chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Influenza like illness, Nasal congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 78-year-old male patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in November 2018, refer case US2019GSK029754). On 9th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 10th February 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, nasal congestion, chills and feeling miserable. On an unknown date, the outcome of the influenza-like symptoms, nasal congestion, chills and feeling miserable were recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, nasal congestion, chills and feeling miserable to be related to SHINGRIX. Additional details were received as follows: Prior to 12:00 noon, the patient was vaccinated with SHINGRIX vaccine. The patient experienced flu like symptoms, including, nasal congestion, occasional chills and feeling miserable. These symptoms were resolving and the patient could function at the time of reporting. The reporter did not consent to follow up. The reporter was unable to obtain additional information.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received SHINGRIX. In February 2019, several hours after receiving SHINGRIX, the patient experienced shivering, general body pain and stomach pain. On an unknown date, the outcome of the shivering, general body pain and stomach pain were not recovered/not resolved. It was unknown if the reporter considered the shivering, general body pain and stomach pain to be related to SHINGRIX. Additional details were provided as follows: The patient stated she had the SHINGRIX vaccine at 5:30 afternoon in the right arm and around midnight she started to experience shivering, body aches and stomach pain which had continued through today. The reporter did not give consent to follow up. The patient did not currently have a physician.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given FLUARIX to (R) deltoid on 2/20/19 and reported pain to the site 1 day after. On exam skin is moderately erythematous with moderate skin warmth to touch, moderate swelling at the site of vaccine administration.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Rash
Clinical narrative: Pt presented with rash and lump in arm pit. Amoxicillin-Pot Clavulante 875-125 mg was started.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Allergy to vaccine, Skin test positive, Urticaria, Vomiting
Clinical narrative: Patient developed full body urticaria and emesis around 30 minutes after receiving vaccine. Patient instructed to give Benadyl po. Phone call follow up with patient throughout weekend showed no progression of allergic symptoms which eventually fully dissipated.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Loss of consciousness, Syncope
Clinical narrative: "Event Description: Patient came in to get a HAVRIX vaccine. After administration, the patient had a vasovagal syncope. I ran to go get help and by the time I returned to the patient she woke up. She was out for about 15 seconds and then slowly came back to consciousness. She explained to me after the fact that she used to have these episodes as a child but hasn't had one in years. She thinks it may be caused by a fear of needles as a child. I sat with her for 10-15 minutes and she seemed to be ok and I explained to her to let us know if she has any other issues."
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Crying, Emotional distress, Head discomfort, Pain in extremity, Screaming
Clinical narrative: Yesterday she had cut her left middle finger on a rusty knife that was found in the basement. So mom had called us and agreed to have ADACEL shot. It was the 1st immunization she has had, since mom has refused shots over the years. She was given the ADACEL yesterday afternoon. Last evening she was fine, but this morning at breakfast she became inconsolable. Mother has a video of her screaming, crying, inconsolable. She complained a little of her legs hurting, seemed to be holding her head a couple of times like maybe the light bothered her. No fever. Mom has been using ibuprofen every 8 hours, the last dose had been about 9:30 AM. This episode of screaming had started a while after that. Mom had called here, I had agreed to see the patient. On the way here in the car she was still screaming, but then they stopped at a gas station for her to use the bathroom. She had incontinence of some urine. It was probably around that time that the screaming stopped.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Urinary incontinence
Clinical narrative: Yesterday she had cut her left middle finger on a rusty knife that was found in the basement. So mom had called us and agreed to have ADACEL shot. It was the 1st immunization she has had, since mom has refused shots over the years. She was given the ADACEL yesterday afternoon. Last evening she was fine, but this morning at breakfast she became inconsolable. Mother has a video of her screaming, crying, inconsolable. She complained a little of her legs hurting, seemed to be holding her head a couple of times like maybe the light bothered her. No fever. Mom has been using ibuprofen every 8 hours, the last dose had been about 9:30 AM. This episode of screaming had started a while after that. Mom had called here, I had agreed to see the patient. On the way here in the car she was still screaming, but then they stopped at a gas station for her to use the bathroom. She had incontinence of some urine. It was probably around that time that the screaming stopped.
