chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Arthralgia, Discomfort, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Sought treatment for neck shoulder arm pain on the right. She received her first SHINGRIX vaccine on 8/1/18 on the left arm and when she went to go-health yesterday (8/15/18) she was told that her pain was "kinda like shingles". She was not diagnosed with shingles, but her pain, dull constant aching from her hairline down to her elbow on her right that inhibits her ability to put her ear to her shoulder and sometimes turn her head to the right seems consistent with pain frequently experienced by shingles patients. She does not have fever, rash, coryzal symptoms at this time. States that discomfort started on Tuesday (8/14/18), sought care yesterday (8/15/18). Prescribed muscle relaxants that did help her sleep last night. Tiger patches have provided some relief as well. Concerned that symptoms are related to SHINGRIX vaccine received 2 weeks ago. Also received PREVNAR vaccine 7/2/18 in right deltoid. Site was initial sore, but it improved to baseline. Concerned that severe neck and right arm pain are vaccine reaction.
Age: 56.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sought treatment for neck shoulder arm pain on the right. She received her first SHINGRIX vaccine on 8/1/18 on the left arm and when she went to go-health yesterday (8/15/18) she was told that her pain was "kinda like shingles". She was not diagnosed with shingles, but her pain, dull constant aching from her hairline down to her elbow on her right that inhibits her ability to put her ear to her shoulder and sometimes turn her head to the right seems consistent with pain frequently experienced by shingles patients. She does not have fever, rash, coryzal symptoms at this time. States that discomfort started on Tuesday (8/14/18), sought care yesterday (8/15/18). Prescribed muscle relaxants that did help her sleep last night. Tiger patches have provided some relief as well. Concerned that symptoms are related to SHINGRIX vaccine received 2 weeks ago. Also received PREVNAR vaccine 7/2/18 in right deltoid. Site was initial sore, but it improved to baseline. Concerned that severe neck and right arm pain are vaccine reaction.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Lip swelling, Urticaria
Clinical narrative: Mother stated that patient developed swollen lips and hives on body overnight.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Skin lesion
Clinical narrative: Rash developed on face and back beginning the day after I got the vaccine and continued to worsen. I now have at least two dozen pus-y lesions on my back that look to be chicken pox.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Erythema, Fatigue, Myalgia
Clinical narrative: Arm is swollen, redness that extends down my arm 5 inches and is 2 inches wide. Nausea, diarrhea, muscle pain, chills, very tired, shivering.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling
Clinical narrative: Arm is swollen, redness that extends down my arm 5 inches and is 2 inches wide. Nausea, diarrhea, muscle pain, chills, very tired, shivering.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: She got shingles after receiving vaccine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N020010 and expiration date of 13-JAN-2019, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -14 Celsius degrees to -10 Celsius degrees for 30 minutes. Previous temperature excursion was reported as -14 Celsius degrees to -10 Celsius degrees for 12 hours and 30 minutes. The vaccine was reconstituted with properly stored DILUENT MRK. No adverse effects were reported. No digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA003654: US-009507513-1808USA003653.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX lot # N015475 and expiration date of 18-MAY-2018, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of -14 Celsius degrees to -10 Celsius degrees for 30 minutes. Previous temperature excursion was reported as -14 Celsius degrees to -10 Celsius degrees for 12 hours and 30 minutes. The vaccine was reconstituted with properly stored DILUENT MRK. No adverse effects were reported. No digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA003614: US-009507513-1808USA003653.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006767: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Sex: U
Vaccine: HEPA, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 07-MAY-2018 and 10-JUL-2018, the patient was vaccinated with an improperly stored dose of VAQTA, lot # N026997, expiration date 10-NOV-2018; and ROTATEQ, lot # R002060, expiration date 05-JUN-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 47 to 77 degrees (also reported as "max 55 degrees") Fahrenheit for 30 minutes and above 32 up to 35 degrees Fahrenheit for 16 hours (also reported as "brief intervals of being too cold lasting for 30 minutes each, ranging from 34 to 35.6 degrees Fahrenheit"). Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA009780: US-009507513-1808USA006765: US-009507513-1808USA006766: US-009507513-1808USA006768: US-009507513-1808USA006769: US-009507513-1808USA006770: US-009507513-1808USA006771: US-009507513-1808USA006772: US-009507513-1808USA006773: US-009507513-1808USA006774: US-009507513-1808USA006775: US-009507513-1808USA006776: US-009507513-1808USA006777: US-009507513-1808USA006778.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 69-year-old female patient who received SHINGRIX for prophylaxis.  On 2nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd August 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, pain and fever. On an unknown date, the outcome of the influenza-like symptoms, pain and fever were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on unknown arm. The patient stated the day after she had the 2nd dose of SHINGRIX, she developed flu like symptoms as aches and fever. The patient provided the contact details of physician. This case has been linked with US2018141960, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of red blotches in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 1st dose of SHINGRIX. On 6th August 2018, 3 days after receiving SHINGRIX, the patient experienced red blotches and itchy rash. On an unknown date, the outcome of the red blotches and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the red blotches and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced red, itchy blotches covering her upper left arm. At the time of this report, the red, itchy blotches were better but not completely gone. The patient had denied permission to contact