chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Adverse drug reaction, Lip swelling, Mouth swelling, Rash, Somnolence
Clinical narrative: The evening of injection my mouth started to swell. The next morning my lips were extremely swollen. Dr. prescribed ZANTAC and XYZAL which made me very sleepy. By midafternoon I noticed a rash developing on my forearms. By evening I had a pervasive rash covering my forearms and lower legs.  The rash moved to my armpits on day two. I continued to take ZANTAC and XYZAL (at night) with no results other than the swelling in my lips subsided. On day 5 after the injection, I started a course of Methylprednisone which is clearing up the rash. I am currently at the end of day 2 of the prednisone and the rash has considerably subsided.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Neuritis, Vertigo
Clinical narrative: The patient developed several blisters on the left ear 3 days after the vaccine followed by severe vertigo. She underwent multiple studies by ENT physician without any explanation; she eventually was treated with acyclovir for a total of 20 days several months later with complete resolution of the vertigo and was diagnosed with vestibular neuritis.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dysarthria, Full blood count, Headache, Injection site erythema, Metabolic function test
Clinical narrative: Headaches, Soreness, Swelling and redness at vaccination site, Nausea, Fever, Blurred speech and vision, Seizure like episode for about a minute. MOTRIN, TYLENOL, Ondansetron.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Nausea, Pyrexia, Seizure like phenomena, Vaccination site pain, Vaccination site swelling
Clinical narrative: Headaches, Soreness, Swelling and redness at vaccination site, Nausea, Fever, Blurred speech and vision, Seizure like episode for about a minute. MOTRIN, TYLENOL, Ondansetron.
Age: 29.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Vision blurred
Clinical narrative: Headaches, Soreness, Swelling and redness at vaccination site, Nausea, Fever, Blurred speech and vision, Seizure like episode for about a minute. MOTRIN, TYLENOL, Ondansetron.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Influenza, Injection site swelling, Pain
Clinical narrative: Patient stopped by the pharmacy on 05/01/2018 to report the adverse event. She stated she experienced dizziness, body aches, flu symptoms and swelling at the injection site. These symptoms abated after a few days.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Panic attack
Clinical narrative: Patient stated that she was having shortness of breath about an hour after administration. She came back to pharmacy and took 50mg of diphenhydramine. She left and went back home because she did not want me calling 911. She called and stated that she was feeling better around 12:08pm. At 12:15pm, patient called back and said she was feeling dizzy and lightheaded (probably a result of the diphenhydramine) but still having some shortness of breath. She was instructed to call 911. When paramedics came, they believed her symptoms were consistent with a panic attack and did not take her to the ER. She was told to call them back if her symptoms got worse, and then they would transport her to the ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling of body temperature change, Hyperaesthesia, Immediate post-injection reaction, Influenza like illness
Clinical narrative: Injection site felt like a strong punch to the arm; like a flu shot immediately after the injection but soon feeling much more painful than a flu shot. Within 6 to 8 hours, body aches. Within about 16 hours, flu-like symptoms of body ache, cold-then-hot, fatigue. Within 24 hours, full flu-like symptoms including skin sensitivity to touch, even hair on scalp. By about 40 hours, flu like symptoms gone but arm soreness at the injection site remained for 5 or 6 days. Only one ibuprofen taken at the worst of the flu symptoms. Never had had this strong a reaction to an immunization before. Going in for the 2nd shot in the series in the next week or so. Side effects from that one should be interesting.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Injection site felt like a strong punch to the arm; like a flu shot immediately after the injection but soon feeling much more painful than a flu shot. Within 6 to 8 hours, body aches. Within about 16 hours, flu-like symptoms of body ache, cold-then-hot, fatigue. Within 24 hours, full flu-like symptoms including skin sensitivity to touch, even hair on scalp. By about 40 hours, flu like symptoms gone but arm soreness at the injection site remained for 5 or 6 days. Only one ibuprofen taken at the worst of the flu symptoms. Never had had this strong a reaction to an immunization before. Going in for the 2nd shot in the series in the next week or so. Side effects from that one should be interesting.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: 10 minutes after vaccine: patient complained of headache. 2 hours after vaccines, patient stated she was nauseous and had vomited once. Shortly after, she vomited again and stated she felt better. 8 hours after vaccines, patient stated the headache and nausea were reduced, no more vomiting.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Dysphagia, Dyspnoea, Myasthenia gravis
