chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 55-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue, localized erythema and headache. On an unknown date, the outcome of the fatigue, localized erythema and headache were recovered/resolved. It was unknown if the reporter considered the fatigue, localized erythema and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced redness near the mid humerus area only as well as fatigue and headache which lasted a few days. This case has been linked with case US2018GSK064276 and US2018GSK064287 reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pruritus, Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of urticaria in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 6 days after receiving SHINGRIX, the patient experienced urticaria, pruritus and intramuscular formulation administered by other route. On an unknown date, the outcome of the urticaria and pruritus were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the urticaria and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that he received a dose of SHINGRIX subcutaneously. The patient experienced extreme itching that lasted up to 10 days after receipt of vaccine and also experienced urticaria which started 6 days after receiving vaccine. Both symptoms were resolved at the time of reporting. Other patients might had been given SHINGRIX subcutaneously at his facility, he did say he could get the lot and expiry date of the SHINGRIX he was given, just did not have at the time of the call. This case has been linked with US2018GSK069183 by the same reporter.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On 12th April 2018, less than a month after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. The reporter considered the shingles to be possibly related to SHINGRIX. Additional information was received as follows: The initial report was reported by the physician, however, during the phone call/report, the physician put medical assistant on the phone to provide further details about the event. The reporters had limited information on the pharmacy that administered the vaccine to the patient. The patient received the vaccine 2 weeks ago, physician stated that the patient presented to the office on the day of reporting with shingles. The patient visited emergency room. The reporters did not have lot information. No other information available at the time of the call.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of localized erythema in a 56-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced localized erythema, local swelling and tenderness. On an unknown date, the outcome of the localized erythema, local swelling and tenderness were recovered/resolved. It was unknown if the reporter considered the localized erythema, local swelling and tenderness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid and by next day had redness and swelling near the elbow only with tenderness that was lasted for 3-5 days. This case has been linked with case US2018GSK064276 and US2018GSK064280, reported by same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a elderly female patient who received SHINGRIX. On 12th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th April 2018, 1 days after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown deltoid. The Registered Pharmacist reported that the patient was in her 70's. The patient experienced achiness. Only partial information was provided by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a 57-year-old male patient who received SHINGRIX. On 29th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. The reporter considered the rash to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 56 years or 57 years. The patient received SHINGRIX in unknown deltoid. In 2018, the patient experienced rash described as non-itchy, relatively mild, and non-disseminated. The rash resolved within 24 hours of presentation. This case has been linked with US2018064601, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, several hours after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, night sweat and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, fever and night sweat were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, night sweat and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the first injection around 4 PM and by midnight that night experienced flu like symptoms that included fever of 101.5 degree F and night sweats that lasted for just over 48 hours. The patient experienced sore arm as well and that this had not resolved. The caller reports that he did notify his physician. The caller declined to provide further details for the report and ended the call. The caller noted that he preferred to keep his information private and requests no correspondence relating to this report. The patient had denied permission to contact their physician.