chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called Friday night (5/25/18) at approximately 6:15p or so, reporting adverse events after a SHINGRIX shot received the previous Tuesday evening (5/22/18). Stated he currently has a 3x3 patch around injection site that is red and largely swollen. Seems to have been expanding over the last few days but is holding steady at 3x3. Reports no itching, just red, swollen and painful. Also reported having flu-like symptoms the day after, along with his wife, however she has not developed the rash. Has tried an icepack and ibuprofen for the swelling and pain with minimal relief. Advised adding BENADRYL, in case of allergic reaction.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: L upper arm became painful, slightly swollen, and itchy 3 days after administration of Tdap vaccine. Area approx. 6" x 7". Suggested home treatment at this time cool cloth, OTC anti-inflammatory and anti-histamine, Instructed if Sx worsening should see PCP. Employee aware that VAERS report being filed.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Severe hives starting the 3rd day of vaccine. Since then, patient gets hives all the time from eating something or during a flu. Her body doesn't get hives before the vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fall, Head injury, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Patient stated she felt fine the day of injection. When she awoke the next morning, she noticed stiff/achy muscles all over her body. She continued her morning routine of going downstairs and taking her levothyroxine and drinking a glass of water. A little while later her stomach started to hurt and she thought she may be hungry. She said the next thing she remembers is waking up in the floor. She has a concrete floor so she had a "goose egg" on her head. She states she did nothing else that day except sit around with an ice pack on her head.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient stated she felt fine the day of injection. When she awoke the next morning, she noticed stiff/achy muscles all over her body. She continued her morning routine of going downstairs and taking her levothyroxine and drinking a glass of water. A little while later her stomach started to hurt and she thought she may be hungry. She said the next thing she remembers is waking up in the floor. She has a concrete floor so she had a "goose egg" on her head. She states she did nothing else that day except sit around with an ice pack on her head.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Localized cellulitis, cephalexin 500 mg tid for 10 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Fatigue, Nausea, Pain in extremity
Clinical narrative: Patient states that the next day she was very weak, nauseated, tired, and occasional trouble breathing. Her arm was also sore but that was not her primary concern. I suggested she seek immediate medical attention for the trouble breathing - she did not feel she needed to do so. I also encouraged her to check with her MD regarding the symptoms. I called her later that day and she was feeling a little better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: Patient complains of a severe headache, low grade fever 100.5, patient advised to take some medication (ie TYLENOL or ibuprofen) symptoms should go away within 24 hours.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild injection site reaction with erythema and swelling/possible blistering. Swelling size just smaller than a baseball. No reaction was seen after first injection.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: All over rash.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site reaction, warm, red just below injection area.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills, muscle aches especially neck but most muscles, headache. Lasted about 4 hours overall.  The next day I was very tired (not sleepy) and low energy, but after that I was back to normal.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Patient stated his arm was numb for 1 full day after getting vaccine and interfered with normal mobility on the left arm but completely subsided after 24 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Patient called 5 hours after receiving the shot to say that he has developed 2 contiguous lines of welts on either side of his spine all the way from his neck to his tail bone. He said he was experiencing pain, itching, redness and swelling in the affected areas. He noticed the welts seem to subside with oral BENADRYL but would return.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt experienced redness and swelling at the site of injection. It spread from his shoulder down to his elbow. He also mentioned it being very sore.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at the injection site and pain.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Influenza like illness, Nausea, Peripheral swelling, Skin warm
Clinical narrative: Redness at the injection site and pain.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Feeling abnormal, Herpes zoster, Hyperaesthesia
Clinical narrative: Started feeling bad with sensitive skin on 5/17/2018 then had blisters on 5/20/2018.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Red, warm to the touch. Had a rash.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, dizziness, vomiting, s/p injection. Has tenderness at injection site but no swelling. Encouraged hydration, rest, bland diet, acetaminophen as needed for fever/pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Injection site extravasation, Injection site pain
