chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Rash, Rash erythematous
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 731734), concerns a 40-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 11-Oct-2017 at approximately 10:00 AM, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (2 as reported), anatomical location: right arm, batch number: XF33108, route of administration and expiry date: not reported). On the same day at 03:00 PM, the patient had rash which consist of 4 red patches to right forearm with no itchy. After one hour at 04:00 PM, the rash was almost resolved. On the same day at 06:40 PM, the patient had shiver, headache and dizziness, which were resolved by next morning. It was reported that, the patient treated with NYQUIL and ALEVE. At the time of the report, the patient had recovered from the events (dizziness, shivers, headache, rash and rash erythematous). The reporter assessed the case as non-serious.
Age: 49.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Fatigue, Mobility decreased
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 732597), concerning a 49-year-old, adult male patient. The patient's medical history, current illness and concomitant medications were not reported. On 11-Apr-2017, the patient was administered with AFLURIA (TIV) (reported as AFLURIA QUADRIVALENT), dose: 0.5 ml (reported as 2 dose), anatomical location: left arm, batch number: WT58108, route of administration, expiry date: not reported). On the same day of vaccination, the patient experienced fatigue and was unable to move to his arm. The patient had recovered from the events fatigue and mobility decreased. The reporter assessed the events as non-serious.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 732624), concerning a 66-year-old, elderly female patient. The patient's medical history, current illness and concomitant medications were not reported. On 03-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 2 dose), anatomical location: left arm, batch number: XF30306, route of administration, expiry date: not reported). On the same day, after vaccination, the patient experienced urticaria and pruritus. The patient had recovered from the events urticaria and pruritus. The reporter assessed the events as non-serious.
Age: 33.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: This spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 732629), concerns a 33-year-old, adult male patient. On 06-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (reported as 2), route of administration: unknown, anatomical location: left arm, batch number: 01444612A, expiry date: not reported). On 07-Oct-2017, the next day of vaccination, the patient developed skin rash. On an unspecified date, the patient recovered from the event skin rash. The reporter assessed the case as non-serious.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site discolouration, Injection site reaction, Musculoskeletal pain, Rash macular, Swelling
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 732641), concerns a 71-year-old, elderly, male patient. The patient historical procedure included right neck muscle surgery (on an unspecified date in 1975) and anal fissure-repair (on an unspecified date in Apr-2013). The patient's historical condition included left hydrocele (unspecified date in 1976), GERD (gastroesophageal reflux disease), HH (hiatal hernia) (unspecified date in 1980) and hearing loss (unspecified date). The patient's current condition and concomitant medications were not reported. On 12-Dec-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, intramuscular: injection, anatomical location: right arm, batch number: 01444612A and expiry date: not reported) and PNEUMOVAX (dose number: 2, route of administration: injection, anatomical location: left arm, batch number: N0255653 and expiry date: not reported). On the same day of vaccination, the patient developed large black, blue and red blotches on his left arm down to his elbow, swelling and shoulder pain. He denied itchiness or fever and received ALEVE for shoulder pain. His shoulder pain had improved, and he was able to sleep. It was reported that, patient had mild reaction to PNEUMOVAX and recommended to apply ice to the affected area hourly for relief of pain and swelling for 20 minutes. It was stated, that patient might use TYLENOL or ibuprofen for additional comfort measures and follow up if not improved. The patient was recovering from the event shoulder pain and had not yet recovered from all other events. The reporter assessed the events as non-serious.