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Chills, Dehydration, Dizziness, Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received at the age of 65 year without adverse events), Flu vaccine with an associated reaction of pain in extremity and Pneumonia Vaccine with an associated reaction of pain in extremity (experienced arm soreness after receiving Flu vaccine and Pneumonia vaccine, refer case US2018GSK070403). Concomitant products included Atorvastatin, Baby Aspirin, Calcium D, CLARITIN, FLONASE, Losartan, omeprazole, SINGULAIR, ZANTAC, Tumeric. On 12th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 7 hrs after receiving SHINGRIX, the patient experienced sickened, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the sickness, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, leg cramps, abnormal dreams, fear, dizziness and fever were recovered/resolved and the outcome of the sweating and exhaustion were not recovered/not resolved and the outcome of the headache and neck pain were recovering/resolving. The reporter considered the sickness, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, abnormal dreams, dizziness and fever to be related to SHINGRIX. The reporter considered the leg cramps and fear to be unlikely related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. On 12th April 2018 at 16:00, the patient received SHINGRIX in the left arm. The patient did not have lot and expiration date of vaccine, the dose or how given other than it was an injection. By 23:00, 7 hours after receiving SHINGRIX, the patient was sick. Less than a day after receiving SHINGRIX, the patient experienced sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was waking up having to go to the bathroom with urgency. The patient slept till 12:00 on the day of reporting (13th April 2018) and she was so exhausted. The patient took TYLENOL for the headache and neck pain. The patient was scared of what she was experiencing because she lived alone. Most of the issues from last evening have resolved with just a few lingering symptoms but improvement of the headache and neck ache after TYLENOL was taken. The patient described the hallucination dreams as recurring dreams throughout the night of the same thing. She had been hydrating with juice and teas. The patient was encouraged to discuss the events with her physician. The prescribing information was reviewed for the common side effects reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fear, Headache, Hyperhidrosis, Malaise, Micturition urgency
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received at the age of 65 year without adverse events), Flu vaccine with an associated reaction of pain in extremity and Pneumonia Vaccine with an associated reaction of pain in extremity (experienced arm soreness after receiving Flu vaccine and Pneumonia vaccine, refer case US2018GSK070403). Concomitant products included Atorvastatin, Baby Aspirin, Calcium D, CLARITIN, FLONASE, Losartan, omeprazole, SINGULAIR, ZANTAC, Tumeric. On 12th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 7 hrs after receiving SHINGRIX, the patient experienced sickened, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the sickness, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, leg cramps, abnormal dreams, fear, dizziness and fever were recovered/resolved and the outcome of the sweating and exhaustion were not recovered/not resolved and the outcome of the headache and neck pain were recovering/resolving. The reporter considered the sickness, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, abnormal dreams, dizziness and fever to be related to SHINGRIX. The reporter considered the leg cramps and fear to be unlikely related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. On 12th April 2018 at 16:00, the patient received SHINGRIX in the left arm. The patient did not have lot and expiration date of vaccine, the dose or how given other than it was an injection. By 23:00, 7 hours after receiving SHINGRIX, the patient was sick. Less than a day after receiving SHINGRIX, the patient experienced sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was waking up having to go to the bathroom with urgency. The patient slept till 12:00 on the day of reporting (13th April 2018) and she was so exhausted. The patient took TYLENOL for the headache and neck pain. The patient was scared of what she was experiencing because she lived alone. Most of the issues from last evening have resolved with just a few lingering symptoms but improvement of the headache and neck ache after TYLENOL was taken. The patient described the hallucination dreams as recurring dreams throughout the night of the same thing. She had been hydrating with juice and teas. The patient was encouraged to discuss the events with her physician. The prescribing information was reviewed for the common side effects reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Nausea, Neck pain, Pain in extremity, Pollakiuria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received at the age of 65 year without adverse events), Flu vaccine with an associated reaction of pain in extremity and Pneumonia Vaccine with an associated reaction of pain in extremity (experienced arm soreness after receiving Flu vaccine and Pneumonia vaccine, refer case US2018GSK070403). Concomitant products included Atorvastatin, Baby Aspirin, Calcium D, CLARITIN, FLONASE, Losartan, omeprazole, SINGULAIR, ZANTAC, Tumeric. On 12th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 7 hrs after receiving SHINGRIX, the patient experienced sickened, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the sickness, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, leg cramps, abnormal dreams, fear, dizziness and fever were recovered/resolved and the outcome of the sweating and exhaustion were not recovered/not resolved and the outcome of the headache and neck pain were recovering/resolving. The reporter considered the sickness, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, abnormal dreams, dizziness and fever to be related to SHINGRIX. The reporter considered the leg cramps and fear to be unlikely related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. On 12th April 2018 at 16:00, the patient received SHINGRIX in the left arm. The patient did not have lot and expiration date of vaccine, the dose or how given other than it was an injection. By 23:00, 7 hours after receiving SHINGRIX, the patient was sick. Less than a day after receiving SHINGRIX, the patient experienced sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was waking up having to go to