chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: have a full blown case of shingles. I have to go to an eye doctor now because it's in my eye; full blown case of shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, after receiving vaccine had a full blown case of shingles. The shingles was in eye.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise. Shingles vaccine was discontinued. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and felt sick and refused the second shot.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: sight is hot; red and bit of a knot; knot; This case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth in a 22-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On 15th August 2020, the patient received the 2nd dose of Bexsero. In August 2020, less than a week after receiving Bexsero, the patient experienced injection site warmth, injection site erythema and injection site mass. On an unknown date, the outcome of the injection site warmth, injection site erythema and injection site mass were unknown.   It was unknown if the reporter considered the injection site warmth, injection site erythema and injection site mass to be related to Bexsero.  Additional details were provided as follows: The case was reported by the parent of the patient. The patient received Bexsero and site was hot and red and a bit of a knot.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had pain in arm. Consented to follow up. For tolerances of 2nd dose, refer case US2020167499, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167499:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Skin lesion
Clinical narrative: Shingrix series there are multiple lesions in a new spot; multiple genital herpes lesions in new; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included genital herpes (had 40 year history of genital herpes outbreaks consistently in 2 spots just one at a time.). Previously administered products included Shingrix (1st dose received on an unknown date).   In December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced skin lesion and genital herpes. On an unknown date, the outcome of the skin lesion and genital herpes were unknown.   It was unknown if the reporter considered the skin lesion and genital herpes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had  40 year history of genital herpes outbreaks consistently in 2 spots just one at a time. The reporter stated that, after vaaccination with shingrix series, the patient edxperienced multiple lesions in a new spot that has never had lesions before. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Incomplete course of vaccination, Malaise, Pain, Pyrexia
Clinical narrative: chills; fever; malaise; body aches; overall feeling of not wanting to get out of bed; in Nov 2019, the patient received the first dose of Shingrix, however did not return; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, fever, malaise, general body pain, somnolence and incomplete course of vaccination. The patient was treated with ibuprofen. On an unknown date, the outcome of the chills, fever, malaise, general body pain and somnolence were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the chills, fever, malaise, general body pain and somnolence to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The reporter stated that, the patient experienced COVID like symptoms after 1st dose. The reporter stated that, the patient got the shot in afternoon. The next morning woke up with symptoms by the next day they were resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Somnolence
Clinical narrative: chills; fever; malaise; body aches; overall feeling of not wanting to get out of bed; in Nov 2019, the patient received the first dose of Shingrix, however did not return; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills, fever, malaise, general body pain, somnolence and incomplete course of vaccination. The patient was treated with ibuprofen. On an unknown date, the outcome of the chills, fever, malaise, general body pain and somnolence were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the chills, fever, malaise, general body pain and somnolence to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported for 1st dose and was not applicable for 2nd dose. The reporter stated that, the patient experienced COVID like symptoms after 1st dose. The reporter stated that, the patient got the shot in afternoon. The next morning woke up with symptoms by the next day they were resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection given 8/25/2020 in left thigh IM. Next day presented with red, swollen skin around the injection site that measures 7"x6.5" in diameter. 8/27/2020 was given cephalexin & Ibuprofen
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm large are redness and swelling started on 8/20/2020 actual time unknown. Mother of child came to clinic on 8/27/20 to report symptoms.
