chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Feeling hot, Hypersensitivity, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a adult female patient who received dTpa vaccine. Co-suspect products included glycerol unknown for an unknown indication. Concurrent medical conditions included infected toe. On an unknown date, the patient received dTpa vaccine and glycerol at an unknown dose and frequency. On an unknown date, less than a day after receiving dTpa vaccine and unknown after starting glycerol, the patient experienced feeling hot, generalized pruritus and hypersensitivity. The patient was treated with BENADRYL. On an unknown date, the outcome of the feeling hot and generalized pruritus were not recovered/not resolved and the outcome of the hypersensitivity was unknown. It was unknown if the reporter considered the feeling hot, generalized pruritus and hypersensitivity to be related to dTpa vaccine and glycerol. Additional details were provided as follows: The age at vaccination was not reported. On an unknown Monday, the patient went to the emergency room due to an infected toe and received dTpa as tetanus shot for the infected toe. During the night she woke up with her body on fire and itching all over. The patient took BENADRYL as treatment which provided some relief. The patient thought that the symptoms might be related to an allergic reaction to Glycerol. It was unknown, if the patient received BOOSTRIX or another dTpa booster from another manufacturer. The patient called the hospital back to find out which vaccine she had received and she was provided with GSK number to call. It was reported that, limited information was obtained as caller disconnected the call.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Dyspnoea, Erythema, Rash generalised, Rash papular, Swelling
Clinical narrative: Pt broke out in generalized papular rash, up swelling, some labored breathing, and redness to face.
Age: 95.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash on arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Local reaction
Clinical narrative: Cellulitis vs large area allergic/local reaction that include entire upper arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Malaise
Clinical narrative: 3 days malaise, flu-like symptoms.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye movement disorder, Mood altered, Somnolence, Tremor, Unresponsive to stimuli
Clinical narrative: Woke up at 7 in a bad mood, usually is happy. Sister reported patient lay down, started shaking, eyes rolled back, not responding, lasted a few minutes, sleepy afterwards, taken to clinic and then the ED.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Pallor
Clinical narrative: Became light headed "don't feel good" Pale in the face and sweaty did not faint.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ, MNQ, TDAP
Symptoms: Abdominal pain, Nausea, Peripheral swelling, Skin warm, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) via other non-healthcare professional (merk employee) on 16-JUN-2017. This case involves a male (also reported as female) patient (age reported as 13 or 14 year old) who was vaccinated with a dose of DAPTACEL and a dose of MENACTRA (for both vaccines batch number, expiry date, route and site of administratoin were not reported) on 19-JAN-2017. The patient's medical history, drug reactions/ allergies and concomitant medications were reported as unknown. On an unspecified date, following the vaccination, the patient experienced abdominal pain, nausea, vomiting and peripheral swelling/ swelling of his whole arm which was also hot to touch/ skin warm. Patient's lab data was not reported. The patient did not received any corrective treatment. The event's outcome was not reported by reporter (patient's present status was unknown by reporter). List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ, MNQ, TDAP
Symptoms: Aortic aneurysm, Nausea, Peripheral swelling, Skin abrasion, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) via other non-healthcare professional (merk employee) on 16-JUN-2017. This case involves a male (also reported as female) patient (age reported as 13 or 14 year old) who was vaccinated with a dose of DAPTACEL and a dose of MENACTRA (for both vaccines batch number, expiry date, route and site of administratoin were not reported) on 19-JAN-2017. The patient's medical history, drug reactions/ allergies and concomitant medications were reported as unknown. On an unspecified date, following the vaccination, the patient experienced abdominal pain, nausea, vomiting and peripheral swelling/ swelling of his whole arm which was also hot to touch/ skin warm. Patient's lab data was not reported. The patient did not received any corrective treatment. The event's outcome was not reported by reporter (patient's present status was unknown by reporter). List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: High fever (101), headache, sore throat.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (dose,route, anatomical location, lot# and expiration date were not reported).  On an unknown date (reported also as "at later time"), the patient received another dose of ZOSTAVAX 19400 PFU (dose, route, anatomical location, lot# and expiration date were not reported). Both vaccines were reconstituted with sterile diluent (MRK). No adverse effects were reported. The product quality complaint was not reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster, Rash, Visual impairment
