of this type of reaction in my military vaccine history. Telephone consult was completed with attending medical technician on first day after vaccine administration, and symptoms were described as "normal."
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: This is my first time to experience the following after flu vaccination:1.  Body Aches 2. Fever 3. Sore Throat 4. Cough. This is the worst side effects.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 24 hours after injection, the site was erythematous, radiation 3 inches around injection site. Site was hot to touch and painful. Symptoms lasted 36 hours.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: Pt had a irregular "bruise-like" discoloration about 2-3 inches above the elbow but not where the vaccine was administered. Patient said she did not have any adverse reaction to any vaccine before. Patient did not have any ill effects from the vaccination (no fever, no pain at site of "bruising"). When asked if patient has any blood clotting disorders, she answered "no" and also responded with a negative if she bumped into anything recently.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site pain, Nausea, Pain
Clinical narrative: Had the expected soreness at injection site, woke up the next morning with severe headache, nausea, & all over body ache. Headache is unrelieved by any OTC anti inflammatory.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain
Clinical narrative: Severe abdominal cramping for approx. 4 hours that night.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt presented with erythema, swelling and pain to right arm 2 weeks after GARDASIL vaccine. Pt treated with cephalexin for cellulitis, which symptoms improved at follow up visit.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Chest pain, Erythema, Feeling hot, Immediate post-injection reaction
Clinical narrative: Immediate redness and red streaking down the left upper arm when the injection was given. Burning sensation on the arm, face and chest areas immediately following the injection. Face turned red, hot to touch and a rash developed on the face and chest area immediately. Face was swollen. Also, vomited with in 5 minutes of getting the flu shot. Seen by Occupational health doctor at the Clinic. She checked blood pressure and prescribed Benadryl.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site streaking, Rash, Swelling face, Vomiting
Clinical narrative: Immediate redness and red streaking down the left upper arm when the injection was given. Burning sensation on the arm, face and chest areas immediately following the injection. Face turned red, hot to touch and a rash developed on the face and chest area immediately. Face was swollen. Also, vomited with in 5 minutes of getting the flu shot. Seen by Occupational health doctor at the Clinic. She checked blood pressure and prescribed Benadryl.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Chills, Diarrhoea, Hot flush, Vomiting
Clinical narrative: Vomiting and diarrhea at 1230am the night after vaccination. Hot flashes and cold chills, feeling of unease, vomiting the next evening at 10 pm.
Sex: U
Vaccine: HPVX
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Information has been received from the authors of the literature article entitled as stated above concerning to children patients aged less than 9 year old. The patients were sexual assault (SA) victims presenting to the emergency department (ED) for acute postassault care. It was advised that clinicians to address Human papillomavirus (HPV) during ED-based SA care and at follow-up. On unknown dates, these patients were vaccinated with unspecified HPV vaccine (manufacturer unknown) for prophylaxis (drug administered to patient of inappropriate age). A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.17
Sex: M
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This spontaneous report as received from a consumer (patient's grandfather) via agency (ref# US18-033673) refers to a 2 month old male patient. No medical history, concurrent condition and concomitant medications were reported. On 25-SEP-2018, at the two month appointment, the patient was accidently vaccinated with PNEUMOVAX 23 instead of an unspecified product what he was supposed to get (wrong drug administered and  drug administered to patient of inappropriate age). The mother was called later in the day and was informed about the accidental vaccine administration. Laboratory data was unknown. As of 25-SEP-2018, the patient has not received another dose.
Age: 0.58
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Information has been received from a medical assistant referring to a 7 month old female patient. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided. On 25-SEP-2018,  the patient was vaccinated with a dose of VAQTA (25/0.5 with unspecified unit, lot#R013858, expiration date was 12-JUN-2019, intramuscular; dose number was not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effect was reported.
