chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: FLUX, HPV9, MENB
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Information has been downloaded from Regulatory Authority (US-SEQ-201800316). This spontaneous report was received from a physician and refers to a 16 year old female patient. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown.  On 04-NOV-2017 the patient was vaccinated with GARDASIL 9, intramuscular for human papilloma virus immunisation (dose, strength, frequency, lot# and expiration date were unknown). Other suspect therapies included: on the same date, influenza virus vaccine (unspecified) and BEXSERO, for prophylaxis (dose, strength, route of administration, lot# and expiration date were unknown). The same day, after vaccination, the patient felt dizzy, lightheaded, fainted (syncope) and hit her head (head injury) when she fell off of the exam table. The patient was unconscious for 5-10 minutes (loss of consciousness). The patient recovered from syncope, dizziness, and loss of consciousness on the same date. On an unknown date a tuberculin test was performed and the results were not provided. The patient recovered from the head injury on an unknown date in November 2017. The patient recovered from the fall on an unknown date. Causal relationship between the mentioned events and the suspect therapies was unknown. The reporting agency considered all mentioned events to be medically significant.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV9, MENB
Symptoms: Tuberculin test
Clinical narrative: Information has been downloaded from Regulatory Authority (US-SEQ-201800316). This spontaneous report was received from a physician and refers to a 16 year old female patient. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown.  On 04-NOV-2017 the patient was vaccinated with GARDASIL 9, intramuscular for human papilloma virus immunisation (dose, strength, frequency, lot# and expiration date were unknown). Other suspect therapies included: on the same date, influenza virus vaccine (unspecified) and BEXSERO, for prophylaxis (dose, strength, route of administration, lot# and expiration date were unknown). The same day, after vaccination, the patient felt dizzy, lightheaded, fainted (syncope) and hit her head (head injury) when she fell off of the exam table. The patient was unconscious for 5-10 minutes (loss of consciousness). The patient recovered from syncope, dizziness, and loss of consciousness on the same date. On an unknown date a tuberculin test was performed and the results were not provided. The patient recovered from the head injury on an unknown date in November 2017. The patient recovered from the fall on an unknown date. Causal relationship between the mentioned events and the suspect therapies was unknown. The reporting agency considered all mentioned events to be medically significant.
Age: 72.0
Sex: M
Vaccine: VARZOS, PPV
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Pt. had vaccine @ 9:05 AM, went home and took a nap. Around 12:30, he awoke to pain (5-6 on pain scale) and numbness in right arm from shoulder to elbow. Arm was also numb from shoulder to elbow. Pt. sought medical treatment that afternoon when numbness/pain did not abate.
Age: 72.0
Sex: M
Vaccine: VARZOS, PPV
Symptoms: Injection site hypoaesthesia, Injection site pain
Clinical narrative: Pt. had vaccine @ 9:05 AM, went home and took a nap. Around 12:30, he awoke to pain (5-6 on pain scale) and numbness in right arm from shoulder to elbow. Arm was also numb from shoulder to elbow. Pt. sought medical treatment that afternoon when numbness/pain did not abate.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Headache, Herpes zoster, Pain, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 64-year-old female patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (paternal grandmother had). Previously administered products included ZOSTAVAX (received sometime around 2007), percodan with an associated reaction of urticaria and SHINGRIX with an associated reaction of pain in extremity (1st dose received on 13th February 2018, see case US2018GSK120677). On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced unwell, headache, chills, diarrhea, vomiting and fever. On an unknown date, the patient experienced tingling, scratch and weird feeling. On an unknown date, the outcome of the unwell, headache, chills, diarrhea, vomiting and fever were recovered/resolved and the outcome of the tingling, scratch and weird feeling were unknown. It was unknown if the reporter considered the unwell, headache, chills, diarrhea, vomiting, fever, tingling, scratch and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The patient had only one allergic reaction or persistent side effect and that was to Percodan in 1976. The reaction the patient had at that time was hive and nothing like that had happened to her since. The patient had a history of great health and no tendencies towards hypochondria. The patient took vitamins, but did not require