chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Influenza, Influenza A virus test positive, Otitis media acute, Pharyngeal erythema, Pyrexia
Clinical narrative: Fever, Influenza A, acute suppurative OM. AUGMENTIN ES 600 mg/5mls 3.5mls po bid x 10 d, TAMIFLU 6mg/mL 5 m bid x 5 d. 2 yrs old vaccinated now with fever. Patient had red throat and runny nose. Parents concern about vaccine reaction to flu. Most like causes for fever is viral not related to vaccination. But will test for strep. Considering issue of possible reaction to flu vaccine will do nasal swab for influenza and RSV. Flu swab came back positive spoke with mom will start pt, mom and dad on TAMIFLU.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Respiratory syncytial virus test, Rhinorrhoea
Clinical narrative: Fever, Influenza A, acute suppurative OM. AUGMENTIN ES 600 mg/5mls 3.5mls po bid x 10 d, TAMIFLU 6mg/mL 5 m bid x 5 d. 2 yrs old vaccinated now with fever. Patient had red throat and runny nose. Parents concern about vaccine reaction to flu. Most like causes for fever is viral not related to vaccination. But will test for strep. Considering issue of possible reaction to flu vaccine will do nasal swab for influenza and RSV. Flu swab came back positive spoke with mom will start pt, mom and dad on TAMIFLU.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Pyrexia, Upper respiratory tract infection
Clinical narrative: Patient receive Flu vaccine and develop fever within 24hours. On 3-28-18 patient had cough and URI symptoms.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 55-year-old male patient who received SHINGRIX (batch number 5223C, expiry date 28th April 2020). On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional information was received as follows: Between 3:40 pm to 5:00 pm, the patient received SHINGRIX on left arm. On 22 April 2018, the patient went to the pharmacy sometime after noon and showed that he had a red, palm-sized area at the injection site.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 83-year-old female patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site wheal and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site wheal were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site wheal and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient experienced pain at injection site which had resolved. The patient reported that even after 2 weeks, she still had swelling, redness, and a hard welt on her injected arm. The size was about 1 inch below the site, and 1 inch above. The patient had denied permission to contact their physician. The caller did not wish to participate in a safety report.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 83-year-old female patient who received SHINGRIX. In February 2018, the patient received SHINGRIX. In February 2018, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site wheal and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site wheal were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site wheal and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient experienced pain at injection site which had resolved. The patient reported that even after 2 weeks, she still had swelling, redness, and a hard welt on her injected arm. The size was about 1 inch below the site, and 1 inch above. The patient had denied permission to contact their physician. The caller did not wish to participate in a safety report.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Injection site swelling, Pruritus
Clinical narrative: Right Deltoid swollen two days after administering the Tdap. Some itching noted. Parent not sure when swelling started noted 2 days later.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, 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 76-year-old female patient who received SHINGRIX (batch number 79N59, expiry date March 2019). On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient inadvertently received a dose of SHINGRIX via subcutaneous route, which led to inappropriate route vaccine administration. No further information reported regarding the event. Follow up information received from pharmacist 20th April 2018: The patient details were updated. On 16th March 2018, the patient received 1st dose of SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and the pain in arm which was lasted for 1 to 2 days. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. The VAERS details were updated. This was a medication error associated with adverse event.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of myalgia in a 51-year-old male patient who received SHINGRIX. 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 myalgia and pain. On an unknown date, the outcome of the myalgia and pain were unknown. It was unknown if the reporter considered the myalgia and pain to be related to SHINGRIX. Additional details were provided as follows: The health care professional was driving in his car so he did not have any additional details on the patients demographics or lot number since health care professional was not calling from the pharmacy and calling while driving. The health care professional was reporting similar adverse event for another patient. No further information was provided. This case has been linked with case US2018071839, reported by the same reporter.
