chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Haematology test normal, Haemoglobin normal, Troponin I increased, White blood cell count normal
Clinical narrative: Initial unsolicited report received on 06 September 2016 from a healthcare professional via health authority via third party query tool search on the VAERS database, under reference number. This case involves a 23-year-old male patient who was vaccinated with a dose of ACAM2000 intradermally (batch number: VV030019C) (dose in series and expiry date were not reported) in the left arm on 28 April 2016. He was vaccinated at a military facility. The patient had a medical history of Restless Leg Syndrome and Cystic Acne (remote, resolved). He had no known allergies and had no current illness. Concomitant medications included Flonase and Zyrtec. On 06 May 2016, 8 days following the vaccination, the patient experienced sub sternal chest tightness that worsened with exertion. The patient had a visit to the urgent care center. Lab data included Troponin 0.06 (13 May 16, 9:11AM); Troponin 0.036 (13 May 16, 3:46PM); ECG (13 May 16): Early repolarization, otherwise normal; ECG (16 May 16): Unchanged compared to initial; CXR PA and Lateral (13 May 16): No acute pulmonary findings. CBC with AutoDiff (13 May 16). The patient received corrective treatment with colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The patient was treated with Colchicine 0.65mg one tab by mouth twice a day for 90 days and Motrin taper (800mg by mouth three times a day for one week, two times a day for the next week and once a day for the final week). The event's outcome was as reported recovered ("and gradually improved over the week prior to presenting". List of documents held by sender: none.
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Activated partial thromboplastin time normal, Aspartate aminotransferase increased, Burning sensation, Full blood count normal, Haematuria
Clinical narrative: This unsolicited case was received on 06-Sep-2016 via a third party query tool search on the VAERS database, under reference number 637157. This case involves a 23-years old female patient who received the following vaccinations on 05-May-2016: A first dose of ACAM2000, lot number-VV03019C, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route. Patient's medical history was not reported. Current illnesses were reported as none. Concomitant medications were ibuprofen and vitamin D. On 19-May-2016, 14 days post vaccination; patient experienced progressive bilateral lower leg "burning" sensation rash with diffuse petechial, headache and afebrile. Laboratory investigations include activated, full blood count normal. Also reported as CMP (WNL except mild AST (aspartate aminotransferase elevation 41); PT/PTT/INR (prothrombin time normal) (international normalized ratio normal) (partial thromboplastin time normal); CBC (WNL); UA (urine analysis abnormal) (noncontrib except moderate microscopic hematuria. No protein). Corrective treatments were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Headache, International normalised ratio normal, Petechiae, Prothrombin time normal, Rash
Clinical narrative: This unsolicited case was received on 06-Sep-2016 via a third party query tool search on the VAERS database, under reference number 637157. This case involves a 23-years old female patient who received the following vaccinations on 05-May-2016: A first dose of ACAM2000, lot number-VV03019C, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route. Patient's medical history was not reported. Current illnesses were reported as none. Concomitant medications were ibuprofen and vitamin D. On 19-May-2016, 14 days post vaccination; patient experienced progressive bilateral lower leg "burning" sensation rash with diffuse petechial, headache and afebrile. Laboratory investigations include activated, full blood count normal. Also reported as CMP (WNL except mild AST (aspartate aminotransferase elevation 41); PT/PTT/INR (prothrombin time normal) (international normalized ratio normal) (partial thromboplastin time normal); CBC (WNL); UA (urine analysis abnormal) (noncontrib except moderate microscopic hematuria. No protein). Corrective treatments were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Urine analysis abnormal
