chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Pyrexia, Therapeutic response unexpected
Clinical narrative: psoriasis on back of scalp has cleared up / Unexpected benefit; Fever following second dose of Shingrix; Rapid heartbeat following second dose of Shingrix; This case was reported by a consumer via and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriasis. Concomitant products included Herpes zoster (Shingrix).   In December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced fever, heartbeats increased and unexpected therapeutic effect. In December 2020, the outcome of the fever and heartbeats increased were recovered/resolved. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the fever and heartbeats increased to be related to Shingrix. The reporter considered the unexpected therapeutic effect to be related to Shingrix.  Additional details were provided as follows:  The patient reported for himself. Both doses were administered intramuscularly in left arm.  Lot numbers and dose volumes were not known. First dose of Shingrix was administered just over two months ago, and the second dose of Shingrix was administered one week ago before the date of reporting. The patient got both doses of the Shingrix vaccine and everything was fine but he was wondering if Shingrix could boost the immune system because he had noticed that his scalp psoriasis had cleared up.  The psoriasis on back of scalp that occurred before receiving either dose of Shingrix had disappeared two days later after 2nd dose of Shingrix (unexpected benefit).  The patient had one day of fever and rapid heartbeat following second dose of Shingrix. The reporter provided limited information. The reporter consented to HCP follow-up but was unable to provide contact Information. Patient's e-mail address was collected for follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Headache, Influenza like illness, Pain
Clinical narrative: flu-like symptoms; muscle aches; stomachache; back pain; skin sensitivity; headache; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband.   The reporter did not know for sure if the patient experienced a fever or not.  The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin sensitisation
Clinical narrative: flu-like symptoms; muscle aches; stomachache; back pain; skin sensitivity; headache; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, stomach pain, back pain, sensitive skin and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's husband.   The reporter did not know for sure if the patient experienced a fever or not.  The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Large rash appeared at injection site one week after first shot and lasted for one week
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: 2 fever blisters; arm soreness; redness at the injection site; Headache; joint and muscle pain; muscle pain; chills; fever; inability to walk straight; tiredness; This case was reported by a consumer and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for further tolerence refer case US2020AMR244333).   On 2nd December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness. On 6th December 2020, the patient experienced fever blister. Rechallenge with Shingrix was positive. On 5th December 2020, the outcome of the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness were recovered/resolved. On 7th December 2020, the outcome of the fever blister was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty, tiredness and fever blister to be related to Shingrix.  Additional details were provided as follows: Patient reported that she received the 2nd dose of Shingrix on 2nd December 2020 and later that evening she experienced arm soreness, redness at the injection site, headache, joint and muscle pain, chills, fever, inability to walk straight and tiredness. Patient also stated that the dy before reporting she experienced 2 fever blisters which was not resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244333:same reporter
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Myalgia, Oral herpes, Pain in extremity, Pyrexia
Clinical narrative: 2 fever blisters; arm soreness; redness at the injection site; Headache; joint and muscle pain; muscle pain; chills; fever; inability to walk straight; tiredness; This case was reported by a consumer and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for further tolerence refer case US2020AMR244333).   On 2nd December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness. On 6th December 2020, the patient experienced fever blister. Rechallenge with Shingrix was positive. On 5th December 2020, the outcome of the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness were recovered/resolved. On 7th December 2020, the outcome of the fever blister was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty, tiredness and fever blister to be related to Shingrix.  Additional details were provided as follows: Patient reported that she received the 2nd dose of Shingrix on 2nd December 2020 and later that evening she experienced arm soreness, redness at the injection site, headache, joint and muscle pain, chills, fever, inability to walk straight and tiredness. Patient also stated that the dy before reporting she experienced 2 fever blisters which was not resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244333:same reporter
