chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash at injection site/swelling at injection site that immigrated down arm below elbow. After patient returned to pharmacy the pharmacist recommended the patient seek medical treatment. Urgent care referred her to the emergency room and the ER dr told her the fluid from the swelling would be reabsorbed by her body.
Age: 67.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Arm hurts at injection site. It has been three weeks and still having problem with range of motion.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Influenza, Peripheral swelling
Clinical narrative: Patient complaint of flu symptom on the day of vaccination and the next her right arm was red and had swelling.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient stated as the injection was going in that the pain was sharper and different then he has ever had getting an IM injection. He stated that usually he notices some soreness a couple hours later but this pain was immediate and started just as the injection went in. Patient was instructed to call in the morning if the pain persisted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling, Varicella
Clinical narrative: Continued itching appropriately 1 inch from injection site. Red bump similar in appearance to the chickenpox rash. As of today, I am still experiencing itching although it seems to be less severe the last 2 days. I plan to visit my doctor tomorrow.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema of eyelid, Headache, Musculoskeletal stiffness, Myalgia
Clinical narrative: 11 pm day of injection chills, fever, muscle pain in injection arm and stiffness in hand didn't sleep well and pain progressed with a severe headache and pain and redness under eyes. Went to ER next morning and ER physician believed symptoms to be related to SHINGRIX immunization.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Poor quality sleep, Pyrexia
Clinical narrative: 11 pm day of injection chills, fever, muscle pain in injection arm and stiffness in hand didn't sleep well and pain progressed with a severe headache and pain and redness under eyes. Went to ER next morning and ER physician believed symptoms to be related to SHINGRIX immunization.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Abnormal faeces, Faeces discoloured, Flatulence, Irritability, Mucous stools
Clinical narrative: Extreme fussiness for 1-3 hours, extreme gas pains, mucousy liquid stools with sour smell, discolored stools.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: ITP.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Hypoaesthesia, Injection site bruising, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient got bruises about 2 inches in diameter at injection site, painful and little numb (little sleepy arm per patient's word) since yesterday after she got home from vaccination. She is able to move her arm when I asked her to move and lift her arm. She was ok, no reaction with her first dose in 12/15/2017.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Injected limb mobility decreased, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: 8-14-2018 6:30 pm achy Lt. arm painful - no redness; 7:00 pm achy cheekbones in face painful extreme pain Lt. arm: unable to move arm. At inj site no redness; 8:00 pm same but more pain (L) arm low grade fever 99. Took 2 extra strength TYLENOL at 9 pm went to bed; 9:00 am 8-15 woke up achy, cheekbones hurt, Lt arm unable to lift due to severe pain. No redness at inj. site. 6 pm arm (L) still painful to lift. Less achy 10 pm pain (L) arm to lift slight achy. 11 pm to bed. 9 am 8-16 not achy arm (L) able to lift more. 1/2 the pain. (L) arm painful and lifting arm less painful. By 8-19 Sun. (L) arm no pain. The pain in (L) arm I never experienced before. When I have my first PNEUMONIA (5-9-2017) inj. I experienced no pain or any reaction.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Faeces discoloured, Gastrooesophageal reflux disease, Infantile spitting up, Vomiting
Clinical narrative: He developed GI reflux, spitting up, and pain prior to 2 month check-up. However, following 2 month immunizations, became much worse with green diarrhea, vomiting, and inconsolable crying. Lasted for several weeks, eventually improved at 3 months with maternal elimination diet for 2-3 weeks prior to 4-month check-up, GERD, green diarrhea, and vomiting had resolved. See in office for 4 month immunizations 8/24/18, that night again developed GERD, spitting, green diarrhea, and severe fussiness. Symptoms seem to be improving 4-5 days after vaccines.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Soreness arm at site of injection, swelling and 2 1/2 square redness still present at day 3; extreme soreness x 2 days; getting better. Recommend to ice; pt mobility of arm is not affected! Call MD or pharmacy if redness persists. No fever reported.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Malaise, Myalgia, Retching
Clinical narrative: Myalgia, dry heaves, arthralgias, malaise for 12-18 hours.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Injected limb mobility decreased, Injection site nodule, Injection site pain, Injection site swelling, Pain
Clinical narrative: Mother of client called 8/24/18 stating daughter cannot move right arm and wants to know which shots she received. States soreness started on 8/22/18 and by 8/24/18 cannot move right arm. Has become extremely painful to move and to touch upper right arm. Mother states there is swelling and a knot where shots were given and has a rash on her right forearm. States did use ice for the first 24 hours, then used heat and took TYLENOL. Nothing relieved symptoms. Our physician suggested using ice again and taking ALEVE. Mother convinced daughter is having an allergic reaction, so advised mother to take child to own PCP or Urgent Care.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Rash
