chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Hair disorder, Hyperaesthesia, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 24th June 2018, the patient received SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced pain in toe and nail pain. On 25th June 2018, the patient experienced fever, appetite absent, neuralgia, fatigue, injection site swelling, general body pain and touch sensitivity increased. On an unknown date, the patient experienced hair disorder and paresthesia of limbs. On 28th June 2018, the outcome of the fever, appetite absent, neuralgia, fatigue, injection site swelling, general body pain and touch sensitivity increased were recovered/resolved. On an unknown date, the outcome of the hair disorder, pain in toe, nail pain and paresthesia of limbs were unknown. The reporter considered the fever, appetite absent, neuralgia, fatigue, injection site swelling and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the hair disorder, pain in toe, nail pain, paresthesia of limbs and touch sensitivity increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that at 9 am on Monday, 1 day after receiving SHINGRIX, the patient experienced number of reactions that included fever (the patient's body temperature was recorded as 100 degree F), body aches, extreme body sensitivity, neuralgia, fatigue, no appetite and swelling at the injection site, which lasted for 3 days. The events were resolved on Thursday. The healthcare professional stated that the patient experienced severe neuralgia. In 2018, less than a month after receiving SHINGRIX, the patient's felt hair hurt, the patient's arm felt like they were not part of her body. The patient did not want anyone to touch her. The severe neuralgia completely resolved after 3 days. The patient did went to a water aerobics class Monday morning at 7 am prior to her symptoms coming on around 9 am. The patient did not visit emergency room or doctor. The health care professional was unsure if the patient had any required intervention. No additional information provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Onychalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 24th June 2018, the patient received SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced pain in toe and nail pain. On 25th June 2018, the patient experienced fever, appetite absent, neuralgia, fatigue, injection site swelling, general body pain and touch sensitivity increased. On an unknown date, the patient experienced hair disorder and paresthesia of limbs. On 28th June 2018, the outcome of the fever, appetite absent, neuralgia, fatigue, injection site swelling, general body pain and touch sensitivity increased were recovered/resolved. On an unknown date, the outcome of the hair disorder, pain in toe, nail pain and paresthesia of limbs were unknown. The reporter considered the fever, appetite absent, neuralgia, fatigue, injection site swelling and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the hair disorder, pain in toe, nail pain, paresthesia of limbs and touch sensitivity increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that at 9 am on Monday, 1 day after receiving SHINGRIX, the patient experienced number of reactions that included fever (the patient's body temperature was recorded as 100 degree F), body aches, extreme body sensitivity, neuralgia, fatigue, no appetite and swelling at the injection site, which lasted for 3 days. The events were resolved on Thursday. The healthcare professional stated that the patient experienced severe neuralgia. In 2018, less than a month after receiving SHINGRIX, the patient's felt hair hurt, the patient's arm felt like they were not part of her body. The patient did not want anyone to touch her. The severe neuralgia completely resolved after 3 days. The patient did went to a water aerobics class Monday morning at 7 am prior to her symptoms coming on around 9 am. The patient did not visit emergency room or doctor. The health care professional was unsure if the patient had any required intervention. No additional information provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 24th June 2018, the patient received SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced pain in toe and nail pain. On 25th June 2018, the patient experienced fever, appetite absent, neuralgia, fatigue, injection site swelling, general body pain and touch sensitivity increased. On an unknown date, the patient experienced hair disorder and paresthesia of limbs. On 28th June 2018, the outcome of the fever, appetite absent, neuralgia, fatigue, injection site swelling, general body pain and touch sensitivity increased were recovered/resolved. On an unknown date, the outcome of the hair disorder, pain in toe, nail pain and paresthesia of limbs were unknown. The reporter considered the fever, appetite absent, neuralgia, fatigue, injection site swelling and general body pain to be related to SHINGRIX. It was unknown if the reporter considered the hair disorder, pain in toe, nail pain, paresthesia of limbs and touch sensitivity increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that at 9 am on Monday, 1 day after receiving SHINGRIX, the patient experienced number of reactions that included fever (the patient's body temperature was recorded as 100 degree F), body aches, extreme body sensitivity, neuralgia, fatigue, no appetite and swelling at the injection site, which lasted for 3 days. The events were resolved on Thursday. The healthcare professional stated that the patient experienced severe neuralgia. In 2018, less than a month after receiving SHINGRIX, the patient's felt hair hurt, the patient's arm felt like they were not part of her body. The patient did not want anyone to touch her. The severe neuralgia completely resolved after 3 days. The patient did went to a water aerobics class Monday morning at 7 am prior to her symptoms coming on around 9 am. The patient did not visit emergency room or doctor. The health care professional was unsure if the patient had any required intervention. No additional information provided.