Clinical narrative: This unsolicited case was received on 06-Sep-2016 via a third party query tool search on the VAERS database, under reference number 637157. This case involves a 23-years old female patient who received the following vaccinations on 05-May-2016: A first dose of ACAM2000, lot number-VV03019C, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route. Patient's medical history was not reported. Current illnesses were reported as none. Concomitant medications were ibuprofen and vitamin D. On 19-May-2016, 14 days post vaccination; patient experienced progressive bilateral lower leg "burning" sensation rash with diffuse petechial, headache and afebrile. Laboratory investigations include activated, full blood count normal. Also reported as CMP (WNL except mild AST (aspartate aminotransferase elevation 41); PT/PTT/INR (prothrombin time normal) (international normalized ratio normal) (partial thromboplastin time normal); CBC (WNL); UA (urine analysis abnormal) (noncontrib except moderate microscopic hematuria. No protein). Corrective treatments were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Aspartate aminotransferase increased, Blood count normal, Blood thromboplastin normal, Burning sensation, Headache
Clinical narrative: This unsolicited case was received on 06-Sep-2016 via a third party query tool search on the VAERS database, under reference number 637157. This case involves a 23-years old female patient who received the following vaccinations on 05-May-2016: A first dose of ACAM2000, lot number-VV03019C, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route. Patient's medical history was not reported. Current illnesses were reported as none. Concomitant medications were ibuprofen and vitamin D. On 19-May-2016, 14 days post vaccination; patient experienced progressive bilateral lower leg "burning" sensation rash with diffuse petechial, headache and afebrile. Laboratory investigations include activated, full blood count normal. Also reported as CMP (WNL except mild AST (aspartate aminotransferase elevation 41); PT/PTT/INR (prothrombin time normal) (international normalized ratio normal) (partial thromboplastin time normal); CBC (WNL); UA (urine analysis abnormal) (noncontrib except moderate microscopic hematuria. No protein). Corrective treatments were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Sex: F
Vaccine: SMALL, SMALL
Symptoms: International normalised ratio normal, Petechiae, Prothrombin level normal, Urine analysis abnormal
Clinical narrative: This unsolicited case was received on 06-Sep-2016 via a third party query tool search on the VAERS database, under reference number 637157. This case involves a 23-years old female patient who received the following vaccinations on 05-May-2016: A first dose of ACAM2000, lot number-VV03019C, manufacturer: Sanofi Pasteur Biologics Co) in the left arm via an unknown route. Patient's medical history was not reported. Current illnesses were reported as none. Concomitant medications were ibuprofen and vitamin D. On 19-May-2016, 14 days post vaccination; patient experienced progressive bilateral lower leg "burning" sensation rash with diffuse petechial, headache and afebrile. Laboratory investigations include activated, full blood count normal. Also reported as CMP (WNL except mild AST (aspartate aminotransferase elevation 41); PT/PTT/INR (prothrombin time normal) (international normalized ratio normal) (partial thromboplastin time normal); CBC (WNL); UA (urine analysis abnormal) (noncontrib except moderate microscopic hematuria. No protein). Corrective treatments were not reported. On an unspecified date, the patient was recovered from the events. List of documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash generalised
Clinical narrative: 05/04/2016- Patient received Meningitis vaccine #1 (MENACTRA) Lot # U5272AA expiration 5/19/2007 and HPV vaccine #1 (GARDASIL) Lot # K010215 expiration 05/05/2017 at pharmacy. 05/07/2016- Patient developed rash and was brought to clinic. Patient was diagnosed to have Erythema Multiforme. Mom was advised to give BENADRYL every 4 hrs. and ZYRTEC once a day. Mom gave the medication and the rash got worse. 05/07/2016- Patient was brought to ER, and he was given Rx for oral steroid and oral dose of BENADRYL and was sent home. 05/08/2016- at 5pm patient developed blotches. 05/08/2016-at 10 pm, patient eyes were swollen and lips were swollen. Patient was brought to ER and was given SOLUMEDROL 80 mg IVP, Diphenhydramine 25 mg IVP, Famotidine 20 mg IVP, Diphenhydramine 25mg. He was prescribed MEDROL pack. 05/09/2016 - He was seen at PCP for follow up. He still have rashes. He started the MEDROL pack and BENADRYL 25mg/cap 1 cap every 4-6 hrs, ZYRTEC once a day. 05/11/2016- Mom called that patient complains of foot pain and joint pains. He was seen at PCP. Patient was complaining of feet hurting when walking and itchiness especially at night. He was taking BENADRYL every 4 hrs and PEPCID 2 x a day. He was on the last day of his MEDROL pack. His exam showed no eyelid swelling nor lips swelling and no rashes. He was prescribed Hydroxyzine 25 mg 1 tab every 8 hrs #15 tablets. He was having rashes off and on and was given Hydroxyzine as needed. 07/08/2016 - He has no more rashes. 07/18/2016- Had allergy test and was positive for molds, horses, cattle, trees and weeds. 08/03/2016- Patient was referred and seen by Allergist who recommended that patient should never receive HPV and Meningitis vaccine again.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Allergy test positive, Allergy to animal, Allergy to plants, Arthralgia, Erythema multiforme
