chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Patient is experiencing fever, swelling, chills, irritation/redness, lots of soreness.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema, Rash pruritic
Clinical narrative: Came into the pharmacy on 9/16/18 stating that she has a rash that is not elevated below her breasts and lower abdomen. It itches and there is nothing oozing from the rash. She also stated that she has eczema. I ask referred her to her current dermatologist since she fills no prescriptions at our pharmacy and wasn't sure if perhaps there was a flare up with eczema. I also recommended Calamine lotion.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever and general malaise.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: RIGHT ARM CELLULITIS FROM INJECTION SITE TO BELOW ELBOW. INTERESTING WHEN MY HUSBAND PICKED UP MY PRESRIPTION I WAS THE 3RD PATIENT SHE HAD HEARD OF WITH THESE SYSTEMS.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Extremity contracture, Neuralgic amyotrophy
Clinical narrative: Patient reported on 09/04/2018 that she had been diagnosed by Dr as suffering from Parsonage Turner Syndrome- which the dr postulated may have been triggered by the vaccine. Patient was vaccinated in left arm, disease presented itself in right hand. Two of her fingers on the right hand are bent toward the palm to a moderately severe degree.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Hyperhidrosis, Loss of consciousness, Pallor, Posture abnormal
Clinical narrative: Approximately 2 minutes after vaccine was administered patient very suddenly became drenched in sweat, appeared very pale, experienced loss of vision, and lost consciousness briefly. Before losing consciousness patient was able to sit down before slumping to the side. Patient's mother and father were able to ensure patient did not fall and alerted pharmacist that administered vaccine. The pharmacist checked patient's vitals at which time consciousness returned and instructed patient to bend down to put her head between her knees. Also provided patient with sips of a cool drink during recovery period. Patient remained seated in pharmacy for 20 minutes after episode resolved before leaving for home with her parents after this information was collected and recorded.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Swelling and hard lump formed under the injection site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: Patient said she felt like she developed the flu from the flu shot, she had fever, chills, aches, fatigue. I told her it is not a live vaccine so you don't develop the flu from the shot, but she wanted me to report it. She is feeling a bit better 4 days after the shot, just a bit tired.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Pt started experiencing right arm soreness that was worse than normal. Pain is all around shoulder and back. Injection site is swollen.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Fever, shivering, exhaustion, extreme pain at injection site. This lasted for about three days.
Age: 29.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Asthenia, Cough, Dyspnoea, Heart rate increased, Wheezing
Clinical narrative: Difficulty breathing, fast heart rate, weakness, wheezing, sudden onset of frequent coughing... these symptoms lasted in their full severity for 30 mins. After 30 mins they began to lessen, until ~ 1 hour after the onset of symptoms the patient felt safe to lay down and try to go to sleep. The following morning (~ 13 hours after shot had been administered).
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain
Clinical narrative: 24 hours post vaccination, patient reports pain and redness at injection site with a radiating of redness to axilla.
