chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Cheilitis, Rash
Clinical narrative: rash from the waist up; his lower lip is "raw." / The lip "raw" symptoms; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 10 days after receiving Shingrix, the patient experienced rash and raw lips. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the raw lips was not recovered/not resolved.   It was unknown if the reporter considered the rash and raw lips to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient himself. The age at vaccination was not reported. The reporter stated that he received dose 1 of Shingrix and 10 days later he developed a rash from his waist up and his lower lip was raw. He stated that he was treated by his doctor with steroids and the rash cleared up, but the lip rawsymptoms were continued. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash pruritic
Clinical narrative: Has a two lines of rash, which is itchy with a few; Itchy with a few pimples; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female 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 itchy rash and pimples. On an unknown date, the outcome of the itchy rash and pimples were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash and pimples to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The age at vaccination was not reported. The patient experienced two lines of rash, which was itchy with a few pimples. On the day of reporting, the patient would be seing the doctor. No additional information was provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Hospice care, Incomplete course of vaccination, Myocardial infarction
Clinical narrative: Heart attack; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 94-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2018, the patient received the 1st dose of Shingrix. In March 2018, between 1 and 3 months after receiving Shingrix, the patient experienced heart attack (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the heart attack was recovered/resolved.   The reporter considered the heart attack to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for the mother. The age at the vaccination was not reported.  The patient had a heart attack in March 2018 and now was out of hospice and doing well.  Heart attack and hospice stay was not related to Shingrix. Till the time of the reporting, the patient did not receive the second dose of Shingrix because of heart attack. The reporter did not consent to follow-up
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Injection site pain, Malaise
Clinical narrative: severely ill; Soreness at injection site; Severe chills; Sweating; Diarrhea; Cramping; her whole body would not quit shaking; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced unwell, injection site pain, chills, sweating, diarrhea, cramp and tremor. On 10th September 2020, the outcome of the unwell, chills, sweating, diarrhea, cramp and tremor were recovered/resolved. On 12th September 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the unwell, injection site pain, chills, sweating, diarrhea, cramp and tremor to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The reporter mentioned that she received 1st dose back on 10th September 2020, because she received a reminder on 10th November 2020 to get the 2nd dose. The patient believed she received the vaccine in her upper right arm (because she was left-handed). The patient was severely ill after vaccination. The patient experienced soreness at the injection site, severe chills, sweating, some diarrhea and cramping (which she thinks it might be associated with the chills). The reporter mentioned that that her whole body would not quit shaking; she submerged herself into a tub of hot water and used a heating pad but it did not help, she was covered with sweat from head to toe and also stated that she was not sick at all. All the adverse events lasted for about 5 hours, except the soreness, which lasted for about 2 days. The reporter mentioned that all adverse events were resolved. The reporter gave permission to follow-up with her health care professional. This case had been linked with US2020229461, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229461:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Tremor
Clinical narrative: severely ill; Soreness at injection site; Severe chills; Sweating; Diarrhea; Cramping; her whole body would not quit shaking; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced unwell, injection site pain, chills, sweating, diarrhea, cramp and tremor. On 10th September 2020, the outcome of the unwell, chills, sweating, diarrhea, cramp and tremor were recovered/resolved. On 12th September 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the unwell, injection site pain, chills, sweating, diarrhea, cramp and tremor to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The reporter mentioned that she received 1st dose back on 10th September 2020, because she received a reminder on 10th November 2020 to get the 2nd dose. The patient believed she received the vaccine in her upper right arm (because she was left-handed). The patient was severely ill after vaccination. The patient experienced soreness at the injection site, severe chills, sweating, some diarrhea and cramping (which she thinks it might be associated with the chills). The reporter mentioned that that her whole body would not quit shaking; she submerged herself into a tub of hot water and used a heating pad but it did not help, she was covered with sweat from head to toe and also stated that she was not sick at all. All the adverse events lasted for about 5 hours, except the soreness, which lasted for about 2 days. The reporter mentioned that all adverse events were resolved. The reporter gave permission to follow-up with her health care professional. This case had been linked with US2020229461, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229461:same reporter
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin, Immediate post-injection reaction, Pain of skin, Rash, Skin discolouration