Clinical narrative: Mother of client called 8/24/18 stating daughter cannot move right arm and wants to know which shots she received. States soreness started on 8/22/18 and by 8/24/18 cannot move right arm. Has become extremely painful to move and to touch upper right arm. Mother states there is swelling and a knot where shots were given and has a rash on her right forearm. States did use ice for the first 24 hours, then used heat and took TYLENOL. Nothing relieved symptoms. Our physician suggested using ice again and taking ALEVE. Mother convinced daughter is having an allergic reaction, so advised mother to take child to own PCP or Urgent Care.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bruxism, Chills, Pain, Pyrexia, Tremor
Clinical narrative: Fever, shivering, body aches, shaking, jaw clenching.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Myalgia, Neck pain
Clinical narrative: Patient reported muscle soreness/pain in arm and neck. Redness, swelling, heat at injection site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reported muscle soreness/pain in arm and neck. Redness, swelling, heat at injection site.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Pt received 2nd dose of MENACTRA along with a PPD placement on 8/28/18 approx 15.05pm. About 7 minutes after injection pt c/o feeling lightheaded, turned pale and blacked out. Pt did not fall, was sitting in chair. I immediately laid her down and took her vital signs which were normal. Pt had high level of anxiety prior to vaccine, also stated after the fact she had not eaten anything that day.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling of body temperature change, Nocturia, Pain
Clinical narrative: Patient felt extremely achy all over body with hot and cold flashes and was up all night going to the bathroom.
Sex: M
Vaccine: VARZOS
Symptoms: Cataract operation, Headache, Herpes zoster, Rash, Visual impairment
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 10-OCT-2016, from a pharmacy for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Between 10-OCT-2016 and 16-OCT-2016 [reported as shortly after receiving ZOSTAVAX], the patient developed a painful rash on the left side of his face, surrounding his left eye, accompanied by headaches and a reduction in left eye vision. In response to these complaints, on or about 16-OCT-2016, the patient presented to a clinic and was diagnosed as suffering from shingles, and it was recommended that the patient follow-up with an optometrist for future evaluation. On or about 17-OCT-2016, the patient presented to an optometrist and it was noted that the patient exhibited a severe reduction in his left eye vision. Thereafter, on or about 26-APR-2018, the patient underwent extracapsular cataract removal surgery to remove a cataract that developed as a result of the damage to his left eye. The outcome of herpes zoster/painful rash on left side of face surrounding his left eye/reduction in left eye vision/shingles is not recovered. The outcome of ZOSTAVAX did not prevent shingles, headache, and extracapsular cataract removal surgery to remove a cataract that developed as a result of damage to his left eye is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster/painful rash on left side of face surrounding his left eye/reduction in left eye vision/shingles and extracapsular cataract removal surgery to remove a cataract that developed as a result of damage to his left eye were determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 67-year-old female patient. The patient's pertinent medical history included urticaria, hypertension and high cholesterol. She had no drug reactions or allergies. On 19-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R006466 and expiration date 24-OCT-2019 (dose and route of administration were not reported) for prophylaxis. Concomitant therapies included atorvastatin calcium (LIPITOR) and unspecified high blood pressure medication. In an approximately July 2018, the patient experienced injection site swelling, injection site pain, headache and nausea. There were no lab diagnostics or studies performed and no treatment was given for the events. At the time of the report, the patient was still suffering from mild soreness at injection site and headache. The outcome of the injection site swelling and nausea was not reported. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: PPV, PPV
Symptoms: Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 67-year-old female patient. The patient's pertinent medical history included urticaria, hypertension and high cholesterol. She had no drug reactions or allergies. On 19-JUL-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R006466 and expiration date 24-OCT-2019 (dose and route of administration were not reported) for prophylaxis. Concomitant therapies included atorvastatin calcium (LIPITOR) and unspecified high blood pressure medication. In an approximately July 2018, the patient experienced injection site swelling, injection site pain, headache and nausea. There were no lab diagnostics or studies performed and no treatment was given for the events. At the time of the report, the patient was still suffering from mild soreness at injection site and headache. The outcome of the injection site swelling and nausea was not reported. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician, regarding a 1 year old patient. of unknown gender. The patient's concurrent, historical conditions and concomitant medications were not provided.  