or generally desired pharmaceuticals in terms of prescriptions. The patient had no history of shingles personally, but her paternal grandmother had them. Based on knowing a couple friends had been unfortunate to experience shingles, the patient first opted to receive the vaccine, ZOSTAVAX, sometime around 2007 and had no problems with it, as far as a reaction. The patient was quite ill the following day and the day after that. Symptoms included a severe headache, chills, diarrhea, vomiting and fever, that passed, but the tingling which the patient experienced following the first injection of SHINGRIX not only persisted, but had become even more prevalent. She was inclined to scratch the tingling, but was quick to remember that this did nothing to alleviate the ongoing strange sensation. She tried to ignore it, but it was something like background noise. On 2nd August 2018, the patient had an appointment with an internist. The patient thought to mention the occurrences of the tingling which had occurred following the SHINGRIX vaccine. She seemed surprised and curious to hear this and suggested that the tingling could resolve with time and that she could prescribe something for it otherwise, as an alternative to waiting. The patient declined medication hoping to find out more about what she had experienced and whether the tingling was something she might have to live with going forward.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 64-year-old female patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (paternal grandmother had). Previously administered products included ZOSTAVAX (received sometime around 2007), percodan with an associated reaction of urticaria and SHINGRIX with an associated reaction of pain in extremity (1st dose received on 13th February 2018, see case US2018GSK120677). On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced unwell, headache, chills, diarrhea, vomiting and fever. On an unknown date, the patient experienced tingling, scratch and weird feeling. On an unknown date, the outcome of the unwell, headache, chills, diarrhea, vomiting and fever were recovered/resolved and the outcome of the tingling, scratch and weird feeling were unknown. It was unknown if the reporter considered the unwell, headache, chills, diarrhea, vomiting, fever, tingling, scratch and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The patient had only one allergic reaction or persistent side effect and that was to Percodan in 1976. The reaction the patient had at that time was hive and nothing like that had happened to her since. The patient had a history of great health and no tendencies towards hypochondria. The patient took vitamins, but did not require or generally desired pharmaceuticals in terms of prescriptions. The patient had no history of shingles personally, but her paternal grandmother had them. Based on knowing a couple friends had been unfortunate to experience shingles, the patient first opted to receive the vaccine, ZOSTAVAX, sometime around 2007 and had no problems with it, as far as a reaction. The patient was quite ill the following day and the day after that. Symptoms included a severe headache, chills, diarrhea, vomiting and fever, that passed, but the tingling which the patient experienced following the first injection of SHINGRIX not only persisted, but had become even more prevalent. She was inclined to scratch the tingling, but was quick to remember that this did nothing to alleviate the ongoing strange sensation. She tried to ignore it, but it was something like background noise. On 2nd August 2018, the patient had an appointment with an internist. The patient thought to mention the occurrences of the tingling which had occurred following the SHINGRIX vaccine. She seemed surprised and curious to hear this and suggested that the tingling could resolve with time and that she could prescribe something for it otherwise, as an alternative to waiting. The patient declined medication hoping to find out more about what she had experienced and whether the tingling was something she might have to live with going forward.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 64-year-old female patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (paternal grandmother had). Previously administered products included ZOSTAVAX (received sometime around 2007), percodan with an associated reaction of urticaria and SHINGRIX with an associated reaction of pain in extremity (1st dose received on 13th February 2018, see case US2018GSK120677). On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced unwell, headache, chills, diarrhea, vomiting and fever. On an unknown date, the patient experienced tingling, scratch and weird feeling. On an unknown date, the outcome of the unwell, headache, chills, diarrhea, vomiting and fever were recovered/resolved and the outcome of the tingling, scratch and weird feeling were unknown. It was unknown if the reporter considered the unwell, headache, chills, diarrhea, vomiting, fever, tingling, scratch