chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Soft tissue disorder, Swelling, Tendon pain, Tendonitis
Clinical narrative: Severe reaction. Swelling, redness, pain, burning, hot to touch - within weeks, ligament, tendon, joint pain and inflammation. Continues to this day.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm is swollen, hot, and red from top to the elbow. She has had a problem in the past with the other pnemonoccal vaccine. She is icing the site and taking BENADRYL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia, Rash generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 20th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain and fever. On 21st August 2018, the patient experienced influenza-like symptoms and generalized rash. On an unknown date, the outcome of the pain, fever, influenza-like symptoms and generalized rash were recovered/resolved. It was unknown if the reporter considered the pain, fever, influenza-like symptoms and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on an unknown arm. One day after receiving vaccination, the patient experienced flu like symptoms and full body rash. The patient reported that she follow-up with her physician. The patient reported the adverse events to the FDA (full form) via website. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 28th December 2018, the patient received SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, injection site erythema and lethargy. On 29th December 2018, the patient experienced shivering, joint pain and influenza-like symptoms. On 31st December 2018, the patient experienced lip swelling, blister and fever blister. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister were unknown. It was unknown if the reporter considered the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister to be related to SHINGRIX. Additional details were provided as follows: One day the after receiving SHINGRIX, the patient experienced shivering, joint pain and influenza-like symptoms. Three day after receiving SHINGRIX, the patient experienced lip swelling, blister and fever blister. Less than a week after receiving SHINGRIX, the patient experienced injection site swelling. The patient stated that, the reason why she said no, or the lowest number, one, for two questions, was because the person she spoke with said they did not have a documented evidence of people who take and got the SHINGRIX vaccine, and then within the three days, start getting like, fever blisters or similar to a chicken pox thing, blisters, all around her top lip, mostly and somewhat on my bottom lip. The patient did not had it on anywhere on her body, but she was concerned that was not mentioned in there literature or the possibility of it. They could not solve the problem because they did not had evidence of what she experienced, which was now the fifth day since she got the shot. The patient was still had flu-like symptoms, arm where she got the shot still had redness around the area, swelling and she felt ache all over. The patient started with stuff, they know pimple like or fever blisters, whatever around her mouth and it was pretty miserable, but the man she spoke with was great and help her all he could.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lip blister, Lip swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 28th December 2018, the patient received SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, injection site erythema and lethargy. On 29th December 2018, the patient experienced shivering, joint pain and influenza-like symptoms. On 31st December 2018, the patient experienced lip swelling, blister and fever blister. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister were unknown. It was unknown if the reporter considered the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister to be related to SHINGRIX. Additional details were provided as follows: One day the after receiving SHINGRIX, the patient experienced shivering, joint pain and influenza-like symptoms. Three day after receiving SHINGRIX, the patient experienced lip swelling, blister and fever blister. Less than a week after receiving SHINGRIX, the patient experienced injection site swelling. The patient stated that, the reason why she said no, or the lowest number, one, for two questions, was because the person she spoke with said they did not have a documented evidence of people who take and got the SHINGRIX vaccine, and then within the three days, start getting like, fever blisters or similar to a chicken pox thing, blisters, all around her top lip, mostly and somewhat on my bottom lip. The patient did not had it on anywhere on her body, but she was concerned that was not mentioned in there literature or the possibility of it. They could not solve the problem because they did not had evidence of what she experienced, which was now the fifth day since she got the shot. The patient was still had flu-like symptoms, arm where she got the shot still had redness around the area, swelling and she felt ache all over. The patient started with stuff, they know pimple like or fever blisters, whatever around her mouth and it was pretty miserable, but the man she spoke with was great and help her all he could.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Chills, Influenza like illness, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 28th December 2018, the patient received SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, injection site erythema and lethargy. On 29th December 2018, the patient experienced shivering, joint pain and influenza-like symptoms. On 31st December 2018, the patient experienced lip swelling, blister and fever blister. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister were unknown. It was unknown if the reporter considered the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister to be related to SHINGRIX. Additional details were provided as follows: One day the after receiving SHINGRIX, the patient experienced shivering, joint pain and influenza-like symptoms. Three day after receiving SHINGRIX, the patient experienced lip swelling, blister and fever blister. Less than a week after receiving SHINGRIX, the patient experienced injection site swelling. The patient stated that, the reason why she said no, or the lowest number, one, for two questions, was because the person she spoke with said they did not have a documented evidence of people who take and got the SHINGRIX vaccine, and then within the three days, start getting like, fever blisters or similar to a chicken pox thing, blisters, all around her top lip, mostly and somewhat on my bottom lip. The patient did not had it on anywhere on her body, but she was concerned that was not mentioned in there literature or the possibility of it. They could not solve the problem because they did not had evidence of what she experienced, which was now the fifth day since she got the shot. The patient was still had flu-like symptoms, arm where she got the shot still had redness around the area, swelling and she felt ache all over. The patient started with stuff, they know pimple like or fever blisters, whatever around her mouth and it was pretty miserable, but the man she spoke with was great and help her all he could.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lethargy, Lip swelling, Oral herpes, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 28th December 2018, the patient received SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, injection site erythema and lethargy. On 29th December 2018, the patient experienced shivering, joint pain and influenza-like symptoms. On 31st December 2018, the patient experienced lip swelling, blister and fever blister. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister were unknown. It was unknown if the reporter considered the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister to be related to SHINGRIX. Additional details were provided as follows: One day the after receiving SHINGRIX, the patient experienced shivering, joint pain and influenza-like symptoms. Three day after receiving SHINGRIX, the patient experienced lip swelling, blister and fever blister. Less than a week after receiving SHINGRIX, the patient experienced injection site swelling. The patient stated that, the reason why she said no, or the lowest number, one, for two questions, was because the person she spoke with said they did not have a documented evidence of people who take and got the SHINGRIX vaccine, and then within the three days, start getting like, fever blisters or similar to a chicken pox thing, blisters, all around her top lip, mostly and somewhat on my bottom lip. The patient did not had it on anywhere on her body, but she was concerned that was not mentioned in there literature or the possibility of it. They could not solve the problem because they did not had evidence of what she experienced, which was now the fifth day since she got the shot. The patient was still had flu-like symptoms, arm where she got the shot still had redness around the area, swelling and she felt ache all over. The patient started with stuff, they know pimple like or fever blisters, whatever around her mouth and it was pretty miserable, but the man she spoke with was great and help her all he could.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 79-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included arthritis. On 28th December 2018, the patient received SHINGRIX. On 28th December 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, injection site erythema and lethargy. On 29th December 2018, the patient experienced shivering, joint pain and influenza-like symptoms. On 31st December 2018, the patient experienced lip swelling, blister and fever blister. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister were unknown. It was unknown if the reporter considered the general body pain, injection site erythema, shivering, joint pain, lethargy, lip swelling, blister, influenza-like symptoms, injection site swelling and fever blister to be related to SHINGRIX. Additional details were provided as follows: One day the after receiving SHINGRIX, the patient experienced shivering, joint pain and influenza-like symptoms. Three day after receiving SHINGRIX, the patient experienced lip swelling, blister and fever blister. Less than a week after receiving SHINGRIX, the patient experienced injection site swelling. The patient stated that, the reason why she said no, or the lowest number, one, for two questions, was because the person she spoke with said they did not have a documented evidence of people who take and got the SHINGRIX vaccine, and then within the three days, start getting like, fever blisters or similar to a chicken pox thing, blisters, all around her top lip, mostly and somewhat on my bottom lip. The patient did not had it on anywhere on her body, but she was concerned that was not mentioned in there literature or the possibility of it. They could not solve the problem because they did not had evidence of what she experienced, which was now the fifth day since she got the shot. The patient was still had flu-like symptoms, arm where she got the shot still had redness around the area, swelling and she felt ache all over. The patient started with stuff, they know pimple like or fever blisters, whatever around her mouth and it was pretty miserable, but the man she spoke with was great and help her all he could.
