chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort
Clinical narrative: A couple of days after receiving the vaccine, the patient reports having soreness approximately 6 inches from her axilla, down her left arm. She denies any redness or warmth and has not had any fevers. She also reports that she is not palpating any mass, or lumps. She reports that it appears at times that the soreness has resolved and then she will notice it again.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: CONTINUE TO FEEL PAIN AND SORENESS IN ARM ONE MONTH FROM ADMINISTRATION OF FLU SHOT.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash near the neck and arm.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient states vaccine was placed too high in arm causing extreme shoulder pain resulting her seeing a Dr. for treatment.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT STARTED TO HAVE RASH STARTING 11-8-2018, MORE SEVERE RASHES TODAY ON BOTH THIGHS AND ARMS.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Child had a rash on the torso right after the vaccine, resolved in a few minutes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Tenderness
Clinical narrative: Left Shoulder very sore to lay on for about a week. After that I have felt the nerves affected like I did back in 2007 when I had the shingles even after the shingles went away. I still had nerves bothered where I was put on Gabapentin for about 6 months after. That is what I am feeling in my left shoulder only.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature increased, Pain in extremity, Skin warm
Clinical narrative: Severe arm pain, warm to the touch, positive low grade temperature.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: CONTINUES TO FEEL PAIN AND SORENESS IN ARM ONE MONTH FROM ADMINISTRATION OF FLU SHOT.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: Injection site induration
Clinical narrative: (R) thigh with 2 areas of red indurated skin, several cm in largest diameter, non-tender, walking normally.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Contusion, Cough, Dysphonia, Dyspnoea
Clinical narrative: Cough, chest pressure, trouble breathing, bruise, stiff arm and neck, light sensitivity, bloodshot eye, headache, weak voice.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Musculoskeletal stiffness, Ocular hyperaemia, Photophobia
Clinical narrative: Cough, chest pressure, trouble breathing, bruise, stiff arm and neck, light sensitivity, bloodshot eye, headache, weak voice.
Age: 15.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Dizziness, Nausea, Seizure, Syncope
Clinical narrative: During administration of HPV vaccine in (L) deltoid (post receipt of Flu, Hep A) patient experienced nausea, light-headed and vasovagal syncope with a mild 20 second convulsion.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis, Headache, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: ON 11/7/18 PT NOTICED WATERY RIGHT EYE WHICH CONTINUED ALL DAY. IN EVENING GOT BAD HEADACHE. ON 11/8/18 WOKE UP WITH NUMB LIPS, TINGLING ON THE LEFT WITH RIGHT MOUTH NUMB. PT TRIED TO DRINK COFFEE AND IT DRIBBLED. PT WENT TO WORK AS A SUBSTITUTE TEACHER, AS SHE WAS GRADING PAPERS SHE NOTICED INCREASE IN WATERY EYE AND SLURRED SPEECH. IN AFTERNOON A COWORKER TOLD HER THAT HER FACE WAS DROOPY, SHE IMMEDIATELY WENT TO HER DOCTOR WHERE SHE WAS DIAGNOSED WITH BELL'S PALSY. HE PRESCRIBED VALACYCLOVIR AND PREDNISONE. TODAY (11/9/18) PT IS EXPERIENCING THE SAME SYMPTOMS.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Dizziness, Gait disturbance, Syncope
Clinical narrative: Patient received FLUZONE HIGH DOSE on 11/8/2018 in the afternoon. Went home and started stumbling in the middle of the night. Felt the same way when he woke up in the morning. Dizzy, disoriented, syncope.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Abnormal behaviour, Blood thyroid stimulating hormone normal, CSF test normal, Diarrhoea, Feeling abnormal
Clinical narrative: Per father, HE believes that ever since the patient received the HPV vaccine, she has not been herself. He reports that her sleeping pattern changed first and she complained that she was not feeling quite like herself. Two weeks after the vaccine was given she started with vomiting and mild diarrhea. Those symptoms resolved but again at the time he expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. Three days later she started complaining about a sore throat, she was seen at ER and diagnosed with Mononucleosis and Strep Throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed. She had been referred to psychologist in October when she reported not feeling quite like herself, and has continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. While I do not believe the vaccine was the cause of the events that transpired, her dad is extremely concerned that it could have contributed to her symptoms.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Full blood count normal, Helicobacter test negative, Infectious mononucleosis, Mental status changes, Metabolic function test normal