Age: 88.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: High fever 104 degrees, swollen red arm.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Erythema, Injection site reaction, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: Arm is extremely red and swollen, patient stated feeling sick with fever like symptoms... redness and swelling are very hot and area is growing over entire top half of arm.... we referred her to a doctor for symptomatic management.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Skin warm
Clinical narrative: Arm is extremely red and swollen, patient stated feeling sick with fever like symptoms... redness and swelling are very hot and area is growing over entire top half of arm.... we referred her to a doctor for symptomatic management.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain, Injection site warmth, Pain
Clinical narrative: Adverse event is with the RIGHT arm (the PNEUMOVAX arm). Patient describes an intense soreness and is having trouble lifting his right arm due to the pain. About 2 inches below the injection site, it feels warm to the touch and appears inflamed. The pain radiates to the triceps, rather than just the deltoid muscle. Left arm is unaffected.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Adverse event is with the RIGHT arm (the PNEUMOVAX arm). Patient describes an intense soreness and is having trouble lifting his right arm due to the pain. About 2 inches below the injection site, it feels warm to the touch and appears inflamed. The pain radiates to the triceps, rather than just the deltoid muscle. Left arm is unaffected.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: Felt like I was smacked in the arm for an entire day. Not really any pain immediately after injection, wasn't noticeable for two days. All the sudden I woke up and if felt like somebody punched me in the shoulder, despite no bruises and no physical injuries.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: The patient let us know that when she had the vaccine in July, she experienced redness at the injection site starting about a week after the vaccine and it has lasted 6 weeks. The redness is in the central deltoid area where she had the shot, and she has not experienced any pain. She saw her physician who examined the area, and he prescribed Hydrocortisone cream.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: 2 days after injection patient reported round circular rash around injection site, red, slightly warm, more than 1 inch. Pt advised to follow up with doctor.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Red rash at injection site- Round circular rash- 2 inches in diameter. Slightly warm- noticed rash Not until 6 hours after shot given. Advised patient to follow up with dr ASAP- walk in clinic.
Age: 69.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in the Right arm that extended to the elbow. The area was warm to the touch. She took OTC NSAID (Ibuprofen). The swelling did get worse so she went to the ER. The ER told her she had cellulitis and prescribed an antibiotic.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphonia, Throat tightness
Clinical narrative: The patient had no observable reactions when I administered the immunization, and reported no previous reactions. Later that evening, she experienced tightness in her throat, and hoarseness. She said she was worried about her breathing, and made her husband watch her that evening. The patient returned to the pharmacy on 9/16/18 in the afternoon to report the reaction. She said that she didn't believe we had done anything wrong, she just wanted to let us know. I gave the patient some liquid diphenhydramine at no charge, and explained that at the first sign of these symptoms returning, that she should take the diphenhydramine, and go to the hospital. I asked her to let us know if she had any further complications.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: The patient came in with his wife 2 days after receiving the immunization. He had some noticeable swelling in his arm where the shots had been administered, and he said that the swelling was going down. His wife had a mild allergic reaction to one of her immunizations, and he was only reporting his, because she was reporting hers. They both said they didn't believe that we had done anything incorrectly. I gave the patient an ice pack at no charge, and asked him to let us and his doctor know if the swelling started getting worse again, or if he had any other adverse reactions.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain
Clinical narrative: Patient complained of body aches, chills, and nausea occuring a few days after the vaccine was administered.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Feeling hot, Immediate post-injection reaction, Injected limb mobility decreased, Paralysis