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction, Injection site reaction
Clinical narrative: Information has been received from a pharmacist via company representative referring to a unknown age male patient. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions/allergies. In December 2018 (reported as "within the past month"), the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml once to prevent pneumococcal disease (prophylaxis) (strength, route of administration, anatomical injection site, lot number and expiration date were not reported). In December 2018 (reported as "within the past month"), after vaccination with PNEUMOVAX 23 the patient "had an injection site reaction that turned into a whole body reaction". The patient did not seek for medical attention. The outcome of the adverse events and the causality assessment between PNEUMOVAX 23 and injection site reaction and adverse reaction were not reported.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-APR-2017, at age 51, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider. On an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an approximately 67 year old female. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2006, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date in 2011, the patient was treated by a by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer and described the occurrence of sickness in a adult patient who received 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 sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient was sick for 2 and half days.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever with the 1st dose of SHINGRIX vaccine dose. The patient asked, for the 2nd one. What's the chance the same thing would happen? Do you have an answer to the likelihood of a second fever episode?
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lymphadenopathy, Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a 57-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 12th February 2019, the patient received the 2nd dose of SHINGRIX. On 12th February 2019, less than a day after receiving SHINGRIX, the patient experienced enlargement of lymph nodes. In February 2019, the patient experienced malaise and influenza-like symptoms. On an unknown date, the outcome of the enlargement of lymph nodes was unknown and the outcome of the malaise and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the enlargement of lymph nodes, malaise and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. Swollen lymph node under her left arm noticed on the night of the day of vaccination and the patient called on 13th February 2019. Office could not reach the patient until 14th February 2019. The patient told to monitor and come back, all malaise and flu like symptoms got resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Injection site erythema, Pruritus, Pruritus generalised, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back surgery (in 2003). Previously administered products included SHINGRIX with an associated reaction of pruritus generalised (For 1st dose, refer case US2019025966). On 4th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and itchy upper limbs. The patient was treated with Anti-Itch Medication. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the itchy upper limbs was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 74 or 75 year old. The patient received vaccine on left arm. She experienced itching with the first dose of the SHINGRIX, and it had continued after receiving the second dose of the SHINGRIX vaccine. The patient experienced itching that was associated all throughout the body. The itching occurred on different parts of the body such as arms, legs, shoulders, and face. At the time of reporting, the patient experienced itching from her right arm and down to elbow and the wrist. She felt like spiders crawling on it. She visited her doctor (the previous week before the date of reporting) and she had been prescribed anti-itch medication. The patient also experienced wide pink area measuring 6 inches long and 2 to 3 inches wide at the injection site. She stated it lasted for about 2 weeks with both the doses. The patient received another medication to calm down the itching that she still had months later. The patient believed it was important to put this as some sort of contraindication on the sheets that were given to people when they were administered SHINGRIX so that they would be aware if experienced same kind of reaction. The reporter did not consent to follow-up. And no further details were provided. The patient was referred to health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Injection site erythema, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back surgery (in 2003). On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced generalized pruritus and injection site erythema. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the generalized pruritus and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 74 or 75 year old. The patient received SHINGRIX on left arm. The patient experienced itching. The itching was associated all throughout the body. The itching occurred on different parts of the body such as arms, legs, shoulders, and face. At the time of reporting, the patient experienced itching from her right arm and down to elbow and the wrist. She felt like spiders crawling on it. She visited her doctor and had been prescribed anti-itch medication. The patient also experienced wide pink area measuring 6 inches long and 2 to 3 inches wide at the injection site that lasted for about 2 weeks. The reporter did not consent to follow-up and no further details were provided. The patient was referred her to healthcare professional. For tolerance to 2nd dose, refer case US2019GSK030779.