chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Asthenia, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 592413). This spontaneous report refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and prior vaccinations were not reported. On 01-SEP-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1 via intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with BOOSTRIX batch/lot # 5MG55, dose 1 via intramuscular route in the left arm (dosage unspecified) and MENACTRA batch/lot # U5172AA, dose 1 via intramuscular route in the right arm for prophylaxis (dosage unspecified). On 01-SEP-2015, the patient experienced abdominal pain upper, syncope and asthenia. Ice packs were place on the patient's forehead and the back of the neck. The patient required emergency room visit. The outcome of abdominal pain upper, syncope and asthenia was unknown. The causality assessment for the events abdominal pain upper, syncope and asthenia with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 596674) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. Patient's other medications, current illness and medical history were reported as unknown. Patient's concurrent therapies was not reported. Patient's mother reported that patient received 1st dose of vaccine with GARDASIL 9 lot # L011846 (dose, frequency and expiration date were not reported) in the right arm, via unknown route, for prophylaxis. On 15-SEP-2015, patient broke out in rash from head to toe. The patient required emergency room visit and was given BENADRYL and steroids.  The outcome of rash generalised was unknown. Causality assessment for the event rash generalised with respect to GARDASIL 9 were not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: FLU3, HEPA, HPV9
Symptoms: Erythema, Injection site erythema, Oral pruritus, Pain in extremity, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611015) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 24 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 19-NOV-2015 the patient was vaccinated with the third dose of GARDASIL 9 in the right arm, lot # L009560 (dose, frequency, route of administration and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUZONE and VAQTA. On 19-NOV-2015 the patient felt that his throat was closing up. At 1:51pm the patient was administered with BENADRYL 25 mg per oral. At 2:00 pm the patient's left arm turned red where flu was given. The patient complained mouth itching and redness was noted at right breast. Again BENADRYL 25 mg per oral was administered. At 2:10 pm the patient complained hands itching and hurting, then patient felt that his throat was opening slowly. At 2:14 pm redness was resolved in left arm, redness at right breast resolved slowly, redness at right arm decreasing. At 2:25 pm the patient's hands had no longer itching and his throat was opened completely. At 2:50 pm the patient's hands no longer hurting, throat remains opened, redness on all areas got resolved. At 3 pm and at 3:15 pm the patient remained stable. The patient was instructed to call MD if any further problems noted and to call 911 if throat starts closing up again and has difficulty in breathing. At 4:05 pm patient was discharged in stable condition with no further complaints with ride. The patient's vital signs were checked after 15 minutes and were WNL and at no time was patient in respiratory distress. The outcome of events erythema, injection site erythema, oral pruritus, pain in extremity and throat tightness was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: FLU3, HEPA, HPV9
Symptoms: Throat tightness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611015) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 24 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 19-NOV-2015 the patient was vaccinated with the third dose of GARDASIL 9 in the right arm, lot # L009560 (dose, frequency, route of administration and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUZONE and VAQTA. On 19-NOV-2015 the patient felt that his throat was closing up. At 1:51pm the patient was administered with BENADRYL 25 mg per oral. At 2:00 pm the patient's left arm turned red where flu was given. The patient complained mouth itching and redness was noted at right breast. Again BENADRYL 25 mg per oral was administered. At 2:10 pm the patient complained hands itching and hurting, then patient felt that his throat was opening slowly. At 2:14 pm redness was resolved in left arm, redness at right breast resolved slowly, redness at right arm decreasing. At 2:25 pm the patient's hands had no longer itching and his throat was opened completely. At 2:50 pm the patient's hands no longer hurting, throat remains opened, redness on all areas got resolved. At 3 pm and at 3:15 pm the patient remained stable. The patient was instructed to call MD if any further problems noted and to call 911 if throat starts closing up again and has difficulty in breathing. At 4:05 pm patient was discharged in stable condition with no further complaints with ride. The patient's vital signs were checked after 15 minutes and were WNL and at no time was patient in respiratory distress. The outcome of events erythema, injection site erythema, oral pruritus, pain in extremity and throat tightness was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Full blood count normal, Headache, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611084) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 26 year old female patient. The patient's other medications included SPRINTEC birth control pill oral. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 19-NOV-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, (dose, frequency, lot # and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO. On 19-NOV-2015, immediately after vaccines were administered the patient turned pallor, started sweating, felt dizzy, had severe headache on right side of the head and neck, felt weak in legs. The patient also experienced neck pain, metabolic function test showed normal, immediate post-injection reaction and full blood count was normal. The patient was shifted to injection room for about 2 hours and gave juice to increase blood sugar level and cold towels were used to bring the body temperature down. The outcome of dizziness, pallor, neck pain, muscular weakness, metabolic function test normal, immediate post-injection reaction, hyperhidrosis, headache and full blood count normal was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Metabolic function test normal, Muscular weakness, Neck pain, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611084) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 26 year old female patient. The patient's other medications included SPRINTEC birth control pill oral. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 19-NOV-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, (dose, frequency, lot # and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO. On 19-NOV-2015, immediately after vaccines were administered the patient turned pallor, started sweating, felt dizzy, had severe headache on right side of the head and neck, felt weak in legs. The patient also experienced neck pain, metabolic function test showed normal, immediate post-injection reaction and full blood count was normal. The patient was shifted to injection room for about 2 hours and gave juice to increase blood sugar level and cold towels were used to bring the body temperature down. The outcome of dizziness, pallor, neck pain, muscular weakness, metabolic function test normal, immediate post-injection reaction, hyperhidrosis, headache and full blood count normal was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Pityriasis lichenoides et varioliformis acuta, Pruritus generalised, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611919). This spontaneous report refers to a 14 year old male patient. The patient's current illness included very mild cold symptoms, mostly congestion. The patient was allergic to peanut. He had seasonal allergic rhinitis and mild intermittent asthma. Other medications included CLARITIN. On 19-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L019287 dose 1, intramuscular in the left arm for prophylaxis. On 20-NOV-2015, the patient experienced rash on trunk which then spread to extremities, pityriasis lichenoides et varioliformis acuta (PLEVA) and pruritus generalized (itching all over). On 27-NOV-2015, on examining, it was found that rash was consistent with PLEVA. The outcome of rash, pityriasis lichenoides et varioliformis acuta and pruritus generalised was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Rash pruritic, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611920). This spontaneous report refers to a 16 year old male patient. The patient's historical drugs included aleve. On 24-NOV-2015 the patient was vaccinated with GARDASIL 9 (lot # not reported) dose 1 in the left arm for prophylaxis.  On the same day, the patient experienced rash pruritic and urticarial on wrist and grew over several hours. The patient was treated with antihistamines. The outcome of rash pruritic and urticaria was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611936). This spontaneous report refers to a 13 year old male patient. No historical and concurrent conditions were reported. On 07-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L016428 dose 3, intramuscular in the right arm for prophylaxis and VARIVAX lot # L021216 and started having some redness. On 08-NOV-2015, he had swelling and warm to touch red area at the injection site which was not itchy and painful. The patient has not taken any over the counter medicine. He had no dyspnea, throat tightness, throat swelling, lip swelling, dysphagia and tongue swelling. Right upper arm had a 5 cm diameter red swollen area warm to touch, no thrombotic thrombocytopenic purpura (TTP), full ROM (random of motion) of his arm, good perfusion and sensation. BENADRYL 25-50 mg orally was given every 4-6 hours regularly if not going to school. Otherwise, CLARITIN or ZYRTEC every morning daily as directed, and BENADRYL 50mg at bedtime. After rash resolved, warm heat and gentle massage for 20 minutes then cool compresses for 20 minutes 3-4 times a day was given. Cool compresses/baking soda compresses or baths or calamine lotion for itching, inc fluids can be used. The patient was advised to go to emergency room if symptoms worsen otherwise was asked to follow-up with primary care physician. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Pharyngeal oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 612031). This spontaneous report refers to a 21 year old female patient. The patient had no concurrent conditions and medical history. Other medications included Gildess FE. On 09-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L027282 dose 1(unspecified dose), intramuscular in the right arm for prophylaxis. On the same day, the patient experienced pharyngeal oedema. She required emergency room visit. Patient returned to Health Center at 1:15 PM with complaint of throat feeling swollen since 11 AM. No shortness of breath/difficulty breathing. Vital signs were stable. BENADRYL 50 mg IM (intramuscular) was given at 1:34 PM. Patient observed and reported resolution of throat swelling sensation. The outcome of pharyngeal oedema was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site abscess, Injection site pain, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 612113) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient with prophylaxis. The patient's medical history, other medications and prior vaccinations were not reported. The patient had no current illnesses. On 13-NOV-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm, lot # L025737 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUARIX QUADRIVALENT (vaccinated date: 13-NOV-2015, intramuscularly in the right arm, lot # 32BH5; dose and expiration date unknown) and on the same day after the vaccine was administrated on the upper deltoid bilaterally, the patient had soreness left upper deltoid since injection. And then on same day the patient experienced abscess like lesion, golf ball sized deep in area of injection, warm and tender. The patient visited the hospital on 24-NOV-2015. The outcome of the events injection site abscess, injection site warmth and injection site pain was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Face injury, Fall, Loss of consciousness, Traumatic haematoma
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613268). This spontaneous report refers to a 14 year old female patient. Information on the patient's medical history and other medications were not reported. Patient had no known current illness. On 01-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L027282, dose 2, intramuscularly in the left arm for prophylaxis. After receiving vaccine, patient was on bedside table. Nurse sat to document injection and patient fell from bedside table to floor face first. She lost consciousness for 30 seconds and large lemon sized hematoma formed in the middle of forehead. Patient was oriented to place and person and her mom was at her side. MD was called to bedside and vitals were stable (VSS). Patient was transported via ambulance to ED. The outcome of the events fall, loss of consciousness, haematoma and face injury was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: FLUN3, HEPA, HPV9, MENB, MNQ
Symptoms: Chills, Influenza virus test negative, Pain, Pain in extremity, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613396) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old male patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 25-NOV-2015 the patient was vaccinated with the first dose of GARDASIL 9 in the right arm, lot # L014415 (dose, frequency, route of administration and lot expiration date were not reported) for prophylaxis. Other suspect therapies included HAVRIX, intranasal FLUMIST, BEXSERO and MENVEO. On 25-NOV-2015 within two and half hours, the patient experienced chills, tremor, pain in extremity, pain and influenza virus test negative. On 30-NOV-2015 the patient's left arm remained sore and the patient visited physician office regularly. The outcome of chills, tremor, pain in extremity, pain and influenza virus test negative was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613691) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old female patient. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications included DASETTA 1-35. On 04-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L007560 dose number 1, intramuscularly in the left arm for prophylaxis. On 06-DEC-2015, the patient experienced lymphadenopathy. Patient stated over the telephone that she had a swollen lymph node under her left arm. No pain or fever was reported. Patient stated that she would take medicine if pain or fever occurred and would visit the ER (Emergency room) or contact the physician if symptoms worsened. The outcome of lymphadenopathy was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613821) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 19-NOV-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L011846, dose number 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX lot# H5299 (vaccination date : 19-NOV-2015, dose, frequency and lot expiration date were not reported) intramuscularly in the left arm and MENVEO (vaccination date : 19-NOV-2015, dose, frequency and lot expiration date were not reported) intramuscularly in the left arm. On 20-NOV-2015, the patient experienced erythema, swelling, skin warm and pain. Redness extended from under axilla, back of arm to just above the elbow. Area was warm to the touch. The outcome of erythema, swelling, skin warm and pain was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram, Generalised tonic-clonic seizure