their physician. The reporter did not agree to be followed up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Tenderness, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of red blotches in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 1st dose of SHINGRIX. On 6th August 2018, 3 days after receiving SHINGRIX, the patient experienced red blotches and itchy rash. On an unknown date, the outcome of the red blotches and itchy rash were not recovered/not resolved. It was unknown if the reporter considered the red blotches and itchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. The patient experienced red, itchy blotches covering her upper left arm. At the time of this report, the red, itchy blotches were better but not completely gone. The patient had denied permission to contact their physician. The reporter did not agree to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, White blood cell count increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and white blood cell count increased. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the pain in arm and white blood cell count increased to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The patient was inquired, if SHINGRIX increases white blood cell count. As per patient her white blood cell count had increased, but she was not sure whether SHINGRIX caused it. The patient refrained from providing any further information, and did not want to get involved in reporting the adverse event.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: 4 days after vaccination, pt. had office visit for reported extreme right arm pain unrelieved by OTC analgesics. Eval. showed no redness, swelling, or warmth.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient contacted pharmacy on 8/16/18 reporting a large/raised red spot the size of a half dollar at the injection site from the vaccination received on 8/13/18. Site was warm to the touch. Patient reported no other symptoms. Recommendation was given verbally by the provider, to take oral Benadryl and to use topical Benadryl plus Hydrocortisone. Patient was to see provider if no improvement in 24hrs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Early flu-like symptoms - aching all over and slight fever on and off for two days, starting the morning of the day after the injection; headache the day after the shot.
Age: 78.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Blood pressure increased, Chills, Feeling abnormal, Head banging, Injection site reaction
Clinical narrative: Patient started feeling really bad around 6pm with a fever over 102, headache, and chills. His blood pressure became elevated (170/90). He took some TYLENOL or MOTRIN and the symptoms decreased some. He was still fevered the next day, but felt better towards that evening. He did not go to the doctor. He had a small site reaction with his arm being "a little sore".
Age: 78.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient started feeling really bad around 6pm with a fever over 102, headache, and chills. His blood pressure became elevated (170/90). He took some TYLENOL or MOTRIN and the symptoms decreased some. He was still fevered the next day, but felt better towards that evening. He did not go to the doctor. He had a small site reaction with his arm being "a little sore".
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Pt given vaccine that expired on 7/20/18. Inventory completed and delivered this am and expiration date checked AFTER administration of medication.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given. Exp date: 07/20/18.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain where shot was given. Fever from 99.4 to 101.2 for 24 hours. Headache. Tiredness. Achy.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Muscle, pain,tired, weak, headache, shivering, diarrhea, vomiting, stomach pain.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Vomiting
Clinical narrative: Muscle, pain,tired, weak, headache, shivering, diarrhea, vomiting, stomach pain.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Insomnia, Myalgia
Clinical narrative: After each injection I've experienced difficulty sleeping the first night, body/muscle aches, chills and feeling tired. After the second dose I also had a headache the next day. Side effects were bearable, but more significant than I've experienced before. I think people should be made aware.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: After each injection I've experienced difficulty sleeping the first night, body/muscle aches, chills and feeling tired. After the second dose I also had a headache the next day. Side effects were bearable, but more significant than I've experienced before. I think people should be made aware.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Chills, body aches, fatigue, redness and tenderness around injection site which has been increasing in size. Area hot to touch and pain rated 4/10 that radiates to R shoulder and back.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain
Clinical narrative: Chills, body aches, fatigue, redness and tenderness around injection site which has been increasing in size. Area hot to touch and pain rated 4/10 that radiates to R shoulder and back.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia, Sensation of foreign body
Clinical narrative: Approximately five minutes after 1.0 ml injection into left deltoid, patient complained of feeling like she had something in the back of throat that could not be cleared and a metallic type of taste in her mouth. Patient continued to have these symptoms but was not in any apparent distress. Patient reported at 1320 that the feeling of something in the back of her throat had reduced substantially.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm red swollen and hot 1 week after shot.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Papule, Rash
Clinical narrative: Rash all over under left arm, skin very tender, hurt, reaction occurred the Monday after the shot (shot was given 7/30/18). Pt thought it was mosquito bites, then saw lots of papules on her skin left arm and some on back. Made appointment to see Dr on 8/15/18. Dr diagnosed it was shingles.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: First day after vaccine given, large, but local area of redness and swelling, hot-to-touch and painful to any pressure. No systemic reactions. Second day, minimal swelling, decreased area of very faint redness (2" x 2"), no longer hot-to-touch and less pressure-sensitive. 3rd VARIVAX dose in 6 MOS, because employee did not provide RECs of previous boosters.
