chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling sensation on both arms; This case was reported by a consumer via interactive digital media and described the occurrence of tingling of extremity in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced tingling of extremity. On an unknown date, the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.  Additional details was not reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The patient had tingling sensation on both arm during 72hrs after vaccination. The patient felt fine after that, want to know about safety to get second dose. The patient stated that, the papers from pharmacy says the weakness or tingling in arms or legs should be reported. No further information was provided by reporter. consented to follow up was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling sensation on both arms; This case was reported by a consumer via interactive digital media and described the occurrence of tingling sensation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tingling sensation. On an unknown date, the outcome of the tingling sensation was unknown.   It was unknown if the reporter considered the tingling sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had tingling sensation on both arms after the vaccine. The reporter want to know if that a concern to get the second dose.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Malaise
Clinical narrative: Typical symptoms / Tiredness; Typical symptoms / just kind of blah; This case was reported by a consumer via other manufacturer and described the occurrence of fatigue in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included osteoporosis (Around 2001 when went to endocrinologist was diagnosed with it) and vitamin d deficiency (Around 2001 given a test for menopause, had gone through menopause so she went to an endocrinologist who found her vitamin d level was not enough to support her calcium so she was diagnosed with Vitamin D deficiency and started on medication for that). Concurrent medical conditions included penicillin allergy (occurred probably around the year 2010 after a flu virus had gotten kind), allergic reaction to analgesics (many years ago.) and adverse drug reaction.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fatigue and feeling unwell. On an unknown date, the outcome of the fatigue and feeling unwell were unknown.   It was unknown if the reporter considered the fatigue and feeling unwell to be related to Shingrix.  Additional details were provided as follows: In sometimes in 2019, the patient received Shingrix and had typical symptoms like tiredness and just kind of blah. The patient was not sure but thinks it was the Shingrix Vaccine. The reporter thought it was the new one, the 2 dose one and at that time some older people had gotten the old version of the shingles shot. The reporter thought the patient and husband were given the new one the Shingrix Vaccine. On 2nd Mar 2021, the patient got Pfizer Covid 19 vaccine and experienced headache and chills.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: arm pain persisted and is still slightly present / had her second dose / experienced some arm pain; arm pain described as sore and stiff; This case was reported by a consumer and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rotator cuff syndrome (torn rotator cuff in right arm). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 1st December 2020, batch number 2XG53, expiry date 12 February 2022, refer case US2021060551).   On 8th March 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm and limbs stiffness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the limbs stiffness was recovered/resolved.   It was unknown if the reporter considered the pain in arm and limbs stiffness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and experienced some arm pain described as sore and stiff and it was resolving. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021060551:different dose.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Strong reaction / A week of fever; Strong reaction / A week of / chills; Strong reaction / A week of / body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had  a week of fever, chills and body aches.  The reporter said that because of this the patient might not want to get the second shot.  The reporter asked would only one dose provide any protection against shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Has had a few patients that complained of a sore arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day 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 age at vaccination was not applicable for this report. The reporter stated that the few patients that complained of a sore arm the next day following a dose of Shingrix. The reporter did not agreed to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shingles shot and still got shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The reporter stated that, after shingles shot still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Eight family members of patient received Shingrix vaccine. After receiving Shingrix vaccine, the patient experienced shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case was 1 of the 4 linked cases reported by same reporter.  ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063309:Same reporter US-GLAXOSMITHKLINE-US2021AMR063288:Same reporter US-GLAXOSMITHKLINE-US2021AMR063311:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. Eight family members of patient received Shingrix vaccine. After receiving Shingrix vaccine, the patient experienced shingles.  This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. This case was 1 of the 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063288:Same reporter US-GLAXOSMITHKLINE-US2021AMR063309:Same reporter US-GLAXOSMITHKLINE-US2021AMR063310:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Near death experience, Vaccine positive rechallenge