Clinical narrative: Severe swallowing and breathing difficulties, resulting in immediate hospital admission. Diagnosed with MG.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fatigue, muscle aches in legs, headache, 100.3 degree fever, all lasting roughly 24 hrs. Also pain at the injection site from day of the injection, lasting 3 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 70-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 27th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced weakness, injection site pain and tingling of extremity. On an unknown date, the outcome of the weakness, injection site pain and tingling of extremity were unknown. It was unknown if the reporter considered the weakness, injection site pain and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. The patient received SHINGRIX in left deltoid. The patient experience soreness and tenderness at the injection site. On 20th April 2018, the patient notified the pharmacist that they began experiencing weakness tingling in the arm which was not improving. The patient had not been seen in the emergency room, or hospitalized at the time of the report, but the health care professional reported that they would refer her to her doctor if the symptoms continued. The health care professional was unsure when the initial symptoms began but stated that the patient returned to the pharmacy a few days after receiving the vaccine with soreness and tenderness. The patient's symptoms were not considered disabling or life threatening. The caller was pharmacist who reported original event. The caller was requesting a copy of the original adverse event report or any other documentation from that report that can be provided to him to share with the involved patient per the request of the patient. This case has been linked with US2018069589, reported by the same reporter.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Feeling hot, Pruritus, Skin tightness, Swelling
Clinical narrative: Right arm MENACTRA was given 4/30/2018. That day pt w/no difficulty breathing or shortness of breath. Able to play baseball in evening. Pt complained 5/1/2018 in the morning reporting redness, swelling and warmth. Pt also advised itchy sensation and feeling that the skin is tight. Pt w/no pain on pressing the reaction per mother. Also patient is right handed and has no difficulties with moving his hand and fingers. Eventually discussed with mother when she contacted offices 5/2/2018 -> if patient w/warmth, skin tightness needs to be evaluated at ED/office as concerns of infection/Genpath compartment syndrome. Mother understands. Informed mother to give BENADRYL 25mg, if symptoms worsen. Patient to return to clinic or seek medical attention.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX (batch number ZX3YA, expiry date 28th April 2020). On 13th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The pharmacist received a call from the patient on 19th April 2018. The pharmacist called and reported that the patient experienced a rash on the face which was heading towards the nose.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of headache in a 49-year-old male patient who received SHINGRIX (batch number B4C42, expiry date 25th April 2020). On 19th April 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 19th April 2018, 4 hrs after receiving SHINGRIX, the patient experienced headache, pain and nausea. On an unknown date, the outcome of the headache, pain and nausea were recovering/resolving. The reporter considered the headache, pain and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving supplement. On 19th April 2018, at about 1 pm, the patient received SHINGRIX vaccine in the left arm at reporter's facility. At about 5 pm, the patient had headache, nausea and was feeling achy. The patient continued to have the same symptoms in morning on the date of reporting but they were better.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: 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 erythema in a 76-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. The reporter considered the injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid and experienced redness and swelling at the injection site. The patient went to her doctor and got a prescription.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pruritus, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, fever and injection site pain. On 18th April 2018, the patient experienced pruritus. On an unknown date, the outcome of the injection site erythema, fever, injection site pain and pruritus were not recovered/not resolved. The reporter considered the injection site erythema, fever, injection site pain and pruritus to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient developed redness at injection  site, itchiness and soreness. It was reported that, the redness got worse and the patient had developed a low grade fever. The reporter declined to provide prescribed information or concomitant medications.