chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TD, VARZOS
Symptoms: Discomfort, Feeling abnormal, Insomnia, Pain, Pain in extremity
Clinical narrative: arm pain; fall asleep; Discomfort; General body pain; feeling like a truck ran you over and over and over; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DIPHTHERIA TOXOID + TETANUS TOXOID (TD) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and TD. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, sleeplessness, discomfort, general body pain and feeling abnormal. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the pain in arm, sleeplessness, discomfort, general body pain and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the pain in arm, sleeplessness, discomfort, general body pain and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient both arms were achy but right arm hurt worse, hard to fall asleep with the discomfort. The patient stated that what was worse was the all over body ache I had when I awoke. The patient felt like a truck ran you over and over and over from top to bottom. The reporter was did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: FLU4
Symptoms: Drug hypersensitivity, Swelling face, Urticaria
Clinical narrative: allergic; Covered in hives; Swelling in my face; This case was reported by a consumer via interactive digital media and described the occurrence of drug allergy in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included cold and influenza. Previously administered products included Proair.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced drug allergy, hives and facial swelling. On an unknown date, the outcome of the drug allergy, hives and facial swelling were unknown.   It was unknown if the reporter considered the drug allergy, hives and facial swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had only pro air and nebulizer to fall back on and tried to avoid cold and flu. The patient reported that, after vaccination had very allegic to flu shot and covered in hives, and swelling on face past 2 times. This case has been linked with case US2019AMR167075, reported by the same reporter.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Miliaria, Rash, Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: Rash that is red, itchy, warm to touch; rash itchy; warm to touch; developed another rash on the left elbow; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoporosis. Concomitant products included denosumab (Prolia).   On 1st September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced red rash, itchy rash, heat rash, rash and raised rash. On an unknown date, the outcome of the red rash was not recovered/not resolved and the outcome of the itchy rash, heat rash and raised rash were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the red rash, itchy rash, heat rash, rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix and 3 days later she developed a raised itchy area on the side of her left hand. Once this rash resolved, the patient developed another rash on the left elbow. This rash resolved and then the patient developed a rash on the right elbow that was red, itchy, warm to touch and 3 inches in diameter. The reporter consented to follow up.  The caller did not provide any additional details.
Age: 76.0
Sex: F
Vaccine: MEA, VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Redness; Arm swelling; Severe Pain; Unable to use Left arm for a couple of days; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included measles virus vaccine live attenuated (Measles Vaccine) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Measles Vaccine at an unknown dose and frequency. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the erythema of extremities, swelling arm, pain in arm and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pain in arm and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter asked how to proceed with the 2nd dose. The patient after receiving 1st dose experienced local reaction of redness, swelling, severe pain and unable to use her Left Arm for a couple days. The patient 2 weeks prior received a measles vaccination. The reporter asked for any information available to continue series or any drug interaction with the measles vaccination. The reporter consented to follow up. This case has been linked with case US2019165633, reported by the same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: blister below his belly button; This case was reported by a consumer via call center representative and described the occurrence of blister in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix. On 8th September 2019, 7 days after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she developed a blister below his belly button. She reported that he was going to see his physician this week and would inform about the blister. The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Rash, Rash vesicular
Clinical narrative: redness at injection site; swelling at injection site; lump at injection site; Full body rash (from head to toe).; Rash looks a little like chickenpox; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 19th November 2021) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site lump, generalized rash and varicella. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, generalized rash and varicella were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, generalized rash and varicella to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced redness, swelling and a lump at the injection site. The patient also experienced full body rash (from head to toe). The reporter stated that the rash looked a little like chickenpox. The patient was taking over the counter Tylenol and Benadryl for the symptoms. The emergency room visit was required. The reporter did not provide any additional information.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: Sunburn feeling of her skin; This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2019, the patient received the 1st dose of Shingrix. On 8th June 2019, less than a day after receiving Shingrix, the patient experienced burning sensation skin. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the burning sensation skin was recovering/resolving.   It was unknown if the reporter considered the burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient had sunburn feeling of her skin after receiving vaccine. The patient had no redness, rash or bumps, just a feeling of a sunburn on her back. The reporter consented to follow up. For tolerance to the VALTREX, refer case US2019166358.
