chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown demographics. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot number M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # M042599) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, expiry date and route of administration were not reported) (lot # M042599) for prophylaxis. The PNEUMOVAX 23)was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Pt's arm became red after injection. One hive appeared shortly after. PT was given BENADRYL and stayed at office for observation for 30 minutes. Pt developed scattered hives the next day. All resolved.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysstasia, Fatigue, Influenza like illness, Malaise, Myalgia
Clinical narrative: Went to bed early (about 7:30 pm) following 5:30 pm vaccination, feeling fatigued and "light" general malaise flu-like symptoms, not at all severe. Woke up at 10:30 pm with severe, almost spasmodic, full-body shakes... like tonic/clonic contractions in jaw, arms, core, legs. Tried to get out of bed, but afraid of falling as I could not stand up. Did not attempt taking my temperature at this time with oral thermometer because it's glass and I was afraid I would chomp on it and break it. Fever seemed to start at about 30 minutes of shaking. Shakes continued for one hour, tapering off last 15 minutes and subsiding at about the one hour mark, at which time I took my temperature and registered 102 F. The fever "broke" four hours later. After that, I slept well, and woke easily but felt very muscle sore all over (my descriptive: like I'd been worked over with a bat). General soreness and fatigue gradually went away over a three-day period. No other lingering effects noted. While shaking was severe enough I debated about going to the ER, in my rural setting this is not a simple 911 call: and the initial contractions did not worsen throughout the episode; so I "rode it out." My breathing was at all times normal. I have no idea what my blood pressure was.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Went to bed early (about 7:30 pm) following 5:30 pm vaccination, feeling fatigued and "light" general malaise flu-like symptoms, not at all severe. Woke up at 10:30 pm with severe, almost spasmodic, full-body shakes... like tonic/clonic contractions in jaw, arms, core, legs. Tried to get out of bed, but afraid of falling as I could not stand up. Did not attempt taking my temperature at this time with oral thermometer because it's glass and I was afraid I would chomp on it and break it. Fever seemed to start at about 30 minutes of shaking. Shakes continued for one hour, tapering off last 15 minutes and subsiding at about the one hour mark, at which time I took my temperature and registered 102 F. The fever "broke" four hours later. After that, I slept well, and woke easily but felt very muscle sore all over (my descriptive: like I'd been worked over with a bat). General soreness and fatigue gradually went away over a three-day period. No other lingering effects noted. While shaking was severe enough I debated about going to the ER, in my rural setting this is not a simple 911 call: and the initial contractions did not worsen throughout the episode; so I "rode it out." My breathing was at all times normal. I have no idea what my blood pressure was.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient developed a rash 6 days after her vaccine was administered.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin exfoliation
Clinical narrative: Pt said that the week after he got the shot the skin on his face slowly started to peel off and he got red spots on his face. I advised pt to be seen by MD to determine if was from the vaccine or other causes.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Bacterial test negative, Diarrhoea, Injection site erythema
Clinical narrative: Large redness area around the injection site. Diarrhea lasting several days.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Electrocardiogram normal, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Severe left arm pain. Patient went to urgent care transferred to ED d/t severity of pain (10/10) and it radiating into left chest. (EKG normal) Patient was unable to make a fist or raise arm. It has improved the next day.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 6 months old infant patient of unknown gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The patient did not have any brothers and sisters. On 13-APR-2018 (reported as today), the patient was in the office and was vaccinated with M-M-R II injection (strength and dose were not reported) (lot number N013296 and expiry date was not reported) (dose 1) subcutaneous in the left thigh for prophylaxis. The vaccine M-M-R II was reconstituted with sterile diluent injection (manufacturer unknown) (lot number and expiry date were not reported). The reason M-M-R II being given early because the family would be travelling internationally (drug administered to patient of inappropriate age). The reporter informed that the patient would also receive ROTATEQ today (13-APR-2018). However, due to lack of information regarding concomitant administration of ROTATEQ with M-M-R II, the provider and parents chose to wait 4 weeks to give ROTATEQ vaccine. On an unknown date, the patient was also vaccinated with PENTACEL (strength and dose were not reported) (lot number C5454AA and expiry date was not reported) (dose 3) intramuscularly in the right thigh, ENGERIX-B (strength and dose were not reported) (lot number L594L and expiry date was not reported) (dose 3) intramuscularly in the right thigh, and PREVENAR 13 (strength and dose were not reported) (lot number T62563 and expiry date was not reported) (dose 3) intramuscularly in the left thigh for prophylaxis. No adverse effects were reported with the given dose of M-M-R II. No further information was available. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: PPV
Symptoms: Adverse event following immunisation
Clinical narrative: This spontaneous report was received from the patient's husband referring to his wife, a female patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The patient's husband stated that the patient reported having unspecified adverse effects (adverse event) after receiving the PNEUMOVAX 23. At the reporting time, the outcome of adverse event was not reported. The reporter did not assess the causality between the adverse event and PNEUMOVAX 23.
