chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a 60-year-old male patient who received SHINGRIX. On 1st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovering/resolving. The reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 59 or 60 years. The nurse reported to the field representative that her husband received SHINGRIX and afterwards had a swollen lymph node. The lymph node was golf ball sized. When the representative spoke with the nurse on 4th May 2018, it was resolving. The vaccine was not administered at the nurse's office.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 18-year-old female patient who received MENVEO (batch number M17032, expiry date March 2019). On 28th April 2018, the patient received the 1st dose of MENVEO. On an unknown date, less than a week after receiving MENVEO, the patient experienced injection site itching, injection site rash and headache. On an unknown date, the outcome of the injection site itching, injection site rash and headache were recovering/resolving. It was unknown if the reporter considered the injection site itching, injection site rash and headache to be related to MENVEO. The reporter is a pharmacist reporting this case on behalf of the patient. In 2018, the reporter stated that, last night she noticed that there was a circle at the injection site with itchiness and rash. The patient also reported that, the patient experienced headache that started last night as well.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site pruritus, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). On 13th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 14th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site itching, fever, chills and general body pain. In April 2018, the outcome of the injection site pain, injection site itching, fever, chills and general body pain were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site itching, fever, chills, and general body pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The fever and chills lasted about a day and a half. The body aches, injection site pain and injection site itching lasted over a week. No further information was reported regarding the event.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The patient was experiencing redness and a lot of swelling at the injection site following administration of BEXSERO. The reporter agreed to be contacted for follow up via mail. No other specifics were provided.
Age: 76.0
Sex: F
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 n a 76-year-old female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included Vitamin D3. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. The patient was treated with Ice Pack (NOS). On an unknown date, the outcome of the pain in arm was not recovered/not resolved. The reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The patient's concomitant product included heart pill, vitamin and blood thinner. On 3rd May 2018 18:00 hours, the patient received SHINGRIX in left arm. The patient experienced pain in her left arm. On the reporting day, the patient's pain was so bad that she could not get out of the bed on her own. The patient had been applying ice to her arm. The patient had denied permission to contact their physician.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Influenza like illness, Pain, Pain in extremity, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 15-year-old female patient who received RABAVERT. Concomitant products included fluoxetine. On 19th April 2018, the patient received the 3rd dose of RABAVERT. In  April 2018, less than a week after receiving RABAVERT, the patient experienced influenza-like symptoms and rash. On 20th April 2018, the patient experienced leg pain, pain localized, pain in hip and pruritus. In April 2018, the outcome of the influenza-like symptoms, leg pain, pain localized, pain in hip, pruritus and rash were recovered/resolved. The reporter considered the influenza-like symptoms, leg pain, pain localized, pain in hip, pruritus and rash to be related to RABAVERT. Additional details were reported as follows: This case was reported by the mother of the patient. The patient's concomitant medication included birth control. The day after vaccination, the patient experienced pain and itching on her right side, hip area and down her leg which lasted for about 2 days. During that time that patient developed rash on her hip area and thighs and had flu like symptoms. All the events resolved within 2 to 3 days after the vaccination. The reporter was unable to provide full demographics for prescriber.
Age: 15.0
Sex: F
Vaccine: RAB
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 15-year-old female patient who received RABAVERT. Concomitant products included fluoxetine. On 19th April 2018, the patient received the 3rd dose of RABAVERT. In  April 2018, less than a week after receiving RABAVERT, the patient experienced influenza-like symptoms and rash. On 20th April 2018, the patient experienced leg pain, pain localized, pain in hip and pruritus. In April 2018, the outcome of the influenza-like symptoms, leg pain, pain localized, pain in hip, pruritus and rash were recovered/resolved. The reporter considered the influenza-like symptoms, leg pain, pain localized, pain in hip, pruritus and rash to be related to RABAVERT. Additional details were reported as follows: This case was reported by the mother of the patient. The patient's concomitant medication included birth control. The day after vaccination, the patient experienced pain and itching on her right side, hip area and down her leg which lasted for about 2 days. During that time that patient developed rash on her hip area and thighs and had flu like symptoms. All the events resolved within 2 to 3 days after the vaccination. The reporter was unable to provide full demographics for prescriber.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Fatigue, Hypoaesthesia, Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 71-year-old female patient who received BOOSTRIX. Concurrent medical conditions included arthritis. Concomitant products included Aspirin baby. On 7th May 2018, the patient received BOOSTRIX (intramuscular). On 7th May 2018, less than a day after receiving BOOSTRIX, the patient experienced injection site bruising, injection site tenderness, weakness of arms and tiredness. In May 208, the patient experienced numbness and burning sensation. On an unknown date, the outcome of the injection site bruising, injection site tenderness, numbness, weakness of arms and burning sensation were not recovered/not resolved and the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the injection site bruising and burning sensation to be related to BOOSTRIX. The reporter considered the injection site tenderness, numbness, weakness of arms and tiredness to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received a BOOSTRIX injection on Monday on left arm. During vaccination, the patient stated that she felt pain, which she described as a pinch. The patient stated that she thought it was probably the needle, but she was not sure. The patient stated that later that day she noticed bruising at and around the injection site. The patient also reported that she felt more tired and tenderness at the injection site. The patient stated that her upper left arm felt weak and she was experiencing a burning sensation or numbness from her elbow to her wrist (left side).
