chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, HEPAB, MMR
Symptoms: Hepatitis B antibody negative, Insomnia, Measles antibody negative, Mumps antibody test negative, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 49-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included TWINRIX for prophylaxis. The patient had a Family History of immunodeficiency (to brother, a few years before the date of reporting). Concomitant products included Hepatitis A vaccine, MEASLES MUMPS RUBELLA and MEASLES MUMPS RUBELLA. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On 7th December 2018, the patient received the 1st dose of Twinrix (intramuscular). On 7th December 2018, not applicable after receiving Hepatitis B vaccine and less than a day after receiving TWINRIX, the patient experienced insomnia and sleep restless. On an unknown date, the patient experienced therapy non-responder. The patient was treated with sleep medication (nos) (Sleeping Pill). On an unknown date, the outcome of the insomnia was not recovered/not resolved and the outcome of the sleep restless and therapy non-responder were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. It was unknown if the reporter considered the insomnia and sleep restless to be related to TWINRIX. Additional details were provided as follows: Around 2007 she was vaccinated for hepatitis B, but when she started her new job it was found she did not had any antibodies to hepatitis B, which was why she was now receiving TWINRIX. In 2013 she got the hepatitis A vaccine and she does not know if she has any antibodies against hepatitis A. She also received the MMR series twice and still did not have any antibodies. The patient received 1st dose of TWINRIX on Friday, and had insomnia since. She had restless sleep Friday, Saturday night and on Sunday night she could not sleep at all. On Monday night she still could not sleep. On Tuesday night, she took a sleeping pill and finally fell asleep after 1.5 hours. Since her brother had common variable immune deficiency, so she was concerned that his might be a problem for her as well. The reporter gave consent to follow up.  Lab Comments: On an unknown date, the patient's antibody test for hepatitis B and MMR were negative.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, HEPAB, MMR
Symptoms: Rubella antibody negative, Serology negative, Therapy non-responder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 49-year-old female patient who received Hepatitis B vaccine for prophylaxis. Co-suspect products included TWINRIX for prophylaxis. The patient had a Family History of immunodeficiency (to brother, a few years before the date of reporting). Concomitant products included Hepatitis A vaccine, MEASLES MUMPS RUBELLA and MEASLES MUMPS RUBELLA. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On 7th December 2018, the patient received the 1st dose of Twinrix (intramuscular). On 7th December 2018, not applicable after receiving Hepatitis B vaccine and less than a day after receiving TWINRIX, the patient experienced insomnia and sleep restless. On an unknown date, the patient experienced therapy non-responder. The patient was treated with sleep medication (nos) (Sleeping Pill). On an unknown date, the outcome of the insomnia was not recovered/not resolved and the outcome of the sleep restless and therapy non-responder were unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. It was unknown if the reporter considered the insomnia and sleep restless to be related to TWINRIX. Additional details were provided as follows: Around 2007 she was vaccinated for hepatitis B, but when she started her new job it was found she did not had any antibodies to hepatitis B, which was why she was now receiving TWINRIX. In 2013 she got the hepatitis A vaccine and she does not know if she has any antibodies against hepatitis A. She also received the MMR series twice and still did not have any antibodies. The patient received 1st dose of TWINRIX on Friday, and had insomnia since. She had restless sleep Friday, Saturday night and on Sunday night she could not sleep at all. On Monday night she still could not sleep. On Tuesday night, she took a sleeping pill and finally fell asleep after 1.5 hours. Since her brother had common variable immune deficiency, so she was concerned that his might be a problem for her as well. The reporter gave consent to follow up.  Lab Comments: On an unknown date, the patient's antibody test for hepatitis B and MMR were negative.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th December 2018, the patient experienced tiredness, muscle pain, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, tiredness, muscle pain, headache, shivering, fever and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, tiredness, muscle pain, headache, shivering, fever and upset stomach to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. On 12th December 2018, 1 day after receiving SHINGRIX, the patient experienced tiredness, muscle pain, headache, shivering, fever and upset stomach. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th December 2018, the patient experienced tiredness, muscle pain, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, tiredness, muscle pain, headache, shivering, fever and upset stomach were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, tiredness, muscle pain, headache, shivering, fever and upset stomach to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. On 12th December 2018, 1 day after receiving SHINGRIX, the patient experienced tiredness, muscle pain, headache, shivering, fever and upset stomach. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 1st dose of SHINGRIX. On 10th December 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm on the same day evening she had arm swelling and redness. She notes the swelling almost was the size of another muscle. She was encouraged to share this with her physician, she stated she did with the pharmacist and they referred her to GSK. She noticed the swelling makes it hard to lay on that side and arm. The reporter gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Middle insomnia, Nausea, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a adult female patient who received SHINGRIX for prophylaxis. On 12th December 2018, the patient received the 1st dose of SHINGRIX. On 12th December 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain, fever, nausea, headache and nocturnal awakening. The patient was treated with TYLENOL. On 12th December 2018, the outcome of the nausea was recovered/resolved. On an unknown date, the outcome of the joint pain and fever were not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the nocturnal awakening was unknown. It was unknown if the reporter considered the joint pain, fever, nausea, headache and nocturnal awakening to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. Less than 24 hours after, the patient experienced severe joint pain and awoke during the night with nausea and a fever of 102.7 degree F. In the morning she reported a headache and fever of 101.7 degree F.  After taking TYLENOL, the patient visited to urgent care. A few hours later the patient reported a fever of 101.5 degree F and persistent painful joints. The batch number and expiration date of SHINGRIX were not available at time of reporting. The emergency room visit required. The reporter gave consent to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 21st November 2018, the patient received the 1st dose of SHINGRIX. On 22nd November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site wheal, injection site warmth and injection site infection. The patient was treated with antibiotics nos and azithromycin (Z Pak). On an unknown date, the outcome of the injection site wheal, injection site warmth and injection site infection were recovered/resolved. It was unknown if the reporter considered the injection site wheal, injection site warmth and injection site infection to be related to SHINGRIX. Additional details were provided as follows: The patient woke up with a huge welt at the injection site and also hot to the touch at the injection site, the next morning of vaccination. She went to see a doctor and she got antibiotics and a zpack prescribed. The physician said that her injection site was infection. The patient clarified that the pharmacist did open a brand new needle and cleaned the site of injection before giving the vaccine. The reporter did not have additional information. The reporter gave consent to follow up. This case has been linked with case US2018225305, reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 21st November 2018, the patient received the 1st dose of SHINGRIX. On 21st November 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The patient only had a sore arm about 4 hours after the vaccine and recovered. This case has been linked with case US2018225303, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Pain, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included lidocaine (Lidocaine Cream). On 12th May 2018, the patient received the 1st dose of SHINGRIX. On 12th August 2018, 92 days after receiving SHINGRIX, the patient experienced shingles, rash, pain and pruritus. On an unknown date, the outcome of the shingles, pain and pruritus were not recovered/not resolved and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the shingles, rash, pain and pruritus to be related to SHINGRIX. Additional details were reported as follows: The patient experienced shingles rash on her right ear, neck, and scalp.  The patient missed her second dose because of the shingles, and was currently past the 6 month period. The patient planned to continue follow up with her physician on an unknown date. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Flatulence, Frequent bowel movements, Retching
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of appetite absent in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 18th June 2018 with no reactions). Concurrent medical conditions included mental disability. On 11th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th December 2018, 1 hr 30 min after receiving SHINGRIX, the patient experienced appetite absent, gagging and gas in stomach. On an unknown date, the patient experienced frequent bowel movements. On an unknown date, the outcome of the appetite absent, gagging and gas in stomach were recovered/resolved and the outcome of the frequent bowel movements was recovering/resolving. It was unknown if the reporter considered the appetite absent, gagging, gas in stomach and frequent bowel movements to be related to SHINGRIX. Additional details were received as follows: This case was received from the patient's brother. About 1.5 to 2 hours after vaccination, the patient did not want to eat dinner. He complained that his stomach was all gas and he was gagging like he was going to throw up. The couple hours after vaccination, the patient had bowel movement and felt better. The patient ate radishes prior to getting the vaccine, so the caller thinks that might have contributed to the problem. It was related to patient.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that a patient received SHINGRIX at their pharmacy either in August or September 2018 and she experienced severe redness and swelling within a day or two of the first dose. The severe redness subsided, however, the patient returned the day of reporting to get the second dose and she still has a red bulls eye mark on her left arm. The pharmacist refused to provide the patient's date of birth. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 19th August 2018, the patient received the 1st dose of SHINGRIX. On 19th August 2018, immediately 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 details were reported as follows: The patient reported that, it hurt at the injection site as she was getting the SHINGRIX vaccine, which went away almost immediately and before she left the pharmacy. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site discolouration, Injection site induration, Injection site mass, Injection site nodule
