chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: felt like the flu" for 2 days; red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date unknown) for prophylaxis.   On 10th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. On an unknown date, the outcome of the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, red, swollen arm, sore arm, headache, fatigue and achy. For tolerance of 2nd dose of Shingrix, refer case US2019AMR234116. This case linked with US2019AMR232150 and US2019102453, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Vaccine positive rechallenge
Clinical narrative: felt like the flu" for 2 days; red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date unknown) for prophylaxis.   On 10th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. On an unknown date, the outcome of the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, red, swollen arm, sore arm, headache, fatigue and achy. For tolerance of 2nd dose of Shingrix, refer case US2019AMR234116. This case linked with US2019AMR232150 and US2019102453, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Fatigue, Headache, Influenza like illness, Pain
Clinical narrative: felt like the flu" for 2 days; red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 10th May 2019, refer case US2019AMR232150).   On 14th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, red, swollen arm, sore arm, headache, fatigue and achy. The event were better after dose 2. This case linked with US2019AMR232150 and US2019102453, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: felt like the flu" for 2 days; red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 10th May 2019, refer case US2019AMR232150).   On 14th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, red, swollen arm, sore arm, headache, fatigue and achy. The event were better after dose 2. This case linked with US2019AMR232150 and US2019102453, reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Vaccine positive rechallenge
Clinical narrative: felt like the flu" for 2 days; red; swollen arm; headache; fatigue; achy; sore arm/Arm ache; This case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of influenza like illness (received 1st dose on 10th May 2019, refer case US2019AMR232150).   On 14th August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, erythema, swelling arm, pain in arm, headache, fatigue and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, red, swollen arm, sore arm, headache, fatigue and achy. The event were better after dose 2. This case linked with US2019AMR232150 and US2019102453, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache
Clinical narrative: upset stomach; chills; TIRED; headache.; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2019, the patient received Shingrix. On 13th December 2019, less than a day after receiving Shingrix, the patient experienced tiredness and headache. On 15th December 2019, the patient experienced chills. On 17th December 2019, the patient experienced upset stomach. On an unknown date, the outcome of the tiredness, headache, chills and upset stomach were unknown.   It was unknown if the reporter considered the tiredness, headache, chills and upset stomach to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient after vaccination wasn ot feeling well, the patient had minimal side effects tired and a headache. The patient also had the chills very badly and had an upset stomach. The patient asked is this coincidental or could there be a 2 day delay in the side effects. The patient was wondering because had to schedule next shot.
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Ophthalmic herpes zoster
Clinical narrative: had shingles in one of her eyes; fell; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, 9 months after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and fall. On an unknown date, the outcome of the ophthalmic herpes zoster and fall were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and fall to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and shortly after that patient was fell and not able to get 2nd shot. About 9 months after the 1st shot, she had shingles in one of her eyes. Her shingles have been gone at least 3 months. The reporter queried if the patient should get the 2nd shot now or should she start over with the 1st shot and then get 2nd in a couple of months. The reporter stated the physician and pharmacist were not been able to answer and told her that she needs to get 2nd dose.
Sex: U
Vaccine: FLUX
Symptoms: Adverse drug reaction
Clinical narrative: unspecified problems; This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in an unspecified number of patients who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not applicable for this report. The reporter stated during telephone conversation that he had been seen thousands of patients over the years that, had reported many, unspecified problems after getting a flu vaccine. The reporter facility required that patients get the flu vaccine, so a patient could be dying of sepsis, but they had to get the flu vaccine in the emergency department. No other details provided, given, or available other than what was documented, at time of initial reporting. The reporter consented to follow up. This is 1 of the 3 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; pain; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a month after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix in in the middle of July and by the 1st week of August had shingles. The patient 2nd dose was due this month and afraid to get it.  The reporter asked what effect would only 1 dose had and how likely would the 2nd shot cause shingles again. That pain was the worst of the worst.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever 100-102 for 2 days after vaccine Redness below vaccine site about 4" in length
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Induration, Pain in extremity, Skin warm
