chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Incomplete course of vaccination, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced sickness, weakness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and weakness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the sickness and weakness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that she had called previously in December or January and noted that she did not receive her 2nd dose of SHINGRIX, which led to incomplete course of vaccination. She also noted she was sick and weak for a week after the 1st dose. The caller disconnected abruptly, no additional information was gathered. The caller clarified name spelling but unable to locate caller in sale force database.
Sex: F
Vaccine: VARZOS
Symptoms: Culture negative, Herpes simplex, Pain, Rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of rash in a 89-year-old female patient who received SHINGRIX for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 28th April 2018, 1 days after receiving SHINGRIX, the patient experienced rash and pain burning. The patient was treated with VALTREX. SHINGRIX was discontinued. On an unknown date, the outcome of the rash and pain burning were not recovered/not resolved. The reporter considered the rash and pain burning to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 88 years or 89 years. Next day after SHINGRIX dose, the patient experienced rash and burning pain. These event continued to get worse so the patient visited physician on 2nd May 2018. As per physician the symptoms were consistent to herpes simplex and started patient on VALTREX. The culture test was negative so they associated rash and burning pain with vaccine. The patient chose not to get 2nd dose of vaccine.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 52-year-old female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2012-13 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2012-13 season. On an unknown date, 1 day after receiving Influenza vaccine unspecified 2012-13 season, the patient experienced pain, loss of energy and mobility decreased. On an unknown date, the outcome of the pain, loss of energy and mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain, loss of energy and mobility decreased to be related to Influenza vaccine unspecified 2012-13 season. Additional details were reported as follows: The age at vaccination was not reported but it could be 51 or 52 year old. In 2012 or 2013, the patient received the flu shot. The next day she was laying on the floor all day with achiness, no energy and motionless. The patient symptoms were resolved after one whole day. This reporter consented to follow up. This case has been linked with case US2019040214, reported by same reporter and having same patient.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a 53-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 22nd October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash and pain in arm. On an unknown date, the outcome of the rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on an unknown arm. The events were lasted for 3 days. The reporter had given permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a elderly male patient who received SHINGRIX for prophylaxis. 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 adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but it could be 71 or 72 year old. The reporter had called earlier in the past and reported the adverse event that her husband experienced with 1st dose of SHINGRIX. For tolerance of 2nd dose refer linked case US2019041406. This case has been linked to case US2019041402 and US2019GSK043645, reported by same reporter (For patient's wife).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-decade-old male patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in late 60s received 2nd dose of SHINGRIX yesterday and experienced the redness, hot and pain at the injection side and experiencing tiredness, muscle pain, body ache. All that the patient need something that would wade her pain. The patient asked if they could receive pain killer ADVIL or TYLENOL and how long would this condition last. This case has been linked to the case US2019AMR042890, reported by same reporter (wife's case).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-decade-old male patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in late 60s received 2nd dose of SHINGRIX yesterday and experienced the redness, hot and pain at the injection side and experiencing tiredness, muscle pain, body ache. All that the patient need something that would wade her pain. The patient asked if they could receive pain killer ADVIL or TYLENOL and how long would this condition last. This case has been linked to the case US2019AMR042890, reported by same reporter (wife's case).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-decade-old male patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain were unknown. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, weakness, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in late 60s received 2nd dose of SHINGRIX yesterday and experienced the redness, hot and pain at the injection side and experiencing tiredness, muscle pain, body ache. All that the patient need something that would wade her pain. The patient asked if they could receive pain killer ADVIL or TYLENOL and how long would this condition last. This case has been linked to the case US2019AMR042890, reported by same reporter (wife's case).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 60-decade-old female patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced weakness, muscle pain and general body pain. On an unknown date, the outcome of the weakness, muscle pain and general body pain were unknown. It was unknown if the reporter considered the weakness, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in late 60s received 2nd dose of SHINGRIX yesterday and experienced the redness, hot and pain at the injection side and experiencing tiredness, muscle pain, body ache. All that the patient need something that would wade his pain. The patient asked if they could receive pain killer ADVIL or TYLENOL and how long would this condition last. This case has been linked to the case US2019GSK046315, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 60-decade-old female patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced weakness, muscle pain and general body pain. On an unknown date, the outcome of the weakness, muscle pain and general body pain were unknown. It was unknown if the reporter considered the weakness, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in late 60s received 2nd dose of SHINGRIX yesterday