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 23rd May 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site mass, injection site discoloration, injection site induration and injection site warmth. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the injection site mass, injection site discoloration, injection site induration and injection site warmth were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site mass, injection site discoloration, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were received as follows: The patient developed a large, hard knot at the injection site that was hot to the touch the day after receiving the first dose of SHINGRIX. The patient also said there was a jagged border with a purplish color around the knot. This lasted for 2 weeks and then the reactions resolved. The patient was also past the 6 month point for the second dose of the SHINGRIX series, which led to drug dose administration interval too long. The reporter did not have vaccine information available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 23rd May 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site mass, injection site discoloration, injection site induration and injection site warmth. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the injection site mass, injection site discoloration, injection site induration and injection site warmth were recovered/resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the injection site mass, injection site discoloration, injection site induration and injection site warmth to be related to SHINGRIX. Additional details were received as follows: The patient developed a large, hard knot at the injection site that was hot to the touch the day after receiving the first dose of SHINGRIX. The patient also said there was a jagged border with a purplish color around the knot. This lasted for 2 weeks and then the reactions resolved. The patient was also past the 6 month point for the second dose of the SHINGRIX series, which led to drug dose administration interval too long. The reporter did not have vaccine information available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Ear pain, Injection site pain, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of adverse event. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced arthritis, shoulder pain, neck pain, ear pain and pain in elbow. The patient was treated with ADVIL. On an unknown date, the outcome of the arthritis and ear pain were unknown and the outcome of the shoulder pain and pain in elbow were not recovered/not resolved and the outcome of the neck pain was recovered/resolved. It was unknown if the reporter considered the arthritis, shoulder pain, neck pain, ear pain and pain in elbow to be related to SHINGRIX. Additional details were provided as follows: The patient had tendency to have reactions to vaccines and always had a weird reaction to the flu vaccine. She did not provide any further details regarding that. In mid of August 2018, the patient received her dose of SHINGRIX in her right arm.  The next morning, the patient woke up with pain in her shoulder that traveled up her neck and behind her ear and down top her elbow, all on the right side. The neck pain resolved after a month of taking ADVIL 3 times a day. The pain in her shoulder down to her elbow was still present. The patient had an x-ray and was told she had slight arthritis. The patient did not consent to follow-up. This case was linked with US2018GSK230613, reported for the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, X-ray abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of arthritis in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of adverse event. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced arthritis, shoulder pain, neck pain, ear pain and pain in elbow. The patient was treated with ADVIL. On an unknown date, the outcome of the arthritis and ear pain were unknown and the outcome of the shoulder pain and pain in elbow were not recovered/not resolved and the outcome of the neck pain was recovered/resolved. It was unknown if the reporter considered the arthritis, shoulder pain, neck pain, ear pain and pain in elbow to be related to SHINGRIX. Additional details were provided as follows: The patient had tendency to have reactions to vaccines and always had a weird reaction to the flu vaccine. She did not provide any further details regarding that. In mid of August 2018, the patient received her dose of SHINGRIX in her right arm.  The next morning, the patient woke up with pain in her shoulder that traveled up her neck and behind her ear and down top her elbow, all on the right side. The neck pain resolved after a month of taking ADVIL 3 times a day. The pain in her shoulder down to her elbow was still present. The patient had an x-ray and was told she had slight arthritis. The patient did not consent to follow-up. This case was linked with US2018GSK230613, reported for the same patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain. On 21st November 2018, the patient experienced tiredness. On 22nd November 2018, the patient experienced localized erythema and local swelling. On 23rd November 2018, the outcome of the pain was recovered/resolved. On 24th November 2018, the outcome of the localized erythema and local swelling were recovered/resolved. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the pain, tiredness, localized erythema and local swelling to be related to SHINGRIX. Additional details were provided as follows: The patient had soreness that lasted for 3 days after the vaccination. One day after the vaccination, the patient had significant tiredness that lasted about 36 hours. Two days after the vaccination, the patient noticed redness and swelling above the injection site about 2.5 inches in diameter. The redness and swelling resolved 4 days after the vaccination. There was a consent for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of itchy rash in a adult female patient who received SHINGRIX for prophylaxis. On 10th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a week after receiving SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. It was unknown if the reporter considered the itchy rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was about 60 to 62 years old. The patient called the office on day of reporting and reported an itchy rash on her hand and around her eye.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Dyskinesia, Hypersomnia, Middle insomnia
Clinical narrative: Information has been downloaded from Regulatory Authority (US-SEQIRUS-201802125). Information has been received from a health professional reporter referring to a 1 year old male patient. The patient's historical drug included polio (22-JUN-2016), hepatitis A virus vaccine (unspecified) (31-AUG-2016), pneumococcal conj vaccine (unspecified) (on 22-JUN-2016 and 31-AUG-2016), DTAP (on 30-OCT-2015, 06-JAN-2016 and 22-JUN-2016) and hepatitis B virus vaccine (unspecified) (22-JUN-2016). The patient's concurrent condition and concomitant therapy were unknown. On 11-JAN-2017 the patient was vaccinated with VARIVAX (dose, route, batch/lot number and expiration date were not provided), M-M-R II (dose, route, batch/lot number and expiration date were not provided) and FLUVIRIN (0.5ml; route, batch/lot number and expiration date were not provided), all for unknown indication. On 12-JAN-2017, the patient experienced shaking, could not move, constant sleeping, randomly collapsing, jolting, screaming in the middle of the night ever since (always wakes screaming), crying for first week and screaming in the middle of the night ever since (he had been walking in to walls). It was reported that the child was constantly crying and sleeping for the first week after vaccination with FLUVIRIN. It was also reported that the child also experienced dyskinesia more than 2 months and syncope and abnormal behaviour, more than 3 months. The outcome of all the events was reported as not recovered. The causality assessments between all events and suspect vaccines were not reported by the reporter. All of these events were considered to be medically significant.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Movement disorder, Screaming, Syncope, Tremor
Clinical narrative: Information has been downloaded from Regulatory Authority (US-SEQIRUS-201802125). Information has been received from a health professional reporter referring to a 1 year old male patient. The patient's historical drug included polio (22-JUN-2016), hepatitis A virus vaccine (unspecified) (31-AUG-2016), pneumococcal conj vaccine (unspecified) (on 22-JUN-2016 and 31-AUG-2016), DTAP (on 30-OCT-2015, 06-JAN-2016 and 22-JUN-2016) and hepatitis B virus vaccine (unspecified) (22-JUN-2016). The patient's concurrent condition and concomitant therapy were unknown. On 11-JAN-2017 the patient was vaccinated with VARIVAX (dose, route, batch/lot number and expiration date were not provided), M-M-R II (dose, route, batch/lot number and expiration date were not provided) and FLUVIRIN (0.5ml; route, batch/lot number and expiration date were not provided), all for unknown indication. On 12-JAN-2017, the patient experienced shaking, could not move, constant sleeping, randomly collapsing, jolting, screaming in the middle of the night ever since (always wakes screaming), crying for first week and screaming in the middle of the night ever since (he had been walking in to walls). It was reported that the child was constantly crying and sleeping for the first week after vaccination with FLUVIRIN. It was also reported that the child also experienced dyskinesia more than 2 months and syncope and abnormal behaviour, more than 3 months. The outcome of all the events was reported as not recovered. The causality assessments between all events and suspect vaccines were not reported by the reporter. All of these events were considered to be medically significant.
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Abnormal behaviour, Emotional distress, Irritability, Musculoskeletal stiffness, Opisthotonus
Clinical narrative: Information has been downloaded from regulatory authority (US-SEQIRUS-201802336) on 20-DEC-2018. This spontaneous report as received from a consumer refers to a 1-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 25-SEP-2017, the patient was vaccinated with M-M-R II 1 dosage form (route of administration, indication, lot number and expiration date were not provided). Other suspect therapies administered on the same day included VARIVAX (1 DF (route of administration, indication, lot number and expiration date were not provided)) and AFLURIA (0.5 ml, injection (route of administration, indication, lot number and expiration date were not provided)). On 25-SEP-2017 in the morning, the patient began acting very differently than his normal extremely happy. On 26-SEP-2017, the patient kept pushing away from the reporter, yet wanted to be held. On that day in the morning, the patient was screaming a high pitched shriek, was stiff and arching his back when the reporter was changing the patient's diaper. The patient continued to shriek throughout the day. He was very fussy and inconsolable throughout the entire day. The outcome of the events was unknown. The relatedness between the suspect therapies and the events was not provided. The events were considered to be medically significant according to the Agency.