On 13-AUG-2018, the patient and her/his sibling  were each inadvertently administered with an expired dose of VARIVAX, subcutaneous, lot# M035688, 10-AUG-2018 (strength and dosage were not reported) (Expired product administered) for prophylaxis. No adverse effect reported (No adverse event). This is one of two reports from same source.; Sender's Comments: US-009507513-1808USA007603:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Headache, Lethargy, Muscle spasms, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-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, less than a year after receiving SHINGRIX, the patient experienced headache, nausea, nerve pain, general body pain and muscle cramp. On an unknown date, the outcome of the headache, nausea, nerve pain, general body pain and muscle cramp were unknown. It was unknown if the reporter considered the headache, nausea, nerve pain, general body pain and muscle cramp to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced severe muscle cramps in ankles, legs, and arms, as well as nerve pain like a lightening bolt up the spine. The contact details of the physician was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-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, less than a year after receiving SHINGRIX, the patient experienced headache, nausea, nerve pain, general body pain and muscle cramp. On an unknown date, the outcome of the headache, nausea, nerve pain, general body pain and muscle cramp were unknown. It was unknown if the reporter considered the headache, nausea, nerve pain, general body pain and muscle cramp to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced severe muscle cramps in ankles, legs, and arms, as well as nerve pain like a lightening bolt up the spine. The contact details of the physician was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Muscle spasms, Nausea, Neuralgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-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, less than a year after receiving SHINGRIX, the patient experienced headache, nausea, nerve pain, general body pain and muscle cramp. On an unknown date, the outcome of the headache, nausea, nerve pain, general body pain and muscle cramp were unknown. It was unknown if the reporter considered the headache, nausea, nerve pain, general body pain and muscle cramp to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced severe muscle cramps in ankles, legs, and arms, as well as nerve pain like a lightening bolt up the spine. The contact details of the physician was provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-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, less than a year after receiving SHINGRIX, the patient experienced headache, nausea, nerve pain, general body pain and muscle cramp. On an unknown date, the outcome of the headache, nausea, nerve pain, general body pain and muscle cramp were unknown. It was unknown if the reporter considered the headache, nausea, nerve pain, general body pain and muscle cramp to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The age at vaccination was not reported. After receiving SHINGRIX, the patient experienced severe muscle cramps in ankles, legs, and arms, as well as nerve pain like a lightening bolt up the spine. The contact details of the physician was provided.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On 15th August 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, the patient experienced a rash two days following the vaccination with SHINGRIX, which was diagnosed as Shingles. The healthcare professional did not have lot number or expiry date available at the time of call, but intended to get this information from the pharmacy and would provide to safety upon follow-up.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old male patient who received SHINGRIX for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX. On 15th August 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, the patient experienced a rash two days following the vaccination with SHINGRIX, which was diagnosed as Shingles. The healthcare professional did not have lot number or expiry date available at the time of call, but intended to get this information from the pharmacy and would provide to safety upon follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Dysphagia, Electrocardiogram, Pain
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of stomach cramps in a 76-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th August 2018, several hours after receiving SHINGRIX, the patient experienced stomach cramps, diarrhea, influenza-like symptoms, chills and fever. On 12th August 2018, the patient experienced facial swelling, throat constriction and swallowing difficult. In August 2018, the patient experienced throat pain, chest pain, neck pain and eye swelling. On an unknown date, the outcome of the stomach cramps, diarrhea, influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the facial swelling, throat constriction, swallowing difficult, throat pain, chest pain and neck pain were not recovered/not resolved and the outcome of the eye swelling was unknown. It was unknown if the reporter considered the stomach cramps, diarrhea, influenza-like symptoms, chills, fever, facial swelling, throat constriction, swallowing difficult, throat pain, chest pain, neck pain and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The case was received on after hours voicemail. The patient received the SHINGRIX vaccine at approximately 2:00 PM in the right arm and that evening she experienced stomach cramps and diarrhea. The patient also had flu like symptoms including aches, chills and a fever that lasted for 24 hours. On Sunday, the patient experienced a swollen right cheek and jaw and it felt like her throat was swollen and she had difficulty swallowing because of the pain and it felt like her throat was clogged. She claimed that her eye was swollen from her jaw up to her eye and the area was puffy. On 13th August 2018, the patient saw an Internist who claimed that she was experiencing a secondary side effect. The patient also saw a cardiologist a day before date of reporting because she was experiencing throat, chest and neck pain and after testing, the results came back negative and she was referred to an Ear, Nose and Throat doctor which she would see in September 2018. The patient had provided contact details of physician.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palatal swelling, Pharyngeal oedema, Pyrexia, Sensation of foreign body, Swelling