Clinical narrative: Sore/dry patches; sore/dry patches / some turn sore; Pink spots under the skin turn brownish almost like sun spots /  some turn brownish; was unable to get her second shot of Shingrix until August 2020 Due to sheltering in place for COVID-19; rash from neck to bottom of toes / heavy rash under the skin / Eruptions seems to be coming from under the skin; This case was reported by a consumer via call center representative and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January).   In August 2020, the patient received the 2nd dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced dry skin, skin pain, skin discoloration and social problem. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the rash, dry skin, skin pain, skin discoloration and social problem were unknown.   It was unknown if the reporter considered the rash, dry skin, skin pain and skin discoloration to be related to Shingrix.  Additional details were provided as follows: Due to sheltering in place for COVID-19 the Patient was unable to get her shot of Shingrix until August 2020 in left arm.  The patient had a rash from neck to bottom of toes. It's a heavy rash under the skin then after a month a few broke out and are sore/dry patches.  Pink spots under the skin turn brownish almost like sun spots, some turn sore and some turn brownish.  Eruptions seems to be coming from under the skin.  The breakout on her back was terrible.  Cortisone cream did not help. She went into ocean water and it seemed to help.  The patient was waiting for biopsy results. The reporter consented to follow up.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Sore/dry patches; sore/dry patches / some turn sore; Pink spots under the skin turn brownish almost like sun spots /  some turn brownish; was unable to get her second shot of Shingrix until August 2020 Due to sheltering in place for COVID-19; rash from neck to bottom of toes / heavy rash under the skin / Eruptions seems to be coming from under the skin; This case was reported by a consumer via call center representative and described the occurrence of rash in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January).   In August 2020, the patient received the 2nd dose of Shingrix. In August 2020, immediately after receiving Shingrix, the patient experienced rash. On an unknown date, the patient experienced dry skin, skin pain, skin discoloration and social problem. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the rash, dry skin, skin pain, skin discoloration and social problem were unknown.   It was unknown if the reporter considered the rash, dry skin, skin pain and skin discoloration to be related to Shingrix.  Additional details were provided as follows: Due to sheltering in place for COVID-19 the Patient was unable to get her shot of Shingrix until August 2020 in left arm.  The patient had a rash from neck to bottom of toes. It's a heavy rash under the skin then after a month a few broke out and are sore/dry patches.  Pink spots under the skin turn brownish almost like sun spots, some turn sore and some turn brownish.  Eruptions seems to be coming from under the skin.  The breakout on her back was terrible.  Cortisone cream did not help. She went into ocean water and it seemed to help.  The patient was waiting for biopsy results. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 12th September 2020, 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 reporter was patient's wife. The reporter believed that the vaccine might have been given in patient's upper left arm because he was right-handed. The patient experienced soreness at the injection site and did not experience any other adverse events. The soreness had resolved, but initially lasted for about 2 days. The reporter gave permission to follow-up with their health care professional. The reporter was unable to provide health care professional's email/fax at the time of report. This case had been linked with US2020229458, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229458:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Injection site reaction, Pain in extremity, Rash vesicular
Clinical narrative: Shingles-like rash near injection site; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 30th August 2020, immediately after receiving Shingrix, the patient experienced pain in arm. On 12th November 2020, the patient experienced vesicular rash. On 2nd September 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sore arm right afterwards for a couple of days and then resolved.  The patient also reported that about a week ago (74 days after receiving vaccine), he developed a shingles-like rash about the size of a half dollar near where he received the injection.  The patient was still experiencing this rash. He asked if he should get the 2nd dose.provided medical disclaimer and suggested he follow up with his health care professional. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Injection site rash
Clinical narrative: rash / diameter of a tennis ball / injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 39KB3, expiry date unknown) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUCELVAX) for prophylaxis.   On 15th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of FLUCELVAX (intramuscular). On 16th September 2020, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and Flucelvax on the same day, and in the same arm, the left.  The patient called the pharmacy to report a rash described as the diameter of a tennis ball, around the injection site.  The pharmacist reported she administered both vaccines in the same arm about one inch apart. The pharmacist did not know if the rash emanated from the Shingrix or Flucelvax injection site. The event has resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199162:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Injection site pain, Injection site swelling
Clinical narrative: Swelling at the injection site; Pain / at the injection site; he gave her a double dose; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included leukemia.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced injection site swelling, injection site pain and overdose. On an unknown date, the outcome of the injection site swelling, injection site pain and overdose were unknown.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The patient reported case for herself. The age at vaccination was not reported. The patient stated that after she received Shingrix, she had pain and swelling at the injection site. She stated that she asked her physician about receiving the second dose of Shingrix. She was told by the physician that she would not need it because he gave her a double dose creating overdose. All information was not available. The reporter was very reluctant to provide information. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Illness, Influenza, Injection site reaction, Pain in extremity