Clinical narrative: 8/2/18: 8:45 PM (time of administration) reports arm immediately felt like it was "on fire" and whole arm ached like it had been punched. Pt reported it felt like poison was injected into her arm. Went home after. 8/3/18: 1:30 AM Pt woke up in bed feeling extremely hot and feverish (did not use thermometer for temperature reading), complained that left side of head, neck, and shoulder felt paralyzed and unable to move. Pt stated she shifted in bed, but did not get out of bed. 8/4/18: 10 AM Began taking ibuprofen 400 mg and diphenhydramine 25 mg PO every 6 hours, "per package instructions" following advice from a friend who had previously worked at FDA and stated she should use this after immunization. Also began pushing fluid intake. 8/4/18: noon saw chiropractor, who reported she physically "felt hot" head to toe, later in the day her massage therapist would not work on her due to her physical temperature. 24-48 hours following the vaccine, pt reports she started to feel more normal, but continued to feel hot despite the scheduled ibuprofen dosing.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 8/2/18: 8:45 PM (time of administration) reports arm immediately felt like it was "on fire" and whole arm ached like it had been punched. Pt reported it felt like poison was injected into her arm. Went home after. 8/3/18: 1:30 AM Pt woke up in bed feeling extremely hot and feverish (did not use thermometer for temperature reading), complained that left side of head, neck, and shoulder felt paralyzed and unable to move. Pt stated she shifted in bed, but did not get out of bed. 8/4/18: 10 AM Began taking ibuprofen 400 mg and diphenhydramine 25 mg PO every 6 hours, "per package instructions" following advice from a friend who had previously worked at FDA and stated she should use this after immunization. Also began pushing fluid intake. 8/4/18: noon saw chiropractor, who reported she physically "felt hot" head to toe, later in the day her massage therapist would not work on her due to her physical temperature. 24-48 hours following the vaccine, pt reports she started to feel more normal, but continued to feel hot despite the scheduled ibuprofen dosing.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Lumbar puncture normal, Paraesthesia
Clinical narrative: Developed tingling/paresthesias in feet progressing up legs.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Headache, Nausea, Pain in extremity
Clinical narrative: Chills, very sore arm, nausea, headache, sore eyes.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Presents for evaluation of swelling in the right arm following administration of a PNEUMOVAX Vaccine two days ago. Of note he also received the SHINGRIX vaccine on 9/14 in the left deltoid however he has no reactions in that arm. After the vaccine on Friday night he reported some joint aching and frequent urination, then those symptoms resolved by the next day. Then on Saturday he developed swelling without redness in the left deltoid area where he received his PNEUMOVAX vaccine. Then this morning he developed redness, warmth and swelling in the deltoid and down the arm toward the elbow. He also reports some swelling developing in the forearm. No warmth or tenderness at time of exam. No erythema or warmth at the left deltoid or right deltoid but erythema present on the medial aspect of the right upper arm and down to the elbow with some swelling, no pitting. Also erythema at the site of the SHINGRIX vaccine in a small dependent semicircle at the base of the left deltoid.
Age: 70.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Pollakiuria
Clinical narrative: Presents for evaluation of swelling in the right arm following administration of a PNEUMOVAX Vaccine two days ago. Of note he also received the SHINGRIX vaccine on 9/14 in the left deltoid however he has no reactions in that arm. After the vaccine on Friday night he reported some joint aching and frequent urination, then those symptoms resolved by the next day. Then on Saturday he developed swelling without redness in the left deltoid area where he received his PNEUMOVAX vaccine. Then this morning he developed redness, warmth and swelling in the deltoid and down the arm toward the elbow. He also reports some swelling developing in the forearm. No warmth or tenderness at time of exam. No erythema or warmth at the left deltoid or right deltoid but erythema present on the medial aspect of the right upper arm and down to the elbow with some swelling, no pitting. Also erythema at the site of the SHINGRIX vaccine in a small dependent semicircle at the base of the left deltoid.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site warmth, Muscular weakness
Clinical narrative: Pain, heat and redness at site. Muscle weakness. Woozy feeling. Low grade fever. Rash.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Pain, heat and redness at site. Muscle weakness. Woozy feeling. Low grade fever. Rash.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cognitive disorder, Dizziness, Fatigue, Injection site erythema, Injection site inflammation
Clinical narrative: Patient experienced redness and inflammation at injection site. Patient also reported limited mobility, and overall feeling of fatigue, dizziness, as well as difficulty maintaining focus the day after having received the vaccine. Patient was seen by physician and instructed to inform us as the immunizing facility to report adverse reaction appropriately. Patient still instructed by MD to receive second dose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: Patient experienced redness and inflammation at injection site. Patient also reported limited mobility, and overall feeling of fatigue, dizziness, as well as difficulty maintaining focus the day after having received the vaccine. Patient was seen by physician and instructed to inform us as the immunizing facility to report adverse reaction appropriately. Patient still instructed by MD to receive second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Burning at site. Pain x 2 weeks. Achy. Fever.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Eye movement disorder, Flushing, Haemorrhage, Hyperhidrosis, Malaise