Sex: F
Vaccine: FLUX
Symptoms: Back pain
Clinical narrative: Severe Back Pain; This case was reported by a consumer via call center representative and described the occurrence of back pain in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included open heart surgery. Previously administered products included Flu vaccine with an associated reaction of malaise (received flu vaccine in 1976 and reaction ill ). Concurrent medical conditions included allergy to antibiotic (allergic to neomycin) and penicillin allergy.   On an unknown date, the patient received Flu vaccine. On an unknown date, several years after receiving Flu vaccine, the patient experienced back pain. On an unknown date, the outcome of the back pain was resolved with sequelae.   It was unknown if the reporter considered the back pain to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that approximately 10 years before the reporting date, she received a flu vaccine and experienced severe back pain that lasted 48 hours. The patient did not consent to follow up. The patient did not provide any additional details.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Goose Egg; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was recovered/resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The healthcare professional stated that, the patient had a goose egg that lasted for 2 to 3 days. The reporter did not consent to follow up. The healthcare professional declined to provide any additional information. The healthcare professional declined follow up regarding the case. This case is 1 of the 2 linked cases, reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Up and down red sports and the spots are raised; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of erythromacular rash in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, 3 days after receiving Shingrix, the patient experienced erythromacular rash and raised rash. On an unknown date, the outcome of the erythromacular rash and raised rash were recovering/resolving.   It was unknown if the reporter considered the erythromacular rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on left arm. The patent developed a rash on both of his legs. The rash was on the entire legs and the patient described it as up and down red sports and the spots are raised. The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient developed shingles after first dose of Shingrix. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Nausea; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 81-year-old 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 day after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was recovered/resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter's father experienced nausea the next day after receiving the first dose of the Shingrix vaccine.  The nausea resolved within one day. The reporter unable to obtain additional details. The reporter was unable to provide additional details. This was 1 of 4 linked cases reported by the same reporter.
Age: 78.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Acupuncture, Headache, Nausea, Neck pain, Pain in extremity
Clinical narrative: Sharp pain in both arms,  and by the neck; Sharp pain in both arms,  and by the neck; headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen (Advil) for pain.   On 16th August 2019, the patient received the 1st dose of Shingrix. In August 2019, the patient started Advil at an unknown dose and frequency. In August 2019, less than 2 months after receiving Shingrix, the patient experienced nausea. On 19th August 2019, the patient experienced pain in arm, neck pain and headache. The action taken with Advil was unknown. On an unknown date, the outcome of the pain in arm, neck pain, headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, neck pain, headache and nausea to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The patient stated that approximately 3 days after receiving the vaccine, she developed sharp pain in both arms, and by the neck.  The patient also developed a headache. Patient stated that she went to see her doctor and received acupuncture to help with the pain, however, this did not resolve the pain.  The patient stated that she was also taking Advil and other pain medications for the pain, which were not helping. On an unknown date, less than 2 months after receiving a dose of Shingrix, Advil and pain medications, the patient was also experiencing nausea that she believed was caused by the pain medications. The reporter considered the nausea to be related to Advil and pain medication as well. It was reported that emergency room visit required. The contact information not available at the time of the call. The reporter did not provided any additional information. The reporter consented to follow up. This case had been linked to the case US2019166404, reported by same reporter. In the XML document outcome of events was reported as recovering, but in Argus its mentioned as not recovered, so kept as reported in Argus.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Mobility decreased, Pyrexia, Tachycardia
Clinical narrative: fever; tachycardia; fatigue; headache; difficulty getting out of bed; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 2G2T7, expiry date 15th November 2021) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, less than a week after receiving Shingrix, the patient experienced fever, tachycardia, fatigue, headache and mobility decreased. In September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tachycardia, fatigue, headache and mobility decreased were unknown.   It was unknown if the reporter considered the fever, tachycardia, fatigue, headache and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient experienced fever, which was resolved, and had tachycardia, fatigue, headache, difficulty getting out of bed. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Balance disorder, Diarrhoea, Disorientation, Dizziness