Clinical narrative: almost killed me; This case was reported by a consumer via other manufacturer and described the occurrence of near death experience in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself The age at vaccination was not reported. The patient received 1st dose of shingrix and stated that experienced near death experience. The patient also stated that while completing Shingrix series second one was horrible. Almost killed her consider for both dose as it was not confirmed 1st or 2nd dose of Shingrix which almost killed her. No further information available. For further tolerance of 2nd dose refer case US2021AMR063320 reported by same the reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR063320:1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Her arm was super sore after the first dose; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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: This case was reported by patient herself. The age at vaccination was not reported The patient stated that her arm was super sore after 1st dose of Shingrix. For tolerance of 2nd dose refer case US2021AMR064854 and for Flu Shot refer US2021AMR064858. The reporter and healthcare professional consents to follow up was reported as not applicable.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064854:Same reporter. US-GLAXOSMITHKLINE-US2021AMR064858:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: just a little sick for about 24 hours.; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingles vaccine and little sick for about 24hrs. The reporter stated if one had chicken pox as a child, the virus was in and could come out again later as shingles.  If one was lucky enough to be vaccinated for chicken pox the he/she did not have to be worried about shingles. This case linked with US2020AMR223617, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223617:same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling cold, Inappropriate schedule of product administration, Mobility decreased, Product supply issue
Clinical narrative: Dizziness; Chills; fever of 102; first  dose on August 2018 /  6 months after the vaccine was not available; This case was reported by a consumer and described the occurrence of dizziness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st vaccine on an unknown date, many years before reporting day).   In August 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, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced dizziness, chills, fever and product supply issue. On an unknown date, the outcome of the dizziness, chills, fever and product supply issue were unknown.   It was unknown if the reporter considered the dizziness, chills and fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not applicable for 2nd dose of vaccine. The patient reported that she got her first Shingrix vaccine dose and had a severe reactions. The patient reported fever of 102 degrees Fahrenheit, chills and dizziness that did not let her get out of bed. The patient reported that about 6 months after the vaccine was not available and she reported that her Healthcare professional stated to forget of getting the vaccine, which led to product supply issue. The reporter stated that this healthcare professional was a new doctor and not the one that she had when she got her vaccine. The reporter consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Dizziness; Chills; fever of 102; first  dose on August 2018 /  6 months after the vaccine was not available; This case was reported by a consumer and described the occurrence of dizziness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st vaccine on an unknown date, many years before reporting day).   In August 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, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced dizziness, chills, fever and product supply issue. On an unknown date, the outcome of the dizziness, chills, fever and product supply issue were unknown.   It was unknown if the reporter considered the dizziness, chills and fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself. The age at vaccination was not applicable for 2nd dose of vaccine. The patient reported that she got her first Shingrix vaccine dose and had a severe reactions. The patient reported fever of 102 degrees Fahrenheit, chills and dizziness that did not let her get out of bed. The patient reported that about 6 months after the vaccine was not available and she reported that her Healthcare professional stated to forget of getting the vaccine, which led to product supply issue. The reporter stated that this healthcare professional was a new doctor and not the one that she had when she got her vaccine. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site / upper left arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 17-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th February 2021, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 11th February 2021, 6 hrs after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was patient's mother. The patient had soreness at the injection site on the upper left arm. The soreness at the injection site started approximately 6 hours after receiving the injection of Bexsero. Reporter did not consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: dragging her arm around / unable to move her right arm back to put a jacket on; could not sleep due to this arm pain; injection site pain in her right arm never resolved / getting worse; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th February 2021, the patient experienced insomnia. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the insomnia and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, insomnia and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient reported injection site pain in her right arm never resolved and was  now getting worse. The patient was dragging her arm around. Last night from day of reporting she could not sleep due to this arm pain and she was trying to massage her arm. She was unable to move her right arm back to put a jacket on.  