the bathroom with urgency. The patient slept till 12:00 on the day of reporting (13th April 2018) and she was so exhausted. The patient took TYLENOL for the headache and neck pain. The patient was scared of what she was experiencing because she lived alone. Most of the issues from last evening have resolved with just a few lingering symptoms but improvement of the headache and neck ache after TYLENOL was taken. The patient described the hallucination dreams as recurring dreams throughout the night of the same thing. She had been hydrating with juice and teas. The patient was encouraged to discuss the events with her physician. The prescribing information was reviewed for the common side effects reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old female patient who received SHINGRIX. Previously administered products included ZOSTAVAX (received at the age of 65 year without adverse events), Flu vaccine with an associated reaction of pain in extremity and Pneumonia Vaccine with an associated reaction of pain in extremity (experienced arm soreness after receiving Flu vaccine and Pneumonia vaccine, refer case US2018GSK070403). Concomitant products included Atorvastatin, Baby Aspirin, Calcium D, CLARITIN, FLONASE, Losartan, omeprazole, SINGULAIR, ZANTAC, Tumeric. On 12th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 7 hrs after receiving SHINGRIX, the patient experienced sickened, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the sickness, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, leg cramps, abnormal dreams, fear, dizziness and fever were recovered/resolved and the outcome of the sweating and exhaustion were not recovered/not resolved and the outcome of the headache and neck pain were recovering/resolving. The reporter considered the sickness, sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, abnormal dreams, dizziness and fever to be related to SHINGRIX. The reporter considered the leg cramps and fear to be unlikely related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. On 12th April 2018 at 16:00, the patient received SHINGRIX in the left arm. The patient did not have lot and expiration date of vaccine, the dose or how given other than it was an injection. By 23:00, 7 hours after receiving SHINGRIX, the patient was sick. Less than a day after receiving SHINGRIX, the patient experienced sweating, shivers, nausea, increased urinary frequency, urinary urgency, dehydration, exhaustion, headache, neck pain, leg cramps, abnormal dreams, fear, dizziness and fever. The patient was waking up having to go to the bathroom with urgency. The patient slept till 12:00 on the day of reporting (13th April 2018) and she was so exhausted. The patient took TYLENOL for the headache and neck pain. The patient was scared of what she was experiencing because she lived alone. Most of the issues from last evening have resolved with just a few lingering symptoms but improvement of the headache and neck ache after TYLENOL was taken. The patient described the hallucination dreams as recurring dreams throughout the night of the same thing. She had been hydrating with juice and teas. The patient was encouraged to discuss the events with her physician. The prescribing information was reviewed for the common side effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site inflammation, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site infection in a adult female patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site infection, injection site erythema, injection site inflammation and vaccine administered at inappropriate site. The patient was treated with KEFLEX. On an unknown date, the outcome of the injection site infection, injection site erythema, injection site inflammation and vaccine administered at inappropriate site were unknown. The reporter considered the injection site infection, injection site erythema and the injection site inflammation to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown arm. The healthcare professional reported that a dose of SHINGRIX was administered to the patient possibly slightly below the deltoid muscle, which led to vaccine administered to inappropriate site. Within 1 to 2 days, the injection site appeared red and inflamed. The patient saw her physician and was diagnosed with a skin infection and KEFLEX was prescribed. The healthcare professional was not at the pharmacy at time of report and was unable to provide any further information. The patient required emergency room visit.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient experience Bell's Palsy like symptoms on face 3 weeks after receiving SHINGRIX vaccination.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Electrocardiogram normal, Haematocrit decreased, Pregnancy test negative, Presyncope
Clinical narrative: Dizziness, lightheaded, near syncope, low grade fever Given IV Fluids.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Urine analysis normal, White blood cell count increased
Clinical narrative: Dizziness, lightheaded, near syncope, low grade fever Given IV Fluids.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Crying, Dizziness, Drug administered to patient of inappropriate age, Dry eye