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX. On 1st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating. On an unknown date, the outcome of the fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating were unknown. It was unknown if the reporter considered the fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating to be related to SHINGRIX. Additional details were provided as follows: The registered pharmacist reported this case. The patient received SHINGRIX on the left arm. About 6 hours after receiving SHINGRIX, the patient experienced non-descriptive flu like symptoms, fatigue, loss of appetite, left arm soreness, chills, and sweating.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX. On 1st July 2018, 6 hrs after receiving SHINGRIX, the patient experienced fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating. On an unknown date, the outcome of the fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating were unknown. It was unknown if the reporter considered the fatigue, injection site pain, appetite lost, influenza-like symptoms, chills and sweating to be related to SHINGRIX. Additional details were provided as follows: The registered pharmacist reported this case. The patient received SHINGRIX on the left arm. About 6 hours after receiving SHINGRIX, the patient experienced non-descriptive flu like symptoms, fatigue, loss of appetite, left arm soreness, chills, and sweating.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed flu-like symptoms after receiving initial dose. No further information regarding the patient's experience was available at the time of report.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Neuralgia, Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 71-year-old male patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. Concurrent medical conditions included blood pressure high, diabetes, asthma, allergic rhinitis, chronic obstructive pulmonary disease, gastroesophageal reflux disease, cerebrovascular accident, coronary artery disease, carotid artery stenosis and drug allergy (erythromycin). Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair Diskus), fluticasone propionate (Flonase), gabapentin (Neurontin), isosorbide mononitrate (Imdur), salbutamol sulphate (Albuterol), acetylsalicylic acid (Aspirin), atorvastatin calcium (Atorvastatin), folic acid, metformin hydrochloride (Metformin), omeprazole, glimepiride (Amaryl), ticagrelor (Brilinta), tadalafil (Cialis), pregabalin (Lyrica), lisinopril and metoprolol. On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 7 days after receiving SHINGRIX, the patient experienced shingles, rash, nerve pain and burning sensation. The patient was treated with valaciclovir hydrochloride (Valtrex) and lidocaine hydrochloride (Lidocream). On an unknown date, the outcome of the shingles, rash, nerve pain and burning sensation were unknown.  It was unknown if the reporter considered the shingles, rash, nerve pain and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. One week after receiving first dose of SHINGRIX, the patient experienced rash on the right side of his face, around his forehead and eyes. There was also burning and nerve pain at the site. The patient went to an eye doctor, and also had two doctor visits. The patient was prescribed Valtrex and Lidocream for symptoms, and was also diagnosed with shingles. On 21st May 2018 and 5th July 2018, the patient visited doctor. The reporting MA (medical assistant) stated the that patient's physician believes the symptoms are related to SHINGRIX.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 18th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, inflammation localized and swelling arm. On an unknown date, the outcome of the erythema of extremities, inflammation localized and swelling arm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, inflammation localized and swelling arm to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient did not have dose, strength, lot number, or expiration date for SHINGRIX. The patient noted redness, inflammation, and swelling in her arm within 24 hours of receiving a dose of SHINGRIX series. Redness, inflammation, and swelling completely resolved after 5 to 6 days.  Exact dates were not provided. The patient had denied permission to contact their physician.  The patient did not provide complete mailing address or phone number of the vaccine facility.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included allergic reaction to antibiotics. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The next day she experienced a tender, red, swollen area on upper arm about an inch or more below the injection site which hurt a bit. It did not itch. The redness on the left upper arm was about 2 to 3 inches wide and about 5 inches from top to bottom. It was a little swollen. They discussed what grade 3 pain meant (defined as significant pain at rest, prevents normal everyday activities) and the patient said it was not grade 3. All events resolved after about 4 to 5 days. The caller reported these events to her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Gingival pain
