chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Pt started having headaches since getting the flu shot, has HA approx. QOD, last an hour or so on those days, has taken Ibuprofen few times but usually self resolves, HA is bifrontal, no known hx of headaches otherwise, No red flags re pathological cause of HA. Has not had flu vaccine in the past, done this year due to MA mandate. was advised to try magnesium 600mg daily x1wk for prevention, or can continue to treat episodically as needed and to keep in touch with sxs, esp any worsening
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes simplex, Vision blurred
Clinical narrative: herpes simplex dendritic keratitis; This spontaneous report was received from a lawyer referring to a female patient (pt) of unknown age. Information regarding current condition, historical condition or concomitant medication was not reported. On or around 12-SEP-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, route, dose number, batch/lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered blurred vision and was diagnosed with herpes simplex dendritic keratitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not presented prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Herpes simplex dendritic keratitis was considered as disabling. Upon internal review, herpes simplex dendritic keratitis was considered as medically significant.
Sex: U
Vaccine: PNC13, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse event; patient received a dose of Prevnar in June 2019/ patient then received a dose of Pneumovax 23 on 10/21/2019; patient received a dose of Prevnar in June 2019/ patient then received a dose of Pneumovax 23 on 10/21/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in June 2019, the patient was vaccinated with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (route of administration, anatomical location, lot #, and expiration date were not reported), for prophylaxis. On 21-OCT-2019) (also reported as 4 months after a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13)), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 1 dose (route of administration, anatomical location, lot #, and expiration date were not reported), for prophylaxis. The patient did not have any other adverse events.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: With first injection, only had injection site soreness; This case was reported by a consumer and described the occurrence of injection site pain in a 55-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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site soreness with 1st dose. For tolerance to 2nd dose refer linked case US2020034250, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR218281:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Oral pain, Stomatitis
Clinical narrative: Very painful sores inside my mouth; This case was reported by a consumer via interactive digital media and described the occurrence of sores mouth in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced sores mouth. The patient was treated with valaciclovir hydrochloride (Valtrex) and magic mouthwash (nos) (Magic Mouthwash). The action taken with Shingrix was unknown. On an unknown date, the outcome of the sores mouth was unknown.   It was unknown if the reporter considered the sores mouth to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient had developed very painful sores inside my mouth.  The patient's primary care physician told me it was a side effect of the vaccine and put me on Valtrex and magic mouthwash.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pruritus, Pain in extremity, Peripheral swelling
Clinical narrative: painful arm; itching at the injection site; swelling of the arm below the injection site; 1 of Shingrix on September 28, 2020 / dose 2 of Shingrix on October 29, 2020; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 28th September 2020, refer case US2020218701).   On 29th October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, injection site itching, swelling arm and drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, injection site itching and swelling arm were recovering/resolving and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm, injection site itching and swelling 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 painful arm, itching at the injection site, and swelling of the arm below the injection site.  The patient received 2nd dose early, which led to shortening of vaccination schedule. The events had improved. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020218701:same reporter
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dyspnoea, Endotracheal intubation, Heart rate irregular
Clinical narrative: ill; diagnosed w/pneumonia and placed on breathing tubes; erratic and racing HR, unable to get it in control; Severe pain; muscle aches; joint pain; shivers; fever; breathing issues; This case was reported by a consumer via other manufacturer and described the occurrence of illness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix, the patient experienced illness (serious criteria hospitalization). On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing. On an unknown date, the outcome of the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing were unknown.   The reporter considered the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing to be possibly related to Shingrix.  Additional details were reported as follows: The patient became ill on the night of vaccination and was admitted to hospital for 12 to 13 days The patient also experienced severe pain, muscle aches, joint pain, shivers, fever, erratic and racing heart rate which were unable to get it in control, breathing issues. The patient stated that he was diagnosed with pneumonia and placed on breathing tubes. The patient's 5 tests for Covid came back negative. The reporter felt good possibiity related to the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Illness, Myalgia, Pain, Palpitations, Pneumonia