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: 2 fever blisters; arm soreness; redness at the injection site; Headache; joint and muscle pain; muscle pain; chills; fever; inability to walk straight; tiredness; This case was reported by a consumer and described the occurrence of pain in arm in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for further tolerence refer case US2020AMR244333).   On 2nd December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness. On 6th December 2020, the patient experienced fever blister. Rechallenge with Shingrix was positive. On 5th December 2020, the outcome of the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty and tiredness were recovered/resolved. On 7th December 2020, the outcome of the fever blister was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site erythema, headache, joint pain, muscle pain, chills, fever, walking difficulty, tiredness and fever blister to be related to Shingrix.  Additional details were provided as follows: Patient reported that she received the 2nd dose of Shingrix on 2nd December 2020 and later that evening she experienced arm soreness, redness at the injection site, headache, joint and muscle pain, chills, fever, inability to walk straight and tiredness. Patient also stated that the dy before reporting she experienced 2 fever blisters which was not resolved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244333:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: administration of the second dose of Shingrix after a patient had treatment with antibodies for Covid-19 diagnose.; This case was reported by a pharmacist and described the occurrence of covid-19 in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix (unknown). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter called regarding the administration of the second dose of Shingrix after a patient had treatment with antibodies for Covid-19 diagnose. The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood glucose normal, Blood pressure normal, Chromaturia, Confusional state
Clinical narrative: arm tenderness; difficulty walking to bathroom; Pale; profuse sweating/soaking wet; Lethargy; upset stomach; confusion; dark urnine that was brown; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Heart attack and shingrix with an associated reaction of pain in extremity (received 1st dose on 10th August 2020, refer case US2020AMR244097). Concurrent medical conditions included diabetes.   On 9th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach and brown urine were recovered/resolved and the outcome of the confusion was unknown.   It was unknown if the reporter considered the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's wife. The patient received Shingrix and 24 hours later developed arm tenderness, difficulty walking to bathroom, pale, profuse sweating, lethargy, upset stomach, and confusion.  The reporter was scared and unsure of what was occurring with patient. The reporter asked if the patient was had chest pain due to history of heart attack, but due to confusion patient did not provide a response to reporter.  The reporter checked patients' blood pressure, pulse, and glucose which were all within normal limits.  After lunch, the patient's upset stomach went away and looked better and moved around better.  At bedtime, patient used bathroom and stated observing dark urine that was brown.  During the middle of that night the patient woke up soaking wet.  The reporter stated that the patient woke up like normal as if nothing happened the day and night before.  All symptoms reportedly resolved.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244097:same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Heart rate normal, Hyperhidrosis, Lethargy, Limb discomfort
Clinical narrative: arm tenderness; difficulty walking to bathroom; Pale; profuse sweating/soaking wet; Lethargy; upset stomach; confusion; dark urnine that was brown; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Heart attack and shingrix with an associated reaction of pain in extremity (received 1st dose on 10th August 2020, refer case US2020AMR244097). Concurrent medical conditions included diabetes.   On 9th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach and brown urine were recovered/resolved and the outcome of the confusion was unknown.   It was unknown if the reporter considered the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's wife. The patient received Shingrix and 24 hours later developed arm tenderness, difficulty walking to bathroom, pale, profuse sweating, lethargy, upset stomach, and confusion.  The reporter was scared and unsure of what was occurring with patient. The reporter asked if the patient was had chest pain due to history of heart attack, but due to confusion patient did not provide a response to reporter.  The reporter checked patients' blood pressure, pulse, and glucose which were all within normal limits.  After lunch, the patient's upset stomach went away and looked better and moved around better.  At bedtime, patient used bathroom and stated observing dark urine that was brown.  During the middle of that night the patient woke up soaking wet.  The reporter stated that the patient woke up like normal as if nothing happened the day and night before.  All symptoms reportedly resolved.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244097:same reporter