Reporter did not consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: headache / after first dose; slept the whole day; muscle aches; fatigue / was so tired; slight fever; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles in April 2020). Previously administered products included zostavax (received 4 to 5 years ago from reporting date).   On 2nd December 2020, the patient received the 1st dose of Shingrix. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, fatigue, fever, pain in arm and daytime sleepiness. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the muscle pain, fatigue, fever, pain in arm, headache and daytime sleepiness were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, fever, pain in arm, headache and daytime sleepiness to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose in the left arm. The reporter stated that within a couple of hours after receiving 1st vaccine the symptoms of muscles aches, fatigue, slight fever and arm soreness were presented. On an unknown date. Less than 3 months after receiving vaccine, the patient experienced headache. The patient was so tired that she slept the whole day after receiving 1st dose of vaccine.  The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR052743.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR052743:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: headache / after first dose; slept the whole day; muscle aches; fatigue / was so tired; slight fever; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles in April 2020). Previously administered products included zostavax (received 4 to 5 years ago from reporting date).   On 2nd December 2020, the patient received the 1st dose of Shingrix. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, fatigue, fever, pain in arm and daytime sleepiness. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the muscle pain, fatigue, fever, pain in arm, headache and daytime sleepiness were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, fever, pain in arm, headache and daytime sleepiness to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose in the left arm. The reporter stated that within a couple of hours after receiving 1st vaccine the symptoms of muscles aches, fatigue, slight fever and arm soreness were presented. On an unknown date. Less than 3 months after receiving vaccine, the patient experienced headache. The patient was so tired that she slept the whole day after receiving 1st dose of vaccine.  The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR052743.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR052743:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: some back pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's disease.   In September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a day after receiving Shingrix, the patient experienced back pain. On an unknown date, the outcome of the back pain was recovered/resolved.   It was unknown if the reporter considered the back pain to be related to Shingrix.  Additional details was reported as follows: Age at vaccination was not reported. After receiving 1 st dose of Shingrix and experienced back pain,that resolved the same day. The reported did not consent to follow up. For tolerance of 2nd dose, refer case US2021AMR053971; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR053971:same patient,2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Respiratory tract congestion
Clinical narrative: redness at the injection site; redness at the injection site from the injection site all the way down to her elbow; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included sleep apnea and memory impairment. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included osteopenia and asthma.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and erythema. On an unknown date, the outcome of the injection site erythema and erythema were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that, she started Nucala about a year ago from the date of reporting.  Before starting Nucala, the patient received both doses of Shingrix.  After receiving 2nd dose of Shingrix, the patient experienced redness at the injection site from the injection site all the way down to her elbow.  The patient also said that, she had missed her doses of Nucala during the month of February.  She might miss March's dose if she did not get it quickly shipped to her.  The patient had missed her doses because she forgot to call and request it to Nucala. The patient was experiencing some congestion as a result of not taking Nucala, because her symptoms were coming back. The patient also stated that, she had experienced swelling of her legs. She had spoken to her physician about it and they could not figure out what was causing it. This started happening recently and while on Nucala. For the tolerance of Nucala dose, refer linked case US2021AMR060167. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR060167:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Tongue pruritus