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (received 1st dose in August 2018 and experienced pain in arm and swelling, refer case US2019GSK032752). Concurrent medical conditions included intervertebral disc disorder. Concomitant products included MEDROL and meloxicam. On 11th February 2019, the patient received the 2nd dose of SHINGRIX. On 11th February 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 14th February 2019, the patient experienced allergic reaction and erythromacular rash. In February 2019, the patient experienced pain in arm, swelling arm and skin discoloration. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the swelling arm, allergic reaction and erythromacular rash were not recovered/not resolved and the outcome of the skin discoloration and drug dose administration interval too long were unknown. It was unknown if the reporter considered the pain in arm, swelling arm, skin discoloration, allergic reaction and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on an unknown arm. The patient's arm was swollen pretty quickly than after the 1st dose and experienced swelling that was purple in color. At the time of reporting the patient's arm was tender. The patient experienced allergic reaction to her face and had two big spots on her left and right cheek. The patient received 2nd dose of SHINGRIX late than the recommended schedule, which led to lengthening of vaccination schedule. The patient had a back disk problem for the past couple of years which flared badly on 10th February 2019, so she received MEDROL pack (4 mg) one tablet before breakfast and  Meloxicam (50 mcg). The reporter consented to follow up. This case has been linked with case US2019GSK032752 reported for the same patient by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration, Tenderness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of peripheral swelling (received 1st dose in August 2018 and experienced pain in arm and swelling, refer case US2019GSK032752). Concurrent medical conditions included intervertebral disc disorder. Concomitant products included MEDROL and meloxicam. On 11th February 2019, the patient received the 2nd dose of SHINGRIX. On 11th February 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 14th February 2019, the patient experienced allergic reaction and erythromacular rash. In February 2019, the patient experienced pain in arm, swelling arm and skin discoloration. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the swelling arm, allergic reaction and erythromacular rash were not recovered/not resolved and the outcome of the skin discoloration and drug dose administration interval too long were unknown. It was unknown if the reporter considered the pain in arm, swelling arm, skin discoloration, allergic reaction and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine on an unknown arm. The patient's arm was swollen pretty quickly than after the 1st dose and experienced swelling that was purple in color. At the time of reporting the patient's arm was tender. The patient experienced allergic reaction to her face and had two big spots on her left and right cheek. The patient received 2nd dose of SHINGRIX late than the recommended schedule, which led to lengthening of vaccination schedule. The patient had a back disk problem for the past couple of years which flared badly on 10th February 2019, so she received MEDROL pack (4 mg) one tablet before breakfast and  Meloxicam (50 mcg). The reporter consented to follow up. This case has been linked with case US2019GSK032752 reported for the same patient by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Malaise, Nausea, Peripheral swelling
Clinical narrative: Swollen, red arm x 7 days, nausea/vomiting x24 hours, fever over 100.0F x 24 hours, fatigue/malaise x3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Swollen, red arm x 7 days, nausea/vomiting x24 hours, fever over 100.0F x 24 hours, fatigue/malaise x3 days.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Dizziness, Headache, Influenza virus test negative, Myalgia
Clinical narrative: Fever, Headache, dizziness, muscle/joint pain.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Fever, Headache, dizziness, muscle/joint pain.
Age: 63.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site is still red and sore one week after injection in left deltoid muscle.
Age: 34.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt called today 2/22/19 and stated she started having redness on underneath side of Rt arm on 2/19/19. Pt stated the redness has gotten bigger with pain and swelling. She states she has been taking BENADRYL. Nurse instructed her of the need to see a doctor today. Pt did not want to go. Educated pt on importance of being seen even if she has to go to ER. The reaction could be serious. Pt states she will let nurse know how she is doing this afternoon and if she goes to doctor.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient had an out break of shingles after 1st dose of SHINGRIX vaccine. This was the only information available for this report. The pharmacist did not consent to follow up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Allergy test, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to PEDIARIX. Additional details were provided as follows: The age at vaccination was reported. The patient demographic details and vaccine information were not reported. After vaccination, the patient experienced high intensity rash. The patient was taken to hospital for performed an allergy test. The physician would like to know, if the GlaxoSmithKline recommended an allergy test to the components of the vaccine. Lab Comments: On an unknown date, the patient performed allergy test in the hospital.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen arm and very sore from injection site down to elbow. Soreness and redness started roughly one hour after injection. Pt took advil for pain.
Age: 0.17
Sex: M
Vaccine: IPV, PPV, RV5
Symptoms: Differential white blood cell count, Full blood count, Intussusception, Metabolic function test, Ultrasound abdomen
Clinical narrative: I am not sure as to which brand of rotavirus vaccine was given as it was not documented in the record given to me. My son was given the rotavirus vaccine on April 25, you will have to find out from the doctor which vaccine they were using. My son developed intestinal intussusception.