Age: 19.0
Sex: F
Vaccine: MENB, MENB, MENB
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received TRUMENBA (lot# W09937, exp date Jan2020), intramuscular, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. The patient passed out on an unspecified date with outcome of recovering. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine TRUMENBA contributed to the development of the reported event passed out.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site bruising, Injection site swelling, Swelling
Clinical narrative: Client reports pain in arm as well as swelling of the neck on right side. Noted small skin discoloration at shot site. Right side of neck is swollen palpated no hardness or lump. left side skin is with in normal limit no discoloration, pale and intact.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site discolouration, Pain in extremity, Swelling
Clinical narrative: Client reports pain in arm as well as swelling of the neck on right side. Noted small skin discoloration at shot site. Right side of neck is swollen palpated no hardness or lump. left side skin is with in normal limit no discoloration, pale and intact.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, DTAP, FLU4, HIBV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: My infant had a fever the day after her shots. I was never asked or informed that the flu shot was going to be given and it was the second one given in 3 months without talking to me about it. On January 8th, she had a febrile seizure. The ER doctor was stating it was probably caused by the fever due to recent vaccinations. No treatment given.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, DTAP, FLU4, HIBV
Symptoms: Cyanosis, Febrile convulsion, Neurological examination normal, Pallor, Postictal state
Clinical narrative: My infant had a fever the day after her shots. I was never asked or informed that the flu shot was going to be given and it was the second one given in 3 months without talking to me about it. On January 8th, she had a febrile seizure. The ER doctor was stating it was probably caused by the fever due to recent vaccinations. No treatment given.
Age: 1.25
Sex: F
Vaccine: DTAP, FLUX, HIBV, DTAP, FLU4, HIBV
Symptoms: Pyrexia, Seizure, Urine analysis normal
Clinical narrative: My infant had a fever the day after her shots. I was never asked or informed that the flu shot was going to be given and it was the second one given in 3 months without talking to me about it. On January 8th, she had a febrile seizure. The ER doctor was stating it was probably caused by the fever due to recent vaccinations. No treatment given.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Myalgia
Clinical narrative: Muscle/joint pain, chills, fever (100.7), weak, tired, rash.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Muscle/joint pain, chills, fever (100.7), weak, tired, rash.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Amino acid level, Antibody test, Blood copper, Blood heavy metal test, Blood thyroid stimulating hormone
Clinical narrative: "2-3 days after my flu shot in Oct 2018, I started to have numbness and burning feeling in my feet- 5 days after that, it started to involve both hands, and 4-5 days later perioral/face/scalp. From there, it went on to affect my entire body, a nagging numbness and tingling feeling, with periods of burning sensation, itchiness, worse at nighttime. Feet numbness and burning worse during the day as well, with walking and prolonged standing. This triggered 2 visits to 2 different neurologists (diagnosed with small fiber-sensory neuropathy- Guillain-Barre- Variant) blood tests (B6,B12, Ceruloplasmin, heavy metal panel, ESR/CRP, Lyme, Mycoplasma titers, Sjogren antibodies, CBC, Chem 7, Copper, Methylmalonic Acid, SPEP, TSH cascade, A1c, Zinc level etc. MRI of Brain and Cervical Spine, EMG- started on 12 days of prednisone taper, Alpha lipoic acid TID, Acetyl L-Carnitine TID, Fish oil TID, daily B complex vitamin, Vitamin C, Biotin, Vitamin D, Magnesium - continues to take some of these medications to help with recovery. Symptoms are improving, still having mainly hands and feet symptoms- numbness and burning dysesthesias and only intermittent whole body burning sensation, not as bad as at its worse in November and beginning of December. Was advised to not get flu shots in the future.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood zinc, Borrelia test, Burning sensation, C-reactive protein, Ceruloplasmin