Clinical narrative: After administering needed cotton ball for blood drop - after patient looked at blood said didn't feel well. Called in his wife. His head went back, eyes rolled back, started snoring loudly, didn't respond to yelling to him - sir, can you hear me. Patient came to, was very flushed, sweated slightly. We had called EMT - they arrived. He said felt better. He said believed just anxiety. Apparently had had similar episode to MMR as adult he did not report to us even after pharmacist questioned checking yes to fainting question he reported only as child not as adult, allergen and msc.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Posture abnormal, Snoring, Unresponsive to stimuli
Clinical narrative: After administering needed cotton ball for blood drop - after patient looked at blood said didn't feel well. Called in his wife. His head went back, eyes rolled back, started snoring loudly, didn't respond to yelling to him - sir, can you hear me. Patient came to, was very flushed, sweated slightly. We had called EMT - they arrived. He said felt better. He said believed just anxiety. Apparently had had similar episode to MMR as adult he did not report to us even after pharmacist questioned checking yes to fainting question he reported only as child not as adult, allergen and msc.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Pruritus, Rash, Urticaria
Clinical narrative: Patient experience rash on left arm of small, raised, itchy whelps between wrist and shoulder. Whelp near elbow is somewhat blistered. Recommended hydrocortisone 1% cream OTC for treatment and that patient contact primary doctor.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash over bicep and upper arm.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neuropathy peripheral in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hepatitis c (previously diagnosed) and neuropathy (in 2015). Previously administered products included Unspecified medication with an associated reaction of paraesthesia (in 2015, three years ago, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved) and SHINGRIX with an associated reaction of influenza like illness (in April 2018, received 1st dose refer case US2018GSK167250). Concurrent medical conditions included drug hypersensitivity (according to her rheumatologist). On 20th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced neuropathy peripheral (serious criteria GSK medically significant). On an unknown date, the patient experienced tiredness. On an unknown date, the outcome of the neuropathy peripheral was not recovered/not resolved and the outcome of the tiredness was unknown. It was unknown if the reporter considered the neuropathy peripheral and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination could be 65 or 66 years. The patient had 3 glucose tests in the past 3 years that came back in the normal range.  Three years before the reporting date, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved. After receiving 2nd dose, within 3-4 days she started to get peripheral neuropathy in her legs and hands and she still had it at the reporting time and it was awful. Less than a year after receiving SHINGRIX, the patient was very tired. The patient claimed that she was very thin and active. The patient refused to answer any questions regarding her experience. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Neuropathy peripheral
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neuropathy peripheral in a 66-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hepatitis c (previously diagnosed) and neuropathy (in 2015). Previously administered products included Unspecified medication with an associated reaction of paraesthesia (in 2015, three years ago, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved) and SHINGRIX with an associated reaction of influenza like illness (in April 2018, received 1st dose refer case US2018GSK167250). Concurrent medical conditions included drug hypersensitivity (according to her rheumatologist). On 20th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced neuropathy peripheral (serious criteria GSK medically significant). On an unknown date, the patient experienced tiredness. On an unknown date, the outcome of the neuropathy peripheral was not recovered/not resolved and the outcome of the tiredness was unknown. It was unknown if the reporter considered the neuropathy peripheral and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. The age at vaccination could be 65 or 66 years. The patient had 3 glucose tests in the past 3 years that came back in the normal range.  Three years before the reporting date, she was diagnosed with neuropathy from a neurologist within eight hours after receiving another medication and she experienced needles and pins but the side effects resolved. After receiving 2nd dose, within 3-4 days she started to get peripheral neuropathy in her legs and hands and she still had it at the reporting time and it was awful. Less than a year after receiving SHINGRIX, the patient was very tired. The patient claimed that she was very thin and active. The patient refused to answer any questions regarding her experience. The patient had denied permission to contact their physician.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anti-thyroid antibody, Antinuclear antibody, Blood thyroid stimulating hormone, Body temperature increased, C-reactive protein
