chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Parent emailed Dr. and stated his upper left thigh, where they administered his shot, is now extremely red, swollen and hot to the touch. Treatment recommended: Cold towel or an ice pack wrapped in a towel. Recommended to give him TYLENOL or ibuprofen to reduce his pain.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Diarrhoea, Gingival swelling, Headache
Clinical narrative: Patient states she had swollen gums, a headache, diarrhea and back pain. When she called this evening 6/27/18 she said symptoms subsided except for headache and back pain.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Gingival oedema, Headache
Clinical narrative: Patient states she had swollen gums, a headache, diarrhea and back pain. When she called this evening 6/27/18 she said symptoms subsided except for headache and back pain.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Paraesthesia oral, Swollen tongue
Clinical narrative: Patient states she had swollen gums, a headache, diarrhea and back pain. When she called this evening 6/27/18 she said symptoms subsided except for headache and back pain.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: The patient reported severe burning hours later. The is a retired pharmacist and said it was nothing like anything she had ever experienced before in her vaccine history. She stated the pharmacist who gave the vaccine had good technique.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: Pt had dot on 6/25/18, upon waking up the next day (6/26th), the right arm felt "red", warm, tender to the touch and itchy. Today, 6/27th, the symptoms are still present.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Patient experienced the normal redness/soreness at and around the injection site. But about 2-3 days after immunization patient experienced a rash around neck, on her torso (under breast) and around her groin. Patient reports no itching or pain associated with rash. Patients PCP recommended hydrocortisone cream.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site swelling, Nausea
Clinical narrative: Immediate swelling at injection site along with nausea, and sweating. This lasted for about 1/2 hr.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: 6/25/18 ADE note: short self-limiting tonic-clonic seizure observed minutes after administration of GARDASIL 9 first injection in the series.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Malaise, Myalgia, Pain in extremity
Clinical narrative: Pt felt unwell on 6/25 PM. Developed fever of 101 and vomited x 2 early on 6/26. On 6/26-no->headache, myalgias, fatigue and arm pain.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt felt unwell on 6/25 PM. Developed fever of 101 and vomited x 2 early on 6/26. On 6/26-no->headache, myalgias, fatigue and arm pain.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Mobility decreased
Clinical narrative: On 4-3 we administered an IM SHINGRIX: Pt stated on 6-27-18 difficulty moving her arm and decreased range of motion in the joint. No pain reported.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Eye movement disorder, Musculoskeletal stiffness, Posture abnormal, Presyncope, Seizure
Clinical narrative: After giving Hepatitis A vaccine #2, I was placing the bandaid and looked at pt who head started to lean back and eyes was starting to roll and pt mouth was opening wide. Called pt name no response opened door and called for DR. Dr. came and stated call 911. I put arm under pt shoulder and under chin for pt would not hit head on desk. Pt was having a vago response and became very tight. Other Dr.'s and nurses arrive. Pt slowly started coming out and then we were able to put pt on bed. Blood pressure, pulse was monitored. EMS arrived then it was canceled. Dr. stayed with pt for about another 20-30 minutes. Pt left walking on his own. Per Dr./RN The patient had a seizure that was caused by his vasovagal reaction. The vasovagal episode triggered the seizure.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Unresponsive to stimuli
Clinical narrative: After giving Hepatitis A vaccine #2, I was placing the bandaid and looked at pt who head started to lean back and eyes was starting to roll and pt mouth was opening wide. Called pt name no response opened door and called for DR. Dr. came and stated call 911. I put arm under pt shoulder and under chin for pt would not hit head on desk. Pt was having a vago response and became very tight. Other Dr.'s and nurses arrive. Pt slowly started coming out and then we were able to put pt on bed. Blood pressure, pulse was monitored. EMS arrived then it was canceled. Dr. stayed with pt for about another 20-30 minutes. Pt left walking on his own. Per Dr./RN The patient had a seizure that was caused by his vasovagal reaction. The vasovagal episode triggered the seizure.
