chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MENB
Symptoms: Face injury, Syncope
Clinical narrative: recieved dose of Bexsero, fainted; fainted and hit his face; This case was reported by a nurse via sales rep and described the occurrence of faint in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced faint (serious criteria GSK medically significant) and face injury. On an unknown date, the outcome of the faint and face injury were unknown.   It was unknown if the reporter considered the faint and face injury to be related to Bexsero.  Additional deatils were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero, fainted and hit his face The reporter consented to follow up. This was 1 of 2 cases reported by same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Soreness in the right arm; Redness on her right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and developed soreness in the right arm and redness on right arm. The follow up consent was granted.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Headache, body ache, flu like symptoms
Age: 68.0
Sex: F
Vaccine: FLUA3, PNC13, TDAP, VARZOS
Symptoms: Fatigue, Malaise, Pyrexia
Clinical narrative: Pt had high fever for first couple days, then fever went down. For the next couple weeks, patient said she felt very tired and sickly.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored pneumovax 23; NO SYMPTOMS; This spontaneous report was received from a medical assistant referring to 9 patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-NOV-2019, 08-NOV-2019, 06-JAN-2020, 08-JAN-2020 and 09-JAN-2020, the patients were vaccinated with one dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength and anatomical location was not provided) of lot# S018405, expiry date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021, intramuscularly for prophylaxis. On 10-JAN-2020, the patients were vaccinated with 2 doses of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). On 28-JAN-2020 and 03-FEB-2020, the patients were vaccinated with 1 dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  the patient was vaccinated with one dose each, improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent a temperature excursion of 36 degree Fahrenheit to 46 degree Fahrenheit for a time frame of 2 minutes. The previous temperature excursion was reported to be below 36 degree Fahrenheit for 1 minute. The digital data logger was involved. No additional adverse effects were reported. It was reported that the medical assistant did not want to provide the patient information without the approval from her manager. No product quality complaint (PQC) was associated with this report.   This is an amended report. This case was a valid report (9 patients whose details were withheld) and should have been distributed instead of routing to non-valid workflow.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 26-JAN-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; received improperly stored vaccine which was administered via unspecified route; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 05-FEB-2020, the patient was vaccinated with an improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot number S033516 and expiry date 29-JUN-2021 (strength, exact dose and anatomical location were not reported) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature excursion total time and highest temperature as follows: above 47 degree fahrenheit/ 9 degree Celsius 47.6 degree fahrenheit and for a time frame of 15 minutes, above 47 degree fahrenheit/ 9 degree Celsius 52.5 degree fahrenheit and for a time frame of 15 minutes, above 47 degree fahrenheit/ 9 degree Celsius 46.7 degree fahrenheit and for a time frame of 15 minutes and above 47 degree fahrenheit/ 9 degree Celsius 47.1 degree fahrenheit and for a time frame of 15 minutes, as recorded by a data logger. The vaccines had previous temperature excursion. No additional adverse event was reported. No product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: injection site for second dose was defiinitely more sore; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced pain in arm after vaccination. This is 1 of the 4 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Received Shingix and experienced shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The health care provider called asking for information about Shingrix causing shingles because he had a patient that heard that another patient received Shingix and experienced shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED A 4TH HPV9 VACCINE THAT WAS NOT NECESSARY. NO NONE ISSUES RELATED TO THE EXTRA DOSE. MOM REQUESTING REPORT BE FILED.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Muscle spasms, Tremor
Clinical narrative: Patient with severe back spasm, shortness of breath and shaking. Patient monitored in office for 45 minutes and symptoms subsided without intervention. Vital signs stable and within normal limits
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Screaming, Speech disorder developmental