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of stomach cramps in a 76-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th August 2018, several hours after receiving SHINGRIX, the patient experienced stomach cramps, diarrhea, influenza-like symptoms, chills and fever. On 12th August 2018, the patient experienced facial swelling, throat constriction and swallowing difficult. In August 2018, the patient experienced throat pain, chest pain, neck pain and eye swelling. On an unknown date, the outcome of the stomach cramps, diarrhea, influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the facial swelling, throat constriction, swallowing difficult, throat pain, chest pain and neck pain were not recovered/not resolved and the outcome of the eye swelling was unknown. It was unknown if the reporter considered the stomach cramps, diarrhea, influenza-like symptoms, chills, fever, facial swelling, throat constriction, swallowing difficult, throat pain, chest pain, neck pain and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The case was received on after hours voicemail. The patient received the SHINGRIX vaccine at approximately 2:00 PM in the right arm and that evening she experienced stomach cramps and diarrhea. The patient also had flu like symptoms including aches, chills and a fever that lasted for 24 hours. On Sunday, the patient experienced a swollen right cheek and jaw and it felt like her throat was swollen and she had difficulty swallowing because of the pain and it felt like her throat was clogged. She claimed that her eye was swollen from her jaw up to her eye and the area was puffy. On 13th August 2018, the patient saw an Internist who claimed that she was experiencing a secondary side effect. The patient also saw a cardiologist a day before date of reporting because she was experiencing throat, chest and neck pain and after testing, the results came back negative and she was referred to an Ear, Nose and Throat doctor which she would see in September 2018. The patient had provided contact details of physician.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of stomach cramps in a 76-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th August 2018, several hours after receiving SHINGRIX, the patient experienced stomach cramps, diarrhea, influenza-like symptoms, chills and fever. On 12th August 2018, the patient experienced facial swelling, throat constriction and swallowing difficult. In August 2018, the patient experienced throat pain, chest pain, neck pain and eye swelling. On an unknown date, the outcome of the stomach cramps, diarrhea, influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the facial swelling, throat constriction, swallowing difficult, throat pain, chest pain and neck pain were not recovered/not resolved and the outcome of the eye swelling was unknown. It was unknown if the reporter considered the stomach cramps, diarrhea, influenza-like symptoms, chills, fever, facial swelling, throat constriction, swallowing difficult, throat pain, chest pain, neck pain and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The case was received on after hours voicemail. The patient received the SHINGRIX vaccine at approximately 2:00 PM in the right arm and that evening she experienced stomach cramps and diarrhea. The patient also had flu like symptoms including aches, chills and a fever that lasted for 24 hours. On Sunday, the patient experienced a swollen right cheek and jaw and it felt like her throat was swollen and she had difficulty swallowing because of the pain and it felt like her throat was clogged. She claimed that her eye was swollen from her jaw up to her eye and the area was puffy. On 13th August 2018, the patient saw an Internist who claimed that she was experiencing a secondary side effect. The patient also saw a cardiologist a day before date of reporting because she was experiencing throat, chest and neck pain and after testing, the results came back negative and she was referred to an Ear, Nose and Throat doctor which she would see in September 2018. The patient had provided contact details of physician.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chest pain, Chills, Diarrhoea, Dysphagia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of stomach cramps in a 76-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th August 2018, several hours after receiving SHINGRIX, the patient experienced stomach cramps, diarrhea, influenza-like symptoms, chills and fever. On 12th August 2018, the patient experienced facial swelling, throat constriction and swallowing difficult. In August 2018, the patient experienced throat pain, chest pain, neck pain and eye swelling. On an unknown date, the outcome of the stomach cramps, diarrhea, influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the facial swelling, throat constriction, swallowing difficult, throat pain, chest pain and neck pain were not recovered/not resolved and the outcome of the eye swelling was unknown. It was unknown if the reporter considered the stomach cramps, diarrhea, influenza-like symptoms, chills, fever, facial swelling, throat constriction, swallowing difficult, throat pain, chest pain, neck pain and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The case was received on after hours voicemail. The patient received the