and experienced the redness, hot and pain at the injection side and experiencing tiredness, muscle pain, body ache. All that the patient need something that would wade his pain. The patient asked if they could receive pain killer ADVIL or TYLENOL and how long would this condition last. This case has been linked to the case US2019GSK046315, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of weakness in a 60-decade-old female patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced weakness, muscle pain and general body pain. On an unknown date, the outcome of the weakness, muscle pain and general body pain were unknown. It was unknown if the reporter considered the weakness, muscle pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was in late 60s received 2nd dose of SHINGRIX yesterday and experienced the redness, hot and pain at the injection side and experiencing tiredness, muscle pain, body ache. All that the patient need something that would wade his pain. The patient asked if they could receive pain killer ADVIL or TYLENOL and how long would this condition last. This case has been linked to the case US2019GSK046315, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patients experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter had talked to many people who also had unpleasant reactions. This case has been linked with US2019GSK018910, reported by same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 75-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 4th July 2021) for prophylaxis. On 2nd March 2019, the patient received SHINGRIX (intramuscular). On 3rd March 2019, 1 days after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving. The reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient began to experience swelling at the site of injection on Sunday and it has continued to swell. At the time of report, the swelling was smaller than softball but larger than golf ball. There was no pain. No further information provided.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in November 2018). On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 21st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 23rd February 2019, the patient experienced itchy rash and red rash. On an unknown date, the patient experienced pain in arm, erythema of extremities, extremities hot feeling of and painful rash. On an unknown date, the outcome of the injection site pain, erythema of extremities, red rash and extremities hot feeling of were unknown and the outcome of the pain in arm and painful rash were recovered/resolved and the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the injection site pain, pain in arm, erythema of extremities, itchy rash, red rash, extremities hot feeling of and painful rash to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX vaccine on left arm. At the time of vaccine administration the injection hurt, the patient's arm was sore and became hot and red. 2 days after vaccination, the patient started to develop red bumps which could not be felt. The bumps broke on her thighs, on the inside of her legs, behind her knee caps and back. The rash was itchy. The patient went to a clinic on 25th February 2019 and was provided creams. The patient went to her primary care physician on 27th February 2019 because she felt like she was not getting better. The patient noted that she red bumps broke out in places on her buttock and inside of left arm that were the size of a pencil eraser and solid red.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in November 2018). On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 21st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 23rd February 2019, the patient experienced itchy rash and red rash. On an unknown date, the patient experienced pain in arm, erythema of extremities, extremities hot feeling of and painful rash. On an unknown date, the outcome of the injection site pain, erythema of extremities, red rash and extremities hot feeling of were unknown and the outcome of the pain in arm and painful rash were recovered/resolved and the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the injection site pain, pain in arm, erythema of extremities, itchy rash, red rash, extremities hot feeling of and painful rash to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX vaccine on left arm. At the time of vaccine administration the injection hurt, the patient's arm was sore and became hot and red. 2 days after vaccination, the patient started to develop red bumps which could not be felt. The bumps broke on her thighs, on the inside of her legs, behind her knee caps and back. The rash was itchy. The patient went to a clinic on 25th February 2019 and was provided creams. The patient went to her primary care physician on 27th February 2019 because she felt like she was not getting better. The patient noted that she red bumps broke out in places on her buttock and inside of left arm that were the size of a pencil eraser and solid red.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysphagia, Dyspnoea, Mouth swelling, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 56-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 1st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd March 2019, 1 days after receiving SHINGRIX, the patient experienced fever and chills. On 4th March 2019, the patient experienced swollen mouth, difficulty breathing, unable to swallow, pain and tingling of extremity. The patient was treated with BENADRYL. On 4th March 2019, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the swollen mouth, difficulty breathing and unable to swallow were recovered/resolved and the outcome of the pain and tingling of extremity were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, swollen mouth, difficulty breathing, unable to swallow, pain and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On 2nd March 2019 and 3rd March 2019, the patient experienced chills and fever. Three days after vaccination, the patient experienced mouth swelling, difficulty breathing and swallowing, aches, pain, and tingling in her left arm. On Monday morning, 4th March 2019, she felt fine. However, in the afternoon, her mouth began to swell, causing her to have difficulty breathing and swallowing. She took BENADRYL and the symptoms resolved. Then, after an unknown time on the same day, she began to experience aches, pain, and tingling in her left arm that has not resolved. The reporter did not consent to follow up. The reporter was unable to obtain additional information.