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received SHINGRIX (batch number EK279,expiry date 31st March 2020). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving. The reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient developed goose egg at the site of injection after receiving the SHINGRIX vaccine. The health care professional was no sure when the reaction started but the patient contacted them the next day to report the event. The goose egg on the arm was bout the size of a 50 cent piece.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Grip strength decreased, Pyrexia
Clinical narrative: On 4/30/18 patient came to pick up other Rx and while here made us aware she experienced fever, chills, and fatigue for about 24 hrs after vaccine. She also complained of not being able to easily pick up an object with hand (rt hand) opposite of injection site arm (left arm). Pt states this also resolved w/in 24 hrs.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Bronchiolitis, Cough, Full blood count normal, Irritability, Pyrexia
Clinical narrative: Patient presented to clinic 2/16/16 with bright red rash, fever, cough, runny nose, fussiness. Patient parent report treated for RSV at ER previously. Treated for bronchiolitis; and RSV admitted to Hospital. 2/16/16 - patient was "admitted" to hospital for rash, fever, cough, runny nose, fussiness.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash erythematous, Respiratory syncytial virus infection, Rhinorrhoea
Clinical narrative: Patient presented to clinic 2/16/16 with bright red rash, fever, cough, runny nose, fussiness. Patient parent report treated for RSV at ER previously. Treated for bronchiolitis; and RSV admitted to Hospital. 2/16/16 - patient was "admitted" to hospital for rash, fever, cough, runny nose, fussiness.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence if pain in arm in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fever, headache, injection site erythema and injection site swelling. The patient was treated with analgesics, nos (pain medication). On an unknown date, the outcome of the pain in arm, fever, injection site erythema and injection site swelling were recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the pain in arm, fever, headache, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm (not specified). The specific dosing was not provided. The site and other details for vaccines administration were unknown. In the evening of vaccination, the patient's arm became sore and the patient had a mild headache. Later, the patient woke up at 12:30 AM (1 day after vaccination), feeling feverish and headache and arm pain were severe. The patient took OTC (over the counter) pain medicine and then slept through the night. In the morning, the nurse described that the fever was gone in that the patient denied feeling feverish and her arm was still very sore and there was now at the injection spot a small red or pink-colored circle with a bit of swelling. It was like that for a few days and then it faded it away. At the time of reporting, the arm was fine and back to normal. The fever was gone. The status of the headache was unknown. The nurse discussed the adverse event profile with medical science liaison (MSL) and seemed to indicate that the symptoms were consistent with the labeling, though she did not specifically say that SHINGRIX caused the symptoms. The nurse said the patient was planning to get a second SHINGRIX dose in the future. It was reported that it was okay to contact the reporter but the MSL did not have any phone number for her office. The nurse did not provide further related details.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site swelling. The patient was treated with antibiotics NOS. On an unknown date, the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site swelling to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX in unknown deltoid. The patient experienced swelling in her arm near the injection site which has lasted for 4 to 5 days, and was described as 6 mm in width. The event on set timing was not known, but the physician did say soon after the injection. The patient had denied permission to contact their physician. Field representative said that physician did not wish to be contacted. This case was previously reported to physician. The patient required to visit emergency room.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 58-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). The patient's past medical history included cancer (at unknown site). On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced headache. On an unknown, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported by registered pharmacist (Rph). The patient received a dose of SHINGRIX in left deltoid. Only partial information was provided by the pharmacist.
