chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Asthma, Condition aggravated
Clinical narrative: Frequent and severe asthma attacks often requiring multiple doses of albuterol to control. Usually two-five times every day since 7/6/18. Previous asthma attacks would occur only once every few months and not severely.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Paraesthesia, Rash
Clinical narrative: Red, oval shaped, 3 inch, swollen area around injection site w a bruise at the site noted. A red raised blister rash under arm noted w tenderness. Tingly and numb down R arm to R hand and fingers. Started 08/01/18 at 0900 and is still continuing today 8/2/18.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular, Tenderness
Clinical narrative: Red, oval shaped, 3 inch, swollen area around injection site w a bruise at the site noted. A red raised blister rash under arm noted w tenderness. Tingly and numb down R arm to R hand and fingers. Started 08/01/18 at 0900 and is still continuing today 8/2/18.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuropathy peripheral, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with the ZOSTAVAX vaccine at a physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 17-OCT-2016, the patient was treated by a physician assistant for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient was prescribed acyclovir and gabapentin for management of his painful symptoms and chronic pain. On or about 14-NOV-2016, the patient sought subsequent treatment from physician assistant for a blistering vesicular outbreak that was diagnosed as severe neuropathy. The patient was prescribed gabapentin and lidocaine for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Upon internal review, severe neuropathy was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-NOV-2011, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 24-APR-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a 12 month old female patient. On 26-JUL-2018 the patient was vaccinated with improperly stored M-M-R II from dose 1, subcutaneous in the right thigh from lot N027782 expiry date 16-AUG-2019 for prophylaxis. On the same day, the patient was vaccinated with dose 1 of improperly stored VARIVAX from lot R002051 expiry date 22-JAN-2020 by subcutaneous route in the left thigh and dose 1 of improperly stored VAQTA by intramuscular route in the left thigh from lot R002086 expiry date 22-APR-2019; both for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, muscle pain and fever. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the muscle pain and fever were unknown. It was unknown if the reporter considered the influenza-like symptoms, muscle pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter was patient's wife. The reporter stated that her husband experienced flu like symptoms after vaccination. She disconnected call abruptly and was not able to clarify if this was with SHINGRIX, but since the discussion of the call was around this product it was being captured. The reporter disconnected the call abruptly and was asked for name but declined. The reporter noted she would be calling back to see if any other reports in 2 months about numbness. The reporter disconnected before she could be told, GSK would not be able to provide that information. All questions were not asked before the reporter disconnected abruptly. This case was linked with US2018131398, reported by same reporter for the patient's wife.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cyst, Pain in extremity, Wrong technique in product usage process
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old male patient who received SHINGRIX (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On 27th June 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced injection site cyst and wrong injection technique. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site cyst and wrong injection technique were unknown. It was unknown if the reporter considered the pain in arm and injection site cyst to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 65 or 64 years old. The patient believed that, the SHINGRIX vaccine was given too deep into the deltoid which caused it to pool behind the muscle forming a liquid filled cyst, which led to wrong injection technique. At the time of this report, 3 weeks after receiving SHINGRIX, the patient still had pain in injected arm during strenuous exercise such as weight lifting at the gym.