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Screaming
Clinical narrative: Information has been downloaded from regulatory authority (US-SEQIRUS-201802336) on 20-DEC-2018. This spontaneous report as received from a consumer refers to a 1-year-old male patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On 25-SEP-2017, the patient was vaccinated with M-M-R II 1 dosage form (route of administration, indication, lot number and expiration date were not provided). Other suspect therapies administered on the same day included VARIVAX (1 DF (route of administration, indication, lot number and expiration date were not provided)) and AFLURIA (0.5 ml, injection (route of administration, indication, lot number and expiration date were not provided)). On 25-SEP-2017 in the morning, the patient began acting very differently than his normal extremely happy. On 26-SEP-2017, the patient kept pushing away from the reporter, yet wanted to be held. On that day in the morning, the patient was screaming a high pitched shriek, was stiff and arching his back when the reporter was changing the patient's diaper. The patient continued to shriek throughout the day. He was very fussy and inconsolable throughout the entire day. The outcome of the events was unknown. The relatedness between the suspect therapies and the events was not provided. The events were considered to be medically significant according to the Agency.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red Rash 4 in diameter warm to touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Had the injection at about 1:30 pm. By evening my arm was very sore. Woke up at 2:00 am feeling headachy, fatigued and nauseous. Threw up. Had fever of 100.7. My left arm had a 2 inch red welt and was painful. Had muscle aches, similar to the flu. Slept most of the morning. By evening my fever was normal. I was still very fatigues. Today, Monday, al the symptoms are gone except a very sore left arm. The red welt is still there.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Somnolence, Urticaria
Clinical narrative: Had the injection at about 1:30 pm. By evening my arm was very sore. Woke up at 2:00 am feeling headachy, fatigued and nauseous. Threw up. Had fever of 100.7. My left arm had a 2 inch red welt and was painful. Had muscle aches, similar to the flu. Slept most of the morning. By evening my fever was normal. I was still very fatigues. Today, Monday, al the symptoms are gone except a very sore left arm. The red welt is still there.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Had the injection at about 1:30 pm. By evening my arm was very sore. Woke up at 2:00 am feeling headachy, fatigued and nauseous. Threw up. Had fever of 100.7. My left arm had a 2 inch red welt and was painful. Had muscle aches, similar to the flu. Slept most of the morning. By evening my fever was normal. I was still very fatigues. Today, Monday, al the symptoms are gone except a very sore left arm. The red welt is still there.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Nausea, Tremor
Clinical narrative: Patient called complaining of chills, shaking, nausea, and pain at injection site not experienced with the previous injection.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria, Local reaction
Clinical narrative: Local reaction to site with redness and hives.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Autoimmune disorder, Blood test, Colonoscopy, Constipation, Diarrhoea
Clinical narrative: Information has been received from a consumer concerning of his son, a current 12 year old male patient. The patient was allergic to morphine. The patient had no pertinent medical history nor concomitant medications. In August 2017, the patient was vaccinated with the first dose of GARDASIL 9, route reported as "shot" (strength, anatomical location, lot number and expiration date not reported) to prevent human papilloma virus (HPV) prophylaxis. On an unknown date in 2017 (reported as "soon afterwards"), the patient complained of leg hurting and starting to lose weight. On an unknown date, the patient suffered from constipation, diarrhea, chronic inflammation and his weight went from 81 pounds to 69 pounds. On an unknown date, the patient visited a gastrointestinal specialist who gave unspecified treatment. Multiple tests were done included blood work, magnetic resonance imaging, "MRE", ultrasounds, colonoscopy and endoscopy; no results reported. In March 2018, the patient received dose 2 of GARDASIL 9, route reported as "shot" (lot number and expiration date not reported). About three weeks after the second dose, the patient was hospitalized as his condition worsened. On an unknown date, as his condition continued to get worse and the patient saw a vaccination specialist who was considering an autoimmune disease. At the time of the report, the patient had not recovered from the aforementioned events. The causal relationship between aforementioned adverse events and GARDASIL 9 was not reported. Upon internal review, the autoimmune disorder was considered as a medically significant event.