Clinical narrative: ill; diagnosed w/pneumonia and placed on breathing tubes; erratic and racing HR, unable to get it in control; Severe pain; muscle aches; joint pain; shivers; fever; breathing issues; This case was reported by a consumer via other manufacturer and described the occurrence of illness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix, the patient experienced illness (serious criteria hospitalization). On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing. On an unknown date, the outcome of the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing were unknown.   The reporter considered the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing to be possibly related to Shingrix.  Additional details were reported as follows: The patient became ill on the night of vaccination and was admitted to hospital for 12 to 13 days The patient also experienced severe pain, muscle aches, joint pain, shivers, fever, erratic and racing heart rate which were unable to get it in control, breathing issues. The patient stated that he was diagnosed with pneumonia and placed on breathing tubes. The patient's 5 tests for Covid came back negative. The reporter felt good possibiity related to the vaccine.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: ill; diagnosed w/pneumonia and placed on breathing tubes; erratic and racing HR, unable to get it in control; Severe pain; muscle aches; joint pain; shivers; fever; breathing issues; This case was reported by a consumer via other manufacturer and described the occurrence of illness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix, the patient experienced illness (serious criteria hospitalization). On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing. On an unknown date, the outcome of the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing were unknown.   The reporter considered the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing to be possibly related to Shingrix.  Additional details were reported as follows: The patient became ill on the night of vaccination and was admitted to hospital for 12 to 13 days The patient also experienced severe pain, muscle aches, joint pain, shivers, fever, erratic and racing heart rate which were unable to get it in control, breathing issues. The patient stated that he was diagnosed with pneumonia and placed on breathing tubes. The patient's 5 tests for Covid came back negative. The reporter felt good possibiity related to the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Injection site pain
Clinical narrative: redness; warmth; Soreness at the injection; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2020, the patient received Shingrix. On 30th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 1st November 2020, the patient experienced erythema and feeling of warmth. On an unknown date, the outcome of the injection site pain, erythema and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, erythema and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix in the left arm at a pharmacy and went into the reporter's office on the day of reporting for medical treatment.  The soreness at the injection presented on the same day after the administration.  Two days later, redness and warmth presented distal of the injection site. The reporter did not consent to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus, Rash
Clinical narrative: having pain at the injection site; redness at the injection site; A rash is moving down the arm; red pumps that are very itchy the / redness then started to get itchy; red pumps that are very itchy; rash is like urticaria; scratched; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluocinolone acetonide (Fluocinolone Cream).   On 11th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, rash, pruritus, erythema, urticaria and scratch. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the rash and pruritus were not recovered/not resolved and the outcome of the erythema, urticaria and scratch were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, rash, pruritus, erythema, urticaria and scratch to be related to Shingrix.  Additional details were provided as follows: The patient reported initially having pain and redness at the injection site but the vaccine site is good now. A rash was moving down the arm.  The reporter asked was this normal or not normal the rash was like urticaria with red pumps that are very itchy.  The patient reported, the redness then started to get itchy and scratched, and it had been moving down to the forearm area. It had been almost 2 months later and the rash with urticaria was still happening.  It has moved to the inside of the forearm area. It was like  the patient chasing it. This was my new normal.  The patient do not know if want to get the 2nd vaccine. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Scratch, Urticaria
Clinical narrative: having pain at the injection site; redness at the injection site; A rash is moving down the arm; red pumps that are very itchy the / redness then started to get itchy; red pumps that are very itchy; rash is like urticaria; scratched; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluocinolone acetonide (Fluocinolone Cream).   On 11th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, rash, pruritus, erythema, urticaria and scratch. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the rash and pruritus were not recovered/not resolved and the outcome of the erythema, urticaria and scratch were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, rash, pruritus, erythema, urticaria and scratch to be related to Shingrix.  Additional details were provided as follows: The patient reported initially having pain and redness at the injection site but the vaccine site is good now. A rash was moving down the arm.  The reporter asked was this normal or not normal the rash was like urticaria with red pumps that are very itchy.  The patient reported, the redness then started to get itchy and scratched, and it had been moving down to the forearm area. It had been almost 2 months later and the rash with urticaria was still happening.  It has moved to the inside of the forearm area. It was like  the patient chasing it. This was my new normal.  The patient do not know if want to get the 2nd vaccine. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pain in extremity, Pyrexia, Swelling
