chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
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. On or about 01-JAN-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2017, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2017, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a community health center for the onset of a severe vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 08-MAY-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 26-MAY-2016, the patient was treated at a family medicine for the onset of a vesicular rash which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-NOV-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot number, dose and route not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated by a physician for a severe vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical group for a blistering vesicular outbreak, which was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, 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.  The outcome of the events was unknown. Causality assessment was considered related. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash, Rash maculo-papular
Clinical narrative: Macular papular rash over torso, no pain or fever. Site swollen on left arm.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Rash, Rash generalised, Rash maculo-papular
Clinical narrative: Macular papular rash over torso, no pain or fever. Site swollen on left arm.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Discomfort, Imaging procedure, Occult blood positive
Clinical narrative: Guaiac positive stool with symptoms of discomfort requiring emergency room visit to rule out intussusception.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Approximately 80 hours (3.3 days) following the vaccination, site became noticeably reddened and very warm to the touch, encompassing a 12x9 cm area on the upper arm. Injections was given in the distal deltoid v proximal. Up until this time, site had been significantly sorer than previous vaccinations. Sxs persisting on Day #4 w/o worsening. Pt is a retired surgical nurse who sees no reason for medical intervention.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Shivering; Fever of 101; Severe aches; Overall weakness and tiredness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Back pain, Depression, Musculoskeletal pain, Neck pain
Clinical narrative: Patient experienced the side effects around dinner time, got the vaccine at 3Pm. Body aches, weakness, back pain, neck pain and shoulder pain that lasted for 2 weeks, also some depression and suicidal thoughts.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Suicidal ideation
Clinical narrative: Patient experienced the side effects around dinner time, got the vaccine at 3Pm. Body aches, weakness, back pain, neck pain and shoulder pain that lasted for 2 weeks, also some depression and suicidal thoughts.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate pain upon injection (upper left shoulder at top of shoulder), red/swelling/hot at  injection site, muscle pains in various parts of the body, upset stomach, followed by hotness of neck and ears. Required ice on injection site to calm down injection site. Two days later, still have injection site pain.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Skin warm
Clinical narrative: Immediate pain upon injection (upper left shoulder at top of shoulder), red/swelling/hot at  injection site, muscle pains in various parts of the body, upset stomach, followed by hotness of neck and ears. Required ice on injection site to calm down injection site. Two days later, still have injection site pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dyspnoea, Electrocardiogram, Fatigue, Feeling cold
Clinical narrative: Fragmented sleep, urine breaks, racing heart-aging, tachycardia, labored breathing, fatigue, weak, headache, very cold, arm pain where injected and hot for 2 days, and perspires so badly had to change clothes and sheets. 5/14 still felt tired and slept all morning and missed work. 5/15 I feel normal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Hyperhidrosis, Hypersomnia, Injection site pain
Clinical narrative: Fragmented sleep, urine breaks, racing heart-aging, tachycardia, labored breathing, fatigue, weak, headache, very cold, arm pain where injected and hot for 2 days, and perspires so badly had to change clothes and sheets. 5/14 still felt tired and slept all morning and missed work. 5/15 I feel normal.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pollakiuria, Sleep disorder, Tachycardia
Clinical narrative: Fragmented sleep, urine breaks, racing heart-aging, tachycardia, labored breathing, fatigue, weak, headache, very cold, arm pain where injected and hot for 2 days, and perspires so badly had to change clothes and sheets. 5/14 still felt tired and slept all morning and missed work. 5/15 I feel normal.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to pharmacy today complaining that her right arm was swollen, warm to the touch and painful for the last 3 days. She also had a headache and dizziness as well. Patient also stated that she had a similar reaction with her first injection of PNEUMOVAX 23. She received this injection at a different pharmacy. Patient is feeling better today and stated that her arm feels better. Upon examination patients arm looked normal.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: First 3 days soreness in muscle of arm, normal reaction I've had from big shots. Then pain in joint of shoulder started about day 4 after10 days soreness in joint promenent especailly when raising arm above shoulder height. Went into doctor and got a cortisone shot in shoulder on day 11. Pain went away about 3 days later.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, VARCEL
Symptoms: Blood creatine phosphokinase increased, Blood creatinine normal, Carbon dioxide normal, Chills, Headache
Clinical narrative: Patient presented with generalized tremors vs rigors, headache, numbness and tingling to bilateral lower extremities, and weakness to lower extremities. Cranial nerves intact, reflexes intact and symmetrical, normal strength to upper extremities. After observation in ED, symptoms spontaneously resolved.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ, VARCEL
