chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: RN reported a improperly stored VARIVAX administration; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 01-OCT-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 1 dosage form, lot number T000341 and expiration date on 05-JAN-2022, for prophylaxis.         The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (°F) to 14°F with an average of 11.8°F for 31 hours. No previous temperature excursions. The call was due to digital data logger.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: an adult received "MMR administered IM not SQ."; This spontaneous report was received from a registered nurse via company representative referring to an adult patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, vaccine dosage detail, lot# and expiration date were not reported) via intramuscular (IM) not subcutaneous (SQ) for prophylaxis (incorrect route of product administration).
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: The PHN came back twicw since the last booster; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included hearing impaired.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was unknown.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix and the booster 5 years later. After receiving the last dose (booster) of Shingrix, the patient experienced post herpetic neuralgia (PHN) which came back twice since the last booster in the summer and goes away in the fall. The patient asked could I get a third booster. The patient's only concern was if Shingrix could prevent a 2nd round why could not it be used for a 3rd. After all the booster kept the PHN away for almost 5 years. The patient stated no phone call hearing impaired.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Shingrix vaccine arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received shingrix and experinced arm pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Photophobia
Clinical narrative: Feeling lightheaded; Sensitivity to light; Headache; This case was reported by a pharmacist via patient support programs and described the occurrence of light headedness in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced light headedness, photophobia and headache. On an unknown date, the outcome of the light headedness, photophobia and headache were unknown.   The reporter considered the light headedness, photophobia and headache to be related to Shingrix.  Additional details were reported as follows: The pharmacist reported the patient was feeling lightheaded, sensitivity to light, headache from last few days.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: pain at the injection site with both doses; swelling at the injection site with both doses; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip surgery. Previously administered products included Shingrix with an associated reaction of injection site pain (also experienced injection site swelling after receiving 1st dose in October 2019, refer case US2020212947). Concurrent medical conditions included degenerative joint disease.   In October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain and injection site swelling. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Nurse wanted to know that if the patient had the 1st dose of Shingrix in October 2019 but was not able to obtain the 2nd dose due to surgery and recuperation time do they now need to get both doses 1st and 2nd again with proper interval between them. The patient had received the 2nd dose within the last week and reported pain and swelling at the injection site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212947:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: had a rash to the side of the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   In 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 rash. The patient was treated with topical steroid nos (Steroid Cream) and cetirizine (Zyrtek). On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient stated that the physician suggested that patient should pick up the injection and bring it to the physician's office for them to administer, but the pharmacy said they had to administer it. In September 2020, the patient received 1st dose of Shingrix and after the injection patient had a rash to the side of the injection site. The patient went to the physician and they prescribed a steroid creme and said to take Zyrtek. Patient's 2nd dose would be due in a couple of weeks and patient wondering if it would be okay to get the 2nd dose at the pharmacy since patient had a rash after the 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Small, red, itchy rash on my abdomen; Itchy rash on my abdomen; This case was reported by a consumer via call center representative and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were unknown.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and experienced small red, itchy rash on abdomen. The informaton regarding consent to follow up not reported. No further information was available.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Intracranial pressure increased, Nausea, Pyrexia
Clinical narrative: High eye pressures in both eyes; headache; nausea; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of increased intraocular pressure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 18th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 18 hrs after receiving Shingrix, the patient experienced headache, nausea, chills and fever. On 20th October 2020, the patient experienced increased intraocular pressure. On an unknown date, the outcome of the increased intraocular pressure was unknown and the outcome of the headache, nausea, chills and fever were recovered/resolved.   It was unknown if the reporter considered the increased intraocular pressure, headache, nausea, chills and fever to be related to Shingrix.  Additional details were reported as follows: The patient received dose Shingrix and after approximately 18 hours post injection, the patient experienced fever, chills, nausea, and headache.   The events resolved after 1 day.   The patient saw his eye doctor on 20th October 2020 for a routine eye exam and it was discovered that the patient had high eye pressures in both eyes. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling cold, Headache, Nausea, Peripheral swelling
