chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2013 the patient was inoculated with ZOSTAVAX vaccine at a pharmacy for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-MAR-2016 the patient was treated by a physician for a vesicular rash which was diagnosed as herpes zoster. The patient was prescribed KENALOG for her painful symptoms and chronic pain. On or about 11-MAR-2016 the patient again sought treatment by the physician for peripheral facial neuropathy which was diagnosed as Ramsay-Hunt Syndrome, a peripheral facial nerve palsy secondary to herpes zoster infections. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, 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, pain, suffering and other damages. Upon internal review Ramsay-Hunt Syndrome was determined to be a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. On or about 16-OCT-2007 the patient was inoculated with ZOSTAVAX vaccine at a medical center for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 22-JUNE-2010 the patient was treated at a medical center for a severe vesicular outbreak, which was diagnosed as shingles. The patient was prescribed acyclovir and azithromycin for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, 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, pain, suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 13-JUL-2012, the patient was inoculated with ZOSTAVAX at a family medicine office as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2012, the patient was treated at a hospital (not specified whether admitted therefore considered an Emergency Room visit) for the onset of a severe vesicular rash which was diagnosed as herpes zoster or shingles. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-JAN-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 03-JAN-2015, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as shingles. She was prescribed acyclovir topical ointment and tablet for management of her painful symptoms and chronic pain. On or about 05-JAN-2015, the patient sought treatment from an ophthalmologist for a blistering vesicular outbreak which was diagnosed as herpes zoster keratoconjunctivitis. On or about 13-APR-2016, she sought further treatment from a physician's assistant for another vesicular outbreak which was diagnosed as shingles. She was prescribed acyclovir and NORCO for management of her painful symptoms and excruciating pain. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Upon internal review, herpes zoster keratoconjunctivitis was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-MAY-2004, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-SEP-2016, the patient was treated by a physician at an internal medicine office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. He was prescribed VALTREX for management for his painful symptoms and chronic pain.  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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-OCT-2012, the patient was inoculated with the ZOSTAVAX vaccine at a Health Department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-OCT-2015, the patient was treated at a county health center for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed acyclovir and TRAMADOL for management of her painful symptoms and chronic pain. As a direct and proximate result of 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Exposure via eye contact, Injection site haematoma, Injection site swelling, Pain, Syringe issue
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 05-Oct-2018 from a consumer. This case involves a 69 years old male patient who experienced caused a hematoma, egg sized area on arm that is 5 cm wide and 4 cm  tall, swelling at injection site, soreness, while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm. On an unknown date, the patient developed a non-serious welling at injection site, soreness, caused an egg sized area on  arm that is 5cm wide and 4cm tall and noted vaccine leaking down his arm at time of injection, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that pharmacist held the syringe and pinched my shoulder, gave injection to right arm and than I felt liquid down my arm. It was also reported that might have hit a vein and caused a hematoma. There was medicine still in the syringe.  It was an actual medication error due to wrong injection technique (hit a vein), underdose (there was medicine still in the syringe) and exposure via skin contact (vaccine leaking down his arm at the time of injection). This is also a case of syringe leak. Other relevant tests included no lab data. Final diagnosis was caused a hematoma, egg sized area on arm that is 5 cm wide and 4 cm  tall, swelling at injection site, soreness. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 05-Oct-2018 from a consumer. This case involves a 69 years old male patient who experienced caused a hematoma, egg sized area on arm that is 5 cm wide and 4 cm  tall, swelling at injection site, soreness, while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm. On an unknown date, the patient developed a non-serious welling at injection site, soreness, caused an egg sized area on  arm that is 5cm wide and 4cm tall and noted vaccine leaking down his arm at time of injection, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that pharmacist held the syringe and pinched my shoulder, gave injection to right arm and than I felt liquid down my arm. It was also reported that might have hit a vein and caused a hematoma. There was medicine still in the syringe.  It was an actual medication error due to wrong injection technique (hit a vein), underdose (there was medicine still in the syringe) and exposure via skin contact (vaccine leaking down his arm at the time of injection). This is also a case of syringe leak. Other relevant tests included no lab data. Final diagnosis was caused a hematoma, egg sized area on arm that is 5 cm wide and 4 cm  tall, swelling at injection site, soreness. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA279966, 2018SA279967, 2018SA281637, 2018SA279973, 2018SA279965, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281636, 2018SA281634, 2018SA281632, 2018SA281687 and 2018SA281692, same reporter. This case involves a 16 years old female patient who received vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On unknown date, the patient received injection of suspect MENACTRA lot U5984AB, expiry date 14-Aug-2019 via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient received vaccine of which had Temperature on 11 Sep 2018 through 13 Sep 2018 was too low at 30 F, below freezing for 4 hours. The patient did not experience any adverse reaction after the injection. this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281636, 2018SA279979, 2018SA281632, 2018SA281692 (Same reporter). This case involves a 17 years old male patient who was vaccinated with 0.5 ml dose of MENACTRA (lot U5984AB, expiry date: 14-Aug-2019) in the left deltoid (dose in series and route of administration were not reported) on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis, Hypoaesthesia, Swelling, Toothache
Clinical narrative: Mild Bells Palsy: Numbness in lower left chin and jaw. Extreme teeth pain and swelling (multiple).
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Injection site movement impairment, Pyrexia
Clinical narrative: Mother called day after vaccines were given. She stated that the child had a 105 temp last night and that the child was favoring his left leg. Mom said that she gave Ibuprofen and that the fever was down today. I suggested that she take the child to his doctor and mom says he doesn't have one until he gets his shots.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site reaction, Rash macular
Clinical narrative: Face became red and blotchy. Left leg and left buttock was red and blotchy,within 5 minutes of giving vaccine. She was given 6ml of Benadryl PO and all red areas ( except for leg) were gone after 15 minutes. The area on her leg was improving but still red.
Age: 55.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Patient reports starting the following morning, nausea vomiting, fever of 103 for 24 hours, headache, sore throat, aches, pains, arm sore for 4 days.
Age: 55.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient reports starting the following morning, nausea vomiting, fever of 103 for 24 hours, headache, sore throat, aches, pains, arm sore for 4 days.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient woke up around 9PM with severe itching and then visibly saw hives/welps and went to ER and saw Dr and was given 2 Benadryl's, 2.5 Pepcids, and steroids and patient was discharged at 5AM.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient experienced erythema at site of injection. Diagnosed with cellulitis by business health nurse. Pain from shoulder to wrist. At this point for 3 days pain is not getting worse but not improving significantly.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Skin tightness
Clinical narrative: Patient called the pharmacy on 10/11/18 and stated that she has had tightness in the left arm that she received the vaccine since she received the vaccine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Oropharyngeal pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: Low grade fever. Severe sore throat. Severe upper respiratory congestion. Diarrhea. Nausea/vomiting.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Low grade fever. Severe sore throat. Severe upper respiratory congestion. Diarrhea. Nausea/vomiting.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Pain in extremity, Rash, Rash pruritic, Vomiting
Clinical narrative: Patient began complaining of pain in arm by evening on day of shot. Over next several days she had complaints of Headache x 1, Vomiting x2, by 10/6/2018 patient was complaining of itchy rash on one arm and by 10/09/2018 the rash had spread to the opposite arm as well. She was  seen by the PCP and treated with ATARAX. The rash was described as dry bumps, no blisters, no discharge or weeping. Over the entire arm up to the shoulder. She did not report any fever.
