chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received SHINGRIX (intramuscular). On 2nd July 2018, 8 hrs 45 min after receiving SHINGRIX, the patient experienced tiredness and vaccine administered at inappropriate site. On 3rd July 2018, the patient experienced diarrhea, stomach pain, weakness, pain, headache, shivering, feeling hot, lethargy, influenza like illness and buttock pain. On an unknown date, the outcome of the diarrhea was recovering/resolving and the outcome of the stomach pain, weakness, pain, headache and lethargy were not recovered/not resolved and the outcome of the tiredness, influenza like illness, buttock pain and vaccine administered at inappropriate site were unknown and the outcome of the shivering and feeling hot were recovered/resolved. It was unknown if the reporter considered the diarrhea, stomach pain, weakness, tiredness, pain, headache, shivering, feeling hot, lethargy, influenza like illness, buttock pain and vaccine administered at inappropriate site to be related to SHINGRIX. Additional details were provided as follow: At 11:15 hours, the patient received SHINGRIX and it was administered in the left side of her butt, which led to vaccine administered at inappropriate site and off label use. The patient's provider told her that it made the patients arms too sore and that why she was administering into the butt. In night at 22:00 PM, 10 hours 45 min after receiving SHINGRIX, the patient felt tired so she went to bed. On 30th July 2018, the patient woke up at midnight and receiving SHINGRIX, she had to run to the bathroom because of diarrhea. She also felt hot and was shivering. She had a headache and stomachache and felt weak, lethargic, and achy all over. The shivering and hot feeling happened only that one time, but the patient woke up again at 2:15 AM, 4:30 AM and 7 AM because of diarrhea. The patient was generally feeling like she had the flu and her left butt cheek was also very sore. The diarrhea was improving, but not resolved and the patient was experiencing the other symptoms. This case has been linked to the US2018GSK125061, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Influenza like illness, Lethargy, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received SHINGRIX (intramuscular). On 2nd July 2018, 8 hrs 45 min after receiving SHINGRIX, the patient experienced tiredness and vaccine administered at inappropriate site. On 3rd July 2018, the patient experienced diarrhea, stomach pain, weakness, pain, headache, shivering, feeling hot, lethargy, influenza like illness and buttock pain. On an unknown date, the outcome of the diarrhea was recovering/resolving and the outcome of the stomach pain, weakness, pain, headache and lethargy were not recovered/not resolved and the outcome of the tiredness, influenza like illness, buttock pain and vaccine administered at inappropriate site were unknown and the outcome of the shivering and feeling hot were recovered/resolved. It was unknown if the reporter considered the diarrhea, stomach pain, weakness, tiredness, pain, headache, shivering, feeling hot, lethargy, influenza like illness, buttock pain and vaccine administered at inappropriate site to be related to SHINGRIX. Additional details were provided as follow: At 11:15 hours, the patient received SHINGRIX and it was administered in the left side of her butt, which led to vaccine administered at inappropriate site and off label use. The patient's provider told her that it made the patients arms too sore and that why she was administering into the butt. In night at 22:00 PM, 10 hours 45 min after receiving SHINGRIX, the patient felt tired so she went to bed. On 30th July 2018, the patient woke up at midnight and receiving SHINGRIX, she had to run to the bathroom because of diarrhea. She also felt hot and was shivering. She had a headache and stomachache and felt weak, lethargic, and achy all over. The shivering and hot feeling happened only that one time, but the patient woke up again at 2:15 AM, 4:30 AM and 7 AM because of diarrhea. The patient was generally feeling like she had the flu and her left butt cheek was also very sore. The diarrhea was improving, but not resolved and the patient was experiencing the other symptoms. This case has been linked to the US2018GSK125061, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received SHINGRIX (intramuscular). On 2nd July 2018, 8 hrs 45 min after receiving SHINGRIX, the patient experienced tiredness and vaccine administered at inappropriate site. On 3rd July 2018, the patient experienced diarrhea, stomach pain, weakness, pain, headache, shivering, feeling hot, lethargy, influenza