Clinical narrative: fever; headache; nausea; chills; swollen, red, warm left arm; red, warm left arm; warm left arm; first dose of Shingrix in November 2019/because of the COVID lockdown, she has not gotten her second dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, headache, nausea, chills, swelling arm, erythema of extremities, skin warm and social problem. On an unknown date, the outcome of the fever, headache, nausea, chills and swelling arm were recovered/resolved and the outcome of the erythema of extremities, skin warm and social problem were unknown.   It was unknown if the reporter considered the fever, headache, nausea, chills, swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in November 2019 but she cannot remember the exact date, but it was in her left arm, and because of the COVID lockdown, she has not gotten her second dose.  The patient states that the first dose caused her had fever, headache, nausea, chills, and a swollen, red, warm left arm which all events subsided.   The patient did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm, Social problem
Clinical narrative: fever; headache; nausea; chills; swollen, red, warm left arm; red, warm left arm; warm left arm; first dose of Shingrix in November 2019/because of the COVID lockdown, she has not gotten her second dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, headache, nausea, chills, swelling arm, erythema of extremities, skin warm and social problem. On an unknown date, the outcome of the fever, headache, nausea, chills and swelling arm were recovered/resolved and the outcome of the erythema of extremities, skin warm and social problem were unknown.   It was unknown if the reporter considered the fever, headache, nausea, chills, swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in November 2019 but she cannot remember the exact date, but it was in her left arm, and because of the COVID lockdown, she has not gotten her second dose.  The patient states that the first dose caused her had fever, headache, nausea, chills, and a swollen, red, warm left arm which all events subsided.   The patient did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain in the injection site.; redness, swelling and pain in the injection site.; swelling and pain in the injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain 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, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. Pharmacist reported that every once in a while she has a patient that received a dose of Shingrix and develops redness, swelling and pain in the injection site.  The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dyspnoea, Gait disturbance, Injection site erythema, Pain in extremity
Clinical narrative: shortness of breath; hip pain /  pain in her hips; pain in both legs / pain in her legs; she had to use a walker; swelling in both arms /  swelling in both legs; redness around injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation, hip surgery and shingles.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine in left arm and the same night after receiving the injection had swelling in both arms, redness around injection site, shortness of breath, and hip pain and all these lasted until just before the patient received the second dose of Shingrix. The pain in both legs and swelling in both legs that began the same and was still ongoing at time of reporting.  The patient applied ice to the sites of swelling.  Patient reported she had to use a walker due to the pain in her hips and legs. The patient reported she went to the ER after vaccination due to swelling in her legs.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210794:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: shortness of breath; hip pain /  pain in her hips; pain in both legs / pain in her legs; she had to use a walker; swelling in both arms /  swelling in both legs; redness around injection site; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included knee operation, hip surgery and shingles.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty were recovered/resolved.   It was unknown if the reporter considered the swelling arm, injection site erythema, shortness of breath, pain in hip, leg pain and walking difficulty to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine in left arm and the same night after receiving the injection had swelling in both arms, redness around injection site, shortness of breath, and hip pain and all these lasted until just before the patient received the second dose of Shingrix. The pain in both legs and swelling in both legs that began the same and was still ongoing at time of reporting.  The patient applied ice to the sites of swelling.  Patient reported she had to use a walker due to the pain in her hips and legs. The patient reported she went to the ER after vaccination due to swelling in her legs.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR210794:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: fever; headache; shakes; started feeling miserable; had a red, painful arm; painful arm; body aches; This case was reported by a consumer via call center representative and described the occurrence of feeling miserable in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2020, the patient received the 1st dose of Shingrix. On 16th July 2020, less than a day after receiving Shingrix, the patient experienced feeling miserable, erythema of extremities, pain in arm and general body pain. On 18th July 2020, the patient experienced fever, headache and tremor. On 20th July 2020, the outcome of the feeling miserable, erythema of extremities, pain in arm, general body pain, fever, headache and tremor were recovered/resolved.   It was unknown if the reporter considered the feeling miserable, erythema of extremities, pain in arm, general body pain, fever, headache and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient started feeling miserable, had a red, painful arm and body aches. Two days after receiving Shingrix, the patient developed fever, headache, and shakes. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: fever; headache; shakes; started feeling miserable; had a red, painful arm; painful arm; body aches; This case was reported by a consumer via call center representative and described the occurrence of feeling miserable in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2020, the patient received the 1st dose of Shingrix. On 16th July 2020, less than a day after receiving Shingrix, the patient experienced feeling miserable, erythema of extremities, pain in arm and general body pain. On 18th July 2020, the patient experienced fever, headache and tremor. On 20th July 2020, the outcome of the feeling miserable, erythema of extremities, pain in arm, general body pain, fever, headache and tremor were recovered/resolved.   