Sex: U
Vaccine: 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 adult patient who received SHINGRIX. 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The health care professional (HCP) reported that the patient experienced arm soreness. This report came from Inside sales. The Inside Sales representative did not have any patient or vaccine information. The representative only had limited information about the adverse event. This is one of the 7 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Injection site induration, Injection site pain, Injection site urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site induration. On 20th April 2018, the patient experienced injection site pain and hives. On 21st April 2018, the patient experienced joint pain and influenza-like symptoms. The patient was treated with TYLENOL #3 WITH CODEINE. On 23rd April 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the injection site pain and injection site induration were not recovered/not resolved and the outcome of the hives and joint pain were unknown. It was unknown if the reporter considered the injection site pain, injection site induration, hives, joint pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 65 year or older. According to the reporter she did not think the patient received any other vaccines concomitantly. The patient received 1 dose of SHINGRIX at a pharmacy, this past Friday. She developed what looked like non-elevated hives. She woke up in the middle of the night (Saturday morning) with joint pain. She had flu like symptoms on Saturday. The flu like symptoms had resolved by Monday morning and she went to work. However, her arm was still sore at the injection site. Her skin was still hard around the injection site. The patient took 2 TYLENOL 3 WITH CODEINE for pain over the weekend. The reporter did think the adverse events were due to the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX. 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 adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The Medical Practitioner called in and stated that, she might have a potential adverse event with the SHINGRIX vaccine. No information was provided by the nurse, due to them calling on behalf of the patient. Attempt to warm transfer the nurse to the line and received a voicemail that, the users voicemail was full and the nurse was disconnected.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a month after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were recovered/resolved. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that one of his patients had a SHINGRIX vaccine at a pharmacy. It was not at the physician's office. The patient experienced 102 degrees (fever) and shaking chills for several hours when she had the vaccine. It was just temporary. The patient was fine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Feeling hot, Lethargy, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old male patient who received SHINGRIX. Concomitant products included CRESTOR, Metformin and terazosin. On 28th February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced chills, lethargy, fever, tremor, feeling hot, pain and feeling bad. In March 2018, the outcome of the chills, lethargy, fever, tremor, feeling hot, pain and feeling bad were recovered/resolved. The reporter considered the chills, lethargy, fever, tremor, feeling hot, pain and feeling bad to be possibly related to SHINGRIX. Additional information was received as follows: The lot number and expiration date was not reported for SHINGRIX. The patient reported that he could not recall the pharmacist whom administered SHINGRIX vaccine. After receiving the vaccine later that night the patient had fever, lethargy and was feeling bad. The patient described feeling bad as chills, shaking, hot and soreness. Four days after receiving injection, all events fully were resolved, no exact dates were provided. The reporter denied any hospitalization for treatment of events reported.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old male patient who received SHINGRIX. Concomitant products included CRESTOR, Metformin and terazosin. On 28th February 2018, the patient received SHINGRIX. In February 2018, less than a day after receiving SHINGRIX, the patient experienced chills, lethargy, fever, tremor, feeling hot, pain and feeling bad. In March 2018, the outcome of the chills, lethargy, fever, tremor, feeling hot, pain and feeling bad were recovered/resolved. The reporter considered the chills, lethargy, fever, tremor, feeling hot, pain and feeling bad to be possibly related to SHINGRIX. Additional information was received as follows: The lot number and expiration date was not reported for SHINGRIX. The patient reported that he could not recall the pharmacist whom administered SHINGRIX vaccine. After receiving the vaccine later that night the patient had fever, lethargy and was feeling bad. The patient described feeling bad as chills, shaking, hot and soreness. Four days after receiving injection, all events fully were resolved, no exact dates were provided. The reporter denied any hospitalization for treatment of events reported.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 57-year-old female patient who received SHINGRIX. Concomitant products included LYRICA and TOPAMAX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 20th April 2018, 2 hours after receiving SHINGRIX, the patient experienced influenza-like symptoms and headache. The patient was treated with ADVIL and TYLENOL. On an unknown date, the outcome of the influenza-like symptoms and headache were recovering/resolving. The reporter considered the influenza-like symptoms and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient took TYLENOL and ADVIL to manage adverse events. The patient had denied permission to contact their physician.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old male patient who received SHINGRIX. Concurrent medical conditions included shingles and cataract extraction. Concomitant products included cholesterol. On 18th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site pain, injection site erythema, injection site warmth and injection site rash. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, injection site warmth and injection site rash were recovering/resolving. The reporter considered the injection site swelling, injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was received as follows: The patient took blood pressure medication as a concomitant drug. The reporter did not provide the lot number or expiration date for SHINGRIX. The patient reported that after receiving SHINGRIX he experienced injection site reactions. The patient experienced pain, swelling, redness and warmth to the touch just below his injection site by about 3 inches on his left arm. Caller states that it appears almost like a rash and is about 3.5 inch circumference around his arm. The reporter states that on the day of injection the reactions were at a 10 and at the time of reporting they were about a 5 on a 10-point scale. The patient was began to take TYLENOL yesterday and on the day of reporting to help with the symptoms.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient complained of light-headedness/dizziness and saw spots. Local reaction was reported as well (hot, elevated, sore inject. site, lasted several days).