Clinical narrative: Per father, HE believes that ever since the patient received the HPV vaccine, she has not been herself. He reports that her sleeping pattern changed first and she complained that she was not feeling quite like herself. Two weeks after the vaccine was given she started with vomiting and mild diarrhea. Those symptoms resolved but again at the time he expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. Three days later she started complaining about a sore throat, she was seen at ER and diagnosed with Mononucleosis and Strep Throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed. She had been referred to psychologist in October when she reported not feeling quite like herself, and has continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. While I do not believe the vaccine was the cause of the events that transpired, her dad is extremely concerned that it could have contributed to her symptoms.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Mononucleosis heterophile test positive, Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pharyngitis streptococcal, Sleep disorder
Clinical narrative: Per father, HE believes that ever since the patient received the HPV vaccine, she has not been herself. He reports that her sleeping pattern changed first and she complained that she was not feeling quite like herself. Two weeks after the vaccine was given she started with vomiting and mild diarrhea. Those symptoms resolved but again at the time he expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. Three days later she started complaining about a sore throat, she was seen at ER and diagnosed with Mononucleosis and Strep Throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed. She had been referred to psychologist in October when she reported not feeling quite like herself, and has continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. While I do not believe the vaccine was the cause of the events that transpired, her dad is extremely concerned that it could have contributed to her symptoms.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Streptococcus test positive, Ultrasound abdomen normal, Urine analysis normal, Vomiting
Clinical narrative: Per father, HE believes that ever since the patient received the HPV vaccine, she has not been herself. He reports that her sleeping pattern changed first and she complained that she was not feeling quite like herself. Two weeks after the vaccine was given she started with vomiting and mild diarrhea. Those symptoms resolved but again at the time he expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. Three days later she started complaining about a sore throat, she was seen at ER and diagnosed with Mononucleosis and Strep Throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed. She had been referred to psychologist in October when she reported not feeling quite like herself, and has continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. While I do not believe the vaccine was the cause of the events that transpired, her dad is extremely concerned that it could have contributed to her symptoms.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Communication disorder, Decreased appetite, Disturbance in attention, Fatigue, Headache
Clinical narrative: Per father, HE believes that ever since the patient received the HPV vaccine, she has not been herself. He reports that her sleeping pattern changed first and she complained that she was not feeling quite like herself. Two weeks after the vaccine was given she started with vomiting and mild diarrhea. Those symptoms resolved but again at the time he expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. Three days later she started complaining about a sore throat, she was seen at ER and diagnosed with Mononucleosis and Strep Throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed. She had been referred to psychologist in October when she reported not feeling quite like herself, and has continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. While I do not believe the vaccine was the cause of the events that transpired, her dad is extremely concerned that it could have contributed to her symptoms.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Nuclear magnetic resonance imaging brain, Poor quality sleep, Slow response to stimuli, Slow speech, Vomiting