Clinical narrative: diarhea; loss of balance; disoriented; food allergy; nausea; feeling faint; low grade fever; stomach pain; tired/sleepy; Sleepiness; malaise; hives; Itchy; This case was reported by a consumer via call center representative and described the occurrence of food allergy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 3 days after receiving Shingrix, the patient experienced hives and pruritus. On 27th August 2019, the patient experienced food allergy, nausea, felt faint, low grade fever, stomach pain, tiredness, sleepiness and malaise. On 9th September 2019, the patient experienced diarrhea, loss of balance and disorientation. The patient was treated with benadryl (nos) (Benadryl), topical steroid nos (Steroid Cream) and eucerin (nos) (Eucerin Cream). On 6th September 2019, the outcome of the low grade fever was resolved with sequelae. On an unknown date, the outcome of the food allergy was unknown and the outcome of the nausea, felt faint, hives, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance and pruritus were recovering/resolving and the outcome of the disorientation was resolved with sequelae.   It was unknown if the reporter considered the food allergy, nausea, felt faint, hives, low grade fever, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance, disorientation and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed nausea, faintness, low grade fever, stomach pain, tired/sleepy, malaise. The patient developed itchy hives 3-4 days after her dose 1 and they are still ongoing and in a variety of locations. The patient went to the doctors regarding these symptoms on 9/6/19 and was diagnosed with food allergies, patient disagrees with this diagnosis. The patient was prescribed benadryl at bedtime, and a steroid cream for the hives. The patient stated that had diarrhea, loss of balance and disorientation. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Food allergy, Malaise, Nausea, Pruritus
Clinical narrative: diarhea; loss of balance; disoriented; food allergy; nausea; feeling faint; low grade fever; stomach pain; tired/sleepy; Sleepiness; malaise; hives; Itchy; This case was reported by a consumer via call center representative and described the occurrence of food allergy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 3 days after receiving Shingrix, the patient experienced hives and pruritus. On 27th August 2019, the patient experienced food allergy, nausea, felt faint, low grade fever, stomach pain, tiredness, sleepiness and malaise. On 9th September 2019, the patient experienced diarrhea, loss of balance and disorientation. The patient was treated with benadryl (nos) (Benadryl), topical steroid nos (Steroid Cream) and eucerin (nos) (Eucerin Cream). On 6th September 2019, the outcome of the low grade fever was resolved with sequelae. On an unknown date, the outcome of the food allergy was unknown and the outcome of the nausea, felt faint, hives, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance and pruritus were recovering/resolving and the outcome of the disorientation was resolved with sequelae.   It was unknown if the reporter considered the food allergy, nausea, felt faint, hives, low grade fever, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance, disorientation and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed nausea, faintness, low grade fever, stomach pain, tired/sleepy, malaise. The patient developed itchy hives 3-4 days after her dose 1 and they are still ongoing and in a variety of locations. The patient went to the doctors regarding these symptoms on 9/6/19 and was diagnosed with food allergies, patient disagrees with this diagnosis. The patient was prescribed benadryl at bedtime, and a steroid cream for the hives. The patient stated that had diarrhea, loss of balance and disorientation. The patient did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence, Urticaria
Clinical narrative: diarhea; loss of balance; disoriented; food allergy; nausea; feeling faint; low grade fever; stomach pain; tired/sleepy; Sleepiness; malaise; hives; Itchy; This case was reported by a consumer via call center representative and described the occurrence of food allergy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 3 days after receiving Shingrix, the patient experienced hives and pruritus. On 27th August 2019, the patient experienced food allergy, nausea, felt faint, low grade fever, stomach pain, tiredness, sleepiness and malaise. On 9th September 2019, the patient experienced diarrhea, loss of balance and disorientation. The patient was treated with benadryl (nos) (Benadryl), topical steroid nos (Steroid Cream) and eucerin (nos) (Eucerin Cream). On 6th September 2019, the outcome of the low grade fever was resolved with sequelae. On an unknown date, the outcome of the food allergy was unknown and the outcome of the nausea, felt faint, hives, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance and pruritus were recovering/resolving and the outcome of the disorientation was resolved with sequelae.   It was unknown if the reporter considered the food allergy, nausea, felt faint, hives, low grade fever, stomach pain, tiredness, sleepiness, malaise, diarrhea, loss of balance, disorientation and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed nausea, faintness, low grade fever, stomach pain, tired/sleepy, malaise. The patient developed itchy hives 3-4 days after her dose 1 and they are still ongoing and in a variety of locations. The patient went to the doctors regarding these symptoms on 9/6/19 and was diagnosed with food allergies, patient disagrees with this diagnosis. The patient was prescribed benadryl at bedtime, and a steroid cream for the hives. The patient stated that had diarrhea, loss of balance and disorientation. The patient did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Scab