Age: 1.08
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given PROQUAD subcutaneous injection to right thigh as well as varicella vaccine. No adverse reactions occurred, follow up phone call made to family within 1 hour, no symptoms reported. Will follow up with patient within 24-48 hours.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache, Fatigue, Pain in upper arm.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Eczema, Nasopharyngitis
Clinical narrative: 3 to 5 days after this shot she began to develop Eczema on her arms and legs. Began to have cold like symptoms as well that last 5 days.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Viral infection
Clinical narrative: 3 to 5 days after this shot she began to develop Eczema on her arms and legs. Began to have cold like symptoms as well that last 5 days.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Eczema, Nasopharyngitis
Clinical narrative: Onset of another viral infection. This is the second PENTACEL shot in a row she has gotten a viral infection.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Viral infection
Clinical narrative: Onset of another viral infection. This is the second PENTACEL shot in a row she has gotten a viral infection.
Age: 31.0
Sex: M
Vaccine: YF
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Local red raised reaction. Compresses and BENADRYL for treatment.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Lymphadenopathy
Clinical narrative: Redness at injection site and redness throughout upper arm, shivering, and swollen lymph node (armpit).
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Acne, Pyrexia, Somnolence, Vomiting
Clinical narrative: Fever. Sleeping more than normal. Acne all over body. Vomiting.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Epistaxis, Fatigue, Gait disturbance, Headache
Clinical narrative: Patient presented with flu-like symptoms, nausea, and a headache the day after the vaccine. After 48 hours the patient had difficulty walking due to severe pain in her legs, also felt fatigued, achy, lost appetite and stated that she lost consciousness just before starting her car. On 5/04/2018 the patient stated that a Scarlett red rash developed at the site of the injection. The 6-7 inch wide rash ran horizontal across her arm and was warm to the touch. The patient didn't go to the hospital and didn't tell us about the adverse event until 05/10/2018. The patient came into the pharmacy the day after the vaccination with flu-like symptoms and we told the patient that was a normal side effect of the vaccine but then presented with the other adverse effects 48 hours after the vaccine. The patient also stated she had a bad case of the chicken pox at the age of 34.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site reaction, Injection site warmth, Loss of consciousness, Pain
Clinical narrative: Patient presented with flu-like symptoms, nausea, and a headache the day after the vaccine. After 48 hours the patient had difficulty walking due to severe pain in her legs, also felt fatigued, achy, lost appetite and stated that she lost consciousness just before starting her car. On 5/04/2018 the patient stated that a Scarlett red rash developed at the site of the injection. The 6-7 inch wide rash ran horizontal across her arm and was warm to the touch. The patient didn't go to the hospital and didn't tell us about the adverse event until 05/10/2018. The patient came into the pharmacy the day after the vaccination with flu-like symptoms and we told the patient that was a normal side effect of the vaccine but then presented with the other adverse effects 48 hours after the vaccine. The patient also stated she had a bad case of the chicken pox at the age of 34.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Patient presented with flu-like symptoms, nausea, and a headache the day after the vaccine. After 48 hours the patient had difficulty walking due to severe pain in her legs, also felt fatigued, achy, lost appetite and stated that she lost consciousness just before starting her car. On 5/04/2018 the patient stated that a Scarlett red rash developed at the site of the injection. The 6-7 inch wide rash ran horizontal across her arm and was warm to the touch. The patient didn't go to the hospital and didn't tell us about the adverse event until 05/10/2018. The patient came into the pharmacy the day after the vaccination with flu-like symptoms and we told the patient that was a normal side effect of the vaccine but then presented with the other adverse effects 48 hours after the vaccine. The patient also stated she had a bad case of the chicken pox at the age of 34.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Eczema, Pruritus, Rash
Clinical narrative: Widespread eczema rash started 3 days after the vaccination. Still bothers patient with itching and rash at 6 weeks. Treated with prednisone and topical steroid ointment.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Dyspnoea, Pain, Tremor
Clinical narrative: Patient experienced SOB, shooting lower back pain, and shaking within minutes of the injection.  Patient Symptoms lasted 15 minutes but consistently improved.  Blood pressure was checked 3 times (every 5 minutes): 113/73mmHg, 113/78mmHg and 111/75mmHg. Symptoms resolved completely within 30 minutes and patient left with his daughter.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: SHARP PAIN NEXT DAY IN FINGER, HURT TO PUSH SHOPPING CART, TO PICK UP A PLATE OR A SPOON, SHARP PAIN IN ANKLES FROM TIME TO TIME, ONE TIME IT HURT TO WRITE WITH A PEN,TO TYPE ON A KEYBOARD HAVE PAINS IN  MY BODY TO THIS DAY, FEET HURT ALL THE TIME  DURING NOV AND DEC I NEVER HAD ANY PAIN AT ALL EVER I STILL HAVE PROBLEMS TO THIS DAY!