Clinical narrative: Hello, I'm 31 years old. I would like to report some side effects that are not listed anywhere yet and I believe that people should know what to expect in case they decide to have this vaccine administered. Please pay close attention to what happened on the 3rd day. SHINGRIX->Date of administration: 04/20/18 Location of the pharmacy where the shot was administered: Pharmacy. My doctor recommended this vaccine because I had several shingles outbursts during a 1 year period. Side effects: 1st Day: Didn't sleep throughout the whole night, tossing and turning, unable to rest on my left side at all 2nd day: Very painful, injection site swollen, sore and red. On a scale from 1 to 10, it was 9. I woke up crying because of the pain. Joint pain overall tiredness dizziness lethargy sleepiness symptoms started to alleviate after I took 400mg of ibuprofens x2 times I drank more than 3 quarts of liquids (water and herbal tea). I went to sleep at 00:30AM 3rd day I woke up at 10:00 AM unable to open my left eye, it felt very dry, no discharge of any kind. I washed my face with cold water, warm water, wiped my eye with a special eyelid wipe. I put eye drops. My eye didn't open until 40 minutes later. I put a cold ice pack on it, later I put a warm one which seemed to do its job. I was able to open my eyes although both of them felt dry, but the left one significantly dryer. I managed to keep them open until 2:30 pm when I decided to lay outside because I felt the pain that I had in the morning it's coming back. I slept for 1.5h and I felt better when I woke up. My eyes are still sensitive, especially the left one. 4th day-> I slept all night, the side effects are almost gone, the injection site is still red and sore, but otherwise I am able to do my daily activities.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Eyelid function disorder, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Hello, I'm 31 years old. I would like to report some side effects that are not listed anywhere yet and I believe that people should know what to expect in case they decide to have this vaccine administered. Please pay close attention to what happened on the 3rd day. SHINGRIX->Date of administration: 04/20/18 Location of the pharmacy where the shot was administered: Pharmacy. My doctor recommended this vaccine because I had several shingles outbursts during a 1 year period. Side effects: 1st Day: Didn't sleep throughout the whole night, tossing and turning, unable to rest on my left side at all 2nd day: Very painful, injection site swollen, sore and red. On a scale from 1 to 10, it was 9. I woke up crying because of the pain. Joint pain overall tiredness dizziness lethargy sleepiness symptoms started to alleviate after I took 400mg of ibuprofens x2 times I drank more than 3 quarts of liquids (water and herbal tea). I went to sleep at 00:30AM 3rd day I woke up at 10:00 AM unable to open my left eye, it felt very dry, no discharge of any kind. I washed my face with cold water, warm water, wiped my eye with a special eyelid wipe. I put eye drops. My eye didn't open until 40 minutes later. I put a cold ice pack on it, later I put a warm one which seemed to do its job. I was able to open my eyes although both of them felt dry, but the left one significantly dryer. I managed to keep them open until 2:30 pm when I decided to lay outside because I felt the pain that I had in the morning it's coming back. I slept for 1.5h and I felt better when I woke up. My eyes are still sensitive, especially the left one. 4th day-> I slept all night, the side effects are almost gone, the injection site is still red and sore, but otherwise I am able to do my daily activities.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Insomnia, Lethargy, Pain, Restlessness
Clinical narrative: Hello, I'm 31 years old. I would like to report some side effects that are not listed anywhere yet and I believe that people should know what to expect in case they decide to have this vaccine administered. Please pay close attention to what happened on the 3rd day. SHINGRIX->Date of administration: 04/20/18 Location of the pharmacy where the shot was administered: Pharmacy. My doctor recommended this vaccine because I had several shingles outbursts during a 1 year period. Side effects: 1st Day: Didn't sleep throughout the whole night, tossing and turning, unable to rest on my left side at all 2nd day: Very painful, injection site swollen, sore and red. On a scale from 1 to 10, it was 9. I woke up crying because of the pain. Joint pain overall tiredness dizziness lethargy sleepiness symptoms started to alleviate after I took 400mg of ibuprofens x2 times I drank more than 3 quarts of liquids (water and herbal tea). I went to sleep at 00:30AM 3rd day I woke up at 10:00 AM unable to open my left eye, it felt very dry, no discharge of any kind. I washed my face with cold water, warm water, wiped my eye with a special eyelid wipe. I put eye drops. My eye didn't open until 40 minutes later. I put a cold ice pack on it, later I put a warm one which seemed to do its job. I was able to open my eyes although both of them felt dry, but the left one significantly dryer. I managed to keep them open until 2:30 pm when I decided to lay outside because I felt the pain that I had in the morning it's coming back. I slept for 1.5h and I felt better when I woke up. My eyes are still sensitive, especially the left one. 4th day-> I slept all night, the side effects are almost gone, the injection site is still red and sore, but otherwise I am able to do my daily activities.