Clinical narrative: Chills; Arm Soreness; Hard bump; Swollen bump; Bump that was hot to the touch; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of induration in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th November 2019, 3 days after receiving Shingrix, the patient experienced induration, swelling, skin warm and headache. On an unknown date, the patient experienced chills and pain in arm. On 11th November 2019, the outcome of the induration, swelling, skin warm and headache were resolved with sequelae. On an unknown date, the outcome of the chills was resolved with sequelae and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the induration, swelling, skin warm, headache, chills and pain in arm to be related to Shingrix.  Additional details were received as follows: The reporter stated that patient had side effects following the second dose of Shingrix. The patient had a hard, swollen bump that was hot to the touch and a headache for approximately 2 to 3 days.  The reporter stated that the patient had chills at evening and arm soreness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Chills; Arm Soreness; Hard bump; Swollen bump; Bump that was hot to the touch; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of induration in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th November 2019, 3 days after receiving Shingrix, the patient experienced induration, swelling, skin warm and headache. On an unknown date, the patient experienced chills and pain in arm. On 11th November 2019, the outcome of the induration, swelling, skin warm and headache were resolved with sequelae. On an unknown date, the outcome of the chills was resolved with sequelae and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the induration, swelling, skin warm, headache, chills and pain in arm to be related to Shingrix.  Additional details were received as follows: The reporter stated that patient had side effects following the second dose of Shingrix. The patient had a hard, swollen bump that was hot to the touch and a headache for approximately 2 to 3 days.  The reporter stated that the patient had chills at evening and arm soreness.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Varicella zoster virus infection
Clinical narrative: Varicella zoster; Rash 2 months after the first dose of Shingrix.; This case was reported by a physician via call center representative and described the occurrence of varicella zoster in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included varicella. Previously administered products included Zoster vaccine (specified this patient had received the Zoster vaccine many years ago, and that she had varicella this year) and Valacyclovir (dermatologist prescribed her to take Valacyclovir, wich made dissapear the varicella rash).   On 27th September 2019, the patient received the 1st dose of Shingrix. On 12th November 2019, 46 days after receiving Shingrix, the patient experienced varicella zoster and vesicular rash. On an unknown date, the outcome of the varicella zoster and vesicular rash were unknown.   It was unknown if the reporter considered the varicella zoster and vesicular rash to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed a vesicular rash over the right heap. The health care professional asked if the patient should receive the 2nd shot. The health care professional thinks that the rash following the first dose of Shingrix means that the patient has Varicella Zoster again. The patient did not receive the 2nd dose yet. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Rash on her back that is itchy and is spreading; 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.   The patient's past medical history included aneurysm cerebral. Concurrent medical conditions included back pain and degenerative joint disease.   On 20th November 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced itchy rash. 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 case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a rash on her back that was itchy and was spreading.She did not know exactly when the rash started in relation to receiving the vaccine but insists it did not start until after receiving the vaccine.She also indicated that she has had the rash for almost one month. The reporter unable to obtain additional information and reporter ended the call.
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction, Autism spectrum disorder, Guillain-Barre syndrome, Influenza, Vaccination failure
Clinical narrative: Suspected vaccination faliure; autism; Guillain-Barré syndrome; flu symptoms; other unspecified problems; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in an unspecified number of patients who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), autism (serious criteria GSK medically significant), guillain barre syndrome (serious criteria GSK medically significant), flu symptoms and adverse reaction. On an unknown date, the outcome of the vaccination failure, autism, guillain barre syndrome, flu symptoms and adverse reaction were unknown.   It was unknown if the reporter considered the vaccination failure, autism, guillain barre syndrome, flu symptoms and adverse reaction to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, he had seen thousands of patients over the years that had reported many, unspecified problems after getting a flu vaccine.  He gave example like, sometimes patients said that after getting a flu vaccine, they had developed autism, Guillain-Barre syndrome or flu symptoms and many other unspecified problems. The reporter further added, his facility required that the patients get the flu vaccine, so a patient cant be dying of sepsis but they have to get the flu vaccine in the emergency department. No other details were provided other than what was documented at time of initial report. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for influenza were not provided. The reporter consented to follow up. This case is one of the three cases, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood glucose increased, Chills, Hyperhidrosis
Clinical narrative: Extreme pain in right arm at inj. site within 2 hours. Became very weak, shivers, chills, sweats, unable to sleep. Sore muscles & joints, no energy. Uncontrollable sugar which has stayed just over 200.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Myalgia
