chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed clinical social worker referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have been administered improperly stored GARDASIL (lot # M014929, expiration date 27-MAY-2017; dose and route were unknown). The vaccines were stored under temperature 11 Celsius degree for 17 days. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's concomitant medication, pertinent medical history and drug reactions/allergies was unknown. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M03616; expiration date, dose and route were unknown). On an unknown date, the patient experienced cellulitis. It was unknown if the patient sought medical attention. No treatment was given for the event. The outcome of cellulitis was unknown. The causality was not reported. Upon internal review, cellulitis was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report was received from a male patient (also a pharmacist) of unknown age concerning himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, while preparing a dose of PNEUMOVAX 23 for administration to a patient, an unspecified amount of the vaccine accidentally splashed into one of his eyes. He used and eye wash to flush out the vaccine from his eye, and he was currently suffering no adverse effects. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-OCT-2016 from a medical assistant who reported that multiple unspecified patients received either VARIVAX (confirmed lot no. M028553, expiration 07-JUN-2018) M004330, 26-JAN-2018; M009766, 23-FEB-2018; M017290, 07-APR-2018; M024683, 18-MAY-2018), or PROQUAD (confirmed M006107, expiration 01-AUG-2017; M007962, 15-AUG-2017; M017337, 05-OCT-2017; M029599, 10-DEC-2017) that were improperly stored. No adverse effects reported. All fields pertain to all unspecified patients and all products. No further information was provided. This is one of two reports. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 14-OCT-2016 from a medical assistant who reported that multiple unspecified patients received either VARIVAX (confirmed lot no. M028553, expiration 07-JUN-2018; M004330, 26-JAN-2018; M009766, 23-FEB-2018; M017290, 07-APR-2018; M024683, 18-MAY-2018), or PROQUAD (confirmed M006107, expiration 01-AUG-2017; M007962, 15-AUG-2017; M017337, 05-OCT-2017; M029599, 10-DEC-2017) that were improperly stored. No adverse effects reported. All fields pertain to all unspecified patients and all products. No further information was provided. This is one of two reports. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". On 02-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursions of 24 hours. The lowest recorded temperature was 34 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". On 25-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". On 21-JUL-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFD-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unspecified date, the GARDASIL 9 vaccine had a temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". On 24-JUN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "0.5mL-10 Pk SD PFS-Luer-Lok" which had a lot number of M003659 and expiration date on 20-SEP-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Erythema, swelling of arm.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: States last night had fever, chills and arm swelling. This AM (6/25/16), had erythema and arm pain. Redness expanding from deltoid to mid axillary area. Cephalexin 500mg TID.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant medications was not provided. On an unspecified date in 2014, the patient was vaccinated with the first dose of ZOSTAVAX which had a lot number of J011213 and expiration date on 14-NOV-2014 (route of administration and anatomical location were not reported). Then, on 03-NOV-2016, reported as "today", the patient was vaccinated with the second dose of ZOSTAVAX 0.65ml, subcutaneously, which had a lot number of M026876 and expiration date on 26-JUL-2017 (anatomical location was not reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Seizure like phenomena
Clinical narrative: Information has been received from a physician via company representative, concerning a "teenager" female patient of unknown age. No pertinent medical history, drug reactions, allergies, concurrent conditions or concomitant therapies were reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL 9 also reported as GARDASIL (dosage schedule, lot number, expiration date, route and anatomical location of administration, were not reported). On an unknown date, the patient experienced "seizure like activity" after receiving GARDASIL 9 also reported as GARDASIL. It was unknown if any treatment was given for the adverse event. No Product Quality Complaint (PQC) was involved. The outcome of seizure was unknown at the time of reporting. The relatedness between the event and therapy was not reported. Upon internal review, seizure was determined to be a medically significant event. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on an unknown date, the patient had prior exposure to Pneumococcal vaccine (manufacturer unknown) (start date, dose, route of administration, lot # and expiration date were not reported). In approximately April 2016 (reported as about 6 months ago), the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). In approximately April 2016, the patient experienced injection site reaction. In fact, the event started on day one after injection and that reaction progressed in severity over next couple of days. The outcome of abnormally large injection site was unknown. The relatedness between the event and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: MMR Sub Q vaccine needle out of patient's leg when vaccine given due to patient twisting his body. Another MMR was given w/consent from guardian.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information had been received on 09-OCT-2016 from a registered nurse who reported that four unspecified patients received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 21-SEP-2016 and one unspecified patient received improperly stored GARDASIL 9 (lot# M007764, expiration date 30-JAN-2018) on 14-OCT-2016. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Decreased appetite, Discomfort, Erythema, Feeling hot, Headache