Age: 0.17
Sex: M
Vaccine: IPV, PPV, RV5
Symptoms: X-ray
Clinical narrative: I am not sure as to which brand of rotavirus vaccine was given as it was not documented in the record given to me. My son was given the rotavirus vaccine on April 25, you will have to find out from the doctor which vaccine they were using. My son developed intestinal intussusception.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Within the hour redness and swelling at site of injection. By next morning swelling had travelled down to elbow and was also hot to the touch. By the second day side effects had not worsened and then became less as the day progressed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site rash, Pruritus generalised
Clinical narrative: Headache, Rash on L bicep, itchy skin all over body w/out visible rash, fatigue, joint pain, especially in L hip and knee. Oatmeal bath, BENADRYL, Calamine lotion, 800mg Ibuprofen
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Experienced mild flu like symptoms. Fatigue and body aches. The symptoms were not severe and only lasted for about a day and a half.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Impaired work ability, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: The day of shot, the injection are was sore. The next lot of days the injection grew as big as a grapefruit! It was to touch and my are was painful to move. I felt like I was hit by a truck for three weeks! I did call the pharmacy and they said there were no complaints and this was the first they ever heard of it. I needed to miss work, take pain killers, and rest for an additional three weeks. So disappointing, that the pharmacists' took no interest in the complaint. To this day, I still feel a lump in the injection side. My left arm.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The day of shot, the injection are was sore. The next lot of days the injection grew as big as a grapefruit! It was to touch and my are was painful to move. I felt like I was hit by a truck for three weeks! I did call the pharmacy and they said there were no complaints and this was the first they ever heard of it. I needed to miss work, take pain killers, and rest for an additional three weeks. So disappointing, that the pharmacists' took no interest in the complaint. To this day, I still feel a lump in the injection side. My left arm.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Soreness, redness, itching at the injection site; and surrounding muscles, body aches fever, chills off and on, headache, vomiting, runny nose, sneezing nonstop.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Myalgia, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Soreness, redness, itching at the injection site; and surrounding muscles, body aches fever, chills off and on, headache, vomiting, runny nose, sneezing nonstop.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Soreness, redness, itching at the injection site; and surrounding muscles, body aches fever, chills off and on, headache, vomiting, runny nose, sneezing nonstop.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Flushing, Injection site erythema, Tachycardia
Clinical narrative: ABNORMAL BEHAVIOR, ERYTHEMA TO INJECTION SITE, FACIAL FLUSH, TACHYCARDIA.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Cold sweat, Colitis microscopic, Fatigue, Gastrointestinal disorder, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 778851) and refers to a 13-year-old female patient. It was reported that the patient had no health conditions before administration of GARDASIL 9. The patient was not on any concomitant medications. On 18-MAY-2007, the patient was vaccinated with GARDASIL 9 dose 1, batch/lot# 0389U, in the arm for prophylaxis (route: needle and syringe). Other suspect therapy included HAVRIX lot# AHAVB148AA, administered in the arm for prophylaxis (Route: Needle and syringe) on the same day. The vaccine was administered at a private facility. On 18-MAY-2007, after the first shot of GARDASIL 9, later that night the patient broke out in cold sweats and experienced heart palpitations and she became extremely fatigued. On 18-JUL-2007, the patient received the second dose of GARDASIL 9. After the 2nd dose, she passed out for the first time in her life in the doctor's office about 10 minutes after receiving vaccination. She began feeling even more fatigued and started seeing black upon standing. On 27-NOV-2007, the patient received third dose of GARDASIL 9. After the third dose, she was unable to hold her back up straight and started experiencing terrible gastrointestinal (G.I) symptoms. She started to miss numerous days of school and got sick all the time.  The patient went to numerous doctors with no answers until 2012 when she became diagnosed with postural orthostatic tachycardia syndrome (POTS). She was since been diagnosed with several other illnesses. The patient now had POTS, renal vein compression ("NCS"), Sjogren's syndrome, renal tubular acidosis and lymphocytic colitis. The outcome of cold sweat, visual impairment, Sjogren's syndrome, renal vein compression, renal tubular acidosis, posture abnormal, postural orthostatic tachycardia syndrome, palpitations, malaise, loss of personal independence in daily activities, loss of consciousness, gastrointestinal disorder, fatigue and colitis microscopic was reported as not recovered. The causality assessment was not reported. The health authority considered the events as serious due to hospitalization and disability. Follow up information was received on 15-FEB-2019. Lot Number 0389U was not valid for GARDASIL 9. However batch# 0389U with lot # 2118907 with expiry date of 06-FEB-2010 is valid for GARDASIL (Product lot number issue). Outcome and causality of product lot number issue was unknown.