Age: 17.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Abdominal pain upper, Feeling hot, Pruritus, Throat tightness
Clinical narrative: APPROX 30 MINUTES AFTER VACCINES - 0932: PATIENT COMPLAINED OF TIGHTNESS IN THROAT, ITCHING, STOMACH PAIN 7/10, FEELING HOT, TALKING , ALERT 0933: EPINEPHRINE SC TO RIGHT THIGH  0940 IV 20 G,  NS, 50MG BENADRYL IVP AND 125MG SOLUMEDROL IVP 0942 ITCHING , TIGHTNESS TO THROAT, HOT FEELING RELIEVED, STOMACH PAIN 1/10 0944PEPCID 20MG IV, 0948 ALLSYMPTOMS RELIEVED, PAIN 0/10, TALKING REMAINS UNDER OBSERVATION , NO CHANGE , DENIED SYMPTOMS, AFTER 2 HOURS, REMAINS UNDER OBSERVATION
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Body temperature increased, Cough, Fatigue, Feeling abnormal
Clinical narrative: Within 24 hours of injection had softball size swelling, redness, and heat at injection site.  L arm and L leg felt heavy and had difficulty walking.  Aching muscles and fatigue.  Temp 99-100. Also with headache, sore throat, and cough. Balance was off.  After 5 days, swelling remained the same but redness had improved.  Walking and balance improved but not back to normal.  L arm and L leg "continue to fee odd". Still with symptoms to date.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hours of injection had softball size swelling, redness, and heat at injection site.  L arm and L leg felt heavy and had difficulty walking.  Aching muscles and fatigue.  Temp 99-100. Also with headache, sore throat, and cough. Balance was off.  After 5 days, swelling remained the same but redness had improved.  Walking and balance improved but not back to normal.  L arm and L leg "continue to fee odd". Still with symptoms to date.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: Within 24 hours of injection had softball size swelling, redness, and heat at injection site.  L arm and L leg felt heavy and had difficulty walking.  Aching muscles and fatigue.  Temp 99-100. Also with headache, sore throat, and cough. Balance was off.  After 5 days, swelling remained the same but redness had improved.  Walking and balance improved but not back to normal.  L arm and L leg "continue to fee odd". Still with symptoms to date.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Lymphadenopathy
Clinical narrative: Severe swelling in glands under both arms. Joint pain severe and headache
Age: 65.0
Sex: M
Vaccine: UNK
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms "except no fever"
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Heart rate increased, Injection site pain
Clinical narrative: I just wanted to let you know that after my vaccine on 8/24/20 I did have several side effects. I felt okay all day, other than pain at the injection site, but then went I went to bed I had a lot of difficulty sleeping that night. I had shivering and unusual muscle pain throughout my body, a slight fever (although I didn't take my temperature). I did take Tylenol several times in about 36 hours. I also had an unsettled stomach and my heart seemed to be beating faster than normal. I was extremely tired until early afternoon the next day.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: I just wanted to let you know that after my vaccine on 8/24/20 I did have several side effects. I felt okay all day, other than pain at the injection site, but then went I went to bed I had a lot of difficulty sleeping that night. I had shivering and unusual muscle pain throughout my body, a slight fever (although I didn't take my temperature). I did take Tylenol several times in about 36 hours. I also had an unsettled stomach and my heart seemed to be beating faster than normal. I was extremely tired until early afternoon the next day.
Age: 52.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Two vaccines administered on same day.  Fever, muscle ache, headache and exhaustion began approx. 12 hours after administration and lasted approx. 12 hours.   Fever broke approx. 12 hours after symptoms began.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes, Rash, Rash erythematous
Clinical narrative: Patient came back into the pharmacy to show me her reactions to the vaccine that she had received on Saturday afternoon. She has a half-dollar-sized red rash on the upper front portion of her right thigh. It appears to not be raised or itchy, but did appear after her vaccination. She also reports that she has a past medical history of recurrent but very infrequent oral cold sores.  Not soon after administration of the shingles vaccine, she developed a cold sore on the left corner of her mouth. These adverse events are not of concern to the patient, but she wanted to bring them both to my attention as a pharmacist.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin burning sensation
Clinical narrative: claims burning skin.   rash on hips and both arms
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain
Clinical narrative: Redness and soreness. Treated took cetirizine and cortisone cream applied the evening after. This happened hours after vaccine administration.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Client had a Trumenba at his doctor's office. Came here to get the second Men B . Gave Bexsero.  This clinic does not carry Trumenba but this nurse aware that manufacturer needs to stay the same. Oversight when looking at the Record.  There was no adverse event at this time. Explained error to the mother.