Clinical narrative: This case was reported by a pharmacist via out of hour services and described the occurrence of soreness gum in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included soreness gum. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced soreness gum. On an unknown date, the outcome of the soreness gum was unknown. It was unknown if the reporter considered the soreness gum to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced sore gums on one side for a couple days, then on the other side after getting SHINGRIX.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal lymphadenopathy, Computerised tomogram kidney normal, Flank pain, Headache, Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of mesenteric lymphadenopathy in a 18-year-old female patient who received MENVEO (batch number M17038, expiry date 1st March 2019) for prophylaxis. Previously administered products included Meningococcal vaccine (the healthcare professional thought it was the MENACTRA). On 3rd July 2018, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On an unknown date, 12 hrs after receiving MENVEO, the patient experienced mesenteric lymphadenopathy (serious criteria other: As per reporter), flank pain (serious criteria other: As per reporter), vomiting (serious criteria other: As per reporter), headache (serious criteria other: As per reporter) and nausea (serious criteria other: As per reporter). The patient was treated with TORADOL, morphine and hydrocodone. On an unknown date, the outcome of the mesenteric lymphadenopathy was unknown and the outcome of the flank pain, vomiting, headache and nausea were recovering/resolving. The reporter considered the mesenteric lymphadenopathy, flank pain, vomiting, headache and nausea to be possibly related to MENVEO. Additional details were provided as follows: The patient woke up from severe right flank pain, nausea, vomiting, and headache. The patient went to the emergency room and underwent performed CT scan for possible kidney stones but it was negative. The patient had mesenteric lymphadenopathy but had a normal abdominal exam. The healthcare professional stated that the patient's appetite was off for 2 days prior to the vaccination. Lab Comments: the patient underwent for CT scan for possible kidney stones but it was negative.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of mesenteric lymphadenopathy in a 18-year-old female patient who received MENVEO (batch number M17038, expiry date 1st March 2019) for prophylaxis. Previously administered products included Meningococcal vaccine (the healthcare professional thought it was the MENACTRA). On 3rd July 2018, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On an unknown date, 12 hrs after receiving MENVEO, the patient experienced mesenteric lymphadenopathy (serious criteria other: As per reporter), flank pain (serious criteria other: As per reporter), vomiting (serious criteria other: As per reporter), headache (serious criteria other: As per reporter) and nausea (serious criteria other: As per reporter). The patient was treated with TORADOL, morphine and hydrocodone. On an unknown date, the outcome of the mesenteric lymphadenopathy was unknown and the outcome of the flank pain, vomiting, headache and nausea were recovering/resolving. The reporter considered the mesenteric lymphadenopathy, flank pain, vomiting, headache and nausea to be possibly related to MENVEO. Additional details were provided as follows: The patient woke up from severe right flank pain, nausea, vomiting, and headache. The patient went to the emergency room and underwent performed CT scan for possible kidney stones but it was negative. The patient had mesenteric lymphadenopathy but had a normal abdominal exam. The healthcare professional stated that the patient's appetite was off for 2 days prior to the vaccination. Lab Comments: the patient underwent for CT scan for possible kidney stones but it was negative.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced stiff neck and neck pain. On an unknown date, the outcome of the stiff neck and neck pain were unknown. It was unknown if the reporter considered the stiff neck and neck pain to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The reporter did not have batch number at the time of reporting. The patient experienced stiff neck after a dose of SHINGRIX. The patient reported that it hurts if he turns his head to the right or left. The pharmacist was unsure if the symptoms started after each dose and if it resolved after the first dose and then came back again after the second dose. The patient did see his physician.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site haemorrhage, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received SHINGRIX (intravenous). On 1st July 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route, vaccine administered at inappropriate site and injection site hemorrhage. In July 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the intramuscular formulation administered by other route, vaccine administered at inappropriate site, injection site hemorrhage and injection site erythema were unknown. It was unknown if the reporter considered the injection site hemorrhage and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The patient received SHINGRIX injection in the left arm below the deltoid. The patient noted that the pharmacist hit a vein, and there was blood running down the arm, which led to intramuscular formulation administered by other route. There was redness at the injection site. The patient showed her arm to her doctor, and reports that she did not get her injection in the deltoid, which led to vaccine administered at inappropriate site.