Clinical narrative: 05/04/2016- Patient received Meningitis vaccine #1 (MENACTRA) Lot # U5272AA expiration 5/19/2007 and HPV vaccine #1 (GARDASIL) Lot # K010215 expiration 05/05/2017 at pharmacy. 05/07/2016- Patient developed rash and was brought to clinic. Patient was diagnosed to have Erythema Multiforme. Mom was advised to give BENADRYL every 4 hrs. and ZYRTEC once a day. Mom gave the medication and the rash got worse. 05/07/2016- Patient was brought to ER, and he was given Rx for oral steroid and oral dose of BENADRYL and was sent home. 05/08/2016- at 5pm patient developed blotches. 05/08/2016-at 10 pm, patient eyes were swollen and lips were swollen. Patient was brought to ER and was given SOLUMEDROL 80 mg IVP, Diphenhydramine 25 mg IVP, Famotidine 20 mg IVP, Diphenhydramine 25mg. He was prescribed MEDROL pack. 05/09/2016 - He was seen at PCP for follow up. He still have rashes. He started the MEDROL pack and BENADRYL 25mg/cap 1 cap every 4-6 hrs, ZYRTEC once a day. 05/11/2016- Mom called that patient complains of foot pain and joint pains. He was seen at PCP. Patient was complaining of feet hurting when walking and itchiness especially at night. He was taking BENADRYL every 4 hrs and PEPCID 2 x a day. He was on the last day of his MEDROL pack. His exam showed no eyelid swelling nor lips swelling and no rashes. He was prescribed Hydroxyzine 25 mg 1 tab every 8 hrs #15 tablets. He was having rashes off and on and was given Hydroxyzine as needed. 07/08/2016 - He has no more rashes. 07/18/2016- Had allergy test and was positive for molds, horses, cattle, trees and weeds. 08/03/2016- Patient was referred and seen by Allergist who recommended that patient should never receive HPV and Meningitis vaccine again.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Eye swelling, Lip swelling, Mycotic allergy, Pain in extremity, Pruritus
Clinical narrative: 05/04/2016- Patient received Meningitis vaccine #1 (MENACTRA) Lot # U5272AA expiration 5/19/2007 and HPV vaccine #1 (GARDASIL) Lot # K010215 expiration 05/05/2017 at pharmacy. 05/07/2016- Patient developed rash and was brought to clinic. Patient was diagnosed to have Erythema Multiforme. Mom was advised to give BENADRYL every 4 hrs. and ZYRTEC once a day. Mom gave the medication and the rash got worse. 05/07/2016- Patient was brought to ER, and he was given Rx for oral steroid and oral dose of BENADRYL and was sent home. 05/08/2016- at 5pm patient developed blotches. 05/08/2016-at 10 pm, patient eyes were swollen and lips were swollen. Patient was brought to ER and was given SOLUMEDROL 80 mg IVP, Diphenhydramine 25 mg IVP, Famotidine 20 mg IVP, Diphenhydramine 25mg. He was prescribed MEDROL pack. 05/09/2016 - He was seen at PCP for follow up. He still have rashes. He started the MEDROL pack and BENADRYL 25mg/cap 1 cap every 4-6 hrs, ZYRTEC once a day. 05/11/2016- Mom called that patient complains of foot pain and joint pains. He was seen at PCP. Patient was complaining of feet hurting when walking and itchiness especially at night. He was taking BENADRYL every 4 hrs and PEPCID 2 x a day. He was on the last day of his MEDROL pack. His exam showed no eyelid swelling nor lips swelling and no rashes. He was prescribed Hydroxyzine 25 mg 1 tab every 8 hrs #15 tablets. He was having rashes off and on and was given Hydroxyzine as needed. 07/08/2016 - He has no more rashes. 07/18/2016- Had allergy test and was positive for molds, horses, cattle, trees and weeds. 08/03/2016- Patient was referred and seen by Allergist who recommended that patient should never receive HPV and Meningitis vaccine again.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash erythematous, Rash generalised, Rash macular, Urticaria, Vaccination complication