SHINGRIX vaccine at approximately 2:00 PM in the right arm and that evening she experienced stomach cramps and diarrhea. The patient also had flu like symptoms including aches, chills and a fever that lasted for 24 hours. On Sunday, the patient experienced a swollen right cheek and jaw and it felt like her throat was swollen and she had difficulty swallowing because of the pain and it felt like her throat was clogged. She claimed that her eye was swollen from her jaw up to her eye and the area was puffy. On 13th August 2018, the patient saw an Internist who claimed that she was experiencing a secondary side effect. The patient also saw a cardiologist a day before date of reporting because she was experiencing throat, chest and neck pain and after testing, the results came back negative and she was referred to an Ear, Nose and Throat doctor which she would see in September 2018. The patient had provided contact details of physician.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye swelling, Influenza like illness, Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of stomach cramps in a 76-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th August 2018, several hours after receiving SHINGRIX, the patient experienced stomach cramps, diarrhea, influenza-like symptoms, chills and fever. On 12th August 2018, the patient experienced facial swelling, throat constriction and swallowing difficult. In August 2018, the patient experienced throat pain, chest pain, neck pain and eye swelling. On an unknown date, the outcome of the stomach cramps, diarrhea, influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the facial swelling, throat constriction, swallowing difficult, throat pain, chest pain and neck pain were not recovered/not resolved and the outcome of the eye swelling was unknown. It was unknown if the reporter considered the stomach cramps, diarrhea, influenza-like symptoms, chills, fever, facial swelling, throat constriction, swallowing difficult, throat pain, chest pain, neck pain and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The case was received on after hours voicemail. The patient received the SHINGRIX vaccine at approximately 2:00 PM in the right arm and that evening she experienced stomach cramps and diarrhea. The patient also had flu like symptoms including aches, chills and a fever that lasted for 24 hours. On Sunday, the patient experienced a swollen right cheek and jaw and it felt like her throat was swollen and she had difficulty swallowing because of the pain and it felt like her throat was clogged. She claimed that her eye was swollen from her jaw up to her eye and the area was puffy. On 13th August 2018, the patient saw an Internist who claimed that she was experiencing a secondary side effect. The patient also saw a cardiologist a day before date of reporting because she was experiencing throat, chest and neck pain and after testing, the results came back negative and she was referred to an Ear, Nose and Throat doctor which she would see in September 2018. The patient had provided contact details of physician.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Swelling face, Throat tightness
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of stomach cramps in a 76-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 9th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th August 2018, several hours after receiving SHINGRIX, the patient experienced stomach cramps, diarrhea, influenza-like symptoms, chills and fever. On 12th August 2018, the patient experienced facial swelling, throat constriction and swallowing difficult. In August 2018, the patient experienced throat pain, chest pain, neck pain and eye swelling. On an unknown date, the outcome of the stomach cramps, diarrhea, influenza-like symptoms, chills and fever were recovered/resolved and the outcome of the facial swelling, throat constriction, swallowing difficult, throat pain, chest pain and neck pain were not recovered/not resolved and the outcome of the eye swelling was unknown. It was unknown if the reporter considered the stomach cramps, diarrhea, influenza-like symptoms, chills, fever, facial swelling, throat constriction, swallowing difficult, throat pain, chest pain, neck pain and eye swelling to be related to SHINGRIX. Additional details were provided as follows: The case was received on after hours voicemail. The patient received the SHINGRIX vaccine at approximately 2:00 PM in the right arm and that evening she experienced stomach cramps and diarrhea. The patient also had flu like symptoms including aches, chills and a fever that lasted for 24 hours. On Sunday, the patient experienced a swollen right cheek and jaw and it felt like her throat was swollen and she had difficulty swallowing because of the pain and it felt like her throat was clogged. She claimed that her eye was swollen from her jaw up to her eye and the area was puffy. On 13th August 2018, the patient saw an Internist who claimed that she was experiencing a secondary side effect. The patient also saw a cardiologist a day before date of reporting because she was experiencing throat, chest and neck pain and after testing, the results came back negative and she was referred to an Ear, Nose and Throat doctor which she would see in September 2018. The patient had provided contact details of physician.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Insomnia, Pain
Clinical narrative: For 4 weeks I was unable to use my left arm without extreme pain. Sharp/shooting pain through entire arm, difficulty sleeping through pain, occasional numbness in arm. Pain is still present.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pyrexia, Vaccination site pain
Clinical narrative: Very sore site of vaccine. Weakness. High fever. 101.9.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting.