Sex: F
Vaccine: HPVX
Symptoms: Infertility female
Clinical narrative: This spontaneous report was received from an unspecified reporter via company representative regarding multiple adult (reported as aged 25-29) female patients of unknown age. Information on pertinent medical conditions and concomitant medications was not reported. On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dosing details and lot # were not reported) for prophylaxis. It was reported that there was a lowered probability of pregnancy in females who received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (female infertility). Outcome of the event was not reported. Causality assessment was not provided.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Impaired driving ability, Influenza like illness, Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report was received from a consumer who is the wife of a 79-year-old male patient. Information on the patient's pertinent medical history included diabetes which was well controlled (diabetes mellitus). The patient's concomitant medications included GLUMETZA, omeprazole and simvastatin. The patient's historical drug included PREVNAR 13. The patient had no known drug reactions/allergies. On 06-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 standard dosage of 0.5 ml (lot # N010105, expiry date was not reported) intramuscular in the left arm for recommended for age group. On 06-AUG-2018, not long after receiving the vaccine, the patient started having inflammation at the site of injection (vaccination site inflammation) and there was a significant pain in the arm of the injection (pain in extremity). Later in the night of the same day, the patient developed a high fever (pyrexia), aching throughout his body, felt like he was getting the flu (influenza like illness), he was shivering (chills) and had poor sleep (poor quality sleep). On an unknown date in August 2018, the patient sought medical attention and received treatment for the events. No lab diagnostics/studies were performed. It was reported that the patient was recovering and was slowly feeling better. On 08-AUG-2018, the patient was not feeling well (malaise) and his arms appeared extremely swollen and red at the area of injection which was 9 inches in length and 4 inches in diameter. On the same day, the patient sought medical attention at an unspecified location and was diagnosed with an infection (vaccination site infection). The patient was prescribed cephalexin as the treatment for the event. At the time of this report, the events of vaccination site infection and malaise was not resolved. Causality assessment was not provided. No product quality complaint was reported. The reporter considered the events; vaccination site inflammation, pain in extremity, pyrexia, influenza like illness, chills and poor-quality sleep to be cause of significant disability or incapacity as he was temporarily incapacitated and could not drive a car. The reporter considered the event pyrexia (also reported as it could be because of the high fever) to be life threatening.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a consumer who is the wife of a 79-year-old male patient. Information on the patient's pertinent medical history included diabetes which was well controlled (diabetes mellitus). The patient's concomitant medications included GLUMETZA, omeprazole and simvastatin. The patient's historical drug included PREVNAR 13. The patient had no known drug reactions/allergies. On 06-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 standard dosage of 0.5 ml (lot # N010105, expiry date was not reported) intramuscular in the left arm for recommended for age group. On 06-AUG-2018, not long after receiving the vaccine, the patient started having inflammation at the site of injection (vaccination site inflammation) and there was a significant pain in the arm of the injection (pain in extremity). Later in the night of the same day, the patient developed a high fever (pyrexia), aching throughout his body, felt like he was getting the flu (influenza like illness), he was shivering (chills) and had poor sleep (poor quality sleep). On an unknown date in August 2018, the patient sought medical attention and received treatment for the events. No lab diagnostics/studies were performed. It was reported that the patient was recovering and was slowly feeling better. On 08-AUG-2018, the patient was not feeling well (malaise) and his arms appeared extremely swollen and red at the area of injection which was 9 inches in length and 4 inches in diameter. On the same day, the patient sought medical attention at an unspecified location and was diagnosed with an infection (vaccination site infection). The patient was prescribed cephalexin as the treatment for the event. At the time of this report, the events of vaccination site infection and malaise was not resolved. Causality assessment was not provided. No product quality complaint was reported. The reporter considered the events; vaccination site inflammation, pain in extremity, pyrexia, influenza like illness, chills and poor-quality sleep to be cause of significant disability or incapacity as he was temporarily incapacitated and could not drive a car. The reporter considered the event pyrexia (also reported as it could be because of the high fever) to be life threatening.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Poor quality sleep, Pyrexia, Vaccination site infection