Clinical narrative: fever of 102F; Inflamed arm described as pink and puffy; Inflamed arm described as pink and puffy; inflamed arm; arm became sore; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 3rd November 2020, the patient experienced fever, tissue puffing, erythema and inflammation. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, tissue puffing, erythema, inflammation and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, tissue puffing, erythema, inflammation and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in right deltoid and that evening arm became sore.  On 3rd November 2020, the patient waking up with a fever of 102F and a sore and inflamed arm. Inflamed arm described as pink and puffy. Consumer reports taking Tylenol this morning and fever dropped down to 99.7 F. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Pain in extremity
Clinical narrative: diarrhea; pain / ran like a band to the upper back / back pain; and upper abdominal pain; arm pain; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   The patient's past medical history included tick bite, rheumatoid arthritis, connective tissue disorder, colitis (colon inflammation) and diverticulosis. Concomitant products included hydroxychloroquine and doxycycline.   On 21st October 2020, the patient received the 1st dose of Shingrix and FLUAD. On 23rd October 2020, 2 days after receiving Shingrix, the patient experienced diarrhea, upper back pain, upper abdominal pain and pain in arm. The patient was treated with loperamide hydrochloride (Imodium), ibuprofen (Advil) and steroids nos (Steroids). On an unknown date, the outcome of the diarrhea, upper back pain and upper abdominal pain were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the diarrhea, upper back pain, upper abdominal pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix vaccine in her left deltoid. She also received the flu vaccine, Fluad in the other arm on that same day.  The reporter stated she had left arm pain, for about 2.5 days and then it resolved. Two days after receiving the Shingrix vaccine, she had diarrhea and upper abdominal pain which ran like a band to the upper back.  The patient taken Immodium the 22nd October 2020, and also stopped taking meat products and then the diarrhea resolved, but she continues to have the upper abdominal and back pain.  The patient stated has a past medical history of rheumatoid arthritis, connective tissue disorder, with colitis, diverticulosis and colon inflammation. She also has a history of tick bite and thus has alpha-gal allergy.  The patient was currently taking Advil and steroid to treat the abdominal and back pain. The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rush appears on the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix. On 28th October 2020, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix was administrated to a female patient on 27th October 2020, an rush appears on the injection site on 28th October 2020. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Broke in zoster like rash; This case was reported by a other health professional via call center representative and described the occurrence of vesicular rash in a 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, 1 day after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The reporter stated that patient broke in zoster like rash day after Shingrix vaccine. The reporter also asked does this mean she should not get second shot. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Feeling abnormal
Clinical narrative: strip of redness from injection site which extendes to about 2.5 inches with  itching; strip of redness from injection site which extendes to about 2.5 inches; arm pain/ pain; soreness to the touch / tenderness / pain; loss of appetite; low energy; foggy; low grade fever of 99.8; dizziness; headache; chills; feeling more cold than normal; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer. Concurrent medical conditions included hot flashes.   On 16th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site itching, injection site erythema, pain in arm, tenderness, appetite lost, energy decreased, foggy feeling in head, fever, dizziness, headache, chills and feeling cold. On an unknown date, the outcome of the injection site itching, appetite lost, energy decreased, foggy feeling in head, dizziness, headache, chills and feeling cold were unknown and the outcome of the injection site erythema, pain in arm, tenderness and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, pain in arm, tenderness, appetite lost, energy decreased, foggy feeling in head, fever, dizziness, headache, chills and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient was a breast cancer survivor. The patient received the first dose of the Shingrix vaccine in her right arm. The patient reported right arm pain and soreness to touch and there was a strip of redness from injection site which extended to about 2.5 inches with  itching. The patient experienced headache, chills, feeling more cold than normal, low grade fever of 99.8 degree F, low energy, loss of appetite, dizziness, and foggy.  Most of the adverse event had resolved. The reporter at the time of reporting still had low grade fever, redness of the injection site of the right arm, tenderness and pain. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Injection site erythema, Injection site pruritus, Pain in extremity