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 56-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 1st March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd March 2019, 1 days after receiving SHINGRIX, the patient experienced fever and chills. On 4th March 2019, the patient experienced swollen mouth, difficulty breathing, unable to swallow, pain and tingling of extremity. The patient was treated with BENADRYL. On 4th March 2019, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the swollen mouth, difficulty breathing and unable to swallow were recovered/resolved and the outcome of the pain and tingling of extremity were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, swollen mouth, difficulty breathing, unable to swallow, pain and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On 2nd March 2019 and 3rd March 2019, the patient experienced chills and fever. Three days after vaccination, the patient experienced mouth swelling, difficulty breathing and swallowing, aches, pain, and tingling in her left arm. On Monday morning, 4th March 2019, she felt fine. However, in the afternoon, her mouth began to swell, causing her to have difficulty breathing and swallowing. She took BENADRYL and the symptoms resolved. Then, after an unknown time on the same day, she began to experience aches, pain, and tingling in her left arm that has not resolved. The reporter did not consent to follow up. The reporter was unable to obtain additional information.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure increased, Chills, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hot flashes. Previously administered products included SHINGRIX (received 1st dose in fall of 2018). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th February 2019, 1 days after receiving SHINGRIX, the patient experienced fatigue and pain in arm. On 17th February 2019, the patient experienced chills, upset stomach, headache and malaise. On 26th February 2019, the patient experienced increased blood pressure and heart rate increased. On an unknown date, the outcome of the fatigue, pain in arm, upset stomach, headache and malaise were recovered/resolved and the outcome of the chills, increased blood pressure and heart rate increased were not recovered/not resolved. The reporter considered the fatigue, pain in arm, chills, upset stomach, headache, malaise, increased blood pressure and heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient arm was sore and she was a little tired. Two days after vaccination, the patient experienced chills, upset stomach, headache and malaise. When she woke up on 17th February 2019, and stepped out of bed, she was exhausted and started to have chills, shivering, headache, and an upset stomach. She did feel good in general. The stomach problems lasted only one day but the other symptoms resolved after about five days except the chills which she still experiences. Eleven days after vaccination, the patient experienced blood pressure increased and heart rate decreased. Last week, she noticed her blood pressure had increased to around 150/90. Emergency room visit was required. It normally stays in the regular range but had increased at times with medication. However, it was remaining high and went to 189/117 this morning so her doctor prescribed medication. She was seeing her doctor tomorrow to try and determine if this might have been caused by the SHINGRIX or a new condition she was developing. Along with the increased blood pressure, her heart rate had increased. It usually was in the 80s but now falls within the 80s or 90s. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Malaise, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included hot flashes. Previously administered products included SHINGRIX (received 1st dose in fall of 2018). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th February 2019, 1 days after receiving SHINGRIX, the patient experienced fatigue and pain in arm. On 17th February 2019, the patient experienced chills, upset stomach, headache and malaise. On 26th February 2019, the patient experienced increased blood pressure and heart rate increased. On an unknown date, the outcome of the fatigue, pain in arm, upset stomach, headache and malaise were recovered/resolved and the outcome of the chills, increased blood pressure and heart rate increased were not recovered/not resolved. The reporter considered the fatigue, pain in arm, chills, upset stomach, headache, malaise, increased blood pressure and heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The patient arm was sore and she was a little tired. Two days after vaccination, the patient experienced chills, upset stomach, headache and malaise. When she woke up on 17th February 2019, and stepped out of bed, she was exhausted and started to have chills, shivering, headache, and an upset stomach. She did feel good in general. The stomach problems lasted only one day but the other symptoms resolved after about five days except the chills which she still experiences. Eleven days after vaccination, the patient experienced blood pressure increased and heart rate decreased. Last week, she noticed her blood pressure had increased to around 150/90. Emergency room visit was required. It normally stays in the regular range but had increased at times with medication. However, it was remaining high and went to 189/117 this morning so her doctor prescribed medication. She was seeing her doctor tomorrow to try and determine if this might have been caused by the SHINGRIX or a new condition she was developing. Along with the increased blood pressure, her heart rate had increased. It usually was in the 80s but now falls within the 80s or 90s. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 52-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received SHINGRIX. On 6th March 2019, 1 days after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: The health care professional called to report that the patient experienced chills.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Oral herpes, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 77-year-old male patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. In February 2019, 14 days after receiving SHINGRIX, the patient experienced cold sores, tremor and fatigue. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the tremor and fatigue were unknown. It was unknown if the reporter considered the cold sores, tremor and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient chose to remain anonymous and declined to answer any detailed questions. The patient received the vaccine 4 weeks ago and a week or so after that he had shaking and fatigue. A week later a sore appeared on his penis. The patient described it as a cold sore. The patient said he used to get cold sores on his cheek but has not had one in years. The reporter did not give consent to follow up.