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Erythema, Mucous stools, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: My son woke up with red hives all over him, fingers were a little swollen. While changing his diaper I noticed that his bowel movement had a little mucus. Took him to the doctor and doctor said it could've been an allergic reaction to food. So he put my son on the BRAT diet. He did not improve. I took him back because he then had a low grade fever and then there was more red spots (face, butt, private area, neck, ears, hands, feet) and he wasn't acting like his self. It took about 5 days for my son to improve. His doctor quarantined us when I took him back the second time. We were given prednisone and was told to keep him on the BRAT diet.
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: My son woke up with red hives all over him, fingers were a little swollen. While changing his diaper I noticed that his bowel movement had a little mucus. Took him to the doctor and doctor said it could've been an allergic reaction to food. So he put my son on the BRAT diet. He did not improve. I took him back because he then had a low grade fever and then there was more red spots (face, butt, private area, neck, ears, hands, feet) and he wasn't acting like his self. It took about 5 days for my son to improve. His doctor quarantined us when I took him back the second time. We were given prednisone and was told to keep him on the BRAT diet.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Malaise, Pain, Pyrexia, Vaccination site swelling
Clinical narrative: She received her tetanus vaccine ((Td) on 8 February of this year and complains that several hours later developed fever/chills, body aches, and malaise that lasted for the next 7-10 days. She also reports swelling at the vaccination site that extended down the back of her upper arm. She denies hives, laryngeal, pulmonary, GI, and CV symptoms. She tolerated her Tdap vaccine and denies prior adverse vaccine reactions.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Patient has a big circle of redness and it was little warm. Patient advised to take TYLENOL and do some cold compression. If it lasts longer have the Dr take a look at it. Patient.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain
Clinical narrative: Patient received SHINGRIX and then later that day she started having a lot of body aches/muscle pains in the legs. She said she was in bed for a couple days because of the pain. Patient stated that she also felt a little flu-like.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness and swelling at injection site, pain and tenderness at injection site, decreased ROM.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Bursitis, Pain in extremity
Clinical narrative: Although a sore arm was to be expected, the patient returned to the pharmacy months later and is still complaining of arm pain. He states that it started after the immunization and that it is in the joint. Although I don't remember the details of this immunization, I did administer it IM but he's complaining of symptoms of bursitis from inappropriate administration of an IM vaccine.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: PATIENT WAS ACCIDENTALLY GIVEN ADULT DOSE INSTEAD OF PEDIATRIC DOSE BUT NO ADVERSE EVENTS WERE REPORTED.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concurrent medical conditions included cholesterol (took medication for that condition), blood pressure abnormal (takes medications for the current condition) and seasonal allergy (takes medications for the current condition). Concomitant products included medication unknown (Other Medications). On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema, injection site discoloration, injection site inflammation and injection site swelling. In April 2018, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved and the outcome of the injection site inflammation was recovered/resolved. The reporter considered the injection site erythema, injection site discoloration and injection site inflammation to be related to SHINGRIX. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The patient experienced redness and swelling at the injection site which lasted for 7 days. The patient then experienced discoloration at the injection site. The batch number for the suspect vaccine SHINGRIX was reported as C5237T, however it was changed to C523T as per latest sales data sheet.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Herpes zoster, Pain, Swelling
Clinical narrative: .This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX. Concurrent medical conditions included eczema and cold sores. On 27th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, pain localized, localized erythema, local swelling and pimples. The patient was treated with VALTREX and antibiotics nos (Antibiotic (drug Name Unknown)). On an unknown date, the outcome of the shingles, pain localized, localized erythema, local swelling and pimples were unknown. It was unknown if the reporter considered the shingles, pain localized, localized erythema, local swelling and pimples to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2018, she developed all the side effects that representative mentioned, she also developed shingles on her middle and ring finger where she had eczema it was very painful, red, swollen, she had what looked like 2 white pimples on each finger that grew, and eventually burst and oozed, she ended up in the followed up with her doctor who confirmed it was shingle, she was put on VALTREX and antibiotic. It was still red to this day but much better. Not sure if anyone else had commented on this, or any other type of reactions such as that.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Wound secretion