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 71-year-old female patient who received BOOSTRIX. Concurrent medical conditions included arthritis. Concomitant products included Aspirin baby. On 7th May 2018, the patient received BOOSTRIX (intramuscular). On 7th May 2018, less than a day after receiving BOOSTRIX, the patient experienced injection site bruising, injection site tenderness, weakness of arms and tiredness. In May 208, the patient experienced numbness and burning sensation. On an unknown date, the outcome of the injection site bruising, injection site tenderness, numbness, weakness of arms and burning sensation were not recovered/not resolved and the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the injection site bruising and burning sensation to be related to BOOSTRIX. The reporter considered the injection site tenderness, numbness, weakness of arms and tiredness to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received a BOOSTRIX injection on Monday on left arm. During vaccination, the patient stated that she felt pain, which she described as a pinch. The patient stated that she thought it was probably the needle, but she was not sure. The patient stated that later that day she noticed bruising at and around the injection site. The patient also reported that she felt more tired and tenderness at the injection site. The patient stated that her upper left arm felt weak and she was experiencing a burning sensation or numbness from her elbow to her wrist (left side).
Age: 79.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Area redden, hot to touch 15 cm x 10 cm. Patient to follow up 5-18-2018. Patient given BENADRYL 50 mg 5-17-18 IM at 855 am.
Age: 79.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Area redden, hot to touch 15 cm x 10 cm. Patient to follow up 5-18-2018. Patient given BENADRYL 50 mg 5-17-18 IM at 855 am.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Burning sensation, Erythema multiforme, Peripheral swelling, Polymerase chain reaction, Pruritus
Clinical narrative: 4/27/18 Local erythema and pruritus at site of vaccine. 4/30/18 seen for burning, itchy feet. Onset 4/28/18. Feet swollen. DX: Erythema multiforme.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Streptococcus test negative, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: 4/27/18 Local erythema and pruritus at site of vaccine. 4/30/18 seen for burning, itchy feet. Onset 4/28/18. Feet swollen. DX: Erythema multiforme.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and rash. On an unknown date, the outcome of the influenza-like symptoms and rash were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that patient experienced flu-like symptoms for 3 days and a rash on the arm for 5 days. The pharmacist did not want to provide any further information. She stated that both, herself and the patient submitted a report to VAERS and she only wanted to discuss the questions she called in about.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Feeling cold, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 80-year-old female patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, 2 days after receiving SHINGRIX, the patient experienced upset stomach, weakness, chills, influenza-like symptoms and feeling cold. In March 2018, the outcome of the upset stomach, weakness, chills, influenza-like symptoms and feeling cold were recovered/resolved. The reporter considered the upset stomach, weakness, chills, influenza-like symptoms and feeling cold to be related to SHINGRIX. Additional information was received as follows: The side effects the patient experienced were almost like to flu. The patient reported chills, caused the patient to feel very cold. The patient was shivering, layering clothes and using blankets to stay warm. All the events were resolved in the next day. The patient could not remember the exact date she had the injection. The patient has denied permission to contact their physician.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 71-year-old male patient who received SHINGRIX. Previously administered products included ZOSTAVAX (on an unknown date, the patient received ZOSTAVAX). On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular), In April 2018, less than a month after receiving SHINGRIX, the patient experienced hives, pain, pruritus and shingles. On an unknown date, the outcome of the hives, pain and pruritus were not recovered/not resolved and the outcome of the shingles was unknown. The reporter considered the hives, pain and pruritus to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient reported that approximately 1 week ago from the date of reporting, he experienced hives on his arms and legs. The patient stated that spots are itchy and some are painful. The patient stated that hives was growing in number and some of them looked like they were healing. The patient stated that he has never had Shingles before. The hives look like the pictures of Shingles that he had seen on the internet.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site swelling