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 65-year-old male patient. No information was provided regarding the patient's concomitant medications, pertinent medical history and drug reactions or allergies. On 30-AUG-2013, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot number and expiration date were not reported), to prevent shingles. On 25-MAY-2017, the patient developed the shingles. He developed a rash on his forehead and into the right eye area, which caused the eye to swell, impairing his vision. The eye was not directly affected. The patient sought medical attention and was treated at an ophthalmologist's office (details not provided). No product quality complaint (PQC) was involved. The outcome of the events was not recovered at the time of this report. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored PROQUAD Lot #M038860 with an expiration date on 13-MAR-2018, non-valid Lot # M033294 with an expiration date on 13-FEB-2018, Lot # M023931 with an expiration date on 09-NOV-2017 and Lot # M022402 with an expiration date on 01-NOV-2017 (strength, dose and route of administration were not provided) for prophylaxis; all reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccines temperature excursion was between 15°F to 46°F (29°F) for a time frame of 16 hours and 30 minutes. There were previous temperature excursions at 6°F to 14°F for 15 hours and 15°F to 46°F (16.3°F) for 5 hours. A data logger was involved in this report. This is one of two reports received by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008290.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a nurse via employee refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced injection site rash. The outcome of the event and the relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected due to lack of the reporter's contact details.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referrings to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies or concomitant medications were not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored VARIVAX Lot #M037008 with an expiration date on 25-AUG-2018 (strength, dose and route of administration were not provided) for prophylaxis; all reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine temperature excursion was between 15°F to 46°F (29°F) for a time frame of 16 hours and 30 minutes. There were previous temperature excursions from 6°F to 14°F for 15 hours and 15°F to 46°F (16.3°F) for 5 hours. A data logger was involved in this report. This one of two reports received by the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004340:
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia, Tenderness, Ultrasound scan abnormal
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 17-year-old female patient with penicillin allergy. The patient's medical history included kidney transplantation on 02-DEC-2016. Concomitant therapies included calcitriol, cholecalciferol (reported as vitamin D3), ferrous sulfate, PLAQUENIL, labetalol, KEPPRA, MYFORTIC, PRILOSEC), VALCYTE, PROCARDIA and TYLENOL. On 24-MAY-2017, the patient was vaccinated with a dose of PNEUMOVAX23 injection, lot # M042324 with an expiration date on 10-JUN-2018, in the left deltoid for prevention of pneumonia (dose and route of administration were not reported). On the same day, the patient developed a fever and her left arm became "red, tender and had profound swelling". On 26-MAY-2017, the patient was admitted to hospital where she had an ultrasound scan of the left upper extremity done. The scan showed a possible cellulitis and infection at the site where the PNEUMOVAX23 was administered. During hospitalization, the patient was treated with unspecified antibiotics (details were not reported). On 30-MAY-2017, the patient was discharged to home with oral clindamycin for 7 days. The outcome of the events was reported as recovered on an unknown date in approximately 2017. The relatedness between the events and PNEUMOVAX23 was not reported. This is one of two reports received from this reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008507.
Sex: U
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age, Therapeutic response unexpected
Clinical narrative: This spontaneous report has been received from an unspecified reporter and refers to 4 patients of unknown age and gender. There was no information about the patients' concomitant therapies and medical history provided. The patients' concurrent conditions included wards. On unknown dates, the patients administered unidentified Merck HPV vaccine (name and lot number not provided), while they were all over the 26 years of age. On unknown dates, after the receiving the vaccines, all the patients recovered from the warts (reported as the wards "went away"). No product quality complaint was involved. Additional information is not expected because there was no consent to contact the patients' physician.