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613872) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. Patient's medical history included basal ganglia calcifications found during CT at time of seizure. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 03-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported)  lot # L023230 dose number 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL (dose, frequency and lot expiration date were not reported), vaccinated date: 03-DEC-2015, lot # C4697AA, intramuscularly in the right arm, FLUMIST Quadrivalent (dose, frequency and lot expiration date were not reported), vaccinated date: 03-DEC-2015, lot # FL2013, via intranasal route and MENVEO (dose, frequency and lot expiration date were not reported), vaccinated date: 03-DEC-2015, lot # M15032, intramuscularly in the left arm. Patient was presented to ER (Emergency room) the next day with two tonic clonic seizures per ER note. Lab data included computerised tomogram (CT), electrocardiogram (EKG), urine analysis (UA), blood work and magnetic resonance imaging (MRI). On 04-DEC-2015, the patient underwent blood test, urine analysis, nuclear magnetic resonance imaging, generalised tonic-clonic seizure, electroencephalogram, electrocardiogram and computerised tomogram which required ER visit. Patient was treated with ATIVAN and discharged home. The outcome of blood test, urine analysis, nuclear magnetic resonance imaging, generalised tonic-clonic seizure, electroencephalogram, electrocardiogram and computerised tomogram were reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Urine analysis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613872) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. Patient's medical history included basal ganglia calcifications found during CT at time of seizure. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 03-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported)  lot # L023230 dose number 1, intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL (dose, frequency and lot expiration date were not reported), vaccinated date: 03-DEC-2015, lot # C4697AA, intramuscularly in the right arm, FLUMIST Quadrivalent (dose, frequency and lot expiration date were not reported), vaccinated date: 03-DEC-2015, lot # FL2013, via intranasal route and MENVEO (dose, frequency and lot expiration date were not reported), vaccinated date: 03-DEC-2015, lot # M15032, intramuscularly in the left arm. Patient was presented to ER (Emergency room) the next day with two tonic clonic seizures per ER note. Lab data included computerised tomogram (CT), electrocardiogram (EKG), urine analysis (UA), blood work and magnetic resonance imaging (MRI). On 04-DEC-2015, the patient underwent blood test, urine analysis, nuclear magnetic resonance imaging, generalised tonic-clonic seizure, electroencephalogram, electrocardiogram and computerised tomogram which required ER visit. Patient was treated with ATIVAN and discharged home. The outcome of blood test, urine analysis, nuclear magnetic resonance imaging, generalised tonic-clonic seizure, electroencephalogram, electrocardiogram and computerised tomogram were reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Loss of personal independence in daily activities, Nausea
Clinical narrative: Activities of daily living impaired; Chills; Nausea; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 614103) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 08-DEC-2015 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis.  On 09-DEC-2015, 14 hours post vaccination of GARDASIL 9 the patient developed chills without fever and nausea. The outcome of activities of daily living impaired, nausea and chills was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 88.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Cough, Malaise, Mobility decreased
Clinical narrative: Couldn't get up next day. Felt weak, tired all the time, cough, loss of appetite. Went to doctor 3 weeks later, given prednisone but did not help. Another doctor visit. By March feeling better, only cough and little tiredness continues. Cough worse at night despite of purifier. Pt has not been this sick in many years.
Age: 88.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Cough, Decreased appetite, Fatigue, Malaise
Clinical narrative: Couldn't get up next day. Felt weak, tired all the time, cough, loss of appetite. Went to doctor 3 weeks later, given prednisone but did not help. Another doctor visit. By March feeling better, only cough and little tiredness continues. Cough worse at night despite of purifier. Pt has not been this sick in many years.