Age: 55.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Fatigue, Palpitations, Pyrexia
Clinical narrative: Later afternoon - felt chills/feverish (or day of vaccine). Did not check temperature. Felt fatigued. At bedtime heart was racing like it did when he went into atrial flutter in June. Took 2 doses of PRN propranolol. At 4 AM 7/24 felt like went back into sinus rhythm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection site reaction consisting of redness and very tender, warm to the touch and hard to the touch at the injection site.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Patient woke up feeling dizzy and nausea, did not vomit or faint.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain upper, Blood test, Pyrexia, Vomiting, X-ray
Clinical narrative: PER MOTHER, PATIENT DEVELOPED A HIGH FEVER AND VOMITING "A FEW HOURS" AFTER HEP A VACCINATION ON 7/31/18. FEVER AND VOMITING CONTINUED THROUGH THE NIGHT. ON 8/1/18 THE PATIENT WENT TO ER, HAD BLOODWORK AND RADIOLOGY TESTING THEN WAS RELEASED TO HOME. PATIENT CONTINUED TO HAVE STOMACH CRAMPING AND VOMITING LAST NIGHT AND TODAY.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Pruritus, Pyrexia
Clinical narrative: Within a couple hours after the SHINGRIX vaccine was adminisitered, patient reported a red, raised band from below her injection site. It was also hard and itchy to the touch. She felt achy the first 2 days also. She had a low grade fever and after the fever subsided her rash began to clear. It took 1 week to resolve.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Within a couple hours after the SHINGRIX vaccine was adminisitered, patient reported a red, raised band from below her injection site. It was also hard and itchy to the touch. She felt achy the first 2 days also. She had a low grade fever and after the fever subsided her rash began to clear. It took 1 week to resolve.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Mobility decreased, Pain in extremity
Clinical narrative: 10 hrs sweating & chills. Severe arm pain....still cannot lift arm 6 weeks later.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: Erythema and pruritus around injection site (immediate, approx. 2" diameter), headache, diaphoresis. No orthostasis. Patient's baseline condition includes wheeze, SOB, so hard to determine worsening.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Local reaction, Wheezing
Clinical narrative: Erythema and pruritus around injection site (immediate, approx. 2" diameter), headache, diaphoresis. No orthostasis. Patient's baseline condition includes wheeze, SOB, so hard to determine worsening.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given shot on friday evening of July 27, 2018. Pt came to the pharmacy with concern because of her left tricep area had doubled in size, felt hot, was redish in color and felt like a know was in the back side of her left arm. Instructed her take tylenol and if by sunday it wasn't better to go and get it checked out by a physician. I texted her to check on the situation and she responded that it was ALOT better. I followed up again on monday and she was back to normal.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash generalised
Clinical narrative: Patient reported experiencing a full-body rash, beginning on the day the vaccine was given (07/30/2018). The rash was still present when she reported it to the pharmacy on 08/01/2018. She declined experiencing any anaphylactic or other life-threatening reactions.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site of injection red, swollen and painful to the touch.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Day 1: extreme fatigue all day and night. Day 2: slight fatigue, extremely sore left arm. Day 3: no more fatigue, left arm slightly less sore. Day 4: continuing soreness, but to a lesser degree. Itchiness. Day 5: Soreness gone, but swelling, itchiness, small patch of rash or hives around injection site. Day 6: Swelling still apparent, spreading rash or hives with a strange band of lighter skin going around the arm just below injection site. Less itchy. Hives responded to Blemish Stick. The redness left, but returned a few hours after application.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Day 1: extreme fatigue all day and night. Day 2: slight fatigue, extremely sore left arm. Day 3: no more fatigue, left arm slightly less sore. Day 4: continuing soreness, but to a lesser degree. Itchiness. Day 5: Soreness gone, but swelling, itchiness, small patch of rash or hives around injection site. Day 6: Swelling still apparent, spreading rash or hives with a strange band of lighter skin going around the arm just below injection site. Less itchy. Hives responded to Blemish Stick. The redness left, but returned a few hours after application.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Burning pain over whole of body, stabbing pain over all of body, left arm hurts when moved; started soon after vaccine was administered.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash erythematous
Clinical narrative: Patient began to have red rash to bilateral arms, chest, back, and face 10 min. after administration of vaccines. Patient denied any difficulty breathing. BENADRYL 50mg/ml was administered IM to patients right glute 5 minutes after appearance of rash per orders of PA-C. Rash began to dissipate within 1-2 minutes of administration of BENADRYL. Education was provided by PA-C on administration of oral BENADRYL at home if rash persisted and that no further doses of these vaccines should be given to patient. Telephone number for Health Department was provided for family to contact if need arises.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site swelling