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Injection site discolouration, Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: This is a spontaneous case, reported by healthcare professional (other) to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 732641), concerns a 71-year-old, elderly, male patient. The patient historical procedure included right neck muscle surgery (on an unspecified date in 1975) and anal fissure-repair (on an unspecified date in Apr-2013). The patient's historical condition included left hydrocele (unspecified date in 1976), GERD (gastroesophageal reflux disease), HH (hiatal hernia) (unspecified date in 1980) and hearing loss (unspecified date). The patient's current condition and concomitant medications were not reported. On 12-Dec-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, intramuscular: injection, anatomical location: right arm, batch number: 01444612A and expiry date: not reported) and PNEUMOVAX (dose number: 2, route of administration: injection, anatomical location: left arm, batch number: N0255653 and expiry date: not reported). On the same day of vaccination, the patient developed large black, blue and red blotches on his left arm down to his elbow, swelling and shoulder pain. He denied itchiness or fever and received ALEVE for shoulder pain. His shoulder pain had improved, and he was able to sleep. It was reported that, patient had mild reaction to PNEUMOVAX and recommended to apply ice to the affected area hourly for relief of pain and swelling for 20 minutes. It was stated, that patient might use TYLENOL or ibuprofen for additional comfort measures and follow up if not improved. The patient was recovering from the event shoulder pain and had not yet recovered from all other events. The reporter assessed the events as non-serious.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 732646), concerning a 56-year-old, adult female patient. The patient's historical adverse reaction included shellfish reaction. The patient's concomitant medications included NATURE THROID, testosterone, estradiol, daily multivitamin. On 12-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, the patient received ZOSTAVAX (route of administration: intramuscular, anatomical location: right arm, dose, batch number and expiry date: not reported). On the same day (12-Oct-2017), after vaccination, the patient experienced pain at the injection site and her range of motion was decreased. It was reported that, patient made her physician's office visit and on 04-Jan-2018, the patient received orthopaedic referral. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious.
Age: 61.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chills, Pyrexia
Clinical narrative: This spontaneous case, reported by Other Health Professional to VAERS and initially retrieved on 11-MAR-2018 by Seqirus from VAERS (VAERS ID: 732839), concerns a 61-year-old male patient. The patient's historical conditions included, GERD, bee stings. The patient's historical procedures included post-operative cardiac catheterisation and gastric bypass R/y. The patient's concomitant medications included SUCRATE, PRILOSEC. On 01-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: not reported). On 06-Jan-2018, 6 days after vaccination, the patient developed sudden onset of fever (102.5) and severe chills which were relieved by TYLENOL over a period of six hours. The patient had a recurrent low-grade temperature of 99.5 on 07-Jan-2018 at 4:00 PM which was also relived by TYLENOL. The patient recovered from the events (chills and pyrexia). The reporter assessed the case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Tenderness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733056), concerns a 27-year-old, adult, female patient. The patient had no relevant medical history, current illness or lab data. The patient was allergic to penicillin. On 13-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration; intramuscular, anatomical location; left arm, batch number: XF33008, expiry date: not reported). On the same day, after vaccination, the patient developed tenderness on the left arm. At night, the patient experienced numbness in the arm and had continuous pain. On 08-Dec-2017, the patient reported to a healthcare employee, who referred to another healthcare provider. The patient did not go for consultation or respond to email sent on 22-Dec-2017. Later, it was reported that, the patient had short term relief from the pain. On an unspecified date, left arm pain reoccurred during ice fishing. The patient reported that, "cold made her arm hurt again" and suspected that nurse had given the shot too high in the arm. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Non-significant case correction received with the IRD 11-Mar-2018: The case comment was corrected.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Product administered at inappropriate site, Temperature intolerance, Tenderness
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733056), concerns a 27-year-old, adult, female patient. The patient had no relevant medical history, current illness or lab data. The patient was allergic to penicillin. On 13-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration; intramuscular, anatomical location; left arm, batch number: XF33008, expiry date: not reported). On the same day, after vaccination, the patient developed tenderness on the left arm. At night, the patient experienced numbness in the arm and had continuous pain. On 08-Dec-2017, the patient reported to a healthcare employee, who referred to another healthcare provider. The patient did not go for consultation or respond to email sent on 22-Dec-2017. Later, it was reported that, the patient had short term relief from the pain. On an unspecified date, left arm pain reoccurred during ice fishing. The patient reported that, "cold made her arm hurt again" and suspected that nurse had given the shot too high in the arm. At the time of this report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Non-significant case correction received with the IRD 11-Mar-2018: The case comment was corrected.