Clinical narrative: fever, piercing screaming fits that last for hours, swollen leg and red bump at injection sight. This started within 2 hrs of the vaccination.  At 17 months old, patient was diagnosed with speech delays and qualified for speech therapy through Early Intervention. He received 2 hour long speech therapy sessions that lasted until his 3rd birthday.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Local reaction, Pain, Peripheral swelling, Pruritus
Clinical narrative: Very large local reaction to left arm, pt's PCP believes to be related to the Tdap vaccine; on Friday 1/31/20 pt's left arm began with large amount of swelling to upper arm down to elbow - pt's mother stated it was twice it's normal size; some pain and itching as well; swelling remained from 1/31/20 to 2/5/20; mother gave Ibuprofen as needed for pain/comfort as well as application of cold pack as needed.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Blood test, Chest X-ray, Chills, Computerised tomogram
Clinical narrative: Fever, chills, and body aches began 04/29/2020, after the injection.  Awoke on 05/04/09 to swelling and aches all over, and pain with walking.  The following day, 05/05/19 treated in a local Emergency Room.  Blood work, CTscan, chest x-ray, and nasal swab reportedly completed.  Antibiotic given and sent home.  Reports that the ER stated she had elevated transaminases.  Employee then missed work on Monday, 05/06/2019 due to the illness.  I was made aware of the issue on 05/09/2019.  On 05/10/2019 the employee still reported achy joints and lower extremity swelling, but both were reportedly improved from the prior weekend.  She was still on the antibiotics.  The employee had spoken to her primary care physician and scheduled a follow-up for June 2019.  On 05/22/2019, reported feeling better everyday. On June 12, 2019 the employee reported her liver enzymes were back to normal after evaluation with her primary care physician.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Culture, Impaired work ability, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, chills, and body aches began 04/29/2020, after the injection.  Awoke on 05/04/09 to swelling and aches all over, and pain with walking.  The following day, 05/05/19 treated in a local Emergency Room.  Blood work, CTscan, chest x-ray, and nasal swab reportedly completed.  Antibiotic given and sent home.  Reports that the ER stated she had elevated transaminases.  Employee then missed work on Monday, 05/06/2019 due to the illness.  I was made aware of the issue on 05/09/2019.  On 05/10/2019 the employee still reported achy joints and lower extremity swelling, but both were reportedly improved from the prior weekend.  She was still on the antibiotics.  The employee had spoken to her primary care physician and scheduled a follow-up for June 2019.  On 05/22/2019, reported feeling better everyday. On June 12, 2019 the employee reported her liver enzymes were back to normal after evaluation with her primary care physician.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Swelling, Transaminases increased
Clinical narrative: Fever, chills, and body aches began 04/29/2020, after the injection.  Awoke on 05/04/09 to swelling and aches all over, and pain with walking.  The following day, 05/05/19 treated in a local Emergency Room.  Blood work, CTscan, chest x-ray, and nasal swab reportedly completed.  Antibiotic given and sent home.  Reports that the ER stated she had elevated transaminases.  Employee then missed work on Monday, 05/06/2019 due to the illness.  I was made aware of the issue on 05/09/2019.  On 05/10/2019 the employee still reported achy joints and lower extremity swelling, but both were reportedly improved from the prior weekend.  She was still on the antibiotics.  The employee had spoken to her primary care physician and scheduled a follow-up for June 2019.  On 05/22/2019, reported feeling better everyday. On June 12, 2019 the employee reported her liver enzymes were back to normal after evaluation with her primary care physician.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a healthcare provided for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the patient was treated by medical providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the shingles was unknown. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm hurt so much; Arm hurt so much it was hard to move if; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient's arm hurted so much and it was hard to move if for about a week. Till the time of reporting the arm still hurted and this was 3 months later. The patient inquired about whom should he/she contact.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Loss of consciousness
Clinical narrative: recieved Bexsero and passed out; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, less than a year after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Bexsero.  Additional details were provided as follows: The patient was vaccinated and passed out. The reporter consented to follow up. This was 1 of 2 cases reported by same reporter.