Age: 1.0
Sex: F
Vaccine: FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Band neutrophil count increased, Full blood count, Pyrexia, Seizure, Unresponsive to stimuli
Clinical narrative: Patient had seizure and was unresponsive for a few seconds. Family went to the emergency department and patient had fever documented but no previous sick symptoms. WBC showed elevated bands but no significant other ABN.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old female patient who received SHINGRIX. The patient's past medical history included thyroid gland cancer (thyroid removed) and mononucleosis. On 18th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th April 2018, several hours after receiving SHINGRIX, the patient experienced feeling unwell, influenza-like symptoms, fever, general body pain, pain of skin, hypersensation skin, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough. On an unknown date, the outcome of the feeling unwell, general body pain, pain of skin and hypersensation skin were unknown and the outcome of the influenza-like symptoms was recovering/resolving and the outcome of the fever, headache, photophobia, fatigue, abdominal discomfort and difficulty breathing were recovered/resolved and the outcome of the cough was unchanged. It was unknown if the reporter considered the feeling unwell, general body pain, pain of skin and hypersensation skin to be related to SHINGRIX. The reporter considered the influenza-like symptoms, fever, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. At 10:00, the patient received SHINGRIX vaccine in left arm. Around 8:00 pm that evening the patient was not feeling well and started to feel worse during then night. The patient had flu-like symptoms which included, low-grade fever, body aches, skin sensitivity (her skin hurt when it touched the bed sheets), headache, bright light bothered her eyes, and extremely fatigued. The patient also felt sick to her stomach and found it hard to breath. On 19th April 2018, she was unable to get out of bed that day due to these symptoms. On the day of reporting, the patient was feeling a lot better but still felt fatigued and wiped out. She said her eyes do not look good because she was still not feeling well. She also started coughing on the same day. The reporter gave permission for her physician to be contacted.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Influenza like illness, Malaise, Pain, Pain of skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old female patient who received SHINGRIX. The patient's past medical history included thyroid gland cancer (thyroid removed) and mononucleosis. On 18th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th April 2018, several hours after receiving SHINGRIX, the patient experienced feeling unwell, influenza-like symptoms, fever, general body pain, pain of skin, hypersensation skin, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough. On an unknown date, the outcome of the feeling unwell, general body pain, pain of skin and hypersensation skin were unknown and the outcome of the influenza-like symptoms was recovering/resolving and the outcome of the fever, headache, photophobia, fatigue, abdominal discomfort and difficulty breathing were recovered/resolved and the outcome of the cough was unchanged. It was unknown if the reporter considered the feeling unwell, general body pain, pain of skin and hypersensation skin to be related to SHINGRIX. The reporter considered the influenza-like symptoms, fever, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. At 10:00, the patient received SHINGRIX vaccine in left arm. Around 8:00 pm that evening the patient was not feeling well and started to feel worse during then night. The patient had flu-like symptoms which included, low-grade fever, body aches, skin sensitivity (her skin hurt when it touched the bed sheets), headache, bright light bothered her eyes, and extremely fatigued. The patient also felt sick to her stomach and found it hard to breath. On 19th April 2018, she was unable to get out of bed that day due to these symptoms. On the day of reporting, the patient was feeling a lot better but still felt fatigued and wiped out. She said her eyes do not look good because she was still not feeling well. She also started coughing on the same day. The reporter gave permission for her physician to be contacted.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old female patient who received SHINGRIX. The patient's past medical history included thyroid gland cancer (thyroid removed) and mononucleosis. On 18th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 18th April 2018, several hours after receiving SHINGRIX, the patient experienced feeling unwell, influenza-like symptoms, fever, general body pain, pain of skin, hypersensation skin, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough. On an unknown date, the outcome of the feeling unwell, general body pain, pain of skin and hypersensation skin were unknown and the outcome of the influenza-like symptoms was recovering/resolving and the outcome of the fever, headache, photophobia, fatigue, abdominal discomfort and difficulty breathing were recovered/resolved and the outcome of the cough was unchanged. It was unknown if the reporter considered the feeling unwell, general body pain, pain of skin and hypersensation skin to be related to SHINGRIX. The reporter considered the influenza-like symptoms, fever, headache, photophobia, fatigue, abdominal discomfort, difficulty breathing and cough to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. At 10:00, the patient received SHINGRIX vaccine in left arm. Around 8:00 pm