chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Myalgia
Clinical narrative: itchiness above her elbow; hives; tenderness; swelling; red sore spot at the injection site; red sore spot at the injection site; red sore spot at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix (intramuscular). On 16th May 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site discoloration and swelling. On 17th May 2019, the patient experienced pruritus, hives and tenderness. On 18th May 2019, the outcome of the pruritus was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site discoloration and swelling were recovering/resolving and the outcome of the hives and tenderness were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site discoloration, pruritus, hives, swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the patient.  The patient received a dose of Shingrix in left deltoid. The patient developed a red sore spot at the injection site that was 2 by 4 inches in size. She also had an area above her left ankle that was tender and swollen. She did not recall banging her ankle on any objects. On 17th May 2019, she developed severe itchiness above her elbow with hives. She also has hives on her right arm.  At the time of reporting, the redness was better and the itching lasted for 24 hours.  The patient consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: itchiness above her elbow; hives; tenderness; swelling; red sore spot at the injection site; red sore spot at the injection site; red sore spot at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix (intramuscular). On 16th May 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site discoloration and swelling. On 17th May 2019, the patient experienced pruritus, hives and tenderness. On 18th May 2019, the outcome of the pruritus was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site discoloration and swelling were recovering/resolving and the outcome of the hives and tenderness were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site discoloration, pruritus, hives, swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the patient.  The patient received a dose of Shingrix in left deltoid. The patient developed a red sore spot at the injection site that was 2 by 4 inches in size. She also had an area above her left ankle that was tender and swollen. She did not recall banging her ankle on any objects. On 17th May 2019, she developed severe itchiness above her elbow with hives. She also has hives on her right arm.  At the time of reporting, the redness was better and the itching lasted for 24 hours.  The patient consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Tenderness, Urticaria
Clinical narrative: itchiness above her elbow; hives; tenderness; swelling; red sore spot at the injection site; red sore spot at the injection site; red sore spot at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2019, the patient received Shingrix (intramuscular). On 16th May 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain, injection site discoloration and swelling. On 17th May 2019, the patient experienced pruritus, hives and tenderness. On 18th May 2019, the outcome of the pruritus was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site discoloration and swelling were recovering/resolving and the outcome of the hives and tenderness were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site discoloration, pruritus, hives, swelling and tenderness to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the patient.  The patient received a dose of Shingrix in left deltoid. The patient developed a red sore spot at the injection site that was 2 by 4 inches in size. She also had an area above her left ankle that was tender and swollen. She did not recall banging her ankle on any objects. On 17th May 2019, she developed severe itchiness above her elbow with hives. She also has hives on her right arm.  At the time of reporting, the redness was better and the itching lasted for 24 hours.  The patient consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anxiety, Injection site bruising, Injection site erythema, Injection site warmth, Pain in extremity
Clinical narrative: Injection site bruise; area is warm to the touch; doesn't feel well; Burning sensation; itching; redness on her arm below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2019, 3 days after receiving Shingrix, the patient experienced erythema of extremities. On 20th May 2019, the patient experienced burning sensation and itchy upper limbs. On 21st May 2019, the patient experienced injection site bruising, localized feeling of warmth and discomfort. On an unknown date, the outcome of the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs and discomfort were not recovered/not resolved and the outcome of the localized feeling of warmth was recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs, localized feeling of warmth and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received her 1st dose on Wednesday in unknown arm. On Saturday, 3 days after receiving Shingrix, she developed redness on her arm below the injection site. The day before reporting date, 5 days after receiving Shingrix, the red area started itching and burning. Today, at the day of reporting, 6 days after receiving Shingrix, there was a bruise at the injection site. Below the bruise, there was a 7 into 7 inch area of redness encircling an area of normal skin tone. The red area was warm to the touch and the patient generally did not feel well.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Discomfort, Erythema, Feeling hot, Injection site bruising
Clinical narrative: Injection site bruise; area is warm to the touch; doesn't feel well; Burning sensation; itching; redness on her arm below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2019, 3 days after receiving Shingrix, the patient experienced erythema of extremities. On 20th May 2019, the patient experienced burning sensation and itchy upper limbs. On 21st May 2019, the patient experienced injection site bruising, localized feeling of warmth and discomfort. On an unknown date, the outcome of the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs and discomfort were not recovered/not resolved and the outcome of the localized feeling of warmth was recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs, localized feeling of warmth and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received her 1st dose on Wednesday in unknown arm. On Saturday, 3 days after receiving Shingrix, she developed redness on her arm below the injection site. The day before reporting date, 5 days after receiving Shingrix, the red area started itching and burning. Today, at the day of reporting, 6 days after receiving Shingrix, there was a bruise at the injection site. Below the bruise, there was a 7 into 7 inch area of redness encircling an area of normal skin tone. The red area was warm to the touch and the patient generally did not feel well.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Malaise
