chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram normal, Flushing, Full blood count normal, Metabolic function test
Clinical narrative: Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine,  developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later;  cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Paraesthesia, Pregnancy test, Troponin normal
Clinical narrative: Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine,  developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later;  cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis normal
Clinical narrative: Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine,  developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later;  cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Extreme fatigue, chills, joint pain, muscle aches, fever, headache, pain at injection site
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Extreme fatigue, chills, joint pain, muscle aches, fever, headache, pain at injection site
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Diarrhea followed by hives. I took two antihistamine pills and an anti-diarrhea pill and used an anti-itch cream.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site rash, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Patient developed large egg sized welt at the site of injection 1/26/2020, 9 days after administration. Raised, erythematous lesion accompanied by pruritus ("Covid arm.") Pruritus was controlled by topical cream (Sarna). This subsided by 2/4/2020, but the following day patient developed rash at site of injection with punctate, erythematous lesions (bumps) accompanied by severe pruritus. Was given diagnosis (remotely) of shingle.  Patient has had both doses of shingles vaccine (Shingrix). Pruritus resolved within 4 days. Lesions persisted for 10-12 days.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: Patient developed large egg sized welt at the site of injection 1/26/2020, 9 days after administration. Raised, erythematous lesion accompanied by pruritus ("Covid arm.") Pruritus was controlled by topical cream (Sarna). This subsided by 2/4/2020, but the following day patient developed rash at site of injection with punctate, erythematous lesions (bumps) accompanied by severe pruritus. Was given diagnosis (remotely) of shingle.  Patient has had both doses of shingles vaccine (Shingrix). Pruritus resolved within 4 days. Lesions persisted for 10-12 days.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site pain, Injection site swelling, Lymphadenopathy, Somnolence
Clinical narrative: Moderate pain at injection site. for 3 days.  Injection site very swollen for 3 days. Very sleepy for 2 days. Swollen Neck Lymph node on left side of neck noticed  on Wednesday, February 18. Swelling much worse Thursday Februarys 19, late evening. Noticed bruising on lower stomach Thursday Feb. 19.  I have no income and no money to go to the doctor to have  these checked out. Do you know where I can get some money to  have my lymph node checked out and to have a blood platelet test?  Thank you. I might die from not getting the blood platelet test.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: 2/18/2021 4:30am woke up nauseous, having muscle aches from injection site in left bicep to top of head on same side, not able to think clearly ?foggy?.  1:30pm having muscle aches in both sides of neck and headache left sided
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: 2/18/2021 4:30am woke up nauseous, having muscle aches from injection site in left bicep to top of head on same side, not able to think clearly ?foggy?.  1:30pm having muscle aches in both sides of neck and headache left sided
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blepharospasm, Lacrimation increased
Clinical narrative: Transient and intermittant twitching and minor tearing of  left eye.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Death, Haemorrhagic stroke
Clinical narrative: Death due to hemorrhagic stroke.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Headache, Injection site pain
Clinical narrative: Injection site arm pain, headache, grabbing low back pain first on 2/11, resolved on 2/13. Then repeated on 2/16 with injection site arm pain followed by back pain & headache. Arm pain gone on 2/18, but back pain and headache persisting.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Loss of personal independence in daily activities, Vaccination site pain
Clinical narrative: Injection site arm pain, headache, grabbing low back pain first on 2/11, resolved on 2/13. Then repeated on 2/16 with injection site arm pain followed by back pain & headache. Arm pain gone on 2/18, but back pain and headache persisting.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain
Clinical narrative: Two weeks after the first vaccine had a large circular red area appear around the area of the shot.  The area was tender, especially at the injection spot. The red area was large like three inches by two inches.  sometimes solid red and sometimes just a big ring.  It lasted several days. Unusual in that it appeared two weeks after.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Sleep disorder
Clinical narrative: Moderna COVID-19 Vaccine EUA  Site of injection increasingly sore.  Unable to sleep.  Chilled the morning after the injection. Continued to increase in soreness through the next day.  Unable to sleep next night.  Took 500 mg acetaminophen at 1 am, 2/19/21.  Still sore.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Severe soreness at injection site, lasting about 24 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Ear pain, Eyelid function disorder, Facial pain, Facial paralysis