Clinical narrative: Per father, HE believes that ever since the patient received the HPV vaccine, she has not been herself. He reports that her sleeping pattern changed first and she complained that she was not feeling quite like herself. Two weeks after the vaccine was given she started with vomiting and mild diarrhea. Those symptoms resolved but again at the time he expressed his concern that this was due to the vaccine despite discussions of viral illnesses that could be present. Three days later she started complaining about a sore throat, she was seen at ER and diagnosed with Mononucleosis and Strep Throat. Despite treatment for strep throat, her sleep pattern and behavior continued to worsen, so she was seen again in ER. At that time she was admitted for altered mental status for two days, while tests were performed. She had been referred to psychologist in October when she reported not feeling quite like herself, and has continued in counseling. At the hospital, she was referred to a neurologist for continued care as well. While I do not believe the vaccine was the cause of the events that transpired, her dad is extremely concerned that it could have contributed to her symptoms.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Dizziness, Pallor, Vomiting
Clinical narrative: PT BECAME PALE SHORTLY AFTER IMMUNIZATION WAS ADMINISTERED. HE WAS OBSERVED TO BE UNSTABLE ON HIS FEET. PT DID NOT SPEAK THE LANGUAGE AND THERE WAS A INTERPRETER PRESENT AT TIME OF VACCINATION AND AT TIME OF EVENT. INTERPRETER REPEATEDLY ASKED THE PT TO DESCRIBE HIS SYMPTOMS WITH NO RESPONSE. PT'S MOTHER, TOOK HIM OUTSIDE WHERE HE WAS OBSERVED TO VOMIT. PT WAS BROUGHT IMMEDIATELY BACK INTO THE OFFICE WHERE HE WAS PLACED ON THE EXAM TABLE TO LAY DOWN. HE REPORTED FEELING DIZZY BUT HAVING NO OTHER SYMPTOMS. PALENESS WAS STILL NOTED BUT COLOR WAS RETURNING AND PT REPORTED THAT HE WAS BEGINNING TO FEEL BETTER. HE WAS GIVEN SOME WATER AND A SUCKER AND CONTINUED TO IMPROVE. PT WAS ASKED TO STAY ANOTHER 10 MINUTES AND REPORTED TO BE FEELING FINE BEFORE HE WAS ADMITTED TO LEAVE.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin irritation, Vaccination site mass
Clinical narrative: PATIENT ARM WAS RED AND IRRITATED & HAD A SMALL LUMP AROUND THE VACCINE AREA.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Musculoskeletal pain, Myalgia, Pain, Peripheral swelling
Clinical narrative: Onset yesterday after receiving influenza vaccination. Related symptoms: Complaining of muscle pain, left shoulder pain and mild swelling. Complaints of difficulty lifting/moving the arm without pain. Patient is able to move the arm but is painful. Exam revealed muscle spasm to the left arm left deltoid. No acute deformities, erythema, swelling or discharge. The affected area is not warm to touch. Patient is able to move for range of motion but expresses pain with certain movements. Will treat conservatively. Recommend over-the-counter Tylenol take as directed, consider using Tizanidine for muscle spasm that as previously prescribed, alternate with ice and heat.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Defaecation urgency, Hyperhidrosis, Nausea
Clinical narrative: Vagal nerve response-racing heart, cold clammy skin, shivering, profuse sweating, almost simultaneous bowel movement and vomiting, nausea.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations, Presyncope, Vomiting
Clinical narrative: Vagal nerve response-racing heart, cold clammy skin, shivering, profuse sweating, almost simultaneous bowel movement and vomiting, nausea.
Age: 31.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Injection site erythema, Myalgia, Night sweats
Clinical narrative: Left arm with 5 cm x 4 cm redness and erythema at injection site of PCV23 site (left deltoid). Experiencing chills, night sweats, myalgias in legs, headache.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: After approximately one hour following the immunization in the right deltoid he experienced dull constant aching sensation in the posterior shoulder behind the right shoulder joint line. Pain is worse with lifting or pulling. Rates pain at rest 1/10 and 6/10 with movement. Denies shortness of breath, rash, dyspnea, dizziness, or numbness or tingling in right lower arm or fingers. Recommend ice, and Ibuprofen 600mg with food every 6 hours as needed. Seek medical attention if condition worsens.