Clinical narrative: Injection site bruise; area is warm to the touch; doesn't feel well; Burning sensation; itching; redness on her arm below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2019, 3 days after receiving Shingrix, the patient experienced erythema of extremities. On 20th May 2019, the patient experienced burning sensation and itchy upper limbs. On 21st May 2019, the patient experienced injection site bruising, localized feeling of warmth and discomfort. On an unknown date, the outcome of the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs and discomfort were not recovered/not resolved and the outcome of the localized feeling of warmth was recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs, localized feeling of warmth and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received her 1st dose on Wednesday in unknown arm. On Saturday, 3 days after receiving Shingrix, she developed redness on her arm below the injection site. The day before reporting date, 5 days after receiving Shingrix, the red area started itching and burning. Today, at the day of reporting, 6 days after receiving Shingrix, there was a bruise at the injection site. Below the bruise, there was a 7 into 7 inch area of redness encircling an area of normal skin tone. The red area was warm to the touch and the patient generally did not feel well.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Injection site bruise; area is warm to the touch; doesn't feel well; Burning sensation; itching; redness on her arm below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 86-year-old female patient who received Herpes zoster (Shingrix) (batch number NE3TG, expiry date 10th August 2021) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th May 2019, 3 days after receiving Shingrix, the patient experienced erythema of extremities. On 20th May 2019, the patient experienced burning sensation and itchy upper limbs. On 21st May 2019, the patient experienced injection site bruising, localized feeling of warmth and discomfort. On an unknown date, the outcome of the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs and discomfort were not recovered/not resolved and the outcome of the localized feeling of warmth was recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, injection site bruising, burning sensation, itchy upper limbs, localized feeling of warmth and discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received her 1st dose on Wednesday in unknown arm. On Saturday, 3 days after receiving Shingrix, she developed redness on her arm below the injection site. The day before reporting date, 5 days after receiving Shingrix, the red area started itching and burning. Today, at the day of reporting, 6 days after receiving Shingrix, there was a bruise at the injection site. Below the bruise, there was a 7 into 7 inch area of redness encircling an area of normal skin tone. The red area was warm to the touch and the patient generally did not feel well.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site inflammation, Nausea
Clinical narrative: weakness; fatigue; nausea; muscle aches; patient felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th May 2019, less than a day after receiving Shingrix, the patient experienced weakness, fatigue, nausea, muscle pain and feeling bad. On an unknown date, the outcome of the weakness, fatigue, nausea, muscle pain and feeling bad were recovering/resolving.   It was unknown if the reporter considered the weakness, fatigue, nausea, muscle pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient felt severe weakness, fatigue, nausea and muscle aches after getting Shingrix vaccine.  The patient felt bad right after the Shingrix vaccine, but the symptoms started worsening by that evening.  The patient did not want to get out of bed.  The pharmacist spoke with the patient 3 days after getting the Shingrix vaccine the symptoms were improving. The pharmacist had not spoken with the patient since, so was not sure if they had resolved or not.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Immediate post-injection reaction, Myalgia
Clinical narrative: weakness; fatigue; nausea; muscle aches; patient felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th May 2019, less than a day after receiving Shingrix, the patient experienced weakness, fatigue, nausea, muscle pain and feeling bad. On an unknown date, the outcome of the weakness, fatigue, nausea, muscle pain and feeling bad were recovering/resolving.   It was unknown if the reporter considered the weakness, fatigue, nausea, muscle pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient felt severe weakness, fatigue, nausea and muscle aches after getting Shingrix vaccine.  The patient felt bad right after the Shingrix vaccine, but the symptoms started worsening by that evening.  The patient did not want to get out of bed.  The pharmacist spoke with the patient 3 days after getting the Shingrix vaccine the symptoms were improving. The pharmacist had not spoken with the patient since, so was not sure if they had resolved or not.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea
Clinical narrative: weakness; fatigue; nausea; muscle aches; patient felt bad; This case was reported by a pharmacist via call center representative and described the occurrence of weakness in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th May 2019, less than a day after receiving Shingrix, the patient experienced weakness, fatigue, nausea, muscle pain and feeling bad. On an unknown date, the outcome of the weakness, fatigue, nausea, muscle pain and feeling bad were recovering/resolving.   It was unknown if the reporter considered the weakness, fatigue, nausea, muscle pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient felt severe weakness, fatigue, nausea and muscle aches after getting Shingrix vaccine.  The patient felt bad right after the Shingrix vaccine, but the symptoms started worsening by that evening.  The patient did not want to get out of bed.  The pharmacist spoke with the patient 3 days after getting the Shingrix vaccine the symptoms were improving. The pharmacist had not spoken with the patient since, so was not sure if they had resolved or not.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site pain, Pain