Clinical narrative: On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right.  There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face.  By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours.  I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face.  From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding.  He said it was Bells Palsy.  He prescribed 10 days of prednisone  and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face.    By the 2nd week I was able to sit up more, but still very tired/fatigued.   I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Headache, Hypersomnia
Clinical narrative: On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right.  There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face.  By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours.  I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face.  From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding.  He said it was Bells Palsy.  He prescribed 10 days of prednisone  and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face.    By the 2nd week I was able to sit up more, but still very tired/fatigued.   I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Impaired work ability, Mobility decreased, Pain, Sinus pain
Clinical narrative: On Sunday, Jan 31, 2021 I woke up around noon after working a graveyard shift and wasn't feeling right.  There was a pressure in my head, along with sinus and ear pain and a fuzzy feeling in my face.  By Monday, Feb, 1, 2021, the pain was worse now with a fatigued feeling after sleeping 20 of the last 24 hours.  I went to my Dr on 2/1/2021 and recognized a slide on the left side of my face.  From my forehead not wrinkling up the same as right side, left eye wasn't closing as tight and the left cheek and side of mouth were sliding.  He said it was Bells Palsy.  He prescribed 10 days of prednisone  and an antivirus medicine to be taken 3 times a day. That week I slept a lot and wasn't able to sit up much due to the head pain and the lightening bolt feeling in my face.    By the 2nd week I was able to sit up more, but still very tired/fatigued.   I was off work for 2 weeks, returning to work on 2/14/2021. There is still a slight slide on the left side in the eye and cheek.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Pain, Pyrexia
Clinical narrative: Chills described as ?internally cold,? uncontrollable shaking, fever,  body aches, light headache onset 14 hours after second vaccine dose administered. Woke up from sleeping with these symptoms. Shaking discontinued after taking vitamin C, zinc, and Tylenol.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tremor
Clinical narrative: Chills described as ?internally cold,? uncontrollable shaking, fever,  body aches, light headache onset 14 hours after second vaccine dose administered. Woke up from sleeping with these symptoms. Shaking discontinued after taking vitamin C, zinc, and Tylenol.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Sudden bloody nose a little less than 2 hours after the shot and it away pretty quickly.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Injection site pain
Clinical narrative: Pfizer, dizzyness, sore injection site, fast heart rate
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Dizziness, Fatigue
Clinical narrative: Pfizer, dizzyness, sore injection site, fast heart rate
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pulse abnormal, Vaccination site pain
Clinical narrative: Pfizer, dizzyness, sore injection site, fast heart rate
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 3 hours after injection: Sore arm (where injected).  Symptoms faded within 24 hours. 7 days after the injection: a large (~3" diameter) raised circular red spot appeared at the injection site.  It was itchy but painless.  It disappeared 36-48 hours after it began. Not other side effects were noted.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: 2 hours after injection: sore arm.  Relief within 24 hours 12 hours after injection: mild headache lasting 12 hours
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever Chills Aches
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: On Feb. 15th after injection - which hurt when I was given shot, Arm was sore and swollen which is normal. Developed fever,chills tiredness,on Feb. 16th. On Feb. 17th. Arm was sore and quite itchy. Noticed a round red blotch about size of half dollar and assumed this was normal. The itching has become worse and the red blotch has spread more on arm . Today it was very itchy and used cortisone cream which helped for about 2 hours and them became itchy again. . i looked on line they called it Covid Arm. I will contact my Doctor on Monday if this does not go away.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular
Clinical narrative: On Feb. 15th after injection - which hurt when I was given shot, Arm was sore and swollen which is normal. Developed fever,chills tiredness,on Feb. 16th. On Feb. 17th. Arm was sore and quite itchy. Noticed a round red blotch about size of half dollar and assumed this was normal. The itching has become worse and the red blotch has spread more on arm . Today it was very itchy and used cortisone cream which helped for about 2 hours and them became itchy again. . i looked on line they called it Covid Arm. I will contact my Doctor on Monday if this does not go away.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Electrocardiogram normal, Loss of consciousness, Paraesthesia oral
Clinical narrative: About 2 hours after injection tongue started swelling, became difficult to breath, mouth and throat started tingling, started blacking out. Chewed 2 benadryl and went to emergency room. Was given more antihistamines there and monitored until reaction stopped.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: About 2 hours after injection tongue started swelling, became difficult to breath, mouth and throat started tingling, started blacking out. Chewed 2 benadryl and went to emergency room. Was given more antihistamines there and monitored until reaction stopped.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysgeusia, Taste disorder