Sex: U
Vaccine: RV5
Symptoms: Manufacturing product shipping issue, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 02-OCT-2018, the patient was vaccinated with ROTATEQ, (strength and dose were not reported) (lot # R007150 and expiration date: 15-OCT-2019) orally for prophylaxis which "spent too many days in transit" and which was exposed to unknown temperature conditions during transit. There was no previous temperature excursion. The digital data logger was not involved in recording the temperature excursion. No known adverse effects were reported. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JUN-2009, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-OCT-2015 the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2007, the patient was inoculated with ZOSTAVAX by a physician at the physician's office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2010, the patient was treated by the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster.  In 2014, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a different physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. 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 further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13 and FLU VACCINE, both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pneumococcal pneumonia vaccine co-administered with flu vaccine at the same injection site and reported redness and painful to touch. The action taken in response to the events for the vaccines was not applicable. The clinical outcome for the events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Feeling hot, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: This is spontaneous report from a contactable consumer (patient). A 64 years old patient of unspecified gender received PREVNAR 13, via an unspecified route of administration in the arm on 05Oct2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 06Oct2018 in the morning the patient experienced feeling hot with pain on arm and from night the patient had fever, throw up and pain all over body was like a truck run he/she over, the pain is the arm was like have an operation, the patient was not able to move it. The outcome of fever was recovering, for the other events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: This is spontaneous report from a contactable consumer (patient). A 64 years old patient of unspecified gender received PREVNAR 13, via an unspecified route of administration in the arm on 05Oct2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. On 06Oct2018 in the morning the patient experienced feeling hot with pain on arm and from night the patient had fever, throw up and pain all over body was like a truck run he/she over, the pain is the arm was like have an operation, the patient was not able to move it. The outcome of fever was recovering, for the other events was unknown.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Pt reported she had redness and swelling at the site that started the evening she received the vaccine. Pt states she also became nausea and dizzy. These symptoms lasted approximately one week.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: REDNESS, SWELLING DOWN THE ARM, HEAT.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Malaise, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Patient received the vaccination around 12:05 PM on October 11, 2018. After 2-3 hours the patient started feeling a general malaise, swelling under the right arm, fever and chills. By 7:00 PM, on October 11, 2018, the patient states that she experienced a fever of 101 degrees Fahrenheit. At this point, the patient began taking Ibuprofen to help with the pain and Acetaminophen to help with the fever. Patient has been seen by the pharmacist, and has been advised to continue NSAID use to control the symptoms, to apply heat at the site, and to document any changes in fever or pain. Patient has been advised by the pharmacist that the normal course of adverse reaction is less than 72 hours, patient has been given information explaining the adverse reaction that she is experiencing. Patient has also been informed of being entered into VAERS, due to the adverse reaction that she has experienced.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Headache, muscle aches, nausea, low grade fever (less than 100 degrees), chills; fatigue; pain, redness, and swelling at injection site. Stayed in bed all day. ALKA-SELTZER early, then ibuprofen later helped some with symptoms. Symptoms lasted morning to night the day after injection; next morning all were gone except the soreness at injection site. This was the 2nd SHINGRIX shot. Same symptoms the first time, but I think were more severe with round 2.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Pyrexia
Clinical narrative: Headache, muscle aches, nausea, low grade fever (less than 100 degrees), chills; fatigue; pain, redness, and swelling at injection site. Stayed in bed all day. ALKA-SELTZER early, then ibuprofen later helped some with symptoms. Symptoms lasted morning to night the day after injection; next morning all were gone except the soreness at injection site. This was the 2nd SHINGRIX shot. Same symptoms the first time, but I think were more severe with round 2.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Musculoskeletal pain
Clinical narrative: Flu-like symptoms, muscular and joint pain, headache, low grade fever, chills, jaw and tooth pain on left side, pain in left arm and shoulder.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain in extremity, Pain in jaw, Pyrexia, Toothache
Clinical narrative: Flu-like symptoms, muscular and joint pain, headache, low grade fever, chills, jaw and tooth pain on left side, pain in left arm and shoulder.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain
Clinical narrative: Injection site sore, aches, chills, headache.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient presented with swollen left upper arm, red & itchy. I instructed patient to monitor & I left message with pcp.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blood lactic acid, Erythema, Full blood count, Metabolic function test, Skin warm
Clinical narrative: Redness, swelling, hot to touch, tender.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Swelling, Tenderness
Clinical narrative: Redness, swelling, hot to touch, tender.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient reported swelling and pain involving upper half left arm.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pharyngeal lesion, Tongue disorder
Clinical narrative: Employee developed lesions on pharynx and at the side of tongue with lymphadenopathy.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Feeling hot, Pruritus, Swelling face
Clinical narrative: 10/9/18-Evening-face felt itchy and warm. 10/10/18-AM facial swelling, red and warm.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Immunisation, Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects have been noted to date. According to CDC recommendations listed here: on website, the patient returned to the clinic and was given a repeat dose by IM route the same day.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Chills, Headache, Nausea, Pallor
Clinical narrative: Had severe chills, nausea with abd. pain, pale, headache about 3 1/2 hrs after receiving BEXSERO (Men B) vaccine. He was seen in ED.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: It was brought to my attention that shortly after this patient was administered FLUZONE, she walked to the front of the store to shop, but had to sit down on the register table to rest because she was having severe back pain. A team-member called EMS and they arrived, but patient refused medical care at that time.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: After my flu shot my arm really hurt at the site of injection; much more than other years and lasted for days. It seemed to be given higher than in the past. About 2-3 weeks later I noticed pain when raising my arm about my head. By September 19th I really noticed the pain as I had a hard time taking off my clothes over my head and needed assistance. It continues to be painful when raised above my head to this day.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site pain, Myalgia, Somnolence
Clinical narrative: Systemic myalgia, headache, dizziness, extreme drowsiness, injection site pain.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Approximately 4 hours post injection, pt developed a full-body rash; fine red pruritic.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: On the next day after administration of vaccine, pt developed hives and swelling in her legs, symptoms resided 10/10/18.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Atrial fibrillation, Chills, Condition aggravated, Malaise, Pyrexia
Clinical narrative: Patient received the vaccine on 10/3/2018 the next morning she called the pharmacy 10/4 and said last night she was really sick with fever and chills. Then 10/10 she called the pharmacy back to let us know she was admitted for afib and believes it was from the vaccine that caused all of this for her. Her doctor had to put her on Eliquis.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient passed out and became unresponsive. An ambulance was called and she was taken to the hospital. We are unsure of outcomes at this time.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT REPORTED PAIN, REDNESS, AND SWELLING TO INJECTION SITE. PATIENT STATED PAIN IN ENTIRE LEFT ARM. PATIENT STATES A FEW DAYS AFTER RECEIVING, HAD PERIODS OF SHORTNESS OF BREATH, THROAT PAIN, FEVER. PATIENT SEEN IN OUR FACILITY ON 10/11/2018 AND HAD A 5 MM IN DIAMETER RAISED DARK PINK IN COLOR AREA TO LEFT DELTOID  AND WARM TO TOUCH. PATIENT HAD FULL USE OF LEFT ARM AND STATED AREA TO LEFT UPPER ARM WAS LARGER THAN WHEN PATIENT VISITED OFFICE. PATIENT STATED HE HAD TDAP AT APPROXIMATELY AT AGE 18 PRIOR TO ATTENDING COLLEGE. PATIENT REPORT ON 10/11/2018 ALL SYMPTOMS HAD SUBSIDED EXCEPT FOR SOME MINOR TENDERNESS TO LEFT UPPER ARM.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: PATIENT REPORTED PAIN, REDNESS, AND SWELLING TO INJECTION SITE. PATIENT STATED PAIN IN ENTIRE LEFT ARM. PATIENT STATES A FEW DAYS AFTER RECEIVING, HAD PERIODS OF SHORTNESS OF BREATH, THROAT PAIN, FEVER. PATIENT SEEN IN OUR FACILITY ON 10/11/2018 AND HAD A 5 MM IN DIAMETER RAISED DARK PINK IN COLOR AREA TO LEFT DELTOID  AND WARM TO TOUCH. PATIENT HAD FULL USE OF LEFT ARM AND STATED AREA TO LEFT UPPER ARM WAS LARGER THAN WHEN PATIENT VISITED OFFICE. PATIENT STATED HE HAD TDAP AT APPROXIMATELY AT AGE 18 PRIOR TO ATTENDING COLLEGE. PATIENT REPORT ON 10/11/2018 ALL SYMPTOMS HAD SUBSIDED EXCEPT FOR SOME MINOR TENDERNESS TO LEFT UPPER ARM.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Feeling cold, Hot flush, Injection site inflammation, Injection site pain
Clinical narrative: In the evening of the dose she had pain & inflammation at injections site, couldn't sleep on that side.  The following morning around 5 am she started to experience viral type symptoms with hot and cold flashes and very foggy head which continued for about 36 hours. No other person she knew experienced these symptoms, except a coworker that also received a SHINGRIX vaccination from the same lot number.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: In the evening of the dose she had pain & inflammation at injections site, couldn't sleep on that side.  The following morning around 5 am she started to experience viral type symptoms with hot and cold flashes and very foggy head which continued for about 36 hours. No other person she knew experienced these symptoms, except a coworker that also received a SHINGRIX vaccination from the same lot number.