Age: 28.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given SHINGRIX vaccine instead of BOOSTRIX given in error. Contacted medical rep at GSK and she stated that there was no problem to give BOOSTRIX concurrently w/SHINGRIX. The patient did not experience any adverse effects throughout the day. BOOSTRIX was given in right arm, SHINGRIX was given in left arm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site rash
Clinical narrative: Parent noticed rash in area of vaccine 1 week after admin.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Pain, swelling, bruising, erythema, itching, warm to touch.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pain, swelling, bruising, erythema, itching, warm to touch.
Age: 1.67
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Emotional distress, Pyrexia
Clinical narrative: 1 wk after developed low grade fever w/emotional outbursts that lasted for apx. 1 week.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Cold sweat, Fall, Head injury, Seizure, Tremor
Clinical narrative: I was informed that while standing there waiting on his mother to get some paperwork at the front desk he had fallen/was having a seizure in the lobby-I arrived he was lying on the floor with his head in his mother's lap-I noted he was trembling/skin was clammy-staff informed he had fallen back hitting back of his head on the floor-patient was alert to mother speaking to him-I assessed patient's head for noticeable injuries and glanced at entire body for noticeable injuries-I called for my supervisor-before my supervisor arrived patient's mother had him stand/walk to a nearby chair-he did without any noticeable problems-my supervisor and NP arrived and we helped him to a w/c vital signs were taken and assessed by NP.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Decreased appetite, Fall, Immediate post-injection reaction, Injection site pain
Clinical narrative: Immediately following the SHINGRIX injection, patient complained of pain at the injection site. Patient was advised to take TYLENOL to relieve symptoms. Six days following the injection on 5-29-18, the patient's daughter came to the pharmacy to explain her mother was experiencing continued pain, fever, loss of appetite, nausea, lethargy, and malaise. The pharmacist advised the patient to supplement her hydration with extra electrolytes to prevent dehydration and for the patient to seek further evaluation/treatment at urgent care. Two days later on 5-31-18 the patient's daughter returned to pharmacy again to report patient was feeling better. On June 17, 2018, a different daughter called the pharmacy to inform the staff that patient unfortunately passed away following a fall. The daughter did not give details to her mother's death, and she did not disclose to the pharmacist that the SHINGRIX vaccine contributed to her death.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Immediately following the SHINGRIX injection, patient complained of pain at the injection site. Patient was advised to take TYLENOL to relieve symptoms. Six days following the injection on 5-29-18, the patient's daughter came to the pharmacy to explain her mother was experiencing continued pain, fever, loss of appetite, nausea, lethargy, and malaise. The pharmacist advised the patient to supplement her hydration with extra electrolytes to prevent dehydration and for the patient to seek further evaluation/treatment at urgent care. Two days later on 5-31-18 the patient's daughter returned to pharmacy again to report patient was feeling better. On June 17, 2018, a different daughter called the pharmacy to inform the staff that patient unfortunately passed away following a fall. The daughter did not give details to her mother's death, and she did not disclose to the pharmacist that the SHINGRIX vaccine contributed to her death.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt husband states a patchy rash started on her body a few days after receiving vaccine. Was going to dr on 6/26/18.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Pt reports he received SHINGRIX vaccine from Pharmacy staff. The injection hurt immediately and the left shoulder has had pain and stiffness since injection. He reports he developed a large bruise over the upper shoulder. He reports he used ice and NSAIDS, TYLENOL no relief. He was seen in physical therapy as he could not lift the arm above the shoulder height and they used heat, ice and stretching and told him to see his PCP for follow up (he was being treated or a right shoulder problem and they assisted him during same time).