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives (serious criteria hospitalization). On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported but could be 67 or 68 years old. The patient could not say if the SHINGRIX vaccine was administered intramuscular but it was given in the upper part of arm. The patient developed hives a couple of days after having the vaccination.  The patient had been to various specialists which got better for awhile but at the time of reporting was reappearing.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Fatigue, Full blood count, Induration, Injection site erythema, Injection site oedema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives (serious criteria hospitalization). On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported but could be 67 or 68 years old. The patient could not say if the SHINGRIX vaccine was administered intramuscular but it was given in the upper part of arm. The patient developed hives a couple of days after having the vaccination.  The patient had been to various specialists which got better for awhile but at the time of reporting was reappearing.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site pain, Injection site warmth, Laboratory test, Lip swelling, Metabolic function test
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives (serious criteria hospitalization). On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported but could be 67 or 68 years old. The patient could not say if the SHINGRIX vaccine was administered intramuscular but it was given in the upper part of arm. The patient developed hives a couple of days after having the vaccination.  The patient had been to various specialists which got better for awhile but at the time of reporting was reappearing.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Myalgia, Rash, Rash erythematous, Rash pruritic, Red blood cell sedimentation rate
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives (serious criteria hospitalization). On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported but could be 67 or 68 years old. The patient could not say if the SHINGRIX vaccine was administered intramuscular but it was given in the upper part of arm. The patient developed hives a couple of days after having the vaccination.  The patient had been to various specialists which got better for awhile but at the time of reporting was reappearing.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Skin warm, Swelling face, Thyroxine, Ultrasound scan, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives (serious criteria hospitalization). On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported but could be 67 or 68 years old. The patient could not say if the SHINGRIX vaccine was administered intramuscular but it was given in the upper part of arm. The patient developed hives a couple of days after having the vaccination.  The patient had been to various specialists which got better for awhile but at the time of reporting was reappearing.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urticaria chronic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives (serious criteria hospitalization). On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported but could be 67 or 68 years old. The patient could not say if the SHINGRIX vaccine was administered intramuscular but it was given in the upper part of arm. The patient developed hives a couple of days after having the vaccination.  The patient had been to various specialists which got better for awhile but at the time of reporting was reappearing.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced hives (serious criteria hospitalization). On an unknown date, the outcome of the hives was not recovered/not resolved. The reporter considered the hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported but could be 67 or 68 years old. The patient could not say if the SHINGRIX vaccine was administered intramuscular but it was given in the upper part of arm. The patient developed hives a couple of days after having the vaccination.  The patient had been to various specialists which got better for awhile but at the time of reporting was reappearing.
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 from a claims administrator for a pharmacy and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 02-SEP-2018, the patient was vaccinated with PNEUMOVAX 23, lot # N030111 at a pharmacy (dose and route not provided). A few hours later, the patient called the pharmacy to inform them that she had a rash on her arm near the vaccination site, was feeling hot, and had an itchy throat. She sought medical attention (not further specified) for a possible allergic reaction to the vaccine. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Throat irritation
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 from a claims administrator for a pharmacy and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 02-SEP-2018, the patient was vaccinated with PNEUMOVAX 23, lot # N030111 at a pharmacy (dose and route not provided). A few hours later, the patient called the pharmacy to inform them that she had a rash on her arm near the vaccination site, was feeling hot, and had an itchy throat. She sought medical attention (not further specified) for a possible allergic reaction to the vaccine. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling hot, Throat irritation, Vaccination site rash