Clinical narrative: "2-3 days after my flu shot in Oct 2018, I started to have numbness and burning feeling in my feet- 5 days after that, it started to involve both hands, and 4-5 days later perioral/face/scalp. From there, it went on to affect my entire body, a nagging numbness and tingling feeling, with periods of burning sensation, itchiness, worse at nighttime. Feet numbness and burning worse during the day as well, with walking and prolonged standing. This triggered 2 visits to 2 different neurologists (diagnosed with small fiber-sensory neuropathy- Guillain-Barre- Variant) blood tests (B6,B12, Ceruloplasmin, heavy metal panel, ESR/CRP, Lyme, Mycoplasma titers, Sjogren antibodies, CBC, Chem 7, Copper, Methylmalonic Acid, SPEP, TSH cascade, A1c, Zinc level etc. MRI of Brain and Cervical Spine, EMG- started on 12 days of prednisone taper, Alpha lipoic acid TID, Acetyl L-Carnitine TID, Fish oil TID, daily B complex vitamin, Vitamin C, Biotin, Vitamin D, Magnesium - continues to take some of these medications to help with recovery. Symptoms are improving, still having mainly hands and feet symptoms- numbness and burning dysesthesias and only intermittent whole body burning sensation, not as bad as at its worse in November and beginning of December. Was advised to not get flu shots in the future.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Electromyogram, Electrophoresis protein, Full blood count, Glycosylated haemoglobin, Guillain-Barre syndrome
Clinical narrative: "2-3 days after my flu shot in Oct 2018, I started to have numbness and burning feeling in my feet- 5 days after that, it started to involve both hands, and 4-5 days later perioral/face/scalp. From there, it went on to affect my entire body, a nagging numbness and tingling feeling, with periods of burning sensation, itchiness, worse at nighttime. Feet numbness and burning worse during the day as well, with walking and prolonged standing. This triggered 2 visits to 2 different neurologists (diagnosed with small fiber-sensory neuropathy- Guillain-Barre- Variant) blood tests (B6,B12, Ceruloplasmin, heavy metal panel, ESR/CRP, Lyme, Mycoplasma titers, Sjogren antibodies, CBC, Chem 7, Copper, Methylmalonic Acid, SPEP, TSH cascade, A1c, Zinc level etc. MRI of Brain and Cervical Spine, EMG- started on 12 days of prednisone taper, Alpha lipoic acid TID, Acetyl L-Carnitine TID, Fish oil TID, daily B complex vitamin, Vitamin C, Biotin, Vitamin D, Magnesium - continues to take some of these medications to help with recovery. Symptoms are improving, still having mainly hands and feet symptoms- numbness and burning dysesthesias and only intermittent whole body burning sensation, not as bad as at its worse in November and beginning of December. Was advised to not get flu shots in the future.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Laboratory test, Mycoplasma test, Nuclear magnetic resonance imaging brain
Clinical narrative: "2-3 days after my flu shot in Oct 2018, I started to have numbness and burning feeling in my feet- 5 days after that, it started to involve both hands, and 4-5 days later perioral/face/scalp. From there, it went on to affect my entire body, a nagging numbness and tingling feeling, with periods of burning sensation, itchiness, worse at nighttime. Feet numbness and burning worse during the day as well, with walking and prolonged standing. This triggered 2 visits to 2 different neurologists (diagnosed with small fiber-sensory neuropathy- Guillain-Barre- Variant) blood tests (B6,B12, Ceruloplasmin, heavy metal panel, ESR/CRP, Lyme, Mycoplasma titers, Sjogren antibodies, CBC, Chem 7, Copper, Methylmalonic Acid, SPEP, TSH cascade, A1c, Zinc level etc. MRI of Brain and Cervical Spine, EMG- started on 12 days of prednisone taper, Alpha lipoic acid TID, Acetyl L-Carnitine TID, Fish oil TID, daily B complex vitamin, Vitamin C, Biotin, Vitamin D, Magnesium - continues to take some of these medications to help with recovery. Symptoms are improving, still having mainly hands and feet symptoms- numbness and burning dysesthesias and only intermittent whole body burning sensation, not as bad as at its worse in November and beginning of December. Was advised to not get flu shots in the future.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Nuclear magnetic resonance imaging spinal, Paraesthesia, Pruritus, Red blood cell sedimentation rate, Skin burning sensation
Clinical narrative: "2-3 days after my flu shot in Oct 2018, I started to have numbness and burning feeling in my feet- 5 days after that, it started to involve both hands, and 4-5 days later perioral/face/scalp. From there, it went on to affect my entire body, a nagging numbness and tingling feeling, with periods of burning sensation, itchiness, worse at nighttime. Feet numbness and burning worse during the day as well, with walking and prolonged standing. This triggered 2 visits to 2 different neurologists (diagnosed with small fiber-sensory neuropathy- Guillain-Barre- Variant) blood tests (B6,B12, Ceruloplasmin, heavy metal panel, ESR/CRP, Lyme, Mycoplasma titers, Sjogren antibodies, CBC, Chem 7, Copper, Methylmalonic Acid, SPEP, TSH cascade, A1c, Zinc level etc. MRI of Brain and Cervical Spine, EMG- started on 12 days of prednisone taper, Alpha lipoic acid TID, Acetyl L-Carnitine TID, Fish oil TID, daily B complex vitamin, Vitamin C, Biotin, Vitamin D, Magnesium - continues to take some of these medications to help with recovery. Symptoms are improving, still having mainly hands and feet symptoms- numbness and burning dysesthesias and only intermittent whole body burning sensation, not as bad as at its worse in November and beginning of December. Was advised to not get flu shots in the future.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Small fibre neuropathy, Vitamin B12, Vitamin B6