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX (batch number 4FS5N, expiry date 8th March 2019) for prophylaxis. On 9th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced shingles and post herpetic neuralgia. On an unknown date, the outcome of the shingles and post herpetic neuralgia were unknown. It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to SHINGRIX. Additional case details were reported as follows: Approximately one month later after vaccination, the patient developed Shingles which progressed to post herpetic neuralgia. Collected while tried to escalated an medical information (MI) questions. The reporter had to look in several different locations for the information and did not get to pull up scans. No additional details were provided.
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a neonate male patient who received ENGERIX B pediatric for prophylaxis.  On 15th January 2019, the patient received the 1st dose of ENGERIX B B pediatric (intramuscular) 10 µg. On an unknown date, less than a month after receiving ENGERIX B pediatric, the patient experienced injection site erythema, injection site swelling and injection site induration. The patient was treated with phytomenadione (Vitamin K). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site induration to be related to ENGERIX B pediatric. Additional details were provided as follows: The batch number was not reported. The physician reported that the patient received hepatitis B pediatric on date of birth 15th January 2019. She was not sure of where it was given, as it wasn't documented. The doctor believes it was given in the right thigh because Vitamin K was given in the left thigh. The doctor stated that she called the hospital and it was noted the product given was ENGERIX B. It was unknown when the events started, but the physician states she was 1st made aware at the 1 month well checkup visit.  The patient has been seen again in the office for these events on 4th March 2019 and has a follow up appointment also. Emergency room (ER) visit was required.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Injection site nodule
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 17th January 2019 09:00, the patient received the 1st dose of SHINGRIX (intrameningeal) .5 ml. On 17th January 2019, several hours after receiving SHINGRIX, the patient experienced fever, injection site pain, shivering, headache, tiredness, injection site nodule and muscle pain. On 18th January 2019, the patient experienced sleepiness and inability to work. On an unknown date, the outcome of the fever, shivering, headache, tiredness and inability to work were recovered/resolved and the outcome of the injection site pain, sleepiness, injection site nodule and muscle pain were not recovered/not resolved. The reporter considered the fever, injection site pain, shivering, headache, tiredness, sleepiness, injection site nodule, muscle pain and inability to work to be related to SHINGRIX. Additional details were provided as follows: On Thursday at 9:00 am, the patient received vaccine and immediately experienced injected site soreness. The patient was tired that evening and went to bed early, in the night the patient developed shivering, headache, fever and muscle pain. On Friday the patient was unable to work and slept most of the day. The patient reported that shivering was worse and these lasted for about 3 days except for the muscle pain and the nodule that form around the site. The muscle pain didn't resolve until that week but the nodule was smaller but was still there. The patient consented to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 17th January 2019 09:00, the patient received the 1st dose of SHINGRIX (intrameningeal) .5 ml. On 17th January 2019, several hours after receiving SHINGRIX, the patient experienced fever, injection site pain, shivering, headache, tiredness, injection site nodule and muscle pain. On 18th January 2019, the patient experienced sleepiness and inability to work. On an unknown date, the outcome of the fever, shivering, headache, tiredness and inability to work were recovered/resolved and the outcome of the injection site pain, sleepiness, injection site nodule and muscle pain were not recovered/not resolved. The reporter considered the fever, injection site pain, shivering, headache, tiredness, sleepiness, injection site nodule, muscle pain and inability to work to be related to SHINGRIX. Additional details were provided as follows: On Thursday at 9:00 am, the patient received vaccine and immediately experienced injected site soreness. The patient was tired that evening and went to bed early, in the night the patient developed shivering, headache, fever and muscle pain. On Friday the patient was unable to work and slept most of the day. The patient reported that shivering was worse and these lasted for about 3 days except for the muscle pain and the nodule that form around the site. The muscle pain didn't resolve until that week but the nodule was smaller but was still there. The patient consented to follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site pain after receiving 1st dose of SHINGRIX vaccine. The event lasted for 3 to 5 days.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Myosclerosis, Pain in extremity
Clinical narrative: ARM VERY VERY SORE- WORSE THAN EXPECTED, OVER THE PAST WEEK HAS GOTTEN SO SORE IT CAN BARELY BE LIFTED (BEEN TAKING TYLENOL WITHOUT ANY RELIEF) ENTIRE DELTOID MUSCLE IS HARD AS A ROCK.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Headache, Nausea, Vomiting
Clinical narrative: Patient is experiencing Headache, Nausea, Hot and Cold chills. The first shot in the series caused Nausea and Vomiting, Hot and Cold chills. The second shot is all the same as the first except the headache is now added.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Headache, Insomnia, Nausea
Clinical narrative: Woke up around 0130 on 03/14 with chills and body aches. Uncomfortable and unable to go back to sleep. Took Advil- only minimal relief. Developed nausea and worsening headache - described pain as shooting across the top of her head - cold packs provided some relief. Headache continues today but is described as dull, only occasional chills, nausea continues.. Red, flat rash noticed this morning. Not itchy, raised, or warm. Missed work yesterday but feeling improved today.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous
Clinical narrative: Woke up around 0130 on 03/14 with chills and body aches. Uncomfortable and unable to go back to sleep. Took Advil- only minimal relief. Developed nausea and worsening headache - described pain as shooting across the top of her head - cold packs provided some relief. Headache continues today but is described as dull, only occasional chills, nausea continues.. Red, flat rash noticed this morning. Not itchy, raised, or warm. Missed work yesterday but feeling improved today.