Age: 50.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: This spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733218), concerns a 50-year-old, adult female patient. It was reported that, the patient was allergic to strawberries. The patient had no concomitant medications. On 05-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml (1 as reported), route of administration: intramuscular, anatomical location: left arm, batch number: XF31407 and expiry date: not reported). On 08-Jan-2018, after 4 days of vaccination, the patient experienced pain and swelling which was axil. It was reported that, no lab tests were performed to the patient. At the time of the report, the patient had recovered from the events (axillary pain and oedema peripheral). The reporter assessed the case as non-serious. Significant case correction received 11-Mar-2018: The causality of the events axillary pain and oedema peripheral was corrected from related to unassessable.
Age: 3.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733534), concerns a 03-year-old, child, male patient. The patient's medical history, allergy and concomitant medications were not reported. On 22-Dec-2017, a 03-year-old (under age of 5 years) patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: XF33308 (reported as XF333308), expiry date: not reported) by mistake. The reporter assessed the event as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Gout, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733616), concerns a 60-year-old, adult, female patient. The patient historical drug included flu vaccine administered on unspecified date in 2015, after vaccination the patient had gout on the right big toe. The patient had unspecified allergies. The patient's concomitant medication included ZYRTEC. On 31-Dec-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 05-Jan-2018, after 5 days of vaccination, the patient's pointer finger on the right hand became tender. On 08-Jan-2018, the patient described that her right hand swollen, became red, very hot and was throbbing. The patient stated about the historical event gout on toe, which happened during previous vaccination and the patient reported, she knew this was gout. At the time of this report, the patient had not recovered from all the events. The reporter considered the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Tenderness
Clinical narrative: This spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733616), concerns a 60-year-old, adult, female patient. The patient historical drug included flu vaccine administered on unspecified date in 2015, after vaccination the patient had gout on the right big toe. The patient had unspecified allergies. The patient's concomitant medication included ZYRTEC. On 31-Dec-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 05-Jan-2018, after 5 days of vaccination, the patient's pointer finger on the right hand became tender. On 08-Jan-2018, the patient described that her right hand swollen, became red, very hot and was throbbing. The patient stated about the historical event gout on toe, which happened during previous vaccination and the patient reported, she knew this was gout. At the time of this report, the patient had not recovered from all the events. The reporter considered the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Gout, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733616), concerns a 60-year-old, adult, female patient. The patient historical drug included flu vaccine administered on unspecified date in 2015, after vaccination the patient had gout on the right big toe. The patient had unspecified allergies. The patient's concomitant medication included ZYRTEC. On 31-Dec-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 05-Jan-2018, after 5 days of vaccination, the patient's pointer finger on the right hand became tender. On 08-Jan-2018, the patient described that her right hand swollen, became red, very hot and was throbbing. The patient stated about the historical event gout on toe, which happened during previous vaccination and the patient reported, she knew this was gout. At the time of this report, the patient had not recovered from all the events. The reporter considered the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Skin warm, Tenderness
Clinical narrative: This spontaneous case, reported by other non-health care professional to VAERS and initially retrieved on 11-Mar-2018 by Seqirus from VAERS (VAERS ID: 733616), concerns a 60-year-old, adult, female patient. The patient historical drug included flu vaccine administered on unspecified date in 2015, after vaccination the patient had gout on the right big toe. The patient had unspecified allergies. The patient's concomitant medication included ZYRTEC. On 31-Dec-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left arm, batch number and expiry date: not reported). On 05-Jan-2018, after 5 days of vaccination, the patient's pointer finger on the right hand became tender. On 08-Jan-2018, the patient described that her right hand swollen, became red, very hot and was throbbing. The patient stated about the historical event gout on toe, which happened during previous vaccination and the patient reported, she knew this was gout. At the time of this report, the patient had not recovered from all the events. The reporter considered the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Rash erythematous