Clinical narrative: Patient complained about muscle aches, chills, fatigue, headache, flu like symptoms, and swelling at the injection site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Patient complained about muscle aches, chills, fatigue, headache, flu like symptoms, and swelling at the injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Eyelid oedema, Headache, Herpes zoster
Clinical narrative: The day after the vaccination, patient experienced dizziness with a mild headache. The second and third day following the vaccination patient experienced more severe headache, heavy sweating, and noticed redness and bumps on her forehead. On 8/2/18 patient presented at doctor's office with swollen right nodule on throat, dizziness, redness with itching of the face/forehead/scalp, and swollen eyelids. Prescriber did not conduct any blood work or diagnostic tests but informed patient she had Shingles and prescribed VALTREX 1 gram to be taken one tablet three times daily for 7 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Nodule, Pruritus, Rash
Clinical narrative: The day after the vaccination, patient experienced dizziness with a mild headache. The second and third day following the vaccination patient experienced more severe headache, heavy sweating, and noticed redness and bumps on her forehead. On 8/2/18 patient presented at doctor's office with swollen right nodule on throat, dizziness, redness with itching of the face/forehead/scalp, and swollen eyelids. Prescriber did not conduct any blood work or diagnostic tests but informed patient she had Shingles and prescribed VALTREX 1 gram to be taken one tablet three times daily for 7 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Body temperature increased, Feeling cold, Pain in extremity
Clinical narrative: Sore arm (this was the only side effect I had from shot #1) - soreness from shot #2 began 3:00 pm. Became cold about 6:00 pm -sweaters/ blankets did not help. Took my temperature - it was 101 degrees. My blood pressure was slightly elevated. Took 2 BENADRYL and 3 ibuprofen.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, warm, swollen. Ice pack given.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-JUL-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). In July 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and injection site swelling. On 19th July 2018, the patient experienced intramuscular formulation administered by other route, underdose and syringe leak. On an unknown date, the outcome of the pain in arm, erythema of extremities, injection site swelling, intramuscular formulation administered by other route, underdose and syringe leak were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional received the SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to incorrect route of drug administration. The health care professional stated that the arm had an egg shell appearance and was red and sore. The health care professional reported possibly some of the vaccine may have leaked when they received the injection. The health care professional thought she received more than 0.5ml of SHINGRIX when it was administered. She thought it was a 1ml injection. She would follow up with pharmacy. Update to case details post call escalation. Clarification had been requested for verbatim egg shell appearance, validity of undedose with reference to quantity and replacement dose, If this case was associated with Pharmaceutical product complaint and overdose.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX. On 4th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness. On 5th July 2018, the outcome of the injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The next day, the patient experienced pain, swelling, redness and warmth at the injection site. The patient felt tired and slept all the day on 4th July 2018. She also experienced nausea and fever the day after receiving the SHINGRIX vaccine. The patient stated that by 5th July 2018, she felt fine again. The patient stated that, she mentioned the symptoms to her physician who advised that, she should not get the 2nd dose of the vaccine. The patient had denied permission to contact their physician.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018, the patient received the 1st dose of SHINGRIX. On 4th July 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness. On 5th July 2018, the outcome of the injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, nausea, fever, tiredness, injection site swelling, injection site warmth and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The next day, the patient experienced pain, swelling, redness and warmth at the injection site. The patient felt tired and slept all the day on 4th July 2018. She also experienced nausea and fever the day after receiving the SHINGRIX vaccine. The patient stated that by 5th July 2018, she felt fine again. The patient stated that, she mentioned the symptoms to her physician who advised that, she should not get the 2nd dose of the vaccine. The patient had denied permission to contact their physician.
Age: 85.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Blood glucose fluctuation, Blood glucose normal, Dyspnoea, Fatigue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 85-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included diabetes mellitus, hypertension and hypothyroidism. Concomitant products included PNEUMOVAX. On 29th June 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, pain, headache, blood glucose fluctuation, shortness of breath, heart rate increased and weakness generalized. The patient was treated with TYLENOL. On an unknown date, the outcome of the fatigue and pain were recovering/resolving and the outcome of the headache, blood glucose fluctuation, shortness of breath and heart rate increased were unknown and the outcome of the weakness generalized was not recovered/not resolved. It was unknown if the reporter considered the fatigue, pain, headache, blood glucose fluctuation, shortness of breath, heart rate increased and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The patient was generally in good health. The patient was administered initial dose of SHINGRIX in the left arm and on the same day administered PNEUMOVAX in the right arm. The patient developed several reactions after receiving a dose of SHINGRIX and PNEUMOVAX. The healthcare professional (HCP) called to check on the patient 3 days later at which time the patient reported trouble with mobility and pain in the arm which the pneumonia vaccine was administered. The patient was advised to take TYLENOL around the clock at which the symptoms resolved. However, the patient continued to experience symptoms of fatigue, headache and overall achiness. After 2 weeks from the day of administration, the patient reported symptoms remained the same and in addition began to notice fluctuations in her blood glucose levels ranging from 80 to 170, which were previously controlled. The patient followed up with her primary care physician and was found to have shortness of breath and increased heart rate. The patient's physician conducted laboratory test which showed no results that would cause reported symptoms. The patient was also seen by their endocrinologist to test thyroid function and was still awaiting test results from the endocrinologist, however reported symptoms of fatigue and generalized weakness were still ongoing. The HCP reported otherwise, there had been no other changes in the patient's diet or medication regimen that would contribute to these symptoms. No further information was reported regarding the event. Lab Comments: In 2018, the patient had fluctuations in her blood glucose levels ranging from 80s to 170s, which were previously controlled. The laboratory test showed no results should be changed to showed no results which would cause reported symptoms.
Age: 85.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Heart rate increased, Pain, Thyroid function test
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 85-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date 2nd February 2021) for prophylaxis. Concurrent medical conditions included diabetes mellitus, hypertension and hypothyroidism. Concomitant products included PNEUMOVAX. On 29th June 2018, the patient received the 1st dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, pain, headache, blood glucose fluctuation, shortness of breath, heart rate increased and weakness generalized. The patient was treated with TYLENOL. On an unknown date, the outcome of the fatigue and pain were recovering/resolving and the outcome of the headache, blood glucose fluctuation, shortness of breath and heart rate increased were unknown and the outcome of the weakness generalized was not recovered/not resolved. It was unknown if the reporter considered the fatigue, pain, headache, blood glucose fluctuation, shortness of breath, heart rate increased and weakness generalized to be related to SHINGRIX. Additional details were provided as follows: The patient was generally in good health. The patient was administered initial dose of SHINGRIX in the left arm and on the same day administered PNEUMOVAX in the right arm. The patient developed several reactions after receiving a dose of SHINGRIX and PNEUMOVAX. The healthcare professional (HCP) called to check on the patient 3 days later at which time the patient reported trouble with mobility and pain in the arm which the pneumonia vaccine was administered. The patient was advised to take TYLENOL around the clock at which the symptoms resolved. However, the patient continued to experience symptoms of fatigue, headache and overall achiness. After 2 weeks from the day of administration, the patient reported symptoms remained the same and in addition began to notice fluctuations in her blood glucose levels ranging from 80 to 170, which were previously controlled. The patient followed up with her primary care physician and was found to have shortness of breath and increased heart rate. The patient's physician conducted laboratory test which showed no results that would cause reported symptoms. The patient was also seen by their endocrinologist to test thyroid function and was still awaiting test results from the endocrinologist, however reported symptoms of fatigue and generalized weakness were still ongoing. The HCP reported otherwise, there had been no other changes in the patient's diet or medication regimen that would contribute to these symptoms. No further information was reported regarding the event. Lab Comments: In 2018, the patient had fluctuations in her blood glucose levels ranging from 80s to 170s, which were previously controlled. The laboratory test showed no results should be changed to showed no results which would cause reported symptoms.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back pain in a 79-year-old male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced back pain. On an unknown date, the outcome of the back pain was recovered/resolved. It was unknown if the reporter considered the back pain to be related to SHINGRIX. Additional details reported as follows: This case was reported by the reporter's wife. The wife called back for follow up on her previous reported events and mentioned during this call her husband, who was retired physician had his first shot of SHINGRIX in May and experienced back pain within about 12 hours of the injection. He took a hot shower and went to bed. He also used a heating pad for the pain. He was sedentary for a short while, no physical activity and the issue resolved. The reporter noted that the patient stated it was about a 5 out of 10 as far as pain goes. The patient plans to get the second shot. The patient had denied permission to contact their physician. The wife reported her husband being a retired physician directs the management. This case has been linked with US2018115098 and US2018GSK121406, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included neuropathy peripheral (peripheral neuropathy on the suboccipital neuralgia), pneumonia and shingles. Previously administered products included antidepressant, opioids and calcium channel drugs. Concurrent medical conditions included pain. 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 unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's father. The age at vaccination was not reported. The patient had pneumonia and all the sudden she started having Peripheral Neuropathy on the suboccipital neuralgia (PHN). Investigating physician was suspecting that it was PHN related to the shingles. Even though the patient did not get a rash, physician believes she had symptoms that were related to PHN due to shingles. At the time of this report, the physician was investigating the cause. The patient had been on opioids, antidepressant, calcium channel drugs and all sort of drugs to treat her pain and the reporter had been struggling with that for 5 years. The reporter stated that, his daughter then had the first SHINGRIX injection and all the pain went away for 3 to 4 days. Then it would come back. The reporter wanted to let the company know, that it could be worth investigating using SHINGRIX vaccine for other indications. This case has been linked to the US2018GSK138666, reported by the same reporter.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A, Hepatitis A virus test positive, Vaccination failure
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 28-year-old female patient who received HAVRIX (batch number 4H37Y, expiry date 8th November 2020) for prophylaxis. On 20th June 2018, the patient received the 1st dose of HAVRIX. On an unknown date, less than a year after receiving HAVRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and hepatitis A. On an unknown date, the outcome of the vaccination failure and hepatitis A were unknown. It was unknown if the reporter considered the vaccination failure and hepatitis A to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient received HAVRIX and after having labs drawn tested positive for hepatitis A. No further information was reported. This case was considered as suspected vaccination failure as time to onset for the event and details regarding vaccination schedule were unknown. The batch number reported for HAVRIX (4H374) did not exist and was updated to 4H37Y, as per sales database.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Limb injury, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder injury in a 37-year-old female patient who received FLUARIX QUADRIVALENT (batch number F3T75, expiry date 31st May 2018) for prophylaxis. On 13th October 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular). On 13th October 2017, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder injury, injection site pain, shoulder pain, injected limb mobility decreased and difficulty sleeping. Rechallenge with FLUARIX QUADRIVALENT was positive. On an unknown date, the outcome of the shoulder injury, injection site pain, shoulder pain, injected limb mobility decreased and difficulty sleeping were not recovered/not resolved. It was unknown if the reporter considered the shoulder injury, injection site pain, shoulder pain, injected limb mobility decreased and difficulty sleeping to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was administered FLUARIX QUADRIVALENT in the left deltoid. Last year, after the vaccination, the injection site hurt a lot more than usual (injection site pain) and the pain had been progressing since then to the point that she could no longer move her shoulder (injected limb mobility decreased). The pain kept her up at night and she had lost range of motion. The patient has had a month of pain management and rehabilitation, but she was still experiencing the problem. The patient was told the Flu vaccine she received was manufactured by GlaxoSmithKline, but did not know the name. The batch number of the suspect vaccine was reported as F3Y75, however it was changed to F3T75 as per latest sales data sheet.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder injury in a 37-year-old female patient who received FLUARIX QUADRIVALENT (batch number F3T75, expiry date 31st May 2018) for prophylaxis. On 13th October 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular). On 13th October 2017, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced shoulder injury, injection site pain, shoulder pain, injected limb mobility decreased and difficulty sleeping. Rechallenge with FLUARIX QUADRIVALENT was positive. On an unknown date, the outcome of the shoulder injury, injection site pain, shoulder pain, injected limb mobility decreased and difficulty sleeping were not recovered/not resolved. It was unknown if the reporter considered the shoulder injury, injection site pain, shoulder pain, injected limb mobility decreased and difficulty sleeping to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was administered FLUARIX QUADRIVALENT in the left deltoid. Last year, after the vaccination, the injection site hurt a lot more than usual (injection site pain) and the pain had been progressing since then to the point that she could no longer move her shoulder (injected limb mobility decreased). The pain kept her up at night and she had lost range of motion. The patient has had a month of pain management and rehabilitation, but she was still experiencing the problem. The patient was told the Flu vaccine she received was manufactured by GlaxoSmithKline, but did not know the name. The batch number of the suspect vaccine was reported as F3Y75, however it was changed to F3T75 as per latest sales data sheet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscle swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle swelling in a 60-year-old female patient who received SHINGRIX (batch number 95LX9 ?, expiry date 22nd February 2021) for prophylaxis. On 19th July 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced muscle swelling and localized erythema. On an unknown date, the outcome of the muscle swelling and localized erythema were unknown. It was unknown if the reporter considered the muscle swelling and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional stated that a patient developed redness and swelling of the bicep. The SHINGRIX was administered in the deltoid. The health care professional shared adverse information to the Agency via health care professional chat. The health care professional stated injection was in the deltoid, but the bicep was red and swollen, not the deltoid. Clarification had been requested for the batch number.
Sex: M
Vaccine: MENB
Symptoms: Fall, Syncope
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient (age: 16, unknown unit) of an unspecified age and ethnicity received TRUMENBA, (Lot # S85201, Exp 31Dec2019) via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient was given a TRUMENBA and fell back on the table, fainting on an unspecified date with outcome of unknown. Information about lot number already provided.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, itchy bump on arm where vaccine was administered. This is a known side effect. Will monitor for worsening signs or symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Headache most of the day after the injection; soreness around injection site.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Disorientation, Dizziness, Fall, Mobility decreased, Muscular weakness
Clinical narrative: Patient received the vaccine, the next morning when he woke up he felt very dizzy and disoriented. He experienced extreme muscle weakness which caused him to fall to the floor. Due to his muscle weakness he was unable to pull himself up and was helpless until his handyman arrived 4 hours later.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oral disorder
Clinical narrative: Swelling at injection site, hot and red. Also red bump on child body and one in childs mouth.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Oral mucosal erythema, Swelling
Clinical narrative: Swelling at injection site, hot and red. Also red bump on child body and one in childs mouth.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: Ache and sore muscles and tired.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth, Rash
Clinical narrative: Soreness at site, redness at site, rash on arm, fever on arm and at site, large lump on and rash on bicep muscle. All symptoms have occurred in 7 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Soreness at site, redness at site, rash on arm, fever on arm and at site, large lump on and rash on bicep muscle. All symptoms have occurred in 7 days.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 2 min. after GARDASIL, pt. fainted for 5-10 sec. Did not hit head. No vomiting. OJ and sucker given prior to administration. Laid down. BP 113/67 HR 82. Monitored for 20 more min. in office. VS WNL 115/69 HR 77.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh swollen, redness, tender.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Neck pain, Rash, Skin discolouration
Clinical narrative: Fine skin colored palpable rash primarily (L) arm but elsewhere as well developed night after vaccination. Extreme fatigue and neck pain day after. Now starting to improve three days later.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Dizziness, Hyperhidrosis
Clinical narrative: Upon administration of vaccine, pt experienced light headedness and profuse sweating, called 911 within 2 minutes, paramedics arrived, took pt blood pressure, pulse and sugar, all within normal range, within minutes pt began feeling better, paramedics asked if pt wanted to go to ER, pt refused, pt was able to get up on her own strength and walk out, I followed up with pt later in the afternoon, pt states all was well.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Dr's office called reporting that Pt came in the next day after vaccine was given complaining of swelling in the right arm and pain. the dr said that pt. Has experienced allergic reaction and prescribed keflex , prednisone and ibuprofen.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Malaise, Swelling
Clinical narrative: Patient reported breathing difficulty, swelling, feeling sick. She visited urgent care morning of 8/2/18.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Patient started to notice trouble focusing with his eyes the day after getting vaccine. He was able to see normally, but if he tried to focus to read music (he is a musician) then he had trouble. Continued 7/12 with trouble focusing to read music until the evening. Felt like things were just out of focus. He does have bifocal glasses. He noticed if he tipped his glasses up and looked through the bottom of the lens, things became more clear, came back into focus. Seen in office 7/13/18. Felt his vision was completely back to normal. No headaches. No double vision or blurry vision. No eye pain.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came to the pharmacy with concerns of injection site redness, swelling, and itching. We discussed using ibuprofen OTC, BENADRYL OTC, and seeking medical attention in case of infection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Ocular hyperaemia, Swelling face
Clinical narrative: 7.27.2018 Patient got the 2nd dose of SHINGRIX. Developed rash at injection site, swollen face, and bloodshot eyes post-vaccination. Symptoms started on 7.28.2018. She notified her doctor on 7.30.2018 regarding her adverse reactions. Doctor told her to continue with BENADRYL and ADVIL. 8.1.2018 symptoms have subsided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature decreased, Muscle spasms, Nausea, Pain
Clinical narrative: Normal pain turning to nausea. After 12 hours patient's temperature dropped to 74.3 resulting in shaking and muscle spasms. I did not go to the hospital because we live in a remote area. I used hot tea warm clothes and blankets until my temperature started to come back up. It rose to 100.5 and I took one 500mg aspirin and it gradually dropped back to normal. This was over a period of 8 hours. I was no longer nauseated and was able to eat and drink but was very weak for the rest of the day.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Normal pain turning to nausea. After 12 hours patient's temperature dropped to 74.3 resulting in shaking and muscle spasms. I did not go to the hospital because we live in a remote area. I used hot tea warm clothes and blankets until my temperature started to come back up. It rose to 100.5 and I took one 500mg aspirin and it gradually dropped back to normal. This was over a period of 8 hours. I was no longer nauseated and was able to eat and drink but was very weak for the rest of the day.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Aggression, Crying, Head banging, Headache, Intentional self-injury
Clinical narrative: After the vaccination my son had hours of crying, fussiness and irritability. Then he started punching his head with his fists and crying saying his head hurt. He also started banging his head on the headboard of the bed. In the days after the shot he continued to bang his head on the floor, headboard and punch himself in the head. He had a very similar reaction to the vaccine shots in 2016 and the doctor told me that it was normal behavior for his age and that he was have temper tantrums. My son has had issues ever since then with meltdowns, crying fits and other things. This is only some of the reactions and symptoms he has had.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Irritability
Clinical narrative: After the vaccination my son had hours of crying, fussiness and irritability. Then he started punching his head with his fists and crying saying his head hurt. He also started banging his head on the headboard of the bed. In the days after the shot he continued to bang his head on the floor, headboard and punch himself in the head. He had a very similar reaction to the vaccine shots in 2016 and the doctor told me that it was normal behavior for his age and that he was have temper tantrums. My son has had issues ever since then with meltdowns, crying fits and other things. This is only some of the reactions and symptoms he has had.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: Large rash, tenderness and warmth to (L) arm.