Clinical narrative: 05/04/2016- Patient received Meningitis vaccine #1 (MENACTRA) Lot # U5272AA expiration 5/19/2007 and HPV vaccine #1 (GARDASIL) Lot # K010215 expiration 05/05/2017 at pharmacy. 05/07/2016- Patient developed rash and was brought to clinic. Patient was diagnosed to have Erythema Multiforme. Mom was advised to give BENADRYL every 4 hrs. and ZYRTEC once a day. Mom gave the medication and the rash got worse. 05/07/2016- Patient was brought to ER, and he was given Rx for oral steroid and oral dose of BENADRYL and was sent home. 05/08/2016- at 5pm patient developed blotches. 05/08/2016-at 10 pm, patient eyes were swollen and lips were swollen. Patient was brought to ER and was given SOLUMEDROL 80 mg IVP, Diphenhydramine 25 mg IVP, Famotidine 20 mg IVP, Diphenhydramine 25mg. He was prescribed MEDROL pack. 05/09/2016 - He was seen at PCP for follow up. He still have rashes. He started the MEDROL pack and BENADRYL 25mg/cap 1 cap every 4-6 hrs, ZYRTEC once a day. 05/11/2016- Mom called that patient complains of foot pain and joint pains. He was seen at PCP. Patient was complaining of feet hurting when walking and itchiness especially at night. He was taking BENADRYL every 4 hrs and PEPCID 2 x a day. He was on the last day of his MEDROL pack. His exam showed no eyelid swelling nor lips swelling and no rashes. He was prescribed Hydroxyzine 25 mg 1 tab every 8 hrs #15 tablets. He was having rashes off and on and was given Hydroxyzine as needed. 07/08/2016 - He has no more rashes. 07/18/2016- Had allergy test and was positive for molds, horses, cattle, trees and weeds. 08/03/2016- Patient was referred and seen by Allergist who recommended that patient should never receive HPV and Meningitis vaccine again.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Rash, Rash macular
Clinical narrative: 05/04/2016- Patient received Meningitis vaccine #1 (MENACTRA) Lot # U5272AA expiration 5/19/2007 and HPV vaccine #1 (GARDASIL) Lot # K010215 expiration 05/05/2017 at pharmacy. 05/07/2016- Patient developed rash and was brought to clinic. Patient was diagnosed to have Erythema Multiforme. Mom was advised to give BENADRYL every 4 hrs. and ZYRTEC once a day. Mom gave the medication and the rash got worse. 05/07/2016- Patient was brought to ER, and he was given Rx for oral steroid and oral dose of BENADRYL and was sent home. 05/08/2016- at 5pm patient developed blotches. 05/08/2016-at 10 pm, patient eyes were swollen and lips were swollen. Patient was brought to ER and was given SOLUMEDROL 80 mg IVP, Diphenhydramine 25 mg IVP, Famotidine 20 mg IVP, Diphenhydramine 25mg. He was prescribed MEDROL pack. 05/09/2016 - He was seen at PCP for follow up. He still have rashes. He started the MEDROL pack and BENADRYL 25mg/cap 1 cap every 4-6 hrs, ZYRTEC once a day. 05/11/2016- Mom called that patient complains of foot pain and joint pains. He was seen at PCP. Patient was complaining of feet hurting when walking and itchiness especially at night. He was taking BENADRYL every 4 hrs and PEPCID 2 x a day. He was on the last day of his MEDROL pack. His exam showed no eyelid swelling nor lips swelling and no rashes. He was prescribed Hydroxyzine 25 mg 1 tab every 8 hrs #15 tablets. He was having rashes off and on and was given Hydroxyzine as needed. 07/08/2016 - He has no more rashes. 07/18/2016- Had allergy test and was positive for molds, horses, cattle, trees and weeds. 08/03/2016- Patient was referred and seen by Allergist who recommended that patient should never receive HPV and Meningitis vaccine again.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Crying, Seizure
Clinical narrative: My son was found on the floor at home 2 hours after taking the shot. Coughed up blood, high fever, screaming that he could not feel his legs. He was losing vision and finally became non-responsive. Was having seizure like episodes and altered mental status. We were transferred to three different hospitals throughout this ordeal.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Seizure
Clinical narrative: My son was found on the floor at home 2 hours after taking the shot. Coughed up blood, high fever, screaming that he could not feel his legs. He was losing vision and finally became non-responsive. Was having seizure like episodes and altered mental status. We were transferred to three different hospitals throughout this ordeal.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Blindness, Blood test, Computerised tomogram, Drug screen, Electrocardiogram
Clinical narrative: My son was found on the floor at home 2 hours after taking the shot. Coughed up blood, high fever, screaming that he could not feel his legs. He was losing vision and finally became non-responsive. Was having seizure like episodes and altered mental status. We were transferred to three different hospitals throughout this ordeal.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Electroencephalogram, Haemoptysis, Lumbar puncture, Mental status changes, Nuclear magnetic resonance imaging