Clinical narrative: several days after vaccine I developed a bitter taste in my mouth which persists now, almost  a month later.  It has affected my appetite, everything tastes bad.  I am treating it with salt water rinses.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Full body  Hives, swollen feet and hands
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Ear discomfort, Fatigue, Headache
Clinical narrative: 24 hours after vaccination - moderate muscular and joint pain, mild headache, mild arm pain at injection site 48 hours after vaccination - moderate joint and muscular pain, mild headache, mild fatigue 72 hours after vaccination - mild joint and muscular pain, moderate fatigue, diarrhea, nausea, mild ear pressure (worst overall day after vaccination) 88 hours after vaccination - feeling much better as symptoms listed above have dissipated
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea
Clinical narrative: 24 hours after vaccination - moderate muscular and joint pain, mild headache, mild arm pain at injection site 48 hours after vaccination - moderate joint and muscular pain, mild headache, mild fatigue 72 hours after vaccination - mild joint and muscular pain, moderate fatigue, diarrhea, nausea, mild ear pressure (worst overall day after vaccination) 88 hours after vaccination - feeling much better as symptoms listed above have dissipated
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adberse event; Temperature -7.9 for 53 minutes and -10.5 C for 52 minutes; This spontaneous report was received from a vaccine administrator and refers to a 16-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-FEB-2021, the patient was vaccinated with incorrectly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # 1637651 and expiration date on 09-JUN-2022 (also reported as 09-SEP-2022) or with lot # T026954 with expiration date on 13-APR-2022 (exact dose, route of administration were unknown) for prophylaxis. On 29-JAN-2021, the suspected vaccines underwent the temperature excursions of -7.9 degrees Celsius for 53 minutes and of 10.5 degrees Celsius for 52 minutes. The digital data logger was not involved. There was no previous temperature excursions. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error, Wrong product administered
Clinical narrative: was stored in the refrigerator instead of the freezer since 01DEC2020 and has since then been administered to patients; It was also administered concomitantly with VARlVAX / intended to give MMRII but instead administered PROQUAD; intended to give MMRII but instead administered PROQUAD; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-DEC-2020, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was stored in the refrigerator instead of the freezer. It experienced the temperature excursion of 44 degrees Fahrenheit for 1506 hours. There was no previous temperature excursion. The digital data logger was not involved. On 01-FEB-2021, the patient was administered with the incorrectly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # T025221, expiration date 19-JAN-2022 (route of administration was not reported) for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. Additionally, on 01-FEB-2021, the patient received varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2102USA000941: US-009507513-2102USA001248: US-009507513-2102USA001301: US-009507513-2102USA001487: US-009507513-2102USA001044:
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous report was received from a lawyer referring to a 67 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.   The patient was vaccinated with pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) via intramuscular in left arm on 16-OCT-2014 to 07-OCT-2015 (strength, dose, lot# and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The patient was vaccinated with tetanus toxoid vaccine in 2015 and influenza virus whole virion 3v vaccine inactivated (FLUZONE) in left arm on 14-SEP-2018.   This case was split from a legal case regarding the same patient.; Sender's Comments:  US-009507513-2101USA004646:
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Ear pain, Feeling hot, Malaise
Clinical narrative: Malaise; ear pain and/or pressure; "Hot ears"/ felt like they had hot liquid in them; ear pain and/or pressure; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a day after receiving Shingrix, the patient experienced sensation of pressure in ear, ear pain and feeling hot. On an unknown date, the patient experienced malaise. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the malaise, sensation of pressure in ear, ear pain and feeling hot were recovered/resolved.   It was unknown if the reporter considered the malaise, sensation of pressure in ear, ear pain and feeling hot to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported but could be 50 or 51 years. On 21st March 2020, the patient received 1st dose of Shingrix and experienced malaise and tiredness, refer case US2020252546. On 21st May 2020 at around 2 to 3 pm, the patient received 2nd dose of Shingrix in left arm and experienced pain and/or pressure, as well as hot ears, a sensation she described as felt like they had hot liquid in them and later that night was when she felt the hot ears. The patient visited to the ENT physician. The patient stated that less than 9 months after 2nd dose, she might possibly had malaise with the 2nd dose but did not notice it due to the ear pain and/or pressure overpowering it. The patient stated that this sensation and/or pressure took 2 months to resolve and was on and off. The patient reported that everything had resolved. The patient reported that she getting the flu shot annually, with the most recent one given back on August 2020. The reporter provided limited information and requested to remain anonymous. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020252546:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: received 1st dose of shingrix / get a case of hives / still have hives (mild); This case was reported by a consumer via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 3 weeks after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   The reporter considered the hives to be unrelated to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was captured as adult as per vaccine indication. The patient received the vaccine and not long after, seemed to get a case of hives. The patient stated that he/she still had hives (mild) 6 weeks later. The patient wanted to know if it was possible that he/she might have a mild case of shingles from the vaccine or a reaction. The patient did not associate it with the vaccine. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253665:Dupliacte case US-GLAXOSMITHKLINE-US2020AMR253498:Dupliacte case