that evening the patient was not feeling well and started to feel worse during then night. The patient had flu-like symptoms which included, low-grade fever, body aches, skin sensitivity (her skin hurt when it touched the bed sheets), headache, bright light bothered her eyes, and extremely fatigued. The patient also felt sick to her stomach and found it hard to breath. On 19th April 2018, she was unable to get out of bed that day due to these symptoms. On the day of reporting, the patient was feeling a lot better but still felt fatigued and wiped out. She said her eyes do not look good because she was still not feeling well. She also started coughing on the same day. The reporter gave permission for her physician to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient experienced soreness and tenderness at the injection site. This was one of the 2 cases reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 70-year-old female patient who received SHIGNRIX. In April 2018, the patient received SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site pain. The patient was treated with NSAID's (NOS). On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site pain were recovering/resolving. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The physician reported to a GlaxoSmithKline field representative at the SHINGRIX booth at a national convention that his wife who was the consumer had a reaction. The patient's concomitant medication included antidepressant and cholesterol medication. The patient received the vaccine either on Monday 16th April 2018 or on Tuesday 17th April 2018 at a retail pharmacy by a pharmacy intern. The injection site was the left deltoid of the upper arm. The symptoms all started within 24 hours of the vaccination. The symptoms were currently resolving, and the patient had been using a nonsteroidal anti-inflammatory medication of unknown name for the symptoms. There was no prescription ordered or required for the patient to have the SHINGRIX vaccination. The reporter advised the patient to go to the pharmacy and have the vaccination. No further details were provided during the call. The reporter was an internal medicine MD and granted permission to be contacted via phone with further related questions. The exact mailing address for the pharmacy could not be provided nor the exact names of the cholesterol and antidepressant therapies.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pain, Pruritus, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pruritus in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included breast cancer, osteoporosis and clot blood. Concomitant products included Aspirin, Vitamin B12, ARIMIDEX, biotin, finasteride, magnesium, nifedipine, PROLIA, hydrochlorothiazide, calcium + magnesium + zinc + vitamin D, Valacyclovir, Coenzyme Q10, Selenium, Flax Oil, fish oil, Vitamin C and Vitamin D. On 23rd February 2018 03:00, the patient received SHINGRIX (intramuscular). On 23rd February 2018, less than a day after receiving SHINGRIX, the patient experienced pruritus, vesicles, erythema, swelling and pain. On an unknown date, the outcome of the pruritus, vesicles, erythema, swelling and pain were recovered/resolved. The reporter considered the pruritus, vesicles, erythema, swelling and pain to be related to SHINGRIX. Additional details were provided as follows: Concurrent medical conditions included polymorphism. The patient experienced itchy vesicles, redness, swelling, soreness after vaccination with SHINGRIX on right arm and it was 4 inches long. The events were lasted 4 days.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Immediate post-injection reaction, Laceration, Product container issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a 56-year-old female patient who was inadvertently exposed to SHINGRIX (batch number B327C, expiry date 4th July 2020). On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, immediately after receiving SHINGRIX, the patient experienced laceration of finger, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date,  the outcome of the laceration of finger, exposure via skin contact, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable for this report. The pharmacist reported one adjuvant suspension component vial from a box of ten was defective because its bottom was broken. When starting to prepare the product for administration on the day of reporting, after putting the needle in the adjuvant suspension vial to draw out the suspension, she noticed there was no product inside to be withdrawn because the bottom of the vial was broken. The reporter would send GlaxoSmithKline a photo of the defect. There were shards of glass in the bottom of the box. The product box was not damaged in any way. There was no evidence of leakage of product inside the box. The vial's bottom was mostly intact with about one-fourth of the bottom's being missing. She described that it looks like a single hairline crack where the bottom of the vial was broken. The product was stored in the refrigerator. There was no damage or opening to the package upon receipt at the pharmacy. The product was not administered. Instead she proceeded to start the reconstitution process over again using a different syringe and another new dose from the box of ten which was then administered to a consumer without issue. The reporter later noticed that her own middle right finger was bleeding. She attributed the bleeding to her finger's being cut while she had held the broken product in question.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product quality issue