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Endoscopy, Imaging procedure, Inflammation, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning of his son, a current 12 year old male patient. The patient was allergic to morphine. The patient had no pertinent medical history nor concomitant medications. In August 2017, the patient was vaccinated with the first dose of GARDASIL 9, route reported as "shot" (strength, anatomical location, lot number and expiration date not reported) to prevent human papilloma virus (HPV) prophylaxis. On an unknown date in 2017 (reported as "soon afterwards"), the patient complained of leg hurting and starting to lose weight. On an unknown date, the patient suffered from constipation, diarrhea, chronic inflammation and his weight went from 81 pounds to 69 pounds. On an unknown date, the patient visited a gastrointestinal specialist who gave unspecified treatment. Multiple tests were done included blood work, magnetic resonance imaging, "MRE", ultrasounds, colonoscopy and endoscopy; no results reported. In March 2018, the patient received dose 2 of GARDASIL 9, route reported as "shot" (lot number and expiration date not reported). About three weeks after the second dose, the patient was hospitalized as his condition worsened. On an unknown date, as his condition continued to get worse and the patient saw a vaccination specialist who was considering an autoimmune disease. At the time of the report, the patient had not recovered from the aforementioned events. The causal relationship between aforementioned adverse events and GARDASIL 9 was not reported. Upon internal review, the autoimmune disorder was considered as a medically significant event.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Ultrasound scan, Weight decreased
Clinical narrative: Information has been received from a consumer concerning of his son, a current 12 year old male patient. The patient was allergic to morphine. The patient had no pertinent medical history nor concomitant medications. In August 2017, the patient was vaccinated with the first dose of GARDASIL 9, route reported as "shot" (strength, anatomical location, lot number and expiration date not reported) to prevent human papilloma virus (HPV) prophylaxis. On an unknown date in 2017 (reported as "soon afterwards"), the patient complained of leg hurting and starting to lose weight. On an unknown date, the patient suffered from constipation, diarrhea, chronic inflammation and his weight went from 81 pounds to 69 pounds. On an unknown date, the patient visited a gastrointestinal specialist who gave unspecified treatment. Multiple tests were done included blood work, magnetic resonance imaging, "MRE", ultrasounds, colonoscopy and endoscopy; no results reported. In March 2018, the patient received dose 2 of GARDASIL 9, route reported as "shot" (lot number and expiration date not reported). About three weeks after the second dose, the patient was hospitalized as his condition worsened. On an unknown date, as his condition continued to get worse and the patient saw a vaccination specialist who was considering an autoimmune disease. At the time of the report, the patient had not recovered from the aforementioned events. The causal relationship between aforementioned adverse events and GARDASIL 9 was not reported. Upon internal review, the autoimmune disorder was considered as a medically significant event.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Night sweats
Clinical narrative: Nightsweats overnight one day after vaccination.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Chest X-ray, Oxygen saturation decreased, Stridor, Tremor
Clinical narrative: Approximately one hour after the patient received the flu vaccine he began shaking and his daughter called his nurse into the room. Upon entering the room the nurse he was found to be shaking and wheezing with an O2 saturation of 83% and developed an upper airway stridor.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination complication, Wheezing
Clinical narrative: Approximately one hour after the patient received the flu vaccine he began shaking and his daughter called his nurse into the room. Upon entering the room the nurse he was found to be shaking and wheezing with an O2 saturation of 83% and developed an upper airway stridor.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Blood pressure decreased, Heart rate decreased, Syncope
Clinical narrative: Vasovagal syncope. Blood pressure to 80/40 from 141/92. Reduced pulse rate. Recovery within 15 minutes.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Donor states symptoms initially began with a headache, then about 5 minutes after than began feeling weak, dizziness and fatigued. Donor was brought to office. Sat down in chair and was given an ice pack to put behind the neck. V/S at 10:56 P-62, BP-118/66, Temp 99.2. States she now feels a headache 5/10. Was initially an 8/10.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Joint stiffness, Local reaction, Peripheral swelling