Clinical narrative: strip of redness from injection site which extendes to about 2.5 inches with  itching; strip of redness from injection site which extendes to about 2.5 inches; arm pain/ pain; soreness to the touch / tenderness / pain; loss of appetite; low energy; foggy; low grade fever of 99.8; dizziness; headache; chills; feeling more cold than normal; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer. Concurrent medical conditions included hot flashes.   On 16th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site itching, injection site erythema, pain in arm, tenderness, appetite lost, energy decreased, foggy feeling in head, fever, dizziness, headache, chills and feeling cold. On an unknown date, the outcome of the injection site itching, appetite lost, energy decreased, foggy feeling in head, dizziness, headache, chills and feeling cold were unknown and the outcome of the injection site erythema, pain in arm, tenderness and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, pain in arm, tenderness, appetite lost, energy decreased, foggy feeling in head, fever, dizziness, headache, chills and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient was a breast cancer survivor. The patient received the first dose of the Shingrix vaccine in her right arm. The patient reported right arm pain and soreness to touch and there was a strip of redness from injection site which extended to about 2.5 inches with  itching. The patient experienced headache, chills, feeling more cold than normal, low grade fever of 99.8 degree F, low energy, loss of appetite, dizziness, and foggy.  Most of the adverse event had resolved. The reporter at the time of reporting still had low grade fever, redness of the injection site of the right arm, tenderness and pain. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tenderness
Clinical narrative: strip of redness from injection site which extendes to about 2.5 inches with  itching; strip of redness from injection site which extendes to about 2.5 inches; arm pain/ pain; soreness to the touch / tenderness / pain; loss of appetite; low energy; foggy; low grade fever of 99.8; dizziness; headache; chills; feeling more cold than normal; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer. Concurrent medical conditions included hot flashes.   On 16th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced injection site itching, injection site erythema, pain in arm, tenderness, appetite lost, energy decreased, foggy feeling in head, fever, dizziness, headache, chills and feeling cold. On an unknown date, the outcome of the injection site itching, appetite lost, energy decreased, foggy feeling in head, dizziness, headache, chills and feeling cold were unknown and the outcome of the injection site erythema, pain in arm, tenderness and fever were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site erythema, pain in arm, tenderness, appetite lost, energy decreased, foggy feeling in head, fever, dizziness, headache, chills and feeling cold to be related to Shingrix.  Additional details were provided as follows: The patient was a breast cancer survivor. The patient received the first dose of the Shingrix vaccine in her right arm. The patient reported right arm pain and soreness to touch and there was a strip of redness from injection site which extended to about 2.5 inches with  itching. The patient experienced headache, chills, feeling more cold than normal, low grade fever of 99.8 degree F, low energy, loss of appetite, dizziness, and foggy.  Most of the adverse event had resolved. The reporter at the time of reporting still had low grade fever, redness of the injection site of the right arm, tenderness and pain. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient receive dthe vaccine and one week later developed shingles.  He was still an active case of shingles.  No additional details were available. The reporter consented to follow up. This case has been linked with US2020220495, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220495:same reporter
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Magnetic resonance imaging normal, Migraine, Vomiting
Clinical narrative: vomiting; migraine; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2015-2016 season) (batch number 3L9LD, expiry date unknown) for prophylaxis.   In October 2015, the patient received Fluarix Quadrivalent 2015-2016 season. In October 2015, immediately after receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced vomiting and migraine headache. On an unknown date, the outcome of the vomiting and migraine headache were recovered/resolved.   It was unknown if the reporter considered the vomiting and migraine headache to be related to Fluarix Quadrivalent 2015-2016 season.  Additional details were provided as follows: The age at vaccination was not reported. In October 2015, the patient received a Fluarix shot and almost immediately began to experience migraine and vomiting. The patient was taken to the emergency department and given an unspecified cocktail of migraine drugs via intravenous and released.  The patient had a follow up with a neurologist, an Magnetic resonance imaging was taken and nothing was found.  At time of this report, the migraine and vomiting resolved after 3 weeks post injection. The patient required emergency room Visit. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash, Urticaria
Clinical narrative: soreness and redness at the injection site; soreness and redness at the injection site; hives that broke out on the back of her head and lower wrists; rashes that occurred on both arms and around the back and torso; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2020, 2 days after receiving Shingrix, the patient experienced injection site pain, injection site erythema, hives and rash. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Other Medications). On an unknown date, the outcome of the injection site pain, injection site erythema, hives and rash were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, hives and rash to be related to Shingrix.  Additional details were reported as follows: The vaccine was given on the upper left deltoid at the local pharmacy. The patient experienced soreness and redness at the injection site, hives that broke out on the back of her head and lower wrists, and rashes that occurred on both arms and around the back and torso.  She states these adverse events occurred two to three days after getting the shot and resolved since taking Benadryl and other medications.  Her doctor was not aware of these adverse events. The reporter consented to follow-up.