Age: 1.0
Sex: F
Vaccine: PNC13, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: 2 days after receiving the vaccine patient reported redness, swelling, pain and fever. She then went to urgent care and was diagnosed with cellulitis. She was prescribed an antibiotic and is now feeling fine.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date in 2016, the patient was vaccinated with the first dose of their human papilloma virus (HPV) vaccination series with GARDASIL 9 intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. On an unknown date in 2018, the patient was vaccinated with the second dose of their HPV vaccination series with GARDASIL 9 intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Age: 30.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 30 year old patient (unknown gender). No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with first dose of GARDASIL 9 (confirmed not GARDASIL quadrivalent) (dose, anatomical site of administration, lot number and expiration date were not reported). No adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2013 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2015, the patient was treated at a medical facility for a blistering vesicular outbreak, that was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 21-MAY-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. In 2015, the patient was treated at a medical facility for a blistering vesicular outbreak, that was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 05-JUL-2016, the patient was treated at a medical facility for a blistering vesicular outbreak, that was diagnosed as herpes zoster. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 23-DEC-2010 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 11-NOV-2014, the patient was treated by a physician for a blistering vesicular outbreak, that was diagnosed as herpes zoster dermatitis. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored doses of PROQUAD (dose, frequency and route were unknown) lot # R002936 expiration date 29-JUL-2019, lot# R008207 expiration date 16-SEP-2019, lot# R003298 expiration date 31-JUL-2019, lot# R003298 expiration date 31-JUL-2019; for prophylaxis. Other suspect therapies included VARIVAX (dose, frequency and route were unknown) lot # R011809 expiration date 23-APR-2020, lot# R002054 expiration date 22-JAN-2020, lot# N031003 expiration date 03-NOV-2019, lot# N026072 expiration date 20-SEP-2019 and lot# N023957 expiration date 01-SEP-2019, for prophylaxis. The vaccines were reconstituted with properly stored sterile diluent(manufacturer unknown). Digital data logger registered a temperature excursion between 15 Fahrenheit degrees and 46 Fahrenheit degrees along 40 minutes. Other temperature excursion was registered between 6 Fahrenheit degrees and 24 Fahrenheit degrees along 54 minutes.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a 14 month old patient of unknown gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 23-AUG-2018, the patient was vaccinated with expired dose of Oka/Merck VARIVAX expiration date 10-AUG-2018(exact dose, route of administration and lot # were not reported), for prophylaxis. Concomitant therapies included sterile diluent. No adverse effect reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/ allergies were reported. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (which had a lot # of N029670 and an expiration date of 03-SEP-2019; however, was not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 47 F degrees to 77 F degrees  for 20 minutes. Reportedly, there had been no previous temperature excursions and the aformentioned one was identified due to a data logger. Furthermore, no product quality complaint was involved.  This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA011769: US-009507513-1808USA011770:
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Aspiration bone marrow, Full blood count, Leukaemia, Stem cell transplant
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a 30 year old female patient with allergy to BACTRIM (hives and shortness of breath), allergy to Acyclovir (ataxia and confusion), allergy to PEG-asparaginase (anaphylaxis) and allergy to Erwinia L-Asparaginase (anaphylaxis). The patient had no concomitant medications and no medical history. On an unspecified date in 2008, the patient was vaccinated with the first dose of GARDASIL, intramuscularly, to prevent human papillomavirus (dose, frequency, lot number and expiration date were not provided). Furthermore, it was also reported that between an unspecified date in 2008 to an unspecified date in 2009 the patient received the 2 doses of GARDASIL intramuscularly (dose, frequency, lot number and expiration date were not provided), also to prevent human papillomavirus. On 06-SEP-2017, the patient was diagnosed with leukemia. As a result, the patient was sought for medical attention and hospitalized for 4 weeks. Additionally, it was reported that on an unknown date, the patient underwent a complete blood count (CBC) and a bone marrow aspiration, however the results were not provided. Moreover, on 02-FEB-2018, the patient was again hospitalized for 4 weeks and was treated with a stem cell transplant. At the time of reporting, the outcome of leukemia was reported as resolving. The causal relationship between GARDASIL and leukemia was not provided. Upon internal review, the event leukemia was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/ allergies were reported. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (which had a lot # of N029670 and an expiration date of 03-SEP-2019; however, dosage number was not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 47 F degrees to 77 F degrees for 20 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned one was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA011662: US-009507513-1808USA011770.