Clinical narrative: Shingles (that are scabbed over); developed shingles (that were scabbed over); This case was reported by a nurse via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles and scab. On an unknown date, the outcome of the shingles and scab were unknown.   It was unknown if the reporter considered the shingles and scab to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 74 or 75 years. The patient was unable to receive the 2nd dose at the recommended time frame due to surgery with complications.  The patient had since developed shingles (that were scabbed over) and reporter was inquiring when he should receive the 2nd dose or if he should restart the series. The patient had knee surgery, which she states was unrelated to him receiving Shingrix.  The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angioedema, Antinuclear antibody positive, Complement fixation test positive, Joint swelling, Laboratory test normal
Clinical narrative: positive complement titer; swelling; Lip swelling; swelling on eyelids; ankle swelling; positive ANA titer; angeoedema; urticaria; rash; This case was reported by a consumer via sales rep and described the occurrence of angioedema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In February 2019, less than 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), chronic urticaria and rash. In May 2019, the patient experienced antinuclear antibody positive. On an unknown date, the patient experienced complement fixation test positive, facial swelling, lip swelling, swelling of eyelid and ankle swelling. On an unknown date, the outcome of the angioedema, chronic urticaria and rash were not recovered/not resolved and the outcome of the antinuclear antibody positive, complement fixation test positive, facial swelling, lip swelling, swelling of eyelid and ankle swelling were unknown.   It was unknown if the reporter considered the angioedema, chronic urticaria, rash, antinuclear antibody positive, complement fixation test positive, facial swelling, lip swelling, swelling of eyelid and ankle swelling to be related to Shingrix. It was unknown if the reporter considered the complement fixation test positive to be related to Shingrix.  Additional details were provided as follows: The case was reported by the field representative, who was also the patient. At the end of February 2019, the patient experienced a rash and chronic urticaria with angioedema. Her face, lips, eyelids and ankles swell and this happened daily.  In May 2019, she saw an allergist and had a positive antinuclear antibody (ANA) titer. The patient also saw a rheumatologist, but all the tests for autoimmune diseases were negative except for a positive complement factor, which she expected with the reaction she had.      Lab Comments: on an unknown date, all the tests for autoimmune diseases were negative
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Rash, Swelling face, Swelling of eyelid, Urticaria chronic
Clinical narrative: positive complement titer; swelling; Lip swelling; swelling on eyelids; ankle swelling; positive ANA titer; angeoedema; urticaria; rash; This case was reported by a consumer via sales rep and described the occurrence of angioedema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In February 2019, less than 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), chronic urticaria and rash. In May 2019, the patient experienced antinuclear antibody positive. On an unknown date, the patient experienced complement fixation test positive, facial swelling, lip swelling, swelling of eyelid and ankle swelling. On an unknown date, the outcome of the angioedema, chronic urticaria and rash were not recovered/not resolved and the outcome of the antinuclear antibody positive, complement fixation test positive, facial swelling, lip swelling, swelling of eyelid and ankle swelling were unknown.   It was unknown if the reporter considered the angioedema, chronic urticaria, rash, antinuclear antibody positive, complement fixation test positive, facial swelling, lip swelling, swelling of eyelid and ankle swelling to be related to Shingrix. It was unknown if the reporter considered the complement fixation test positive to be related to Shingrix.  Additional details were provided as follows: The case was reported by the field representative, who was also the patient. At the end of February 2019, the patient experienced a rash and chronic urticaria with angioedema. Her face, lips, eyelids and ankles swell and this happened daily.  In May 2019, she saw an allergist and had a positive antinuclear antibody (ANA) titer. The patient also saw a rheumatologist, but all the tests for autoimmune diseases were negative except for a positive complement factor, which she expected with the reaction she had.      Lab Comments: on an unknown date, all the tests for autoimmune diseases were negative
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Tinnitus
Clinical narrative: Noticed very high pitched ringing in both ears about 3.5 hours after injection. Ringing in both ears persists 22 hours after injection.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Diet refusal, Rash, Vomiting
Clinical narrative: Severe Rash on Sept 15, vomiting and refusal to eat, diarrhea. It is now 15 days after the vaccine and the rash is looking better but the vomiting and diarrhea continue. We have been to urgent care and also the Pediatrician who are recommending just treating the symptoms.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Red bullseye around vaccination site 1.5-2 hours after, swollen and red next morning
Age: 84.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Patient's right arm is red, swollen, hot, and hard to the touch.