Sex: U
Vaccine: MMR, MMR
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 21-MAR-2017, the patient was inadvertently vaccinated with an expired 0,5 ml dose of M-M-R II rHA, lot # L009544, expiration date 19-MAR-2017 (route was not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR, MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown demographics. No information regarding the patient's medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 21-MAR-2017, the patient was inadvertently vaccinated with an expired 0,5 ml dose of M-M-R II rHA, lot # L009544, expiration date 19-MAR-2017 (route was not reported). No adverse events were reported. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given. Correct vaccine was ordered by provider. The medical assistant administered the expired vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Diarrhoea, Dizziness, Feeling of body temperature change, Headache
Clinical narrative: Immediately following shingles vaccination I experienced itching, pain and swelling at injection site by early evening I had a severe headache and dizziness. I felt hot and cold and flu like for several days and had diarrhea for several days. Pain and swelling at injection site continued to increase over the first week. The area grew in size and was hot to touch and hard. Over several weeks a  Severe rash appeared and itching and sharp pricking pain increased. Spread all over arm. The redness, swelling and rash Rash was present for one month with sharp shooting zinging pain and itching. I also developed Severe sharp intermittent nerve pain in my breast at week 3 and this weird shock like pain is still present 2 months post injection. I would never never recommend this vaccine to anybody and angry it was recommended to me!!!!!!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site discomfort, Injection site erythema, Injection site induration
Clinical narrative: Immediately following shingles vaccination I experienced itching, pain and swelling at injection site by early evening I had a severe headache and dizziness. I felt hot and cold and flu like for several days and had diarrhea for several days. Pain and swelling at injection site continued to increase over the first week. The area grew in size and was hot to touch and hard. Over several weeks a  Severe rash appeared and itching and sharp pricking pain increased. Spread all over arm. The redness, swelling and rash Rash was present for one month with sharp shooting zinging pain and itching. I also developed Severe sharp intermittent nerve pain in my breast at week 3 and this weird shock like pain is still present 2 months post injection. I would never never recommend this vaccine to anybody and angry it was recommended to me!!!!!!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Immediately following shingles vaccination I experienced itching, pain and swelling at injection site by early evening I had a severe headache and dizziness. I felt hot and cold and flu like for several days and had diarrhea for several days. Pain and swelling at injection site continued to increase over the first week. The area grew in size and was hot to touch and hard. Over several weeks a  Severe rash appeared and itching and sharp pricking pain increased. Spread all over arm. The redness, swelling and rash Rash was present for one month with sharp shooting zinging pain and itching. I also developed Severe sharp intermittent nerve pain in my breast at week 3 and this weird shock like pain is still present 2 months post injection. I would never never recommend this vaccine to anybody and angry it was recommended to me!!!!!!
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Immediately following shingles vaccination I experienced itching, pain and swelling at injection site by early evening I had a severe headache and dizziness. I felt hot and cold and flu like for several days and had diarrhea for several days. Pain and swelling at injection site continued to increase over the first week. The area grew in size and was hot to touch and hard. Over several weeks a  Severe rash appeared and itching and sharp pricking pain increased. Spread all over arm. The redness, swelling and rash Rash was present for one month with sharp shooting zinging pain and itching. I also developed Severe sharp intermittent nerve pain in my breast at week 3 and this weird shock like pain is still present 2 months post injection. I would never never recommend this vaccine to anybody and angry it was recommended to me!!!!!!