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Loss of personal independence in daily activities, Malaise, Palpitations, Postural orthostatic tachycardia syndrome, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 778851) and refers to a 13-year-old female patient. It was reported that the patient had no health conditions before administration of GARDASIL 9. The patient was not on any concomitant medications. On 18-MAY-2007, the patient was vaccinated with GARDASIL 9 dose 1, batch/lot# 0389U, in the arm for prophylaxis (route: needle and syringe). Other suspect therapy included HAVRIX lot# AHAVB148AA, administered in the arm for prophylaxis (Route: Needle and syringe) on the same day. The vaccine was administered at a private facility. On 18-MAY-2007, after the first shot of GARDASIL 9, later that night the patient broke out in cold sweats and experienced heart palpitations and she became extremely fatigued. On 18-JUL-2007, the patient received the second dose of GARDASIL 9. After the 2nd dose, she passed out for the first time in her life in the doctor's office about 10 minutes after receiving vaccination. She began feeling even more fatigued and started seeing black upon standing. On 27-NOV-2007, the patient received third dose of GARDASIL 9. After the third dose, she was unable to hold her back up straight and started experiencing terrible gastrointestinal (G.I) symptoms. She started to miss numerous days of school and got sick all the time.  The patient went to numerous doctors with no answers until 2012 when she became diagnosed with postural orthostatic tachycardia syndrome (POTS). She was since been diagnosed with several other illnesses. The patient now had POTS, renal vein compression ("NCS"), Sjogren's syndrome, renal tubular acidosis and lymphocytic colitis. The outcome of cold sweat, visual impairment, Sjogren's syndrome, renal vein compression, renal tubular acidosis, posture abnormal, postural orthostatic tachycardia syndrome, palpitations, malaise, loss of personal independence in daily activities, loss of consciousness, gastrointestinal disorder, fatigue and colitis microscopic was reported as not recovered. The causality assessment was not reported. The health authority considered the events as serious due to hospitalization and disability. Follow up information was received on 15-FEB-2019. Lot Number 0389U was not valid for GARDASIL 9. However batch# 0389U with lot # 2118907 with expiry date of 06-FEB-2010 is valid for GARDASIL (Product lot number issue). Outcome and causality of product lot number issue was unknown.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Renal tubular acidosis, Renal vein compression, Sjogren's syndrome, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (Agency# 778851) and refers to a 13-year-old female patient. It was reported that the patient had no health conditions before administration of GARDASIL 9. The patient was not on any concomitant medications. On 18-MAY-2007, the patient was vaccinated with GARDASIL 9 dose 1, batch/lot# 0389U, in the arm for prophylaxis (route: needle and syringe). Other suspect therapy included HAVRIX lot# AHAVB148AA, administered in the arm for prophylaxis (Route: Needle and syringe) on the same day. The vaccine was administered at a private facility. On 18-MAY-2007, after the first shot of GARDASIL 9, later that night the patient broke out in cold sweats and experienced heart palpitations and she became extremely fatigued. On 18-JUL-2007, the patient received the second dose of GARDASIL 9. After the 2nd dose, she passed out for the first time in her life in the doctor's office about 10 minutes after receiving vaccination. She began feeling even more fatigued and started seeing black upon standing. On 27-NOV-2007, the patient received third dose of GARDASIL 9. After the third dose, she was unable to hold her back up straight and started experiencing terrible gastrointestinal (G.I) symptoms. She started to miss numerous days of school and got sick all the time.  The patient went to numerous doctors with no answers until 2012 when she became diagnosed with postural orthostatic tachycardia syndrome (POTS). She was since been diagnosed with several other illnesses. The patient now had POTS, renal vein compression ("NCS"), Sjogren's syndrome, renal tubular acidosis and lymphocytic colitis. The outcome of cold sweat, visual impairment, Sjogren's syndrome, renal vein compression, renal tubular acidosis, posture abnormal, postural orthostatic tachycardia syndrome, palpitations, malaise, loss of personal independence in daily activities, loss of consciousness, gastrointestinal disorder, fatigue and colitis microscopic was reported as not recovered. The causality assessment was not reported. The health authority considered the events as serious due to hospitalization and disability. Follow up information was received on 15-FEB-2019. Lot Number 0389U was not valid for GARDASIL 9. However batch# 0389U with lot # 2118907 with expiry date of 06-FEB-2010 is valid for GARDASIL (Product lot number issue). Outcome and causality of product lot number issue was unknown.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-SEP-2012, at age 62, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a healthcare provider at a county health department. On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a patient of unknown age and gender, and the spouse of the patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 07-DEC-2016, at age 59, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received 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 chills, general body pain, headache, influenza-like symptoms and fever. The patient was treated with TYLENOL. On an unknown date, the outcome of the chills, general body pain, headache and influenza-like symptoms were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the chills, general body pain, headache, influenza-like symptoms and fever to be related to SHINGRIX. Additional details were provided as follows: The patient clarified upon outbound callback that she only experienced the flulike symptoms on Day 1 and on days 2 through 6, she only experienced the headache. She never gets headaches or takes TYLENOL however, she took TYLENOL for this headache. The patient scheduled to get the second dosage on 2nd April 2019. Would the patient experience the same side effect or worse or milder.