Age: 60.0
Sex: M
Vaccine: UNK, UNK, UNK, VARZOS
Symptoms: Arthralgia, Erythema, Feeling hot, Inflammation, Influenza like illness
Clinical narrative: had flu like symptoms over Christmas; inflamed area slowly got smaller; nerve pain in joints / nerve pain in joints throughout his body; pain; his arm swelled from elbow to shoulder; arm was red; hot to the touch; arm was also very sore; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone propionate (Fluticasone Diskus) inhalation powder for asthma and salmeterol xinafoate (Salmeterol Diskus) for asthma and reactive airways disease.   The patient's past medical history included knee pain. Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose in September 2019, refer case US2020AMR022243) and Advair Diskus 500/50 with an associated reaction of bronchial hyperreactivity (received puff twice daily and started in 2000). Concurrent medical conditions included asthma and reactive airways disease. Concomitant products included glucosamine and ipratropium bromide + salbutamol sulfate (Combivent).   On 21st December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient started Fluticasone Diskus 1 puff(s) once daily (1 puff(s) daily) and Salmeterol Diskus 1 puff(s) once daily (1 puff(s) daily). On an unknown date, less than 2 weeks after receiving Shingrix, less than a year after starting Fluticasone Diskus and an unknown time after starting glucosamine, the patient experienced influenza-like symptoms, swelling arm, erythema of extremities, feeling hot, pain in arm, inflammation, nerve pain and joint pain. The patient was treated with codeine phosphate + paracetamol (Tylenol #4). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, nerve pain and joint pain were unknown and the outcome of the swelling arm, erythema of extremities, feeling hot, pain in arm and inflammation were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, swelling arm, erythema of extremities, feeling hot, pain in arm, inflammation, nerve pain and joint pain to be related to Shingrix and Fluticasone Diskus.  Additional details were received as follows: The patient after vaccination had arm swelling from elbow to shoulder, and was red and hot to the touch. The patient arm was sore. The patient also had nerve pain in joints throughout his body. The patient past medical history include damage to his lungs, bulging discs. The patient shoulder blades and elbows were the worst, but he also gets joint pain in his ankles, knees, hips and wrists. The patient felt like when the dentist gets too close to the nerve of a tooth. In addition to the local symptoms and joint pain, he also had flu like symptoms.
Age: 60.0
Sex: M
Vaccine: UNK, UNK, UNK, VARZOS
Symptoms: Neuralgia, Pain in extremity, Peripheral swelling
Clinical narrative: had flu like symptoms over Christmas; inflamed area slowly got smaller; nerve pain in joints / nerve pain in joints throughout his body; pain; his arm swelled from elbow to shoulder; arm was red; hot to the touch; arm was also very sore; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone propionate (Fluticasone Diskus) inhalation powder for asthma and salmeterol xinafoate (Salmeterol Diskus) for asthma and reactive airways disease.   The patient's past medical history included knee pain. Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose in September 2019, refer case US2020AMR022243) and Advair Diskus 500/50 with an associated reaction of bronchial hyperreactivity (received puff twice daily and started in 2000). Concurrent medical conditions included asthma and reactive airways disease. Concomitant products included glucosamine and ipratropium bromide + salbutamol sulfate (Combivent).   On 21st December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient started Fluticasone Diskus 1 puff(s) once daily (1 puff(s) daily) and Salmeterol Diskus 1 puff(s) once daily (1 puff(s) daily). On an unknown date, less than 2 weeks after receiving Shingrix, less than a year after starting Fluticasone Diskus and an unknown time after starting glucosamine, the patient experienced influenza-like symptoms, swelling arm, erythema of extremities, feeling hot, pain in arm, inflammation, nerve pain and joint pain. The patient was treated with codeine phosphate + paracetamol (Tylenol #4). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, nerve pain and joint pain were unknown and the outcome of the swelling arm, erythema of extremities, feeling hot, pain in arm and inflammation were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, swelling arm, erythema of extremities, feeling hot, pain in arm, inflammation, nerve pain and joint pain to be related to Shingrix and Fluticasone Diskus.  Additional details were received as follows: The patient after vaccination had arm swelling from elbow to shoulder, and was red and hot to the touch. The patient arm was sore. The patient also had nerve pain in joints throughout his body. The patient past medical history include damage to his lungs, bulging discs. The patient shoulder blades and elbows were the worst, but he also gets joint pain in his ankles, knees, hips and wrists. The patient felt like when the dentist gets too close to the nerve of a tooth. In addition to the local symptoms and joint pain, he also had flu like symptoms.