Clinical narrative: welts; was feeling flu-ish; arm was sore; raised rash about 2x3 inches in size near the injection site; welts are red; welts are / hot; welts are / itchy; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2020, less than a week after receiving Shingrix, the patient experienced raised rash, erythema, skin warm and itchy rash. On 17th November 2020, the patient experienced influenza like illness and pain in arm. On 18th November 2020, the patient experienced welts. On 19th November 2020, the outcome of the influenza like illness was recovered/resolved and the outcome of the pain in arm and welts were not recovered/not resolved. On an unknown date, the outcome of the raised rash, erythema, skin warm and itchy rash were unknown.   It was unknown if the reporter considered the influenza like illness, pain in arm, welts, raised rash, erythema, skin warm and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The next day, her arm was sore and she reports that she was feeling flu-ish.  On 18th November 2020, the patient had welts or raised rash about 2 by 3 inches in size near the injection site.  The welts are red, hot and itchy.  The patient was still experiencing the welts but that they seem to be improving and look less red. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic, Skin warm, Urticaria
Clinical narrative: welts; was feeling flu-ish; arm was sore; raised rash about 2x3 inches in size near the injection site; welts are red; welts are / hot; welts are / itchy; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2020, less than a week after receiving Shingrix, the patient experienced raised rash, erythema, skin warm and itchy rash. On 17th November 2020, the patient experienced influenza like illness and pain in arm. On 18th November 2020, the patient experienced welts. On 19th November 2020, the outcome of the influenza like illness was recovered/resolved and the outcome of the pain in arm and welts were not recovered/not resolved. On an unknown date, the outcome of the raised rash, erythema, skin warm and itchy rash were unknown.   It was unknown if the reporter considered the influenza like illness, pain in arm, welts, raised rash, erythema, skin warm and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The next day, her arm was sore and she reports that she was feeling flu-ish.  On 18th November 2020, the patient had welts or raised rash about 2 by 3 inches in size near the injection site.  The welts are red, hot and itchy.  The patient was still experiencing the welts but that they seem to be improving and look less red. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Emotional distress, Pain
Clinical narrative: difficulty breathing/ huffing and puffing; pain; Distress; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a adult female 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 difficulty breathing and pain. On an unknown date, the outcome of the difficulty breathing and pain were not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing and pain to be related to Shingrix.  Additional information was provided as follows: The patient was in pain and having difficulty breathing.  She was huffing and puffing on the phone asking what should she do. She was informed to call 911, her doctor, or go to the emergency department.  Demographic information about the patient was not collected.   The caller needed emergency assistance immediately. The patient was in such distress, it was reporter's opinion that she call 911 immediately. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient developed a rash after the 1st dose of Shingrix. The reporter did not consent to follow up. The Pharmacist stated she was not providing PHI and gave no additional information. Collected via chat. PFC declined.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain in extremity
Clinical narrative: slight reaction / pain in her right arm (at the injection site); felt tired; 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 Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Prior outbreak of shingles near her eye in last september). Previously administered products included Zostavax (receivied about 5 to 6 years before reporting).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were recovered/resolved.   It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but could be 68 or 69 years old. The patient received her first and second dose of Shingrix at the same pharmacy. She always gets her shots in her right arm.. The patient had a slight reaction, She said that she had pain in her right arm (at the injection site) and also felt tired. Both of these events resolved after a couple days. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020AMR230563; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR230563:same patient (2nd dose
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Illness, Myalgia
Clinical narrative: became "really sick"; in bed for 24 hours with a fever; shaking; chills; "the worst headache I ever had / had to "pack my head in ice; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced sickness, fever, tremor, chills, headache, muscle pain and weakness. The patient was treated with non-drug therapy (Ice Pack (No Medication)). In November 2020, the outcome of the sickness, fever, tremor, chills, headache, muscle pain and weakness were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, tremor, chills, headache, muscle pain and weakness to be related to Shingrix.  Additional details were reported as follows: The patient reported that she became really sick after getting the 1st dose of the Shingrix vaccine. She was in bed for 24 hours with a fever, shaking, chills, headache, muscle ache and weakness. She reported that the headache was so bad she had to pack her head in ice. The patient was fine at the day of reporting. She reported about not having trouble breathing nor having an anaphylactic reaction. She stated her healthcare professional was not aware of these reactions, but she has an upcoming appointment and would inform them. The reporter did not consent to follow-up. This case was linked with case US2020229498, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229498:same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: became "really sick"; in bed for 24 hours with a fever; shaking; chills; "the worst headache I ever had / had to "pack my head in ice; muscle ache; weakness; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced sickness, fever, tremor, chills, headache, muscle pain and weakness. The patient was treated with non-drug therapy (Ice Pack (No Medication)). In November 2020, the outcome of the sickness, fever, tremor, chills, headache, muscle pain and weakness were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, tremor, chills, headache, muscle pain and weakness to be related to Shingrix.  