Clinical narrative: SHINGRIX Vaccine extravasation into the (L) arm subcutaneous tissue instead of intermuscular (IM).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult patient who received SHINGRIX. On 7th May 2018, the patient received the 1st dose of SHINGRIX. On 8th May 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: MD called pharmacy to report redness 3" in diameter under injection site. Pt. reported no fever. I have not seen Pt. Injection was administered in (L) deltoid. Pt. had no reaction to 1st injection. Patient presented to MD office, as reported by Dr. with redness 3" diameter under injection site. The patient had no fever. Since I did not examine patient unsure if actually under injection site. I administered shot and administer all IM shots on lower deltoid to avoid most nerve endings. Patient was advised to monitor over weekend and report any fever to Clinic. RPh.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and adverse drug reaction. On an unknown date, the outcome of the pain in arm and adverse drug reaction were recovered/resolved. It was unknown if the reporter considered the pain in arm and adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated the earliest he/she could get the second shot (two month period) was shortly before he/she leave for a three week vacation. The patient was asking if the patient could wait until return for the 2nd shot. The reporter asked if one shot do anything and how quickly did the 2nd shot provided protection. The patient stated if there was a delayed effectiveness, the patient would wait until return since the patient did have some soreness in arm and mild other side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Back pain, Inflammation, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of back pain in a male patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced back pain, inflammation localized, pain in hip, coxarthritis, muscle pain, muscle inflammation and injection site swelling. On an unknown date, the outcome of the back pain, inflammation localized, pain in hip, coxarthritis, muscle pain and muscle inflammation were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the back pain, inflammation localized, pain in hip, coxarthritis, muscle pain, muscle inflammation and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced pain and inflammation in the back, hips and other muscles and joints. The reporter wanted to know if could expect these events to subside. The patient stated that the first symptoms appeared 3 to 4 days after the vaccination. The typical site swelling subsided after the first few days.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Myositis
Clinical narrative: This case was reported by a consumer and described the occurrence of back pain in a male patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced back pain, inflammation localized, pain in hip, coxarthritis, muscle pain, muscle inflammation and injection site swelling. On an unknown date, the outcome of the back pain, inflammation localized, pain in hip, coxarthritis, muscle pain and muscle inflammation were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. It was unknown if the reporter considered the back pain, inflammation localized, pain in hip, coxarthritis, muscle pain, muscle inflammation and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced pain and inflammation in the back, hips and other muscles and joints. The reporter wanted to know if could expect these events to subside. The patient stated that the first symptoms appeared 3 to 4 days after the vaccination. The typical site swelling subsided after the first few days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a non-health professional and described the occurrence of painful rash in a 74-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced painful rash. On an unknown date, the outcome of the painful rash was not recovered/not resolved. It was unknown if the reporter considered the painful rash to be related to SHINGRIX. Additional information was reported as follows: The patient experienced painful rash around the torso, after vaccination with SHINGRIX. The patient experienced the event painful rash continuing for a period of 3 days and till the date of reporting was not resolved. The patient had informed this to the pharmacist and the doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown. It was unknown if the reporter considered the swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter contacted through live chat and did not provide any additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Influenza like illness, Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose (see case US2018079563)). On 2nd May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. In May 2018, the patient experienced headache, fever, chills, general body pain, feeling unwell, enlargement of lymph nodes, skin warm, sweating and nausea. On an unknown date, the outcome of the headache, fever, chills and general body pain were recovered/resolved and the outcome of the feeling unwell and skin warm were unknown and the outcome of the influenza-like symptoms, enlargement of lymph nodes and sweating were unchanged and the outcome of the nausea was recovering/resolving. The reporter considered the headache, fever, chills, general body pain, feeling unwell, influenza-like symptoms, enlargement of lymph nodes, sweating and nausea to be related to SHINGRIX. It was unknown if the reporter considered the skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left deltoid. The patient noted that she experienced side effects with 2nd dose of the SHINGRIX vaccine. The patient had the same side effects as the 1st dose but the events were more intense. Yesterday morning within 24 hours on 3rd May 2018, the patient was not feeling well and felt like she was having flu like symptoms. This time with the chills, she felt like she could never get warm until this morning. The patient noticed today that her left armpit felt funny. When she went to look in the mirror, she saw an enlarged lymph node. She said it was in the lower part of her armpit, literally in the crease near her breast. She was asked if she could describe the size of the lymph node. She stated that if felt like it was about 2 and half inches in diameter. It was