and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The patient had only one allergic reaction or persistent side effect and that was to Percodan in 1976. The reaction the patient had at that time was hive and nothing like that had happened to her since. The patient had a history of great health and no tendencies towards hypochondria. The patient took vitamins, but did not require or generally desired pharmaceuticals in terms of prescriptions. The patient had no history of shingles personally, but her paternal grandmother had them. Based on knowing a couple friends had been unfortunate to experience shingles, the patient first opted to receive the vaccine, ZOSTAVAX, sometime around 2007 and had no problems with it, as far as a reaction. The patient was quite ill the following day and the day after that. Symptoms included a severe headache, chills, diarrhea, vomiting and fever, that passed, but the tingling which the patient experienced following the first injection of SHINGRIX not only persisted, but had become even more prevalent. She was inclined to scratch the tingling, but was quick to remember that this did nothing to alleviate the ongoing strange sensation. She tried to ignore it, but it was something like background noise. On 2nd August 2018, the patient had an appointment with an internist. The patient thought to mention the occurrences of the tingling which had occurred following the SHINGRIX vaccine. She seemed surprised and curious to hear this and suggested that the tingling could resolve with time and that she could prescribe something for it otherwise, as an alternative to waiting. The patient declined medication hoping to find out more about what she had experienced and whether the tingling was something she might have to live with going forward.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 64-year-old female patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (paternal grandmother had). Previously administered products included ZOSTAVAX (received sometime around 2007), percodan with an associated reaction of urticaria and SHINGRIX with an associated reaction of pain in extremity (1st dose received on 13th February 2018, see case US2018GSK120677). On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced unwell, headache, chills, diarrhea, vomiting and fever. On an unknown date, the patient experienced tingling, scratch and weird feeling. On an unknown date, the outcome of the unwell, headache, chills, diarrhea, vomiting and fever were recovered/resolved and the outcome of the tingling, scratch and weird feeling were unknown. It was unknown if the reporter considered the unwell, headache, chills, diarrhea, vomiting, fever, tingling, scratch and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The patient had only one allergic reaction or persistent side effect and that was to Percodan in 1976. The reaction the patient had at that time was hive and nothing like that had happened to her since. The patient had a history of great health and no tendencies towards hypochondria. The patient took vitamins, but did not require or generally desired pharmaceuticals in terms of prescriptions. The patient had no history of shingles personally, but her paternal grandmother had them. Based on knowing a couple friends had been unfortunate to experience shingles, the patient first opted to receive the vaccine, ZOSTAVAX, sometime around 2007 and had no problems with it, as far as a reaction. The patient was quite ill the following day and the day after that. Symptoms included a severe headache, chills, diarrhea, vomiting and fever, that passed, but the tingling which the patient experienced following the first injection of SHINGRIX not only persisted, but had become even more prevalent. She was inclined to scratch the tingling, but was quick to remember that this did nothing to alleviate the ongoing strange sensation. She tried to ignore it, but it was something like background noise. On 2nd August 2018, the patient had an appointment with an internist. The patient thought to mention the occurrences of the tingling which had occurred following the SHINGRIX vaccine. She seemed surprised and curious to hear this and suggested that the tingling could resolve with time and that she could prescribe something for it otherwise, as an alternative to waiting. The patient declined medication hoping to find out more about what she had experienced and whether the tingling was something she might have to live with going forward.