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a patient's father's friend's friend refers to a 16 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not provided). It was reported that on an unknown date, the patient developed supraclavicular lymph nodes. The outcome of the adverse event and the relatedness between the adverse event and GARDASIL 9 were not provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011253.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported. Administered doses of vaccines experienced the temperature excursion between -14 and -10 degrees Celsius for 19 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011671: US-009507513-1706USA011669: US-009507513-1706USA011668: US-009507513-1706USA011670:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M027347 and expiration date on 01-JUN-2018 (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. The storage temperature was 6 to 14 degrees Fahrenheit (°F) (-14 to -10 degrees Celsius (°C)) for a time frame of 24 hours with multiple temperature excursions for a total cumulative time frame of 432 hours (dates between 12-JAN-2017 and 01-JUN-2017). This lot # was also exposed to storage temperature as 15 to 46 degrees Fahrenheit (°F) (-9 to 8 degrees Celsius (°C)) for a time frame of 24 hours with multiple temperature excursions for a total cumulative time frame of 1080 hours (dates between 15-FEB-2017 and 01-JUN-2017); and temperatures from 47 to 77 degrees Fahrenheit (°F) (9 to 25 degrees Celsius (°C)) for a time frame of 24 hours with multiple temperature excursions for a total cumulative time frame of 144 hours (dates between 27-MAR-2017 and 01-JUN-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA011488: US-009507513-1706USA002362: US-009507513-1706USA011484: US-009507513-1706USA011486:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported.  Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011670: US-009507513-1706USA011669: US-009507513-1706USA011671: US-009507513-1706USA011307:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were orally vaccinated with improperly stored doses of ROTATEQ (dose, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-00507513-1706USA011670: US-00507513-1706USA011307: US-00507513-1706USA011671: US-00507513-1706USA011668:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration dte were not reported). No adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011307: US-009507513-1706USA011669: US-009507513-1706USA011671: US-009507513-1706USA011668:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot# and expiration date were not reported). No adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 47 and 77 degrees Fahrenheit for 2 hours. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-00507513-1706USA011670: US-00507513-1706USA011669: US-00507513-1706USA011307: US-00507513-1706USA011668.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, MNQ, RV1
Symptoms: Seizure
Clinical narrative: Seizure.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness reported. Patient reported "room spinning."
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13 (Lot # R12276, Expiry Date 01Feb2018, NDC # 0005197102) via an unspecified route of administration at single dose on 16Jun2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was getting red, it was warm, it was itchy on 16Jun2017 evening. The pharmacist stated and there was an area that was continuing to move out past the injection site about 5-6 inches in diameter and 5 days later the pharmacist saw the border around the injection site was moving, there was an area that was continuing to move out past the injection site. The outcome was reported as worsened. The pharmacist assessed the events warm and area that was continuing to move out past the injection site as related.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13 (Lot # R12276, Expiry Date 01Feb2018, NDC # 0005197102) via an unspecified route of administration at single dose on 16Jun2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was getting red, it was warm, it was itchy on 16Jun2017 evening. The pharmacist stated and there was an area that was continuing to move out past the injection site about 5-6 inches in diameter and 5 days later the pharmacist saw the border around the injection site was moving, there was an area that was continuing to move out past the injection site. The outcome was reported as worsened. The pharmacist assessed the events warm and area that was continuing to move out past the injection site as related.
Sex: M
Vaccine: MENB
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported 2 cases for different patients. This is the 1st of 2 reports. A male patient of unspecified age and race/ethnicity received TRUMENBA (NDC# 0005-0100-01), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site/ pain in the arm in Jun2017 with outcome of unknown. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL, but pain came back.
Sex: F
Vaccine: FLUX
Symptoms: Dyskinesia, Dystonia, Eating disorder, Gait disturbance, Loss of consciousness
Clinical narrative: Initial unsolicited report received from a non-health care professional on 16 June 2017. This case involves a 25-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Seasonal FLU SHOT) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 23 August of an unspecified year. Patient's medical history and concomitant medications were not reported. On an unknown date, 10 days following the vaccination, the patient had started experiencing neurological symptoms like not being able to eat without passing out, unable to walk without twisting and jerking movements of uncontrollable muscle contractions. It was reported that the symptoms "disappear" when she ran, she was able to speak normally and she was able to walk backwards normally. On an unknown date, doctors had diagnosed her with a rare neurological disorder - dystonia which was triggered after receiving the Flu shot. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from events. This case was considered as serious by the reporter due to seriousness criteria persistent or significant disability or incapacity. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 23-May-2017: Patient was vaccinated with FLU SHOT. Patient also experienced dystonia and associated symptoms which are unlisted with Influenza vaccine (unknown manufacturer) . The time to onset is compatible with the role of vaccine. Additional information regarding results of investigations (infectious work-up and cerebral work-up as EEG, MRI) ruling out alternative etiology, any seizure disorder, trauma, any infection needed for complete assessment of the case.