Additional details were reported as follows: The patient reported that she became really sick after getting the 1st dose of the Shingrix vaccine. She was in bed for 24 hours with a fever, shaking, chills, headache, muscle ache and weakness. She reported that the headache was so bad she had to pack her head in ice. The patient was fine at the day of reporting. She reported about not having trouble breathing nor having an anaphylactic reaction. She stated her healthcare professional was not aware of these reactions, but she has an upcoming appointment and would inform them. The reporter did not consent to follow-up. This case was linked with case US2020229498, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229498:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm 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 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 reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient's domestic partner reported that they experienced a sore arm after receiving the 1st dose of the Shingrix vaccine. The reporter did not consent to follow-up. This case was linked with US2020229497, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229497:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Buttock injury, Fall, Fatigue, Haematoma, Hypoaesthesia oral
Clinical narrative: was not feeling well; white count was found to be slightly elevated; hematoma on buttock; fell on ice; first dose in November of 2019; injection site was warm; injection site was / puffy; had fatigue; achiness; numbness and tingleness of the lips; tingleness of the lips; This case was reported by a consumer via call center representative and described the occurrence of numb lips in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (many years ago patient had shingles). Previously administered products included Shingles vaccine (received the old Shingles vaccine (unknown manufacturer)).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2019, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced numb lips and tingling lips. On an unknown date, the patient experienced injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma, fall and incomplete course of vaccination. On an unknown date, the outcome of the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain and unwell were recovered/resolved and the outcome of the increased white cell count, fall and incomplete course of vaccination were unknown and the outcome of the hematoma was not recovered/not resolved.   It was unknown if the reporter considered the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma and fall to be related to Shingrix.  Additional details were provided as follows: The age at vaccinaton was not applicable for the second suspect vaccine. The patient received 1st dose and soon after receiving the vaccine at the pharmacy she experienced numbness and tingling of her lips which resolved in 20 minutes. The patient had reported it to health care professional, but he/she informed that it was not from vaccine and that it was a year ago so she would be immune to taking the second dose. The patient's injection site was warm and puffy. The patient later had fatigue, achiness and was not feeling well, which also had resolved. The patient did not receive the second dose till the time of reporting, which led to incomplete course of vaccination. The patient was recently fell on ice and had a hematoma on her right buttock and her white count was found to be slightly elevated. The reporter consented to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site inflammation, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: was not feeling well; white count was found to be slightly elevated; hematoma on buttock; fell on ice; first dose in November of 2019; injection site was warm; injection site was / puffy; had fatigue; achiness; numbness and tingleness of the lips; tingleness of the lips; This case was reported by a consumer via call center representative and described the occurrence of numb lips in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (many years ago patient had shingles). Previously administered products included Shingles vaccine (received the old Shingles vaccine (unknown manufacturer)).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2019, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced numb lips and tingling lips. On an unknown date, the patient experienced injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma, fall and incomplete course of vaccination. On an unknown date, the outcome of the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain and unwell were recovered/resolved and the outcome of the increased white cell count, fall and incomplete course of vaccination were unknown and the outcome of the hematoma was not recovered/not resolved.   It was unknown if the reporter considered the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma and fall to be related to Shingrix.  Additional details were provided as follows: The age at vaccinaton was not applicable for the second suspect vaccine. The patient received 1st dose and soon after receiving the vaccine at the pharmacy she experienced numbness and tingling of her lips which resolved in 20 minutes. The patient had reported it to health care professional, but he/she informed that it was not from vaccine and that it was a year ago so she would be immune to taking the second dose. The patient's injection site was warm and puffy. The patient later had fatigue, achiness and was not feeling well, which also had resolved. The patient did not receive the second dose till the time of reporting, which led to incomplete course of vaccination. The patient was recently fell on ice and had a hematoma on her right buttock and her white count was found to be slightly elevated. The reporter consented to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Paraesthesia oral, White blood cell count increased