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Injection site reaction, Myalgia, Rash
Clinical narrative: Site reaction, left arm myalgias, rash cellulitis of (L) arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: This serious spontaneous case, reported by health care professional (other) to VAERS and initially retrieved on 21-Feb-2018 by Seqirus from VAERS (VAERS ID: 724562), concerns a 25-year-old male patient. On 12-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: XF32908, anatomical location, expiry date: not reported). On the same day, after 2 hours of vaccination, the patient experienced nausea, for which no treatment was required. It was reported that, after 2 days from vaccination the patient recovered from the event. The reporter assessed this case as non-serious.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019) for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT (intramuscular). In March 2018, immediately after receiving RABAVERT, the patient experienced tremor, fever and pain in arm. On an unknown date, the outcome of the tremor was not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the tremor, fever and pain in arm to be related to RABAVERT. Additional details were provided as follows: The physician reported that a college student was supposed to receive RABAVERT for pre-exposure prophylaxis in order to go to veterinary school. The patient received a dose of RABAVERT in late March in left deltoid and later that evening developed a low grade fever and arm soreness and within 24 hours developed hand tremors and tongue tremors occurring shortly after the vaccine was administered. In 2018, the fever and arm soreness had since resolved but the tremors had not resolved. The patient had not received any doses since that first dose. The patient was seen by a neurologist for this issue. The physician stated this was previously reported to VAERS. The physician did not want to provide any further information.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019) for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT (intramuscular). In March 2018, immediately after receiving RABAVERT, the patient experienced tremor, fever and pain in arm. On an unknown date, the outcome of the tremor was not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the tremor, fever and pain in arm to be related to RABAVERT. Additional details were provided as follows: The physician reported that a college student was supposed to receive RABAVERT for pre-exposure prophylaxis in order to go to veterinary school. The patient received a dose of RABAVERT in late March in left deltoid and later that evening developed a low grade fever and arm soreness and within 24 hours developed hand tremors and tongue tremors occurring shortly after the vaccine was administered. In 2018, the fever and arm soreness had since resolved but the tremors had not resolved. The patient had not received any doses since that first dose. The patient was seen by a neurologist for this issue. The physician stated this was previously reported to VAERS. The physician did not want to provide any further information.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019) for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT (intramuscular). In March 2018, immediately after receiving RABAVERT, the patient experienced tremor, fever and pain in arm. On an unknown date, the outcome of the tremor was not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the tremor, fever and pain in arm to be related to RABAVERT. Additional details were provided as follows: The physician reported that a college student was supposed to receive RABAVERT for pre-exposure prophylaxis in order to go to veterinary school. The patient received a dose of RABAVERT in late March in left deltoid and later that evening developed a low grade fever and arm soreness and within 24 hours developed hand tremors and tongue tremors occurring shortly after the vaccine was administered. In 2018, the fever and arm soreness had since resolved but the tremors had not resolved. The patient had not received any doses since that first dose. The patient was seen by a neurologist for this issue. The physician stated this was previously reported to VAERS. The physician did not want to provide any further information.
Age: 20.0
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Fatigue, Injection site pain, Pyrexia, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tremor in a 20-year-old female patient who received RABAVERT (batch number 590011A, expiry date April 2019) for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT (intramuscular). In March 2018, immediately after receiving RABAVERT, the patient experienced tremor, fever and pain in arm. On an unknown date, the outcome of the tremor was not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved. It was unknown if the reporter considered the tremor, fever and pain in arm to be related to RABAVERT. Additional details were provided as follows: The physician reported that a college student was supposed to receive RABAVERT for pre-exposure prophylaxis in order to go to veterinary school. The patient received a dose of RABAVERT in late March in left deltoid and later that evening developed a low grade fever and arm soreness and within 24 hours developed hand tremors and tongue tremors occurring shortly after the vaccine was administered. In 2018, the fever and arm soreness had since resolved but the tremors had not resolved. The patient had not received any doses since that first dose. The patient was seen by a neurologist for this issue. The physician stated this was previously reported to VAERS. The physician did not want to provide any further information.
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Neurological examination normal, Nuclear magnetic resonance imaging, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site muscle pain in a female patient who received RABAVERT for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT. In March 2018, less than a day after receiving RABAVERT, the patient experienced injection site muscle pain, fever, fatigue and tremor of hands. On an unknown date, the outcome of the injection site muscle pain, fever and fatigue were recovered/resolved and the outcome of the tremor of hands was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain, fever, fatigue and tremor of hands to be related to RABAVERT. Additional details were provided as follows: It was unknown whether the patient received Rabipur for pre or post exposure prophylaxis. The age at vaccination was not reported. In late March 2018, the patient received a single dose of RABAVERT in the deltoid. Within 24 hours, the patient developed a low grade fever, hand tremors and muscle soreness in the deltoid where the patient received the vaccine. The physician declined to provide further information at this time. She may call back to medical information and provide more information.