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 1st July 2018, 1 days after receiving SHINGRIX, the patient experienced pain, weakness, pruritus, skin warm, swelling and erythema. On an unknown date, the outcome of the pain, weakness, pruritus, swelling and erythema were recovering/resolving and the outcome of the skin warm was recovered/resolved. It was unknown if the reporter considered the pain, weakness, pruritus, skin warm, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow-up with her physician on an unknown date.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 1st July 2018, 1 days after receiving SHINGRIX, the patient experienced pain, weakness, pruritus, skin warm, swelling and erythema. On an unknown date, the outcome of the pain, weakness, pruritus, swelling and erythema were recovering/resolving and the outcome of the skin warm was recovered/resolved. It was unknown if the reporter considered the pain, weakness, pruritus, skin warm, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow-up with her physician on an unknown date.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 30th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 1st July 2018, 1 days after receiving SHINGRIX, the patient experienced pain, weakness, pruritus, skin warm, swelling and erythema. On an unknown date, the outcome of the pain, weakness, pruritus, swelling and erythema were recovering/resolving and the outcome of the skin warm was recovered/resolved. It was unknown if the reporter considered the pain, weakness, pruritus, skin warm, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient planned to follow-up with her physician on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm, pruritus and swelling arm. On an unknown date, the outcome of the pain in arm, pruritus and swelling arm were unknown. It was unknown if the reporter considered the pain in arm, pruritus and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX the unknown arm. The healthcare professional (HCP) stated that the patient reported pain and swelling in her arm, as well as itching around her hairline and behind her knees, all beginning shortly after administration of a dose of SHINGRIX. The HCP did not provide further details.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of skin eruption in a 60-year-old female patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced skin eruption. On an unknown date, the outcome of the skin eruption was unknown. It was unknown if the reporter considered the skin eruption to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the pharmacy intern. The patient received the vaccine in the left deltoid. The patient called the pharmacy on 8th July 2018, to report that she developed a break out on both sides of her toes and hands. The patient felt that the break out was related to the SHINGRIX. The reporter was unable to provide additional details. The call was transferred to MI (Medical information).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 76-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date June 2019) for prophylaxis. On 27th June 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 9th July 2018, 12 days after receiving SHINGRIX, the patient experienced generalized pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized pruritus was unchanged. It was unknown if the reporter considered the generalized pruritus to be related to SHINGRIX. Additional details were provided  as follows: The patient received SHINGRIX on an left deltoid. The pharmacist states patient experienced itching all over the body. The patient took Benadryl and it was not helped her till the time of reporting. No further information was provided by the pharmacist.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 72-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date November 2020) for prophylaxis. Concurrent medical conditions included asthma, diabetes mellitus (Unknown Type) and obesity. On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, 1 days after receiving  SHINGRIX, the patient experienced injection site wheal (serious criteria other: as per reporter), injection site swelling (serious criteria other: as per reporter), injection site erythema (serious criteria other: as per reporter), weight loss (serious criteria other: as per reporter), muscle pain (serious criteria other: as per reporter), decreased appetite (serious criteria other: as per reporter), headache (serious criteria other: as per reporter) and fatigue (serious criteria other: as per reporter). The patient was treated with (NOS) BENADRYL. On 9th July 2018, the outcome of the injection site wheal, injection site swelling, injection site erythema, weight loss, muscle pain, decreased appetite, headache and fatigue were recovered/resolved. The reporter considered the injection site wheal, injection site swelling, injection site erythema, weight loss, muscle pain, decreased appetite, headache and fatigue to be probably related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the right deltoid. The patient developed a large, swollen red welt at the injection site that spread along her right upper arm and had a decrease in appetite that resulted in 5 pound weight loss. The healthcare professional stated all the adverse event symptoms were worse on 3rd July 2018 and started to improve on 4th July 2018. Only intervention was BENADRYL, and no medical care was sought.