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pallor, Tenderness, Vaccine positive rechallenge
Clinical narrative: arm tenderness; difficulty walking to bathroom; Pale; profuse sweating/soaking wet; Lethargy; upset stomach; confusion; dark urnine that was brown; This case was reported by a consumer and described the occurrence of pain in arm in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Heart attack and shingrix with an associated reaction of pain in extremity (received 1st dose on 10th August 2020, refer case US2020AMR244097). Concurrent medical conditions included diabetes.   On 9th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach and brown urine were recovered/resolved and the outcome of the confusion was unknown.   It was unknown if the reporter considered the pain in arm, walking difficulty, pallor, sweating, lethargy, upset stomach, confusion and brown urine to be related to Shingrix.  Additional details were reported as follows: The reporter was patient's wife. The patient received Shingrix and 24 hours later developed arm tenderness, difficulty walking to bathroom, pale, profuse sweating, lethargy, upset stomach, and confusion.  The reporter was scared and unsure of what was occurring with patient. The reporter asked if the patient was had chest pain due to history of heart attack, but due to confusion patient did not provide a response to reporter.  The reporter checked patients' blood pressure, pulse, and glucose which were all within normal limits.  After lunch, the patient's upset stomach went away and looked better and moved around better.  At bedtime, patient used bathroom and stated observing dark urine that was brown.  During the middle of that night the patient woke up soaking wet.  The reporter stated that the patient woke up like normal as if nothing happened the day and night before.  All symptoms reportedly resolved.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR244097:same reporter
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Migraine, Pain in extremity, Photophobia
Clinical narrative: Woke up the next morning  with an extremely bad headache/migraine.  Light sensitive to my eyes.  I had to take ibuprofen and acetaminophen around the clock, and I went back to bed and slept until 1pm that day.  Headache remained dull the rest of the day, but I began feeling better.  My left arm was also very sore and second day past vaccine now have armpit soreness/pain.  Took ibuprofen again today for that.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Chills; Headache; Tiredness; Flu-like Symptoms; Aches/pain; Inappropriate Schedule of Vaccine; This case was reported by a consumer and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 8th December 2020, the patient experienced chills, headache, tiredness, influenza-like symptoms and pain. On 8th December 2020, the outcome of the chills, tiredness and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the headache, pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills, headache, tiredness, influenza-like symptoms and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and 1day after the patient had chills, pain,headache, tiredness and influenza-like symptoms. The patient first dose of Shingrix 3 weeks ago and that she received the 2nd dose day before reporting which led to shortening of vaccination schedule. The reporter asked when the 2nd dose was recommended.   The reporter refused to answer any questions related to the AE and abruptly ended the call. The reporter did not consent to follow up. Limited information was able to be collected from reporter and did not provide HCP contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Chills; Headache; Tiredness; Flu-like Symptoms; Aches/pain; Inappropriate Schedule of Vaccine; This case was reported by a consumer and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 8th December 2020, the patient experienced chills, headache, tiredness, influenza-like symptoms and pain. On 8th December 2020, the outcome of the chills, tiredness and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the headache, pain and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the chills, headache, tiredness, influenza-like symptoms and pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and 1day after the patient had chills, pain,headache, tiredness and influenza-like symptoms. The patient first dose of Shingrix 3 weeks ago and that she received the 2nd dose day before reporting which led to shortening of vaccination schedule. The reporter asked when the 2nd dose was recommended.   The reporter refused to answer any questions related to the AE and abruptly ended the call. The reporter did not consent to follow up. Limited information was able to be collected from reporter and did not provide HCP contact information.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Oral herpes