not on the surface, just under her skin in the armpit and it felt warm to the touch. The patient explained that she had been sweating and it was more than what would be normal to her because she rarely sweats. She was not able to speak to her doctor, but it was suggested that she go to urgent care for treatment. This case has been linked with US2018079563, reported for 1st dose of SHINGRIX for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain, Pyrexia, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose (see case US2018079563)). On 2nd May 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 2nd May 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms. In May 2018, the patient experienced headache, fever, chills, general body pain, feeling unwell, enlargement of lymph nodes, skin warm, sweating and nausea. On an unknown date, the outcome of the headache, fever, chills and general body pain were recovered/resolved and the outcome of the feeling unwell and skin warm were unknown and the outcome of the influenza-like symptoms, enlargement of lymph nodes and sweating were unchanged and the outcome of the nausea was recovering/resolving. The reporter considered the headache, fever, chills, general body pain, feeling unwell, influenza-like symptoms, enlargement of lymph nodes, sweating and nausea to be related to SHINGRIX. It was unknown if the reporter considered the skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on left deltoid. The patient noted that she experienced side effects with 2nd dose of the SHINGRIX vaccine. The patient had the same side effects as the 1st dose but the events were more intense. Yesterday morning within 24 hours on 3rd May 2018, the patient was not feeling well and felt like she was having flu like symptoms. This time with the chills, she felt like she could never get warm until this morning. The patient noticed today that her left armpit felt funny. When she went to look in the mirror, she saw an enlarged lymph node. She said it was in the lower part of her armpit, literally in the crease near her breast. She was asked if she could describe the size of the lymph node. She stated that if felt like it was about 2 and half inches in diameter. It was not on the surface, just under her skin in the armpit and it felt warm to the touch. The patient explained that she had been sweating and it was more than what would be normal to her because she rarely sweats. She was not able to speak to her doctor, but it was suggested that she go to urgent care for treatment. This case has been linked with US2018079563, reported for 1st dose of SHINGRIX for the same patient.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure abnormal, esophageal acid reflux and blood cholesterol abnormal. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd May 2018, 3 days after receiving SHINGRIX, the patient experienced injection site abrasion. On 4th May 2018, the patient experienced injection site warmth, injection site itching and injection site erythema. On an unknown date, the patient experienced pain in arm. On 7th May 2018, the outcome of the injection site warmth, injection site itching, injection site abrasion and injection site erythema were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm, injection site warmth and injection site erythema to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site itching and injection site abrasion to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The patient's concomitant medication included blood pressure medication, cholesterol medication and acid reflux medication. The patient received SHINGRIX on the right upper arm. In 2018, less than a week after vaccination, the patient's upper arm was sore for 3 days. On 3rd May 2018, the patient scratched the right arm. On 4th May 2018, the patient noticed that her arm just below the area of the injection was hot to touch, red and itchy which were lasted for 3 days. On 7th May 2018, the redness faded away and all other symptoms were resolved. It was the patient's choice to get the vaccine and was not ordered by an healthcare professional (HCP). The patient was not sure whether to take the follow up shot or not. The patient stated, no one seemed to have heard about this reaction. The patient denied permission to contact their physician and did not have additional information pertaining to these adverse events.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Scratch
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX. Concurrent medical conditions included blood pressure abnormal, esophageal acid reflux and blood cholesterol abnormal. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd May 2018, 3 days after receiving SHINGRIX, the patient experienced injection site abrasion. On 4th May 2018, the patient experienced injection site warmth, injection site itching and injection site erythema. On an unknown date, the patient experienced pain in arm. On 7th May 2018, the outcome of the injection site warmth, injection site itching, injection site abrasion and injection site erythema were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm, injection site warmth and injection site erythema to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site itching and injection site abrasion to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The patient's concomitant medication included blood pressure medication, cholesterol medication and acid reflux medication. The patient received SHINGRIX on the right upper arm. In 2018, less than a week after vaccination, the patient's upper arm was sore for 3 days. On 3rd May 2018, the patient scratched the right arm. On 4th May 2018, the patient noticed that her arm just below the area of the injection was hot to touch, red and itchy which were lasted for 3 days. On 7th May 2018, the redness faded away and all other symptoms were resolved. It was the patient's choice to get the vaccine and was not ordered by an healthcare professional (HCP). The patient was not sure whether to take the follow up shot or not. The patient stated, no one seemed to have heard about this reaction. The patient denied permission to contact their physician and did not have additional information pertaining to these adverse events.