Clinical narrative: Swelling and discomfort at injection site.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 85-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 3rd May 2018, the patient received SHINGRIX. On 3rd May 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema and injection site hemorrhage. In May 2018, the patient experienced injection site bruising. In May 2018, the outcome of the injection site erythema and injection site hemorrhage were recovered/resolved. On an unknown date, the outcome of the injection site bruising was recovering/resolving. The reporter considered the injection site erythema, injection site bruising and injection site hemorrhage to be almost certainly related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX at the reporter's facility, but by a different healthcare professional (HCP). The patient experienced bleeding and redness both at the injection site. Two hours after receiving SHINGRIX, the patient experienced bruising at the injection site, which persisted on the day of reporting, but improved.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Electrocardiogram, Paraesthesia, Pyrexia, Tachycardia
Clinical narrative: Shaking, fever, dizziness, tingling of legs, tachycardia. All started about 2 hours after receiving vaccine. He was taken to urgent care by mother. He was given 600 mg ibuprofen and EKG was done.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: Shaking, fever, dizziness, tingling of legs, tachycardia. All started about 2 hours after receiving vaccine. He was taken to urgent care by mother. He was given 600 mg ibuprofen and EKG was done.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: Right bicep weakness.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Weight bearing difficulty
Clinical narrative: Right bicep weakness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Almost a week after I received the vaccine, I noticed a rash on one side of my upper back (same side as the arm in which  the vaccine was given). I noticed it because it itches very slightly. It didn't hurt, but didn't go away, so 5 days later (5/10/18) I went to my dermatologist and was diagnosed with a mild case of shingles.
Age: 0.17
Sex: F
Vaccine: MENB
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Men B instead of Hep B.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Varicella
Clinical narrative: Patient said she developed red bumps 9-10 days after receiving injection (thought she had poison ivy from gardening) went to md and they said they thought it was chicken pox and to use calamine lotion and make an appointment with a dermatologist.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Mobility decreased, Pain
Clinical narrative: PATIENT SAID SHE WOKE UP THE MORNING FOLLOWING HER VACCINATION FEELING AWFUL. SHE HURT ALL OVER, COULD BARELY LIFT HER ARM, AND DID NOT HAVE THE ENERGY TO GET OUT OF BED ALL DAY. SHE FELT SOME BETTER THE FOLLOWING DAY AND WAS FEELING MUCH BETTER THE DAY FOLLOWING THAT.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Headache, first occurred during sleep night after injection; awakened at 3:30 AM- pain on-and-off all day. Intensified at 1PM next day. Moderate Muscle soreness at injection site (Left arm).
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Local reaction, Vaccination site erythema, Vaccination site oedema, Vaccination site pain
Clinical narrative: Large local reaction: 3" x 4" area of erythema, edema, itching, mild tenderness at vaccination site L deltoid area.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Contusion, Pain, Varicose vein
Clinical narrative: Bruising/varicose veins came on 2-3 days after receiving SHINGRIX. No fevers or rashes. Painful- started out 5/10 now only 3/10 per Dr.. Patient reported that he had massaged the area. Treatment Plan: Observe.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Contusion, Deep vein thrombosis, Injection site bruising, Pain in extremity, Subclavian vein thrombosis
Clinical narrative: Bruising/varicose veins came on 2-3 days after receiving SHINGRIX. No fevers or rashes. Painful- started out 5/10 now only 3/10 per Dr.. Patient reported that he had massaged the area. Treatment Plan: Observe.