Clinical narrative: This initial spontaneous report was received on 11-SEP-2018 from a claims administrator for a pharmacy and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 02-SEP-2018, the patient was vaccinated with PNEUMOVAX 23, lot # N030111 at a pharmacy (dose and route not provided). A few hours later, the patient called the pharmacy to inform them that she had a rash on her arm near the vaccination site, was feeling hot, and had an itchy throat. She sought medical attention (not further specified) for a possible allergic reaction to the vaccine. The outcome of the event was unknown. Causality assessment was related. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, Computerised tomogram head, Culture urine, Electroencephalogram, Full blood count
Clinical narrative: Generalized tonic clonic seizure the following morning at 3am requiring admission to the hospital. This was the first seizure of the patient's life. He would go on to have a second seizure at his next round of shots (which I have reported), and a third unprovoked seizure in 9/2018.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Generalised tonic-clonic seizure, Lumbar puncture, Metabolic function test, Nuclear magnetic resonance imaging brain, Urine analysis
Clinical narrative: Generalized tonic clonic seizure the following morning at 3am requiring admission to the hospital. This was the first seizure of the patient's life. He would go on to have a second seizure at his next round of shots (which I have reported), and a third unprovoked seizure in 9/2018.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram head, Electroencephalogram, Generalised tonic-clonic seizure, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Generalized tonic clonic seizure the following morning at 3am requiring admission to the hospital. This was the first seizure of the patient's life. He would go on to have a second seizure at his next round of shots (which I have reported), and a third unprovoked seizure in 9/2018.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Seizure
Clinical narrative: Generalized tonic clonic seizure the following morning at 3am requiring admission to the hospital. This was the first seizure of the patient's life. He would go on to have a second seizure at his next round of shots (which I have reported), and a third unprovoked seizure in 9/2018.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Myalgia, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 69-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness, queasy and headache. On 5th September 2018, the patient experienced muscle pain. On 5th September 2018, the outcome of the queasy and headache were recovered/resolved. On an unknown date, the outcome of the injection site tenderness and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the injection site tenderness, queasy, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient complained of headache and queasiness beginning the evening after administration of a dose of SHINGRIX. In addition, the patient reported tenderness at the injection site, without redness or swelling. The patient experienced muscle pain in both arms began the day after administration. At the time of reporting, the patient's headache and queasiness had resolved, but the tenderness and muscle pain persisted.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 69-year-old female patient who received SHINGRIX (batch number P45M9, expiry date 27th February 2021) for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site tenderness, queasy and headache. On 5th September 2018, the patient experienced muscle pain. On 5th September 2018, the outcome of the queasy and headache were recovered/resolved. On an unknown date, the outcome of the injection site tenderness and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the injection site tenderness, queasy, muscle pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The healthcare professional (HCP) reported that the patient complained of headache and queasiness beginning the evening after administration of a dose of SHINGRIX. In addition, the patient reported tenderness at the injection site, without redness or swelling. The patient experienced muscle pain in both arms began the day after administration. At the time of reporting, the patient's headache and queasiness had resolved, but the tenderness and muscle pain persisted.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, 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 swelling in a 75-year-old male patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 4th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 4th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th September 2018, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unchanged and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the arm. 2 days after receiving SHINGRIX, the patient noticed severe redness and swelling on the back of his arm, which was warm to the touch. The reporter suspected that vaccine was given subcutaneously, and that this was a local reaction at the site of injection, which led to intramuscular formulation administered by other route. The reporter did not administer vaccine (same site, different health care professional) and had not visually inspected the area. The reporter was not certain that it was given subcutaneously, but was assuming that it was based on the patient's description of the event. When asked about the timing of the event in relation to the vaccine, reporter stated that the patient just noticed it today.