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Patient complained of light-headedness/dizziness and saw spots. Local reaction was reported as well (hot, elevated, sore inject. site, lasted several days).
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Very tender area under (L) breast that radiates around the trunk to the spine. Tender to light touch. Prescribed VALTREX 1 gm TID, topical lidocaine.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Decreased activity, Headache, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity. On an unknown date, the outcome of the headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity were unknown. It was unknown if the reporter considered the headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX was received at Pharmacy and the patient came in 1 day later to report her symptoms. The patient experienced neck stiffness and activity changes (not as active as usual).
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Photosensitivity reaction, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity. On an unknown date, the outcome of the headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity were unknown. It was unknown if the reporter considered the headache, chills, fever, photosensitivity, neck pain, back pain, stiff neck and decreased activity to be related to SHINGRIX. Additional details were provided as follows: SHINGRIX was received at Pharmacy and the patient came in 1 day later to report her symptoms. The patient experienced neck stiffness and activity changes (not as active as usual).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Product quality issue
Clinical narrative: This case was reported by pharmacist via call center representative and described the occurrence of shingles in a 75-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 7th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 61 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the shingles and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The patient's doctor reached out to the pharmacy to report patient's adverse event. This case was associated with product complaint, as the patient felt that the lot was defective. The patient received SHINGRIX on left deltoid. The patient got a full blown case of shingles.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received SHINGRIX. On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 12 hrs after receiving SHINGRIX, the patient experienced injection site pain, fever, fatigue, feeling unwell and chills. The patient was treated with TYLENOL. In April 2018, the outcome of the injection site pain, fever, fatigue, feeling unwell and chills were recovered/resolved. The reporter considered the injection site pain, fever, fatigue, feeling unwell and chills to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The caller was reporting on behalf of her husband (patient). The patient received SHINGRIX in the left arm. The caller stated that the patient experienced soreness in his left arm. The caller stated that the patient took TYLENOL for these symptoms, which helped a little and the patient experienced these symptoms for approximately 3 days and then the symptoms resolved. The patient had denied permission to contact their physician.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Pain at day at injection time, overnight knot form hardened red swoll area and painful. Lasted 4 day until relief. Hardened red area still present but going down and less pain.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Mass, Mobility decreased, Pain, Swelling
Clinical narrative: Shot given towards under arm, large swelling, large lump bruising very sore couldn't move arm lasted 2 wks right arm
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Generalised erythema, Pruritus generalised
Clinical narrative: Patient reported itching/redness all over body including arms, legs and stomach. Took a few BENADRYL and has been getting better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Bone pain, Chest pain, Chills, Myalgia
Clinical narrative: At midnight, developed full body tremors and chills. This progressed to body aches involving bones and muscles. Later stomach and chest pain developed. All symptoms gradually improved until about 5 am at which time the patent felt recovered. At this time no lasting issues.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: At midnight, developed full body tremors and chills. This progressed to body aches involving bones and muscles. Later stomach and chest pain developed. All symptoms gradually improved until about 5 am at which time the patent felt recovered. At this time no lasting issues.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth
Clinical narrative: Redness at injection site, warmth, allergic type reaction from SHINGRIX.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: Increased erythema, itching over past 48 hrs (significant area). Encouraged compresses, BENADRYL for itching, ibuprofen for inflammation.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative 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 year after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site swelling to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was placed on phone by retired GSK employee. She stated a pharmacist at the store received SHINGRIX and had injection site swelling. No other details were known. Encouraged to have individual contact GSK to report events as well, and note it was a follow up call. The caller was cashier at pharmacy. This case has been linked to the case US2018071884 and US2018071881, reported by the same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Face and mouth X-ray normal, Hyperaesthesia, Hypoaesthesia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included prostate cancer. Concomitant products included testosterone. On 16th 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 post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired. On 16th April 2018, the patient experienced nerve pain and unable to walk. The patient was treated with gabapentin and analgesic, NOS (Narcotic Analgesic). On an unknown date, the outcome of the nerve pain, unable to walk, post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired were not recovered/not resolved. The reporter considered the nerve pain, unable to walk and post herpetic neuralgia to be related to SHINGRIX. It was unknown if the reporter considered the touch sensitivity increased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received first dose of SHINGRIX in morning. At night, the patient awoke with excruciating nerve pain up his leg so that he could not walk. The pharmacist reported that patient was also experiencing post herpetic neuralgia like sensitivity to touch and cannot wear clothing on the area due to sensitivity. The pharmacist reported that patient went to ER that night and received gabapentin and narcotic pain relievers. The pharmacist that events have not resolved and that today patient has gone back to ER seeking additional treatment. The pharmacist that patient received SHINGRIX at another pharmacy location.