Clinical narrative: was not feeling well; white count was found to be slightly elevated; hematoma on buttock; fell on ice; first dose in November of 2019; injection site was warm; injection site was / puffy; had fatigue; achiness; numbness and tingleness of the lips; tingleness of the lips; This case was reported by a consumer via call center representative and described the occurrence of numb lips in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (many years ago patient had shingles). Previously administered products included Shingles vaccine (received the old Shingles vaccine (unknown manufacturer)).   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2019, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced numb lips and tingling lips. On an unknown date, the patient experienced injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma, fall and incomplete course of vaccination. On an unknown date, the outcome of the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain and unwell were recovered/resolved and the outcome of the increased white cell count, fall and incomplete course of vaccination were unknown and the outcome of the hematoma was not recovered/not resolved.   It was unknown if the reporter considered the numb lips, tingling lips, injection site warmth, injection site swelling, fatigue, pain, unwell, increased white cell count, hematoma and fall to be related to Shingrix.  Additional details were provided as follows: The age at vaccinaton was not applicable for the second suspect vaccine. The patient received 1st dose and soon after receiving the vaccine at the pharmacy she experienced numbness and tingling of her lips which resolved in 20 minutes. The patient had reported it to health care professional, but he/she informed that it was not from vaccine and that it was a year ago so she would be immune to taking the second dose. The patient's injection site was warm and puffy. The patient later had fatigue, achiness and was not feeling well, which also had resolved. The patient did not receive the second dose till the time of reporting, which led to incomplete course of vaccination. The patient was recently fell on ice and had a hematoma on her right buttock and her white count was found to be slightly elevated. The reporter consented to follow-up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bone pain, Burning sensation, Chest pain, Hypoaesthesia
Clinical narrative: neck pain; neck stiffness / upper back stiffness; upper back pain; hand pain, finger pain; hand and finger numbness; soreness in her sternum; decreased neck mobility; clavicle burning sensation; soreness at her clavicle; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 1 days after receiving Shingrix, the patient experienced neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain. The patient was treated with naproxen (Aleve) and lidocaine (Lidocaine Patch). On an unknown date, the outcome of the neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain were recovering/resolving.   It was unknown if the reporter considered the neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that one day after receiving 1st dose of Shingrix, she experienced neck pain, neck stiffness, upper back pain, upper back stiffness, hand pain, finger pain, hand and finger numbness, soreness at her clavicle and soreness in her sternum.  The patient had been using Alleve and lidocaine patches, and at time of report events were slightly improving. The reporter did not consent to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: neck pain; neck stiffness / upper back stiffness; upper back pain; hand pain, finger pain; hand and finger numbness; soreness in her sternum; decreased neck mobility; clavicle burning sensation; soreness at her clavicle; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 1 days after receiving Shingrix, the patient experienced neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain. The patient was treated with naproxen (Aleve) and lidocaine (Lidocaine Patch). On an unknown date, the outcome of the neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain were recovering/resolving.   It was unknown if the reporter considered the neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that one day after receiving 1st dose of Shingrix, she experienced neck pain, neck stiffness, upper back pain, upper back stiffness, hand pain, finger pain, hand and finger numbness, soreness at her clavicle and soreness in her sternum.  The patient had been using Alleve and lidocaine patches, and at time of report events were slightly improving. The reporter did not consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever 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 age at vaccination was not reported. The pharmacist technician reported that the patient had fever after receiving Bexsero. The reporter did not consent to follow up. No patient's identifiers were provided No lot number or expiration date provided No vaccination date was provide.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Developed shingles 4 days ago; Shingles rash on back and buttocks; Shingles rash on back and buttocks and "near hind end" / Rash is painful; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 92-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 14th July 2020, the patient received the 1st dose of Shingrix. On 16th November 2020, 47 days after receiving Shingrix and 125 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure, shingles and painful rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and painful rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient was the wife of reporter. The Patient received 1st dose of Shingrix was in July of 2020 and her 2nd Shingrix shot was on 30th September 2020. Four days ago from the day of reporting the patient developed a shingles-type rash.  She had not been to the doctor yet but she had shingles in the past so she was familiar with what a shingles rash looks like.  She also said that the rash was painful. Still present now with rash on back and near hind end Consented to follow up
Age: 71.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blister, Eye disorder, Herpes zoster, Ophthalmic herpes zoster, Paraesthesia
Clinical narrative: diagnosed on 10/21/2020 as having shingles of the eye; rash on her left side of her forehead; nerve tingling on the area surrounding the left eye; blisters on the left eye lid / below left eye brow; blisters / and on the left side of the bridge of her nose; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 31st August 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 18th October 2020, 48 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), rash, tingling, eye disorder and blister. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster, rash, tingling, eye disorder and blister were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, rash, tingling, eye disorder and blister to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The reporter stating she never had shingles before. The patient started to have nerve tingling on the area surrounding the left eye and she had rash on her left side of her forehead and she had shingles like blisters on the left eye lid, below left eye brow and on the left side of the bridge of her nose. The patient was diagnosed on 21st October 2020 as having shingles of the eye and was started on 5 day course of Valtrex by a doctor in Urgent care and since it did not resolve, she saw her ophthalmologist and was again given additional 5 day course of Valtrex. The patient stating the shingles had not completely resolved to date.