Clinical narrative: "2-3 days after my flu shot in Oct 2018, I started to have numbness and burning feeling in my feet- 5 days after that, it started to involve both hands, and 4-5 days later perioral/face/scalp. From there, it went on to affect my entire body, a nagging numbness and tingling feeling, with periods of burning sensation, itchiness, worse at nighttime. Feet numbness and burning worse during the day as well, with walking and prolonged standing. This triggered 2 visits to 2 different neurologists (diagnosed with small fiber-sensory neuropathy- Guillain-Barre- Variant) blood tests (B6,B12, Ceruloplasmin, heavy metal panel, ESR/CRP, Lyme, Mycoplasma titers, Sjogren antibodies, CBC, Chem 7, Copper, Methylmalonic Acid, SPEP, TSH cascade, A1c, Zinc level etc. MRI of Brain and Cervical Spine, EMG- started on 12 days of prednisone taper, Alpha lipoic acid TID, Acetyl L-Carnitine TID, Fish oil TID, daily B complex vitamin, Vitamin C, Biotin, Vitamin D, Magnesium - continues to take some of these medications to help with recovery. Symptoms are improving, still having mainly hands and feet symptoms- numbness and burning dysesthesias and only intermittent whole body burning sensation, not as bad as at its worse in November and beginning of December. Was advised to not get flu shots in the future.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received a registered nurse referring to a patient of an unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. On 03-JAN-2019, the patient was vaccinated with an improperly stored dose of VARIVAX with lot number N028715 and expiration date on 13-OCT-2019, administered for prophylaxis (strength, dose, dose number, route of administration and anatomical injection site were not reported). The vaccine was reconstituted using a properly stored sterile diluent. It was reported that on unknown date, the vaccine was exposed to a temperature between 15 Fahrenheit degrees and 46 Fahrenheit degrees (25.7 F degrees) for 4 hours and 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around September 2016, the patient received the ZOSTAVAX from a physician for its intended purpose: the prevention of shingles. Shortly thereafter, the patient suffered a severe rash. In or around January 2017, the patient presented to a physician for this injury and was diagnosed with shingles. Subsequently, and because of the shingles that the patient had because of ZOSTAVAX, the patient began having troubles with his vision. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence 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. Shingles and trouble with his vision were considered disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Pain, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In 2015, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster including, but not limited to, postherpetic neuralgia and neuropathy. Shortly after receiving ZOSTAVAX, the patient developed a rash, accompanied by pain. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from shingles, postherpetic neuralgia and neuropathy. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review neuropathy was considered medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2009, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-NOV-2013, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 10-NOV-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2012, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In 2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2009, a physician at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2014, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 27-APR-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On 02-FEB-2017, the patient was treated by a family nurse practitioner at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Incomplete course of vaccination