Clinical narrative: This spontaneous report was received from a consumer who is the wife of a 79-year-old male patient. Information on the patient's pertinent medical history included diabetes which was well controlled (diabetes mellitus). The patient's concomitant medications included GLUMETZA, omeprazole and simvastatin. The patient's historical drug included PREVNAR 13. The patient had no known drug reactions/allergies. On 06-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 standard dosage of 0.5 ml (lot # N010105, expiry date was not reported) intramuscular in the left arm for recommended for age group. On 06-AUG-2018, not long after receiving the vaccine, the patient started having inflammation at the site of injection (vaccination site inflammation) and there was a significant pain in the arm of the injection (pain in extremity). Later in the night of the same day, the patient developed a high fever (pyrexia), aching throughout his body, felt like he was getting the flu (influenza like illness), he was shivering (chills) and had poor sleep (poor quality sleep). On an unknown date in August 2018, the patient sought medical attention and received treatment for the events. No lab diagnostics/studies were performed. It was reported that the patient was recovering and was slowly feeling better. On 08-AUG-2018, the patient was not feeling well (malaise) and his arms appeared extremely swollen and red at the area of injection which was 9 inches in length and 4 inches in diameter. On the same day, the patient sought medical attention at an unspecified location and was diagnosed with an infection (vaccination site infection). The patient was prescribed cephalexin as the treatment for the event. At the time of this report, the events of vaccination site infection and malaise was not resolved. Causality assessment was not provided. No product quality complaint was reported. The reporter considered the events; vaccination site inflammation, pain in extremity, pyrexia, influenza like illness, chills and poor-quality sleep to be cause of significant disability or incapacity as he was temporarily incapacitated and could not drive a car. The reporter considered the event pyrexia (also reported as it could be because of the high fever) to be life threatening.
Age: 1.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assitant, and refers to a 1 year old infant of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 13-AUG-2018, the patient was vaccinated with an expired VARIVAX lot # M035688 with expiration date on 10-AUG-2018, subcutaneous for prophylaxis (dose was not reported) with MERCK STERILE DILUENT. However, the patient did not experienced any adverse event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA006876.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 3rd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 4th August 2018, 1 days after receiving SHINGRIX, the patient experienced pain, diarrhea, fever and influenza-like symptoms. On an unknown date, the outcome of the pain, diarrhea and fever were recovered/resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the pain, diarrhea, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter was the wife of the patient. Her husband was vaccinated the day after she was. He had the same symptoms (flu like symptoms, aches and fever) as she but also had diarrhea. This case has been linked with US2018141957, reported by the same reporter.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Pain, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 50-year-old male patient who received SHINGRIX (batch number ZG47A, expiry date 21st February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 31st July 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, 2 days after receiving SHINGRIX and less than a year after receiving SHINGRIX, the patient experienced tiredness, pruritus, erythema and feeling hot. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the tiredness, pruritus, erythema, pain and feeling hot were unknown. It was unknown if the reporter considered the tiredness, pruritus, erythema, pain and feeling hot to be related to SHINGRIX. Additional details were provided as follow: On 29th May 2018, the patient received 1st dose of SHINGRIX (batch numbe LT533, expiration date 11th October 2020) intramuscularly and the patient experienced tiredness and soreness, refer linked case US2018GSK147923. The healthcare professional (HCP) stated that, on day 2 after receiving SHINGRIX the patient felt tired and felt like his whole body was hot. On day 3 after receiving SHINGRIX, the patient felt hot and experienced redness. On day 4 after receiving SHINGRIX, the patient was worse, he felt hot, experienced redness, felt sore and was itchy. He said if felt like a bee sting. The HCP instructed the patient to contact his doctor.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersensitivity, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 16th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, injection site erythema, injection site swelling and rash. On an unknown date, the patient experienced injection site itching, injection site pain, influenza-like symptoms, shivering, fever, muscle pain and sickness. The patient was treated with benadryl (nos) (Benadryl), analgesic, nos (Pain Medication) and naproxen (Aleve). On an unknown date, the outcome of the allergic reaction, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, shivering, fever, muscle pain and sickness were unknown and the outcome of the injection site erythema was recovered/resolved.  