Clinical narrative: Shoulder pain; Arm mobility decreased; This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX6C1AA, expiry date 31st August 2019) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 17th May 2019, 1 days after receiving Bexsero, the patient experienced shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the shoulder pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the shoulder pain and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: The patent received 1st dose of Bexsero in left deltoid and expressed pain in the front of her left shoulder and could not move her arm.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Shoulder pain; Arm mobility decreased; This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABX6C1AA, expiry date 31st August 2019) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 17th May 2019, 1 days after receiving Bexsero, the patient experienced shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the shoulder pain and injected limb mobility decreased were unknown.   It was unknown if the reporter considered the shoulder pain and injected limb mobility decreased to be related to Bexsero.  Additional details were provided as follows: The patent received 1st dose of Bexsero in left deltoid and expressed pain in the front of her left shoulder and could not move her arm.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered
Clinical narrative: No adverse effects reported; received Expired dose of Varivax; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 20-MAY-2019, the patient was vaccinated with a dose of an expired varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, for prophylaxis lot #N015477 and expiration date18-MAY-2019 (strength, frequency and route of administration were not reported) which was reconstituted with an sterile diluent with lot numer and expiration date unknown. No adverse effects were reported.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; received Expired dose of Varivax; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 20-MAY-2019, the patient was vaccinated with a dose of an expired varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, for prophylaxis lot #N015477 and expiration date18-MAY-2019 (strength, frequency and route of administration were not reported) which was reconstituted with an sterile diluent with lot numer and expiration date unknown. No adverse effects were reported.
Age: 1.25
Sex: F
Vaccine: DTAP, DTAP, DTAP
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered from expired lot. Parent was counseled re: need for repeat of vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash outbreak on his face which spread down to both his arms and legs.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 18-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  Shortly after the vaccination (approximately in 18-NOV-2015), the patient suffered a rash outbreak on his face which spread down to both his arms and legs (widespread rash). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition.  The outcome of the event was considered unknown.  The event was considered related to zoster vaccine live (ZOSTAVAX).  Widespread rash was considered to be disabling.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine administered to a patient that is 6 months pregnant on 5/13/2019; Information has been received from a physician referring to a 19 years old female pregnant patient. The patient's medical history, concurrent condition and concomitant medication were not reported.    On 13-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, lot # and expiration date unknown) subcutaneously for prophylaxis (reported as measles) when she was 6 months pregnant (Vaccine exposure during pregnancy).  The patient's  last menstrual period (LMP) and estimated date delivery (EDD) was not reported. The outcome of the patient's pregnancy was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 64 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 26-SEP-2014, the patient was vaccinated at a Military Clinic/Hospital with a dose of zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a health care professional for the herpes zoster. The outcome of the event was not reported. The reporter considered the herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 67-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 09-OCT-2013, at the age of approximately 67-year-old, the patient was administered with zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions (lot#, expiration date, dosage and route of administration not specified). On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the time of the report, the outcome of shingles was unknown. The reporter considered that shingles was related to Zoster Vaccine Live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 75-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 2014, at the age of approximately 71-year-old, the patient was administered with zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions (lot#, expiration date, dosage and route of administration not specified). On an unknown date, the patient was treated by a physician for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. At the time of the report, the outcome of shingles was unknown. The reporter considered that shingles was related to Zoster Vaccine Live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVERSE EFFECT; patient received a dose of varivax after the vaccine had been delivered to the facility late and potentially experienced a temperature excursioin; This spontaneous report was received from a health professional (nurse) refers to a patient of age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 22-MAY-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, lot# R035223 and expiry date 04-DEC-2020, dose, frequency and anatomical location were unknown) via subcutaneous route for prophylaxis and that had been delivered to the facility late (product storage error). No adverse effects were reported. The temperature and time frame of vaccine exposure was unknown. There was no previous temperature excursion reported. Data logger was not involved. No product quality complaint (PQC) was associated with this report.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: After receiving the vaccination, she suffered a painful rash/was diagnosed with herpes zoster and postherpetic neuralgia; After receiving the vaccination, she suffered a painful rash/was diagnosed with herpes zoster and postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was administered with zoster vaccine live (ZOSTAVAX) for routine health maintenance and prevention of shingles (lot#, expiration date, dosage and route of administration not specified). After receiving the vaccination, the patient suffered a painful rash. As a result of these symptoms, she presented to a medical provider and was diagnosed with herpes zoster and postherpetic neuralgia. Thereafter, she had continued to suffer the effects of herpes zoster and postherpetic neuralgia. The reporter considered that shingles was related to Zoster Vaccine Live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Cerebrovascular accident, Speech disorder