Age: 11.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Discomfort, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Parent called stating she noted Pt's Right Arm with redness at both injection sites along with pain a day after receiving vaccines. Parent stated she applied cool compresses as instructed by this Nurse for relief of discomfort. Parent stated the redness has improved on today when she called in. Stated pain is also improving. Pt no longer complaining as often like day  before. Parent also stated she notes some bruising at one injection site only which has improved since day after injection. Parent stated Pt is not disoriented or confused and is otherwise normal.   Advised Parent to continue to apply cool compress and to also administer a pain reliever to help with discomfort and seek medical assistance if Pt worsens or if she feels Pt needs to be examined. Pt verbalized understanding stating she will monitor and administer pain reliever and cool compress.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse outcome, was given wrong dose as described above
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: About 10 min after receiving the vaccination, patient felt faint and passed out while walking around in the store. EMS was called and assessed the patient. Patient was conscious and did not need to leave with EMS.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Shivers, rapid heart rate, feeling of big air bubbles up and down inside my body- mostly my legs, fatigue, nausea, severe headache, all extremities hurt, freezing cold feet, skin hot to the touch, no fever, feeling of 'blood boiling', extreme weakness.  The second day the pain was less but still there, absolutely no energy or strength, nausea, headache.  Today, third day since, still very weak and tired but pain is gone.  Upper left arm still hurts to touch.   I will not get the second shot!  Ever.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Heart rate increased, Injection site pain, Nausea, Pain in extremity, Peripheral coldness
Clinical narrative: Shivers, rapid heart rate, feeling of big air bubbles up and down inside my body- mostly my legs, fatigue, nausea, severe headache, all extremities hurt, freezing cold feet, skin hot to the touch, no fever, feeling of 'blood boiling', extreme weakness.  The second day the pain was less but still there, absolutely no energy or strength, nausea, headache.  Today, third day since, still very weak and tired but pain is gone.  Upper left arm still hurts to touch.   I will not get the second shot!  Ever.
Age: 63.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Skin warm
Clinical narrative: Shivers, rapid heart rate, feeling of big air bubbles up and down inside my body- mostly my legs, fatigue, nausea, severe headache, all extremities hurt, freezing cold feet, skin hot to the touch, no fever, feeling of 'blood boiling', extreme weakness.  The second day the pain was less but still there, absolutely no energy or strength, nausea, headache.  Today, third day since, still very weak and tired but pain is gone.  Upper left arm still hurts to touch.   I will not get the second shot!  Ever.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling Redness Hot Pain at injection site Lasting 3 days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Patient reported flu like symptoms that started approximately 5 hours after receiving the vaccination and lasted approximately 24 hours. Symptoms included muscle aches and pain. No fever was reported.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse effects reported; the Varivax was administered about two inches above the back of the child's knee; This spontaneous report was received from a registered nurse, who was also a mother of the patient and refers to a 15-month old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 03-AUG-2020, the patient was vaccinated at the pediatrician office with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose and route of administration were not reported) for prophylaxis. The nurse reported that the suspect vaccine was administered about two inches above the back of the patient's knee. No adverse effects reported. The outcome of the event was unknown.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Incorrect route of product administration; The patient has complained of no other issues; This spontaneous report was received from a pharmacist referring to a male patient of 54 years old. Information about patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.      On 17-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml  (lot # T000344 and expiration date 05-JAN-2022) via intramuscular route (Inappropriate route of vaccination) for prophylaxis. The patient did not complain of any other issues (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional adverse effects reported; administered intramuscularly instead of subcutaneously; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.   On 13-AUG-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHA, lot # S021622, expiration date 09-JAN-2021 (dose, strength and anatomical location were not reported) intramuscularly instead of subcutaneously, for prophylaxis. No additional adverse effects were reported.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Eye haemorrhage, Vomiting
Clinical narrative: Vomiting was so severe that he burst a blood vessel in his eye; severe emesis; This spontaneous report was received from a health professional (also reported as administrator) and refers to a 16-year-old male patient. The patient's medical history was not reported. His concurrent conditions included allergic rhinitis and unspecified tic disorder; he had no know allergies. Concomitant medications included unspecified over the counter (OTC) antihistamine medicine. On an unknown date in July 2020, the patient was vaccinated with unspecified hepatitis A vaccine (manufacturer unknown) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) with no issues.  