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Nuclear magnetic resonance imaging normal, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site muscle pain in a female patient who received RABAVERT for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT. In March 2018, less than a day after receiving RABAVERT, the patient experienced injection site muscle pain, fever, fatigue and tremor of hands. On an unknown date, the outcome of the injection site muscle pain, fever and fatigue were recovered/resolved and the outcome of the tremor of hands was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain, fever, fatigue and tremor of hands to be related to RABAVERT. Additional details were provided as follows: It was unknown whether the patient received Rabipur for pre or post exposure prophylaxis. The age at vaccination was not reported. In late March 2018, the patient received a single dose of RABAVERT in the deltoid. Within 24 hours, the patient developed a low grade fever, hand tremors and muscle soreness in the deltoid where the patient received the vaccine. The physician declined to provide further information at this time. She may call back to medical information and provide more information.
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site muscle pain in a female patient who received RABAVERT for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT. In March 2018, less than a day after receiving RABAVERT, the patient experienced injection site muscle pain, fever, fatigue and tremor of hands. On an unknown date, the outcome of the injection site muscle pain, fever and fatigue were recovered/resolved and the outcome of the tremor of hands was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain, fever, fatigue and tremor of hands to be related to RABAVERT. Additional details were provided as follows: It was unknown whether the patient received Rabipur for pre or post exposure prophylaxis. The age at vaccination was not reported. In late March 2018, the patient received a single dose of RABAVERT in the deltoid. Within 24 hours, the patient developed a low grade fever, hand tremors and muscle soreness in the deltoid where the patient received the vaccine. The physician declined to provide further information at this time. She may call back to medical information and provide more information.
Sex: F
Vaccine: RAB, RAB, RAB, RAB
Symptoms: Fatigue, Injection site pain, Pyrexia, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site muscle pain in a female patient who received RABAVERT for prophylaxis. In March 2018, the patient received the 1st dose of RABAVERT. In March 2018, less than a day after receiving RABAVERT, the patient experienced injection site muscle pain, fever, fatigue and tremor of hands. On an unknown date, the outcome of the injection site muscle pain, fever and fatigue were recovered/resolved and the outcome of the tremor of hands was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain, fever, fatigue and tremor of hands to be related to RABAVERT. Additional details were provided as follows: It was unknown whether the patient received Rabipur for pre or post exposure prophylaxis. The age at vaccination was not reported. In late March 2018, the patient received a single dose of RABAVERT in the deltoid. Within 24 hours, the patient developed a low grade fever, hand tremors and muscle soreness in the deltoid where the patient received the vaccine. The physician declined to provide further information at this time. She may call back to medical information and provide more information.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fall, Guillain-Barre syndrome, Lumbar puncture abnormal, Nuclear magnetic resonance imaging
Clinical narrative: Per patient's son-he experienced numbness in feet and weakness in legs and went to ER. Was hospitalized. He is currently in the hospital and MD told son it could be Guillain-Barre from vaccine.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Syncope
Clinical narrative: Per patient's son-he experienced numbness in feet and weakness in legs and went to ER. Was hospitalized. He is currently in the hospital and MD told son it could be Guillain-Barre from vaccine.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Per patient's son-he experienced numbness in feet and weakness in legs and went to ER. Was hospitalized. He is currently in the hospital and MD told son it could be Guillain-Barre from vaccine.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Contusion, Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and bruising of arm. On 20th June 2018, the patient experienced headache, mobility decreased, nausea, dizziness, tiredness and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, bruising of arm, headache, mobility decreased, nausea, dizziness, tiredness and chills were not recovered/not resolved. The reporter considered the pain in arm, bruising of arm, headache, mobility decreased, nausea and dizziness to be related to SHINGRIX. It was unknown if the reporter considered the tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: In the evening of 19th June 2018 the patient's arm was very painful and bruised. On 20th Jun 2018 the patient reported headache, chills, nausea, dizzy and tired, she was also unable to lift her arm above her chest. The patient had denied permission to contact their physician.