Age: 75.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 75-year-old male patient who received SHINGRIX (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 4th September 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 4th September 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th September 2018, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were unchanged and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the arm. 2 days after receiving SHINGRIX, the patient noticed severe redness and swelling on the back of his arm, which was warm to the touch. The reporter suspected that vaccine was given subcutaneously, and that this was a local reaction at the site of injection, which led to intramuscular formulation administered by other route. The reporter did not administer vaccine (same site, different health care professional) and had not visually inspected the area. The reporter was not certain that it was given subcutaneously, but was assuming that it was based on the patient's description of the event. When asked about the timing of the event in relation to the vaccine, reporter stated that the patient just noticed it today.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Joint noise, Musculoskeletal discomfort, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint noise in a 61-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 28th June 2018, the patient received SHINGRIX. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced joint noise and joint pain. On an unknown date, the outcome of the joint noise was unchanged and the outcome of the joint pain was recovered/resolved. It was unknown if the reporter considered the joint noise and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness and arm popping with the shoulder joint.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Joint noise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint noise in a 61-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 28th June 2018, the patient received SHINGRIX. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced joint noise and joint pain. On an unknown date, the outcome of the joint noise was unchanged and the outcome of the joint pain was recovered/resolved. It was unknown if the reporter considered the joint noise and joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced soreness and arm popping with the shoulder joint.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Livedo reticularis, Rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of mottled skin in a 84-year-old male patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced mottled skin, generalized rash, erythematous rash and pale skin. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the mottled skin, generalized rash, erythematous rash and pale skin were recovering/resolving. It was unknown if the reporter considered the mottled skin, generalized rash, erythematous rash and pale skin to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. At 11:00, the patient was administered SHINGRIX in the left arm. Within 24 hours after vaccination, the patient developed a white and red non raised rash on his face, torso, arms, groin, buttocks and thighs. The patient developed a red and white, mottled rash all over his body. The rash did not turn white when pressed and was not raised.  The emergency room had never seen anything like it. The rash was now turning pale. The patient was asymptomatic, with no anaphylactic symptoms. This was not listed as a normal side effect. The reporter called the emergency room and spoke to a nurse and a doctor who advised to him Benadryl. Emergency room physician suggested Benadryl. The patient had one 50 mg dose 12 hours ago but the mottling was still there 12 hours later. The reporter wanted comment or advise from GlaxoSmithKline. No further details were provided by the caller.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Livedo reticularis, Pallor, Rash erythematous, Rash generalised
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of mottled skin in a 84-year-old male patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2018, less than a day after receiving SHINGRIX, the patient experienced mottled skin, generalized rash, erythematous rash and pale skin. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the mottled skin, generalized rash, erythematous rash and pale skin were recovering/resolving. It was unknown if the reporter considered the mottled skin, generalized rash, erythematous rash and pale skin to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. At 11:00, the patient was administered SHINGRIX in the left arm. Within 24 hours after vaccination, the patient developed a white and red non raised rash on his face, torso, arms, groin, buttocks and thighs. The patient developed a red and white, mottled rash all over his body. The rash did not turn white when pressed and was not raised.  The emergency room had never seen anything like it. The rash was now turning pale. The patient was asymptomatic, with no anaphylactic symptoms. This was not listed as a normal side effect. The reporter called the emergency room and spoke to a nurse and a doctor who advised to him Benadryl. Emergency room physician suggested Benadryl. The patient had one 50 mg dose 12 hours ago but the mottling was still there 12 hours later. The reporter wanted comment or advise from GlaxoSmithKline. No further details were provided by the caller.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal discomfort, Diarrhoea, Haematochezia, Irritability, Muscle spasms
Clinical narrative: Abdominal discomfort on 9/8/18. Extreme fussiness. Diarrhea on 9/10/18. Blood in stool 9/11/18.  Cramping and screaming fits until 9/15/18.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Polymerase chain reaction positive, Rotavirus test positive, Screaming, Stool analysis, Ultrasound abdomen
Clinical narrative: Abdominal discomfort on 9/8/18. Extreme fussiness. Diarrhea on 9/10/18. Blood in stool 9/11/18.  Cramping and screaming fits until 9/15/18.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swelled up in an area about 3 inches by 3 inches and became extremely itchy, red and warm the day after the injection. I then developed a flare-up of my psoriasis. I had a break out on my right knee about 48 hours after the injection. I also noticed small patches about a half inch circle in size on other spots like my left ankle and under my left knee where I had never had break outs before.