On 14-AUG-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly into right arm, once for 3 doses (lot# S022598, expiration date was reported as 25-FEB-2022; exact dose and frequency were not reported) for prophylaxis (reported as vaccination). Within the first 12 hours after receiving the vaccination, he developed severe emesis. The vomiting lasted for about 24 hours after the dose and no other members of the household were ill, which led the patient's mother to believe the vomiting was a reaction to the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient's mother was nervous, because the he had 2 additional doses to go to complete the vaccination schedule. Vomiting was so severe that the patient burst a blood vessel in his eye, but he did not seek additional treatment. No lab diagnostic tests were performed.  On 15-AUG-2020, the patient recovered from the events, per mother, he seemed fine. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of broken blood vessel in eye was determined to be medically significant. 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: S022598; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncopal episode of adolescent female; This spontaneous report was received from a nurse via a company representative and refers to an adolescent female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date, reported as more than a year ago, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, she experienced syncopal episode. It was reported that the patient recovered in the office and was able to walk out to go home.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of syncope was considered to be medically significant.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, Malaise
Clinical narrative: got very sick; received two vaccines; This spontaneous report was received from a lawyer and refers to a currently 69-year-old female patient. Her concurrent conditions included unspecified rheumatic disorder, chiropractic, anxiety, bursitis of hips, back pain and arthritis. She did not smoke or use tobacco. The patient's medical history included uterine cancer treated with hysterectomy and shingles. The patient's concomitant therapies included alprazolam. Her historical vaccines included unspecified flu vaccines and zoster vaccine live (ZOSTAVAX).   On an unknown date in 2018, the patient was vaccinated with two doses of unspecified pneumococcal vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. She stated that one of the vaccines might not have been pneumonia vaccine. On an unknown date, the patient got very sick due to vaccinations. The outcome of the event was not reported.  The reporter considered the event to be related to pneumococcal vaccine (manufacturer unknown).  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1805USA005951:
Sex: U
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Headache, Tenderness
Clinical narrative: broken blood vessel in my left eye; had headaches; arm is still tender; This case was reported by a consumer via call center representative and described the occurrence of broken blood vessel in eye in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced broken blood vessel in eye (serious criteria GSK medically significant), headache and tenderness. On an unknown date, the outcome of the broken blood vessel in eye, headache and tenderness were unknown.   It was unknown if the reporter considered the broken blood vessel in eye, headache and tenderness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix a week ago and till of reporting patient's arm was tender. On the day of reporting the patient had headaches and awoke with broken blood vessel in left eye. The patient asked are these common side effects.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster, Ophthalmic herpes zoster, Paraesthesia, Rash
Clinical narrative: eye was swollen / eye was swollen shut; full blown case of shingles / IS IN MY EYE; shingles; rash was in the eyebrows; had a feeling of shots or pin pricks in the hair line; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th August 2020, 3 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced tingling. On 19th August 2020, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and rash. On 21st August 2020, the patient experienced eye swelling. The patient was treated with acyclovir and prednisone. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the shingles, rash, eye swelling and tingling were recovering/resolving.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, rash, eye swelling and tingling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported received Shingrix in left arm.  The patient reported that after the vaccine on 17th August 2020 and 18th August 2020 had a feeling of shots or pin pricks in the hair line and then rash started on right side of face and progressed to right eye on 19th August 2020.  The patient reported the rash was in the eyebrows on 20th August 2020 and her right eye was swollen on 21st August 2020. The patient reported her medical doctor diagnosed her with having Shingles on the right side of her face and on the right cornea. The patient was treated with Prednisone and Acyclovir. The patient reported her right eye was swollen shut on 22nd August 2020. The patient reported at the time of reporting the rash has dried up and the right eye was better but the Shingles had not resolved completely. The patient did not have lot number or expiration date information to provide. The patient never heard of the vaccine could give a case of it. The patient asked what were the chances it could happen ? It was very upsetting. This was the worse ever had it.  The patient asked If the patient had known this the patient would never ever had gotten. The patient did give permission to follow up with HCP.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: eye was swollen / eye was swollen shut; full blown case of shingles / IS IN MY EYE; shingles; rash was in the eyebrows; had a feeling of shots or pin pricks in the hair line; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th August 2020, 3 days after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced tingling. On 19th August 2020, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and rash. On 21st August 2020, the patient experienced eye swelling. The patient was treated with acyclovir and prednisone. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the shingles, rash, eye swelling and tingling were recovering/resolving.   