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia, Tremor
Clinical narrative: Patient presented with generalized tremors vs rigors, headache, numbness and tingling to bilateral lower extremities, and weakness to lower extremities. Cranial nerves intact, reflexes intact and symmetrical, normal strength to upper extremities. After observation in ED, symptoms spontaneously resolved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: She reported pain at the injection site the evening the shot was given, then within 24 hours of receiving it the injection site became a large red area warm to the touch. It took 4 days for the heat to go away and 7 days for the redness to go away. I informed her to visit a physician if she continued having this reaction 2 days after receiving the shot. She waited it out instead and reaction cleared on its own. She does not have internet access so I am submitting this on her behalf.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Prescriber diagnosed patient with cellulitis and prescribed cephalexin 500mg. Pharmacy was notified same day.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Erythema over humerus, just distal to left deltoid. Firm subcutaneous nodule under site of injection. Telangiectasia just proximal to injection site. Pt. reports itchiness over patch and pain upon palpation of nodule. Cephalexin started for cellulitis.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site telangiectasia, Skin mass
Clinical narrative: Erythema over humerus, just distal to left deltoid. Firm subcutaneous nodule under site of injection. Telangiectasia just proximal to injection site. Pt. reports itchiness over patch and pain upon palpation of nodule. Cephalexin started for cellulitis.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site papule
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 67-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the right deltoid. In 2018, the patient stated she had small bumps resembling little mosquito bites at the site of the injection. The pharmacist did not know when the bumps first appeared. The pharmacist's call was transferred to Medical Information for additional assistance.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received SHINGRIX. On 22nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced fatigue (serious criteria disability), muscle pain (serious criteria disability) and injection site pain (serious criteria disability). On an unknown date, the outcome of the fatigue and muscle pain were recovered/resolved and the outcome of the injection site pain was unknown. The reporter considered the fatigue and muscle pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) stated that her husband experienced severe fatigue and muscle pain that lasted for about 10 to 14 days. Less than a year after vaccination, the patient experienced soreness at injection site. The HCP reported this adverse event to her husband's primary care physician. The HCP did not want to provide her address. This case was linked with US2018080685, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre Syndrome in a elderly female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza  vaccine Quadrivalent. On an unknown date, less than a year after receiving Influenza  vaccine Quadrivalent, the patient experienced Guillain Barre Syndrome (serious criteria GSK medically significant) and general body pain. On an unknown date, the outcome of the Guillain Barre Syndrome and general body pain were unknown. It was unknown if the reporter considered the Guillain Barre Syndrome and general body pain to be related to Influenza  vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient, over the age of 65, reported that she got Guillain Barre from the flu vaccine last year before the date of reporting. The patient did not get a lot of information, as the questions were more could the SHINGRIX vaccine cause this if the patient got it from the flu vaccine. The manufacturer of the flu vaccine was unknown. He denied the patient was hospitalized, noting she had pain all over her body for 6 months. No other information known about the events, product or patient at time of call.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received SHINGRIX. On 22nd March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced fatigue (serious criteria disability), muscle pain (serious criteria disability) and injection site pain (serious criteria disability). On an unknown date, the outcome of the fatigue and muscle pain were recovered/resolved and the outcome of the injection site pain was unknown. The reporter considered the fatigue and muscle pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporting nurse was the patient. The healthcare professional (HCP) stated that she experienced severe fatigue and muscle pain that lasted about 10 to 14 days. The HCP also stated that less than a year after vaccination, she experienced soreness at injection site. The HCP reported this adverse event to her primary care physician. The HCP did not want to provide her address. This case was linked with US2018080686, reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Blood test, Fatigue, Vertigo
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old male patient who received SHINGRIX. Concomitant products included PLAVIX, Atorvastatin, hydrochlorothiazide and lisinopril. On 7th May 2018, the patient received SHINGRIX. On 7th may 2018, immediately after receiving SHINGRIX, the patient experienced fatigue, unsteadiness and spinning sensation. On an unknown date, the outcome of the fatigue and spinning sensation were recovering/resolving and the outcome of the unsteadiness was unchanged. The reporter considered the fatigue, unsteadiness and spinning sensation to be probably related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. The patient received SHINGRIX in the left arm. The patient had a blood draw for laboratory on the same office visit. About 40 minutes after receiving SHINGRIX, the patient was home and had to take a nap. Less than a day after receiving SHINGRIX, upon awakening, the patient stated that, the room began to spin and he felt unstable.