Clinical narrative: My son was found on the floor at home 2 hours after taking the shot. Coughed up blood, high fever, screaming that he could not feel his legs. He was losing vision and finally became non-responsive. Was having seizure like episodes and altered mental status. We were transferred to three different hospitals throughout this ordeal.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MENB, MNQ
Symptoms: Pyrexia, Screaming, Seizure like phenomena, Sensory loss, Unresponsive to stimuli
Clinical narrative: My son was found on the floor at home 2 hours after taking the shot. Coughed up blood, high fever, screaming that he could not feel his legs. He was losing vision and finally became non-responsive. Was having seizure like episodes and altered mental status. We were transferred to three different hospitals throughout this ordeal.
Age: 25.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Nausea, Pain in extremity, Pyrexia, Somnolence, Vomiting
Clinical narrative: Initial unsolicited report received from a pharmacist on 29 August 2016. This case involves a 25-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number: U541AA, expiry date, dose), intramuscularly in the left deltoid on 27 August 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as oranges. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 28 August 2016, one day following the vaccination, the patient had fever and slept all day with a sore arm. On 29 August 2016, two days following the vaccination, the patient vomited after drinking Gatorade. The lab data and corrective treatment was not reported. The outcome of the events were unknown. List of documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Hypersomnia, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Initial unsolicited report received from a pharmacist on 29 August 2016. This case involves a 25-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number: U541AA, expiry date, dose), intramuscularly in the left deltoid on 27 August 2016. Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as oranges. Any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 28 August 2016, one day following the vaccination, the patient had fever and slept all day with a sore arm. On 29 August 2016, two days following the vaccination, the patient vomited after drinking Gatorade. The lab data and corrective treatment was not reported. The outcome of the events were unknown. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63 year old female patient. The patient did not have any pertinent medical history, drug reactions, allergies or concomitant therapies. On 26-AUG-2016, the patient was vaccinated with a dose of ZXOSTAVAX in the back of left arm (lot #, expiration date, exact dose and route of administration were not reported). On an unspecified date in August 2016, the patient experienced a pinkish red color, warm to the touch on the back of her left arm, where the vaccine was given. The reporter also stated it had itchiness. The patient presented an injection site red itchy rash. According to the pharmacist, it was not a shingles like rash as it was completely flat, with no blisters or raised areas whatsoever. The patient received treatment for the events and she had a non-volatile fatty acid derivatives (NFADs) test performed (result was not reported). The outcome of the events was not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63 year old female patient. The patient did not have any pertinent medical history, drug reactions, allergies or concomitant therapies. On 26-AUG-2016, the patient was vaccinated with a dose of ZXOSTAVAX in the back of left arm (lot #, expiration date, exact dose and route of administration were not reported). On an unspecified date in August 2016, the patient experienced a pinkish red color, warm to the touch on the back of her left arm, where the vaccine was given. The reporter also stated it had itchiness. The patient presented an injection site red itchy rash. According to the pharmacist, it was not a shingles like rash as it was completely flat, with no blisters or raised areas whatsoever. The patient received treatment for the events and she had a non-volatile fatty acid derivatives (NFADs) test performed (result was not reported). The outcome of the events was not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Pain in extremity, Sleep disorder, Vaccination site pain
Clinical narrative: Left arm swollen, red, hard. Unable to lift arm.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Vaccination site swelling
Clinical narrative: Left arm swollen, red, hard. Unable to lift arm.