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia, Scratch, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unwell in a 64-year-old female patient who received SHINGRIX (batch number B9739, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (paternal grandmother had). Previously administered products included ZOSTAVAX (received sometime around 2007), percodan with an associated reaction of urticaria and SHINGRIX with an associated reaction of pain in extremity (1st dose received on 13th February 2018, see case US2018GSK120677). On 28th June 2018, the patient received the 2nd dose of SHINGRIX. On 29th June 2018, 1 days after receiving SHINGRIX, the patient experienced unwell, headache, chills, diarrhea, vomiting and fever. On an unknown date, the patient experienced tingling, scratch and weird feeling. On an unknown date, the outcome of the unwell, headache, chills, diarrhea, vomiting and fever were recovered/resolved and the outcome of the tingling, scratch and weird feeling were unknown. It was unknown if the reporter considered the unwell, headache, chills, diarrhea, vomiting, fever, tingling, scratch and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The patient had only one allergic reaction or persistent side effect and that was to Percodan in 1976. The reaction the patient had at that time was hive and nothing like that had happened to her since. The patient had a history of great health and no tendencies towards hypochondria. The patient took vitamins, but did not require or generally desired pharmaceuticals in terms of prescriptions. The patient had no history of shingles personally, but her paternal grandmother had them. Based on knowing a couple friends had been unfortunate to experience shingles, the patient first opted to receive the vaccine, ZOSTAVAX, sometime around 2007 and had no problems with it, as far as a reaction. The patient was quite ill the following day and the day after that. Symptoms included a severe headache, chills, diarrhea, vomiting and fever, that passed, but the tingling which the patient experienced following the first injection of SHINGRIX not only persisted, but had become even more prevalent. She was inclined to scratch the tingling, but was quick to remember that this did nothing to alleviate the ongoing strange sensation. She tried to ignore it, but it was something like background noise. On 2nd August 2018, the patient had an appointment with an internist. The patient thought to mention the occurrences of the tingling which had occurred following the SHINGRIX vaccine. She seemed surprised and curious to hear this and suggested that the tingling could resolve with time and that she could prescribe something for it otherwise, as an alternative to waiting. The patient declined medication hoping to find out more about what she had experienced and whether the tingling was something she might have to live with going forward.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: Woke up at 4 am after vaccine with fever of 101, severe muscle aches, chills, headache..Symptoms lasted 48 hours and I missed work.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Pyrexia
Clinical narrative: Woke up at 4 am after vaccine with fever of 101, severe muscle aches, chills, headache..Symptoms lasted 48 hours and I missed work.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Pyrexia, Rash
Clinical narrative: Got shot around four pm on 10/11/2018, went home. Starting to notice around seven pm that my arm was getting hard to lift, it was hurting and when I went to bed couldn't lay on it, did not get much sleep for the pain. On Friday, my arm I notice my arm was swelling and pinkish color, hurt all day Friday, call store and told them it was hurting and red. They told me that was normal to take Tynedol and put hydrocortisone cream on it. Went to bed around nine and took pictures of my arm and sent it to my daughter and she thought I needed to go to ER because it didn't look normal. So she took to me to urgent care that night. I was admitted at 22:00 EDTon 10/12/2018 and discharge at 1:15 EDT. They took blood work, gave me pain pill and gave me Rocephin in IV.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood test, Culture, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Got shot around four pm on 10/11/2018, went home. Starting to notice around seven pm that my arm was getting hard to lift, it was hurting and when I went to bed couldn't lay on it, did not get much sleep for the pain. On Friday, my arm I notice my arm was swelling and pinkish color, hurt all day Friday, call store and told them it was hurting and red. They told me that was normal to take Tynedol and put hydrocortisone cream on it. Went to bed around nine and took pictures of my arm and sent it to my daughter and she thought I needed to go to ER because it didn't look normal. So she took to me to urgent care that night. I was admitted at 22:00 EDTon 10/12/2018 and discharge at 1:15 EDT. They took blood work, gave me pain pill and gave me Rocephin in IV.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: Got shot around four pm on 10/11/2018, went home. Starting to notice around seven pm that my arm was getting hard to lift, it was hurting and when I went to bed couldn't lay on it, did not get much sleep for the pain. On Friday, my arm I notice my arm was swelling and pinkish color, hurt all day Friday, call store and told them it was hurting and red. They told me that was normal to take Tynedol and put hydrocortisone cream on it. Went to bed around nine and took pictures of my arm and sent it to my daughter and she thought I needed to go to ER because it didn't look normal. So she took to me to urgent care that night. I was admitted at 22:00 EDTon 10/12/2018 and discharge at 1:15 EDT. They took blood work, gave me pain pill and gave me Rocephin in IV.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain, Anxiety, Babesiosis, Blood immunoglobulin M increased, Constipation