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 69-year-old male patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 8th May 2018 17:35, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced chills, influenza-like symptoms and pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the chills, influenza-like symptoms and pain were unknown. The reporter considered the chills, influenza-like symptoms and pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: No concomitant vaccines were administered at the time of reporting. The patient received SHINGRIX in the left deltoid. The patient experienced achiness. The healthcare professionals (HCP) was informed about the adverse events the day after administration (around lunch). The HCP was unsure when the patient developed the events and whether the events are resolved or not. The HCP believed the symptoms were almost certainly or probably related to the SHINGRIX.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None-med error.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX. Previously administered products included SHINGRIX (refer case: US2018GSK085941). In March 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, tiredness, headache and energy decreased. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the tiredness, headache and energy decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain, tiredness, headache and energy decreased to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced worst constitutional symptoms than with first dose. The patient experienced tiredness, headache and low energy lasting about 2 days. The reporter agreed to receive follow up from GlaxoSmithKline. This case has been linked with the case US2018GSK061148 and US2018GSK085969 and US2018GSK085941 reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a male patient who received SHINGRIX. 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 injection site pain and adverse event. On an unknown date, the outcome of the injection site pain and adverse event were unknown. It was unknown if the reporter considered the injection site pain and adverse event to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced local pain at the injection site and minimal constitutional symptoms. The patient said he was willing to have followed up from GlaxoSmithKline. This case has been linked with the case US2018GSK061148 and US2018GSK061147 and US2018GSK085969 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Injection site pain, Local reaction
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX. Previously administered products included SHINGRIX (refer case: US2018GSK085969). In March 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and adverse event. On an unknown date, the outcome of the injection site pain and adverse event were unknown. It was unknown if the reporter considered the injection site pain and adverse event to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced local injection site symptoms. This case has been linked with the case US2018GSK085969, US2018GSK085941 and US2018GSK061147, reported by the same reporter. The reporter agreed to receive follow up from GlaxoSmithKline.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Facial neuralgia, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. Concurrent medical conditions included ophthalmic herpes zoster. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th April 2018, several hours after receiving SHINGRIX, the patient experienced headache, weakness, tiredness, chills, fever, facial neuralgia, muscle pain and malaise. On 22nd April 2018, the patient experienced rib pain. In April 2018, the outcome of the facial neuralgia was recovered/resolved. On 22nd April 2018, the outcome of the headache, weakness, tiredness, chills, fever and muscle pain were recovered/resolved. On an unknown date, the outcome of the rib pain was not recovered/not resolved and the outcome of the malaise was unknown. The reporter considered the headache, weakness, tiredness, rib pain, chills, fever, facial neuralgia, muscle pain and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was also reported via Merck Service Center. At 11:30, the patient received SHINGRIX on left deltoid. The patient got very ill, went to bed, and could not get up. In the evening of the vaccination day, the patient severe headache, severe neuralgia of the eyes, muscle aches, chills, fever, weak and tiredness. The next day headache was horrific, blinding headache and it couldn't function. Also, chills, fever, weakness and tiredness were worst the next day. Severe neuralgia of eyes was 80 percent resolved by 22nd April 2018. It was fully resolved as of date of report. Three days after receiving SHINGRIX, the patient experienced pain and ache in the lower rib cage area with no rash. The patient also reported shingles in the eyes and was prescribed unknown treatment for this condition. The patient's current condition is unknown since the call got disconnected before all the information could be obtained. The patient stated that the doctor was aware that the patient got the SHINGRIX shot but was not aware that she experienced side effects. The pharmacy was aware that this patient experienced side effects. The lot number and expiration date were unknown by the reporter. No more information was available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Musculoskeletal chest pain, Myalgia, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. Concurrent medical conditions included ophthalmic herpes zoster. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th April 2018, several hours after receiving SHINGRIX, the patient experienced headache, weakness, tiredness, chills, fever, facial neuralgia, muscle pain and malaise. On 22nd April 2018, the patient experienced rib pain. In April 2018, the outcome of the facial neuralgia was recovered/resolved. On 22nd April 2018, the outcome of the headache, weakness, tiredness, chills, fever and muscle pain were recovered/resolved. On an unknown date, the outcome of the rib pain was not recovered/not resolved and the outcome of the malaise was unknown. The reporter considered the headache, weakness, tiredness, rib pain, chills, fever, facial neuralgia, muscle pain and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was also reported via Merck Service Center. At 11:30, the patient received SHINGRIX on left deltoid. The patient got very ill, went to bed, and could not get up. In the evening of the vaccination day, the patient severe headache, severe neuralgia of the eyes, muscle aches, chills, fever, weak and tiredness. The next day headache was horrific, blinding headache and it couldn't function. Also, chills, fever, weakness and tiredness were worst the next day. Severe neuralgia of eyes was 80 percent resolved by 22nd April 2018. It was fully resolved as of date of report. Three days after receiving SHINGRIX, the patient experienced pain and ache in the lower rib cage area with no rash. The patient also reported shingles in the eyes and was prescribed unknown treatment for this condition. The patient's current condition is unknown since the call got disconnected before all the information could be obtained. The patient stated that the doctor was aware that the patient got the SHINGRIX shot but was not aware that she experienced side effects. The pharmacy was aware that this patient experienced side effects. The lot number and expiration date were unknown by the reporter. No more information was available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX. Concurrent medical conditions included ophthalmic herpes zoster. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th April 2018, several hours after receiving SHINGRIX, the patient experienced headache, weakness, tiredness, chills, fever, facial neuralgia, muscle pain and malaise. On 22nd April 2018, the patient experienced rib pain. In April 2018, the outcome of the facial neuralgia was recovered/resolved. On 22nd April 2018, the outcome of the headache, weakness, tiredness, chills, fever and muscle pain were recovered/resolved. On an unknown date, the outcome of the rib pain was not recovered/not resolved and the outcome of the malaise was unknown. The reporter considered the headache, weakness, tiredness, rib pain, chills, fever, facial neuralgia, muscle pain and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was also reported via Merck Service Center. At 11:30, the patient received SHINGRIX on left deltoid. The patient got very ill, went to bed, and could not get up. In the evening of the vaccination day, the patient severe headache, severe neuralgia of the eyes, muscle aches, chills, fever, weak and tiredness. The next day headache was horrific, blinding headache and it couldn't function. Also, chills, fever, weakness and tiredness were worst the next day. Severe neuralgia of eyes was 80 percent resolved by 22nd April 2018. It was fully resolved as of date of report. Three days after receiving SHINGRIX, the patient experienced pain and ache in the lower rib cage area with no rash. The patient also reported shingles in the eyes and was prescribed unknown treatment for this condition. The patient's current condition is unknown since the call got disconnected before all the information could be obtained. The patient stated that the doctor was aware that the patient got the SHINGRIX shot but was not aware that she experienced side effects. The pharmacy was aware that this patient experienced side effects. The lot number and expiration date were unknown by the reporter. No more information was available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020). Concomitant products included simvastatin and hydrochlorothiazide, olmersartan, hydrochlorothiazide, olmersartan, BENICAR HCT. On 3rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd May 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were not recovered/not resolved. The reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported the case on behalf of the patient. The patient came back to the pharmacy the day after receiving SHINGRIX and stated that she was experiencing injection site pain and body aches. On the day of reporting, the symptoms were worse.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site dermatitis
Clinical narrative: 6 days after injection, pt developed 9 x 7 cm cellulitis - like Rxn at injection that developed into a 6 x 8 cm dermatitis by day 15 (slowly resolving).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Radioallergosorbent test, Urticaria
Clinical narrative: Acute urticaria. No respiratory distress.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient followed up with doctor after vaccine given 10-11-17. Patient stated pain improved with exercises given, but pain still present at rest. Pain described as soreness in upper arm.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood disorder, Bone marrow transplant, Contusion
Clinical narrative: This Spontaneous report has been received from a physician via company representative regarding a 18 years old male patient. The patient's medical history, concurrent conditions, concomitant medications and reactions/allergies were not provided. In September 2017 (reported as sometime in the fall of last year), the patient was vaccinated with properly stored dose of GARDASIL 9 for prophylaxis (dose, strength, frequency, lot#, expiration date and route of administration were not reported). On the same date (reported as sometime in the fall of last year), the patient experienced bruising at unspecified area (contusion), after the bruise appeared the patient experienced blood dyscrasia (blood disorder). The patient was admitted to hospital and received bone marrow transplant due to blood dyscrasia sometime in the fall of last year. The outcomes of the events were unknown. The causal relationship between events and GARDASIL 9 was not reported. Upon internal review, Blood disorder was determined to be medically significant as it required bone marrow transplant. No Product Quality Complain was reported.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The patient received SHINGRIX subcutaneously, which led to intramuscular formulation administered by other route. Follow up information received from other health professional via call center representative on 8th May: It was reported that error occurred in administration, pharmacist gave injection subcutaneously instead of intramuscularly. The outcome of swollen arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. The VAERS details were updated. The patient paid for her vaccine in case and received vaccine in retail pharmacy. It was a medication error with harm.