Clinical narrative: Extreme pain in right arm at inj. site within 2 hours. Became very weak, shivers, chills, sweats, unable to sleep. Sore muscles & joints, no energy. Uncontrollable sugar which has stayed just over 200.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blister, Pruritus, Rash erythematous, Scar
Clinical narrative: I got large round red rash over arms, legs & most of back & belly. There was a tiny blister in center of each red circle--a "bulls eye rash." So my whole body itched. Felt extremely anxious. Doc knew from the kind of rash that was not a "contact dermatitis-type rash. ER doc the night Before at Midnight when it got bad, No idea what to do about it. Just finally gave me one Benedril tab & sent me home. Saw My PCP next day. He prescribed 3 allergy meds + prednisone, each taken at dif intervals. Needed ex meds for 1 month. (Scars gone by end of November)
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Biopsy, Blood test abnormal, Chills, Diarrhoea
Clinical narrative: Rash, Hives, Diahrea, vomiting, Low Blood pressure, flu like symtoms, fatigue weakness, Dizziness, no energy. Blood work numbers way off normal. Slept for days. Total exhaustion. Chills
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Hypersomnia, Hypotension, Influenza like illness
Clinical narrative: Rash, Hives, Diahrea, vomiting, Low Blood pressure, flu like symtoms, fatigue weakness, Dizziness, no energy. Blood work numbers way off normal. Slept for days. Total exhaustion. Chills
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria, Vomiting
Clinical narrative: Rash, Hives, Diahrea, vomiting, Low Blood pressure, flu like symtoms, fatigue weakness, Dizziness, no energy. Blood work numbers way off normal. Slept for days. Total exhaustion. Chills
Age: 69.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left arm muscle: a large painful bulge formed between Left shoulder and elbow - was sore 5-7 days. Went to my doctor's office to have it checked out. Received a prescription to get ONLY if it didn't get better in a few days. I never got it filled
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: After getting Shingrix on July 21, 2019, the patient started breaking out on his back July 23, 2019. Realized it was shingles on Sat. following July 23. Went to emergency room at Hospital & was given the proper meds
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Rotator cuff syndrome
Clinical narrative: Patient reports swelling and pain at the vaccine injection site following injection that resolved in two days. Two days following the injection, she developed deltoid and shoulder pain with left upper extremity abduction, forward flexion and external rotation and positive impingement signs. She reports this started 2 or 3 days following the vaccine injection and have gotten progressively worse since.
Age: 16.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Syncope
Clinical narrative: Snycopal Episode.  BP was taken.  Gave juice and rest, recovered quickly.  Did not eat prior to coming in for visit.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Skin reaction
Clinical narrative: Patient received his Kinrix and Proquad in his left thigh on 12/27/19.  Patient came in with his father on 12/30/19 due to redness and swelling of his left thigh.  He denied pain, had no limp, no fever and the swelling was improved since 12/29/19.  I measured the red area to be 16 cm down his thigh by 23 cm across.  It was slightly warm to the touch but non-tender and pt was using his legs fully, squatting spontaneously during the visit.  He had a very small, mobile non-tender lymph node in left inguinal area.  No streaking.  Discussed with patient's father that sometimes we see a localized skin reaction related to the diptheria in the vaccine.  Recommend continue Benadryl for 48 hours and warm compresses.  If fever, pain, not walking normally, return to clinic to consider giving antibiotics.   Since he is doing better with Benadryl, we chose to not start antibiotics today.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site swelling, Myalgia
Clinical narrative: Headache; Muscle aches; Swelling at the injection site; feeling awful; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced headache, myalgia, injection site swelling and feels awful. The patient was treated with nsaid's (Nsaid). On an unknown date, the outcome of the headache, myalgia, injection site swelling and feels awful were unknown.   It was unknown if the reporter considered the headache, myalgia, injection site swelling and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The age group was not reported but was selected as adult as per vaccine indication.  After receiving second shot of shingles on next day the patient experienced headache, myalgia, injection site swelling and feels awful. The patient ask to reporter that how long do these symptoms usually last. On reporting date the patient take NSAID . The reporter is not a health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nerve injury, Pain, Post herpetic neuralgia
Clinical narrative: shingles; PHN/throbbing pain and residual nerve demage; Information has been received from a lawyer concerning a case in litigation and refers to female patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On 27-FEB-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date in 2018 (reported as "less than two (2) months after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered debilitating injuries including painful and debilitating shingles as well as post herpetic neuralgia (PHN), significant throbbing pain and residual nerve damage. All of these injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the Company's product and caused by the zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and has suffered economic losses due to her inability to work. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, the patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  The events of shingles and PHN were considered to be disabling.