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Injection site discomfort, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site warmth in a 76-year-old female patient who received SHINGRIX. Concomitant products included PROLIA, amlodipine, famotidine, lorazepam, simvastatin, BENTYL, SYNTHROID and L-Methylfolate. On 7th May 2018, the patient received SHINGRIX. On 8th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, fever, headache, injection site induration, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site warmth was not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the headache was recovering/resolving and the outcome of the injection site induration, injection site swelling and injection site erythema were unknown. The reporter considered the injection site warmth, fever, headache, injection site induration, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left upper arm. The patient experienced symptoms the day after the patient received her first dose in the SHINGRIX series. The reporter had no further specific pharmacy or dosing information. The reporter examined the patient's arm at an office appointment. There was localized swelling at the injection site which is warm, hard, swollen, and red. The headache was described by the patient to had been severe and debilitating with the patient having described that she had thought she might have meningitis because of the severity of the headache. At the time of reporting, the left upper arm injection site reaction was still uncomfortable and swollen, and the headache has lessened. The patient received BENADRYL for the swelling. The call was transferred to the GlaxoSmithKline medical information regarding her inquiry of whether or not this patient should have a second dose in the series, no further doses, or perhaps a half of a dose.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site warmth in a 76-year-old female patient who received SHINGRIX. Concomitant products included PROLIA, amlodipine, famotidine, lorazepam, simvastatin, BENTYL, SYNTHROID and L-Methylfolate. On 7th May 2018, the patient received SHINGRIX. On 8th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site warmth, fever, headache, injection site induration, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site warmth was not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the headache was recovering/resolving and the outcome of the injection site induration, injection site swelling and injection site erythema were unknown. The reporter considered the injection site warmth, fever, headache, injection site induration, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left upper arm. The patient experienced symptoms the day after the patient received her first dose in the SHINGRIX series. The reporter had no further specific pharmacy or dosing information. The reporter examined the patient's arm at an office appointment. There was localized swelling at the injection site which is warm, hard, swollen, and red. The headache was described by the patient to had been severe and debilitating with the patient having described that she had thought she might have meningitis because of the severity of the headache. At the time of reporting, the left upper arm injection site reaction was still uncomfortable and swollen, and the headache has lessened. The patient received BENADRYL for the swelling. The call was transferred to the GlaxoSmithKline medical information regarding her inquiry of whether or not this patient should have a second dose in the series, no further doses, or perhaps a half of a dose.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Pt receive vaccines on 05/23/18 for 15 month well visit. Right thigh started swelling on 05/24/18 mom brought patient to office on 05/25/18. Doctor prescribed AUGMENTIN due to cellulitis.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Injection site erythema, Malaise, Palpitations
Clinical narrative: Vaccination at about, 1:00PM, started feeling bad about 10:00PM, went to bed and then woke up at about 1:00a.m. - fever, chills, palpitations, malaise until about 6:00a.m., fever and malaise through the next day. Reddened injection site for 5 days about 2 inches diameter. Continued to feel bad for 5-7 days, Injection site took about 7 days to clear up completely. Almost had to go to emergency room on night after injections but finally started getting better after TYLENOL and BENADRYL about 7:00 a.m.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Vaccination at about, 1:00PM, started feeling bad about 10:00PM, went to bed and then woke up at about 1:00a.m. - fever, chills, palpitations, malaise until about 6:00a.m., fever and malaise through the next day. Reddened injection site for 5 days about 2 inches diameter. Continued to feel bad for 5-7 days, Injection site took about 7 days to clear up completely. Almost had to go to emergency room on night after injections but finally started getting better after TYLENOL and BENADRYL about 7:00 a.m.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 12th May 2018, the outcome of the fever was recovered/resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in the left deltoid. The patient experienced high fever and her cheeks, neck and forehead were hot after the vaccination and the issue resolved 10 to 12 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 11th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 12th May 2018, the outcome of the fever was recovered/resolved. The reporter considered the fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine in the left deltoid. The patient experienced high fever and her cheeks, neck and forehead were hot after the vaccination and the issue resolved 10 to 12 hours.