It was unknown if the reporter considered the feeling miserable, erythema of extremities, pain in arm, general body pain, fever, headache and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient started feeling miserable, had a red, painful arm and body aches. Two days after receiving Shingrix, the patient developed fever, headache, and shakes. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: charlie horse/stiff neck.; charlie horse/stiff neck.; This case was reported by a pharmacist via call center representative and described the occurrence of stiff neck in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received Shingrix. On 20th October 2020, 30 min after receiving Shingrix, the patient experienced stiff neck and charley horse. On an unknown date, the outcome of the stiff neck and charley horse were not recovered/not resolved.   It was unknown if the reporter considered the stiff neck and charley horse to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A pharmacist reported that a female of unknown age received Shingrix 3 days ago from the day of reporting and about 30 minutes after the vaccination she experienced a charlie horse, stiff neck. The report was given via chat and the HCP did not provide additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: some no-local itches day after Shingrix first shot; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus 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 pruritus. The patient was treated with benadryl (nos) (Benadryl Oral). On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist believed that this patient had no history of allergy. Pharmacist called a patient was unhappy with the information that her doctor gave regarding some no-local itches day after Shingrix shot. The patient took oral Benadryl and then she was perfect.  The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: never got the second dose on time and wants to have it; first dose of Shingrix on Feb 4th, 2020. On April 16th, 2020 she developed shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 4th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 16th April 2020, 72 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix and she developed shingles.  The age at the vacination was not applicable for the 2nd dose. She recovered but never got the second dose on time which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: she has rash on both sides of her back and also on her stomach; her stomach which is red and itchy; she has rash on both sides of her back and also on her stomach which is red; did not feel well; shivering , chills; headache; shooting pain in the right arm; injection site was swollen; injection site was swollen, red, itchy and had a rash; injection site was swollen, red, itchy; injection site was swollen, red,; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 21st October 2020, 1 days after receiving Shingrix, the patient experienced malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching and injection site erythema. On 23rd October 2020, the patient experienced rash, itchy rash and red rash. On an unknown date, the outcome of the malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching, injection site erythema, rash and itchy rash were unknown and the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching, injection site erythema, rash, itchy rash and red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix her left arm and the next day she did not feel well.  She had the shivering, chills, headache, shooting pain in the right arm and the injection site was swollen, red, itchy and had a rash.  On the day of reporting she had rash on both sides of her back and on her stomach which was red and itchy. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise, Pain in extremity, Rash erythematous, Rash pruritic
Clinical narrative: she has rash on both sides of her back and also on her stomach; her stomach which is red and itchy; she has rash on both sides of her back and also on her stomach which is red; did not feel well; shivering , chills; headache; shooting pain in the right arm; injection site was swollen; injection site was swollen, red, itchy and had a rash; injection site was swollen, red, itchy; injection site was swollen, red,; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 21st October 2020, 1 days after receiving Shingrix, the patient experienced malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching and injection site erythema. On 23rd October 2020, the patient experienced rash, itchy rash and red rash. On an unknown date, the outcome of the malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching, injection site erythema, rash and itchy rash were unknown and the outcome of the red rash was not recovered/not resolved.   It was unknown if the reporter considered the malaise, shivering, headache, pain in arm, injection site swelling, injection site rash, injection site itching, injection site erythema, rash, itchy rash and red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix her left arm and the next day she did not feel well.  She had the shivering, chills, headache, shooting pain in the right arm and the injection site was swollen, red, itchy and had a rash.  On the day of reporting she had rash on both sides of her back and on her stomach which was red and itchy. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Braking out both legs slightly above both ankles /  big clusters and small clusters near ankle; looks like chicken pox; This case was reported by a consumer via call center representative and described the occurrence of skin breakout in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 16th October 2020, the patient received the 2nd dose of Shingrix. On 21st October 2020, 5 days after receiving Shingrix, the patient experienced skin breakout and vesicular rash. On an unknown date, the outcome of the skin breakout was not recovered/not resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the skin breakout and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Consumer reported and received 2nd dose of Shingrix last Friday from date of reporting and began breaking out on Wednesday on both legs slightly above both ankles that looks like chicken pox.  First assumed to be a mosquito bite, but then spread and concluded not a mosquito bite.  Break out extended midway up right leg big clusters and small clusters near ankle.  On left leg couple of clusters in middle of leg.  Breakout was not sore, painful or itchy. The reporter consented to follow up. This case was 1 of the 3 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020212045:same reporter US-GLAXOSMITHKLINE-US2020AMR212682:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site erythema, Injection site swelling, Rash