Sex: F
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Cough, Dyspnoea, Herpes zoster
Clinical narrative: shingles; shortness of breath and cough/chronic obstructive pulmonary disease exacerbation; shortness of breath and cough/pneumonia; vertigo; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information has been received about the patient's medical history, concurrent conditions and concomitant medications. On 09-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, lot #, expiry date and vaccination site were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shortness of breath and cough. The patient was hospitalized and diagnosed with chronic obstructive pulmonary disease exacerbation, pneumonia, vertigo and herpes zoster. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  The events of chronic obstructive pulmonary disease exacerbation, pneumonia, vertigo and herpes zoster were considered to be disabling. Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia, Vertigo
Clinical narrative: shingles; shortness of breath and cough/chronic obstructive pulmonary disease exacerbation; shortness of breath and cough/pneumonia; vertigo; Information has been received from a lawyer concerning a case in litigation and refers to a female patient of an unknown age. No information has been received about the patient's medical history, concurrent conditions and concomitant medications. On 09-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, lot #, expiry date and vaccination site were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shortness of breath and cough. The patient was hospitalized and diagnosed with chronic obstructive pulmonary disease exacerbation, pneumonia, vertigo and herpes zoster. As a direct and proximate result of the Company's defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the Company's product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The causality was related.  The events of chronic obstructive pulmonary disease exacerbation, pneumonia, vertigo and herpes zoster were considered to be disabling. Upon internal review, the event of pneumonia was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Nasal congestion, Pain, Pyrexia
Clinical narrative: Body ache; fever; congestion; cough; This case was reported by a nurse via sales rep and described the occurrence of general body pain in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced general body pain, fever, nasal congestion and cough. On an unknown date, the outcome of the general body pain, fever, nasal congestion and cough were unknown.   It was unknown if the reporter considered the general body pain, fever, nasal congestion and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 78 or 79 years old. Post vaccination with Shingrix the patient had body ache, fever, congestion and cough. The reporter consented to follow up.
Sex: M
Vaccine: MEN
Symptoms: Near death experience
Clinical narrative: Almost lost my son from the vaccine; This case was reported by a consumer via interactive digital media Facebook and described the occurrence of near death experience in a male patient who received Men B NVS (Bexsero) for prophylaxis.  On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced near death experience (serious criteria GSK medically significant). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient's parent reported that, it was tough one that almost lost his son from  the vaccine.
Age: 54.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Pain
Clinical narrative: injection site pain; body aches; headache; exhaustion; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-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.   On 25th November 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 25th November 2019, 3 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain, general body pain, headache and exhaustion. On an unknown date, the outcome of the injection site pain, general body pain, headache and exhaustion were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, general body pain, headache and exhaustion to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received dose Shingrix and an unknown flu shot and 3 hours after that dose he developed injection site pain. He states that seven hours after he received his vaccines he developed body pain, exhaustion, and severe headache. All the symptoms have improved, but not resolved. The reporter consented to follow up. The consumer did not have any further information for this Adverse event, did not know details of either vaccine other than those documented.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 90-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows.  The patient reported flu like symptoms after receiving the vaccine. The reporter could not remember much more than what was reported. The reporter did not consent to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Musculoskeletal pain, Pyrexia
Clinical narrative: headache; tired; fever; shivering; shoulder is tender; This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 19th December 2019, less than a day after receiving Shingrix, the patient experienced headache, tiredness, fever, shivering and shoulder pain. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the tiredness, fever, shivering and shoulder pain were unknown.   It was unknown if the reporter considered the headache, tiredness, fever, shivering and shoulder pain to be related to Shingrix.  Additional details were provided as follows:  The patient exprienced headache, tiredness, fever, shivering and shoulder pain after receiving 1st dose of Shingrix. The headache was getting less intense. The reporter asked if the 2nd shot will produce side effects too. Consent to follow up was denied.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Flushing, Nausea, Vomiting
Clinical narrative: Patient called day after receiving second Shingrix shot complaining of fatigue, nausea/vomiting, flushing, and chills.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Myalgia
Clinical narrative: Muscle pain. Joint pain. Headache. Glue like symptoms.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus, Shoulder arthroplasty
Clinical narrative: Starting at about 8:00PM approximately 7 hours after shot swelling occurred; intense itching; redness and some heat sensation; swelling proceded down arm over next 8 hours or so. After proceding down arm the swelling then went up arm. The swelling was hard 2 doctors were contacted by wife; NP ER Doctor and Primary Care doctor. They both recommended BENADRYL 50MG and cold compresses. They recommended ER visit if breathing problems occurred. No problems wit breathing occured. The situation resolved over aproximately 3 days with no residual effects. What is significant is patient has a titanium plated in this arm. He described it as a reversed shoulder replacement.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Starting at about 8:00PM approximately 7 hours after shot swelling occurred; intense itching; redness and some heat sensation; swelling proceded down arm over next 8 hours or so. After proceding down arm the swelling then went up arm. The swelling was hard 2 doctors were contacted by wife; NP ER Doctor and Primary Care doctor. They both recommended BENADRYL 50MG and cold compresses. They recommended ER visit if breathing problems occurred. No problems wit breathing occured. The situation resolved over aproximately 3 days with no residual effects. What is significant is patient has a titanium plated in this arm. He described it as a reversed shoulder replacement.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Cellulitis, Red, swollen, tender
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Headache, Impaired work ability
Clinical narrative: Within 4 hours, delevoped mild headache (same as with first dose). By 5am, feeling extremely achey, headache, nauseated, followed by dizziness.  Debilitating symptoms, unable to go to work due to the dizziness and stomach upset.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Within 4 hours, delevoped mild headache (same as with first dose). By 5am, feeling extremely achey, headache, nauseated, followed by dizziness.  Debilitating symptoms, unable to go to work due to the dizziness and stomach upset.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Demyelinating polyneuropathy, Guillain-Barre syndrome, Laboratory test
Clinical narrative: developed demylinating neuropathy thought to be Guillane Barre.