Clinical narrative: This spontaneous report was received from a nurse via company representative concerning to a male patient of approximately 11 years old. The patient's historical conditions, concurrent condition and concomitant medications were not provided. In Fall 2018, the patient received a dose of unidentified Merck GARDASIL 9 or GARDASIL (strength, route of administration, anatomic location, lot number and expiration date were not provided) as prophylaxis. On an unspecified date, the patient experienced stroke. The patient sought for medical attention from unspecified healthcare provider and he received unspecified medical treatment on unspecified date. The nurse also reported that the patient had a speech impediment. The outcome of cerebrovascular accident was reported as not recovered. The causality assessment between the events and unidentified Merck GARDASIL 9 or GARDASIL was not provided. Upon internal review, cerebrovascular accident was determined to be a medically significant event and the speech disorder to be significant disability.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The patient was administered MMR II, via intramuscular route.; No adverse effects reported.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     On 23-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA recombinant Human albumin (rHA) (M-M-R II) via intramuscular route (strength, dose, frequency, and anatomical location were unknown) with lot # R031679 and expiration date 01-NOV-2020, recostituted with a steril diluent with lot # S002624 and expiration date 05-NOV-2021 for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a patient of an unknown age. Information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medication was not reported.   On 20-MAY-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) batch # R012001, expiration date 06-NOV-2020, (strength, dose, frequency, route of administration and anatomical location, were not reported) for prophylaxis. No adverse effect were reported.   The vaccine was stored at temperature above of 47° fahrenheit (F) (48.7 F) for the time frame of 1 hour and 38 minutes. No previous temperature excursion was reported.  The call was because of data logger.  This is one of three cases received by the same reporter (1905USA013165-1905USA013166).; Sender's Comments:  US-009507513-1905USA013166: US-009507513-1905USA013165:
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: I had a lot of pain and some swelling at the injection site. This lasted about 4 days. The site remained tender and slightly sore for another 5 days or so after that; 3 weeks after receiving the first dose of Gardasil 9, I had a lot of pain and some swelling at the injection site.; This spontaneous report was received from a company representative who is also the female patient of unknown age, reporting on herself. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. Patient stated that 3 weeks after the vaccination, she had a lot of pain and some swelling at the injection site. This lasted about 4 days. The site remained tender and slightly sore for another 5 days or so after that." No additional information provided.    The reporter did not assess the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: She developed a lump around the area of the injection site; She also experienced injection site tenderness and pain; This spontaneous report was received from a physician refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent condition and concomitant medications was not reported.   On 25-APR-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  dose 1, 0.5 milliliter, for human papilloma virus prevention, lot # R027577, expiration date  23-JUN-2021 (route of administration was not reported).  On an unspecified date in 2019 (reported as around the time she got the first shot) the patient developed a lump around the area of injection (injection site mass) and she also experienced injection site tenderness and pain. The physician advised the patient to take ibuprofen (MOTRIN) and ice the area around he injection site.   The outcome of injection site mass and injection site pain was unknown.      The causality between  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not reported.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: The patient noticed a red, hard lump on her left arm at the injection site/The redness has since subsided but the lump is still present; The patient noticed a red, hard lump on her left arm at the injection site/The redness has since subsided but the lump is still present; she reported that it was painful for about a day and a half after the injection; This spontaneous report was received from a to a 32-year-old female pharmacist referring on herself. The patient did not have any concurrent conditions or pertinent medical history, did not take any concomitant medications. The patient had an allergy to sulfa drugs.   On 22-MAY-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) on her left arm intramuscularly (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis.   On 23-MAY-2019, the patient began to notice a red, hard lump on her left arm at the injection site (injection site hard lump/Injection site erythema). The patient reported that the redness had subsided, but the lump was still present. She reported that the injection site was painful for about a day and a half after the injection (Injection site pain). At the reporting time, the patient was recovering from injection site hard lump and Injection site erythema.   The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) regarding the events was not applicable.   Furthermore, it was reported that the patient did not received any treatment for the event, no laboratory diagnostic or studies were performed or sought for medical attention.   The relatedness between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events was not provided.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: two confirmed cases of mumps in age-appropriately vaccinated students; This spontaneous report as received from a consumer refers to a patient of unknown age.    On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis.       On an unknown date the patient experienced mumps.    The outcome of mumps is unknown.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a male patient of an unknown age. Information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medication was not reported.   On 20-MAY-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) batch # R012001, expiration date 06-NOV-2020, (strength, dose, frequency, route of administration and anatomical location, were not reported) for prophylaxis. No adverse effect were reported.   The vaccine was stored at temperature above of 47° fahrenheit (F) (48.7 F) for the time frame of 1 hour and 38 minutes. No previous temperature excursion was reported.  The call was because of data logger.; Sender's Comments:  US-009507513-1905USA011967: US-009507513-1905USA013166:
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a female patient of an unknown age. Information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medication was not reported.   On 18-MAY-2019, the patient was vaccinated with an improperly stored (product storage error) dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) batch # R012001, expiration date 06-NOV-2020, (strength, dose, frequency, route of administration and anatomical location, were not reported) for prophylaxis. No adverse effect were reported.   The vaccine was stored at temperature above of 47° fahrenheit (F) (48.7 F) for the time frame of 1 hour and 38 minutes. No previous temperature excursion was reported.  The call was because of data logger.; Sender's Comments:  US-009507513-1905USA011967: US-009507513-1905USA013165:
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: she developed "a lump" around the area of the injection site "with increased tenderness and pain" around that local area as well.; she developed "a lump" around the area of the injection site "with increased tenderness and pain" around that local area as well.; Information has been received from an office nurse via a field representative referring to a 25 years old non-pregnant female patient. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was unknown.  On 01-MAY-2019, the patient was vaccinated with the third and final dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 milliliter, lot # 1602283, expiration date was auto-generated as 18-AUG-2021, strength, frequency and route were unknown) in the left arm for human papillomavirus (HPV) prevention.         On 01-MAY-2019 (reported as "within a day or two"), the patient experienced "a lump" around the area of the injection site "with increased tenderness and pain" around that local area as well. None lab diagnostics or studies were performed. The patient sought for medical attention. No overdose was reported. The outcome of the event was unknown. The causality assessment was not provided by the reporter.  This is one of two reports received from the same field representative.; Sender's Comments:  US-009507513-1905USA013057:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site swelling; Injection site redness; small bruise; stings strongly; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site bruising and injection site stinging. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site bruising and injection site stinging were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site bruising and injection site stinging to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient  experienced injection site swelling, injection site erythema, injection site bruising and stinging.  The patient want to know if need to be concerned. The reporter asked the patient to call healthcare provider for more information.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: This case was reported by a patient's wife. The age at vaccination was not reported. The patient experienced every listed side effects. The reporter wants to know how long this side effects could last.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The registered pharmacist called to report that the patient was complaining of pain in arm of injection for one month after receiving Shingrix.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: arm soreness; achiness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2019, the patient received the 1st dose of Shingrix. On 20th May 2019, several hours after receiving Shingrix, the patient experienced pain in arm and pain. On an unknown date, the outcome of the pain in arm and pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingrix.  Additional details were provided as follows: The patient reported some arm soreness and achiness a few hours after receiving Shingrix on left arm. The reporter did not consent to follow-up. There is a discrepancy with respect to the outcome of the events soreness and achiness, In database core the outcome is reported as not recovered for both the events, however in provided source document it is recovering/resolving. The outcome of these events retains as per the database structural field.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: itching on her hands; redness; swollen; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2019, the patient received the 1st dose of Shingrix .5 ml. On 15th May 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the patient experienced itching both hands. The patient was treated with benadryl (nos) (Benadryl), ibuprofen, prednisone and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site erythema and itching both hands were unknown and the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and itching both hands to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and returned to the pharmacy with redness and swelling at the injection site.  She was advised to ice it and take benadryl and ibuprofen. She came back with a prescription from the urgent care for predisone for itching on her hands.  The reporter consented to follow up. There is a discrepancy between the outcome reported in the structured field (not recovered/not resolved) for swelling and the outcome reported in the source document (recovering/resolving). Kept as per fields.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity
Clinical narrative: Sore arm; Malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix (intramuscular). In May 2019, less than a month after receiving Shingrix, the patient experienced pain in arm and malaise. In May 2019, the outcome of the malaise was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm and malaise to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. Sore arm and feeling of malaise were lasted for 3 days. The reporter did not consent to follow up No further details were provided.  This case has been linked with case US2019090293, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: injection site is painful; Wrong route of administration; This case was reported by a other health professional 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 (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was given Shingrix subcutaneously which led to incorrect route of product administration. The patient experienced injection site pain. The patient reported the event to her physician's office. The office administrator did not want to follow up with this report, but would have the physician handle everything instead. The reporter did not consent to follow up.