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Arthralgia, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: This spontaneous report was received from a physician via social media refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date the patient was vaccinated with GARDASIL (lot# and expiry date unknown) (dosing details, lot# and expiry date unknown) for prophylaxis. On unknown dates, the patient experienced an unspecified adverse event, unspecified illness, unspecified chronic condition, poor concentration, extreme tiredness, dizziness, pain in joint and pain in muscle. The patient was hospitalized due to the unspecified adverse event. The outcome of the events were unknown. Causality assessment was not provided. The reporter considered adverse event (NOS) to be life threatening. This is one of the three reports received from the same reporting source.; Sender's Comments: US-009507513-1810USA002766: US-009507513-1810USA003394:
Sex: F
Vaccine: HPV4
Symptoms: Ill-defined disorder, Myalgia
Clinical narrative: This spontaneous report was received from a physician via social media refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown. On an unknown date the patient was vaccinated with GARDASIL (lot# and expiry date unknown) (dosing details, lot# and expiry date unknown) for prophylaxis. On unknown dates, the patient experienced an unspecified adverse event, unspecified illness, unspecified chronic condition, poor concentration, extreme tiredness, dizziness, pain in joint and pain in muscle. The patient was hospitalized due to the unspecified adverse event. The outcome of the events were unknown. Causality assessment was not provided. The reporter considered adverse event (NOS) to be life threatening. This is one of the three reports received from the same reporting source.; Sender's Comments: US-009507513-1810USA002766: US-009507513-1810USA003394:
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Seizure
Clinical narrative: This spontaneous report was received from the patient's grandfather and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in September 2018, reported as "last 3 weeks", the patient was vaccinated with a dose GARDASIL 9 as vaccination (dose, route, frequency, lot/batch # and expiration date were not reported). It was reported that the patient experienced a seizure immediately after the vaccine was administered and the seizures had been ongoing for the last 3 weeks (since an unknown date in September 2018). The patient received unspecified treatment at an unspecified hospital (unspecified if the patient was hospitalized) and had seen various specialists including a neurologist for unspecified treatment. The outcome of seizure was reported as not resolved. The causality assessment between seizure and GARDASIL 9 was not reported. Upon internal review, seizure was determined to be a medically significant event.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 78-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were unknown by the reporter. On 19-SEP-2018, the patient was vaccinated with PNEUMOVAX23 (the dosage regimen information was not reported) lot # N025384 (expiration date: 19-APR-2019) for prophylaxis. On that same date, a few hours after vaccination, her arm was red, swollen, warm to touch extending down to her elbow. No treatment was provided to the patient. On 21-SEP-2018, the patient went to the pharmacist and it was found that the patient's arm was still swollen but it was getting better. No causality assessment was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 22-MAR-2016, the patient was inoculated with the ZOSTAVAX, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 25-MAR-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-FEB-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 20-MAR-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. On or about 21-MAR-2016, the patient sought subsequent treatment from an optometrist for the onset of another vesicular rash, which was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX) did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 26-AUG-2014, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as severe shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) and hydrocodone for management of his painful symptoms and excruciating pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-FEB-2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 18-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a medical clinic, as recommended for routine adult health maintenance and for the long-term prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 02-NOV-2015, the patient was treated by a physician assistant, for the onset of a severe vesicular rash, which was as diagnosed as shingles. The patient was prescribed VALTREX, prednisone and LIDODERM for management of her painful symptoms and excruciating pain. On or about 10-NOV-2015, the patient sought subsequent treatment from the same medical clinic from the same physician assistant for the diagnosis of post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. She was prescribed tramadol for management of her painful symptoms and persistent pain. As a direct and proximate result of the ZOSTAVAX, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 25-AUG-2016 the patient was inoculated with ZOSTAVAX vaccine at a health clinic for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-SEP-2016 the patient was treated at a health clinic for a blistering vesicular outbreak, accompanied by weakened immune system which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. In October 2017, "1 year ago", the patient was vaccinated with a dose of PREVNAR 13 (dose and lot # not reported) and was administered a dose of PNEUMOVAX 23 (Lot # R018741 exp date 06-APR-2020) (dose and route not reported) 23 days earlier than the recommended interval in the prescribing information. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-JAN-2014, the patient was inoculated with the ZOSTAVAX vaccine at a local health department as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 03-FEB-2014, the patient was treated by a physician for a vesicular outbreak which was diagnosed as shingles. The patient was prescribed acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-NOV-2015 the patient was inoculated with the ZOSTAVAX vaccine at a doctor's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-SEP-2016, the patient was treated by a physician at a hospital for a severe vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed lidocaine, oxycodone, valacyclovir hydrochloride (VALTREX) and acyclovir for management of his painful symptoms and excrutiating pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by a physician for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 01-FEB-2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 01-JUN-2016, the patient was treated at a health center for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history, concurrent condition and concomitant medications were reported. On 05-OCT-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N029628, expiry date 23-NOV-2018) (dosing details unknown) for prophylaxis. The vaccine was reconstituted with sterile diluent stored at room temperature. No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour 33 minutes. Previous temperature excursion included temperature exposure to 6 degree Fahrenheit to 14 degree Fahrenheit for 42 hours 48 minutes and 15 degree Fahrenheit to 46 degree Fahrenheit for 39 hours 57 minutes. A digital data logger was involved. No product quality complaint was filed.