Sex: F
Vaccine: HEPA
Symptoms: Cough, Exposure via breast milk, Irritability, Rhinorrhoea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of runny nose in a 9-month-old female patient after exposure to breast milk of the mother who received HAVRIX. On an unknown date, the patient received HAVRIX (transmammary). On 7th May 2018, less than a week after exposure to HAVRIX via breast milk, the patient experienced runny nose, irritability and cough. On an unknown date, the patient experienced vaccine exposure via breast milk. On 9th May 2018, the outcome of the runny nose, irritability and cough were recovered/resolved. It was unknown if the reporter considered the runny nose, irritability and cough to be related to HAVRIX. See case US2018085744 for details regarding the mother case. Additional details were provided as follows: The age at vaccination was not applicable for this report, as patient's mother received HAVRIX on 4th May 2018 while she was breastfeeding her child (patient). The reporter stated the baby had her symptoms on 7th, 8th and 9th May 2018. The patient felt off for two to three days. The patient experienced runny nose and cough possibly from the breast milk as per the patient. The patient had a 9 month check up with the pediatrician and was notified of the mother having the vaccine. The patient's mother gave permission to contact child's pediatrician if needed. No additional information was available.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Sensory loss
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of numbness in a 77-year-old male patient who received SHINGRIX. Concomitant products included lisinopril and metoprolol. On 12th May 2018, the patient received the 1st dose of SHINGRIX. On 12th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced numbness. In May 2018, the patient experienced loss of sensation. On an unknown date, the outcome of the numbness was not recovered/not resolved and the outcome of the loss of sensation was unknown. The reporter considered the numbness to be related to SHINGRIX. It was unknown if the reporter considered the loss of sensation to be related to SHINGRIX. Additional details were provided as followed: This case was reported by the optometrist who himself was the patient. The patient's concomitant medications included statins. At 9:00, the patient received SHINGRIX vaccine on the left arm. The physician reported that after receiving the SHINGRIX vaccine, he began to experience numbness on the right side of his face and his right ear and his head became numb the same day. It started to resolve and was no longer present on the day before reporting and then on the reporting day it returned to both areas. When the physician brushed his hair on the right side, he could not feel it. The number for Medical Information was provided and the physician said he was about to see a patient and would call back. The physician was instructed to tell the representative that he had already filed an adverse event report with GlaxoSmithKline. This case was identified as duplicate of US2018085771. Case US2018085771 was deleted and all the future correspondence will be added in the present case which stands as case of record for this patient.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Lethargy, Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of lethargy in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than year after receiving SHINGRIX, the patient experienced lethargy, pain in arm, erythema of extremities and tiredness. On an unknown date, the outcome of the lethargy, pain in arm, erythema of extremities and tiredness were unknown. It was unknown if the reporter considered the lethargy, pain in arm, erythema of extremities and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient had 2.5 days of severe arm pain with redness and the patient also felt tired and lethargic. The physician did not feel it was outside of the pain reported labeling adverse events.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site pain, Irritability, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received SHINGRIX. On 4th May 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th May 2018, less than an hour after receiving SHINGRIX, the patient experienced pain in arm, discomfort and irritability. On an unknown date, the outcome of the pain in arm, discomfort and irritability were unchanged. The reporter considered the pain in arm, discomfort and irritability to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced left arm pain within 1 to 2 hours after receiving the SHINGRIX. Pain had gotten worse. The patient experienced sharp pains form her shoulder down to her elbow when she used her left arm. The patient stated that when her arm was at rest, it was just annoying and uncomfortable. There was no redness or swelling at the injection site. The reporter gave permission for her physician to be contacted.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Angular cheilitis, Injection site pruritus, Lip swelling, Swelling face
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of lip swelling in a elderly female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). Concurrent medical conditions included blood pressure. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced lip swelling, injection site itching, angular cheilitis and facial swelling. The patient was treated with BENADRYL. In May 2018, the outcome of the lip swelling, injection site itching, angular cheilitis and facial swelling were recovered/resolved. The reporter considered the lip swelling, injection site itching and facial swelling to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the angular cheilitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist was administered the vaccine last Monday. The patient had lip swelling that following day of vaccination. The patient took BENADRYL and it resolved. The patient had another flare where the corner of her mouth swelled up and below the lip near her chin had swelling as well on the 3rd day after vaccination. The patient took BENADRYL for each incident but reported that her symptoms were slow to resolve and it took a better part of the day for them to resolve. The patient also reported that her arm at the injection site itched on and off. The patient was symptom free. The only change that the patient reported to the pharmacist was that she increased her blood pressure medication a few weeks ago. No other information available. The patient had not yet reported her symptoms to her doctor.