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: she thinks his provider gave the Prevnar 13 subq; she thinks his provider gave the Prevnar 13 subq; his arm is super red; he can't lift his arm above his shoulder; severe pain; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Nov2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer received via a sales representative. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), subcutaneous in arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient's wife reported that the patient got the shot from his primary care doctor and now the patient's arm was super red and can't lift his arm above his shoulder. It was added that it was in severe pain. The wife also reported that she  thinks that his provider gave the pneumococcal 13-val conj vac (dipht crm197 protein) subcutaneously. The outcome of the events was unknown.  No follow-up attempts are needed. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Body temperature increased, Chills, Headache, No adverse event, Pain
Clinical narrative: 103 temperature; Chills; Headache; Body aches; This is a spontaneous report from a contactable physician (Paediatrician). An 18-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Pfizer, lot number: CW2843, NDC number: 0005-0100-01), via an unspecified route of administration on 02Jul2020 at a single dose for immunization, meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, manufacture: Sanofi, lot number: U6486AC, NDC number: 49281-589-05, Expiry Date: 10Jan2021) on 02Jul2020 for immunization. Patient was received TRUMENBA and also the meningococcal conjugate at the same time too, the MENACTRA. The patient previously took meningococcal vaccine a/c/y/w conj (dip tox) for immunization, and no adverse effect. There were no medical history and no concomitant medications. On 03Jul2020, 24 hours after meningococcal group b rlp2086, the patient experienced 103 temperature, chills, headache, body aches. The outcome of events was unknown. When probed in the medical opinion of physician, does physician believe that the side effects was due to the vaccine (TRUMENBA and MENACTRA), physician thought so TRUMENBA because when physician gave her the MENACTRA when she was younger there was no side effects, this is the first side effects from this vaccine she had.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: FLUX, MEN, UNK
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; headache; temperature of 101 F; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received meningococcal group b rlp2086 (MENINGOCOCCAL GROUP B RLP2086) at single dose,  meningococcal vaccine a (MENINGOCOCCI A VACCINE) at unknown dose, and influenza vaccine (FLU VACCINE VII) at unknown dose, all via an unspecified route of administration on 10Nov2020 immunisation. The patient medical history and concomitant medications were not reported. The consumer was reporting an event that occurred after the application of Meningococcal B Vaccine. A 16-year-old female patient received the meningococcal A and B vaccine as well as the flu vaccine yesterday (on 10Nov2020). Today (on 11Nov2020) she woke up with a sore throat, headache and a temperature of 101 F. She took 2 TYLENOL EXTRA STRENGTH for symptoms. Therapeutic measures were taken as a result of sore throat, headache and a temperature of 101 F. The event outcome was unknown.  Pfizer is a marketing authorization holder of meningococcal group b rlp2086 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities.  Information on lot/batch number has been request.
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: A low fever; This is a spontaneous report from a contactable consumer.   An 18-months-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at single dose, for immunization. It was reported that the patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) and 2 other shots (unspecified). Relevant medical history and concomitant medications were unknown. On an unspecified date, at night, after the vaccination, the patient experienced low fever. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Woke up with headache and fever 101.6 and tiredness all day.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: swelling, redness, itchiness (at the beginning), and soreness
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Lethargy, Pain in extremity
Clinical narrative: Arm sore, bad headache, lethargic, temp increased to 101.6.  No medical treatment
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient described arm being more painful then his boostrix vaccine he received in the left arm within a few hours. He woke up the next day with swelling and rash down his arm. He was treated for cellulitis on 11/15/2020.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Contusion, Full blood count, Immune thrombocytopenia, Thrombocytopenia
Clinical narrative: PT CAME TO CLINIC 11-13-20 FOR UNEXPLAINED BRUISING X 3-4 DAYS AGO, LABS SHOWED THROMBOCYTOPENIA, SENT TO  ER FOR EVAL. PT DIAGNOSED WITH ITP, ER RECOMMENDS VAERS REPORT D/T THIS BEING RELATED TO MMR VACCINE.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11/14/20 Went to Pharmacy Clinic to get Dtap, IPV, MMR and Varicella vaccines.   On 11/15/20, she had adverse reaction on the left deltoid, site was red, hot and swollen.  On 11/16/20-came into PCP office, left arm was still red, swollen and hot to the touch.-Cellulitis