Age: 60.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK, VARZOS
Symptoms: Influenza like illness
Clinical narrative: he felt like he had the flu for 3-4 days; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone propionate (Fluticasone Diskus) inhalation powder for asthma and reactive airways disease and salmeterol xinafoate (Salmeterol Diskus) for asthma and reactive airways disease.   The patient's past medical history included knee pain. Previously administered products included Advair Diskus (received 1 puff twice dailyand started in 2000). Concurrent medical conditions included asthma and reactive airways disease. Concomitant products included ipratropium bromide, salbutamol sulfate (Combivent) and glucosamine.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Fluticasone Diskus at an unknown dose and frequency and Salmeterol Diskus at an unknown dose and frequency. On an unknown date, less than 4 months after receiving Shingrix, less than a year after starting Fluticasone Diskus and an unknown time after starting Combivent and glucosamine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix and Fluticasone Diskus.  Additional details were received as follows: The patient received the 1st dose in September 2019 and had the flu for 3 to 4 days. For tolerance to 2nd dose, refer case US2020AMR022223.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it is painful; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. Vaccination date was not provided batch number and expiration dates were not provided as the reporter did not had the information at the moment. The patient mentioned that he did not had a family history to get the vaccine. The patient did not want to receive the second dose of Shingrix as it was painful. The follow up consent was granted. No more details were provided as the reporter just wanted to get the information about administration of only one dose of Shingrix.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Muscular weakness, Myalgia, Pain in extremity, Peripheral swelling, Weight bearing difficulty
Clinical narrative: Pt reports muscle pain ongoing 6 weeks after injection, when she touches arm, bubble is still located there.  Very painful. Not exercise induced. Weakness in arm, unable to carry things. On the left side, deltoid area
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Computerised tomogram, Disorientation, Electrocardiogram, Electroencephalogram
Clinical narrative: Fever reached 105 within 30 minutes of administration of vaccine. I was unaware and incoherent. Went to work and passed put. Fell asleep and went to er once I woke up again on Friday night.  Went medical whereon was prescribed valium, licoderm patches and tramadol, and valium for severe pain because I had already taken enough tylenol and ibuprofen to break the fever. I was sent home. Got up the next day to  fill the prescriptions but was still to incoherent to realize what was going on, no fever and didn't understand that I was sick. Filled prescriptions and was in pain but thought I could make it to work. Pulled over at a gas station because I became disoriented where Iproceeded to have a seizure. I have no history of seizures. I am now unable to drive or work for three months and Agency instructed me not to report these reactions when I called to ask if I was possibly having a reaction to the vaccine on Friday afternoon.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Impaired driving ability, Impaired work ability, Incoherent, Loss of consciousness, Pain
Clinical narrative: Fever reached 105 within 30 minutes of administration of vaccine. I was unaware and incoherent. Went to work and passed put. Fell asleep and went to er once I woke up again on Friday night.  Went medical whereon was prescribed valium, licoderm patches and tramadol, and valium for severe pain because I had already taken enough tylenol and ibuprofen to break the fever. I was sent home. Got up the next day to  fill the prescriptions but was still to incoherent to realize what was going on, no fever and didn't understand that I was sick. Filled prescriptions and was in pain but thought I could make it to work. Pulled over at a gas station because I became disoriented where Iproceeded to have a seizure. I have no history of seizures. I am now unable to drive or work for three months and Agency instructed me not to report these reactions when I called to ask if I was possibly having a reaction to the vaccine on Friday afternoon.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Seizure
Clinical narrative: Fever reached 105 within 30 minutes of administration of vaccine. I was unaware and incoherent. Went to work and passed put. Fell asleep and went to er once I woke up again on Friday night.  Went medical whereon was prescribed valium, licoderm patches and tramadol, and valium for severe pain because I had already taken enough tylenol and ibuprofen to break the fever. I was sent home. Got up the next day to  fill the prescriptions but was still to incoherent to realize what was going on, no fever and didn't understand that I was sick. Filled prescriptions and was in pain but thought I could make it to work. Pulled over at a gas station because I became disoriented where Iproceeded to have a seizure. I have no history of seizures. I am now unable to drive or work for three months and Agency instructed me not to report these reactions when I called to ask if I was possibly having a reaction to the vaccine on Friday afternoon.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Child presented with localized reaction to injection sites.  Redness warm to touch.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Hypotension, Pallor, Presyncope