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and slight temperature. On an unknown date, the outcome of the injection site pain and slight temperature were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and slight temperature to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that arm where she had the 2nd shot was so sore. The patient was asking was it ok to use heat or cold or take TYLENOL for the pain, would it be alright to use light therapy on it. The patient reported that the arm at site of injection was extremely sore and she had a low grade temperature. The patient just wanted to be sure this would not interfere with the vaccine. Lab Comments: On an unknown date, patient's body temperature was performed.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash generalised
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 82-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received SHINGRIX. In September 2018, immediately after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown. The reporter considered the generalized rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced rash from head to toe immediate onset in September 2018 with ongoing symptoms. The reporter thought this was from the vaccine. The reporter agreed to follow up with GlaxoSmithKline.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the right arm. On the next day after receiving the SHINGRIX, the patient's injection site was very sore to the touch and sore when he moved his arm which lasted for over a week but resolved. For tolerance to next dose refer case US2019027595.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included intervertebral disc disorder. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were recovered/resolved. It was unknown if the reporter considered the pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a huge arm for 10 days that was hurting and swollen. For tolerance of 2nd dose refer case US2019027627.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Myalgia, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of bone pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (experienced after receiving 1st dose on 25th November 2018, refer case US2019027684). On 1st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, less than a month after receiving SHINGRIX, the patient experienced bone pain, pain in arm, muscle pain and pain in elbow. On an unknown date, the outcome of the bone pain, pain in arm, muscle pain and pain in elbow were not recovered/not resolved. It was unknown if the reporter considered the bone pain, pain in arm, muscle pain and pain in elbow to be related to SHINGRIX. Additional details were provided as follows: Last few days from the date of reporting, the patient experienced bone pain in her left arm, the pain was also in her forearm and she cannot tense her muscle because of the pain. The patient push on her elbow and it hurts. The patient felt that the pain was getting worse. The patient was wondering if it could be related to the second dose of the SHINGRIX.
Sex: F
Vaccine: HEPAB
Symptoms: Injection site mass, Injection site nodule, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a female patient who received TWINRIX adult (batch number 3C422, expiry date 27th April 2021) for prophylaxis. On 11th January 2019, the patient received TWINRIX adult. In January 2019, 2 days after receiving TWINRIX adult, the patient experienced pain in arm and injection site lump. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site lump was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and injection site lump to be related to TWINRIX adult. Additional details were provided as follows: The patient experienced sore arm and a lump under the skin at the injection site, 2 to 3 days after vaccination. The lump took a while to decrease in size. At the time of reporting, she reported a nodule under the skin at the injection site which was size of a pea. The patient stated that, it was not painful or sore. The patient gave consent to follow up.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Pruritus, Rash, Rash macular, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itching both hands in a 90-year-old female patient who received SHINGRIX for prophylaxis. On 21st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, 14 days after receiving SHINGRIX, the patient experienced itching both hands, erythromacular rash, skin scaly and patchy rash. On an unknown date, the patient experienced eye pruritus. The patient was treated with betamethasone. On an unknown date, the outcome of the itching both hands, erythromacular rash and skin scaly were not recovered/not resolved and the outcome of the eye pruritus and patchy rash were unknown. It was unknown if the reporter considered the itching both hands, erythromacular rash, skin scaly, eye pruritus and patchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced itching on the palms of both hands. This itching would come and go. She also developed red, scaly spots in between her knees and ankles, and one large patch on her right hip approximately two weeks after receiving the vaccine. She had itching in both eye for the last few months. Her dermatologist gave a lotion (she thought it was betamethasone) to put on the red, scaly spots. When she used the cream, the spots fade. The reporter gave permission to contact her dermatologist. This case has been linked with case US2019025959 and US2019025968, reported by the same reporter.