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: elevated pulse rate above 100 3 days
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition or concomitant medication was not provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, route, dose number, batch/lot# and expiration date were unknown) by a healthcare provider (HCP) in a clinic for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a HCP for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Rash, Rash erythematous
Clinical narrative: Red rash; diffused rash; Chest pain; Shortness of breath; This case was reported by a physician via call center representative and described the occurrence of chest pain in a 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 chest pain, shortness of breath, red rash and widespread rash. On an unknown date, the outcome of the chest pain and shortness of breath were recovered/resolved and the outcome of the red rash and widespread rash were unknown.   It was unknown if the reporter considered the chest pain, shortness of breath, red rash and widespread rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed sudden onset of chest pain and shortness of breath and a couple days later she developed a rash. The physician stated the shortness of breath and chest pain completely resolved within 2 minutes because the patient used her inhaler. The physician described rash as red and diffuse.  The outcome for rash was not provided The reporter did not provide patients initials or date of birth, lot number, or expiration date. The reporter consent to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Aphasia, Dizziness
Clinical narrative: Student tolerated shot well. Was standing by mom about 4 minutes after injection and began to stagger verbalizing that she felt dizzy.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: THE MORNING FOLLOWING THE VACCINE, HER ARM WAS SLIGHTLY SWOLLEN, SORE, AND ITCHY. SHE USED ASPERCREME AND TYLENOL WHICH ALLEVIATED THE SYMPTOMS SOME. SYMPTOMS HAVE SUBSIDED MOSTLY AFTER 4 DAYS. SHE REPORTS THIS DID NOT HAPPEN AFTER THE FIRST ONE
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Ultrasound scan normal
Clinical narrative: After 2 weeks from injection, patient developed pain, some relief with OTC Advil, some relief with Medrol dose pak, no heat nor ice, pain continues at week 3 and 4.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
Clinical narrative: patient is complaining of pain in her shoulder area
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient reported severe systemic hives ~24 hours post-injection. Did not experience any flu-like symptoms or other adverse effects. Reported the reaction as "Horrible itching." Per patient, this lasted ~2.5 days until she sought reprieve at urgent care.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Eye discharge, Eye irritation, Eye swelling, Eyelid margin crusting
Clinical narrative: Right eye started to bother me like there was something in it.  Eyes were watering and beginning to swell.  Eye lid and surrounding tissues began to swell.  It looked its' worst early in the next morning with the eyes crusted shut from discharge.  The swelling slowly began to recede and after a visit to Dr with 24 hours on Benadryl, the symptoms were gone.  Also, I had chills and fever that first night.   This was the first flu vaccination I have had in approximately 20 years.  Previous reactions  were sore arm and mild cold/flu like symptoms.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: Lacrimation increased, Pyrexia, Swelling of eyelid
Clinical narrative: Right eye started to bother me like there was something in it.  Eyes were watering and beginning to swell.  Eye lid and surrounding tissues began to swell.  It looked its' worst early in the next morning with the eyes crusted shut from discharge.  The swelling slowly began to recede and after a visit to Dr with 24 hours on Benadryl, the symptoms were gone.  Also, I had chills and fever that first night.   This was the first flu vaccination I have had in approximately 20 years.  Previous reactions  were sore arm and mild cold/flu like symptoms.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Pain of skin, Pruritus, Swelling
Clinical narrative: Patient received her flu vaccine and an hour after she states that it was itching. as the day and night went on it got really swollen and tough as well as redness. She states that it was still very itchy and hurt to the touch.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Malaise, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Left arm raised, red, painful and hot starting 11/15/20,  Both arms red Monday, low grade fever started on 11/16/20 with general feeling of malaise. Not treatment at this time.  Reported incident to Health Clinic.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Left arm raised, red, painful and hot starting 11/15/20,  Both arms red Monday, low grade fever started on 11/16/20 with general feeling of malaise. Not treatment at this time.  Reported incident to Health Clinic.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Ultrasound scan normal
Clinical narrative: Left arm is sore 2 weeks after injection, OTC Advil not helping, denies redness, swelling or warm skin.  Advised to increase ibuprofen to 400 mg every 6-8 hrs with food, apply heat to area 3 -4 times a day 20 minutes.