Clinical narrative: Red, warmth, swelling, discomfort, hot flashes, sweating, nausea, decreased appetite, headache and muscle aches. Acetaminophen.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Hot flush, Hyperhidrosis, Myalgia, Nausea, Swelling
Clinical narrative: Red, warmth, swelling, discomfort, hot flashes, sweating, nausea, decreased appetite, headache and muscle aches. Acetaminophen.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX which had lot # numbers of L015048, M015731, M025871, L048468 and a lot # reported as "M027344", with expiration dates of 29-APR-2017, 30-MAR-2018, 24-MAY-2018, 02-DEC-2017 and 01-JUN-2018 respectively (concentration, dose, route and anatomical place of vaccination were not provided). Nevertheless, no adverse symptoms reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Exposure via eye contact, Eye irrigation
Clinical narrative: This spontaneous report was received from a female certified nurse assistance of an unknown age, with type 1 diabetes mellitus and no allergies or drug reactions reported, referring to herself. The nurse assistance reported that, on 3-NOV-2016, while she was drawing up the vaccine into the syringe, PNEUMOVAX 23, (lot # and expiration date unspecified), a very small amount squirted into her eye. She flushed her eye with water, denied pain, and would be seen by her primary care physician. No treatment for the adverse event was given. No laboratories were performed. At the time of the report, the outcome of the patient and the causality between PNEUMOVAX 23 and Occupational exposure to product were unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 26-OCT-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose, route of administration, lot number and expiration date were unknown). On an unspecified date in 2016, the patient experienced redness at the injection site about the size of a quarter and injection site pain. No product quality complaint was involved. The outcome of injection site erythema was unknown. Moreover, it was reported that she was still sore to the time of reporting. The causality between ZOSTAVAX and the events was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to two unspecified patients of unknown age and gender. Patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 28-OCT-2016, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 PFU, lot # L044528, expiration date: 09-FEB-2017 (Dose and route of administration were not reported), which underwent a temperature excursion of 19 Fahrenheit degrees, for 12 hours. No previous temperature excursions were reported. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning herself, a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unspecified date (reported as "in the summer"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, anatomical location, lot number and expiration date were unknown). The reporter stated that, on an unknown date within 2-3 days after receiving the vaccine, her tricep area turned red. No product quality complaint was involved. The patient was recovered from erythema on an unspecified date. The causality between ZOSTAVAX and erythema was not provided. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning to an approximately 14 year old male patient. His medical history, concurrent conditions and drug reactions/allergies were not reported. In September 2015, when the patient was 13 years of age, the patient received his first dose of GARDASIL (frequency, route, lot # and expiration date were not reported). Subsequently, it was reported that, on 03-NOV-2016, the patient went to the reporter's office to receive his second dose of GARDASIL 9 (frequency, route, lot # and expiration date were not reported) (interchange of vaccine products and inappropriate schedule of drug administration). No product quality complaints or adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an approximately 68 year old male patient. Medical history and concomitant medications were unknown by the reporter. On an unspecified date in 2015 (reported as one year ago), the patient received ZOSTAVAX (lot number unknown). The day after the patient received ZOSTAVAX, the patient sought medical treatment at a facility because he broke out in lesions on his forehead. He was treated with an unspecified antiviral medication. The lesions lasted for an unknown amount of time but at the time of the report the patient was "fully recovered". Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema multiforme, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: She said she had pain in the muscle at the injection site. She developed hardness under the skin. There also developed surrounding redness and soreness. No hives or other raised lesions. Erythema multiform. Cephalexin 500 mg tid.