Sex: F
Vaccine: FLUX
Symptoms: Muscle contractions involuntary, Nervous system disorder, Neurological symptom
Clinical narrative: Initial unsolicited report received from a non-health care professional on 16 June 2017. This case involves a 25-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Seasonal FLU SHOT) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 23 August of an unspecified year. Patient's medical history and concomitant medications were not reported. On an unknown date, 10 days following the vaccination, the patient had started experiencing neurological symptoms like not being able to eat without passing out, unable to walk without twisting and jerking movements of uncontrollable muscle contractions. It was reported that the symptoms "disappear" when she ran, she was able to speak normally and she was able to walk backwards normally. On an unknown date, doctors had diagnosed her with a rare neurological disorder - dystonia which was triggered after receiving the Flu shot. Laboratory investigations and corrective treatment were not reported. The patient was not recovered from events. This case was considered as serious by the reporter due to seriousness criteria persistent or significant disability or incapacity. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 23-May-2017: Patient was vaccinated with FLU SHOT. Patient also experienced dystonia and associated symptoms which are unlisted with Influenza vaccine (unknown manufacturer) . The time to onset is compatible with the role of vaccine. Additional information regarding results of investigations (infectious work-up and cerebral work-up as EEG, MRI) ruling out alternative etiology, any seizure disorder, trauma, any infection needed for complete assessment of the case.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-06-25.
Age: 46.0
Sex: M
Vaccine: PNC13, TDAP, VARCEL, VARCEL
Symptoms: Culture, Herpes zoster disseminated, Polymerase chain reaction, Rash vesicular, Varicella post vaccine
Clinical narrative: Disseminated zoster / primary chickenpox with vaccine strain VZV. Patient was previously non-immune without history of chickenpox as a child. He got a disseminated vesicular rash, predominantly on the trunk but also on head, face, mouth and legs.
Age: 46.0
Sex: M
Vaccine: PNC13, TDAP, VARCEL, VARCEL
Symptoms: Varicella virus test
Clinical narrative: Disseminated zoster / primary chickenpox with vaccine strain VZV. Patient was previously non-immune without history of chickenpox as a child. He got a disseminated vesicular rash, predominantly on the trunk but also on head, face, mouth and legs.
Age: 46.0
Sex: M
Vaccine: PNC13, TDAP, VARCEL, VARCEL
Symptoms: Antibody test positive, Rash vesicular, Varicella post vaccine, Varicella virus test positive
Clinical narrative: Disseminated zoster / primary chickenpox with vaccine strain VZV. Patient was previously non-immune without history of chickenpox as a child. He got a disseminated vesicular rash, predominantly on the trunk but also on head, face, mouth and legs.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Chills, Computerised tomogram head normal, Full blood count normal
Clinical narrative: Sudden onset severe throbbing HA, photophobia, hyperacusis, myalgias, shaking chills tx with IV fentanyl, BENADRYL, ketorolac and IVFs.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Hyperacusis, International normalised ratio normal, Metabolic function test normal, Myalgia
Clinical narrative: Sudden onset severe throbbing HA, photophobia, hyperacusis, myalgias, shaking chills tx with IV fentanyl, BENADRYL, ketorolac and IVFs.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Photophobia, Protein total decreased, Prothrombin time normal, Tremor
Clinical narrative: Sudden onset severe throbbing HA, photophobia, hyperacusis, myalgias, shaking chills tx with IV fentanyl, BENADRYL, ketorolac and IVFs.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Eye pain, Headache, Hyperacusis, Injection site pain, Muscle spasms
Clinical narrative: Sudden onset severe throbbing HA, photophobia, hyperacusis, myalgias, shaking chills tx with IV fentanyl, BENADRYL, ketorolac and IVFs.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Photophobia, Tremor
Clinical narrative: Sudden onset severe throbbing HA, photophobia, hyperacusis, myalgias, shaking chills tx with IV fentanyl, BENADRYL, ketorolac and IVFs.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red patch at vaccine site the size of palm. slight itching but no soreness. Appeared two days post vaccination and is fading at current (six days post vaccination).