Clinical narrative: PT HAS SWOLLEN AND RED ARM, SHOULDER TO ELBOW. PT STATES NOT WARM TO TOUCH OR PAINFUL, EXCEPT WHEN LYING DOWN TO SLEEP ON IT. TIGHT ELBOW FROM SWELLING. RED AREA SEEMS TO BE SPREADING, EVEN 3 DAYS LATER. PT FEELS OK OTHERWISE, JUST SEEKING ADVICE ON IF MEDICAL CARE IS NECESSARY FOR THIS RED AREA SPREADING 3 DAYS LATER. I ADVISED PT TO CONTINUE MONITORING, LOCALIZED REACTION SHOULD BEGIN TO RESOLVE AND IMPROVE MOVING FORWARD. ICE PACKS, BENADRYL, AND IBU WERE RECOMMENDED TO HELP WITH THE SWELLING AND TIGHTNESS HE'S EXPERIENCING.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). On 13th December 2018, the patient received the 1st dose of SHINGRIX. On 13th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, upset stomach and tiredness. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the upset stomach and tiredness were unknown. It was unknown if the reporter considered the injection site pain, upset stomach and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age of patient was reported as 70 plus. A day before reporting, the patient received SHINGRIX on an unknown arm and experienced sore arm at injection site, some stomach upset and general tiredness which does not required medical attention. The patient asked question for his daughter that if SHINGRIX could be administered to a person on Humira who was 50 plus years old had rheumatoid arthritis and no spleen. If SHINGRIX was live or dead vaccine. The call center representative replied that SHINGRIX was non-live vaccine and Your daughter's healthcare provider would determine the right treatment plan for her. There are no warnings, precautions, contraindications for her using it but patients who were immunocompromised were excluded from large clinical trials. Immunosuppressive therapies might reduce the effectiveness of SHINGRIX. The patient also asked if any coupons are available to help offset the cost of the 2nd dose. This case has been linked with case US2018GSK227323 (patient's wife), reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Erythema, Insomnia, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 27th August 2018 at Public health department). On 1st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a day after receiving SHINGRIX, the patient experienced tremor, red rash, sleeplessness, chills and discomfort. The patient was treated with bacitracin, neomycin, NEOSPORIN and Alcohol. On an unknown date, the outcome of the tremor, red rash and sleeplessness were recovered/resolved and the outcome of the chills and discomfort were unknown. It was unknown if the reporter considered the tremor, red rash, sleeplessness, chills and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. About 5 hours after she got the shot her whole body went on alert and she could not sleep. This lasted for about 24 hours. The first night she also had chills and started shaking like she had convulsions for a few seconds until she got under some warm stuff. A week later she got a red mark on her face, about 1 inch long, which had some discomfort underneath. She treated it with NEOSPORIN and it went away after about 1 week. Then she to a round, dark, bright red spot on her right arm that was open and about 1 by 4 inch wide she cleaned it with hydrogen Peroxide and puts NEOSPORIN on it. It was getting better, but still looked like it was open. She wiped it with alcohol and thought it would burn, but it did not. This seems to had dried it up some. The reporter agreed to be contacted for follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tremor in a 73-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 27th August 2018 at Public health department). On 1st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a day after receiving SHINGRIX, the patient experienced tremor, red rash, sleeplessness, chills and discomfort. The patient was treated with bacitracin, neomycin, NEOSPORIN and Alcohol. On an unknown date, the outcome of the tremor, red rash and sleeplessness were recovered/resolved and the outcome of the chills and discomfort were unknown. It was unknown if the reporter considered the tremor, red rash, sleeplessness, chills and discomfort to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. About 5 hours after she got the shot her whole body went on alert and she could not sleep. This lasted for about 24 hours. The first night she also had chills and started shaking like she had convulsions for a few seconds until she got under some warm stuff. A week later she got a red mark on her face, about 1 inch long, which had some discomfort underneath. She treated it with NEOSPORIN and it went away after about 1 week. Then she to a round, dark, bright red spot on her right arm that was open and about 1 by 4 inch wide she cleaned it with hydrogen Peroxide and puts NEOSPORIN on it. It was getting better, but still looked like it was open. She wiped it with alcohol and thought it would burn, but it did not. This seems to had dried it up some. The reporter agreed to be contacted for follow up.