Clinical narrative: Symptoms and adverse events post vaccination include: Sudden onset of depression, mood changes, Anxiety, Anisocoria (unequal pupils), Pressure behind right eye, abdominal pain, lymph node swelling in armpits, groin, and neck, severe constipation, change in spine angle (rounded shoulders), sexual dysfunction, erectile dysfunction. Activation of previously dormant pathogens including Ehrlichia and Babesia.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Depression, Ehrlichia test positive, Erectile dysfunction, Flow cytometry, Human ehrlichiosis
Clinical narrative: Symptoms and adverse events post vaccination include: Sudden onset of depression, mood changes, Anxiety, Anisocoria (unequal pupils), Pressure behind right eye, abdominal pain, lymph node swelling in armpits, groin, and neck, severe constipation, change in spine angle (rounded shoulders), sexual dysfunction, erectile dysfunction. Activation of previously dormant pathogens including Ehrlichia and Babesia.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Intraocular pressure increased, Lymphadenitis, Lymphadenopathy, Lymphocyte percentage decreased, Mood altered
Clinical narrative: Symptoms and adverse events post vaccination include: Sudden onset of depression, mood changes, Anxiety, Anisocoria (unequal pupils), Pressure behind right eye, abdominal pain, lymph node swelling in armpits, groin, and neck, severe constipation, change in spine angle (rounded shoulders), sexual dysfunction, erectile dysfunction. Activation of previously dormant pathogens including Ehrlichia and Babesia.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Parasite blood test positive, Pupils unequal, Sexual dysfunction
Clinical narrative: Symptoms and adverse events post vaccination include: Sudden onset of depression, mood changes, Anxiety, Anisocoria (unequal pupils), Pressure behind right eye, abdominal pain, lymph node swelling in armpits, groin, and neck, severe constipation, change in spine angle (rounded shoulders), sexual dysfunction, erectile dysfunction. Activation of previously dormant pathogens including Ehrlichia and Babesia.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Redness and significant swelling of left thigh surrounding PREVNAR injection site. Swelling has occurred with each injection in this series and gotten progressively worse each time. Swelling is starting to go down on day 5 after injection but appears still hard and painful to the touch. Fever and irritability started 12 hours following injection and resolved around 72 hours later.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Redness and significant swelling of left thigh surrounding PREVNAR injection site. Swelling has occurred with each injection in this series and gotten progressively worse each time. Swelling is starting to go down on day 5 after injection but appears still hard and painful to the touch. Fever and irritability started 12 hours following injection and resolved around 72 hours later.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Neck pain, Skin warm
Clinical narrative: Swelling and soreness at site but it radiates up the left side ofmy neck and my left cheek is warm which is unlike the reaction to the first shop.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching skin 24 hours after vaccine, developed hives on arms, neck and face 48 hours after vaccine.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Feeling abnormal, Local reaction, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: Localized reaction on left arm. Sore, swollen, and mild fever. Patient started having symptoms the evening of her vaccination. She felt too bad the next day to go to church. She called into the pharmacy on Monday, and PharmD, counseled her to use a cold compress, BENADRYL, and/or TYLENOL/MOTRIN  to treat her symptoms. He said if she still felt unwell later that day to seek a physician.
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pyrexia
Clinical narrative: Localized reaction on left arm. Sore, swollen, and mild fever. Patient started having symptoms the evening of her vaccination. She felt too bad the next day to go to church. She called into the pharmacy on Monday, and PharmD, counseled her to use a cold compress, BENADRYL, and/or TYLENOL/MOTRIN  to treat her symptoms. He said if she still felt unwell later that day to seek a physician.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Low grade fever, site of injection is red and hot and hard. Used ibuprofen and put compress on it.