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Middle insomnia, Nausea, Pain in extremity, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and bruising of arm. On 20th June 2018, the patient experienced headache, mobility decreased, nausea, dizziness, tiredness and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, bruising of arm, headache, mobility decreased, nausea, dizziness, tiredness and chills were not recovered/not resolved. The reporter considered the pain in arm, bruising of arm, headache, mobility decreased, nausea and dizziness to be related to SHINGRIX. It was unknown if the reporter considered the tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: In the evening of 19th June 2018 the patient's arm was very painful and bruised. On 20th Jun 2018 the patient reported headache, chills, nausea, dizzy and tired, she was also unable to lift her arm above her chest. The patient had denied permission to contact their physician.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 19th June 2018 15:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and bruising of arm. On 20th June 2018, the patient experienced headache, mobility decreased, nausea, dizziness, tiredness and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, bruising of arm, headache, mobility decreased, nausea, dizziness, tiredness and chills were not recovered/not resolved. The reporter considered the pain in arm, bruising of arm, headache, mobility decreased, nausea and dizziness to be related to SHINGRIX. It was unknown if the reporter considered the tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: In the evening of 19th June 2018 the patient's arm was very painful and bruised. On 20th Jun 2018 the patient reported headache, chills, nausea, dizzy and tired, she was also unable to lift her arm above her chest. The patient had denied permission to contact their physician.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Bursitis, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of subacromial bursitis in a 53-year-old male patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) and (batch number H59LK, expiry date 25th April 2020) for prophylaxis.  On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced subacromial bursitis (serious criteria other: As per reporter) and injection site pain (serious criteria other: As per reporter). On 3rd June 2018, the patient experienced injected limb mobility decreased (serious criteria other: As per reporter) and injection site swelling (serious criteria other: As per reporter). The patient was treated with naproxen (Naprosyn). On an unknown date, the outcome of the subacromial bursitis, injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the subacromial bursitis, injected limb mobility decreased, injection site swelling and injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The reported batch number for antigen was 7FY22 and adjuvant portion was H59LK. Two days after receiving SHINGRIX, the patient experienced swelling, and decreased range of motion to left arm/deltoid region. The patient was diagnosed with sub acromial bursitis at the left deltoid injection area on 19th June 2018. The patient's interventions for symptoms were physician visit and was prescribed Naprosyn BID as an anti-inflammatory. The other health professional stated that the patient described pain as a "nuisance."  The other health professional was willing to provide further information if needed.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of subacromial bursitis in a 53-year-old male patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) and (batch number H59LK, expiry date 25th April 2020) for prophylaxis.  On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced subacromial bursitis (serious criteria other: As per reporter) and injection site pain (serious criteria other: As per reporter). On 3rd June 2018, the patient experienced injected limb mobility decreased (serious criteria other: As per reporter) and injection site swelling (serious criteria other: As per reporter). The patient was treated with naproxen (Naprosyn). On an unknown date, the outcome of the subacromial bursitis, injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the subacromial bursitis, injected limb mobility decreased, injection site swelling and injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The reported batch number for antigen was 7FY22 and adjuvant portion was H59LK. Two days after receiving SHINGRIX, the patient experienced swelling, and decreased range of motion to left arm/deltoid region. The patient was diagnosed with sub acromial bursitis at the left deltoid injection area on 19th June 2018. The patient's interventions for symptoms were physician visit and was prescribed Naprosyn BID as an anti-inflammatory. The other health professional stated that the patient described pain as a "nuisance."  The other health professional was willing to provide further information if needed.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of subacromial bursitis in a 53-year-old male patient who received SHINGRIX (batch number 7FY22, expiry date 25th April 2020) and (batch number H59LK, expiry date 25th April 2020) for prophylaxis.  