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a 56-year-old female patient who was inadvertently exposed to SHINGRIX (batch number B327C, expiry date 4th July 2020). On 20th April 2018, the patient received SHINGRIX. On 20th April 2018, immediately after receiving SHINGRIX, the patient experienced laceration of finger, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date,  the outcome of the laceration of finger, exposure via skin contact, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable for this report. The pharmacist reported one adjuvant suspension component vial from a box of ten was defective because its bottom was broken. When starting to prepare the product for administration on the day of reporting, after putting the needle in the adjuvant suspension vial to draw out the suspension, she noticed there was no product inside to be withdrawn because the bottom of the vial was broken. The reporter would send GlaxoSmithKline a photo of the defect. There were shards of glass in the bottom of the box. The product box was not damaged in any way. There was no evidence of leakage of product inside the box. The vial's bottom was mostly intact with about one-fourth of the bottom's being missing. She described that it looks like a single hairline crack where the bottom of the vial was broken. The product was stored in the refrigerator. There was no damage or opening to the package upon receipt at the pharmacy. The product was not administered. Instead she proceeded to start the reconstitution process over again using a different syringe and another new dose from the box of ten which was then administered to a consumer without issue. The reporter later noticed that her own middle right finger was bleeding. She attributed the bleeding to her finger's being cut while she had held the broken product in question.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Circumstance or information capable of leading to medication error, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 60-year-old patient who received SHINGRIX. Co-suspect products included SHIGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever, chills, injection site pain, injection site swelling, general body pain and exhaustion. On an unknown date, the outcome of the fever, chills, injection site pain, injection site swelling, general body pain, exhaustion, circumstance or information capable of leading to medication error and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fever, chills, injection site pain, injection site swelling, general body pain and exhaustion to be related to SHINGRIX. Additional details were reporter as follows: This case was reported by the patient who was a retired nurse. The patient was in general good health. The patient received a dose of SHINGRIX vaccine two days ago from the date of reporting. The patient stated that, the side effects were terrible. The patient experienced fever, chills and site pain with significant swelling. The body aches were more than aches and quite painful. At the time of reporting, the patient was on day 2, and although the patient was not bedridden that day, continued to suffer from exhaustion and pain. The patient felt that, GlaxoSmithKline misrepresented the level of side affects. Since the patient was a retired nurse, the patient would understand the importance of vaccine, and was very aware of the discomfort and implications of the disease. The patient was concerned and asked what level of immunity can be expected with 1SHINGRIX vaccine, as the patient would not be receiving a 2nd dose, which could lead to or information capable of leading to medication error and incomplete course of vaccination.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 60-year-old patient who received SHINGRIX. Co-suspect products included SHIGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever, chills, injection site pain, injection site swelling, general body pain and exhaustion. On an unknown date, the outcome of the fever, chills, injection site pain, injection site swelling, general body pain, exhaustion, circumstance or information capable of leading to medication error and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fever, chills, injection site pain, injection site swelling, general body pain and exhaustion to be related to SHINGRIX. Additional details were reporter as follows: This case was reported by the patient who was a retired nurse. The patient was in general good health. The patient received a dose of SHINGRIX vaccine two days ago from the date of reporting. The patient stated that, the side effects were terrible. The patient experienced fever, chills and site pain with significant swelling. The body aches were more than aches and quite painful. At the time of reporting, the patient was on day 2, and although the patient was not bedridden that day, continued to suffer from exhaustion and pain. The patient felt that, GlaxoSmithKline misrepresented the level of side affects. Since the patient was a retired nurse, the patient would understand the importance of vaccine, and was very aware of the discomfort and implications of the disease. The patient was concerned and asked what level of immunity can be expected with 1SHINGRIX vaccine, as the patient would not be receiving a 2nd dose, which could lead to or information capable of leading to medication error and incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site rash, Pyrexia, Rash macular