Clinical narrative: itching / itching is off and on and is all over her body including her tongue and face; itching / itching is off and on and is all over her body including her tongue and face; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 16th December 2020, 4 days after receiving Shingrix, the patient experienced generalized pruritus and tongue pruritus. On an unknown date, the outcome of the generalized pruritus and tongue pruritus were not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and tongue pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Shingrix and 4 days later started having itching.  The itching was off and on and was all over her body including her tongue and face.  The caller provided limited information and provided medical disclaimer. The reporter did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: extreme tenderness at the injection site; shooting pain that feels like a knife in the fleshy part of his right arm / feels like a knife in his arm; headache; discomfort that runs to his pinkie; sharp pains if he reaches or stretches his arm muscle; feels pressure on his shoulder which is not fun / discomfort at his shoulder joint; pain in his shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received 1st dose on an unknown date).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, 2 weeks after receiving Shingrix, the patient experienced injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain. On an unknown date, the outcome of the injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient. He had extreme tenderness at the injection site that developed two weeks after the second injection. He also had pain in his shoulder joint, headache, and discomfort that runs to his pinkie. Depending on how he moves his right arm he would get a shooting pain that felt like a knife in the fleshy part of his right arm. More recently (about a month ago of reporting date), he started to get sharp pains if he reaches or stretches his arm muscle and it felt like a knife in his arm. He was having discomfort at his shoulder joint as well. When he roll over at night he felt pressure on his shoulder which was not fun. His symptoms had not changed or improved since he received the second injection. All of his symptoms were occurring on his right arm or right side. The patient consented to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: extreme tenderness at the injection site; shooting pain that feels like a knife in the fleshy part of his right arm / feels like a knife in his arm; headache; discomfort that runs to his pinkie; sharp pains if he reaches or stretches his arm muscle; feels pressure on his shoulder which is not fun / discomfort at his shoulder joint; pain in his shoulder joint; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had received 1st dose on an unknown date).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, 2 weeks after receiving Shingrix, the patient experienced injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain. On an unknown date, the outcome of the injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site tenderness, pain in arm, headache, discomfort, muscle pain, shoulder discomfort and joint pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient. He had extreme tenderness at the injection site that developed two weeks after the second injection. He also had pain in his shoulder joint, headache, and discomfort that runs to his pinkie. Depending on how he moves his right arm he would get a shooting pain that felt like a knife in the fleshy part of his right arm. More recently (about a month ago of reporting date), he started to get sharp pains if he reaches or stretches his arm muscle and it felt like a knife in his arm. He was having discomfort at his shoulder joint as well. When he roll over at night he felt pressure on his shoulder which was not fun. His symptoms had not changed or improved since he received the second injection. All of his symptoms were occurring on his right arm or right side. The patient consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Right arm pain for two weeks; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th March 2021, 1 hr after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and experienced right arm pain for two weeks. Till the time of reporting, arm pain was not resolved. The reporter consented to follow up with physician.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: swelling / general swelling, excluding the throat; hives; rash; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced swelling, hives and rash. On an unknown date, the outcome of the swelling, hives and rash were recovered/resolved.   It was unknown if the reporter considered the swelling, hives and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported however patient could be 66 or 67 years old at time of vaccination. The patient received first dose of Shingrix vaccine while ago from reporting day and experienced rash, hives, and swelling within a day of receiving vaccine. The reporter reported general swelling, excluding the throat and all symptoms lasted approximately 2 to 3 days. The reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Dehydration, Diarrhoea, Headache, Pain in extremity
Clinical narrative: Sore arm; headache; diarrhea; weakness; tachycardia; dehydrated; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, headache, diarrhea, weakness, tachycardia and dehydration. On an unknown date, the outcome of the pain in arm, headache, diarrhea, weakness, tachycardia and dehydration were unknown.   It was unknown if the reporter considered the pain in arm, headache, diarrhea, weakness, tachycardia and dehydration to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and had sore arm, headache and diarrhea. Then some week ago has weakness, tachycardia and diarrhea. No patient's identifiers provided, no lot number, expiration date, vaccination date was provided. The reporter did not specify when the symptoms began or when they ended. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: Sore arm; headache; diarrhea; weakness; tachycardia; dehydrated; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, headache, diarrhea, weakness, tachycardia and dehydration. On an unknown date, the outcome of the pain in arm, headache, diarrhea, weakness, tachycardia and dehydration were unknown.   It was unknown if the reporter considered the pain in arm, headache, diarrhea, weakness, tachycardia and dehydration to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and had sore arm, headache and diarrhea. Then some week ago has weakness, tachycardia and diarrhea. No patient's identifiers provided, no lot number, expiration date, vaccination date was provided. The reporter did not specify when the symptoms began or when they ended. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Pain in extremity, Rash