Age: 64.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: OUTSIDE OF FDA APPROVED AGE RANGE
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Arthralgia, Gait disturbance, Malaise
Clinical narrative: Mother brought in patient for flu vaccine and 2nd dose of Trumenba. Mother called in the afternoon concerned for son. Mother states that he has malaise, joint pain specifically to knees and ankles. Has trouble walking because they ache.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Malaise, Nausea
Clinical narrative: Patient called pharmacy on Tuesday 9-10-2019 to report severe fatigue, nausea, malaise and following vaccination on the morning of 9-9-19. Per follow-up conversations, symptoms took about seven days to resolve.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash pruritic
Clinical narrative: Severe rash extendind from right shoulder, across chest and to the left shoulder. Also rash spots on both hands and inbetween index fingers and middle fingers. Patient states it came up about one month after the vaccine. States it itches, but does not give a burning sensation. Doctor is treating with Valcyclovir 1 gram by mouth twice a day for 7 days.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Mobility decreased, Nausea, Peripheral swelling
Clinical narrative: 24 hours later felt nauseated, projectile vomited down to yellow vile. Called the doctor and told to take Tylenol and rest. Took some Emetrol and Pedialyte.  Arm was swollen from deltoid halfway down; it was hard, hot, red and couldn't move arm.  Used ice/gel packs and took 2 Ibuprofen tablets 400mg but did not help.  Slept a lot.  Can move arm a little bit but it is warm and not as swollen on deltoid.  Will follow-up with doctor in 1 month.   Recovery at 85%
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Somnolence, Vomiting, Vomiting projectile
Clinical narrative: 24 hours later felt nauseated, projectile vomited down to yellow vile. Called the doctor and told to take Tylenol and rest. Took some Emetrol and Pedialyte.  Arm was swollen from deltoid halfway down; it was hard, hot, red and couldn't move arm.  Used ice/gel packs and took 2 Ibuprofen tablets 400mg but did not help.  Slept a lot.  Can move arm a little bit but it is warm and not as swollen on deltoid.  Will follow-up with doctor in 1 month.   Recovery at 85%
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Ageusia, Computerised tomogram head normal, Facial paralysis, Headache, Magnetic resonance imaging brain normal
Clinical narrative: Onset of ageusia, neck pain and headache within 12 hours of receipt of vaccine dose.  Symptoms persisted and within 48 hours unilateral facial paralysis noted.  Evaluated via an emergency department and given diagnosis of Bell's Palsy.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Neck pain
Clinical narrative: Onset of ageusia, neck pain and headache within 12 hours of receipt of vaccine dose.  Symptoms persisted and within 48 hours unilateral facial paralysis noted.  Evaluated via an emergency department and given diagnosis of Bell's Palsy.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Chest pain, Dyspnoea, Facial pain, Induration
Clinical narrative: 09/16/19 pain on right side of face and chest, shortness of breath around 11pm 09/17/19 swelling in right arm, pain in right side of chest and torso. Temp 100.8 Tylenol was taken and  ice packs were applied to arm 09/18/19 Tylenol taken for pain and ice packs applied to right arm 09/19/19 No Tylenol take. Arm was red slightly swollen with induration
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Peripheral swelling, Skin reaction
Clinical narrative: 09/16/19 pain on right side of face and chest, shortness of breath around 11pm 09/17/19 swelling in right arm, pain in right side of chest and torso. Temp 100.8 Tylenol was taken and  ice packs were applied to arm 09/18/19 Tylenol taken for pain and ice packs applied to right arm 09/19/19 No Tylenol take. Arm was red slightly swollen with induration
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: PATIENT STATES SHE EXPERIENCED EXTRA ERYTHEMA AT THE INJECTION SITE THAT SPREAD DOWN HER ARM. SHE IS GOING TO A MEDICAL PHYSICIAN FOR FURTHER EVALUATION.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: nausea, muscle soreness, shivers, fever, headache, starting about 24 hours after injection, continuing into day 2
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient stated had hives, redness, fever, itching, swelling in left arm from shoulder to elbow.  The symptoms lasted for 3 weeks.  She is fine now and just "stuck it out".