Clinical narrative: herpes genitalia.; herpes simplex on her lips; This case was reported by a consumer and described the occurrence of herpes simplex labialis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix. On 17th October 2020, 5 days after receiving Shingrix, the patient experienced herpes simplex labialis. On an unknown date, the patient experienced genital herpes. On an unknown date, the outcome of the herpes simplex labialis and genital herpes were unknown.   It was unknown if the reporter considered the herpes simplex labialis and genital herpes to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix and about 5 days later she started to have herpes simplex on her lips and a few days later herpes genitalia.  The patient did not want to provide her date of birth or address. The reporter did not consent to follow-up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.                                                                                                                                              On 10th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient works in a long care facility suffered from severe reactions with Shingrix first dose (fever for 3 days). The reporter wanted to know if there was any information about receiving Shingrix second dose and Covid vaccine. The lot number and expiration date from Shingrix first dose date was in patient's doctor's office. The reporter consented to follow-up by email.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram
Clinical narrative: Rapid heartbeat, shortness of breath. heaviness in chest, headache, fatigue, soreness at injection site
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Injection site pain
Clinical narrative: Rapid heartbeat, shortness of breath. heaviness in chest, headache, fatigue, soreness at injection site
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood test, Dyspepsia, Fatigue, Incorrect dose administered
Clinical narrative: Injection site soreness; Difficulty lifting arm; Arm heaviness; Muscle aches; Influenza-like symptoms; only the adjuvant was administered without the antigen; only the adjuvant was administered without the antigen; feeling tired; Sniffles; Gastrointestinal symptoms; Altered digestion; Increased urination; This case was reported by a consumer  and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included pneumococcal vaccine (Pneumonia Vaccine).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain, influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered. Shingrix was interrupted. On an unknown date, the outcome of the injection site pain, mobility decreased, tiredness, sniffles, gastrointestinal symptom nos, urinary frequency, muscle pain and influenza-like symptoms were recovered/resolved and the outcome of the heaviness in arm, digestion impaired, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the pneumonia vaccine one month earlier to Shingrix. It was reported that patient received the Shingrix with only adjuvant part and experienced symptoms including injection site soreness, difficulty lifting arm due to heaviness, muscle ache and flu-like symptoms. 24 Hours after the vaccination patient felt tired with mild sniffles, gastrointestinal symptoms including altered digestion, and increased urination. As patient received the Shingrix without antigen,which led to iappropriate preparation of medication and inappropriate dose of vaccine administered. It was reported that the symptoms lasted approximately 1-2 days. The blood test was performed for antibody levels which demonstrated antibodies to shingles. Patient was unwilling to be re-vaccinated with properly reconstituted Shingrix vaccine due to having side effects from adjuvant.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Limb discomfort, Movement disorder, Myalgia
Clinical narrative: Injection site soreness; Difficulty lifting arm; Arm heaviness; Muscle aches; Influenza-like symptoms; only the adjuvant was administered without the antigen; only the adjuvant was administered without the antigen; feeling tired; Sniffles; Gastrointestinal symptoms; Altered digestion; Increased urination; This case was reported by a consumer  and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included pneumococcal vaccine (Pneumonia Vaccine).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain, influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered. Shingrix was interrupted. On an unknown date, the outcome of the injection site pain, mobility decreased, tiredness, sniffles, gastrointestinal symptom nos, urinary frequency, muscle pain and influenza-like symptoms were recovered/resolved and the outcome of the heaviness in arm, digestion impaired, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the pneumonia vaccine one month earlier to Shingrix. It was reported that patient received the Shingrix with only adjuvant part and experienced symptoms including injection site soreness, difficulty lifting arm due to heaviness, muscle ache and flu-like symptoms. 24 Hours after the vaccination patient felt tired with mild sniffles, gastrointestinal symptoms including altered digestion, and increased urination. As patient received the Shingrix without antigen,which led to iappropriate preparation of medication and inappropriate dose of vaccine administered. It was reported that the symptoms lasted approximately 1-2 days. The blood test was performed for antibody levels which demonstrated antibodies to shingles. Patient was unwilling to be re-vaccinated with properly reconstituted Shingrix vaccine due to having side effects from adjuvant.