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Hello, I'm 31 years old. I would like to report some side effects that are not listed anywhere yet and I believe that people should know what to expect in case they decide to have this vaccine administered. Please pay close attention to what happened on the 3rd day. SHINGRIX->Date of administration: 04/20/18 Location of the pharmacy where the shot was administered: Pharmacy. My doctor recommended this vaccine because I had several shingles outbursts during a 1 year period. Side effects: 1st Day: Didn't sleep throughout the whole night, tossing and turning, unable to rest on my left side at all 2nd day: Very painful, injection site swollen, sore and red. On a scale from 1 to 10, it was 9. I woke up crying because of the pain. Joint pain overall tiredness dizziness lethargy sleepiness symptoms started to alleviate after I took 400mg of ibuprofens x2 times I drank more than 3 quarts of liquids (water and herbal tea). I went to sleep at 00:30AM 3rd day I woke up at 10:00 AM unable to open my left eye, it felt very dry, no discharge of any kind. I washed my face with cold water, warm water, wiped my eye with a special eyelid wipe. I put eye drops. My eye didn't open until 40 minutes later. I put a cold ice pack on it, later I put a warm one which seemed to do its job. I was able to open my eyes although both of them felt dry, but the left one significantly dryer. I managed to keep them open until 2:30 pm when I decided to lay outside because I felt the pain that I had in the morning it's coming back. I slept for 1.5h and I felt better when I woke up. My eyes are still sensitive, especially the left one. 4th day-> I slept all night, the side effects are almost gone, the injection site is still red and sore, but otherwise I am able to do my daily activities.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Pain
Clinical narrative: Severe chest pain with itching. Visited ER, given prednisone, antibiotics, and hydrocodone, with a shot of steroids and morphine. 3 days later, pain really severe from middle of chest to back of spine. Red bumps, pain. Back to ER, given CT scan, chest x-ray, blood and urine tested. Given more prednisone, hydrocodone, LIDODERM, LIDODERM patches, and valacyclovir HCL. It has been 42 days, and no relief. Still in severe pain, and rash seems to be coming back.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash erythematous, Spinal pain, Urine analysis
Clinical narrative: Severe chest pain with itching. Visited ER, given prednisone, antibiotics, and hydrocodone, with a shot of steroids and morphine. 3 days later, pain really severe from middle of chest to back of spine. Red bumps, pain. Back to ER, given CT scan, chest x-ray, blood and urine tested. Given more prednisone, hydrocodone, LIDODERM, LIDODERM patches, and valacyclovir HCL. It has been 42 days, and no relief. Still in severe pain, and rash seems to be coming back.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Dysgeusia, Fatigue, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lower extremities weakness of in a 68-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). The patient's past medical history included colonic polyp, diverticulitis, hemorrhoids, frozen shoulder (Periarthritis), scoliosis and spinal column stenosis. Concurrent medical conditions included incompetent cervix, drug exposure in utero (exposed to Diethylstilbestrol in utero), heart murmur, glucose tolerance impaired, cholesterol, vitamin D deficiency and osteopenia (allergies). Concomitant products included Aspirin, calcium carbonate, fish oil, PRESERVISION and PREVENAR. On an unknown date, the patient received SHINGRIX (intramuscular). On 11th April 2018, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On 12th April 2018, the patient experienced lower extremities weakness of, taste metallic, swelling, injection site pain and fatigue. On an unknown date, the outcome of the lower extremities weakness of, taste metallic, swelling, injection site pain, fatigue and pain in arm were unknown. The reporter considered the lower extremities weakness of, taste metallic, swelling, injection site pain and fatigue to be related to SHINGRIX. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's concomitant medications included Probiotics and Vitamin D. The patient received SHINGRIX in left deltoid and experienced jelly like legs, metallic taste, pain at injection site, swelling, fatigue and arm was sore.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of lower extremities weakness of in a 68-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). The patient's past medical history included colonic polyp, diverticulitis, hemorrhoids, frozen shoulder (Periarthritis), scoliosis and spinal column stenosis. Concurrent medical conditions included incompetent cervix, drug exposure in utero (exposed to Diethylstilbestrol in utero), heart murmur, glucose tolerance impaired, cholesterol, vitamin D deficiency and osteopenia (allergies). Concomitant products included Aspirin, calcium carbonate, fish oil, PRESERVISION and PREVENAR. On an unknown date, the patient received SHINGRIX (intramuscular). On 11th April 2018, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On 12th April 2018, the patient experienced lower extremities weakness of, taste metallic, swelling, injection site pain and fatigue. On an unknown date, the outcome of the lower extremities weakness of, taste metallic, swelling, injection site pain, fatigue and pain in arm were unknown. The reporter considered the lower extremities weakness of, taste metallic, swelling, injection site pain and fatigue to be related to SHINGRIX. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's concomitant medications included Probiotics and Vitamin D. The patient received SHINGRIX in left deltoid and experienced jelly like legs, metallic taste, pain at injection site, swelling, fatigue and arm was sore.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site reaction, Musculoskeletal pain, Pruritus, Rash pruritic
Clinical narrative: I got pneumonia shot on 4/18/18. (PNEUMOVAX 23) My shoulder hurt a lot that night. The next day/night I had an itchy rash inside my arm (opposite the area on the outside where I was injected) and was awakened off and on all night with horribly itchy feet. I wouldn't say this was terribly serious, but it was certainly uncomfortable, especially the itchy feet.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: I got pneumonia shot on 4/18/18. (PNEUMOVAX 23) My shoulder hurt a lot that night. The next day/night I had an itchy rash inside my arm (opposite the area on the outside where I was injected) and was awakened off and on all night with horribly itchy feet. I wouldn't say this was terribly serious, but it was certainly uncomfortable, especially the itchy feet.