Clinical narrative: Information has been received from the authors in a published literature article, referring to two adult female patients (age at vaccination between 21.5 and 23.6 years old). Relevant medical history, drug reactions/allergies and concomitant medication at the vaccination time for the patients involved were not reported. The authors aimed to identify and describe a cohort of young women from a single institution in a high incidence region. During this study they identify that only two participants had received one or more doses of the HPV vaccine for prophylaxis but none reported completing the series (strength, route, dosage schedule, lot number and expiration date were not reported). It was not specified if the patients received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure abnormal, Chills, Coronary artery disease, Headache, Heart rate increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd January 2019 10:00, the patient received the 1st dose of SHINGRIX. On 2nd January 2019, 7 hrs after receiving SHINGRIX, the patient experienced chills, headache, tachycardia, blood pressure high, heart rate increased and coronary artery disease. The patient was treated with amlodipine. On an unknown date, the outcome of the chills, headache, tachycardia, blood pressure high and heart rate increased were not recovered/not resolved and the outcome of the coronary artery disease was unknown. It was unknown if the reporter considered the chills, headache, tachycardia, blood pressure high, heart rate increased and coronary artery disease to be related to SHINGRIX. Additional details were provided as follows: On 2nd January 2019 at around 10 am, the patient had received his dose of SHINGRIX. The patient was fine until 5 or 6 o clock when he developed chills, shivering, headache, tachycardia and high blood pressure. The patient went to sleep at 5 or 6 in the morning due to the tachycardia. On 2nd January 2019, the patient's heart rate was normal 50 to 55 when he wokes up in the morning and it went up to 90 to 100 at night. Upon escalation, the patient stated that he took half amlodipine dose and drank fluids to treat symptoms. The patient took amlodipine for mild coronary artery disease. After collection of demographics the patient told that he was also a neurologist and said that safety could follow up with him directly.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 2nd January 2019 10:00, the patient received the 1st dose of SHINGRIX. On 2nd January 2019, 7 hrs after receiving SHINGRIX, the patient experienced chills, headache, tachycardia, blood pressure high, heart rate increased and coronary artery disease. The patient was treated with amlodipine. On an unknown date, the outcome of the chills, headache, tachycardia, blood pressure high and heart rate increased were not recovered/not resolved and the outcome of the coronary artery disease was unknown. It was unknown if the reporter considered the chills, headache, tachycardia, blood pressure high, heart rate increased and coronary artery disease to be related to SHINGRIX. Additional details were provided as follows: On 2nd January 2019 at around 10 am, the patient had received his dose of SHINGRIX. The patient was fine until 5 or 6 o clock when he developed chills, shivering, headache, tachycardia and high blood pressure. The patient went to sleep at 5 or 6 in the morning due to the tachycardia. On 2nd January 2019, the patient's heart rate was normal 50 to 55 when he wokes up in the morning and it went up to 90 to 100 at night. Upon escalation, the patient stated that he took half amlodipine dose and drank fluids to treat symptoms. The patient took amlodipine for mild coronary artery disease. After collection of demographics the patient told that he was also a neurologist and said that safety could follow up with him directly.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX (batch number G45LN, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient developed shingles. There was no further details reported regarding the event. The reporter did not give consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received SHINGRIX for prophylaxis. On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On 1st January 2019, 6 days after receiving SHINGRIX, the patient experienced rash, pruritus and burning sensation. On an unknown date, the outcome of the rash, pruritus and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the rash, pruritus and burning sensation to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. After vaccination, the patient experienced rash, itching and burning on the back. The patient planned to follow-up with her physician on an unknown date. The reporter was provided limited information. The patient disconnected the call while in conversation. The reporter gave consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 29th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site lump, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site pain, injection site lump, injection site erythema and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site lump, injection site erythema and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that patient experienced pain and a knot at the injection site that lasted 2 days and redness and itching encompassing the upper vaccinated arm that lasted 3 weeks following the 1st dose of SHINGRIX.