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haemorrhage, Injection site pain
Clinical narrative: Bleeding at site of injection but resolved.  Then pain at sight of injection following day .
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Pt came with Swollen right arm,  rash, and fever. Treatment included: tylenol, Benadryl QHS, and cold compressions.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient developed redness, heat, pain, and swelling at injection site. Did not seek any medical treatment and tolerated the effects on her own.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started to itch at the site around 5pm the day of the injection.  The site was red and swollen mid bicep on 9/20/19 slightly warm to touch.  Called doctor's office and they told patient to take benadryl, & use cold compress for 15 to 30 minutes every 1 to 2 hours.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site urticaria
Clinical narrative: localized hives at injection site, appeared at 24 hours post vaccination. worsening at 48h.  treated for allergic rxn with decadron, benadryl, ranitidine
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Headache, Nausea
Clinical narrative: 2-3 hours after receiving vaccine, patient reported having headache, chills, nausea, and diarrhea.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash, Rash erythematous, Rash pustular
Clinical narrative: Patient got pustular red bumpy rash on arms and stomach after 2nd dose. It appeared a few days after receiving vaccine. After 1st dose, patient's arm swelled at the site of injection. Patient did not go to MD and self treated with benadryl.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Increased seizure frequency beginning one day after vaccination. Per patient, typically experiences 1 seizure per month; increased to 3 within a 48 hour period
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Gait inability, Headache, Neck pain, Pyrexia
Clinical narrative: He developed fever with 2-3 hours and began stating that he could not walk.  We put him to bed and called the doctor.  He said that his neck and head hurt.  He coughed a few times and later went to sleep.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Chest X-ray, Fatigue, Full blood count, Hyperhidrosis
Clinical narrative: Patient reports acute onset fever to 104, drenching sweats and intense myalgias hours after vaccine.  9 wks later, intense muscle pain, fatigue and low grade fever, occasional sweats persist.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient reports acute onset fever to 104, drenching sweats and intense myalgias hours after vaccine.  9 wks later, intense muscle pain, fatigue and low grade fever, occasional sweats persist.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Bruised arm and redness
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient called to report raised hot area after vaccination. Came up about 2 inches below vaccination site.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: 26 year old year old female who developed pain and swelling at the immunization site in her left arm after receiving the varicella vaccine two days ago.  The pain and swelling have begun to dissipate, but she is now having a rash on the left arm.  Her pain is now 2/10, located in left tricep area and is described as dull in nature.  Denies paresthesia, numbness, or motor weakness.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient broke out in a rash on the back of both elbows and the back of both knees. She contacted her prescriber and was using hydrocortisone
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema
Clinical narrative: Patient had large red spot at injection site, had flu-like symptoms that lasted 5 days after the injection. Patient had similar reaction with the first dose as well
Sex: U
Vaccine: ANTH
Symptoms: Back pain, Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Limited range of motion in arm, constant pain in arm (at/around injection site, down through arm, around shoulder and upper back); growing  red "halo" around injection site; flu like symptoms.