It was unknown if the reporter considered the allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, shivering, fever, muscle pain and sickness to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on the left arm. The patient stated that she felt like she had flu. The patient stated that she was sick as a dog. The rash that appeared spreaded over the vaccination site and down in an oval shape, about the size of a hand. The patient also experienced shivering and elevated body temperature (low grade fever). On 22nd April 2018, 6 days after the vaccination, pictures were taken of the injection site that still showed redness and soreness. The patient took some pain medicine and some Benedryl to combat an allergy against the vaccine. She took Benadryl for the itching and aleve for the other issues. The patient also stated that she experienced the same adverse events with the 2nd dose (refer case US2018GSK141453), but the events were worse for the 1st dose.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 16th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, injection site erythema, injection site swelling and rash. On an unknown date, the patient experienced injection site itching, injection site pain, influenza-like symptoms, shivering, fever, muscle pain and sickness. The patient was treated with benadryl (nos) (Benadryl), analgesic, nos (Pain Medication) and naproxen (Aleve). On an unknown date, the outcome of the allergic reaction, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, shivering, fever, muscle pain and sickness were unknown and the outcome of the injection site erythema was recovered/resolved.  It was unknown if the reporter considered the allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, shivering, fever, muscle pain and sickness to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on the left arm. The patient stated that she felt like she had flu. The patient stated that she was sick as a dog. The rash that appeared spreaded over the vaccination site and down in an oval shape, about the size of a hand. The patient also experienced shivering and elevated body temperature (low grade fever). On 22nd April 2018, 6 days after the vaccination, pictures were taken of the injection site that still showed redness and soreness. The patient took some pain medicine and some Benedryl to combat an allergy against the vaccine. She took Benadryl for the itching and aleve for the other issues. The patient also stated that she experienced the same adverse events with the 2nd dose (refer case US2018GSK141453), but the events were worse for the 1st dose.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 16th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced allergic reaction, injection site erythema, injection site swelling and rash. On an unknown date, the patient experienced injection site itching, injection site pain, influenza-like symptoms, shivering, fever, muscle pain and sickness. The patient was treated with benadryl (nos) (Benadryl), analgesic, nos (Pain Medication) and naproxen (Aleve). On an unknown date, the outcome of the allergic reaction, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, shivering, fever, muscle pain and sickness were unknown and the outcome of the injection site erythema was recovered/resolved.  It was unknown if the reporter considered the allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, shivering, fever, muscle pain and sickness to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on the left arm. The patient stated that she felt like she had flu. The patient stated that she was sick as a dog. The rash that appeared spreaded over the vaccination site and down in an oval shape, about the size of a hand. The patient also experienced shivering and elevated body temperature (low grade fever). On 22nd April 2018, 6 days after the vaccination, pictures were taken of the injection site that still showed redness and soreness. The patient took some pain medicine and some Benedryl to combat an allergy against the vaccine. She took Benadryl for the itching and aleve for the other issues. The patient also stated that she experienced the same adverse events with the 2nd dose (refer case US2018GSK141453), but the events were worse for the 1st dose.
Age: 80.0
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 80-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 14th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that the patient developed a small red circle at the injection site after receiving SHINGRIX. It was reported that the area resembled a small ringworm which appeared after receiving injection and had remained for one and a half month. No further information was reported regarding the event.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional information was reported as follows: The batch number and expiry date for SHINGRIX was not reported. The age at vaccination was not reported. The patient received his dose of SHINGRIX on an unspecified date and stated that it hurt so badly that he did not want to receive the second dose of SHINGRIX. No additional information was provided. This information has not been reported to the food and drug administration (FDA).