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: aches; felt awful; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received over 2 months before and it was fine).   On an unknown date, the patient received the 2nd dose of Shingrix. On 21st December 2020, less than a month after receiving Shingrix, the patient experienced feeling bad. On 22nd December 2020, the patient experienced pain. On an unknown date, the outcome of the feeling bad and pain were not recovered/not resolved.   It was unknown if the reporter considered the feeling bad and pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however it could be 59 or 60 years old. The patient felt awful during the night and on the day of reporting after receiving 2nd booster shot of shingles. The patient wanted to know if there was anything she could take to help with thes aches. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature, Feeling cold, Poor quality sleep, Pyrexia
Clinical narrative: aching in major joins; Went to bed last night very cold; woke up around 2am; fever over 101; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (1st dose received on an unknown date, reference case US2020AMR254730).   On 21st December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced joint pain, feeling cold, poor sleep and fever. On an unknown date, the outcome of the joint pain, feeling cold, poor sleep and fever were unknown.   It was unknown if the reporter considered the joint pain, feeling cold, poor sleep and fever to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient mentioned that he/she went to bed last night from the reporting date and felt very cold, he/she woke up around 2:00 am and had ache in major joins and fever was over 101. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254730:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: aching in major joins; Went to bed last night very cold; woke up around 2am; fever over 101; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of swelling (1st dose received on an unknown date, reference case US2020AMR254730).   On 21st December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a day after receiving Shingrix, the patient experienced joint pain, feeling cold, poor sleep and fever. On an unknown date, the outcome of the joint pain, feeling cold, poor sleep and fever were unknown.   It was unknown if the reporter considered the joint pain, feeling cold, poor sleep and fever to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient mentioned that he/she went to bed last night from the reporting date and felt very cold, he/she woke up around 2:00 am and had ache in major joins and fever was over 101. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254730:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia
Clinical narrative: chills; muscle aches; soreness at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, muscle pain and injection site pain. On an unknown date, the outcome of the chills, muscle pain and injection site pain were unknown.   It was unknown if the reporter considered the chills, muscle pain and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that after the 2nd dose of Shingrix patient experienced chills, muscle ache and  soreness at the injection site. Patient asked about how long these symptoms expected to last.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort
Clinical narrative: Side effects from second shingles shot / discomfort of the shot; This case was reported by a consumer and described the occurrence of injection site discomfort in a 91-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Voltaren with an associated reaction of arthritis (Voltaren Arthritis Pain 1% Gel used it on shoulder, About a year ago,(batch number:-LA9R,expiry date :- 31st January 2023 )).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the Shingles vaccine and experienced injection site discomfort. Reporter wondered if putting some Voltaren on arm would be beneficial. Reporter also stated that she used it for bad shoulder and definitely helped her. Patient hoped to use it for the discomfort of the shot. The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Lethargy
Clinical narrative: Felt more lethargic; Tiredness; This case was reported by a physician via other manufacturer and described the occurrence of lethargy in a 72-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced lethargy and tiredness. On an unknown date, the outcome of the lethargy and tiredness were unknown.   It was unknown if the reporter considered the lethargy and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by physician who was also a patient. Age at vaccination was not reported. The patient felt more lethargic and tired from the shingles shot. No details on the shingles shot provided by the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: my head it felt like it was burning; This case was reported by a consumer via interactive digital media and described the occurrence of burning sensation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced burning sensation. On an unknown date, the outcome of the burning sensation was unknown.   It was unknown if the reporter considered the burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported The age group was not reported but was captured as adult as per vaccine indication. The patient received the Shingrix and within 7 to 10 days after the vaccination patient felt like head was burning.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest pain, Chills, Dyspnoea, Heart rate increased