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-MAR-2018 by Seqirus from VAERS (VAERS ID: 733775), concerns a 52-year-old female patient. The patient's current condition included asthma, anxiety, hypertension. The patient's historical conditions included flu, severe cold (two weeks prior to shot) and muscle pain. The patient's concomitant medications included PROAIR, methocarbamol, potassium, omeprazole, lisinopril, furosemide, buspirone, levothyroxine, hydrocodone, APAP, CIMZIA. On 10-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (N/A as reported), route of administration: intramuscular, anatomical location: right arm, batch number: XF33208) and PNEUMOVAX (dose: N/A as reported, route of administration: intramuscular, anatomical location: right arm, batch number: N014946). On the same day, the patient experienced a little redness starting on the arm 30 min after vaccination. It was red rash with 5-inch margin. The patient was sent to an urgent care and prescribed with ranitidine and cetirizine for the reaction. The pharmacist gave her BENADRYL (50mg, at night). The outcome of the event rash erythematous was unknown. The reporter assessed the case as non-serious.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Rash, Rash erythematous
Clinical narrative: This is spontaneous case, reported by other health professional to VAERS and initially retrieved on 11-MAR-2018 by Seqirus from VAERS (VAERS ID: 733775), concerns a 52-year-old female patient. The patient's current condition included asthma, anxiety, hypertension. The patient's historical conditions included flu, severe cold (two weeks prior to shot) and muscle pain. The patient's concomitant medications included PROAIR, methocarbamol, potassium, omeprazole, lisinopril, furosemide, buspirone, levothyroxine, hydrocodone, APAP, CIMZIA. On 10-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml (N/A as reported), route of administration: intramuscular, anatomical location: right arm, batch number: XF33208) and PNEUMOVAX (dose: N/A as reported, route of administration: intramuscular, anatomical location: right arm, batch number: N014946). On the same day, the patient experienced a little redness starting on the arm 30 min after vaccination. It was red rash with 5-inch margin. The patient was sent to an urgent care and prescribed with ranitidine and cetirizine for the reaction. The pharmacist gave her BENADRYL (50mg, at night). The outcome of the event rash erythematous was unknown. The reporter assessed the case as non-serious.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anger in a 79-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced anger, fever, induration and urticarial rash. On an unknown date, the outcome of the anger, fever, induration and urticarial rash were unknown. It was unknown if the reporter considered the anger, fever, induration and urticarial rash to be related to SHINGRIX. Additional details were provided as follows: The patient complained next day after vaccination of an angry, hard, welted rash and fever.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anger in a 79-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced anger, fever, induration and urticarial rash. On an unknown date, the outcome of the anger, fever, induration and urticarial rash were unknown. It was unknown if the reporter considered the anger, fever, induration and urticarial rash to be related to SHINGRIX. Additional details were provided as follows: The patient complained next day after vaccination of an angry, hard, welted rash and fever.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Induration, Inflammation, Pyrexia, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anger in a 79-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 3rd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 4th May 2018, 1 days after receiving SHINGRIX, the patient experienced anger, fever, induration and urticarial rash. On an unknown date, the outcome of the anger, fever, induration and urticarial rash were unknown. It was unknown if the reporter considered the anger, fever, induration and urticarial rash to be related to SHINGRIX. Additional details were provided as follows: The patient complained next day after vaccination of an angry, hard, welted rash and fever.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Rash vesicular
Clinical narrative: Patient stated she got a 102 degree fever for about 24 hours and broke out with a SHINGLES rash on her arm she received the vaccine from. Patient called her provider.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: Patient stated she got a 102 degree fever for about 24 hours and broke out with a SHINGLES rash on her arm she received the vaccine from. Patient called her provider.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood test normal, Electrocardiogram normal, Hyperhidrosis, Palpitations