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypotension
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of light-headed feeling in a female patient who received SHINGRIX for prophylaxis. On 4th April 2018, the patient received SHINGRIX. On 5th April 2018, 1 days after receiving SHINGRIX, the patient experienced light-headed feeling and low blood pressure. The patient was treated with intravenous fluid (nos) (Intravenous Fluid). On an unknown date, the outcome of the light-headed feeling and low blood pressure were unknown. The reporter considered the light-headed feeling and low blood pressure to be related to SHINGRIX. Additional information was reported as follows: This case was received via Merck National Service Center. On 4th April 2018, the patient was vaccinated with a unspecified dose of SHINGRIX.  The batch number and expiry date of vaccine were unknown. On 5th April 2018, the patient felt light headed, and her blood pressure was measured to be very low. The patient reported calling her healthcare provider, who told her to eat chicken broth. The patient still felt light headed and called an ambulance. The patient received intravenous fluids and her healtcare care provider stated that it was a reaction to the vaccine. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Gait inability, Impaired work ability, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia of lower extremities in a male patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced myalgia of lower extremities, unable to walk and impaired work ability. On an unknown date, the outcome of the myalgia of lower extremities, unable to walk and impaired work ability were unknown. The reporter considered the myalgia of lower extremities, unable to walk and impaired work ability to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The 2nd dose of SHINGRIX was received 2 months following the first dose. The reporter said the patient did not have a reaction to first dose but after second dose the patient had severe muscle aches in both thighs of their legs. The pain was so severe that the patient could not walk for a couple of days and had to take time away from work. The doctor did think the reaction was from the second SHINGRIX injection.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a adult male patient who received SHINGRIX (batch number LT533, expiry date 10th November 2020) for prophylaxis. On 29th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were unknown. It was unknown if the reporter considered the tiredness and pain to be related to SHINGRIX. Additional details were provided as follow: The patient did not share when symptoms started after the 1st dose of SHINGRIX or when or if they resolved. The healthcare professional instructed the patient to contact his doctor. This case was linked with US2018141969, reported for same patient for 2nd dose of SHINGRIX.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness left Deltoid, warmth left Deltoid, pain left deltoid.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Rash red, fever, legs.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning an unknown number of patients of unknown age and gender. There was no information about the patients concurrent conditions, medical history or concomitant medication. On an unknown date the patients received PROQUAD and VARIVAX following a temperature excursion (indication and doses were not reported). Temperature variables reported: 6F to 14F(-14C to -10C) (6F) for 96 hours. Previous temperature excursion 6F to 14F (-14C to-10C) (6F) for another 96 hours. No adverse effects were reported in any patients. No other information is available. This case was considered to be non-valid due to the lack of patients identifiers.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-FEB-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine adult health maintenance and for the long-term prevention of shingles and zoster related injuries and diseases. The ZOSTAVAX did not prevent shingles and zoster-related injuries as intended. On or about 30-SEP-2015, the patient was treated by a physician and was diagnosed with herpes zoster ophthalmicus in the right eye. The patient was prescribed VALTREX and TYLENOL for management of her painful symptoms and chronic pain. On or about 04-DEC-2015, the patient, the patient sought subsequent treatment from a physician assistant for the onset of a rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed lidocaine and other pain medications for management of her painful symptoms and chronic pain, including but not limited to severe headaches related to her zoster related eye injuries. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the lifetime prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, herpes zoster ophthalmicus in the right eye was determined to be medically significant. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assitant, and refers to a 1 year old infant of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 13-AUG-2018, the patient was vaccinated with an expired VARIVAX lot # M035688 with expiration date on 10-AUG-2018, subcutaneous for prophylaxis  (dose was not reported) with MERCK STERILE DILUENT. However, the patient did not experienced any adverse event. This is one of two reports received from the same reporter. Sender's Comments:  US-009507512-1808USA006339.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eating disorder, Feeling abnormal, Hypersensitivity, Influenza like illness
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of hypersensitivity (and other events after receiving 1st dose on 16th April 2018, refer case US2018143007). On 31st July 2018, the patient received the 2nd dose of SHINGRIX. On 4th August 2018, 4 days after receiving SHINGRIX, the patient experienced mouth ulcer, sore mouth and eating disorder. On an unknown date, the patient experienced allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, shivering and fever. The patient was treated with BENADRYL and ALEVE. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the allergic reaction, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever were recovering/resolving and the outcome of the injection site erythema and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, injection site erythema, injection site swelling, injection site itching, injection site pain, influenza-like symptoms, rash, muscle pain, movement disorder, feels awful, mouth ulcer, sore mouth, eating disorder, shivering and fever to be related to SHINGRIX. Additional information was reported as follows: The patient received vaccine on the right arm. The patient experienced similar adverse events with the 2nd dose as that after receiving the 1st dose, with some additional events. The patient stated that she could hardly move, felt terrible, hard to even get out of her bed. The patient experienced ulcers in the mouth, where one was at the roof and the other at the back behind the molars. The patient also stated that it was difficult for her to eat with the ulcers. The patient experienced itchiness after vaccination with both the doses. The patient took BENADRYL for itching and for the other events she took ALEVE. At the time of reporting, the patient stated that the events were better but not completely resolved. The patient also stated that, the patient had redness and swelling at the injection site 6 days after the shot.