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ultrasound scan normal, Urine analysis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included prostate cancer. Concomitant products included testosterone. On 16th 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 post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired. On 16th April 2018, the patient experienced nerve pain and unable to walk. The patient was treated with gabapentin and analgesic, NOS (Narcotic Analgesic). On an unknown date, the outcome of the nerve pain, unable to walk, post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired were not recovered/not resolved. The reporter considered the nerve pain, unable to walk and post herpetic neuralgia to be related to SHINGRIX. It was unknown if the reporter considered the touch sensitivity increased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received first dose of SHINGRIX in morning. At night, the patient awoke with excruciating nerve pain up his leg so that he could not walk. The pharmacist reported that patient was also experiencing post herpetic neuralgia like sensitivity to touch and cannot wear clothing on the area due to sensitivity. The pharmacist reported that patient went to ER that night and received gabapentin and narcotic pain relievers. The pharmacist that events have not resolved and that today patient has gone back to ER seeking additional treatment. The pharmacist that patient received SHINGRIX at another pharmacy location.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Hyperaesthesia, Loss of personal independence in daily activities, Neuralgia, Post herpetic neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included prostate cancer. Concomitant products included testosterone. On 16th 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 post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired. On 16th April 2018, the patient experienced nerve pain and unable to walk. The patient was treated with gabapentin and analgesic, NOS (Narcotic Analgesic). On an unknown date, the outcome of the nerve pain, unable to walk, post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired were not recovered/not resolved. The reporter considered the nerve pain, unable to walk and post herpetic neuralgia to be related to SHINGRIX. It was unknown if the reporter considered the touch sensitivity increased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received first dose of SHINGRIX in morning. At night, the patient awoke with excruciating nerve pain up his leg so that he could not walk. The pharmacist reported that patient was also experiencing post herpetic neuralgia like sensitivity to touch and cannot wear clothing on the area due to sensitivity. The pharmacist reported that patient went to ER that night and received gabapentin and narcotic pain relievers. The pharmacist that events have not resolved and that today patient has gone back to ER seeking additional treatment. The pharmacist that patient received SHINGRIX at another pharmacy location.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Headache, Hyperaesthesia, Intervertebral disc protrusion, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included prostate cancer. Concomitant products included testosterone. On 16th 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 post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired. On 16th April 2018, the patient experienced nerve pain and unable to walk. The patient was treated with gabapentin and analgesic, NOS (Narcotic Analgesic). On an unknown date, the outcome of the nerve pain, unable to walk, post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired were not recovered/not resolved. The reporter considered the nerve pain, unable to walk and post herpetic neuralgia to be related to SHINGRIX. It was unknown if the reporter considered the touch sensitivity increased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received first dose of SHINGRIX in morning. At night, the patient awoke with excruciating nerve pain up his leg so that he could not walk. The pharmacist reported that patient was also experiencing post herpetic neuralgia like sensitivity to touch and cannot wear clothing on the area due to sensitivity. The pharmacist reported that patient went to ER that night and received gabapentin and narcotic pain relievers. The pharmacist that events have not resolved and that today patient has gone back to ER seeking additional treatment. The pharmacist that patient received SHINGRIX at another pharmacy location.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia, Nuclear magnetic resonance imaging spinal abnormal, Pain in extremity, Photophobia, Post herpetic neuralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included prostate cancer. Concomitant products included testosterone. On 16th 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 post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired. On 16th April 2018, the patient experienced nerve pain and unable to walk. The patient was treated with gabapentin and analgesic, NOS (Narcotic Analgesic). On an unknown date, the outcome of the nerve pain, unable to walk, post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired were not recovered/not resolved. The reporter considered the nerve pain, unable to walk and post herpetic neuralgia to be related to SHINGRIX. It was unknown if the reporter considered the touch sensitivity increased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received first dose of SHINGRIX in morning. At night, the patient awoke with excruciating nerve pain up his leg so that he could not walk. The pharmacist reported that patient was also experiencing post herpetic neuralgia like sensitivity to touch and cannot wear clothing on the area due to sensitivity. The pharmacist reported that patient went to ER that night and received gabapentin and narcotic pain relievers. The pharmacist that events have not resolved and that today patient has gone back to ER seeking additional treatment. The pharmacist that patient received SHINGRIX at another pharmacy location.
Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Spinal operation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included prostate cancer. Concomitant products included testosterone. On 16th 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 post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired. On 16th April 2018, the patient experienced nerve pain and unable to walk. The patient was treated with gabapentin and analgesic, NOS (Narcotic Analgesic). On an unknown date, the outcome of the nerve pain, unable to walk, post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired were not recovered/not resolved. The reporter considered the nerve pain, unable to walk and post herpetic neuralgia to be related to SHINGRIX. It was unknown if the reporter considered the touch sensitivity increased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received first dose of SHINGRIX in morning. At night, the patient awoke with excruciating nerve pain up his leg so that he could not walk. The pharmacist reported that patient was also experiencing post herpetic neuralgia like sensitivity to touch and cannot wear clothing on the area due to sensitivity. The pharmacist reported that patient went to ER that night and received gabapentin and narcotic pain relievers. The pharmacist that events have not resolved and that today patient has gone back to ER seeking additional treatment. The pharmacist that patient received SHINGRIX at another pharmacy location.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Previously administered products included pneumococcal vaccine with an associated reaction of rash (had a similar rash after one of the pneumonia vaccines). On 21st April 2018, the patient received the 1st dose of SHINGRIX. On 22nd April 2018, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving. The reporter considered the rash to be probably related to SHINGRIX. Additional details were provided as follows: The patient experienced a rash on her torso the next day. Two days later, it was still resolving on its own, without any medical intervention.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: I reported her patient's fever and muscle aching which occurred on Sunday (the day after the vaccine). Today, patient called to report that she had a stroke on Tuesday morning. She went to the ER and was told she had a stroke and it was possibly due to the SHINGRIX vaccine. (Symptoms she had were numbness on one side, disorientation and vision compromised).
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Disorientation, Hypoaesthesia
Clinical narrative: I reported her patient's fever and muscle aching which occurred on Sunday (the day after the vaccine). Today, patient called to report that she had a stroke on Tuesday morning. She went to the ER and was told she had a stroke and it was possibly due to the SHINGRIX vaccine. (Symptoms she had were numbness on one side, disorientation and vision compromised).
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nuclear magnetic resonance imaging, Pyrexia, Visual impairment
Clinical narrative: I reported her patient's fever and muscle aching which occurred on Sunday (the day after the vaccine). Today, patient called to report that she had a stroke on Tuesday morning. She went to the ER and was told she had a stroke and it was possibly due to the SHINGRIX vaccine. (Symptoms she had were numbness on one side, disorientation and vision compromised).
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Gastrooesophageal reflux disease, Infantile spitting up, Vomiting projectile
Clinical narrative: After each of these vaccines, my infant gets reflux (curdled milk spit up) that is constant (projectile) for a week. This behavior is only present following a vaccination.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: Aching joints, muscles, shivering cold, stomach ache, nausea, diarrea, tiredness.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Myalgia, Nausea
Clinical narrative: Aching joints, muscles, shivering cold, stomach ache, nausea, diarrea, tiredness.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood gases normal, Blood test normal, Body temperature, Dyspnoea, Respiratory syncytial virus test negative
Clinical narrative: Difficulty breathing, temperature, congestion. Went to Hospital on 4/11/2018 at 3:00PM, while in the Emergency room the wall suctioned patient, tried a breathing treatment through an inhaler which did not help. Patient was admitted to the hospital that evening and was on oxygen support for 2 days along with wall suction every two hours. Was discharged on 4/15/2018.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Respiratory tract congestion
Clinical narrative: Difficulty breathing, temperature, congestion. Went to Hospital on 4/11/2018 at 3:00PM, while in the Emergency room the wall suctioned patient, tried a breathing treatment through an inhaler which did not help. Patient was admitted to the hospital that evening and was on oxygen support for 2 days along with wall suction every two hours. Was discharged on 4/15/2018.