Age: 57.0
Sex: M
Vaccine: PPV, VARZOS, PPV, VARZOS
Symptoms: Ultrasound scan abnormal
Clinical narrative: Bruising/varicose veins came on 2-3 days after receiving SHINGRIX. No fevers or rashes. Painful- started out 5/10 now only 3/10 per Dr.. Patient reported that he had massaged the area. Treatment Plan: Observe.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Approximately 12 hours after injection, I experienced headache, chills/shivering, extensive muscle aches including back of neck. I took a 500 mg Tylenol around 2 AM. The next morning I felt like I had the flu (aches, malaise), had a low grade fever and took another 500 mg Tylenol. I noticed on the 2nd night following the injection I had increased soreness in my arm and the injection site area was red and hot and looked about 2 inches splaying in a Christmas tree fashion down my arm. At greater than 48 hours after the injection the injection site redness and tenderness was still present and the red patch was slightly larger. At about 72 hours after injection, the patch on my arm was improving and the redness dissipating. While the possible symptoms were explained to me both verbally and in the handout information I received at the pharmacy, I wanted to file this report as more of a verification that I have experienced the symptoms described. The additional symptom I had regarding injection site reaction was a bit more than I had anticipated so I thought you might want to know this. I have had Flu vaccine and other vaccines (Tetnus, whooping cough) in the past and had never experienced any symptoms. Thought you might want to know this for this current particular vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Myalgia, Pain, Pain in extremity
Clinical narrative: Approximately 12 hours after injection, I experienced headache, chills/shivering, extensive muscle aches including back of neck. I took a 500 mg Tylenol around 2 AM. The next morning I felt like I had the flu (aches, malaise), had a low grade fever and took another 500 mg Tylenol. I noticed on the 2nd night following the injection I had increased soreness in my arm and the injection site area was red and hot and looked about 2 inches splaying in a Christmas tree fashion down my arm. At greater than 48 hours after the injection the injection site redness and tenderness was still present and the red patch was slightly larger. At about 72 hours after injection, the patch on my arm was improving and the redness dissipating. While the possible symptoms were explained to me both verbally and in the handout information I received at the pharmacy, I wanted to file this report as more of a verification that I have experienced the symptoms described. The additional symptom I had regarding injection site reaction was a bit more than I had anticipated so I thought you might want to know this. I have had Flu vaccine and other vaccines (Tetnus, whooping cough) in the past and had never experienced any symptoms. Thought you might want to know this for this current particular vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Approximately 12 hours after injection, I experienced headache, chills/shivering, extensive muscle aches including back of neck. I took a 500 mg Tylenol around 2 AM. The next morning I felt like I had the flu (aches, malaise), had a low grade fever and took another 500 mg Tylenol. I noticed on the 2nd night following the injection I had increased soreness in my arm and the injection site area was red and hot and looked about 2 inches splaying in a Christmas tree fashion down my arm. At greater than 48 hours after the injection the injection site redness and tenderness was still present and the red patch was slightly larger. At about 72 hours after injection, the patch on my arm was improving and the redness dissipating. While the possible symptoms were explained to me both verbally and in the handout information I received at the pharmacy, I wanted to file this report as more of a verification that I have experienced the symptoms described. The additional symptom I had regarding injection site reaction was a bit more than I had anticipated so I thought you might want to know this. I have had Flu vaccine and other vaccines (Tetnus, whooping cough) in the past and had never experienced any symptoms. Thought you might want to know this for this current particular vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, aches, headache, feverish.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Starting day after injection my arm was extremely sore, red and a little swollen. This lasted two days. Then it slowly decreased for a about 2 days. It appeared to be going away then it flared up again. It is red, sore, and itchy. It gets worse during the day as I move around then is a bit better in the morning.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-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 26-SEP-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a blistering vesicular rash 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: 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-JUL-2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a community outpatient clinic, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician at a medical office 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, he 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 was unknown. 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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2013, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a medical group (office) for a blistering 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, he 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 was unknown. Additional information has been requested.
Sex: F
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 patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 20-AUG-2013, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a department of health facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated (by an unspecified healthcare professional) at a medical group (office) 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date during 2015, the patient was inoculated at a hospital with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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 outcome of the events is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, 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 during 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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 outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, 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 or about 31-OCT-2014, the patient was inoculated at a health department with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-JUN-2016, the patient was treated 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 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 is unknown. 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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 03-JUN-2016,  the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) 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 of herpes zoster. On or about 08-JUN-2016, only days after being vaccinated, the patient was treated (by an unspecified healthcare professional) "the" medical center, for a blistering 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, she 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 was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II, intramuscularly for prophylaxis (dose, lot number and expiration date were not reported).
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 24-JAN-2015, the patient was vaccinated with ZOSTAVAX, (lot # and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak which was then diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir and gabapentin 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.
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. Medical history, concurrent conditions, and concomitant medications were not provided. During 2010, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical group office, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2011, the patient was treated (by an unspecified healthcare professional) at a medical group (office) for a blistering vesicular outbreak, which was diagnosed as herpes zoster. 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash all over.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Dysphagia, Injection site rash, Injection site swelling, Oropharyngeal pain
Clinical narrative: Left upper arm swelling from elbow to shoulder, "Zig-zag" rash on left arm, sore throat, trouble swallowing.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Pt presented to clinic for nurse visit. Has softball size red warm to touch area on left thigh, blisters in center, with another area off to side @ 11 o clock, areas marked with permanent marker states hurts and itchy, mom hasn't noticed him scratching. Dr. informed and pt placed on her schedule. Cellulitis of left lower extremity. It is unclear if this is secondary to a reaction to the vaccine vs a cellulitis so will begin treatment with cephalexin to treat a possible cellulitis. Used a marker to outline the erythema, and pt will return tomorrow for a RN visit to ensure that his symptoms are improving. Dr. also examined the area since she will be in the office tomorrow to re-evaluate patient at that time. Instructed to go to the ER if he develops any new symptoms or has any worsening symptoms. KEFLEX 250 mg/5 mL suspension; Take 500 mg (10 ml) four times a day for 7 days.