Clinical narrative: Near-Syncope Episode with marked hypotension and ashen skin pallor. The patient received 0.3 mg epinephrine IM with full recovery.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Pain of skin
Clinical narrative: Skin pain on the left side of the face and pain in the right eye
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis, Seizure like phenomena, Syncope
Clinical narrative: Pt received ppd right forearm, the vzv vaccine right upper deltoid. Pt c/o of feeling like fainting. Pt then syncopized in chair for few seconds. Had an episode of seizure like activity without incontinence. FS was 107. Oxygen was administered via NRB @ 6L. Pt was diaphoretic and HR 52 then 60 bp 107/60. Pt denied hx of epilepsy. Pt vomited 1x, EMS activated for new onset convulsive activity and arrived on the scene. Pt airway was not edematous, pt was not wheezy, no rash manifested.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Pt received ppd right forearm, the vzv vaccine right upper deltoid. Pt c/o of feeling like fainting. Pt then syncopized in chair for few seconds. Had an episode of seizure like activity without incontinence. FS was 107. Oxygen was administered via NRB @ 6L. Pt was diaphoretic and HR 52 then 60 bp 107/60. Pt denied hx of epilepsy. Pt vomited 1x, EMS activated for new onset convulsive activity and arrived on the scene. Pt airway was not edematous, pt was not wheezy, no rash manifested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pain
Clinical narrative: A sensitivity in the skin around my torso from just under my breasts to roughly 4 inches below that. More sensitive in the front. Equal on both sides. The sensation reminds me of the sensitivity my skin feels when I have the flu. Pain level on a scale from 1 - 10 is 3. No really painful, just annoying and always present.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chills, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: I started feeling feverish and pain in my left arm which spread to shoulder and back. Shooting pain and swelling which was not responsive to pain Ibuprofen. For the next 2 days the symptoms worsened with chills, giddiness and nausea. No fever but just the feeling. A lot of sweating. This subsided by day 3.  I tried to handle this with Ibuprofen and Pantoprazole.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: I started feeling feverish and pain in my left arm which spread to shoulder and back. Shooting pain and swelling which was not responsive to pain Ibuprofen. For the next 2 days the symptoms worsened with chills, giddiness and nausea. No fever but just the feeling. A lot of sweating. This subsided by day 3.  I tried to handle this with Ibuprofen and Pantoprazole.
Age: 65.0
Sex: F
Vaccine: YF
Symptoms: Influenza like illness, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: PATIENT STATED SHE HAD FLU LIKE SYMPTOMS WITH FEVER AND CONGESTION AND ALSO HAD A RASH ON HER CHEST
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: On 2/11/20, patient reported having sore left arm upon first Shingrix vaccine on 9/10/19 and second Shingrix vaccine on 12/23/19.  She reports soreness occurs when she tries putting left arm above her head or behind back. Soreness has persisted.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Influenza like illness, Lethargy, Nausea, Pain
Clinical narrative: patient contacted pharmacy and reported that both arms hurt and stated to experience body aches and flu-like symptoms last evening (02/11/2020). Patient contacted pharmacy 02/12/2020 about these symptoms. She was experiencing a fever (felt like she was burning up) but did not take temperature. Also reported body aches and arms hurting, feeling lethargic. Patient took extra strength Tylenol. Advised rest and fluids also. Contacted patient back a few hours later and she said she was feeling better but still had some nausea. Told patient I would check on her again 02/13/2020
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: patient contacted pharmacy and reported that both arms hurt and stated to experience body aches and flu-like symptoms last evening (02/11/2020). Patient contacted pharmacy 02/12/2020 about these symptoms. She was experiencing a fever (felt like she was burning up) but did not take temperature. Also reported body aches and arms hurting, feeling lethargic. Patient took extra strength Tylenol. Advised rest and fluids also. Contacted patient back a few hours later and she said she was feeling better but still had some nausea. Told patient I would check on her again 02/13/2020
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; the patient was administered a dose of VARIVAX on 12/19/2019, that had been improperly stored; This spontaneous report was received from a vaccine coordinator (also reported as an office manager) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number S021926 has been verified to be a valid lot number, expiration date 15-JUL-2021) (exact dose, dose number, route and site of administration were not reported) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with a properly stored sterile diluent.   