Age: 25.0
Sex: F
Vaccine: HIBV
Symptoms: Asthenia, Nausea
Clinical narrative: Nausea, weakness.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient called over a month after immunization complaining with arm pain.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain and product supply issue. On an unknown date, the outcome of the pain and product supply issue were unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a lot of pain and really need to start the treatment with HUMIRA, but there was a shortage of vaccines in her area. The reporter stated that, she need to get the second dose of the vaccine to be able to start her treatment with HUMIRA. As per representative there had been an extraordinary amount of demand from patients and healthcare professionals, as the SHINGRIX got the approval. As per representative, the healthcare provider or local pharmacy was temporarily out of stock, to address the current high demand, GSK had significantly increased deliveries and accelerated shipments of doses of vaccine for this year, and SHINGRIX was expected to be available throughout 2018 and shipped on a regular basis. The reporter's practitioner did not know when he would arrange it. Reporter also check with pharmacy and they would arrange it in March.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: C-reactive protein, Echocardiogram abnormal, Pericarditis, Red blood cell sedimentation rate, Troponin
Clinical narrative: Pericarditis within 20-30 min of receiving flu vaccine. Vaccine given and pat was near hospital when Sx started. He went to ED. Echo confirmed Dx.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Incomplete course of vaccination, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Shingrix for prophylaxis. The patient's past medical history included atrial fibrillation (recent cardioversion). In September 2018, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced fever, nausea, chills and nonspecific reaction. Shingrix was discontinued. On an unknown date, the outcome of the fever, nausea, chills and nonspecific reaction were unknown. It was unknown if the reporter considered the fever, nausea, chills and nonspecific reaction to be related to Shingrix. Additional details were reported as follows: This case was previously reported to the physician. The patient who received a dose of Shingrix experienced severe reaction the next day of fever, chills, shivering and nausea. The patient would not going received 2nd dose of Shingrix vaccine due to this reaction. The patient had denied permission to contact their physician. This case was linked with case US2018192638, reported by the same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Dry mouth, Fatigue, Presyncope
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vasovagal reaction in a 61-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 23rd October 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint. On an unknown date, the outcome of the vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint were unknown. It was unknown if the reporter considered the vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the day of reporting and she sat down and began to feel tired, disoriented and felt like passing out. The patient put her head down and her throat felt tight. The office called a paramedic. The patient was evaluated and it was determined that she was not having an anaphylactic response, but might have had a vasovagal response. The patient was not taken to the hospital.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vasovagal reaction in a 61-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 23rd October 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd October 2018, less than a day after receiving SHINGRIX, the patient experienced vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint. On an unknown date, the outcome of the vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint were unknown. It was unknown if the reporter considered the vasovagal reaction, tiredness, dry mouth, throat tightness, disorientation and felt faint to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the day of reporting and she sat down and began to feel tired, disoriented and felt like passing out. The patient put her head down and her throat felt tight. The office called a paramedic. The patient was evaluated and it was determined that she was not having an anaphylactic response, but might have had a vasovagal response. The patient was not taken to the hospital.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 82-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb and erythema to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional was unable to provide with the batch number and expiry date at the time of reporting. The patient experienced redness and swelling from the shoulder to hand after vaccination with the first dose of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received Shingrix for prophylaxis. On 20th June 2018, the patient received the 1st dose of Shingrix. In June 2018, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were received as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced fever of 102 to 103 degree F for 2 to 3 days. On 23rd June 2018, the healthcare professional stated that the information was reported to GlaxoSmithKline and VAERS.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included fibromyalgia, sjogren's disease, hypothyroidism and white blood cell count low. Previously administered products included Shingrix with an associated reaction of pyrexia (all other events experienced after dose 1 received on 3rd August 2018, refer case US2018188648) and Zostavax. On 10th October 2018, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 10th October 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, feeling cold, fever, pain in arm, fatigue, night sweat, sweating, feeling unwell and injected limb mobility decreased. In October 2018, the patient experienced neck pain and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, neck pain, headache, feeling cold, fatigue, night sweat, sweating and feeling unwell were not recovered/not resolved and the outcome of the fever, pain in arm and injected limb mobility decreased were recovering/resolving. The reporter considered the influenza-like symptoms, neck pain, headache, feeling cold, fever, pain in arm, fatigue, night sweat, sweating, feeling unwell and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The patient had fibromyalgia, Sjogren's disease, and hypothyroidism, low white blood cell count and weakened immune system (all conditions prior to receiving Shingrix vaccine). Later that day of vaccination the patient suddenly started feeling sick with flu like symptoms. She had a fever of 101 F that night, and the next day, 11th October 2018, her fever was 103 F. She started having night sweats that would soak the bed, but would also feel like she was freezing. The sweating was now happening during the day as well. Her arm was very sore after the injection and she had a hard time moving it. The soreness was getting better at the reporting time, but she had pain in her neck that shoots up to her head that she had never had before. 1 to 2 days after receiving Shingrix, the patient experienced headaches. The patient felt a sharp pain in her head and when she turns her head she hears a crackling sound. The fever comes and goes, but at the reporting time, it was about 100 F when it occurred. She saw her doctor on 15th October 2018 about her symptoms and the doctor thought they are related to Shingrix. Her Complete Blood Count (CBC) came back normal. The patient was still feeling sick and fatigued. The patient stated that she was scheduled to have an MRI the upcoming Friday from the date of reporting. The contact details of physician were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injected limb mobility decreased, Malaise, Neck pain, Night sweats