Age: 54.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea, Urticaria, Vaccination complication
Clinical narrative: Hives, diarrhea.
Age: 0.42
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site urticaria, Pyrexia
Clinical narrative: Per MOC, fever started ~30 minutes after the immunization. The area around the injection site turned bright red and hives developed on his leg. MOC gave him BENADRYL, and the hives began to go away in ~24 hours.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness
Clinical narrative: Patient started to feel dizzy. Dizziness lasted for about 5 minutes. Gave patient water and she was fine afterwards. Told patient to call 911 if she doesn't feel well tonight.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt woke up 5/12/18 with swollen, painful arm. Pt had headaches, body aches and fever up to 103.0. Symptoms lasted 48 hours, was taken to an Urgent Care Facility who recommended continuing ice and ibuprofen for pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy
Clinical narrative: Per pt he has been lethargic for the last 3 weeks since getting the vaccine. Today was the first day he said that he was feeling ok.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient started to have a reaction to the vaccine two days after the KINRIX vaccine was administered. The child had an area of erythema about 14.5 cm x 10.5 cm with mild swelling noted on the right thigh. The patient was not having any fevers. The swelling was non tender. There was no limping. The patient was examined in the clinic and was clinical well appearing. The patient was treated with ice packs, BENADRYL, and TYLENOL as needed for pain. Patient site was marked and will follow up with the patient.
Age: 58.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Pt stated that he had nausea and vomiting the night he received his shot and also felt tired and a little feverish. He stated that the nause and vomiting may have been from some pizza he had that night. His nausea and vomiting went away the next day and but he still felt a little fatigued.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Patient experienced itching 2 days after vaccination over various parts of body. Itching reported on both arms, fingers, nipples, buttocks, legs, and trunk.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Patient experienced itching 2 days after vaccination over various parts of body. Itching reported on both arms, fingers, nipples, buttocks, legs, and trunk.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Patient presented with what looked to be a breakout of Shingles on her trunk area. She said that there was also pins and needles / pinching feeling along her waistband line. She called her MD and they put her on a therapy of anti-viral and steroid.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swollen and painful arm at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Site red/swollen, patient felt warm ("but not burning up") last night so mom gave him a dose of ibuprofen and he has not felt warm ever since (mom denies any other possible reactions).
Age: 1.75
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Woke up with fever the next day (May 3) was treated with ADVIL, right thigh was red and swollen. Noticed a rash on her bottom that went up her back to her neck (red with little white dots, was rough to the touch). By Saturday May 7th her nose was looking infected with pus in the cut, her face was red and swollen. Went to the ER, MD was more concerned about the infected nose than the rash. Treated with Amoxicillin. Seemed to get better, but by the 14th or 15h she became covered from head to toe with a red rash and had fever. This morning May 17th, went to PMD, who treated her with antihistamine and a steroid, thought it might be a reaction to the antibiotic. She will follow up with the patient in a few days.
Age: 1.75
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Rash generalised, Skin infection, Swelling face
Clinical narrative: Woke up with fever the next day (May 3) was treated with ADVIL, right thigh was red and swollen. Noticed a rash on her bottom that went up her back to her neck (red with little white dots, was rough to the touch). By Saturday May 7th her nose was looking infected with pus in the cut, her face was red and swollen. Went to the ER, MD was more concerned about the infected nose than the rash. Treated with Amoxicillin. Seemed to get better, but by the 14th or 15h she became covered from head to toe with a red rash and had fever. This morning May 17th, went to PMD, who treated her with antihistamine and a steroid, thought it might be a reaction to the antibiotic. She will follow up with the patient in a few days.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site rash, Pruritus, Rash
Clinical narrative: Patient received the immunization on 5/11/18 around 2 pm. He reports around evening of 5/16/18 he felt itching on the injected arm and on 5/17/18 he felt itchy, burning, sensation that is reminiscent of the time when he had active shingles before. He also notes rash that's appearing on the posterior side of his injected left arm from the wrist to the injected side (deltoid muscle).
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema
Clinical narrative: Pt has redness at site of shot but states that this is normal for every shot that she receieves (steroid, flu shots) however, pt also stated that she had some difficulty breathing the first 2 days (day of and day after receiving the vaccine) she states that this has pretty must resolved but the Dr is following up.