Age: 86.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: On going severe arm pain, after FLU  injection was given very high on left arm. Pain continues despite physical therapy.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Cough, Hyperhidrosis, Injection site pain, Malaise
Clinical narrative: Patient reported "fever of 102.8, generalized muscle aches, sweats and chills and a light cough. Also reports new marble sized swelling left axilla. He received both injections in his left triceps and the site has minimal tenderness and no redness or swelling. Does report vaguely not feeling well before receiving the vaccines and he has no known exposures." to triage phone nurse evening of the vaccines.  He reported feeling better by the morning.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Myalgia, Pyrexia, Swelling
Clinical narrative: Patient reported "fever of 102.8, generalized muscle aches, sweats and chills and a light cough. Also reports new marble sized swelling left axilla. He received both injections in his left triceps and the site has minimal tenderness and no redness or swelling. Does report vaguely not feeling well before receiving the vaccines and he has no known exposures." to triage phone nurse evening of the vaccines.  He reported feeling better by the morning.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Lip blister, Malaise, Myalgia
Clinical narrative: About three hours after the vaccine, I began to feel muscles aches all over my body and fatigue started. I took some Tylenol at noon. The vaccine was on a Friday morning. The next two days (Saturday and Sunday) I felt the same, but with more malaise and continued to take Tylenol. Sunday evening I started to feel better, but not great. Monday I felt the same and then Monday evening my lower lip and chin broke out in blisters about the size of a pea. Tuesday morning I awoke with a larger cluster of blisters on the lower lip and chin that has grown to about the size of my thumb. The blisters are tender and painful. I am uncertain if the vaccine was Shingrix or Zostavax.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: About three hours after the vaccine, I began to feel muscles aches all over my body and fatigue started. I took some Tylenol at noon. The vaccine was on a Friday morning. The next two days (Saturday and Sunday) I felt the same, but with more malaise and continued to take Tylenol. Sunday evening I started to feel better, but not great. Monday I felt the same and then Monday evening my lower lip and chin broke out in blisters about the size of a pea. Tuesday morning I awoke with a larger cluster of blisters on the lower lip and chin that has grown to about the size of my thumb. The blisters are tender and painful. I am uncertain if the vaccine was Shingrix or Zostavax.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: at injection site: area of redness, mild warmth, mild discomfort that took approximately 10 days to resolve completely
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Proquad may have been improperly stored.  No adverse reaction noted.  Will reimmunize in 4 weeks.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: small lump and soreness at site of injection - no redness or warmth
Age: 0.58
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, UNK, UNK, UNK, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: After patient's Wellness check up on 8/01/16, about an hour later after his Polio, HIB, HEP B and PneumoConju shots done same day on 8/01/16, patient started having high fever and had 2 back to back convulsions, seizures. We rushed to the ER where he was kept overnight until next evening.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches and pains, soreness at injection site
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; a male Patient received improperly stored M-M-R II; This spontaneous report as received from a medical assistant refers to a 5-year-old male patient. The patient's pertinent medical history, drug reactions and allergies and concomitant medications were not reported.   On 24-OCT-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose and frequency were not reported) lot # R031680, expiration date 01-NOV-2020. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. The call was because of data logger, with a temperature excursion of -58 degrees Fahrenheit (F) and +46 F (19.13 F) for 1.5 hours. There was a previous temperature excursion reported with a temperature above 47 F (54.93 F) for 15 minutes, -58 F and +46 F for 12 hours and 15 minutes.