On 1st June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced subacromial bursitis (serious criteria other: As per reporter) and injection site pain (serious criteria other: As per reporter). On 3rd June 2018, the patient experienced injected limb mobility decreased (serious criteria other: As per reporter) and injection site swelling (serious criteria other: As per reporter). The patient was treated with naproxen (Naprosyn). On an unknown date, the outcome of the subacromial bursitis, injected limb mobility decreased and injection site pain were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the subacromial bursitis, injected limb mobility decreased, injection site swelling and injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The reported batch number for antigen was 7FY22 and adjuvant portion was H59LK. Two days after receiving SHINGRIX, the patient experienced swelling, and decreased range of motion to left arm/deltoid region. The patient was diagnosed with sub acromial bursitis at the left deltoid injection area on 19th June 2018. The patient's interventions for symptoms were physician visit and was prescribed Naprosyn BID as an anti-inflammatory. The other health professional stated that the patient described pain as a "nuisance."  The other health professional was willing to provide further information if needed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Feeling abnormal, Injection site pain, Mass
Clinical narrative: PATIENT HAD DEVELOPED PAIN AT THE INJECTION SITE. PATIENT STATED SHE DEVELOPED A LUMP THE SIDE OF A TENNIS BALL THAT WAS RED AND WARM TO TOUCH. SHE SOON DEVELOPED DIARRHEA AND DID NOT FEEL GOOD FOR THE NEXT COUPLE OF DAYS.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: PATIENT HAD DEVELOPED PAIN AT THE INJECTION SITE. PATIENT STATED SHE DEVELOPED A LUMP THE SIDE OF A TENNIS BALL THAT WAS RED AND WARM TO TOUCH. SHE SOON DEVELOPED DIARRHEA AND DID NOT FEEL GOOD FOR THE NEXT COUPLE OF DAYS.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Severe chills, nausea, headache, muscle ache in arm, very sleepy - lasted 14 hours then just had a headache and sleepy. Took Tylenol next day. Day 2 - still sleepy and sore arm. Day 3 sore muscle in arm where vaccination took place.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Severe chills, nausea, headache, muscle ache in arm, very sleepy - lasted 14 hours then just had a headache and sleepy. Took Tylenol next day. Day 2 - still sleepy and sore arm. Day 3 sore muscle in arm where vaccination took place.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Malaise, Nausea
Clinical narrative: Patients spouse called pharmacy saying her husband was extremely ill - described as having nausea and tired/weak. Patient was currently sleeping at the time spouse called (6PM). Spouse said she did not think patient had a fever. 30 minutes later patient was contacted at his home by pharmacist and patient reported he was feeling fine. He said he was a little nauseous and tired so he layed down to take a nap. He was unaware his spouse was going to contact the pharmacy. He stated he was okay now after taking a nap and no longer felt nauseous. He did not want medical treatment or for pharmacy to contact his doctor.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to three unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 02-MAR-2018 to 13-APR-2018, the patients were vaccinated with improperly stored Oka-Merck PROQUAD (dosing details were not reported) (lot # N028444, expiry date: 09-APR-2019) for prophylaxis the vaccine was administered with properly stored MERCK STERILE DILUENT (product storage error). The vaccine was stored at a temperature of -14 degree Celsius to -10 Celsius (-9.9 degree Celsius) for 17 hours and 11 minutes. No previous temperature excursions reported. No adverse effects reported. No product quality complaint involved. This is one of the two reports received from the same reporter. This is non-valid report due to lack of patient identifiers. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information was received from medical assistant on 21-JUN-2018. Patient identifier was updated. On 12-MAR-2018, the patient was vaccinated with improperly stored Oka-Merck PROQUAD (lot # N028444, expiry date: 09-APR-2019) for prophylaxis. Sender's Comments: US-009507513-1804USA007217: US-009507513-1806USA011869.
Age: 3.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and a nurse practitioner and refers to a 3-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-MAY-2018, the patient was vaccinated with GARDASIL 9, 1 injection (route of administration, lot number and expiration date were not reported) and subsequently on 21-MAY-2018, he was administered another dose of GARDASIL 9, lot # N020352 with expiration date on 10-APR-2020 (dose and route of administration were not reported) for an unspecified indication outside of prescribing information. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: This spontaneous Non-valid report was received from a Registered Nurse referring to unknown number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of (wistar ra 27-3) M-M-R II lot # N023149 and expiration date on 24-AUG-2019 (strength, dose number, route and anatomical location were not provided) for prophylaxis. Concomitant therapies included sterile diluent. The temperature was 47°F to 77 °F and the time frame was reported as 2 hours, no previous temperature excursions. The case involved data logger.