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included fibromyalgia, sjogren's disease, hypothyroidism and white blood cell count low. Previously administered products included Shingrix with an associated reaction of pyrexia (all other events experienced after dose 1 received on 3rd August 2018, refer case US2018188648) and Zostavax. On 10th October 2018, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 10th October 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, feeling cold, fever, pain in arm, fatigue, night sweat, sweating, feeling unwell and injected limb mobility decreased. In October 2018, the patient experienced neck pain and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, neck pain, headache, feeling cold, fatigue, night sweat, sweating and feeling unwell were not recovered/not resolved and the outcome of the fever, pain in arm and injected limb mobility decreased were recovering/resolving. The reporter considered the influenza-like symptoms, neck pain, headache, feeling cold, fever, pain in arm, fatigue, night sweat, sweating, feeling unwell and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The patient had fibromyalgia, Sjogren's disease, and hypothyroidism, low white blood cell count and weakened immune system (all conditions prior to receiving Shingrix vaccine). Later that day of vaccination the patient suddenly started feeling sick with flu like symptoms. She had a fever of 101 F that night, and the next day, 11th October 2018, her fever was 103 F. She started having night sweats that would soak the bed, but would also feel like she was freezing. The sweating was now happening during the day as well. Her arm was very sore after the injection and she had a hard time moving it. The soreness was getting better at the reporting time, but she had pain in her neck that shoots up to her head that she had never had before. 1 to 2 days after receiving Shingrix, the patient experienced headaches. The patient felt a sharp pain in her head and when she turns her head she hears a crackling sound. The fever comes and goes, but at the reporting time, it was about 100 F when it occurred. She saw her doctor on 15th October 2018 about her symptoms and the doctor thought they are related to Shingrix. Her Complete Blood Count (CBC) came back normal. The patient was still feeling sick and fatigued. The patient stated that she was scheduled to have an MRI the upcoming Friday from the date of reporting. The contact details of physician were provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included fibromyalgia, sjogren's disease, hypothyroidism and white blood cell count low. Previously administered products included Shingrix with an associated reaction of pyrexia (all other events experienced after dose 1 received on 3rd August 2018, refer case US2018188648) and Zostavax. On 10th October 2018, the patient received the 2nd dose of Shingrix (intramuscular) 50 ug. On 10th October 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, feeling cold, fever, pain in arm, fatigue, night sweat, sweating, feeling unwell and injected limb mobility decreased. In October 2018, the patient experienced neck pain and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, neck pain, headache, feeling cold, fatigue, night sweat, sweating and feeling unwell were not recovered/not resolved and the outcome of the fever, pain in arm and injected limb mobility decreased were recovering/resolving. The reporter considered the influenza-like symptoms, neck pain, headache, feeling cold, fever, pain in arm, fatigue, night sweat, sweating, feeling unwell and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The patient had fibromyalgia, Sjogren's disease, and hypothyroidism, low white blood cell count and weakened immune system (all conditions prior to receiving Shingrix vaccine). Later that day of vaccination the patient suddenly started feeling sick with flu like symptoms. She had a fever of 101 F that night, and the next day, 11th October 2018, her fever was 103 F. She started having night sweats that would soak the bed, but would also feel like she was freezing. The sweating was now happening during the day as well. Her arm was very sore after the injection and she had a hard time moving it. The soreness was getting better at the reporting time, but she had pain in her neck that shoots up to her head that she had never had before. 1 to 2 days after receiving Shingrix, the patient experienced headaches. The patient felt a sharp pain in her head and when she turns her head she hears a crackling sound. The fever comes and goes, but at the reporting time, it was about 100 F when it occurred. She saw her doctor on 15th October 2018 about her symptoms and the doctor thought they are related to Shingrix. Her Complete Blood Count (CBC) came back normal. The patient was still feeling sick and fatigued. The patient stated that she was scheduled to have an MRI the upcoming Friday from the date of reporting. The contact details of physician were provided.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Somnolence
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of sleepiness in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sleepiness and malaise. On an unknown date, the outcome of the sleepiness and malaise were unknown. It was unknown if the reporter considered the sleepiness and malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient was in his 70s. The patient experienced sleepiness and malaise for 24 hours. This case has been linked to the case US2018GSK198461, reported by same reporter. The reporter agreed to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain and sleep disturbance. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the pain and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported however; the patient was in her 70s. The patient experienced pain for 3 days and interrupted her sleep. This case has been linked to the case US2018GSK198403, reported by same reporter. The reporter agreed to be contacted for follow up.