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Myalgia, Weight decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 72-year-old female patient who received SHINGRIX (batch number L7F7E, expiry date November 2020) for prophylaxis. Concurrent medical conditions included asthma, diabetes mellitus (Unknown Type) and obesity. On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd July 2018, 1 days after receiving  SHINGRIX, the patient experienced injection site wheal (serious criteria other: as per reporter), injection site swelling (serious criteria other: as per reporter), injection site erythema (serious criteria other: as per reporter), weight loss (serious criteria other: as per reporter), muscle pain (serious criteria other: as per reporter), decreased appetite (serious criteria other: as per reporter), headache (serious criteria other: as per reporter) and fatigue (serious criteria other: as per reporter). The patient was treated with (NOS) BENADRYL. On 9th July 2018, the outcome of the injection site wheal, injection site swelling, injection site erythema, weight loss, muscle pain, decreased appetite, headache and fatigue were recovered/resolved. The reporter considered the injection site wheal, injection site swelling, injection site erythema, weight loss, muscle pain, decreased appetite, headache and fatigue to be probably related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the right deltoid. The patient developed a large, swollen red welt at the injection site that spread along her right upper arm and had a decrease in appetite that resulted in 5 pound weight loss. The healthcare professional stated all the adverse event symptoms were worse on 3rd July 2018 and started to improve on 4th July 2018. Only intervention was BENADRYL, and no medical care was sought.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a 83-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. On 9th July 2018 14:36, the patient received SHINGRIX (intramuscular) .5 ml. On 9th July 2018, several hours after receiving SHINGRIX, the patient experienced injection site urticaria, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site urticaria, injection site warmth and injection site swelling were unchanged. It was unknown if the reporter considered the injection site urticaria, injection site warmth and injection site swelling to be related to SHINGRIX. Additional details were received as follows: The vaccine was administered at 2:36 PM. The pharmacist reported that the patient received a dose of SHINGRIX and that evening experienced a raised, warm and welt at the injection site that was unchanged.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in an unspecified number of patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site warmth, injection site swelling and injection site wheal. On an unknown date, the outcome of the injection site warmth, injection site swelling and injection site wheal were unknown. It was unknown if the reporter considered the injection site warmth, injection site swelling and injection site wheal to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not applicable. The pharmacist reported that other patients have experienced a warm raised welt at injection site after receiving SHINGRIX. This case was linked with case US2018123098, reported by the same reporter.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Joint swelling, Miliaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heat rash in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 6th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, 14 days after receiving SHINGRIX, the patient experienced heat rash, wrist pain, swelling of wrists and burning sensation. On an unknown date, the outcome of the heat rash, wrist pain, swelling of wrists and burning sensation were recovering/resolving. It was unknown if the reporter considered the heat rash, wrist pain, swelling of wrists and burning sensation to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left deltoid. The patient stated that about 2 weeks after receiving the SHINGRIX vaccine he experienced burning rash sensation on his left hand on the top of his hand between his thumb and 1st finger. It was a prickly heat rash. The patient's left wrist was also swollen and had pain moving his wrist. The patient still had a little wrist pain but the swelling has gone down at the reporting time. The patient provided the contact details of the physician.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Feeling cold, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 92-year-old female patient who received SHINGRIX for prophylaxis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, pain, influenza-like symptoms, feeling cold, headache, shivering and feeling abnormal. In July 2018, the patient experienced weakness. On an unknown date, the outcome of the fever, pain, influenza-like symptoms, feeling cold and shivering were recovering/resolving and the outcome of the weakness was not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the fever, pain, influenza-like symptoms, feeling cold, weakness, headache, shivering and feeling abnormal to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX on the left arm and experienced fever, headache and felt terrible like had a bad flu with shivering and feeling cold and a bit weak. The patient didn't felt like herself in the next morning due to being weak. The patient reported that most of her symptoms started last evening after receiving the vaccine around 2:00 PM except weakness which occurred the morning of the reporting date. The patient had denied permission to contact their physician.