Age: 25.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This spontaneous report was received from a nurse referring to a 25 years old patient of unknown gender. Information about concomitant medication, medical history and drug reactions/allergies was not provided. On 12-SEP-2018, the patient was vaccinated with PROQUAD (lot # N021725, expiration date 06-FEB-2019, therapy type: rHA (recombinant Human albumin); strength, dose detail and route were not reported) for prophylaxis, inadvertently instead of MMR II. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from a pharmacist referring to a currently 23 year old patient of unknown gender. Information of pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient was received an improperly stored dose of VARIVAX (lot # R008394, expiration date: 20-MAR-2020, strength and frequency were unknown) subcutaneously for prophylaxis. Sterile diluent (lot # and expiration date were unknown) used to reconstitute was properly stored. The vaccines was exposed to temperature of 15 F to 46 F (19F) for 1 hour 30 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site pain
Clinical narrative: Information has been received from a pharmacist via a field representative referring to a female patient of unknown age. Information of concomitant therapy, historical condition and current condition was unknown. On 01-OCT-2018 the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, strength, dose, frequency and route unknown) for prophylaxis (reported as "prevention of pneumonia"). In October 2018 (reported as "an unspecified amount of time later"), the patient had pain at injection site and trouble breathing. On an unspecified date in October 2018, the patient went to the emergency room at an unspecified location. The patient was not admitted to the hospital and discharged from emergency room on an unspecified date. It was unknown if treatment was given or if lab diagnostics or studies were performed for the events. The patient had sought medical attention. The outcome of the events was unknown. The causality assessment was not provided by the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant therapies were not reported. On 05-OCT-2018, the patient was vaccinated intramuscularly with the second dose of GARDASIL 9 lot # M024261, that expired on 30-JUL-2018, for prophylaxis(strength and dosage schedule were not reported). There were no temperature excursion for this vaccine and no adverse effects were reported.
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning two elderly female patients with unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (lot#: N032092, expiration Date: 12-SEP-2019) one dose, once, for pneumonia prevention and FLUAD (strength, dose, route, frequency, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patients experienced redness and swelling at the injection site (injection site erythema and injection site swelling) that went from shoulder to elbow, the skin at the injection site was painful to touch (injection site pain), and the patients were feeling under the weather with flu-like symptoms that persisted for 3-4 days. At the reporting time, the outcome of injection site pain, flu-like symptoms, injection site erythema and injection site swelling were reported as recovered on an unknown date. The causality between PNEUMOVAX 23 and FLUAD and injection site pain, flu-like symptoms, injection site erythema and injection site swelling were not assessed. This is one of three reports from the same reporter; Sender's Comments: US-009507513-1810USA004434: US-009507513-1810USA006560:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician's assistant, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by the physician's assistant for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 01-JAN-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, 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. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 09-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed valacyclovir for management of his painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: 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 has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) from a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. Later in 2016, the patient sought subsequent treatment from a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles, The outcome of the events was considered as not recovered. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-DEC-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-OCT-2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative, concerning a male patients with unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#: N032092, Exp. Date: 12-SEP-2019) one dose, once for pneumonia prevention and FLUAD (strength, dose, route, frequency, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient experienced redness and swelling at the injection site (injection site erythema and injection site swelling) that went from shoulder to elbow, the skin at the injection site was painful to touch (injection site pain), and the patients were feeling under the weather with flu-like symptoms that persisted for 3-4 days. At the reporting time, the outcome of injection site pain, flu-like symptoms, injection site erythema and injection site swelling were reported as recovered on an unknown date. The causality between PNEUMOVAX 23 and FLUAD and injection site pain, flu-like symptoms, injection site erythema and injection site swelling were not assessed. This is one of three reports from the same reporter; Sender's Comments: US-009507513-1810USA004364: US-009507513-1810USA006560:
Sex: M
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 male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with ZOSTAVAX at a community hospital 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. In 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 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Nervous system disorder, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 18-JUL-2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-OCT-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster with nervous system complications. As a direct and proximate result of these malfunctions, 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. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. On or about 12-SEP-2016, the patient was inoculated with the ZOSTAVAX vaccine 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 a medical center by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: 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. On or about 21-SEP-2010, the patient was inoculated with the ZOSTAVAX vaccine at a health department 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 facility by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.