It was unknown if the reporter considered the ophthalmic herpes zoster, shingles, rash, eye swelling and tingling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported received Shingrix in left arm.  The patient reported that after the vaccine on 17th August 2020 and 18th August 2020 had a feeling of shots or pin pricks in the hair line and then rash started on right side of face and progressed to right eye on 19th August 2020.  The patient reported the rash was in the eyebrows on 20th August 2020 and her right eye was swollen on 21st August 2020. The patient reported her medical doctor diagnosed her with having Shingles on the right side of her face and on the right cornea. The patient was treated with Prednisone and Acyclovir. The patient reported her right eye was swollen shut on 22nd August 2020. The patient reported at the time of reporting the rash has dried up and the right eye was better but the Shingles had not resolved completely. The patient did not have lot number or expiration date information to provide. The patient never heard of the vaccine could give a case of it. The patient asked what were the chances it could happen ? It was very upsetting. This was the worse ever had it.  The patient asked If the patient had known this the patient would never ever had gotten. The patient did give permission to follow up with HCP.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: a knot at the injection site; redness, and a knot at the injection site; she had pain; redness in face; fever; shivering; headache; fatigue; muscle aches; nausea; loss of appetite,; swelling at the injection site,; This case was reported by a consumer via call center representative and described the occurrence of red face in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, less than a day after receiving Shingrix, the patient experienced red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost and injection site swelling. In August 2020, the patient experienced injection site nodule, injection site erythema and injection site pain. In August 2020, the outcome of the red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site nodule, injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost, injection site swelling, injection site nodule, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient reported that after receiving the vaccine on Friday she had pain, redness, and a knot at the injection site and these were all still ongoing at this the time of reporting.  In August 2020, Less than a week after receiving Shingrix,the patient experienced injection site nodule, injection site erythema and injection site pain. The patient reported that on Friday, after receiving the vaccine she had swelling at the injection site, loss of appetite, nausea, muscle aches, fatigue, headache, shivering, fever, and redness in the face that all lasted about 2 days and had since resolved. The reporter consented to follow up
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: a knot at the injection site; redness, and a knot at the injection site; she had pain; redness in face; fever; shivering; headache; fatigue; muscle aches; nausea; loss of appetite,; swelling at the injection site,; This case was reported by a consumer via call center representative and described the occurrence of red face in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, less than a day after receiving Shingrix, the patient experienced red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost and injection site swelling. In August 2020, the patient experienced injection site nodule, injection site erythema and injection site pain. In August 2020, the outcome of the red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site nodule, injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost, injection site swelling, injection site nodule, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient reported that after receiving the vaccine on Friday she had pain, redness, and a knot at the injection site and these were all still ongoing at this the time of reporting.  In August 2020, Less than a week after receiving Shingrix,the patient experienced injection site nodule, injection site erythema and injection site pain. The patient reported that on Friday, after receiving the vaccine she had swelling at the injection site, loss of appetite, nausea, muscle aches, fatigue, headache, shivering, fever, and redness in the face that all lasted about 2 days and had since resolved. The reporter consented to follow up
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: a knot at the injection site; redness, and a knot at the injection site; she had pain; redness in face; fever; shivering; headache; fatigue; muscle aches; nausea; loss of appetite,; swelling at the injection site,; This case was reported by a consumer via call center representative and described the occurrence of red face in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 14th August 2020, less than a day after receiving Shingrix, the patient experienced red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost and injection site swelling. In August 2020, the patient experienced injection site nodule, injection site erythema and injection site pain. In August 2020, the outcome of the red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost and injection site swelling were recovered/resolved. On an unknown date, the outcome of the injection site nodule, injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the red face, fever, shivering, headache, fatigue, muscle pain, nausea, appetite lost, injection site swelling, injection site nodule, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient reported that after receiving the vaccine on Friday she had pain, redness, and a knot at the injection site and these were all still ongoing at this the time of reporting.  In August 2020, Less than a week after receiving Shingrix,the patient experienced injection site nodule, injection site erythema and injection site pain. The patient reported that on Friday, after receiving the vaccine she had swelling at the injection site, loss of appetite, nausea, muscle aches, fatigue, headache, shivering, fever, and redness in the face that all lasted about 2 days and had since resolved. The reporter consented to follow up
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Urticaria