Administered dose of vaccine was exposed to the temperature excursion of 1.2 degrees Celsius for 3 hours and 9 minutes incorrect product storage Data logger was involved. There was no previous temperature excursions. No adverse events were reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: The site was swollen, red, warm to touch with a bump and affected a large part of her arm/ Patient was treated for cellulitis with an unspecified antibiotic; patient had a "skin reaction" at injection site. The site was swollen, red, warm to touch with a bump/ Patient was treated for cellulitis with an unspecified antibiotic; The site was swollen, red, warm to touch with a bump and affected a large part of her arm/ Patient was treated for cellulitis with an unspecified antibiotic; patient had a "skin reaction" at injection site. The site was swollen, red, warm to touch with a bump/ Patient was treated for cellulitis with an unspecified antibiotic; Information has been received from a pharmacist via a field employee referring to an 11 years old female patient, the daughter of the reporter. In October 2019 (also reported as the same day), the patient received concomitant vaccines included influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient had no pertinent medical history. The patient was allergic to ant bites. The patient was not pregnant.  In October 2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml once, intramuscular; lot # and expiration date were unknown) for human papillomavirus (HPV) prevention.      In October 2019, the patient had a skin reaction at injection site. The site was swollen, red, warm to touch with a bump and affected a large part of the patient's arm (cellulitis). The reporter sought assistance for the patient at unspecified pediatrician office. There was no lab diagnostics or studies performed. The patient was treated for cellulitis with an unspecified antibiotic and her condition resolved in one week. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Skin reaction
Clinical narrative: The site was swollen, red, warm to touch with a bump and affected a large part of her arm/ Patient was treated for cellulitis with an unspecified antibiotic; patient had a "skin reaction" at injection site. The site was swollen, red, warm to touch with a bump/ Patient was treated for cellulitis with an unspecified antibiotic; The site was swollen, red, warm to touch with a bump and affected a large part of her arm/ Patient was treated for cellulitis with an unspecified antibiotic; patient had a "skin reaction" at injection site. The site was swollen, red, warm to touch with a bump/ Patient was treated for cellulitis with an unspecified antibiotic; Information has been received from a pharmacist via a field employee referring to an 11 years old female patient, the daughter of the reporter. In October 2019 (also reported as the same day), the patient received concomitant vaccines included influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient had no pertinent medical history. The patient was allergic to ant bites. The patient was not pregnant.  In October 2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml once, intramuscular; lot # and expiration date were unknown) for human papillomavirus (HPV) prevention.      In October 2019, the patient had a skin reaction at injection site. The site was swollen, red, warm to touch with a bump and affected a large part of the patient's arm (cellulitis). The reporter sought assistance for the patient at unspecified pediatrician office. There was no lab diagnostics or studies performed. The patient was treated for cellulitis with an unspecified antibiotic and her condition resolved in one week. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Wrong product administered
Clinical narrative: Interchange of vaccine product; No symptoms; Inappropriate schedule; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The reporter described that on an unknown date, the patient was vaccinated a series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis, it was reported that on 07-FEB-2020, the patient vaccinated  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis (Circumstance or information capable of leading to medication error and wrong product administered). No symptoms experienced.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: the patient received and expired dose of MMR II; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 10-FEB-2020, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) lot # R001658, expiration date 17-JAN-2020, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) lot #R034107, expiration date 24-JUN-2021.
Age: 63.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effect reported; The patient received the GARDASIL 9 at the age of 63.; Information has been received from a 63 years old female patient referring to herself. The patient's medical history and concomitant medications were not provided.   In January 2020 (reported as second week of January), the patient received 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot # and expiration date unknown) for prophylaxis at the age of 63 years (product administered to patient of inappropriate age). Prior to receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had an unspecified human papilloma virus (HPV) type already. No additional adverse effect was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain near the injection site; This case was reported by a consumer and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2019, the patient received Shingles vaccine. In December 2019, less than a month after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced pain near the injection site of her shingles vaccine. The patient said probably within the past month she had the vaccine. The reporter requesting consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular). In February 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced sore arm.. The reporter did not consent to follow up.