Sex: M
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Pneumonia
Clinical narrative: This spontaneous report was received from an 82 year old male patient referring to himself. Pertinent medical history included chronic idiopathic urticaria. The patient had no drug reactions/allergies. Concomitant therapies included omalizumab (XOLAIR) (reported as "XOLAR"). In approximately 2000 (reported as 18 years ago), the patient was vaccinated with PNEUMOVAX 23 (1 injection, strength and lot unknown, route reported as injection in the arm) to avoid pneumonia. In approximately 2007 (reported as 11 years ago), the patient contracted pneumonia which was confirmed by a chest X-Rays and was given antibiotics but was not getting better. The patient was hospitalized for 24 hours observation and given a higher dose of antibiotics intravenously and then treated as an outpatient and recovered. The patient said 2 years ago (in approximately 2016), he received PREVNAR 13. On an unknown date in January 2018 (also reported as this winter), the patient developed pneumonia in the right lung, and developed pneumonia in his left lung in April. He was treated with unspecified "cephalosporin and an azithromycin (Z-PAK) (reported as "Z-PACK")" and said he was recovered after completing a treatment. The causality assessment was not provided. Upon internal review, the event of pneumonia was determined to be medically significant.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician, refers to a currently 16 years old non pregnant female patient. The patient's pertinent medical history and concomitant medications, if any, were unknown by the physician. In addition, the physician mentioned the patient did not have any drug reactions or allergies history. On 06-FEB-2003, at the age of 1 year old; and, on 25-FEB-2003, at the age of 4 years old; the patient was vaccinated with the first and second dose, respectively, of (wistar ra 27-3) M-M-R II, one dosage form each time, as prevention for mumps, measles, and rubella (prophylaxis) (therapy types, routes and anatomical locations of administration, lot numbers and expiration dates were unknown by the physician). On an unspecified date, the physician performed a MMR antibody titer to the patient, which tested negative (mumps antibody test negative, rubella antibody negative and measles antibody negative). It was reported that a physician visit was required; however, no treatment was given to the patient as a result of mumps antibody test negative, rubella antibody negative and measles antibody negative, nor the events caused hospitalization or were life threatening to the patient. No product quality complaints were reported either. By the time of report, the outcome of mumps antibody test negative, rubella antibody negative and measles antibody negative remained unknown. The physician did not provide any causality assessment for mumps antibody test negative, rubella antibody negative and measles antibody negative in regards with (wistar ra 27-3) M-M-R II vaccination.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Lip blister
Clinical narrative: This spontaneous report has been received from a nurse, also the patient's mother, via a company representative; referring to her currently 15 years old male son. The nurse stated that her son did not have any pertinent medical history, nor was taking any medication concomitantly. As part of the patient's drug reactions and allergies information, the nurse reported sesame seeds (food allergy) as current condition. In an unspecified day in June 2017, at the age of 14 years old, the patient was vaccinated with the first dose of GARDASIL 9 vaccines series, by receiving 0.5 ml, intramuscularly, as Human Papillomavirus (HPV) prevention (prophylaxis) (anatomical location of vaccination was not provided; lot number and expiration date were unknown by the nurse). The nurse stated that "the day after" receiving GARDASIL 9, on an unspecified day in June 2017, the patient developed a blister on his upper lip (lip blister). Medical attention was not seek, no laboratory or any other diagnostic studies were performed, nor treatment was given to the patient for lip blister. No product quality complaints were involved either. It was reported that the patient did not receive the following doses in the GARDASIL 9 vaccinations series. The patient was reported to be recovered from lip blister at reporting time. The nurse did not assess the causality relationship between the occurrence of lip blister and GARDASIL 9 vaccination.
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 2011, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. Later in 2011, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 13-AUG-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. In 2010, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the 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: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding 3 unknown age infant patients of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 20-JUN-2018, the "3 infant patients" were administered adult doses of RECOMBIVAX lot# R006746 and 09-NOV-2020 expiration date for prophylaxis (strength, frequency and route of administration were not reported). No adverse effects were reported. No product quality complain was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On 21-JUN-2018, the patient was inadvertently vaccinated with the expired M-M-R II lot # M029230 with expiration date of 08-JUN-2018 and Albumin status of rHA, for prophylaxis (dose and route of administration). The vaccine was reconstituted with sterile diluent MRK INJ lot # M029230 with expiration date of 19-JUL-2018. No adverse effects were reported.