Clinical narrative: localized hives type welt reaction/ type welt reaction about a three by three size on my arm; First dose of Shingrix April 11th, 2018 / Has not received the second dose; This case was reported by a physician via call center representative and described the occurrence of welts in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th April 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced welts and incomplete course of vaccination. On an unknown date, the outcome of the welts was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the welts to be related to Shingrix.  Additional information was provided as follows: The patient reported a localized hives reaction with the first dose. The patient had a huge localized hives type welt reaction, about a three by three size on her arm. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. No consent to follow up with doctor. No lot number and expiration date. No additional information was provide.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Dizziness, Fatigue
Clinical narrative: headache; terribly tired and exhausted; weak; off balance; dizziness; chills; shakes; left arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included headache.   On 14th August 2020, the patient received the 2nd dose of Shingrix. On 14th August 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity. On 15th August 2020, the patient experienced tremor, dizziness and chills. On 16th August 2020, the patient experienced headache, fatigue, weakness and balance disorder. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the tremor, headache, dizziness, chills, fatigue, weakness and balance disorder were unknown.   It was unknown if the reporter considered the pain in extremity, tremor, headache, dizziness, chills, fatigue, weakness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced left arm was sore and then it went away that day. The following night, he experienced shakes, chills, and dizziness. He went to bed and these symptoms continued on and off into the next day and then calmed down.  He then experienced a headache that was much worse than the usual headache he has had for the last 40 years (which he typically experiences 24 hours per day). The headache was much worse now and he feels somewhat weak and terribly tired and exhausted.  The reporter consent to follow up. This case has been linked with case US2020167501, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167501:
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Tremor
Clinical narrative: headache; terribly tired and exhausted; weak; off balance; dizziness; chills; shakes; left arm was sore; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included headache.   On 14th August 2020, the patient received the 2nd dose of Shingrix. On 14th August 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity. On 15th August 2020, the patient experienced tremor, dizziness and chills. On 16th August 2020, the patient experienced headache, fatigue, weakness and balance disorder. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the tremor, headache, dizziness, chills, fatigue, weakness and balance disorder were unknown.   It was unknown if the reporter considered the pain in extremity, tremor, headache, dizziness, chills, fatigue, weakness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced left arm was sore and then it went away that day. The following night, he experienced shakes, chills, and dizziness. He went to bed and these symptoms continued on and off into the next day and then calmed down.  He then experienced a headache that was much worse than the usual headache he has had for the last 40 years (which he typically experiences 24 hours per day). The headache was much worse now and he feels somewhat weak and terribly tired and exhausted.  The reporter consent to follow up. This case has been linked with case US2020167501, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020167501:
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Blood test, Eye swelling, Swelling face, Swollen tongue
Clinical narrative: face was swollen as well as her head, tongue and eyes which were shut closed; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 1-month-old female patient who received Hepatitis B vaccine for prophylaxis.   On 17th August 2020, the patient received Hepatitis B vaccine. On 17th August 2020 21:30, less than a day after receiving Hepatitis B vaccine, the patient experienced facial swelling (serious criteria hospitalization). The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the facial swelling was unknown.   It was unknown if the reporter considered the facial swelling to be related to Hepatitis B vaccine.  Additional details were reported as follows: The patient received 2nd dose of a Hep B vaccine on monday, 17th August 2020 but the patient's mother was unsure if it was Engerix.B and about 9:30 that evening, her husband noticed the left side of the baby's face was swollen as well as her head, tongue and eyes which were shut closed.  The patient was hospitalized thinking it was an allergic reaction.  She was given Benadryl which reduced the swelling.  However, the hospital ruled out an allergic reaction because her entire face wasn't swollen.  She was admitted to the hospital for testing and remains there at the time of reporting.  She was started on an antibiotic in case it was an infection but later her blood work indicated there was no infection.  The reporter did not consent to follow-up.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first dose was administered on March2019 (specific date not given).; Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 1st January 2020, 306 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not applicable for the 2nd dose. Due to pharmacist being a floating pharmacist no more patient, vaccine or reporter information could be collected. The pharmacist asked how to proceed for a second dose of Shingrix given that the first dose was administered on March 2019 (specific date not given).  The pharmacist also mentioned that the patient had experienced a Shingles outbreak on January 2020 (date not specified) and they wanted to administer a second dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.