Sex: U
Vaccine: ANTH
Symptoms: Pain in extremity
Clinical narrative: Limited range of motion in arm, constant pain in arm (at/around injection site, down through arm, around shoulder and upper back); growing  red "halo" around injection site; flu like symptoms.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient had redness and pain at the injection site along with flu-like symptoms that lasted 3 days. Patient's husband received the same dose on the same day and did not have any reaction
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: red round rash that is itchy
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Asthenia, Chills, Headache, Lethargy, Malaise
Clinical narrative: Chills, headache, fever, muscle pain,, lethargy, nausea, lack of energy, general malaise
Age: 68.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, headache, fever, muscle pain,, lethargy, nausea, lack of energy, general malaise
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient mention that the area is red. She does not have any pain but the skin is warm to touch and red
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Enema administration, Intussusception, Vomiting, X-ray
Clinical narrative: This patient received her 4 month vaccines per protocol. One day after receiving vaccines, she developed vomiting and diarrhea. 5 days after receiving vaccines, she was diagnosed with ileocolic intussusception which was reduced with air contrast enema under fluoroscopy on 9/3/19 with no complications or sequelae.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Fatigue, Heart rate increased, Myalgia, Poor quality sleep
Clinical narrative: I felt sore muscles, fatigue, and slight chills, elevated heart rate (up to 110s) and a restless sleep.  Symptoms resolves by the middle of the next day (about 24 hours after the injection.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Inner arm swollen, red and warm to touch. Not near injection site. Stated started 1 day after vaccine.  Pt. does not believe due to injection, just wanted RPH to look at it. Says might have bumped arm somewhere. Informed pt. to go to MD to have looked at.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Sore injection site, bruised, warm, red  3" around site, all-over itching
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Condition aggravated, Dizziness, Hypertension
Clinical narrative: Patient said she felt dizzy and had her blood pressure taken and it was really high so she went to emergency room and they couldn't find anything wrong. She went to her primary care physician and he was not sure if it could have been caused by the vaccine. She is to monitor her blood pressure with the possibility of increasing her blood pressure medication
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event
Clinical narrative: No adverse events reported yet. Md aware. Said it's fine
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: local reaction to the site. Swelling, redness, and warm to touch. Patient came to pharmacy 8/20/19 to show reaction. Pharmacist advised patient to use ice packs for the swelling, ibuprofen for the pain and swelling, and benadryl at night.  Primary Dr. has been contacted and advised same course of action as the pharmacist
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Coordination abnormal, Dizziness, Hyperhidrosis, Transient ischaemic attack
Clinical narrative: on 3rd day after shot, patient experienced sweating, shivers, dizziness, incoordination, "TIA"
Age: 15.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Pyrexia, Respiratory tract infection
Clinical narrative: Respiratory Infection, Fever, tirdness
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: LARGE RED, WARM, RAISED AREA
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Vomiting
Clinical narrative: Patient became extremely dizzy, reported back to pharmacy then vomited. Symptoms began approximately 10 minutes after receiving the vaccine. He was given meclizine 25mg x2 for dizziness/unsteadiness. Approximately 20 minutes after this initial symptoms patient vomited again but stated he was less dizzy than initially.  Symptoms gradually resolved and patient left the store feeling mostly normal approximate 70 minutes after receiving the vaccine.
Age: 14.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Culture throat, Fatigue, Head discomfort, Headache, Lumbar puncture
Clinical narrative: 09/09/2019-present,  persistent headache Motrin/Advil (provided minimal relief) ,fatigue, swollen glands, fevers on & off
Age: 14.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: 09/09/2019-present,  persistent headache Motrin/Advil (provided minimal relief) ,fatigue, swollen glands, fevers on & off
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Eye pain, Malaise, Myalgia
Clinical narrative: muscle aches in BLE, dull ache behind eyes, general  malaise
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient received immunization in a seated position. After the immunization, patient stood around the immunization area for approximately 10 minutes when the patient experienced syncope and collapse. Patient was caught prior to making contact with the floor. No apparent physical injuries were present.
Age: 22.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Fall, Head injury, Loss of consciousness, Seizure, Syncope
Clinical narrative: AFTER RECIEVING THE SHOT, WITHIN 5-7 MINS, PATIENT EXPERIENCED SYNCOPY AND FELL TO THE FLOOR. ON THE WAY, SHE HIT HER HEAD AGAINST THE WALL.  SHE WAS TURNED OVER AND SHE STARTED TO SEIZURE FOR ABOUT 10 - 15 SECONDS THEN SHE REGAINED CONCIOUSNESS WITHIN 5 MINUTES.  911 WAS CONTACTED AND SHE WAS TAKEN TO ER FOR FURTHUR EVALUATION.
Age: 22.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Blood pressure abnormal, Blood test, Chest X-ray, Computerised tomogram, Fatigue
Clinical narrative: AFTER RECIEVING THE SHOT, WITHIN 5-7 MINS, PATIENT EXPERIENCED SYNCOPY AND FELL TO THE FLOOR. ON THE WAY, SHE HIT HER HEAD AGAINST THE WALL.  SHE WAS TURNED OVER AND SHE STARTED TO SEIZURE FOR ABOUT 10 - 15 SECONDS THEN SHE REGAINED CONCIOUSNESS WITHIN 5 MINUTES.  911 WAS CONTACTED AND SHE WAS TAKEN TO ER FOR FURTHUR EVALUATION.