Age: 11.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Beta haemolytic streptococcal infection, Escherichia infection, Escherichia test positive, Immune system disorder, Immunology test abnormal
Clinical narrative: Shoulder arm injury. ICU admission. Surgery I&D. Immune system problems. Multiple infections.
Age: 11.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Incisional drainage, Infection, Infectious mononucleosis, Intensive care, Limb injury
Clinical narrative: Shoulder arm injury. ICU admission. Surgery I&D. Immune system problems. Multiple infections.
Age: 11.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Mononucleosis heterophile test positive, Skin infection, Streptococcus test positive
Clinical narrative: Shoulder arm injury. ICU admission. Surgery I&D. Immune system problems. Multiple infections.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site vesicles
Clinical narrative: A very large blister that formed over the injection site, was painful, lasted for several days, she was unable to put clothing over the affected area, resolved without intervention.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: After 7 days, still has radiating pain down and into shoulder, back and neck.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Feeling cold, Flushing, Gait disturbance
Clinical narrative: She felt faint, and very weak. Had difficulty walking. She felt like she was cold. Her skin flushed.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Feeling hot, Injection site erythema
Clinical narrative: 3-8-19 My wife and I each received a SHINGRIX 50 Mcg/0.5 ml injection at our local Pharmacy store. 3-9 - 530 AM Woke up, did exercise on treadmill, walked the dog. About 9 AM felt really tired. Very unusual for me. Got the shivers, felt hot. Took my Temp is was 99.8. Laid down about 10 AM and slept for a couple of hours. Very unusual for me. Got up had something to eat. Still the chills, temp the same and a few shivers. 2 Laid down and slept for a couple more hours. Still hot but shivers almost gone Went to bed, slept OK 3-10 A little tired. Temp 98.6, no shivers. Went to church took nap in afternoon. 3-11 Felt good, right arm sore where shot given. Hurt to touch, it was red about 4 inch longs about 2' wide, running up and down my arm.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: 3-8-19 My wife and I each received a SHINGRIX 50 Mcg/0.5 ml injection at our local Pharmacy store. 3-9 - 530 AM Woke up, did exercise on treadmill, walked the dog. About 9 AM felt really tired. Very unusual for me. Got the shivers, felt hot. Took my Temp is was 99.8. Laid down about 10 AM and slept for a couple of hours. Very unusual for me. Got up had something to eat. Still the chills, temp the same and a few shivers. 2 Laid down and slept for a couple more hours. Still hot but shivers almost gone Went to bed, slept OK 3-10 A little tired. Temp 98.6, no shivers. Went to church took nap in afternoon. 3-11 Felt good, right arm sore where shot given. Hurt to touch, it was red about 4 inch longs about 2' wide, running up and down my arm.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain, Skin warm
Clinical narrative: Large area of painful redness BELOW injection site (not around it). Maybe 3 by 5 inches. Looks like a large bruise, warm to the touch. Examined at pharmacy 3/14, advised to visit doctor to rule out infection, which he did and doctor determined it was not infected.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Exposure during pregnancy, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Within 2 hours of receiving the shot, my left arm started hurting. I couldn't life my left arm for 2 days. After two days I noticed some improvement in that I could lift my arm slightly and that's when I noticed the pain was more localized in my left shoulder. It hurt to try and lift my left arm forward or to the side. Tasks like getting dressed, showering, reaching for high objects, putting on a seat belt all hurt tremendously. I also can't sleep on my left side and the pain when I lay down radiates down my whole left arm, making it difficult to sleep through the night. I received the shot when I was 16 weeks pregnant and am due July 21, 2019. The pain has now persisted for 6 weeks. 2 weeks after the pain started, I called the clinic nurse line to ask if this was normal to have this pain 2 weeks after a flu shot, the nurse conferred with Doctors and confirmed no it was not normal. She attempted to schedule me with an Ob/Gyn doctor the next day but the appointment got cancelled due to weather. I followed up with my Ob/Gyn 4 weeks after the shot and she looked at my arm, but didn't see any superficial reaction at the injection site and referred me to my primary care doctor. My PCP evaluated my arm and suspected a rotator cuff injury, bursitis, or capsulitis. She provided arm exercises to do at home. When those didn't show progress, my PCP referred me for physical therapy.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Periarthritis, Rotator cuff syndrome