Sex: M
Vaccine: HPV9
Symptoms: Nausea, Skin discolouration, Vomiting
Clinical narrative: Information had been received on 19-OCT-2016 from a field representative regarding an 11 year old male who received GARDASIL 9 (frequency 0, 2, 6 months) intramuscular injection. Physician reported that the patient received his first dose of GARDASIL 9 on 18-OCT-2016 and waited 15 minutes. Towards the end of this time frame, the patient stood up and looked "gray" or "green" and stated that he felt as if he was "going to vomit". The patient then vomited and laid back down and "felt better" after approximately 20 minutes. Patient sought medical attention. No treatment was given for the patient's adverse event. Patient's present status was unknown by reporter. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patients received improperly stored M-M-R II (lot # L036853, expiry date: 24-SEP-2017; lot # M002518, expiry date: 12-JAN-2018, lot # M010426; expiry date: 01-MAR-2018, lot # M015931, expiry date: 30-MAR-2018 and lot # M004899, expiry date: 22-OCT-2018). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There was no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Back injury, Balance disorder, Dizziness, Fall, Joint injury
Clinical narrative: 10/18/2016, I went to bathroom at 3:30 AM, as I was in proceed of sitting down on the commode, dizziness set in, lost balance and fell against the side of bath tub, hitting right side of back and hip, did not blackout, able to get up and return to bed, applying cold pack. Same thing happened again at 5:30 AM the room swirled, did not fall. Dizziness and nausea followed.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, X-ray
Clinical narrative: 10/18/2016, I went to bathroom at 3:30 AM, as I was in proceed of sitting down on the commode, dizziness set in, lost balance and fell against the side of bath tub, hitting right side of back and hip, did not blackout, able to get up and return to bed, applying cold pack. Same thing happened again at 5:30 AM the room swirled, did not fall. Dizziness and nausea followed.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Headache, Induration, Malaise, Pain, Peripheral swelling
Clinical narrative: Patient states that after she received her first meningitis B shot, about 5 hours later she had a headache, she felt unwell, her arm was swollen, hard, warm, and quite sore for around two weeks.
Age: 17.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Skin warm
Clinical narrative: Patient states that after she received her first meningitis B shot, about 5 hours later she had a headache, she felt unwell, her arm was swollen, hard, warm, and quite sore for around two weeks.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Blister/red mark around area of immunization.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eating disorder, Irritability, Pyrexia, Urine analysis normal, Urine output decreased
Clinical narrative: Developed a fever of 104.5 on 10/29, which dropped to 102 with TYLENOL on board. Patient was extremely irritable, was not eating well and had less wet diapers. Patient continued having fevers until 10/31. Patients ears and urine were examined for possible infection but were WNL. No other symptoms.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Experienced swollen injection site that moved down to lower arm. Seems like fluid build up. Advised warm compress and BENADRYL. Follow up w/PCP if not improved after 1 day.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Headache, Pneumonia
Clinical narrative: Everything they advertised that it is supposed to prevent-is what I ended up with. Horrible cough. Headache. Hard time getting my air. Put on antibiotic 1/4/16. Pneumonia set in.
Age: 1.42
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia, Rash macular
Clinical narrative: Fever, swollen, warm thigh (anteriorly) with blotchy red macular rash-significant increase in size of thigh; No systemic rash.