Sex: U
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 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 injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was received as follows: This case was reported by a physician assistant via click to chat. The age at vaccination was not reported. The reporter asked that, if the patient got localized tenderness and redness at the injection site after the 1st dose of SHINGRIX, would they expect an even bigger reaction after the second dose of SHINGRIX. Unable to obtained any additional information, including product and patient identifiers.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Contusion, Erythema, Injection site pruritus, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in an adult female patient who received SHINGRIX. On 7th April 2018, the patient received the 1st dose of SHINGRIX. On 7th April 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In April 2018, the patient experienced swelling arm, chills, contusion, general body pain, injection site itching, erythema of extremities and slight temperature. On an unknown date, the outcome of the swelling arm, contusion, injection site itching and erythema of extremities were recovering/resolving and the outcome of the chills, general body pain and slight temperature were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the swelling arm and erythema of extremities to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the chills, contusion, general body pain, injection site itching and slight temperature to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. Less than a week, after receiving SHINGRIX the patient experienced swelling arm, chills, contusion, general body pain, injection site itching, erythema of extremities and slight temperature. According to the patient, SHINGRIX was administered in the back fatty part of arm leading her to believe it was administered incorrectly. She felt that SHINGRIX was not administered in the deltoid, which led to vaccine administered at inappropriate site. The patient also felt that this contributed to the increased amount of swelling in her left arm. The patient had spoken with her physician. The patient had denied permission to contact her physician.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Product administered at inappropriate site, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in an adult female patient who received SHINGRIX. On 7th April 2018, the patient received the 1st dose of SHINGRIX. On 7th April 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In April 2018, the patient experienced swelling arm, chills, contusion, general body pain, injection site itching, erythema of extremities and slight temperature. On an unknown date, the outcome of the swelling arm, contusion, injection site itching and erythema of extremities were recovering/resolving and the outcome of the chills, general body pain and slight temperature were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the swelling arm and erythema of extremities to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the chills, contusion, general body pain, injection site itching and slight temperature to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. Less than a week, after receiving SHINGRIX the patient experienced swelling arm, chills, contusion, general body pain, injection site itching, erythema of extremities and slight temperature. According to the patient, SHINGRIX was administered in the back fatty part of arm leading her to believe it was administered incorrectly. She felt that SHINGRIX was not administered in the deltoid, which led to vaccine administered at inappropriate site. The patient also felt that this contributed to the increased amount of swelling in her left arm. The patient had spoken with her physician. The patient had denied permission to contact her physician.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Insomnia, Pyrexia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX. On 12th April 2018, the patient received SHINGRIX. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping. In April 2018, the patient experienced fever, injection site rash and injection site swelling. On an unknown date, the outcome of the fever, difficulty sleeping, injection site rash and injection site swelling were unknown. It was unknown if the reporter considered the fever, difficulty sleeping, injection site rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient did not have a spleen. The patient experienced a series of reactions including a bump and rash at the injection site, he could not sleep at all on Thursday night and he experienced a low grade fever.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash pruritic
Clinical narrative: Allergic reaction manifested day following immunization of second dose in series. Itchy rash starting in lower extremities initially then manifested all over person. No other symptoms of an allergic reaction besides an itchy rash. Patient saw primary provider the day following immunization and received a prescription for triamcinolone 0.1% cream which provided minimal relief. She contacted the doctor 2 days following immunization and received a prescription for hydroxyzine 10 mg tablets BID.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Spotty rash began 4-19 which did include a fever up to 102. Started on antihistamines and/or lotion for itch comfort.