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Skin irritation, Swelling
Clinical narrative: Red, itchy, swollen.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition, drug allergies or concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II injection (strength and dose were not reported) (lot # L012481, expiration date 10-APR-2017; lot # L028273; expiration date: 28-JUL-2017) for prophylaxis. According to the reporter, M-M-R II doses were exposed to the following temperature excursions (reported as 82): between 47 degrees Fahrenheit (F) to 77 F, and between 32 F to 35 F, for an unspecified time. No adverse effects were reported. It was unspecified if a digital data logger was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA005263: US-009507513-1704USA005264: US-009507513-1704USA005262.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female patient (who was also a nurse) of unknown age via a company representative, reporting on herself. No information about the patient's medical history and concurrent conditions was provided. On an unknown date, when the patient was in her 50's, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported). No information about the concomitant therapies was provided. On an unknown date (reported as "later"), the patient experienced shingles. The shingles case "was not so bad". Varicella-Zoster Virus (VZV) packet was not sent as the patient's physician was unknown. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not reported. Product quality complaint was not involved. Additional information is not expected as no reporter contact details were provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies. On 31-MAR-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # L024129 and expiration date 31-JAN-2017) for prophylaxis (dose, frequency, and route of administration were not provided) and the vaccine was expired. However, no adverse events were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse, concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 31-MAR-2017, the patient was vaccinated with an expired dose of M-M-R II (rHA) (lot # L009212 with expiration date 17-MAR-2017) (dose, strength, frequency and anatomical location were not provided), subcutaneously, for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received on 04-APR-2017 from a female nurse 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. The nurse reported that since 27-MAR-2017, an unspecified number of patients were administered doses of VARIVAX (Lot # M032493, expiration 06-JUL-2017; Lot # M041513 (as reported), expiration 11-OCT-2018) for prophylaxis and PROQUAD (Lot # M043306, expiration 24-APR-2018) for prophylaxis which were exposed to the temperature range (minus 14 degrees Celsius to minus 10 degrees Celsius) for 94 hours. Previous temperature excursion was reported as "yes".  The call was because of a "data logger." The outcome was reported as "supportive." The strengths, doses, routes of administration and anatomical locations were not provided for VARIVAX and PROQUAD. The nurse could not provide the Lot and expiration date for the properly stored Sterile diluent used to reconstitute the doses of VARIVAX and PROQUAD. No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site swelling
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 medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (intravenously; dose, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced lump at the injection site. In March 2017 (reported as lasts 1-3 weeks), the patient experienced painful swelling at the injection site. The outcome of the adverse events was unknown. The relatedness between lump and painful swelling at the injection site and GARDASIL 9 was not provided. Additional information is not expected as the reporter did not wish to be contacted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cataract, Herpes zoster, Impaired driving ability, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report has been received from a 69 year old female patient consumer referring to herself. The patient's concurrent conditions included diabetes mellitus. She did not have medical history, drug reactions/allergies or concomitant medications. On 03-AUG-2014, the patient received 1 dose of ZOSTAVAX (strength, dose, route, lot #, expiration date or anatomical location were not reported) for prevention of shingles. Approximately in March 2015, the patient experienced shingles and the outbreak lasted for about 3-4 weeks until she recovered in an unspecified date in 2015. The second outbreak of shingles was around April 2016 and lasted for an unspecified amount of time until she recovered from it in an unspecified date in 2016. The third outbreak of shingles was around 04-AUG-2016; the patient developed shingles in her eye and then she had cataracts develop. Though the patient recovered from the shingles on an unspecified date in 2016, the patient still had cataracts to the time of reporting. She also had not been able to drive since then. The patient then developed shingles for a fourth time on an unknown date in December 2016 (reported as "around Christmas of 2016") and lasted for 3 months before she recovered from the shingles on approximately in March 2017. The last time the patient developed shingles was about in March 2017 (reported as a month ago) and she was still recovering. She talked with the physician and although no diagnostic laboratories were performed, the patient received treatment for the adverse events. No further adverse event information was provided. The causal relationship between all the events and the suspect therapy was not provided. Upon internal review the herpes zoster ophthalmic was considered a medically significant and a disability event. The cataracts were considered as a disability event. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Hepatitis, Lymphoma
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date unknown) for prophylaxis. On an unknown date, a few weeks later, the patient was diagnosed with an aggressive lymphoma and developed a severe hepatitis, It was reported that severe hepatitis led to his demise. The outcome of the event aggressive lymphoma was not reported. There were no specimens from the patient. Autopsy was not performed. The causal relationship between the events and ZOSTAVAX was not provided. Upon internal review, aggressive lymphoma and severe hepatitis were determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: a severe hepatitis.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 13 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 03-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 04-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 14 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 09-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 10-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 11-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 13 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-DEC-2016, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517.