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The patient received SHINGRIX subcutaneously, which led to intramuscular formulation administered by other route. Follow up information received from other health professional via call center representative on 8th May: It was reported that error occurred in administration, pharmacist gave injection subcutaneously instead of intramuscularly. The outcome of swollen arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. The VAERS details were updated. The patient paid for her vaccine in case and received vaccine in retail pharmacy. It was a medication error with harm.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Peripheral swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The patient received SHINGRIX subcutaneously, which led to intramuscular formulation administered by other route. Follow up information received from other health professional via call center representative on 8th May: It was reported that error occurred in administration, pharmacist gave injection subcutaneously instead of intramuscularly. The outcome of swollen arm was unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. The VAERS details were updated. The patient paid for her vaccine in case and received vaccine in retail pharmacy. It was a medication error with harm.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Blood test, Computerised tomogram, Hypersensitivity, Injection site rash, Peripheral swelling
Clinical narrative: High fever [102.9]; severe left arm, shoulder, neck pain, finger-like red rash at injection site; arm swollen at site and lacked mobility; headaches; nerve pain; nausea; loss of appetite.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, X-ray
Clinical narrative: High fever [102.9]; severe left arm, shoulder, neck pain, finger-like red rash at injection site; arm swollen at site and lacked mobility; headaches; nerve pain; nausea; loss of appetite.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Asthma, Injection site pain, Lymph node pain, Neck pain, Pyrexia
Clinical narrative: High fever [102.9]; severe left arm, shoulder, neck pain, finger-like red rash at injection site; arm swollen at site and lacked mobility; headaches; nerve pain; nausea; loss of appetite.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Rash
Clinical narrative: High fever [102.9]; severe left arm, shoulder, neck pain, finger-like red rash at injection site; arm swollen at site and lacked mobility; headaches; nerve pain; nausea; loss of appetite.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Decreased appetite, Headache, Injected limb mobility decreased, Injection site pain, Injection site reaction
Clinical narrative: High fever [102.9]; severe left arm, shoulder, neck pain, finger-like red rash at injection site; arm swollen at site and lacked mobility; headaches; nerve pain; nausea; loss of appetite.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Injection site swelling, Nausea, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: High fever [102.9]; severe left arm, shoulder, neck pain, finger-like red rash at injection site; arm swollen at site and lacked mobility; headaches; nerve pain; nausea; loss of appetite.
Age: 56.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS, PPV, VARZOS
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: High fever [102.9]; severe left arm, shoulder, neck pain, finger-like red rash at injection site; arm swollen at site and lacked mobility; headaches; nerve pain; nausea; loss of appetite.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 61-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown). Concomitant products included Alendronate, duloxetine, LIPITOR, phentermine and TOPAMAX. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th April 2018, less than a day after receiving SHINGRIX, the patient experienced rash, allergic reaction and pain in arm. In April 2018, the outcome of the rash, allergic reaction and pain in arm were recovered resolved. It was unknown if the reporter considered the rash and allergic reaction to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The pharmacist reported this case on behalf of the patient. At 17:40, the patient received SHINGRIX on the left arm. The patient experienced an allergic reaction, which was described as a rash on the forehead, on the same day after vaccination, which faded away in 2 to 3 days. The patient also experienced pain in her left arm which resolved in 2 to 3 days. The expiry date of the vaccine was not available.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Pain in extremity, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 61-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date unknown). Concomitant products included Alendronate, duloxetine, LIPITOR, phentermine and TOPAMAX. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th April 2018, less than a day after receiving SHINGRIX, the patient experienced rash, allergic reaction and pain in arm. In April 2018, the outcome of the rash, allergic reaction and pain in arm were recovered resolved. It was unknown if the reporter considered the rash and allergic reaction to be related to SHINGRIX. The reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The pharmacist reported this case on behalf of the patient. At 17:40, the patient received SHINGRIX on the left arm. The patient experienced an allergic reaction, which was described as a rash on the forehead, on the same day after vaccination, which faded away in 2 to 3 days. The patient also experienced pain in her left arm which resolved in 2 to 3 days. The expiry date of the vaccine was not available.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash on 30 percent of body. Started on 5/6/18 in the morning and became worse on Monday, 5/7/18. Used BENADRYL to help w/ s/sx.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Drooling, Dysarthria, Facial paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of Bell's palsy in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the Bell's palsy was unknown. It was unknown if the reporter considered the Bell's palsy to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The reporter did not know any information in regards to the patient or their health care provider. Very limited information was provided.