Age: 40.0
Sex: M
Vaccine: HEPAB, TDAP, TYP
Symptoms: Malaise
Clinical narrative: After receiving the last vaccine which was the Typhoid patient stated that he was not feeling well. I lowered the head of the exam table, took his BP. I kept talking to him and called for help in the clinic room.
Age: 0.17
Sex: M
Vaccine: UNK, UNK, UNK, UNK, UNK
Symptoms: Injection site swelling, Screaming
Clinical narrative: Inconsolable screaming for hours, leg swelling twice it's size. Went to hospital around 6. Swelling went down, screaming stopped on own.
Sex: U
Vaccine: DTAPH, FLU4, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a registered nurse refers to 6-month-old patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On 06-APR-2018, the patient was vaccinated with first dose of ROTATEQ, oral (dose, units, frequency, lot# unknown) expiration date 19-FEB-2019, at about 24 weeks (inappropriate schedule of drug administration). Other suspect therapies included pneumococcal 13v conj vaccine (crm197) (PNEUMOCOCCAL 13V CONJ VACCINE (CRM197)) (Lot# C5368AA) (dose, units, frequency and expiration date unknown) via intramuscular route at quadriceps, influenza virus vaccine (unspecified) (INFLUENZA VIRUS VACCINE (UNSPECIFIED)) (lot# UT5897MA) (dose, units, frequency and expiration date unknown) via intramuscular route at quadriceps and hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid (DIPHTHERIA TOXOID (+) HIB CONJ VACCINE (UNSPECIFIED CARRIER) (+) PERTU) (lot# T52790) (dose, units, frequency and expiration date unknown) via intramuscular route at quadriceps. Data logger was not involved. No product quality complaint was reported.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Nasopharyngitis
Clinical narrative: This spontaneous report was received from a physician regarding a 19 years old female patient. The patient's medical history included hidradenitis suppurativa diagnosed on 02-FEB-2017, and herpes type II positive definite. Concomitant medication included valacyclovir hydrochloride (VALTREX) and concurrent conditions were not reported. She did not have drug reactions or allergies. On 16-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9 in the left deltoid, lot # reported as M04373 with expiration date 26-APR-2019, (route of administration was not reported) for vaccination, 20 years old at risk (prophylaxis). On the same date, the patient complained of a cold described as "lasted for up to a month after receiving the dose". She did not seek medical attention and no treatment was given for the event. The second dose was never received. At the reporting time, the patient recovered from the cold. The causality assessment was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA012316: US-009507513-1804USA012254:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-APR-2018, the patient was inadvertently vaccinated with a dose of VAQTA (lot# N005605, expiration date was 08-APR-2018, strength and frequency were unknown) intramuscularly for prophylaxis (Expired product administered). No adverse effects reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 12 year old patient of unknown gender. The patient's pertinent medical history included leukaemia. The patient's concurrent conditions and concomitant medications were not provided. On 27-APR-2018, the patient was vaccinated with GARDASIL 9 lot # N018273, expiration date on 17-JUN-2019, for prophylaxis (strength and dose were not reported). The Medical Assistant reported it was uncertain if GARDASIL 9 was administered either by subcutaneous or intramuscular route. No side effect were reported.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 1 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 30-APR-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # N025931 with expiration date of 19-SEP-2018 (strength, dose, route, and anatomical location were not provided) for prophylaxis, which was reconstituted with MERCK STERILE DILUENT. No adverse events were reported. The vaccine was exposed to a temperature excursion between -14 °C to -10°C (-11.5°C), during a time frame of 25 minutes which was called because of a data logger. No previous temperature excursions were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1805USA000930.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Fatigue, Headache, Injection site cellulitis, Injection site erythema
Clinical narrative: Patient reports he woke up the day after the vaccination with temperature of 99.4, headache, body aches, fatigue, nausea, redness and soreness at injection site. Systemic symptoms improved over the next 3 days but pain and redness at the injection site worsened. Patient was seen in the office for evaluation on 4/28/18 and diagnosed with cellulitis at the injection site, treated with 7 day course of oral KEFLEX.