Age: 21.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Expired product administered
Clinical narrative: Patient was given expired MMR vaccine on October 12, 2016 at around 1:15 - 1:30 pm. Patient was fine. No treatment needed.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Influenza like illness, Malaise, Mononucleosis heterophile test negative, Pyrexia
Clinical narrative: MMR #1 given 10-12. Arthralgias, fever, general malaise for 3 days 10-22. Evaluated 10-24, negative for mononucleosis. Rash, maculopapular, diffuse 10-26 (resolution of flu-like symptoms at time of rash). Still with rash.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Rash maculo-papular
Clinical narrative: MMR #1 given 10-12. Arthralgias, fever, general malaise for 3 days 10-22. Evaluated 10-24, negative for mononucleosis. Rash, maculopapular, diffuse 10-26 (resolution of flu-like symptoms at time of rash). Still with rash.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Mobility decreased, Pyrexia
Clinical narrative: Fever-3 days. Inability to raise or use injected arm-4 days. Incapacitating fatigue-2 days.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Entire upper extremity was very painful for about a week; still has some pain in that arm 3 weeks later. Mom thinks shot was not given in muscle.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Skin warm
Clinical narrative: Arm very red, warm to touch severe allergic reaction.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Mobility decreased, Myalgia, Pain
Clinical narrative: Patient states she "can't move my arm" shooting pain in arm muscle. Site painful to the touch. Headache.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient present redness, swelling to (Rt) arm after vaccination HPV 2.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chest X-ray normal, Cough, Decreased appetite, Dyspnoea
Clinical narrative: PREVNAR 13 given 10/26/16. States that night had fever, SOB, loss of appetite, runny nose, headache, cough, redness, swelling at injection site. Wheezing, trouble moving arms, weak. Seen 10/31/16. Antihistamines, Prednisone given, CXR. F/U on 11/3/16.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Injection site swelling, Mobility decreased, Pyrexia
Clinical narrative: PREVNAR 13 given 10/26/16. States that night had fever, SOB, loss of appetite, runny nose, headache, cough, redness, swelling at injection site. Wheezing, trouble moving arms, weak. Seen 10/31/16. Antihistamines, Prednisone given, CXR. F/U on 11/3/16.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Rhinorrhoea, Wheezing
Clinical narrative: PREVNAR 13 given 10/26/16. States that night had fever, SOB, loss of appetite, runny nose, headache, cough, redness, swelling at injection site. Wheezing, trouble moving arms, weak. Seen 10/31/16. Antihistamines, Prednisone given, CXR. F/U on 11/3/16.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Rash, Swelling face, Vomiting
Clinical narrative: Within 5-10 minutes of receiving shots, developed belly pain and 15-20 minutes later developed generalized hives and swelling. Required IM epinephrine, steroids, fluid bolus, and watched in ER. Discharged with Epi Pen and allergy clinic follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abdominal pain, Swelling, Urticaria
Clinical narrative: Within 5-10 minutes of receiving shots, developed belly pain and 15-20 minutes later developed generalized hives and swelling. Required IM epinephrine, steroids, fluid bolus, and watched in ER. Discharged with Epi Pen and allergy clinic follow up.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Very much pain in right shoulder/arm while administering vaccine!!! Also, very much pain in shoulder and arm for weeks to follow. Little range of motion. Could not sleep at night because of pain in shoulder/arm for weeks and weeks. Very hard to put seat belt on and drive the car. I am very upset about this and have never had any problems with my right shoulder/arm.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Sleep disorder
Clinical narrative: Very much pain in right shoulder/arm while administering vaccine!!! Also, very much pain in shoulder and arm for weeks to follow. Little range of motion. Could not sleep at night because of pain in shoulder/arm for weeks and weeks. Very hard to put seat belt on and drive the car. I am very upset about this and have never had any problems with my right shoulder/arm.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Hypoaesthesia, Injection site erythema, Injection site pain, Lip swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She had no relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and cholesterol medication. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated that the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. The relatedness between the events and ZOSTAVAX was not reported. Reporter considered all the events to be potentially serious. Follow up information received on 02-NOV-2016, all telephone attempts to obtain follow up information were unsuccessful. Follow up information has been received from a nurse on 04-NOV-2016. The reporting nurse stated that there was no record of any patient with that date of birth at this office. Additionally, she reported that she was not aware of any patient with the mentioned events. Additional information has been requested. It has been determined that case # US-009507513-1610USA009683 was entered with the wrong initial aware date of 17-OCT-2016 instead of 16-OCT-2016. Therefore the case # US-009507513-1610USA009683 is being deleted and a new case # US-009507513-1611USA003814 was created with the appropriate initial aware date of 16-OCT-2016.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Facial pain, Hypoaesthesia, Injection site erythema, Injection site inflammation
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She had no relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and cholesterol medication. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated that the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. The relatedness between the events and ZOSTAVAX was not reported. Reporter considered all the events to be potentially serious. Follow up information received on 02-NOV-2016, all telephone attempts to obtain follow up information were unsuccessful. Follow up information has been received from a nurse on 04-NOV-2016. The reporting nurse stated that there was no record of any patient with that date of birth at this office. Additionally, she reported that she was not aware of any patient with the mentioned events. Additional information has been requested. It has been determined that case # US-009507513-1610USA009683 was entered with the wrong initial aware date of 17-OCT-2016 instead of 16-OCT-2016. Therefore the case # US-009507513-1610USA009683 is being deleted and a new case # US-009507513-1611USA003814 was created with the appropriate initial aware date of 16-OCT-2016.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Lip swelling, Swelling face
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She had no relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and cholesterol medication. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated that the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. The relatedness between the events and ZOSTAVAX was not reported. Reporter considered all the events to be potentially serious. Follow up information received on 02-NOV-2016, all telephone attempts to obtain follow up information were unsuccessful. Follow up information has been received from a nurse on 04-NOV-2016. The reporting nurse stated that there was no record of any patient with that date of birth at this office. Additionally, she reported that she was not aware of any patient with the mentioned events. Additional information has been requested. It has been determined that case # US-009507513-1610USA009683 was entered with the wrong initial aware date of 17-OCT-2016 instead of 16-OCT-2016. Therefore the case # US-009507513-1610USA009683 is being deleted and a new case # US-009507513-1611USA003814 was created with the appropriate initial aware date of 16-OCT-2016.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Lip swelling, Mouth swelling, Swelling face
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 69 year old female patient. The patient had no history of allergies or history of a neomycin allergy. She had no relevant drug history. She had high blood pressure and an unspecified cholesterol condition, for which she was taking unknown high blood pressure medication and cholesterol medication. On 13-OCT-2016, the patient was vaccinated with subcutaneous ZOSTAVAX (lot # M030139, expiry date: 18-AUG-2017) in the right arm. On an unknown date in October 2016, she developed an injection site reaction characterized by slight swelling and inflammation and a little bit of redness on her right arm. She stated that the injection site reaction was mild, it was only slightly pink, inflamed and swollen and was only local and did not involve her whole arm. In the morning of 16-OCT-2016 at about 10:30 EST, she began to experience facial swelling and soreness on the left side of her face. The patient did not had any redness, but her lips and the corner/crease of her mouth were swollen as if she was going to get a cold sore. She also experienced a burning sensation and numbness on the left side of her face. No relevant tests were done. As of 16-OCT-2016, she was no longer getting ZOSTAVAX. The patient continued to experience the injection site reaction characterized by slight swelling and inflammation as well as a little bit of redness on her right arm and facial swelling and soreness on the left side of her face that included a burning sensation and numbness. The relatedness between the events and ZOSTAVAX was not reported. Reporter considered all the events to be