Age: 76.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Axillary pain, Decreased appetite, Inflammation, Skin warm, Somnolence
Clinical narrative: Shoulder inflamed pain radiating under armpit, hot to the touch, very sleepy, loss of appetite.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site discharge, Injection site vesicles, Rash
Clinical narrative: Rash on arm with bruising and blister with serous fluid with no purulence overlying site.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Swelling
Clinical narrative: Employee reported a lump the size of a small orange at the site of injection with swelling spreading to neck area around clavicle.
Age: 57.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Feeling abnormal, Feeling cold, Hot flush, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Started with pain at injection site, continued to hot and cold flashes and severe mental fogginess. Had to go home from work the following afternoon. Did not feel able to perform metal or physical tasks until about 40 hours after the dose.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient came in to our office on 10/5/18 with complaints of severe pain and arm/hand numbness after his SHINGRIX vaccine. It was given on 10/1/18 at pharmacy and started hurting immediately after. After examining patient it looked like the vaccine was given incorrectly, it seems as if it was given more posteriorly than it should have been most likely hitting nerves. His shoulder and arm was in severe pain and his fingers were completely numb. We gave him Prednisone and an antibiotic and those seemed to help within a few days. Reported the incident to the pharmacy and they are looking into it.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-MAY-2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 24-MAY-2012, the patient was treated for the onset of a vesicular rash, which was diagnosed as shingles. The patient was prescribed acyclovir for management of his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: YF
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient of an unknown age who received a dose of YF-VAX lot number not reported via unknown route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage and wrong technique in product usage process. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: None.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-Health Care Professional. This case is linked to cases 2018SA281633, 2018SA279965, 2018SA279979, 2018SA281635, 2018SA281638, 2018SA281636, 2018SA279966, 2018SA279967, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA281687 and 2018SA281692, same reporter. This case involves a 3 months old male patient who received vaccine PENTACEL. The patients past medical history, concomitant medication and family history were not provided. On 13-Sep-2018, the patient received injection of suspect PENTACEL VACCINE lot C5507AA, expiry date 05-Sep-2019 via unknown route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that patient received vaccine of which had Temperature on 11 Sep 2018 through 13 Sep 2018 was too low at 30 F, below freezing for 4 hours. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves male patient (age unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ036AA, expiry date 09-May-2019 via unknown route in unknown administration site. It was an actual medication error due to vaccine underdose and syringe leak. It was reported that Prefilled syringe leaking is at neck. The doctor pushed the plunger and there is drop or 2 of liquid coming out of the neck. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 01-Oct-2018, the patient received a first dose 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261LA, expiry date 30-Jun-2019 via intramuscular route in the right deltoid. On 05-Oct-2018 he also received a second dose 0.5ml of the same vaccine lot UJ035AA, 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to extra dose administered. It was reported that 5 yr old patient was inadvertently given 2 doses of FLUZONE QUAD. Nurse reported patients dad brought patient in on 01-Oct-2018 and received the flu vaccine. Then patients aunt brought patient in on 05-Oct-2018 and did not know patient already received the flu vaccine and it was administered a second time. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.