like illness and buttock pain. On an unknown date, the outcome of the diarrhea was recovering/resolving and the outcome of the stomach pain, weakness, pain, headache and lethargy were not recovered/not resolved and the outcome of the tiredness, influenza like illness, buttock pain and vaccine administered at inappropriate site were unknown and the outcome of the shivering and feeling hot were recovered/resolved. It was unknown if the reporter considered the diarrhea, stomach pain, weakness, tiredness, pain, headache, shivering, feeling hot, lethargy, influenza like illness, buttock pain and vaccine administered at inappropriate site to be related to SHINGRIX. Additional details were provided as follow: At 11:15 hours, the patient received SHINGRIX and it was administered in the left side of her butt, which led to vaccine administered at inappropriate site and off label use. The patient's provider told her that it made the patients arms too sore and that why she was administering into the butt. In night at 22:00 PM, 10 hours 45 min after receiving SHINGRIX, the patient felt tired so she went to bed. On 30th July 2018, the patient woke up at midnight and receiving SHINGRIX, she had to run to the bathroom because of diarrhea. She also felt hot and was shivering. She had a headache and stomachache and felt weak, lethargic, and achy all over. The shivering and hot feeling happened only that one time, but the patient woke up again at 2:15 AM, 4:30 AM and 7 AM because of diarrhea. The patient was generally feeling like she had the flu and her left butt cheek was also very sore. The diarrhea was improving, but not resolved and the patient was experiencing the other symptoms. This case has been linked to the US2018GSK125061, reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020) for prophylaxis. Concomitant products included acyclovir and trazodone. On 12th January 2018, the patient received the 1st dose of SHINGRIX. On 12th January 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms and feeling unwell. On 15th January 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the feeling unwell was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional details were provided as follows: Reporter reported this case for herself. The patient received thyroid medication concomitantly. Before noon of the 12th January 2018, the patient received SHINGRIX in the left arm. After receiving SHINGRIX, the patient experienced mild flu like symptoms for 3 days. The patient claimed that she did not felt well. The patient claims that the lot number was either 9VC39 or 9XC39. However, from sales data sheet, the correct batch number was considered as 9XC39.
Sex: M
Vaccine: MEN
Symptoms: Fatigue, Mobility decreased, Pain in extremity, Sluggishness
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Meningococcal B vaccine for prophylaxis. In June 2018, the patient received Meningococcal B vaccine. In June 2018, less than a day after receiving Meningococcal B vaccine, the patient experienced tiredness and sluggishness. On an unknown date, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved and the outcome of the tiredness and sluggishness were unknown. It was unknown if the reporter considered the pain in arm, mobility decreased, tiredness and sluggishness to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her son got his shot last Thursday and his arm still hurts; he could barely lift it. He was tired and sluggish to but nurse said it would make him that way and to go home and rest.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patients experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The reporter stated, her provider stated that, the SHINGRIX vaccines were making the patient's arm too sore. This case has been linked to the US2018118657, reported by the same reporter.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's parent). This report was received via a Pfizer sales representative. An 18-year-old female patient received the first dose of TRUMENBA (batch number and expiration date were not reported), intramuscular in the upper arm on an unspecified date (reported as two years ago approximately) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The reporter was a medical assistant and it was the patient whom she administered the vaccine to and the patient ended up with big red mark that was very swollen after the first dose and it did disappear within a couple of weeks. No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a non-contactable consumer (a Pfizer employee). A female patient of an unspecified age received TRUMENBA (batch number and lot number were not reported), via an unspecified route of administration on 10Jul2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was headed off to college so it was the requirement. The patient reported that she received a meningococcal group b rlp2086 vaccination on 10Jul2018 through her primary care doctor and she asked were there any side effects to the shot because she said she got it today (10Jul2018) and she was not feeling well. The outcome of the event was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Body temperature increased, Cognitive disorder, Dizziness