potentially serious. Follow up information received on 02-NOV-2016, all telephone attempts to obtain follow up information were unsuccessful. Follow up information has been received from a nurse on 04-NOV-2016. The reporting nurse stated that there was no record of any patient with that date of birth at this office. Additionally, she reported that she was not aware of any patient with the mentioned events. Additional information has been requested. It has been determined that case # US-009507513-1610USA009683 was entered with the wrong initial aware date of 17-OCT-2016 instead of 16-OCT-2016. Therefore the case # US-009507513-1610USA009683 is being deleted and a new case # US-009507513-1611USA003814 was created with the appropriate initial aware date of 16-OCT-2016.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Fall, Fear, Hyperventilation
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a physician who called regarding an 11 year old male patient. Medical history and concomitant medications were not reported. On 10-OCT_2016 this male patient received a dose of GARDASIL 9 intramuscularly (lot # M011117 expiration date 07-DEC-2017). During the same visit the patient also received MENACTRA (unspecified lot # and expiration date) and ADACEL (unspecified lot # and expiration date). The physician reported that immediately after administration, the patient began to roll his eyes and the body was stiff. The physician also stated that the patient was hyperventilating and became pale and fell down. The physician reported that all the symptoms resolved 30 minutes after administration and were fully recovered. Causality for the events was not provided. No additional information was provided. Additional information was requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a physician who called regarding an 11 year old male patient. Medical history and concomitant medications were not reported. On 10-OCT_2016 this male patient received a dose of GARDASIL 9 intramuscularly (lot # M011117 expiration date 07-DEC-2017). During the same visit the patient also received MENACTRA (unspecified lot # and expiration date) and ADACEL (unspecified lot # and expiration date). The physician reported that immediately after administration, the patient began to roll his eyes and the body was stiff. The physician also stated that the patient was hyperventilating and became pale and fell down. The physician reported that all the symptoms resolved 30 minutes after administration and were fully recovered. Causality for the events was not provided. No additional information was provided. Additional information was requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Fall, Hyperventilation, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a physician who called regarding an 11 year old male patient. Medical history and concomitant medications were not reported. On 10-OCT_2016 this male patient received a dose of GARDASIL 9 intramuscularly (lot # M011117 expiration date 07-DEC-2017). During the same visit the patient also received MENACTRA (unspecified lot # and expiration date) and ADACEL (unspecified lot # and expiration date). The physician reported that immediately after administration, the patient began to roll his eyes and the body was stiff. The physician also stated that the patient was hyperventilating and became pale and fell down. The physician reported that all the symptoms resolved 30 minutes after administration and were fully recovered. Causality for the events was not provided. No additional information was provided. Additional information was requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Pallor
Clinical narrative: Information was received 13-OCT-2016 via telephone call from a physician who called regarding an 11 year old male patient. Medical history and concomitant medications were not reported. On 10-OCT_2016 this male patient received a dose of GARDASIL 9 intramuscularly (lot # M011117 expiration date 07-DEC-2017). During the same visit the patient also received MENACTRA (unspecified lot # and expiration date) and ADACEL (unspecified lot # and expiration date). The physician reported that immediately after administration, the patient began to roll his eyes and the body was stiff. The physician also stated that the patient was hyperventilating and became pale and fell down. The physician reported that all the symptoms resolved 30 minutes after administration and were fully recovered. Causality for the events was not provided. No additional information was provided. Additional information was requested.
Age: 76.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Cellulitis, Hypersensitivity, Monocyte count increased, Neutrophil count increased, Platelet count decreased
Clinical narrative: Patient presented to ED on 10/15 with cellulitis (L) arm. T 101.F. Received PNEUMOVAX IM and flu vaccine presents with (L) arm pain for 1 day. Treated with 1gm Ceftriaxone IV and KEFLEX 500 every 6 x 7 d.