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX. On an unknown date, the patient received SHIGNRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, erythromacular rash, fever and chills. On an unknown date, the outcome of the injection site rash, injection site erythema, erythromacular rash, fever and chills were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema, erythromacular rash, fever and chills to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist. The age at vaccination was not reported. The health care professional reported that the patient experienced a red rash at the injection site, described as red spots. The health care professional declined to provide any additional information. This is 1 of the 4 cases reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 72-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). Concomitant products included PREMARIN cream and SYNTHROID. On 6th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 7th April 2018, 1 days after receiving SHINGRIX, the patient experienced hives and erythematous rash. In April 2018, the patient experienced pruritus. On an unknown date, the outcome of the hives and pruritus were unchanged and the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the hives, pruritus and erythematous rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that 1 day after receiving SHINGRIX vaccination, the patient experienced red bumps all over the chest and the back. Less than a week after receiving SHINGRIX, the patient experienced itchiness. The reporter provided information for patients health care provider. All questions were asked.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 58-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 19th April 2018, 2 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On 20th April 2018, the patient experienced tingling. On an unknown date, the outcome of the extensive swelling of vaccinated limb, tingling and injection site erythema were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be possibly related to SHINGRIX. It was unknown if the reporter considered the tingling to be related to SHINGRIX. Additional details were reported as follows: At 8:47 AM, the patient received SHINGRIX in left arm. The patient experienced arm swelling and redness to the elbow and face tingling. The pharmacist reported that the patient denied previous ZOSTAVAX vaccine on questionnaire. The reporter's call was transferred to Medical Information System for inquiry.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast mass, Breast pain, Chills, Fatigue, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). Concomitant products included doxycycline. On 10th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 10th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, shivering, fatigue and fever. On 14th April 2018, the patient experienced breast lump. In April 2018, less than a month after receiving vaccination, the patient experienced breast pain. On 13th April 2018, the outcome of the injection site pain, injection site swelling, shivering, fatigue and fever were recovered/resolved. On an unknown date, the outcome of the breast lump was not recovered/not resolved and the outcome of the breast pain was unknown. The reporter considered the injection site pain, injection site swelling, breast lump, shivering, fatigue and fever to be related to SHINGRIX. It was unknown if the reporter considered the breast pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain and swelling at the injection site, fatigue, shivering, and fever that began later the evening of 10th April 2018. Four days after receiving vaccination, the patient noted a lump on breast and that as of 20th April 2018, the lump had gotten larger and was starting to hurt. Caller reported that patient would be seeing Medical doctor on the day of reporting regarding this lump.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020). Concomitant products included doxycycline. On 10th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 10th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, shivering, fatigue and fever. On 14th April 2018, the patient experienced breast lump. In April 2018, less than a month after receiving vaccination, the patient experienced breast pain. On 13th April 2018, the outcome of the injection site pain, injection site swelling, shivering, fatigue and fever were recovered/resolved. On an unknown date, the outcome of the breast lump was not recovered/not resolved and the outcome of the breast pain was unknown. The reporter considered the injection site pain, injection site swelling, breast lump, shivering, fatigue and fever to be related to SHINGRIX. It was unknown if the reporter considered the breast pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain and swelling at the injection site, fatigue, shivering, and fever that began later the evening of 10th April 2018. Four days after receiving vaccination, the patient noted a lump on breast and that as of 20th April 2018, the lump had gotten larger and was starting to hurt. Caller reported that patient would be seeing Medical doctor on the day of reporting regarding this lump.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Flushing
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of flushing in a 63-year-old female patient who received SHINGRIX. On 17th April 2018, the patient received SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced flushing and feeling of warmth. On an unknown date, the outcome of the flushing and feeling of warmth were unknown. It was unknown if the reporter considered the flushing and feeling of warmth to be related to SHINGRIX. Additional details were provided as follows: The patient reported unexpected flushed feeling and very hot. Duration of episode was not very long. However, the patient was enough to call the provider the next morning.