Sex: M
Vaccine: TDAP
Symptoms: Pertussis
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a male patient who received dTpa vaccine for prophylaxis. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 183 days after receiving dTpa vaccine, the patient experienced whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown. It was unknown if the reporter considered the whooping cough to be related to dTpa vaccine. Additional details were received as follows: As per reporter the number of cases was definitely dropped over the past few years. The reporter said, he was one of the lucky few to get it even with being vaccinated 6 months ago. The patient's wife had asthma and lung disease. Another social media person stated that, he or she also get whooping cough before his or her grandchildren born. But he or she did not regret. The patient stated that, in see no connection it was 7 months later, the patient received dtap before his or her grandchild born. The patient's wife would have gotten the whooping cough if she had not got the dtap vaccine. She never had the single symptoms. The patient decided to get a vaccine dose again if required.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included immunosuppression. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 days after receiving SHINGRIX, the patient experienced fatigue and influenza-like symptoms. On an unknown date, the outcome of the fatigue and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the fatigue and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX about 3 months before the time of reporting, she experienced fatigue and flu like symptoms not specified. The specific dates of injection was not known. Onset of symptoms were about 5 days. The patient received 2nd dose a month before the time of reporting. The time interval from dose 1 injection to dose 2 injection was 2 months. For tolerance after 2nd dose refer case US2018201060. The patient given consent to follow up with her physician and provided address details for the same.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 70-year-old male patient who received SHINGRIX (batch number B57NG, expiry date 16th April 2021) for prophylaxis. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th October 2018, 3 days after receiving SHINGRIX, the patient experienced generalized rash. On 27th October 2018, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in left deltoid. The patient was developed with a rash over his entire body which was discovered on Friday. The reporter reported that the rash was almost fully resolved on Saturday. The reporter was unable to obtain additional information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 24th October 2018, the patient received the 1st dose of SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site muscle pain. On 29th October 2018, the patient experienced injection site warmth, injection site itching, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved and the outcome of the injection site warmth, injection site itching, injection site erythema and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site muscle pain, injection site warmth, injection site itching, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of her patients experienced muscle soreness and pain at injection site on an unknown date. However, the side effects went away after 3 days. Five days after receiving SHINGRIX (a day before reporting, at night), the patient started to get new symptoms at the injection site such as, hot to the touch, itching, redness and swelling. She did not had fever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of erythema in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 13th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, swelling arm, chills, headache and nausea. On an unknown date, the outcome of the erythema, swelling arm, chills, headache and nausea were unknown. It was unknown if the reporter considered the erythema, swelling arm, chills, headache and nausea to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional was the patient and physician. Safety could follow up with the healthcare professional. The patient stated that she experienced adverse events with SHINGRIX. There was consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received SHINGRIX at an unknown dose and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and shingles. (Dechallenge was negative). Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The patient had a history of shingles and had experienced a flair up of shingles after the first dose and the 2nd dose. The reporter did not consent to follow-up. The healthcare professional had not provided any adverse event information and did not wanted to be contacted regarding the adverse event. This case was considered for suspected vaccination failure as the exact time to onset for the event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Dystonia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dystonia in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included seizure. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced dystonia. On an unknown date, the outcome of the dystonia was unknown. It was unknown if the reporter considered the dystonia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and had dystonia at the time of reporting. This report was filed after the call. Adverse event was discovered during call review and limited information was available for this report.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient called and spoke with pharmacist. She reported that her arm was red and swollen, and hot to the touch a few days later. Although, this could be a typical adverse event, as discussed, patient stated that she went to her physician. Patient's physician stated it could be cellulitis, and they discussed a possible antibiotic. That prescription was not called to us, and patient did not call back after this conversation. Patient perceived error, due to the redness/swelling.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Pt. reports that he developed R shoulder pain about 4 days after receiving flu shot on 8/24/18. He first had the typical muscle pain around injection site that went away in a couple of days, then the R shoulder joint started hurting severely. He c/o stiffness, limited ROM due to pain and stiffness. Most of all it bothers him when he sits still or tries to sleep, it just throbs. He has not previously had any problems with the R shoulder. The pain and discomfort have not improved in the 10 weeks since it started. He has taken ibuprofen but it did not help. Heat, ice, voltaren gel were also ineffective. Pt. was now referred to orthopedics for steroid injection to the R shoulder joint, and to physical therapy.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Nerve injury
Clinical narrative: Employee reports prolonged left deltoid muscle pain since receiving the flu vaccination on 10/29/18. She is having difficulty with angular movements (circumduction) of her LUE due to muscle pain. Employee denies any radiating paresthesias down the LUE but does have descending aching pain down through the elbow and forearm. No other symptoms reported. Employee has taken both Ibuprofen and TYLENOL with little effect. PCP evaluated employee's left upper extremity on 11/08/18, employee reports provider feels it is residual nerve irritation s/p vaccination and will take time to go away. Provider advised employee to continue use of ice to the injection site as well as Ibuprofen for pain management. She continues to work full duty since evaluation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Intercepted product prescribing error
Clinical narrative: TDaP was ordered in error. DTaP was given to patient.
Age: 56.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Cold sweat, Hypersensitivity, Hypertension
Clinical narrative: COLD SWEAT, HIGH BLOOD PRESSURE. HE CONSULTED WITH HIS PRIMARY MD AND SHE TOLD HIM THAT IT WAS PROB HYPERSENSITIVITY TO THE VACCINES. HE GETS FLU VACCINES YEARLY AND HAS HAD NO ADVERSE EFFECTS FROM IT. HE BELIEVES IT WAS DUE TO THE FLU VACCINE. MD TOLD HIM SYMPTOMS MAY LAST A FEW DAYS AND HE SHOULD FOLLOW UP WITH HE.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: PATIENT HAD LARGE RED, INFLAMED, WARM TO TOUCH AREA ABOUT 3 INCHES BELOW INJECTION SITE. IT STARTED AFTER RECEIVING INJECTION. SHE WILL USE ICE ON THE AREA, AND POSSIBLY BENADRYL. SHE WILL NOTIFY HER PRIMARY PROVIDER OF ADVERSE REACTION AS WELL.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient states that the morning after the shot site became red and painful. Upon visiting our pharmacy on 11-9-18, she showed me the area and it looked reddish, she says it was warm and painful. I advised her to place cool towels on the area, to take BENADRYL and to inform her physician doctor.
Age: 41.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event
Clinical narrative: No adverse sign of symptom noted or reported.
Age: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Irritability, Vomiting
Clinical narrative: Pain at injection site and irritability in the hours following vaccination; the following morning, several instances of vomiting.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Injection site paraesthesia, Insomnia, Myalgia, Pain
Clinical narrative: Patient called on 9/24, shot was given on 8/15. He stated the next week after the vaccine he had sensitivity to the skin and body/muscle pain. 8/26- he went to med express, and they thought he was having a reaction and told him to do MOTRIN for pain, and ALLEGRA for the allergic reaction he then stated he couldn't sleep for 4-5 days -he spoke with his family doctor and Dr. did not feel this was a reaction associated with the vaccine. On 9/24- he called to report for our records, and said the severe pain had gone away, but still has tingling at the injection site.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling  and redness at injection site, measured 40x30 mm.