Clinical narrative: Pain in left chest; Blood pressure 226/110.; Respiration rate 44; Pulse 126; Fever of 101 degrees; 3 hours of not being able to catch her breath; Really bad chills / 3 hours of shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date unknown) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2020, 1 days after receiving Shingrix, the patient experienced chills, fever, shortness of breath, chest pain, increased blood pressure, respiratory rate increased and high pulse rate. The patient was treated with epinephrine and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chills and shortness of breath were recovered/resolved and the outcome of the fever, chest pain, increased blood pressure, respiratory rate increased and high pulse rate were unknown.   It was unknown if the reporter considered the chills, fever, shortness of breath, chest pain, increased blood pressure, respiratory rate increased and high pulse rate to be related to Shingrix.  Additional details were provided as follows: The patient received her first Shingrix shot in her left arm. At 5 am, the next morning the patient experienced really bad chills and fever of 101 degrees. After 3 hours of shivering and not being able to catch her breath the patient called her doctor and went to the emergency room. The patient had pain in left chest. At emergency room her blood pressure was 226 by110, her respiration rate was 44 and her pulse was 126. She was treated in the emergency room for 3 hours; treated with epinephrine, Benadryl and was discharged from the emergency room with a for a steroidal dosepak. The patient did not have plan to second dose of Shingrix  pursuant to advice from doctor. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Respiratory rate increased
Clinical narrative: Pain in left chest; Blood pressure 226/110.; Respiration rate 44; Pulse 126; Fever of 101 degrees; 3 hours of not being able to catch her breath; Really bad chills / 3 hours of shivering; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date unknown) for prophylaxis.   On 6th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 7th November 2020, 1 days after receiving Shingrix, the patient experienced chills, fever, shortness of breath, chest pain, increased blood pressure, respiratory rate increased and high pulse rate. The patient was treated with epinephrine and benadryl (nos) (Benadryl). On an unknown date, the outcome of the chills and shortness of breath were recovered/resolved and the outcome of the fever, chest pain, increased blood pressure, respiratory rate increased and high pulse rate were unknown.   It was unknown if the reporter considered the chills, fever, shortness of breath, chest pain, increased blood pressure, respiratory rate increased and high pulse rate to be related to Shingrix.  Additional details were provided as follows: The patient received her first Shingrix shot in her left arm. At 5 am, the next morning the patient experienced really bad chills and fever of 101 degrees. After 3 hours of shivering and not being able to catch her breath the patient called her doctor and went to the emergency room. The patient had pain in left chest. At emergency room her blood pressure was 226 by110, her respiration rate was 44 and her pulse was 126. She was treated in the emergency room for 3 hours; treated with epinephrine, Benadryl and was discharged from the emergency room with a for a steroidal dosepak. The patient did not have plan to second dose of Shingrix  pursuant to advice from doctor. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Eye pruritus, Fatigue, Lip pruritus, Nausea
Clinical narrative: cold sore on his lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; tired; fever; shivering; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 16th December 2020, less than a day after receiving Shingrix, the patient experienced fever, shivering and nausea. On 17th December 2020, the patient experienced tiredness. On 21st December 2020, the patient experienced cold sores lip, hives, pruritus facial and lip pruritus. On an unknown date, the outcome of the fever, shivering and nausea were recovered/resolved and the outcome of the tiredness, cold sores lip, hives, pruritus facial and lip pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, shivering, nausea, tiredness, cold sores lip, hives, pruritus facial and lip pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient reported that, same night after receiving the vaccine he had fever, shivering, and nausea and these have resolved.  On next day in the morning, the patient was tired, and this was still ongoing at the time of reporting.  5 days after receiving the Shingrix, he developed a cold sore on his lip, hives and itching around his left eye, hives and itching on the left side of his face from the eye down to the lip and these were all still ongoing at the time of reporting.  The patient reported he used a cold washcloth on his face and lip for the hives and itching. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Pruritus, Urticaria