Sex: M
Vaccine: VARZOS
Symptoms: Pollakiuria, Product preparation issue, Rhinorrhoea
Clinical narrative: Injection site soreness; Difficulty lifting arm; Arm heaviness; Muscle aches; Influenza-like symptoms; only the adjuvant was administered without the antigen; only the adjuvant was administered without the antigen; feeling tired; Sniffles; Gastrointestinal symptoms; Altered digestion; Increased urination; This case was reported by a consumer  and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included pneumococcal vaccine (Pneumonia Vaccine).   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain, influenza-like symptoms, inappropriate preparation of medication and inappropriate dose of vaccine administered. Shingrix was interrupted. On an unknown date, the outcome of the injection site pain, mobility decreased, tiredness, sniffles, gastrointestinal symptom nos, urinary frequency, muscle pain and influenza-like symptoms were recovered/resolved and the outcome of the heaviness in arm, digestion impaired, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain, mobility decreased, heaviness in arm, tiredness, sniffles, gastrointestinal symptom nos, digestion impaired, urinary frequency, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the pneumonia vaccine one month earlier to Shingrix. It was reported that patient received the Shingrix with only adjuvant part and experienced symptoms including injection site soreness, difficulty lifting arm due to heaviness, muscle ache and flu-like symptoms. 24 Hours after the vaccination patient felt tired with mild sniffles, gastrointestinal symptoms including altered digestion, and increased urination. As patient received the Shingrix without antigen,which led to iappropriate preparation of medication and inappropriate dose of vaccine administered. It was reported that the symptoms lasted approximately 1-2 days. The blood test was performed for antibody levels which demonstrated antibodies to shingles. Patient was unwilling to be re-vaccinated with properly reconstituted Shingrix vaccine due to having side effects from adjuvant.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: out is "spots" on his back, side,stomach, and back of neck; This case was reported by a consumer and described the occurrence of rash in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   The reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm. After receiving Shingrix, the patient experienced rash. The patient broke out was spots on his back, side, stomach, and back of neck. The physician told him the rash was a result of the Shingrix vaccine. The reporter consent to follow up. This case has been linked with US2020AMR245356, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR245356:same reporter
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mass, Neck mass, Pain
Clinical narrative: Lump in neck and shoulder area; Lump in neck and shoulder area; Soreness around the lumpin neck/shoulder; Soreness around the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 8th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 9th September 2020, the patient experienced neck mass, mass and pain. On an unknown date, the outcome of the injection site pain, neck mass, mass and pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain to be related to Shingrix. The reporter considered the neck mass and mass to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. After receiving Shingrix, in evening the patient had soreness around the injection site, and this lasted a couple of days and then resolved. About 28 to 29 hours after receiving the Shngrix, the patient also had a lump in her neck and shoulder area and soreness around the lump.  The patient reported she went to her doctor about the lump and the doctor thought it was from the vaccine.  The reporter did not consent to follow-up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Lip swelling
Clinical narrative: swelling pain in right arm at injection site, headache, severe fatigue, swelling in lips (Bottom inparticular)
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site nodule, Skin warm
Clinical narrative: Red golf ball size knot on arm at injection site- warm to the touch.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Persistent pruritic rash; This case was reported by a physician and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in March 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced itchy rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash 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 was captured as an adult as per vaccine indication.  The patient received second dose a few months after the first dose and developed a persistent pruritic rash. The patient received steroids due to this. The patient stated that his/her symptoms might have flared again after receiving Fluzone a few months after the second dose of Shingrix. The physician declined follow-up and did not have the time to provide additional information.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: diagnosed with Covid-19, it was after the first dose of Shingrix; This case was reported by a pharmacist and described the occurrence of covid-19 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 covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient was diagnosed with Covid-19. At the time of reporting, the patient wanted to receive 2nd dose. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: sweating; shivering; fever of 101.9 degrees; pain at the injection site; body aches; This case was reported by a consumer and described the occurrence of sweating in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular) and the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). In December 2019, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sweating, shivering, fever, injection site pain and general body pain. On an unknown date, the outcome of the sweating, shivering, fever, injection site pain and general body pain were recovered/resolved.   