Clinical narrative: Shingles rash / on her back, under arm and chest; Shingles rash / on her back, under arm and chest; swelling at the injection site/arm swollen; redness at the injection site/redness; feeling like she had the flu/flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix. On 25th September 2020, 2 days after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On 26th September 2020, the patient experienced influenza-like symptoms. On 27th September 2020, the patient experienced shingles and rash. On an unknown date, the outcome of the injection site swelling, injection site erythema and influenza-like symptoms were recovered/resolved and the outcome of the shingles and rash were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, influenza-like symptoms, shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced swelling and redness at the injection site two days after administration Shingrix that lasted 2 days. 3 days following administration, she reported feeling like she had the flu which lasted 2 days.  4 days after administration, a shingles rash presented on her back, under arm and chest on the left side of her body.  The rash was resolving. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Condition aggravated
Clinical narrative: Joint aches; had Arthritis before getting Shingrix and that it got worst; This case was reported by a physician via call center representative and described the occurrence of joint pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (before getting Shingrix).   On 23rd September 2020, the patient received the 1st dose of Shingrix. In September 2020, 1 week after receiving Shingrix, the patient experienced joint pain and arthritis aggravated. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the joint pain and arthritis aggravated were unknown.   The reporter considered the joint pain and arthritis aggravated to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Doctor reported that a patient received the 1st dose of Shingrix and 1 week later started to experienced joint aches.  Doctor also said that the patient already had Arthritis before getting Shingrix and that it got worst so after the side effects he started taking Steroids. Doctor did not want to reported the event because he did not think the symptoms were related. The reporter did not consent to follow-up.
Sex: U
Vaccine: FLU4
Symptoms: C-reactive protein increased
Clinical narrative: C-reactive protein was 56 times the normal level; Initial information was received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient (unknown demographics) whose C-reactive protein was 56 times the normal level (C-reactive protein increased), while he/she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2020 at 15:00, the patient received 0.7 mL(once) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 16-Oct-2020 at 10:00, the patient's C-reactive protein was 56 times the normal level (C-reactive protein increased) 2 days 19 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory test results included: C-reactive protein - On 16-Oct-2020:  [C-reactive protein was 56 times the normal level]. It was also reported that physician states all the past C Reactive Protein levels for this patient have been normal.  It was not reported if the patient received any corrective treatment.  Outcome: Not applicable  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUC4
Symptoms: Adverse reaction, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Redness; Swelling; Reaction on the posterior deltoid area; Itching; This spontaneous case was received on 21-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04044) with additional document received on the same day (being processed together) form other non-health professional via Med Communications (reference number: SEQW20-04036) and concerned a patient of unknown age and gender.   The patient had no relevant medical history and was not taking any concomitant medications.    On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for flu prevention. The batch number reported was 283847, expiry date: 30-Jun-2021.    On the same date, the patient experienced redness, swelling, itching, and a reaction on the deltoid posterior area.  On an unknown date in Oct-2020, the patient was admitted to the hospital due to the events. The patient was treated with clindamycin intramuscularly, dexamethasone intramuscularly and Benadryl (diphenhydramine hydrochloride).   At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the events and was still hospitalized.   The reporter assessed the case as serious due to hospitalization.   This case is linked to cases 202005385, 202005362 and 202005363 (the same reporter).  Company comment:The patient developed erythema, swelling, adverse reaction (reported as "reaction on the deltoid posterior area") and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed erythema, swelling, adverse reaction (reported as "reaction on the deltoid posterior area") and pruritus on the same date after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient had no relevant medical history and was not taking any concomitant medications. Considering all above mentioned, causal relationship for the event of adverse reaction is assessed as unassessable, while for all other events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Age: 28.0
Sex: F
Vaccine: FLUA3
Symptoms: Cough, Dyspnoea, Loss of personal independence in daily activities, Nasal congestion, Pain
Clinical narrative: The patient received the vaccine in the left deltoid muscle and developed a fever at home after the vaccine.  She felt very achy and was unable to get out of bed for a while.  "She was down and out for a week."  She noted congestion and shortness of breath.  She notes a cough. The symptoms continued for a month and she did not feel back to her normal self for 8 months.  She denies itching or redness.