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin, Montelukast and SYMBICORT. On 11th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th May 2018, the patient experienced chills, pain and fever. On 13th May 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, chills, fever and injection site warmth were recovering/resolving and the outcome of the pain was recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, chills, pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. This case was previously not reported to anyone. The patient received SHINGRIX in the left arm. In the evening of the vaccination, the patient experienced pain at the injection site such that she could not lay on that arm. One day after receiving SHINGRIX, in the afternoon, the patient experienced achiness and later in the evening the patient developed fever and chills. Two days after receiving SHINGRIX, in the morning, the patient's body temperature was recorded to be 101.5 degree F. The patient also had swollen and red area around the injection site which was 6 inches by 4 inches which was warm to the touch. On the day of reporting, in the morning, the patient's body temperature was found to be 100 degree F. The patient was treated with TYLENOL for these events.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX. Concomitant products included Atorvastatin, Montelukast and SYMBICORT. On 11th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 11th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 12th May 2018, the patient experienced chills, pain and fever. On 13th May 2018, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. The patient was treated with TYLENOL. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, chills, fever and injection site warmth were recovering/resolving and the outcome of the pain was recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, chills, pain and fever to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient. This case was previously not reported to anyone. The patient received SHINGRIX in the left arm. In the evening of the vaccination, the patient experienced pain at the injection site such that she could not lay on that arm. One day after receiving SHINGRIX, in the afternoon, the patient experienced achiness and later in the evening the patient developed fever and chills. Two days after receiving SHINGRIX, in the morning, the patient's body temperature was recorded to be 101.5 degree F. The patient also had swollen and red area around the injection site which was 6 inches by 4 inches which was warm to the touch. On the day of reporting, in the morning, the patient's body temperature was found to be 100 degree F. The patient was treated with TYLENOL for these events.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 58-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 2nd March 2018, the patient received SHINGRIX (intramuscular) .5 ml. In February 2018, several days after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms and pain. On an unknown date, the outcome of the muscle pain, influenza-like symptoms and pain were recovered/resolved. It was unknown if the reporter considered the muscle pain, influenza-like symptoms and pain to be related to SHINGRIX. Additional details were provided as follows: Few days after receiving SHINGRIX, the patient experienced flu like symptoms, muscle aches and pain. The events lasted for 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a nurse and described the occurrence of shingles in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter was seeking information on occurrence of shingles after 1st dose of SHINGRIX. The reporter did not see shingles listed as a possible side effect or adverse reaction to SHINGRIX, but she had a reason to believe that it might had occurred in the patient (possible SHINGRIX reaction). The reporter was aware SHINGRIX was a attenuated vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PT FELT HEADACHY NAUSOUS AND FLU LIKE AND THE ARM FELT HOT AND SWOLLEN BY THE END OF THE DAY AND IS STILL HOT AND SWOLLEN  TODAY 05/26/2018.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Headache, Influenza like illness, Nausea, Peripheral swelling, Skin warm
Clinical narrative: PT FELT HEADACHY NAUSOUS AND FLU LIKE AND THE ARM FELT HOT AND SWOLLEN BY THE END OF THE DAY AND IS STILL HOT AND SWOLLEN  TODAY 05/26/2018.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pyrexia, Sleep disorder
Clinical narrative: Pt is complaining of an oblong bump about 1 & 1/2 inches in diameter at injection site. She could not sleep or lay on it. Slight chills and a mild fever (100.3F) 24 hours after.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Skin rash on both arms proximal and distal to antecubital fossa, both legs proximal and distal to popliteal fossa, right neck (side of injection).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Tiredness, injection site pain. Progressed to pain, redness, swelling at injection site, and tiredness, muscle pain, severe headache, shivering, possibly fever.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia
Clinical narrative: Tiredness, injection site pain. Progressed to pain, redness, swelling at injection site, and tiredness, muscle pain, severe headache, shivering, possibly fever.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal pain, Haematochezia, Intussusception, Irritability, Mucous stools
Clinical narrative: Approx 24 hours after 2 month vaccine, our daughter went from having normal yellow seedy stool to very mucousy stool with streaks of blood. The change is present in ALL diapers and is drastic. Daughter appears to have abdominal pain and is fussy. Three weeks later the symptoms persist and she was also diagnosed with small bowel intussusception. Mother has eliminated dairy & soy from diet to confirm that they are not at issue.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Approx 24 hours after 2 month vaccine, our daughter went from having normal yellow seedy stool to very mucousy stool with streaks of blood. The change is present in ALL diapers and is drastic. Daughter appears to have abdominal pain and is fussy. Three weeks later the symptoms persist and she was also diagnosed with small bowel intussusception. Mother has eliminated dairy & soy from diet to confirm that they are not at issue.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site warmth, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Sore arm (unusually sore for immunization), inflamed at injection site, feel hot to touch; 2nd day same symptoms plus had to leave work due to sickness, fever 102F; 3rd day feeling better, still a little puny but arm is still sore with a 3 sq inch inflamed area around the injection site which is hot to touch. I had none of these symptoms with the initial injection. I cannot remember ever having this type of reaction to any immunization. I have never been allergic to anything.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: She developed shingle symptoms a day after and was treated with VALTREX.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Patient stated that her arm hurt and 2 days later felt feverish, tired, and headache.