It was unknown if the reporter considered the sweating, shivering, fever, injection site pain and general body pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received 1st dose of Shingrix and vaccine Quadrivalent 2019-2020 season in left arm. In December 2019, the patient underwent body temperature test which results 101.9 degree F. After receiving 1st dose of Shingrix, the patient experienced body aches, pain at the injection site, shivering, sweating, and a fever. In March 2020, the patient had 2nd dose of Shingrix. The reporter did not consent to follow up. This case has been linked with US2020244471 and US2020AMR245444, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244471:same reporter US-GLAXOSMITHKLINE-US2020AMR245444:same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: sweating; shivering; fever of 101.9 degrees; pain at the injection site; body aches; This case was reported by a consumer and described the occurrence of sweating in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular) and the 1st dose of Influenza vaccine Quadrivalent 2019-2020 season (intramuscular). In December 2019, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced sweating, shivering, fever, injection site pain and general body pain. On an unknown date, the outcome of the sweating, shivering, fever, injection site pain and general body pain were recovered/resolved.   It was unknown if the reporter considered the sweating, shivering, fever, injection site pain and general body pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received 1st dose of Shingrix and vaccine Quadrivalent 2019-2020 season in left arm. In December 2019, the patient underwent body temperature test which results 101.9 degree F. After receiving 1st dose of Shingrix, the patient experienced body aches, pain at the injection site, shivering, sweating, and a fever. In March 2020, the patient had 2nd dose of Shingrix. The reporter did not consent to follow up. This case has been linked with US2020244471 and US2020AMR245444, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244471:same reporter US-GLAXOSMITHKLINE-US2020AMR245444:same reporter
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient took vaccine and died two weeks later; Spontaneous report s were received from consumers via social media posts concerning an 86 year old male patient who received Moderna's COVID-19 vaccine and died.  There was no medical history provided. There were no concomitant medications provided.  On approximately 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # unknown), intramuscularly for prophylaxis of COVID-19 infection.   All of the social media posts reported the patients death and, according to one post, the patient took two doses of Moderna's vaccine and died two weeks later.  The patient died on or before 23 Jan 2021. No additional information was provided.  Very limited information regarding this event has been provided at this time.  The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reporter's Comments: This case concerns a 86-year old male patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately two weeks after receiving their second of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Eye pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: 2x3" rash at injection site, Covid-arm.  Slight headache, brain fog, achy feeling and balance is off.  Tiredness.  Eye pain.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain
Clinical narrative: 2x3" rash at injection site, Covid-arm.  Slight headache, brain fog, achy feeling and balance is off.  Tiredness.  Eye pain.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Death, Pyrexia, Respiratory distress
Clinical narrative: Respiratory distress; Anxiety; Fever; Passed away; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed fever, respiratory distress, anxiety and passed away.  The patient's medical history was not provided. Concomitant product use was not provided.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, within 24 hours of receiving the vaccine, the patient developed a fever, respiratory distress and anxiety. Treatment for the events included oxygen, morphine, and lorazepam.    On the evening of 26 Dec 2020, the patient passed away.  Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 26 Dec 2020. The cause of death was not reported. Plans for an autopsy were not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of death (unknown cause)  and respiratory distress, the non-serious listed event of fever, and the non-serious unlisted event of anxiety.  The events of respiratory distress, fever, and anxiety occurred within 24 hours of vaccination, while the event of death (unknown cause) occurred an unknown amount of time after vaccination.  Very limited information has been provided regarding the circumstances leading to death and additional information has been requested.  Based on the current available information and temporal association between the use of the product and the onset of events after vaccination, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tongue disorder
Clinical narrative: Tongue Thickness /throat Tightness Taking to ER.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient experienced hives all over the body 4 days after receiving the COVID vaccine. Patient was seen in dermatology clinic and was prescribed Cetirizine 20 mg BID, Famotidine 20 mg BID, hydroxyzine 25-50 mg qhs prn, provided information regarding slow taper off antihistamine regimen. Was advised to reach out if no significant improvement over the next 48 hours (so that he can work and sleep), but wouldn't expect him to be able to go off medications until at least 4-6 weeks.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Heart rate decreased, Pneumonia, Pyrexia
Clinical narrative: fever of over 105. Low pulse ox Sent to ER. Admitted with dx pneumonia
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Paraesthesia
Clinical narrative: after receiving vaccine patient had 2 lumps on site ; some redness at the site of injection; experienced some tingling in the face, and head .
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Hives, red welt, pain and itchiness at site of injection one week after. Redness has increased over njhbt
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain
Clinical narrative: Started with light chills.  12 hours after inoculation severe chills (during sleep).  24 hours after inoculation continued low level chills throughout day.  Body aches and general malaise.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Body Aches, feverish  Sore at site of injection
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, chills, headache, sore throat and achy