Age: 28.0
Sex: F
Vaccine: FLUA3
Symptoms: Pyrexia
Clinical narrative: The patient received the vaccine in the left deltoid muscle and developed a fever at home after the vaccine.  She felt very achy and was unable to get out of bed for a while.  "She was down and out for a week."  She noted congestion and shortness of breath.  She notes a cough. The symptoms continued for a month and she did not feel back to her normal self for 8 months.  She denies itching or redness.
Age: 57.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: Muscle pain, headache, shivering, fever, nausea, weakness, loss of appetite, dizziness
Age: 57.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle pain, headache, shivering, fever, nausea, weakness, loss of appetite, dizziness
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Contusion, Erythema, Nausea, Pain
Clinical narrative: Called 10/28 to report "nausea and red bruised arm from rec'ing pneumonia shot 10/26 , also had chills last night" Reported redness to arm with no itching and no fever.  Called 10/29 to report she was seen at a clinic she works at and given cephalexin for potential cellulitis. Had redness from right shoulder to elbow, swelling (mild to moderate), tight skin, and warmth to arm. Very painful to touch and to move.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Called 10/28 to report "nausea and red bruised arm from rec'ing pneumonia shot 10/26 , also had chills last night" Reported redness to arm with no itching and no fever.  Called 10/29 to report she was seen at a clinic she works at and given cephalexin for potential cellulitis. Had redness from right shoulder to elbow, swelling (mild to moderate), tight skin, and warmth to arm. Very painful to touch and to move.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Oral mucosal blistering, Oral pain, Palatal swelling
Clinical narrative: Blisters on gumline, extreme nerve sensitivity on upper roof of mouth with swelling, unable to wear dentures.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old patient incorrectly given influenza vaccine.  Patient should not have received this vaccine until 6 months old.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Swelling
Clinical narrative: 5 inch red circle, raised, hard, painful
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Myalgia, Nausea
Clinical narrative: headache, nausea, dizziness, muscle soreness
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient has not experienced any additional side effects; they made a mistake and accidentally gave a dose of hepA to a 4-day old.; This spontaneous report has been received from a medical assistant via a company representative, referring to a patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      The reporter stated that on 22-OCT-2020, they made a mistake and accidentally gave a dose of hepatitis a vaccine, inactivated (VAQTA) (lot #, expiration date, route and dose details were unknown) to this patient prophylaxis (product administered to patient of inappropriate age). The patient had not experienced any additional side effects. The reporter wanted to know all the steps they need to take and if the child would be ok to get vaccinated with hepatitis b vaccine in a week.
Sex: F
Vaccine: VARZOS
Symptoms: Laryngeal oedema, Lip swelling
Clinical narrative: laryngeal swelling; swollen lips; This case was reported by a pharmacist via sales rep and described the occurrence of laryngeal edema in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   In July 2020, the patient received Shingrix and PREVNAR. In July 2020, 2 hrs after receiving Shingrix, the patient experienced laryngeal edema (serious criteria GSK medically significant) and lip swelling. On an unknown date, the outcome of the laryngeal edema and lip swelling were unknown.   It was unknown if the reporter considered the laryngeal edema and lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 64 or 65 years. The patient received Shingrix vaccine and Prevnar vaccine at the same time at the end of July and experienced swollen lips and laryngeal swelling within 2 hours of vaccination. It was unknown if the reporter considered the laryngeal edema and lip swelling to be related to Prevnar vaccine.  The permission to follow-up was denied.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash erythematous, Rash pruritic, Varicella
Clinical narrative: blisters / on the stomach and on both arms and feet; blisters looked like chicken pox.; rash / on the back of the neck / extended to the head / abdomen and waist; rash was red; itching/The rash was red, and itching.; This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix (intramuscular). In July 2020, 2 days after receiving Shingrix, the patient experienced chickenpox, rash, red rash and itchy rash. In August 2020, the patient experienced blister. The patient was treated with triamcinolone (Triamcinolone Cream). On an unknown date, the outcome of the chickenpox, rash, red rash, itchy rash and blister were unknown.   It was unknown if the reporter considered the chickenpox, rash, red rash, itchy rash and blister to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid intramuscularly and 2 days later a rash developed on the back of the neck which extended to the head.  There was also rash on the left side of the abdomen and waist.  The rash was red, and itching.  Two weeks later blisters were noted on the stomach and on both arms and feet.  The pharmacist stating the blisters looked like chicken pox.  The patient was seen by a doctor and was prescribed triamcinolone cream but the patient was still itching.  The pharmacist was stating the adverse events had not resolved but had actually gotten worse. The reporter did not consent to follow up.