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called me at the above time and date to say that his left arm has been sore (the same arm in which he was administered an inactivated flu vaccine). We are attempting to contact his primary physician in the meantime.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site reaction, Injection site streaking, Injection site swelling
Clinical narrative: EXTREME SORENESS ON 6/25/2017,TOOK A TYLONAL IN ORDER TO SLEEP. I DRESSED IN THE AM BUT DID NOT NOTICE THE BLOTCHY RASH AROUND INJECTION SITE UNTIL 11PM AT WHICH TIME I SAW STREAKS OF RED SWOLLEN AREAS ACROSS MY UPPER LEFT ARM AND ARM PIT GOING ACROSS TO MY CHEST. THERE HAD BEEN LIGHT ITCHING BUT NOTHING THAT MADE ME CHECK MY SKIN BEFORE I UNDRESSED. I HAVE NEVER HAD A REACTION TO ANY VACCINE BEFORE.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus, Rash macular, Swelling
Clinical narrative: EXTREME SORENESS ON 6/25/2017,TOOK A TYLONAL IN ORDER TO SLEEP. I DRESSED IN THE AM BUT DID NOT NOTICE THE BLOTCHY RASH AROUND INJECTION SITE UNTIL 11PM AT WHICH TIME I SAW STREAKS OF RED SWOLLEN AREAS ACROSS MY UPPER LEFT ARM AND ARM PIT GOING ACROSS TO MY CHEST. THERE HAD BEEN LIGHT ITCHING BUT NOTHING THAT MADE ME CHECK MY SKIN BEFORE I UNDRESSED. I HAVE NEVER HAD A REACTION TO ANY VACCINE BEFORE.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Choking, Diarrhoea, Laboratory test normal, Lethargy, Miliaria
Clinical narrative: Started with choking on saliva that had thickened couldn't cough up was choking. High fevers 103+ that would not break heat rash lethargic diarrhea vomiting. Hospitalized for 7 days because of such high fevers and diarrhea.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Saliva altered, Vomiting
Clinical narrative: Started with choking on saliva that had thickened couldn't cough up was choking. High fevers 103+ that would not break heat rash lethargic diarrhea vomiting. Hospitalized for 7 days because of such high fevers and diarrhea.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site pustule, Rash pustular, Scab
Clinical narrative: Pox site pop up, one to each thigh. Then on 24 June 2017 pox site noted about 1"-1.5" to the left of original inoculation site on left arm.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Insomnia, Pain
Clinical narrative: Pain in arm at injection site spreading and getting worse. I can no longer sleep on my left side (or lay on that side period) because of the resulting increased pain in my upper arm. The pain seems to be spreading to my elbow. Issue is getting worse rather than better. Reported to the doctor that gave me the injection, but she said that there is no treatment for the symptoms other than Tylenol, Ibuprofen, or Naproxen, but none of them seem to help, and I just have to give it more time. But I should not be getting these symptoms at all. A lot of the times I can't even lift my left arm without severe pain.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hallucination, Peripheral swelling, Pyrexia
Clinical narrative: Patient experienced high fever. Mother said her work called and said patient needed to be picked up due to hallucinations. Left arm started swelling.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging abnormal, Pain, Rotator cuff syndrome, Tendon disorder
Clinical narrative: Intense pain and loss of range of motion. No swelling or redness. Heat, ibuprofen and physical therapy.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound scan normal
Clinical narrative: Intense pain and loss of range of motion. No swelling or redness. Heat, ibuprofen and physical therapy.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Feeling abnormal, Thirst
Clinical narrative: Patient informed nurse that she felt like "everything is moving" that she is "very anxious and thirsty". Patient's BP was 145/99 and her Pulse was 128.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Induration, Pain, Swelling
Clinical narrative: Erythema Multiform and swelling, firmness, pain. Ibuprofen.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Peripheral swelling, Skin reaction
Clinical narrative: Patient developed injection site reaction, left arm was red and swollen following injection. Upon review, patient was referred to Dr where she received Clindamycin for possible infection.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Hypotension, Immediate post-injection reaction, Pallor
Clinical narrative: Dizziness - patient turned pale, C/O dizziness, low BP right after the shot within 1-2 minutes.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Local reaction, Rash macular
Clinical narrative: Left thigh with 5 cm x 6 cm warm, red, blotchy area. Temp of 100 degrees. 5 mL BENADRYL, cool compress, monitor.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Not specified.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia, Vaccination site pain
Clinical narrative: 06/22/17- Present fever and redness/pain in upper left arm where vaccine was administered. 06/23/17 - Z-PAK 06/24/17 - KEFLEX 06/25/17 - KEFLEX (increased dose) and BACTRIM DS.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Differential white blood cell count, Full blood count, Mass, Pain, Swelling
Clinical narrative: TDaP received on 6/9/17 Left arm. On 6/11/17 had 2 enlarged, painful, swollen lumps near left clavicle. Has decreased gradually in size. Currently pea size.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Body temperature increased, Cellulitis, Erythema, Skin warm
Clinical narrative: 6/16/17 - seen for 5 yr. well had MMRV, QUADRACEL in Lt. arm. Temp. 101 - redness, warm to touch started that night. Seen in office on 6/18/17 - cellulitis left arm transfer to ER who started him on KEFLEX. Had follow up appt. in office 6/19/17 - Mom cancelled as cellulitis improving.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site extravasation, Injection site haemorrhage, Injection site induration
Clinical narrative: Small portion of blood and vaccine solution poured out from injection site immediately after needle removed from muscle, and induration suddenly built up at IM site. Cold compression applied to IM site.