Clinical narrative: 1st shot: low grade fever, diarrhea, fatigue, flu-like symptoms for 2 days. 2nd shot: tremors in (L) hand w/in 45 min. Followed by sharp pains in both ears (inner) w/diminished hearing, followed by a fitful night of rest a/c sharp pains in legs, arms, shoulders, neck affecting my sinuses and head congestion. Woke w/ 99.8 degree temp. and had a terrible time walking w/o help...spent next 2 days in bed. This was accompanied by reduced cognitive abilities...serious brain fog and a series of inflammatory bouts in extreme-tics along w/IBS. I lost 6 lbs w/this bout (reaction) and still have problems w/fatigue 14 days after 2nd dose of herpes zoster vaccination. Today as I write, I am experiencing swelling and pain in my right hand. Some nights I still experience pain in my right arm and pain in my right hip that travels down my thigh. Throughout this time following my 2 shots of this herpes zoster vaccination I have experienced an accelerated heart rate on and off...it seems to happen at night more often. When this occurs during the daytime I occasionally feel a little dizzy and weak. When I experienced the most problems, after the 2nd shot, I called the office to report these things but got the message of too many calls were coming in and no available operator. Note: I broke out w/shingles on my left back behind my ribs maybe 2-3 wks after my 1st shot. I told the nurse who gave my 2nd shot and she looked and confirmed that it was still there. Note II: 7/10/18: still experiencing muscle, tendon and ligament pain intermittently throughout my body. 2nd dose on 6/22/18.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Fatigue, Feeling abnormal, Gait disturbance, Heart rate increased
Clinical narrative: 1st shot: low grade fever, diarrhea, fatigue, flu-like symptoms for 2 days. 2nd shot: tremors in (L) hand w/in 45 min. Followed by sharp pains in both ears (inner) w/diminished hearing, followed by a fitful night of rest a/c sharp pains in legs, arms, shoulders, neck affecting my sinuses and head congestion. Woke w/ 99.8 degree temp. and had a terrible time walking w/o help...spent next 2 days in bed. This was accompanied by reduced cognitive abilities...serious brain fog and a series of inflammatory bouts in extreme-tics along w/IBS. I lost 6 lbs w/this bout (reaction) and still have problems w/fatigue 14 days after 2nd dose of herpes zoster vaccination. Today as I write, I am experiencing swelling and pain in my right hand. Some nights I still experience pain in my right arm and pain in my right hip that travels down my thigh. Throughout this time following my 2 shots of this herpes zoster vaccination I have experienced an accelerated heart rate on and off...it seems to happen at night more often. When this occurs during the daytime I occasionally feel a little dizzy and weak. When I experienced the most problems, after the 2nd shot, I called the office to report these things but got the message of too many calls were coming in and no available operator. Note: I broke out w/shingles on my left back behind my ribs maybe 2-3 wks after my 1st shot. I told the nurse who gave my 2nd shot and she looked and confirmed that it was still there. Note II: 7/10/18: still experiencing muscle, tendon and ligament pain intermittently throughout my body. 2nd dose on 6/22/18.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoacusis, Inflammation, Irritable bowel syndrome, Ligament pain, Musculoskeletal pain