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a 56-year-old male patient who received SHINGRIX (batch number 32GR4, expiry date 20th July 2020) for prophylaxis. Previously administered products included SHINGRIX (did not have any problems after the 1st dose). Concomitant products included fenofibrate. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intraarticular). On 15th June 2018, several hours after receiving SHINGRIX, the patient experienced heart rate increased (serious criteria hospitalization, life threatening and other: As per reporter), lethargy (serious criteria hospitalization and other: As per reporter) and tiredness (serious criteria hospitalization and other: As per reporter). In June 2018, the outcome of the heart rate increased, lethargy and tiredness were recovered/resolved. It was unknown if the reporter considered the heart rate increased, lethargy and tiredness to be related to SHINGRIX. Additional details were provided as follows: At 17:00 hours, the patient received SHINGRIX on left arm. A couple of hours later the patient started feeling tired and lethargic, then his heart rate went up to 117. The patient's wife took him to the hospital and he was kept overnight for observation. The hospital physician was not sure if this was related to SHINGRIX. The patient underwent an electrocardiography (EKG) and it was found normal. On 16th June 2018, the patient was discharged and he had been fine since. The reporter thought it was life-threatening because he was in the hospital, and it required intervention because he was in the hospital.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Fatigue, Heart rate increased, Lethargy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a 56-year-old male patient who received SHINGRIX (batch number 32GR4, expiry date 20th July 2020) for prophylaxis. Previously administered products included SHINGRIX (did not have any problems after the 1st dose). Concomitant products included fenofibrate. On 15th June 2018, the patient received the 2nd dose of SHINGRIX (intraarticular). On 15th June 2018, several hours after receiving SHINGRIX, the patient experienced heart rate increased (serious criteria hospitalization, life threatening and other: As per reporter), lethargy (serious criteria hospitalization and other: As per reporter) and tiredness (serious criteria hospitalization and other: As per reporter). In June 2018, the outcome of the heart rate increased, lethargy and tiredness were recovered/resolved. It was unknown if the reporter considered the heart rate increased, lethargy and tiredness to be related to SHINGRIX. Additional details were provided as follows: At 17:00 hours, the patient received SHINGRIX on left arm. A couple of hours later the patient started feeling tired and lethargic, then his heart rate went up to 117. The patient's wife took him to the hospital and he was kept overnight for observation. The hospital physician was not sure if this was related to SHINGRIX. The patient underwent an electrocardiography (EKG) and it was found normal. On 16th June 2018, the patient was discharged and he had been fine since. The reporter thought it was life-threatening because he was in the hospital, and it required intervention because he was in the hospital.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Cardiovascular disorder, Eye pain, Fatigue, Fibromyalgia, Migraine
Clinical narrative: Fibromyalgia, migraines, eye pain, 24/7 pain, nausea, constant fatigue, circulation issues - blood pooling in hands and feet, ovarian cysts, multiple strep throat and tonsillectomy.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Ovarian cyst, Pharyngitis streptococcal, Tonsillectomy
Clinical narrative: Fibromyalgia, migraines, eye pain, 24/7 pain, nausea, constant fatigue, circulation issues - blood pooling in hands and feet, ovarian cysts, multiple strep throat and tonsillectomy.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Rx was written for varicella vaccine not SHINGRIX pt was given SHINGRIX. SHINGRIX is for the varicella zoster virus but Rx was intended to be for VARIVAX.
Age: 5.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Fall, Pallor, Syncope
Clinical narrative: After the injection about 1-2 minutes, my son fell in faint for 1-2 minutes. His face turned to very pale for about ten minutes, his lips also turned to very pale.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash, Injection site reaction, Pallor, Skin hyperpigmentation
Clinical narrative: Pt presented to office with a flat, impalpable, blanching, hyperpigmented rash on the left thigh on 06/15/2018. Mother states that the rash began the day after the vaccines were given and has not gone away. No other symptoms noted. No treatment provided.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Fever of greater than 100.2 F starting 24 hours after vaccination. Resolved 2 hours after taking 800 mg ibuprofen. Muscle pain - generalized. Starting 11 hours after vaccination. Resolved 36 hours after vaccination. Muscle weakness - generalized. Starting 11 hours after vaccination. Still unresolved.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product appearance confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician a nurse and the patient's mother referring to her son, an 11 years old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unspecified date in February 2018, the patient was vaccinated with the first dose of pediatric VAQTA (lot # reported as: N023953, expiration date 05-NOV-2018) (route not provided). On 22-MAY-2018, the patient was supposed to be vaccinated with ADACEL, but instead was inadvertently vaccinated with a dose of adult formulation of  VAQTA (lot # R009799, expiration date 02-JUN-2019) intramuscularlly for prophylaxis. The nurse stated that the two vaccines were similar in color. The patient's mother stated that her son received a VAQTA injection early. No adverse effects were reported. Lot number N023953 is an invalid lot number for hepatitis a vaccine, inactivated.