Age: 4.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given adult dose Hep A in error. Should have been a pediatric dose.
Age: 4.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given adult dose Hep A in error. Should have been a pediatric dose.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEPA, IPV
Symptoms: Extra dose administered
Clinical narrative: KINRIX and IPOL administered instead of DTAP so pt received 2 doses of polio vaccine.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain at injection site, unable to lift arm for 8 hrs, pain deminising after 8 hrs.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Injection site - hot and swollen; Fatigue; Low grade fever; chills; general malaise.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site - hot and swollen; Fatigue; Low grade fever; chills; general malaise.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Oropharyngeal pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Began feeling fatigue by 2:00pm, in the evening reports chills with fever over 102.0 F, throat felt "swollen" and sore, felt fatigue and tiredness. Felt fine before the shot and feels fine by the next morning.
Age: 49.0
Sex: M
Vaccine: MMR
Symptoms: Injected limb mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: This spontaneous report was received from a currently 52 year old male patient. The patient's concurrent conditions and medical history were not reported. On 27-SEP-2013, the patient was vaccinated with M-M-R II (lot # J002934 with expiry date on 14-MAR-2015, 0.5 ml, subcutaneous) for prophylaxis (strength and anatomical location were not reported). Concomitant medications were not reported. On an unknown date, the patient developed a lot of pain in his right arm. The patient sought medical attention as he was seen in an unspecified emergency room on an unspecified date due to the pain in his right arm was getting "progressively worse". The patient stated that he was prescribed unspecified pain medication and unspecified muscle relaxers on an unspecified date for the right arm pain. Moreover, he experienced a loss of range in motion in the right arm and was diagnosed with Shoulder Injury Related to Vaccine Administration (SIRVA) on an unspecified date by an unspecified physician. At the time of reporting, the outcome of pain in extremity and injected limb mobility decreased was reported as not recovered/not resolved. The relatedness between the events and the vaccination was not reported. No product quality complaint was involved. Additional information has been requested. This is an amended report. HCP of primary reported has been updated to NO. Sender's Comments: MERCK 1606USA000878: Mfr number.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patient of unknown demographics. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not reported. On 10-APR-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA (dose, frequency, route and lot # were not reported) expiry date: 08-APR-2018 for prophylaxis (expired product administered). No adverse effects were reported. This is a non-valid report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from the registered nurse on 24-APR-2018, concerning the 19 years old male patient who was vaccinated with an expired dose of, also it was reported VAQTA (lot # N005605 was administrated by intramuscular route), it was his first dose. None illness at the time of vaccination, either pre-existing physician-diagnosed allergies, birth defects nor medical conditions were reported.
Sex: F
Vaccine: HEP, HIBV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot #, expiration date, dose, route and site of administration were not provided) for prophylaxis. On an unspecified date, the patient went to her doctor to get a LIQUID PEDVAXHIB booster and was instead given a dose of RECOMBIVAX HB (lot #, expiration date, dose, route and site of administration were not provided).
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 11 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 08-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot reported as "N021572" Expiry date: 01-MAY-2020) (product storage error) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 degrees F to 77 degrees F (67.3 degrees F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.