Clinical narrative: .This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 51-year-old female patient who received SHINGRIX. Concurrent medical conditions included eczema and cold sores. On 27th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles, pain localized, localized erythema, local swelling and pimples. The patient was treated with VALTREX and antibiotics nos (Antibiotic (drug Name Unknown)). On an unknown date, the outcome of the shingles, pain localized, localized erythema, local swelling and pimples were unknown. It was unknown if the reporter considered the shingles, pain localized, localized erythema, local swelling and pimples to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, in 2018, she developed all the side effects that representative mentioned, she also developed shingles on her middle and ring finger where she had eczema it was very painful, red, swollen, she had what looked like 2 white pimples on each finger that grew, and eventually burst and oozed, she ended up in the followed up with her doctor who confirmed it was shingle, she was put on VALTREX and antibiotic. It was still red to this day but much better. Not sure if anyone else had commented on this, or any other type of reactions such as that.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Child received MCV4 injection at our office at approximately 4:45pm on 5/8/18. Patient observed for 15 minutes after injection and no adverse reactions noted. Per mom's report at 6pm on 5/8/18 minimal redness occurred. On 5/9/18 per mom's report redness on (Lt) anterior thigh had increased. Mom called our office and was offered appointment but she declined and continued to watch at home. BENADRYL given to child at 9:30pm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nasopharyngitis
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of cold symptoms in a 60-year-old female patient who received SHINGRIX. On 3rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold symptoms and muscle pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the cold symptoms and muscle pain were recovered/resolved. The reporter considered the cold symptoms and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in an unknown deltoid. The patient experienced cold like symptoms and muscle aches. The symptoms lasted for approximately about 2 weeks. All questions were asked but the reporter provided limited information. For tolerability after 2nd dose of SHINGRIX, refer case US2018GSK080935.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female 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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient wanted to know how to get rid of the pain from the injection site from the shingles vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nasopharyngitis
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of cold symptoms in a 60-year-old female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 3rd April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX and SHINGRIX, the patient experienced cold symptoms and muscle pain. On an unknown date, the outcome of the cold symptoms and muscle pain were recovered/resolved. The reporter considered the cold symptoms and muscle pain to be related to SHINGRIX. Additional details were provided as follows: For tolerability after receiving 1st dose of SHINGRIX, refer case US2018077610. The patient received SHINGRIX in an unknown deltoid. The patient experienced cold like symptoms and muscle aches. The reporter stated that the symptoms during the 2nd dose were even more intensified. The symptoms lasted for approximately about 2 weeks. All questions were asked but the reporter provided limited information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less  than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported to the reporter's friend from a friend of hers (patient). The patient experienced outbreak of SHINGRIX after vaccination. The event resolved in 3 days after receiving VALTREX. The reporter did not agree to be contacted for follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 61-year-old male patient who received SHINGRIX. On 2nd may 2018 08:30, the patient received the 1st dose of SHINGRIX (subcutaneous). In May 2018, 1 day after receiving SHINGRIX, the patient experienced pain, swelling and erythema. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date the outcome of the pain, swelling and erythema were recovering/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the pain, swelling and erythema to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with SHINGRIX via subcutaneously route, in the skin beneath his left tricep instead of intramuscular route, which led to intramuscular formulation administered by other route.