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 92-year-old female patient who received SHINGRIX for prophylaxis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 10th July 2018, less than a day after receiving SHINGRIX, the patient experienced fever, pain, influenza-like symptoms, feeling cold, headache, shivering and feeling abnormal. In July 2018, the patient experienced weakness. On an unknown date, the outcome of the fever, pain, influenza-like symptoms, feeling cold and shivering were recovering/resolving and the outcome of the weakness was not recovered/not resolved and the outcome of the headache was recovered/resolved and the outcome of the feeling abnormal was unknown. It was unknown if the reporter considered the fever, pain, influenza-like symptoms, feeling cold, weakness, headache, shivering and feeling abnormal to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX on the left arm and experienced fever, headache and felt terrible like had a bad flu with shivering and feeling cold and a bit weak. The patient didn't felt like herself in the next morning due to being weak. The patient reported that most of her symptoms started last evening after receiving the vaccine around 2:00 PM except weakness which occurred the morning of the reporting date. The patient had denied permission to contact their physician.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever and chills to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The pharmacist reported that overnight at around 2 am, the patient awoke with fever, chills and all over body aches. In July 2018, the patient's body temperature was recorded as 102 unknown unit. The pharmacist stated that 0.7 ml was the dose of the SHINGRIX and then when asked to clarify, she stated that 0.65ml was the dose. When again asked for clarity she said they only used one vaccine. She also asked was not it the same 0.65 ml dose like ZOSTAVAX. When she was informed the dose was 0.5 ml, she states well that was what it was. This case has been linked to the case US2018GSK125535, reported by the same reporter for the same patient.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On 10th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, general body pain, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, general body pain, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, general body pain, fever and chills to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The pharmacist reported that overnight at around 2 am, the patient awoke with fever, chills and all over body aches. In July 2018, the patient's body temperature was recorded as 102 unknown unit. The pharmacist stated that 0.7 ml was the dose of the SHINGRIX and then when asked to clarify, she stated that 0.65ml was the dose. When again asked for clarity she said they only used one vaccine. She also asked was not it the same 0.65 ml dose like ZOSTAVAX. When she was informed the dose was 0.5 ml, she states well that was what it was. This case has been linked to the case US2018GSK125535, reported by the same reporter for the same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The pharmacist reported that the patient experienced painful arm for few days. The reporter did not have lot number and expiry date of the first dose of SHINGRIX. This case has been linked to the case US2018124009, reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left deltoid. The pharmacist reported that the patient experienced painful arm for few days. The reporter did not have lot number and expiry date of the first dose of SHINGRIX. This case has been linked to the case US2018124009, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Eye patch application, Facial paralysis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of Bell's palsy in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th May 2018, 7 days after receiving SHINGRIX, the patient experienced Bell's palsy (serious criteria GSK medically significant). The patient was treated with prednisone. On an unknown date, the outcome of the Bell's palsy was unknown. The reporter considered the Bell's palsy to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 60 or 61 years. The reporter had the patient that went to the emergency room on 29th May 2018 and was diagnosed with Bell's Palsy. She was given an eye patch. She was not hospitalized overnight. The reporter only wanted to be contacted via the telephone, he did not want to receive a letter. Field representative was unable to provide additional information.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 74-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included scoliosis. Previously administered products included Zocor and tramadol. Concurrent medical conditions included back pain. On 19th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, throbbing pain, shoulder pain and neck pain. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the throbbing pain was not recovered/not resolved and the outcome of the shoulder pain and neck pain were unknown. It was unknown if the reporter considered the injection site erythema, throbbing pain, shoulder pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The patient received SHINGRIX in left arm. He experienced some redness at the injection site after the injections. Some days later, he started having throbbing pain in his shoulder and neck on the same side he got the injection. The reporter remembered that since the patient's birthday, he was miserable with the pain. The patient had a history of back pain and scoliosis, so it was thought to be related to that. His physician had him go off Zocor, but that did not help. He was put on tramadol, but that did not help. Therapy for his back was delayed due to cataract surgery, but now that had been done he had been started.