Age: 0.25
Sex: M
Vaccine: HEP, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gave Rotavirus Vaccine within 10 days of the last dose.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Dyspnoea, Feeling abnormal, Laboratory test, Loss of consciousness, Vaccination complication
Clinical narrative: Per patient-began feeling bad about 1:15/1:20pm-blacked out, came too vomiting, felt SOB, went to the ER. Other tests run to rule out other causes-ER came to conclusion it was a vaccine reaction. Pt feeling well today.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Per patient-began feeling bad about 1:15/1:20pm-blacked out, came too vomiting, felt SOB, went to the ER. Other tests run to rule out other causes-ER came to conclusion it was a vaccine reaction. Pt feeling well today.
Age: 0.5
Sex: F
Vaccine: DTP
Symptoms: Chills, Crying, Pyrexia, Screaming
Clinical narrative: Fever, chills, and hysterical crying/ screaming for 24 hours +.  We tried everything to calm her and nothing worked.  It was aheart breaking event resulting in no more of this vaccine . We called to doctor, but there was nothing he could do.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Activated partial thromboplastin time shortened, Angiotensin converting enzyme, Anion gap decreased, Basophil count normal, Basophil percentage
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood albumin normal, Blood calcium decreased, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood magnesium normal, Blood phosphorus normal, Blood potassium normal, Blood sodium normal, Blood urea decreased
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: C-reactive protein normal, CSF glucose normal, CSF protein increased, Carbon dioxide normal, Eosinophil count normal
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Eosinophil percentage increased, Glomerular filtration rate normal, Guillain-Barre syndrome, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: International normalised ratio normal, Lymphocyte count normal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Mean cell volume normal, Monocyte count increased, Monocyte percentage increased, Neutrophil count increased, Neutrophil count normal
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Neutrophil percentage, Nucleated red cells, Platelet count normal, Prostatic specific antigen, Red blood cell count decreased
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 53.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Red blood cell sedimentation rate increased, Red cell distribution width normal, Treponema test negative, White blood cell count increased
Clinical narrative: GUILLAIN BARRE SYNDROME.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Body temperature increased, Culture urine, Full blood count, Irritability, Urine analysis
Clinical narrative: Received 4 month immunizations that day, in the evening became fussy, mom took rectal temp at 10:00 PM and had temp of 105 rectally, pediatrician on call advised to go to ED for evaluation.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain
Clinical narrative: Headache. Body ache. She took Tylenol as advised.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, IPV
Symptoms: Feeling abnormal, Pyrexia, Regressive behaviour, Screaming, Seizure
Clinical narrative: High Fever. "Mild" seizures off and on for months where he would zone out and shake all over them scream after the shacking stopped Regressed by forgetting how to laugh and smile.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, IPV
Symptoms: Tremor
Clinical narrative: High Fever. "Mild" seizures off and on for months where he would zone out and shake all over them scream after the shacking stopped Regressed by forgetting how to laugh and smile.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site warmth, Muscle spasms
Clinical narrative: Spoke w/ pt Pain 8/10. Received vaccine around 11:30am. Pt went home, took a nap for about 30 minutes, and when pt woke up, pt saw swelling in shoulder. Size of about finger length. Pain is now radiating towards the neck. Denies redness or streaking. Denies fever although pt does not know her temp (states "I don't think so" when asked). Denies chest pain, SOB. Advised ok to go to the ER tonight if pt unable to tolerate pain. Scheduled appt tomorrow.  On 6/27/17 Left Deltoid with large area of erythema,warm to touch,no swelling,but tender to light touch. States pain radiates down arm. Start Cyclobenzaprine HCl Tablet, 5 MG, 1 tablet as needed, Orally, Three times a day, 5 days, 15 Tablet, Refills 0. Start Ibuprofen Tablet, 800 MG, as directed, Orally, twice a day, 5 days, 10, Refills 0. Clinical Notes: Localized vaccine reaction clear, but pain d/t reaction seems to be a rare reaction. Suspect it's related to either muscle spasms or nerve impingement d/t inflammatory response.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Nerve root compression, Pain, Pain in extremity, Swelling