Age: 1.67
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Left thigh anterior edematous, erythematous, warm to touch, tender. Rx: BENADRYL 12.5mg/5ml every 6 hours as needed. Cephalexin 250mg/5ml: 5ml every 12 hours for 10 days. Patient improved as of 5/10/18.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX. On 26th April 2018, the patient received SHINGRIX. On 27th April 2018, 1 days receiving SHINGRIX, the patient experienced injection site erythema. On 28th April 2018, the patient experienced injection site induration and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site induration and injection site itching were recovering/resolving. The reporter considered the injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site induration and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included vitamins. At 11:00, the patient received SHINGRIX on the left arm. The patient noticed a red spot at the injection site on her left arm the morning following the vaccination. It was the size of fifty cent coin and it increased to the size of a palm the next day and it felt hard to the touch. It was also a little itchy when her clothes brushed against it. It had faded but still felt a little but hard in morning of the reporting day. The patient had denied permission to contact their physician. The patient stated her pharmacist might had already reported the event.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 51-year-old female patient who received SHINGRIX (batch number 79N59, expiry date January 2019). On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 27th April 2018, the patient experienced injection site wheal. The patient was treated with medication unknown, medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the injection site wheal and injection site pain were not recovered/not resolved. The reporter considered the injection site wheal and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient had a lot of concurrent medications (not specified). At 16:30 hours, the patient received SHINGRIX in the left deltoid. The patient had a big red welt at the injection site. The injection site was treated with ice right away. Less than a week after receiving SHINGRIX, the welt at the injection site was painful. At the time of the report, the patient still had the welt.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient states about a day after getting shot she experienced itching under her underarms, in her groin area, and behind her knees. Then hives appeared (not severe). They went away after 3 days. Patient did not take any antihistamine for them.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Papule, Rash vesicular, Skin abrasion, Skin lesion
Clinical narrative: Lesions on lt arm, papule on lt cheeks and rt hip with sm. vesicular component. Excoriations on her abd.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever 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 fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown. The reporter considered the fever and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to check the incidence rates of adverse events and commented that 3 patients who received SHINGRIX did report injection site pain or low grade fever. At the time of call, the health care professional did not have patient or vaccine information. The reporter was unsure if anything was done to treat the symptoms and if the symptoms were resolved, etc. This case has been linked with US2018077568 and US2018GSK082721, reported by the same reporter.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old male patient who received SHINGRIX. On 24th April 2018, the patient received SHINGRIX (intramuscular). In April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injected limb mobility decreased and pain upon movement. In April 2018, the outcome of the injection site and injected limb mobility decreased were recovered/resolved. On an unknown date, the outcome of the pain upon movement was not recovered/not resolved. The reporter considered the injection site pain, injected limb mobility decreased and pain upon movement to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in arm. This case was reported by the patient himself. The patient had some achiness at the site of the injection at the beginning. On the 3rd day, after the injections the patient could not lift his arm at all. At the time of reporting, the patient only experienced achiness if he tries to lift his arm. The reporter said that he and his partner experienced a lot of pain at the injection with this vaccine. This case has been linked with case US2018075817 and US2018075819, reported by same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 71-year-old male patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 26th April 2018, the patient received the 1st dose SHINGRIX (intramuscular) .5 ml. In April 2018, less than a week after receiving SHINGRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. The reporter considered the nausea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter did not know, if any other vaccines had been administered within 4 weeks prior to the SHINGRIX administration. The patient received SHINGRIX on left arm. No other vaccines were administered on 26th April 2018 besides SHINGRIX. The reporter was the dispensing pharmacist and the patient called her early morning on the reporting date and said he had been feeling extremely nauseous since receiving the SHINGRIX. The reporter noticed the symptom of nausea described within the product package insert (PI) and called GlaxoSmithKline to discuss how long the reported symptom would last, because the patient asked her how longer the extreme nausea would last. She did not know the status of the symptom at the time of reporting and described it as unknown. The reporter's call was transferred to the Medical Information (MI) team for further discussion upon request. The reporter gave consent to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a elderly male patient who received SHINGRIX. Concomitant products included Atorvastatin, AMBIEN, clonazepam and LEXAPRO. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired physician who reported for himself. This case was previously reported to a doctor. The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. The patient experienced red and swollen area about 3 inches in diameter on his arm near the injection site which resolved after a few days. The patient was unable to provide full demographics of his personal physician. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK080047.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a elderly male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of injection site swelling (For tolerance to 1st dose, refer case US2018076487). Concomitant products included atorvastatin, AMBIEN, clonazepam and LEXAPRO. In April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were recovered/resolved. The reporter considered the chills, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired physician who reported for himself. This case was previously reported to a doctor. The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. The patient received the 2nd dose of SHINGRIX about 2 weeks ago. The patient experienced fever, chills and aching all over that lasted almost 3 full days. The patient considered to go to the emergency room (ER) as it was so bad but he waited it out. The patient was unable to provide full demographics of his personal physician.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Mobility decreased, Muscle spasms, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2019). Concurrent medical conditions included conditions included diabetes and blood pressure abnormal. Concomitant products included atenolol, Atorvastatin, Aspirin, Metformin, ramipril, glimepiride, and esomeprazole. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 7 days after receiving SHINGRIX, the patient experienced muscle pain, fever, chills, charley horse and tiredness. The patient was treated with (NOS) EXCEDRIN. On an unknown date, the outcome of the muscle pain, fever, chills, charley horse and tiredness were not recovered/not resolved. The reporter considered the muscle pain, fever, chills, charley horse and tiredness to be related to SHINGRIX. Additional details were provided as follows: About a week after his injection, the patient experienced muscle pain, like Charley horses in all of his muscles, feeling really tired, shivering and chills. The patient's body temperature recorded not higher than 100 degree F. The most bothersome were the muscle pain in his thighs, arms and legs. The patient said that he had been in bed and could barely go out of bed or to the bathroom. The patient also said that he had put on new diabetes medicine about the same time ramipril and glimepiride. However, his endocrinologist did not believe these product had anything to do with the symptoms. The reported batch number 324KL does not exists and was updated to 3Z4KL, as per sales data sheet.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2019). Concurrent medical conditions included conditions included diabetes and blood pressure abnormal. Concomitant products included atenolol, Atorvastatin, Aspirin, Metformin, ramipril, glimepiride, and esomeprazole. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 7 days after receiving SHINGRIX, the patient experienced muscle pain, fever, chills, charley horse and tiredness. The patient was treated with (NOS) EXCEDRIN. On an unknown date, the outcome of the muscle pain, fever, chills, charley horse and tiredness were not recovered/not resolved. The reporter considered the muscle pain, fever, chills, charley horse and tiredness to be related to SHINGRIX. Additional details were provided as follows: About a week after his injection, the patient experienced muscle pain, like Charley horses in all of his muscles, feeling really tired, shivering and chills. The patient's body temperature recorded not higher than 100 degree F. The most bothersome were the muscle pain in his thighs, arms and legs. The patient said that he had been in bed and could barely go out of bed or to the bathroom. The patient also said that he had put on new diabetes medicine about the same time ramipril and glimepiride. However, his endocrinologist did not believe these product had anything to do with the symptoms. The reported batch number 324KL does not exists and was updated to 3Z4KL, as per sales data sheet.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Dizziness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date January 2019). Concurrent medical conditions included conditions included diabetes and blood pressure abnormal. Concomitant products included atenolol, Atorvastatin, Aspirin, Metformin, ramipril, glimepiride, and esomeprazole. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, 7 days after receiving SHINGRIX, the patient experienced muscle pain, fever, chills, charley horse and tiredness. The patient was treated with (NOS) EXCEDRIN. On an unknown date, the outcome of the muscle pain, fever, chills, charley horse and tiredness were not recovered/not resolved. The reporter considered the muscle pain, fever, chills, charley horse and tiredness to be related to SHINGRIX. Additional details were provided as follows: About a week after his injection, the patient experienced muscle pain, like Charley horses in all of his muscles, feeling really tired, shivering and chills. The patient's body temperature recorded not higher than 100 degree F. The most bothersome were the muscle pain in his thighs, arms and legs. The patient said that he had been in bed and could barely go out of bed or to the bathroom. The patient also said that he had put on new diabetes medicine about the same time ramipril and glimepiride. However, his endocrinologist did not believe these product had anything to do with the symptoms. The reported batch number 324KL does not exists and was updated to 3Z4KL, as per sales data sheet.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Mobility decreased, Muscle spasms, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX. On 18th April 2018, the patient received SHINGRIX (intramuscular). In April 2018, 7 days after receiving SHINGRIX, the patient experienced fever, dizziness and bedridden. On an unknown date, the outcome of the fever, dizziness and bedridden were unknown. It was unknown if the reporter considered the fever, dizziness and bedridden to be related to SHINGRIX. Additional information was reported as follows: In April 2018, 1 week after vaccination with SHINGRIX the patient experienced reaction like fever, could not get out of bed, dizzy. The healthcare professional had not provided any further information.