Clinical narrative: 1st shot: low grade fever, diarrhea, fatigue, flu-like symptoms for 2 days. 2nd shot: tremors in (L) hand w/in 45 min. Followed by sharp pains in both ears (inner) w/diminished hearing, followed by a fitful night of rest a/c sharp pains in legs, arms, shoulders, neck affecting my sinuses and head congestion. Woke w/ 99.8 degree temp. and had a terrible time walking w/o help...spent next 2 days in bed. This was accompanied by reduced cognitive abilities...serious brain fog and a series of inflammatory bouts in extreme-tics along w/IBS. I lost 6 lbs w/this bout (reaction) and still have problems w/fatigue 14 days after 2nd dose of herpes zoster vaccination. Today as I write, I am experiencing swelling and pain in my right hand. Some nights I still experience pain in my right arm and pain in my right hip that travels down my thigh. Throughout this time following my 2 shots of this herpes zoster vaccination I have experienced an accelerated heart rate on and off...it seems to happen at night more often. When this occurs during the daytime I occasionally feel a little dizzy and weak. When I experienced the most problems, after the 2nd shot, I called the office to report these things but got the message of too many calls were coming in and no available operator. Note: I broke out w/shingles on my left back behind my ribs maybe 2-3 wks after my 1st shot. I told the nurse who gave my 2nd shot and she looked and confirmed that it was still there. Note II: 7/10/18: still experiencing muscle, tendon and ligament pain intermittently throughout my body. 2nd dose on 6/22/18.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pain in extremity, Peripheral swelling, Poor quality sleep
Clinical narrative: 1st shot: low grade fever, diarrhea, fatigue, flu-like symptoms for 2 days. 2nd shot: tremors in (L) hand w/in 45 min. Followed by sharp pains in both ears (inner) w/diminished hearing, followed by a fitful night of rest a/c sharp pains in legs, arms, shoulders, neck affecting my sinuses and head congestion. Woke w/ 99.8 degree temp. and had a terrible time walking w/o help...spent next 2 days in bed. This was accompanied by reduced cognitive abilities...serious brain fog and a series of inflammatory bouts in extreme-tics along w/IBS. I lost 6 lbs w/this bout (reaction) and still have problems w/fatigue 14 days after 2nd dose of herpes zoster vaccination. Today as I write, I am experiencing swelling and pain in my right hand. Some nights I still experience pain in my right arm and pain in my right hip that travels down my thigh. Throughout this time following my 2 shots of this herpes zoster vaccination I have experienced an accelerated heart rate on and off...it seems to happen at night more often. When this occurs during the daytime I occasionally feel a little dizzy and weak. When I experienced the most problems, after the 2nd shot, I called the office to report these things but got the message of too many calls were coming in and no available operator. Note: I broke out w/shingles on my left back behind my ribs maybe 2-3 wks after my 1st shot. I told the nurse who gave my 2nd shot and she looked and confirmed that it was still there. Note II: 7/10/18: still experiencing muscle, tendon and ligament pain intermittently throughout my body. 2nd dose on 6/22/18.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Sinus congestion, Tendon pain, Tic, Tremor, Weight decreased
Clinical narrative: 1st shot: low grade fever, diarrhea, fatigue, flu-like symptoms for 2 days. 2nd shot: tremors in (L) hand w/in 45 min. Followed by sharp pains in both ears (inner) w/diminished hearing, followed by a fitful night of rest a/c sharp pains in legs, arms, shoulders, neck affecting my sinuses and head congestion. Woke w/ 99.8 degree temp. and had a terrible time walking w/o help...spent next 2 days in bed. This was accompanied by reduced cognitive abilities...serious brain fog and a series of inflammatory bouts in extreme-tics along w/IBS. I lost 6 lbs w/this bout (reaction) and still have problems w/fatigue 14 days after 2nd dose of herpes zoster vaccination. Today as I write, I am experiencing swelling and pain in my right hand. Some nights I still experience pain in my right arm and pain in my right hip that travels down my thigh. Throughout this time following my 2 shots of this herpes zoster vaccination I have experienced an accelerated heart rate on and off...it seems to happen at night more often. When this occurs during the daytime I occasionally feel a little dizzy and weak. When I experienced the most problems, after the 2nd shot, I called the office to report these things but got the message of too many calls were coming in and no available operator. Note: I broke out w/shingles on my left back behind my ribs maybe 2-3 wks after my 1st shot. I told the nurse who gave my 2nd shot and she looked and confirmed that it was still there. Note II: 7/10/18: still experiencing muscle, tendon and ligament pain intermittently throughout my body. 2nd dose on 6/22/18.