Clinical narrative: Spoke w/ pt Pain 8/10. Received vaccine around 11:30am. Pt went home, took a nap for about 30 minutes, and when pt woke up, pt saw swelling in shoulder. Size of about finger length. Pain is now radiating towards the neck. Denies redness or streaking. Denies fever although pt does not know her temp (states "I don't think so" when asked). Denies chest pain, SOB. Advised ok to go to the ER tonight if pt unable to tolerate pain. Scheduled appt tomorrow.  On 6/27/17 Left Deltoid with large area of erythema,warm to touch,no swelling,but tender to light touch. States pain radiates down arm. Start Cyclobenzaprine HCl Tablet, 5 MG, 1 tablet as needed, Orally, Three times a day, 5 days, 15 Tablet, Refills 0. Start Ibuprofen Tablet, 800 MG, as directed, Orally, twice a day, 5 days, 10, Refills 0. Clinical Notes: Localized vaccine reaction clear, but pain d/t reaction seems to be a rare reaction. Suspect it's related to either muscle spasms or nerve impingement d/t inflammatory response.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling hot, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Reported that she felt warm and sweaty the evening after receiving vaccine. Reports a Temp of 102.2 today with chills, headache, and muscle pains. States she took Tylenol and fever came down to 100.F.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Reported that she felt warm and sweaty the evening after receiving vaccine. Reports a Temp of 102.2 today with chills, headache, and muscle pains. States she took Tylenol and fever came down to 100.F.
Age: 57.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Red, itchy, warm (& somewhat painful) rash developed in the vaccine administration area ... about a half dollar sized area that grew in coverage until 6/25/17 (3 to 6 inch diameter area). Patient took BENADRYL & used ice. She did show her physician. Her spot was much smaller on 6/26/17 (about 1 inch diameter) & was no longer uncomfortable.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Eating disorder, Intussusception, Vomiting
Clinical narrative: Patient began to have symptoms of vomiting and had not been eating well. Patient then went to the ER on 06/22/2017 and was diagnosed with intussusception.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash, Swelling
Clinical narrative: RASH, SWOLLEN AND PAIN.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Muscular weakness, Musculoskeletal pain, Neuralgia
Clinical narrative: Pain along a nerve line on side under the arm in which shot was given.  Saw my physician. Said it could have been shot or shingles. Pain went away in about two weeks. Shoulder became weak and sore about the same time. Saw my orthopedic physician. Recommended exercise. Still not completely back to normal but is better.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site warmth in a adult female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL QUADRIVALENT. In September 2016, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth, injection site redness and injection site swelling. On an unknown date, the outcome of the injection site warmth, injection site redness and injection site swelling were recovered/resolved. The reporter considered the injection site warmth, injection site swelling to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced warm, raised and red areas around the injection site. The area was noted to be approximately 2 to 3 inches in diameter. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. The reported lot number (Y7X92) for FLULAVAL QUADRIVALENT season did not exist and was updated to Y7X9Z, according to sales database. No further information was provided. This case was one of the 4 cases, reported by same reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered at inappropriate site, Injection site bruising, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site bruising in a female patient who received KINRIX. On an unknown date, the patient received KINRIX. On an unknown date, unknown after receiving KINRIX, the patient experienced injection site bruising, injection site induration, injection site swelling and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site bruising, injection site induration, injection site swelling and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site bruising, injection site induration and injection site swelling to be related to KINRIX. Additional details were reported as follows: The patient was 4 years old at the time of vaccination. The healthcare professional thought that the vaccine was not injected into the muscle, but instead was injected into the tendonous tissue of the thigh by mistake which led to vaccine administered at inappropriate site. The patient had a local reaction after getting KINRIX. No further information was provided.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness
Clinical narrative: Patient felt dizzy, lightheaded, and weak after vaccine administration. Patient was placed in supine position with legs elevated for 20 minutes. Patient was able to ambulate without assistance after incident.