Sex: M
Vaccine: VARZOS
Symptoms: Auditory disorder, Cataract, Deafness, Myocardial infarction, Optic nerve infarction
Clinical narrative: This initial spontaneous report was received in 09-OCT-2018 from the approximately 72 year old male patient and also from the supervisor of an unspecified vaccine injury compensation program.  The patient reported medical history of cataracts, heart attack, and stroke.  He is allergic to codeine, safrazine, povidone-iodine (BETADINE), and penicillin. On an unspecified date "over five years ago", the patient received ZOSTAVAX for shingles prevention (dose, route, and lot# not provided) as well as sterile diluent. The patient reported that in 2016, he experienced hearing loss, cataracts, a stroke in his optic nerve, and a heart attack. He was hospitalized (no further details provided) and he received unspecified treatment. The supervisor said he received a call about this patient who received the shingles vaccine and later developed an infarct in the optic nerve bilaterally and he also had "auditory issues." The supervisor further stated his program "does not cover shingles vaccine" and perhaps there was something the Company could do for this patient's issues. The patient was inquiring whether the Company was able to reimburse him in any way after experiencing adverse effects related to ZOSTAVAX. The patient was given information for the Division of Vaccine Injury Compensation.  Because the patient is visually and hearing impaired, he asked that they call him (visual impairment was considered a result of the stroke in the optic nerve and infarct in the optic nerve bilaterally).  The patient believed that the Company did not advertise these types of side effects "because people would sue them." At the time of reporting, the patient had not recovered from  the events.  The patient felt the events were related to ZOSTAVAX. Upon internal review, hearing loss, cataracts, stroke in his optic nerve, heart attack, and an infarct in optic nerve bilaterally were considered to be medically significant events. The patient did not provide consent to be contacted for follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: This initial spontaneous report was received in 09-OCT-2018 from the approximately 72 year old male patient and also from the supervisor of an unspecified vaccine injury compensation program.  The patient reported medical history of cataracts, heart attack, and stroke.  He is allergic to codeine, safrazine, povidone-iodine (BETADINE), and penicillin. On an unspecified date "over five years ago", the patient received ZOSTAVAX for shingles prevention (dose, route, and lot# not provided) as well as sterile diluent. The patient reported that in 2016, he experienced hearing loss, cataracts, a stroke in his optic nerve, and a heart attack. He was hospitalized (no further details provided) and he received unspecified treatment. The supervisor said he received a call about this patient who received the shingles vaccine and later developed an infarct in the optic nerve bilaterally and he also had "auditory issues." The supervisor further stated his program "does not cover shingles vaccine" and perhaps there was something the Company could do for this patient's issues. The patient was inquiring whether the Company was able to reimburse him in any way after experiencing adverse effects related to ZOSTAVAX. The patient was given information for the Division of Vaccine Injury Compensation.  Because the patient is visually and hearing impaired, he asked that they call him (visual impairment was considered a result of the stroke in the optic nerve and infarct in the optic nerve bilaterally).  The patient believed that the Company did not advertise these types of side effects "because people would sue them." At the time of reporting, the patient had not recovered from  the events.  The patient felt the events were related to ZOSTAVAX. Upon internal review, hearing loss, cataracts, stroke in his optic nerve, heart attack, and an infarct in optic nerve bilaterally were considered to be medically significant events. The patient did not provide consent to be contacted for follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Eye irritation, Impaired driving ability, Impaired work ability, Ocular hyperaemia
Clinical narrative: This initial spontaneous report was received from a male patient of unknown age. The patient refused to provide any information regarding his medical history, concurrent conditions, or concomitant medications. In June 2018, the patient was vaccinated with ZOSTAVAX and sterile diluent (lot # and route not provided). An unspecified duration after getting the shingles vaccine, the patient started developing some problems with his eyes. He described the problems as his eyes became severely irritated after getting the vaccine. Also, his eyes became very red and bloodshot all the way up to the pupils. He went to three different physicians to get unspecified treatment for his ocular related adverse reaction. The patient also mentioned that his eyes have gotten bad enough where he can't work or hardly drive anymore. He was not sure if he needed to pursue legal action because he was already out [amount] for medical expenses due to the adverse experiences. The events were not resolved.  Causality assessment was considered related. Eyes became severely irritated and eyes became very red and bloodshot all the way up to his pupils were considered disabling since the patient said he can't work or hardly drive anymore. The patient did not provide consent to be contacted for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 31-DEC-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016, the patient was treated by the physician for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2007, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 24-SEP-2016, the patient was treated by the clinic for a severe vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-APR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 24-SEP-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a nurse prescriber referring to a 10 year old female patient. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were unknown by the reporter. In approximately October 2018 also reported as "the last week ", the patient was vaccinated with her first dose of GARDASIL 9 (strength, dose, route of administration, anatomical location, lot #, and expiration date were not reported) indicated for vaccination. The nurse prescriber reported that the patient had a rash after receiving GARDASIL 9 in approximately October 2018. It was unknown if the patient sought medical attention or if diagnostic laboratory test were performed. Additionally, it was unknown if a treatment was given for the rash. The outcome of rash was unknown and its relationship with GARDASIL 9 was not reported.