Sex: F
Vaccine: VARCEL
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a pharmacist, and refers to a 37 year old female patient. No information about the patient's medical history, concurrent conditions and drug reaction allergies was provided. On 06-MAR-2018, the patient was vaccinated with the first dose of VARIVAX, for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided). The vaccine was reconstituted with sterile diluent (manufacturer unknown). Since an unknown date in 2018, the patient reported being "sick" (malaise), as the patient was scheduled for the second dose of VARIVAX 28 day after the first dose, however, the patient reported being sick. It was reported that the patient sought medical attention by contacting the reporter's pharmacy, nevertheless, it was unknown if a treatment was prescribed to the patient. At the time of reporting, the outcome of malaise was unknown. The causal relationship between VARIVAX and malaise was not provided.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant regarding a male patient of unknown age. The patient's concomitant medications included sterile diluent (manufacturer unknown) (lot number and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of M-M-R II, lot # M045392 with expiration date 17-NOV-2018 for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 15 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect involved.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 12-JUN-2018, the patient was inadvertently vaccinated with an extra dose of VAQTA lot number N030286 and expiration date on 10-NOV-2018 for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). No adverse effect was reported.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 62 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, two years after the patient received ZOSTAVAX, the patient presented to the physician office with a significant case of shingles on one side of his torso. The reporter stated that the patient was treated for the significant case of shingles with an unspecified pain medication as well as unspecified anti-viral medications. It was unknown if the unspecified pain medication as well as unspecified anti-viral medications were effective. It was also unknown by the reporter if the patient was still currently taking the unspecified pain medication as well as unspecified anti-viral medications. The outcome of the event significant case of shingles was unknown was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with ZOSTAVAX.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an infant patient of unknown age and gender. The patient's medical history, concurrent conditions ans concomitant therapies were not reported. On 12-JUN-2018, in the same office visit, the patient was inadvertently administered with PROQUAD (lot # N029672 with expiration date of 21-APR-2019; strength, dose, route and anatomical location were not provided), for prophylaxis; VARIVAX (lot # N032744 with expiration date of 20-NOV-2019; strength, dose, route and anatomical location were not reported), also for prophylaxis; and sterile diluent (manufacturer unknown) (strength, dose, route, lot #, expiration date and indication were not provided). No adverse effects reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This non-valid spontaneous report was received from a doctor of pharmacy referring to a multiple unspecified dialysis patients of unknown age and gender. The patients' medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (strength, dose, route, anatomical location, lot # and expiration date were not provided), for hepatitis B protection. On unknown dates, after receiving RECOMBIVAX HB, the patients did not show antibodies (hepatitis b surface antibody negative). It was unknown if the patients received any treatment. At the time of reporting, the outcome of hepatitis b surface antibody negative was unknown. The causal relationship between the event and the RECOMBIVAX HB was not reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-JUN-2018, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB (lot # M033096 with expiration date of 31-MAY-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUL-2009, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a health care facility/office (by an unspecified healthcare professional) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 08-JUL-2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 29-JUN-2016, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a health care facility/office (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUL-2016, the patient was treated at a hospital (by an unspecified healthcare professional) for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 14-JUN-2018, the patient was inadvertently vaccinated with a expired dose of GARDASIL 9 intramuscularly, lot # M009116 with expiration date: 13-JUN-2018  (strength, dose and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from nurse via a company representative refers to a 16 year old female patient. On 15-JUN-2018, the patient was vaccinated with a dose of GARDASIL 9 lot # N019104, expiration date 03-FEB-2020, intramuscular in arm for prophylaxis. On the same day, the patient experienced dizziness and passing out. She was treated and recovered in the physician's office on the same day. Causality assessment was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056: