chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Concomitant products included amlodipine, DIOVAN, flecainide, glucosamine, hydralazine, Levothyroxine, Montelukast, omeprazole, Pneumococcal vaccine, TYLENOL and XARELTO. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache. On an unknown date, the outcome of the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 14th May 2018 the patient received 1st dose of pneumococcal vaccine on right arm intramuscularly. The patient reported that he experienced muscle aches on his legs, back and shoulders. The patient planned to follow up with his physician on an unknown date.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Concomitant products included amlodipine, DIOVAN, flecainide, glucosamine, hydralazine, Levothyroxine, Montelukast, omeprazole, Pneumococcal vaccine, TYLENOL and XARELTO. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache. On an unknown date, the outcome of the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 14th May 2018 the patient received 1st dose of pneumococcal vaccine on right arm intramuscularly. The patient reported that he experienced muscle aches on his legs, back and shoulders. The patient planned to follow up with his physician on an unknown date.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood creatine phosphokinase, Blood magnesium, Blood phosphorus, Full blood count, Hepatitis B core antibody
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Concomitant products included amlodipine, DIOVAN, flecainide, glucosamine, hydralazine, Levothyroxine, Montelukast, omeprazole, Pneumococcal vaccine, TYLENOL and XARELTO. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache. On an unknown date, the outcome of the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 14th May 2018 the patient received 1st dose of pneumococcal vaccine on right arm intramuscularly. The patient reported that he experienced muscle aches on his legs, back and shoulders. The patient planned to follow up with his physician on an unknown date.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate, Rheumatoid factor, Thyroxine
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Concomitant products included amlodipine, DIOVAN, flecainide, glucosamine, hydralazine, Levothyroxine, Montelukast, omeprazole, Pneumococcal vaccine, TYLENOL and XARELTO. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache. On an unknown date, the outcome of the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 14th May 2018 the patient received 1st dose of pneumococcal vaccine on right arm intramuscularly. The patient reported that he experienced muscle aches on his legs, back and shoulders. The patient planned to follow up with his physician on an unknown date.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Thyroxine free, Vitamin B12
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX. Concomitant products included amlodipine, DIOVAN, flecainide, glucosamine, hydralazine, Levothyroxine, Montelukast, omeprazole, Pneumococcal vaccine, TYLENOL and XARELTO. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache. On an unknown date, the outcome of the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache were not recovered/not resolved. It was unknown if the reporter considered the fever, muscle pain, injection site erythema, dizziness, tiredness, injection site warmth, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 14th May 2018 the patient received 1st dose of pneumococcal vaccine on right arm intramuscularly. The patient reported that he experienced muscle aches on his legs, back and shoulders. The patient planned to follow up with his physician on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever in a adult female 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 fever and myalgia upper extremities. On an unknown date, the outcome of the fever and myalgia upper extremities were unknown. It was unknown if the reporter considered the fever and myalgia upper extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine, more than one month before the date of reporting. The patient did have a fever the first few days. However, the patient still had horrible muscle soreness in arms and shoulders, bilaterally, at the time of reporting. The patient asked what she could do about this and whether it was ok to have the second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling to be related SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to report that the patient was vaccinated at her doctor's office and thought SHINGRIX was given subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The pharmacist did not wanted to provide any additional information since, it wasn't given by the reporter. The pharmacist did not want to be contacted for any follow up information. No further information would be provided.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 85-year-old male patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was unchanged. The reporter considered the diarrhea to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included Vitamins. The patient received SHINGRIX in the left deltoid. The patient experienced diarrhea since receiving the SHINGRIX vaccination. The reporter was unable to provide additional information. The call was transferred to medical information.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX. Concomitant products included LAMICTAL, ZANTAC, MIRAPEX and trazodone. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd May 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue and upset stomach. On 23rd May 2018, the patient experienced rash. On an unknown date, the patient experienced pruritus. On 23rd May 2018, the outcome of the fatigue and upset stomach were recovered/resolved. On an unknown date, the outcome of the rash and pruritus were unchanged. The reporter considered the rash, pruritus, fatigue and upset stomach to be related to SHINGRIX. Additional details were provided as follows: At 18:45, the patient received SHINGRIX on the left arm at 18:45. The patient experienced stomach sickness. Two days after vaccination, the patient stated she woke up with itching and rash on her trunk, chest and middle of waist. The reporter gave permission to contact her health care provider and provided contact details for the same.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. Concurrent medical conditions included pruritus and pain. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patent experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The wife reported that her husband got a SHINGRIX vaccine about a month ago and experienced arm hurting for about 2 to 3 days after the injection. She does not have any other details of the vaccine. She stated her husband was a pharmacist. She did not believe he had reported this, as it was pretty common side effect. This case has been linked with case US2018093518 reported by the same reporter.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blotchy in a 63-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine and Bupropion XL. On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd May 2018, 5 days after receiving SHINGRIX, the patient experienced blotchy, itchy rash, erythematous rash and raised rash. On an unknown date, the outcome of the blotchy, itchy rash, erythematous rash and raised rash were not recovered/not resolved. The reporter considered the blotchy, itchy rash, erythematous rash and raised rash to be probably related to SHINGRIX. Additional details were provided as follows: The patient had originally contacted via social media. The patient received SHINGRIX in left arm. At night (before reporting), the patient experienced a sudden rash that started out on her sides and then spread to a good portion of the trunk of her body. The patient mentioned within last 3 hours she had developed an almost full body itchy rash and she was angry. The rash then spread rapidly to around her waist, the tops of her ears, her arms and thighs. The patient stated when she woke up in the morning of the reporting date, the rash had gone away mostly and there were only a few splotches left. The patient laid down for a nap in the afternoon and when she woke up, the rash was back. The patient stated that she had not done anything different, no new detergents, etc. The patient described the rash as red, itchy and raised. Also, the patient stated that some of the spots were big, the largest one being 2 by 3 inches and some of the spots were small. The patient called her doctor and left a message and was waiting to hear back from her. This patient originally contacted GlaxoSmithKline via social media and was advised to call to report the adverse event. The patient provided the confirmation number that she received in the social media response and details of her doctor. The patient did not have the information on the SHINGRIX vaccination she received.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Swelling, Walking aid user
Clinical narrative: Patient describes pain developing in left hip 5 hours after SHINGRIX vaccine was given in left arm. Required walker to move around. Symptoms improved 2 days after vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult male 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 fever and rash. On an unknown date, the outcome of the fever and rash were unknown. The reporter considered the fever to be related to SHINGRIX. The reporter considered the rash to be unrelated to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that a patient had a fever and a rash on the back of his knee following SHINGRIX.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 85-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. On 16th April 2018, the patient received the 1st dose of SHINGRIX. On 8th May 2018, 22 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 details were provided as follows: The patient had a history of shingles. The office manager reported that after vaccination with SHINGRIX the patient was seen by provider. The provider reported that 24 to 48 hours prior the patient had symptoms of shingles. On 8th May 2018, the shingles was confirmed during the visit.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female 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 erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities and itchy upper limbs were unknown. It was unknown if the reporter considered the erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced red itching of 4 inch in diameter on her arm post vaccination. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Infection, Limb discomfort
Clinical narrative: This case was reported by a consumer and described the occurrence of infection in a adult female patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and arm discomfort. In May 2018, the patient experienced infection. On 15th May 2018, the patient experienced tiredness, shivering, fever and erythema of extremities. The patient was treated with Antibiotics (Brand Names Not Known). SHINGRIX was discontinued. On an unknown date, the outcome of the infection and erythema of extremities were unknown and the outcome of the pain in arm, arm discomfort, tiredness, shivering and fever were recovered/resolved. It was unknown if the reporter considered the infection, pain in arm, arm discomfort, tiredness, shivering, fever and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. By the time the patient had walked outside to car and her arm was hurting and feeling heavy. Approximately 24 hours later, tiredness, shivering and chills came on suddenly and had a fever with body temperature 101.8 degree F, which lasted several hours. The next day of vaccination, arm turned pink or reddish, and ended up with an infection and had to his see primary care physician. The patient still on antibiotics for the infection. The physician suggested not get the 2nd dose of the vaccine. The physician however could not be certain that the infection was not caused by the needle prick opening. The patient did not contact the pharmacy.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of infection in a adult female patient who received SHINGRIX. On 14th May 2018, the patient received the 1st dose of SHINGRIX. On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and arm discomfort. In May 2018, the patient experienced infection. On 15th May 2018, the patient experienced tiredness, shivering, fever and erythema of extremities. The patient was treated with Antibiotics (Brand Names Not Known). SHINGRIX was discontinued. On an unknown date, the outcome of the infection and erythema of extremities were unknown and the outcome of the pain in arm, arm discomfort, tiredness, shivering and fever were recovered/resolved. It was unknown if the reporter considered the infection, pain in arm, arm discomfort, tiredness, shivering, fever and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. By the time the patient had walked outside to car and her arm was hurting and feeling heavy. Approximately 24 hours later, tiredness, shivering and chills came on suddenly and had a fever with body temperature 101.8 degree F, which lasted several hours. The next day of vaccination, arm turned pink or reddish, and ended up with an infection and had to his see primary care physician. The patient still on antibiotics for the infection. The physician suggested not get the 2nd dose of the vaccine. The physician however could not be certain that the infection was not caused by the needle prick opening. The patient did not contact the pharmacy.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 58-year-old male patient who received SHINGRIX (batch number 3S354, expiry date 4th July 2020). On 22nd May 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). In May 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site erythema. On 22nd May 2018, the patient experienced intramuscular formulation administered to other route. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX dose subcutaneously instead of intramuscular, which led to incorrect route of drug administration. The patient had a red area about 4 cm at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of blister in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 21 days after receiving SHINGRIX, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister and pruritus were unknown. It was unknown if the reporter considered the blister and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that after having had chicken pox as a junior high student, and know many with very painful case of shingles, the patient got the SHINGRIX about 3 weeks ago from the time of reporting. On the day of reporting in the morning the patient had noticed a couple itchy blisters, then more areas had developed. The patient asked if it was possibly a side effect. The patient was not sure if it was reaction to vaccine or allergy to something else but just realized it could be and said SHINGRIX was not a live vaccine though.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Flushing, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 69-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020). Concomitant products included pramipexole. On 21st May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced rash and flushing. On 22nd May 2018, the patient experienced upset stomach. On 22nd May 2018, the outcome of the upset stomach was recovered/resolved. On an unknown date, the outcome of the rash and flushing were not recovered/not resolved. It was unknown if the reporter considered the rash, upset stomach and flushing to be related to SHINGRIX. Additional details were provided as follows: The patient started Pramipexole the same day as the SHINGRIX. In less than a week after receiving SHINGRIX, the patient experienced a rash on neck down to waist and flushing. The patient also experienced sickness to the stomach, just for the day. No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic
Clinical narrative: This case was reported by a physician and described the occurrence of allergic skin reaction in a male 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 allergic skin reaction. On an unknown date, the outcome of the allergic skin reaction was unknown. It was unknown if the reporter considered the allergic skin reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporting physician was the patient. The patient received the SHINGRIX vaccine and developed a topical allergic reaction. The patient had photos of allergic reaction and was ready to provide them. This case has been linked with US2018GSK093092, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis allergic
Clinical narrative: This case was reported by a physician and described the occurrence of allergic skin reaction 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 allergic skin reaction. On an unknown date, the outcome of the allergic skin reaction was unknown. It was unknown if the reporter considered the allergic skin reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine and developed a topical allergic reaction. The patient had photos of allergic reaction and was ready to provide them. This case has been linked with US2018GSK093091, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Neuralgia, Oral disorder, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th April 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm. On 1st May 2018, the patient experienced influenza-like symptoms, malaise and general body pain. In May 2018, the patient experienced scar. On an unknown date, the patient experienced nerve pain, oral lesion and skin sensitization. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, nerve pain, malaise and general body pain were recovered/resolved and the outcome of the oral lesion and skin sensitization were recovering/resolving and the outcome of the scar was unknown. The reporter considered the pain in arm, influenza-like symptoms, nerve pain, malaise, general body pain, oral lesion, scar and skin sensitization to be related to SHINGRIX. Additional details were reported as follows: On the same day of vaccination, the patient experienced arm pain that resolved in 1 to 2 days. The patient stated that the day after receiving the vaccine, experienced flu-like symptoms that included malaise, body aches and general malaise and flu-like symptoms resolved within 24 hours. The patient stated that approximately 2.5 weeks following the SHINGRIX vaccine, experienced a lesion on the roof of her mouth that lasted approximately 2 weeks and the lesion had healed, however, there was still some sensitivity on the skin where the lesion was located and also that is feels like a little scar was there. The patient stated that approximately 2.5 weeks after receiving the vaccine, she experienced sharp nerve like pain in her back that felt like someone had shocked her and that pain lasted for 3 to 4 days before going away. The patient stated that he doctor recommended that she should not get the 2nd dose of SHINGRIX.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Scar, Skin sensitisation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th April 2018, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm. On 1st May 2018, the patient experienced influenza-like symptoms, malaise and general body pain. In May 2018, the patient experienced scar. On an unknown date, the patient experienced nerve pain, oral lesion and skin sensitization. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, nerve pain, malaise and general body pain were recovered/resolved and the outcome of the oral lesion and skin sensitization were recovering/resolving and the outcome of the scar was unknown. The reporter considered the pain in arm, influenza-like symptoms, nerve pain, malaise, general body pain, oral lesion, scar and skin sensitization to be related to SHINGRIX. Additional details were reported as follows: On the same day of vaccination, the patient experienced arm pain that resolved in 1 to 2 days. The patient stated that the day after receiving the vaccine, experienced flu-like symptoms that included malaise, body aches and general malaise and flu-like symptoms resolved within 24 hours. The patient stated that approximately 2.5 weeks following the SHINGRIX vaccine, experienced a lesion on the roof of her mouth that lasted approximately 2 weeks and the lesion had healed, however, there was still some sensitivity on the skin where the lesion was located and also that is feels like a little scar was there. The patient stated that approximately 2.5 weeks after receiving the vaccine, she experienced sharp nerve like pain in her back that felt like someone had shocked her and that pain lasted for 3 to 4 days before going away. The patient stated that he doctor recommended that she should not get the 2nd dose of SHINGRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a physician and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and skin warm. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: This case was created for the patient in reporter's building. The age at vaccination was not reported. The events were resolved in several days. The reporter believed it was local reaction to the medication. This was 1 of 4 cases, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a physician and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities, swelling arm and skin warm. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and skin warm were recovered/resolved. It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's arm was so painful during night and the patient applied ice pain on it. Next day after vaccination, the patient's upper arm was red, swollen and warm to touch. The patient believed that it was local reaction to the medication.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of local swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced local swelling, erythema, contusion and skin warm. On an unknown date, the outcome of the local swelling, erythema, contusion and skin warm were unknown. It was unknown if the reporter considered the local swelling, erythema, contusion and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On Tuesday, the patient received SHINGRIX on unknown deltoid. The patient had possible reaction to SHINGRIX and wondered that if any immunization nurses had seen. On Thursday, the patient experienced large swollen area around diameter 8 cm by 6 cm over biceps and the area was sore like bruise and warm but muscle was not painful to use, so it must be fairly superficial. It was unknown whether the events were related to SHINGRIX or not as its edge was at least 4 cm below injection site. This is 1 of 4 cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 8 days after receiving SHINGRIX, the patient experienced itchy rash and popular rash. The patient was treated with hydrocortisone. On an unknown date, the outcome of the itchy rash and popular rash were recovered/resolved. It was unknown if the reporter considered the itchy rash and popular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Eight to nine days after vaccination, the patient experienced rash on her cheeks, forehead, hairline, and both forearms. Rash was mildly itchy and popular. Rash resolved after applying Hydrocortisone cream to affected areas. The lot number or expiry date was not reported by the healthcare professional during call.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX (batch number 32GR4 ?, expiry date 4th July 2020). Concomitant products included ADVAIR and Blood Pressure Medication. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. On 23rd May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, chills, fatigue and headache. On an unknown date, the outcome of the pain in arm, chills, fatigue and headache were not recovered/not resolved. The reporter considered the pain in arm, chills, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The concomitant drug included anxiety medication. The caller was pharmacist reporting that one of his patients received 1st dose of SHINGRIX yesterday that is 23rd May 2018 and was reporting to be experiencing arm pain, headache, chills and overall fatigue.