Clinical narrative: cold sore on his lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; hives and itching around his left eye / on the left side of his face from the eye down to the lip; tired; fever; shivering; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 16th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 16th December 2020, less than a day after receiving Shingrix, the patient experienced fever, shivering and nausea. On 17th December 2020, the patient experienced tiredness. On 21st December 2020, the patient experienced cold sores lip, hives, pruritus facial and lip pruritus. On an unknown date, the outcome of the fever, shivering and nausea were recovered/resolved and the outcome of the tiredness, cold sores lip, hives, pruritus facial and lip pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, shivering, nausea, tiredness, cold sores lip, hives, pruritus facial and lip pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient reported that, same night after receiving the vaccine he had fever, shivering, and nausea and these have resolved.  On next day in the morning, the patient was tired, and this was still ongoing at the time of reporting.  5 days after receiving the Shingrix, he developed a cold sore on his lip, hives and itching around his left eye, hives and itching on the left side of his face from the eye down to the lip and these were all still ongoing at the time of reporting.  The patient reported he used a cold washcloth on his face and lip for the hives and itching. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: fatigue; fever; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue, fever and headache. On an unknown date, the outcome of the fatigue, fever and headache were recovered/resolved.   It was unknown if the reporter considered the fatigue, fever and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced fatigue, fever and headache. The reporter did not consent to follow-up. For the tolerance of 2nd dose, refer linked case US2021AMR000985.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR000985:same patient, 2nd dose
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Depressed mood, Fatigue, Influenza like illness, Pain, Respiratory tract irritation
Clinical narrative: run-down Feeling / TIREDNESS; Body aches; Flu-like symptoms; Lung irritation; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th January 2021, 1 days after receiving Shingrix, the patient experienced fatigue, general body pain, influenza-like symptoms and lung irritation. On an unknown date, the outcome of the fatigue, general body pain, influenza-like symptoms and lung irritation were not recovered/not resolved.   It was unknown if the reporter considered the fatigue, general body pain, influenza-like symptoms and lung irritation to be related to Shingrix.  Additional details were provided as follows: The patient was reporting for himself. The patient received Shingrix in left deltoid. About 24 hours after receiving Shingrix, the patient began to experience a run-down feeling, flu-like symptoms, body aches, tiredness and lung irritation.  The patient stated, the symptoms had not resolved although they were not as bad as they were.   No lot number or expiration date was known for this vaccine. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Periorbital cellulitis
Clinical narrative: preseptal cellulitis/facial cellulitis; flu likesyndrome; This case was reported by a physician via call center representative and described the occurrence of preseptal cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix and an unknown time after starting Augmentin, the patient experienced preseptal cellulitis (serious criteria GSK medically significant) and influenza-like symptoms. The patient was treated with amoxicillin sodium, potassium clavulanate (Augmentin) and sulfamethoxazole + trimethoprim (Bactrim). In January 2020, the outcome of the preseptal cellulitis and influenza-like symptoms were recovered/resolved.   The reporter considered the preseptal cellulitis and influenza-like symptoms to be almost certainly related to Shingrix.  Additional details were provided as follows: The patient experienced typical moderate flu like symptom within first day (24 to 48 hrs) of receiving Shingrix. The patient developed left facial cellulitis, treated some 5 to10 days after vaccination. The patient treated successfully with combination of PO Bactrim and Augmentin for 10 Days. The patient never suffered preseptal cellulitis before. The patient recovered and hesitantly agreed to a second dose. For tolerance of 2nd dose please refer case US2021AMR032306.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR032306:Same reporter
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Loss of consciousness, Muscular weakness
Clinical narrative: laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain); horrible pain on left side (side of the injection); awful pain on left leg; could not raise leg; congestion in head, like a sinus infection; tiredness/fatigue; Headache; Chills; A spontaneous report was received from a consumer, a 79-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, tiredness/fatigue, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection.  The patient's medical history was not provided.  Her allergies included sulfa, mycin, meloxicam and glycopyrrolate.  Concomitant medications included blood pressure medication (name not reported).  On 28 Jan 2021, approximately one day prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 028L20A) on the left side (anatomical location not reported) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, on the night of the vaccination, the patient woke up with a horrible pain one her left side (side of the injection), headache, chills, fatigue/tiredness, an awful pain on her leg, and congestion in her head, like a sinus infection.  She got up thinking that walking would make the pain on her leg go away, but it did not.  When the patient tried to go back to bed, she could not raise her leg so she laid on the floor and she did not know if she passed out on the floor or fell asleep (she thought she could not have fallen asleep with such pain).  When the patient woke up, she could move her leg normally.  Treatment information was not provided.  Action taken in response to the events was unknown.  The events, laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection were considered resolved on 29 Jan 2021.  The event, fatigue/tiredness was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 79 year old female subject, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# 028L20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.