Age: 76.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Vaccination complication, White blood cell count increased
Clinical narrative: Patient presented to ED on 10/15 with cellulitis (L) arm. T 101.F. Received PNEUMOVAX IM and flu vaccine presents with (L) arm pain for 1 day. Treated with 1gm Ceftriaxone IV and KEFLEX 500 every 6 x 7 d.
Age: 76.0
Sex: M
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Blood calcium, Laboratory test abnormal, Pain in extremity, White blood cell count increased
Clinical narrative: Patient presented to ED on 10/15 with cellulitis (L) arm. T 101.F. Received PNEUMOVAX IM and flu vaccine presents with (L) arm pain for 1 day. Treated with 1gm Ceftriaxone IV and KEFLEX 500 every 6 x 7 d.
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Axillary pain, Blood culture, Cough, Diarrhoea
Clinical narrative: Pt presented to ED at Health Center. Received PNEUMOVAX 23 vaccine at PCP office on 10/7/16. On 10/7 started with (R) arm pain, decreased movement on 10/12/16 in ED with temp 101.8
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Headache, Hypoaesthesia, Laboratory test, Liver function test
Clinical narrative: Pt presented to ED at Health Center. Received PNEUMOVAX 23 vaccine at PCP office on 10/7/16. On 10/7 started with (R) arm pain, decreased movement on 10/12/16 in ED with temp 101.8
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Pt presented to ED at Health Center. Received PNEUMOVAX 23 vaccine at PCP office on 10/7/16. On 10/7 started with (R) arm pain, decreased movement on 10/12/16 in ED with temp 101.8
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Pt presented to ED at Health Center. Received PNEUMOVAX 23 vaccine at PCP office on 10/7/16. On 10/7 started with (R) arm pain, decreased movement on 10/12/16 in ED with temp 101.8
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Blood culture negative, Body temperature increased, Full blood count, Laboratory test, Lumbar puncture
Clinical narrative: Pt presented to ED at Health Center. Received PNEUMOVAX 23 vaccine at PCP office on 10/7/16. On 10/7 started with (R) arm pain, decreased movement on 10/12/16 in ED with temp 101.8
Age: 23.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt presented to ED at Health Center. Received PNEUMOVAX 23 vaccine at PCP office on 10/7/16. On 10/7 started with (R) arm pain, decreased movement on 10/12/16 in ED with temp 101.8
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram head normal, Disorientation, Hypertensive crisis, Laboratory test normal, Memory impairment
Clinical narrative: After vaccine was administered patient was in the store parking lot (after 20 minute waiting period) and became disoriented and could not remember her name. She went to the hospital with a caregiver and was admitted on 10/12-10/14 with elevated BP 217/88.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Speech disorder
Clinical narrative: After vaccine was administered patient was in the store parking lot (after 20 minute waiting period) and became disoriented and could not remember her name. She went to the hospital with a caregiver and was admitted on 10/12-10/14 with elevated BP 217/88.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Amnesia, Blood pressure increased, Disorientation
Clinical narrative: After vaccine was administered patient was in the store parking lot (after 20 minute waiting period) and became disoriented and could not remember her name. She went to the hospital with a caregiver and was admitted on 10/12-10/14 with elevated BP 217/88.
Age: 66.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Information had been received on21-OCT-2016 from a nurse regarding a 66 year old female with cerebral palsy, glaucoma, osteoporosis and allergy to penicillin. The nurse reported that the patient received a dose of PNEUMOVAX 23 intramuscular 0.5ml once (lot# M022947, expiration date 12-NOV-2017) on 29-SEP-2016. Concomitant medication included aspirin and TYLENOL. On 30-SEP-2016, the patient developed "warmth, redness, soreness and swelling from the deltoid to the elbow in the same arm that PNEUMOVAX 23 was given" (unspecified arm). The nurse stated that the patient was seen in the office on an unspecified date after receiving the PNEUMOVAX 23, in regards to reaction. When asked present status, the nurse stated, "she is doing better with just a little soreness at the injection site still". No further information was provided. Additional information has been requested.