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Axillary pain, Discomfort, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: GARDASIL 9 intramuscular Suspension Prefilled Syringe on 7/9/18 I went to my PCP and got my 1st shot of HPV vaccine. Name listed above. I felt in my left arm as soon as I got the shot, but I was expecting that because the medical assistant told me right before. However, two days later on 7/11, the pain in my arm went away but I started feeling some pain in my armpit. I believe that my lymph nodes have swollen inside. It hurt when I move my arm to the side or up. It is very uncomfortable, as of today 7/13, I am still in pain. My 2nd shot of HPV vaccine is scheduled for 5 weeks from now 8/9/18.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Large local swelling on thigh around site of DTaP/IPV injection. Self resolved after 5-7 days. No systemic symptoms.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt got PNEUMOVAX 23 on 6/26. Been sore on her right arm and starting a swelling redness with a stripe of 2 inches.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Mild erythema and mild redness on administration site.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Blood culture positive, Blood urine present, Body temperature increased, Chills
Clinical narrative: Chills and muscles aches, pt felt like he was coming down w/ flu. Had sweats and chills at night. These symptoms developed night of vaccine. Temperature was 101 deg F the first night after receiving the vaccine. The second night after the vaccine, temperature was increasing; 103 deg F. Pt made apt for urgent care on day 3 after vaccine. Pt had worsening chills (staying hydrated, alternating Ibuprofen and APAP). Pt then noticed blood in urine. Had (+) blood and urine culture, received antibiotic IV in urgent care; diagnosed w/ bladder infection. Pt sent home after IV abx + oral ciprofloxacin Rx. Pt took first ciprofloxacin, could not make it to take second oral CIPRO dose. Pt was then taken by ambulance to hospital; temperature 108 deg F. Pt ended up with AKI, septic shock and myocardial injury.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Culture urine positive, Cystitis, Haematuria, Hypotension, Influenza like illness
Clinical narrative: Chills and muscles aches, pt felt like he was coming down w/ flu. Had sweats and chills at night. These symptoms developed night of vaccine. Temperature was 101 deg F the first night after receiving the vaccine. The second night after the vaccine, temperature was increasing; 103 deg F. Pt made apt for urgent care on day 3 after vaccine. Pt had worsening chills (staying hydrated, alternating Ibuprofen and APAP). Pt then noticed blood in urine. Had (+) blood and urine culture, received antibiotic IV in urgent care; diagnosed w/ bladder infection. Pt sent home after IV abx + oral ciprofloxacin Rx. Pt took first ciprofloxacin, could not make it to take second oral CIPRO dose. Pt was then taken by ambulance to hospital; temperature 108 deg F. Pt ended up with AKI, septic shock and myocardial injury.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Myocardial reperfusion injury, Night sweats, Pyrexia, Septic shock
Clinical narrative: Chills and muscles aches, pt felt like he was coming down w/ flu. Had sweats and chills at night. These symptoms developed night of vaccine. Temperature was 101 deg F the first night after receiving the vaccine. The second night after the vaccine, temperature was increasing; 103 deg F. Pt made apt for urgent care on day 3 after vaccine. Pt had worsening chills (staying hydrated, alternating Ibuprofen and APAP). Pt then noticed blood in urine. Had (+) blood and urine culture, received antibiotic IV in urgent care; diagnosed w/ bladder infection. Pt sent home after IV abx + oral ciprofloxacin Rx. Pt took first ciprofloxacin, could not make it to take second oral CIPRO dose. Pt was then taken by ambulance to hospital; temperature 108 deg F. Pt ended up with AKI, septic shock and myocardial injury.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Paraesthesia
Clinical narrative: Tingling on right side (side of administration) less than a minute after injection, numbness in lips.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Large (several inches in diameter), swollen, hot, red welt formed at sight of injection.
Sex: U
Vaccine: HEPA
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 pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored VAQTA (which had a lot # of R003739 and an expiration date of 16-MAR-2019; however, dose, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion on an unknown date: below 32F°/0°C (-1.2C) for 21 hours. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. Sender's Comments: US-009507513-1807USA006219: US-009507513-1807USA006220: US-009507513-1807USA006221: US-009507513-1807USA006217: US-009507513-1807USA006218.