Clinical narrative: Within 2 hours of receiving the shot, my left arm started hurting. I couldn't life my left arm for 2 days. After two days I noticed some improvement in that I could lift my arm slightly and that's when I noticed the pain was more localized in my left shoulder. It hurt to try and lift my left arm forward or to the side. Tasks like getting dressed, showering, reaching for high objects, putting on a seat belt all hurt tremendously. I also can't sleep on my left side and the pain when I lay down radiates down my whole left arm, making it difficult to sleep through the night. I received the shot when I was 16 weeks pregnant and am due July 21, 2019. The pain has now persisted for 6 weeks. 2 weeks after the pain started, I called the clinic nurse line to ask if this was normal to have this pain 2 weeks after a flu shot, the nurse conferred with Doctors and confirmed no it was not normal. She attempted to schedule me with an Ob/Gyn doctor the next day but the appointment got cancelled due to weather. I followed up with my Ob/Gyn 4 weeks after the shot and she looked at my arm, but didn't see any superficial reaction at the injection site and referred me to my primary care doctor. My PCP evaluated my arm and suspected a rotator cuff injury, bursitis, or capsulitis. She provided arm exercises to do at home. When those didn't show progress, my PCP referred me for physical therapy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Hypoaesthesia, Malaise, Pain in extremity
Clinical narrative: Patient presents to office for follow up vaccine reaction. SHINGRIX 2/22/19. She experienced a sore arm over the next 3 days. She then developed a scattered "rash" she describes as "chicken pox" like.   A few scattered pox marks on right upper leg, right hand. Blistered pox mark left temple which resolved with hydrocortisone. Malaise. Significant LUE pain radiating down left arm. Applying pressure along lateral epicondyle resulted in numbness of lateral 5th digit. Burning sensation. No rash. She presented to UC and was diagnosed with shingles. Valcyclovir ordered. Symptoms have largely resolved.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Varicella
Clinical narrative: Patient presents to office for follow up vaccine reaction. SHINGRIX 2/22/19. She experienced a sore arm over the next 3 days. She then developed a scattered "rash" she describes as "chicken pox" like.   A few scattered pox marks on right upper leg, right hand. Blistered pox mark left temple which resolved with hydrocortisone. Malaise. Significant LUE pain radiating down left arm. Applying pressure along lateral epicondyle resulted in numbness of lateral 5th digit. Burning sensation. No rash. She presented to UC and was diagnosed with shingles. Valcyclovir ordered. Symptoms have largely resolved.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Rash
Clinical narrative: EE reported low grade fever, rash, sore throat, body aches.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Patient had injection site reaction next day "size of a coin and it doubled by the evening" Patient took ibuprofen and used ice and it was better after couple days. Patient's husband called and said his wife had a reaction to the vaccine next day "size of a coin and then it doubled by the evening" The Pharmacist on duty recommended to take ibuprofen and use some ice. So patient did and was better after couple days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient stated arm was red and sore.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Pt mom reported pt had mostly all of the symptoms on VIS sheet.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Abnormal dreams, Influenza like illness, Nightmare, Oesophageal spasm
Clinical narrative: Flu-like symptoms, severe stomach pain. Worsened next day and developed esophageal spasms. Spams only lasted minutes. Vivid dreams, nightmares for 2 nights. Patient tolerated and did not go to hospital/doctor office. Self-limited symptoms resolved after 2 days.