Clinical narrative: Lot of pain on her arm; rash appeared down her arm; Cellulitis; A spontaneous report was received from other healthcare professional concerning a 34-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis with seriousness criteria of medically significant, rash and painful arm.  The patient's medical history, as provided by the reporter, included migraines, scoliosis, and anxiety. Concomitant medications reported included sertraline (100mg once daily). On 04 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Jan 2021, the patient experienced cellulitis and rash.  On an unspecified date, patient experienced rash down her arm and a lot of pain on arm.  Lab details were not provided by the reporter.  Treatment for the events included steroids, antibiotic, diphenhydramine and non-drowsy antihistamines.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, cellulitis, rash, rash appeared down her arm and a lot of pain on arm were recovered on 18 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted at home 2hs after the shot; A spontaneous report was received from a consumer who reported on behalf of her seventy-eight-years old husband who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the event fainted at home 2hs after the shot.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  The consumer received the first of two planned doses of mRNA-1273 on 22-JAN-2021 (Batch# 029L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22-JAN-2021, the consumer experienced the event fainted at home 2hs after the shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event was unknown.  The assessment for the event was not provided.; Reporter's Comments: This case concerns a 78-year-old male who experienced a medically significant and serious unexpected event of syncope.  Event onset occurred at home about 2 hours after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Vaccination site rash
Clinical narrative: hypersensitivity in his skin; rash all over his body; a rash near injection site; A spontaneous report was received from a consumer concerning a 27-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site rash, hypersensitivity in his skin, and  rash all over his body.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30-JAN-2021, the patient experienced the event(s) hypersensitivity in his skin, rash all over his body. The seriousness criteria for both the event was mention as other as per source document.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hypersensitivity in his skin, rash all over his body was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Nausea
Clinical narrative: dry heaves, uncontrollable dry heaves; sick to my stomach; chills; fatigue; headache; nausea; fever; redness at the injection site and going down the arm; swelling the size of an orange; A spontaneous report was received from a 72-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Retching ( dry heaves and uncontrollable dry heaves), abdominal discomfort (sick to my stomach), chills, fatigue, headache, nausea, pyrexia (fever), vaccination site erythema (redness at the injection site and going down the arm) and vaccination site swelling (swelling the size of an orange).  The patient's medical history was not provided. Concomitant medications reported were omeprazole, simvastatin and vitamins.  On 25-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient developed redness at the injection site and down her arm as well as swelling the size of an orange.  She also reported that she experienced  nausea, dry heaves, headache, fever, chills, fatigue and she was sick to her stomach.  She reported that she went to the emergency room (ER) for over four hours due to the uncontrollable dry heaves.  Admission to the hospital was not described in the initial report.    Treatment for the events included diphenhydramine and ondansetron.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of events, redness at the injection site and going down the arm, swelling the size of an orange, nausea, dry heaves, headache, fever, chills, fatigue and sick to my stomach, were considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Vaccination site erythema, Vaccination site swelling
Clinical narrative: dry heaves, uncontrollable dry heaves; sick to my stomach; chills; fatigue; headache; nausea; fever; redness at the injection site and going down the arm; swelling the size of an orange; A spontaneous report was received from a 72-year-old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Retching ( dry heaves and uncontrollable dry heaves), abdominal discomfort (sick to my stomach), chills, fatigue, headache, nausea, pyrexia (fever), vaccination site erythema (redness at the injection site and going down the arm) and vaccination site swelling (swelling the size of an orange).  The patient's medical history was not provided. Concomitant medications reported were omeprazole, simvastatin and vitamins.  On 25-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26-JAN-2021, the patient developed redness at the injection site and down her arm as well as swelling the size of an orange.  She also reported that she experienced  nausea, dry heaves, headache, fever, chills, fatigue and she was sick to her stomach.  She reported that she went to the emergency room (ER) for over four hours due to the uncontrollable dry heaves.  Admission to the hospital was not described in the initial report.    Treatment for the events included diphenhydramine and ondansetron.  Action taken with mRNA-1273 in response to the events was unknown.  The outcomes of events, redness at the injection site and going down the arm, swelling the size of an orange, nausea, dry heaves, headache, fever, chills, fatigue and sick to my stomach, were considered unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.