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 (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 07-AUG-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On or about 26-SEP-2013, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed VALTREX and VICODIN for management of his painful symptoms and chronic pain. On or about 03-OCT-2013 and 22-OCT-2013 the patient sought subsequent treatment from the physician for continuance of a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed TORADOL and gabapentin for management of his 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On or about 05-APR-2016, the patient was treated by a physician's group for severe herpes zoster and post herpetic neuralgia. The patient was prescribed dexamethasone, valacyclovir, hydrocodone and ibuprofen and silver sulfadiazine for the management of his painful symptoms and excruciating 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. In 2016, the patient was treated by a physician for a vesicular outbreak that was diagnosed as herpes zoster or shingles. 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, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-AUG-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. On or about 02-SEP-2015, the patient was treated at a dermatology clinic for a blistering vesicular outbreak that was diagnosed as herpes zoster. The patient was prescribed FAMVIR 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. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 21 year old male patient. Information about concurrent condition, concomitant medication and medical history was not provided. The patient was administered a first dose of GARDASIL (dose, lot# and expiration date were not reported) intramuscularly for prophylaxis when he was 13 years old in 2010. On 09-JUL-2018, the patient was administered his second dose which would be GARDASIL 9 (dose, lot# and expiration date were not reported) intramuscularly for prophylaxis (Inappropriate schedule of vaccine administered and Interchange of vaccine products). No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. On an unspecified date, the patient experienced an injury (NOS). The outcome of the event was not reported. Additional information has been requested.
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 18-SEP-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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. On or about 09-AUG-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. She was prescribed acyclovir and oxycodone 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: M
Vaccine: VARZOS
Symptoms: 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 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and 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. In 2016, the patient was treated at an Urgent Care for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2006, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 07-NOV-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for 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 02-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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 on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 23-OCT-2007, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a community hospital as recommended for routine adult health maintenance for 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 03-JUL-2016, the patient was treated by a physician's assistant for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed prednisone, tramadol and ketoconazole for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-JUN-2016, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for management of her painful symptoms and excruciating 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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. In 2009, the patient was inoculated with ZOSTAVAX at a medical center (considered a hospital) 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, also known as shingles and other complications. In 2013, the patient was treated at the same medical center (not specified whether admitted; therefore, considered an Emergency Room visit until follow-up is received) for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. 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: M
Vaccine: VARZOS
Symptoms: Blister, 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. In 2012, the patient was inoculated with ZOSTAVAX at a physician'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, also known as shingles and other complications. On or about 07-JUL-2016, the patient was treated at a medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. He was prescribed triamcinolone acetonide (KENALOG) and acetaminophen and hydrocodone (NORCO) for management of his 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: U
Vaccine: RV5
Symptoms: Abdominal distension, Extra dose administered, Immediate post-injection reaction, Infantile spitting up, Oral administration complication
Clinical narrative: This spontaneous report as received from a licensed practical nurse via a company representative refers to an infant patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with one dose of ROTATEQ (lot # and expiry date unknown), 2 ml, oral for prevention of rotavirus. Immediately after the vaccine was administered, the "baby threw up" (described as the baby's "belly was very full") (infantile spitting up, abdominal distension). Subsequently, another dose of ROTATEQ (lot # and expiry date unknown), 2 ml, was administered (extra dose administered). The "baby threw up again". Treatment was provided for the event. No product quality complaint (PQC) was involved. The outcome of abdominal distension was unknown. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a licensed practical nurse via a company representative refers to an infant patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with one dose of ROTATEQ (lot # and expiry date unknown), 2 ml, oral for prevention of rotavirus. Immediately after the vaccine was administered, the "baby threw up" (described as the baby's "belly was very full") (infantile spitting up, abdominal distension). Subsequently, another dose of ROTATEQ (lot # and expiry date unknown), 2 ml, was administered (extra dose administered). The "baby threw up again". Treatment was provided for the event. No product quality complaint (PQC) was involved. The outcome of abdominal distension was unknown. Causality assessment was not provided by the reporter.