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vertigo in male patient who received SHINGRIX. Concomitant products included lamotrigine. In April 2018, the patient received SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unchanged. It was unknown if the reporter considered the vertigo to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. About 4 to 5 weeks before the date of reporting, the patient received SHINGRIX. The patient experienced 3 episodes of vertigo since the vaccination.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chills in a 55-year-old female patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 21st May 2018, the patient received the 1st dose of SHINGRIX. On 21st May 2018, less than a day after receiving SHINGRIX, the patient experienced chills. On 22nd May 2018, the patient experienced fever, headache and influenza-like symptoms. On 24th May 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills and influenza-like symptoms were unknown and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the chills, fever, headache and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: In the evening of the vaccination day, the patient experienced chills and shivering. One day after vaccination, the patient experienced headache, felt like a low grade fever, flu-like symptoms, and did not go to work. On 23rd May 2018, the patient felt better but had a 101 F temperature at 12 noon and slept all day. By 24th May 2018 morning the patient still had the headache and no fever. No additional information was provided.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Diarrhoea, Skin warm, Vomiting
Clinical narrative: Day after injection patient had an episode of emesis and one of diarrhea. Lt arm became beet red and even had blistering on yesterday. Today not as red and non tender. Warm 12.7cm x 12.7cm. Mom gave a dose of ibuprofen yesterday and cool cloth placed on arm. Having mom give ibuprofen every 6 hours for next 48 hr along with cold compressed.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever 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 fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician reported on online chat that the patient received SHINGRIX at a pharmacy and had fever for one day which resolved with ibuprofen. The physician did not provide any other information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX. In May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by medical assistant via chat. The age at vaccination was not reported. The patient received SHINGRIX 2 weeks ago. The 1st couple of days the patient felt pain in arm but now she was unable to lay the left arm due to the pain. The patient went to my chiropractor but that did not help. the patient took an appointment with primary care physician for Tuesday to talk about this. The 1st shot at pharmacy was fine but he booster at another pharmacy. It was unable to clarify or obtain any additional information. The health care professional ended the chat abruptly.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Influenza like illness, Injection site pain, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX. Concurrent medical conditions included shingles (10 years ago) and seasonal allergy. Concomitant products included atenolol, NASACORT, Probiotic, vitamin D and ELIQUIS. On 19th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 19th mMy 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, headache and nightmare. On 20th May 2018, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient was treated with TYLENOL. On 19th May 2018, the outcome of the injection site pain was recovered/resolved. On 20th May 2018, the outcome of the nightmare was recovered/resolved. On 21st May 2018, the outcome of the general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, fever and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, headache and nightmare to be related to SHINGRIX. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The patient experienced pain at injection site during the injection. By the evening of the day of vaccination, at around 9 pm, the patient experienced headache, body ache, difficulty sleeping, had a nightmare, had runny and stuffy nose and felt nauseated. One day after vaccination, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient reported that this contented through Sunday, 20th May 2018 and she also felt weak and shaky and could not shower or attend church. The patient had a fever of 101 degree F and she took TYLENOL to treat this. The patient had flu like symptoms that lasted all day Sunday and that she went to bed Sunday night at 8:30 pm. When she awoke Monday, 21st May 2018 in the morning, the symptoms had resolved, she felt fine and was able to go to work. The patient was unable to provided full demographics for pharmacy or for her physician. The contact details of the physician was provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Nausea, Nervousness, Nightmare, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX. Concurrent medical conditions included shingles (10 years ago) and seasonal allergy. Concomitant products included atenolol, NASACORT, Probiotic, vitamin D and ELIQUIS. On 19th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 19th mMy 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, headache and nightmare. On 20th May 2018, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient was treated with TYLENOL. On 19th May 2018, the outcome of the injection site pain was recovered/resolved. On 20th May 2018, the outcome of the nightmare was recovered/resolved. On 21st May 2018, the outcome of the general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, fever and headache were recovered/resolved. It was unknown if the reporter considered the injection site pain, general body pain, difficulty sleeping, nasal stuffiness, runny nose, nausea, feelings of weakness, shaky feelings, influenza-like symptoms, headache and nightmare to be related to SHINGRIX. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The patient experienced pain at injection site during the injection. By the evening of the day of vaccination, at around 9 pm, the patient experienced headache, body ache, difficulty sleeping, had a nightmare, had runny and stuffy nose and felt nauseated. One day after vaccination, the patient experienced feelings of weakness, shaky feelings, influenza-like symptoms and fever. The patient reported that this contented through Sunday, 20th May 2018 and she also felt weak and shaky and could not shower or attend church. The patient had a fever of 101 degree F and she took TYLENOL to treat this. The patient had flu like symptoms that lasted all day Sunday and that she went to bed Sunday night at 8:30 pm. When she awoke Monday, 21st May 2018 in the morning, the symptoms had resolved, she felt fine and was able to go to work. The patient was unable to provided full demographics for pharmacy or for her physician. The contact details of the physician was provided.