Age: 17.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Erythema, Induration, Mobility decreased, Peripheral swelling
Clinical narrative: Left arm swollen, red, hard. Unable to lift arm.
Age: 32.0
Sex: F
Vaccine: MNQ, TDAP, YF
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurseon 24 August 2016. This case involves a 32 year female patient who was vaccinated with a first dose of MENACTRA (batch number U5513BA, expiration date was not reported) intramuscularly in left deltoid and sixth dose of  ADACEL (batch number U5472AA, expiration date was not reported) intramuscularly in right deltoid both on an unspecified date. patient also received YELLOW FEVER VACCINE (batch number, expiration date, site of administration was not reported) subcutaneously on 18 August 2016 at 09:30 A.M. Illness at vaccination was denied. Pre-existing physician diagnosed allergies, birth defects, medical conditions included Attention Deficit Disorder, Raynaud's, anxiety, depression, hypothyroid, asthma sports induced. Patient had not experienced any adverse event prior to vaccination. Concomitant medications included Synthroid, Prozac 10 mg, Xanax 1 mg, Protonix 40 mg, Norvasc 5 mg, Adderall 20 mg, Gabapentin 400 mg, "Spriniee 26". On 22 August 2016, at 08 P.M, four days following vaccination, patient had red elevated itchy area where shot was given, 40 x 30 mm indurated pink red area. On 23 August 2016, events were reported to health care professional. It was reported that patient received five doses of ADACEL in 1983, 1984, 1984, 1988, 1988 and did not experience any adverse event. Lab data was reported as none. Corrective treatment was not reported. The patient was not recovered from events. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Crying, Culture urine, Decreased appetite, Irritability
Clinical narrative: Fussy, lack of appetite, crying, fever 102.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture, Pyrexia
Clinical narrative: Fussy, lack of appetite, crying, fever 102.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Muscle weakness - eventually admitted on 9/2/16 for Guillain-Barre syndrome.  Not clear if pneumococcal vaccine led to this, but was only vaccine prior and was not sick with other illnesses.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Asthenia
Clinical narrative: Muscle weakness - eventually admitted on 9/2/16 for Guillain-Barre syndrome.  Not clear if pneumococcal vaccine led to this, but was only vaccine prior and was not sick with other illnesses.
Sex: F
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional via a company representative, referring to a newborn female patient. Patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 18-AUG-2016, at an age that the patient was not supposed to, the patient was vaccinated with the first dose of an expired ROTATEQ orally, lot #: K022990 (expiration date and strength were not provided). There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: RV5, RV5
Symptoms: Drug administered to patient of inappropriate age, Expired product administered
Clinical narrative: This spontaneous report was received from a healthcare professional via a company representative, referring to a newborn female patient. Patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 18-AUG-2016, at an age that the patient was not supposed to, the patient was vaccinated with the first dose of an expired ROTATEQ orally, lot #: K022990 (expiration date and strength were not provided). There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial solicited report received on 17 August 2016 from an investigator participating in the below mentioned study. This case involves a six-year-old subject who had a bad reaction to flu shot at 16 months that almost killed him during the study participation. The subject's medical history was not reported. The subject's concomitant therapies were not reported. The subject received the INFLUENZA QUADRIVAL A-B VACCINE on an unknown date. In consumer online market research survey about flu vaccination. The subject had bad reaction to flu shot at 16 months that almost killed him. The subject had no agreed to be identified or provide further information. No relevant physician or other reporter can be identified to provide additional information. According to investigator the event was considered as life threatening. The lab data and corrective treatment were not reported. The event of 6 year old had a bad reaction to flu shot at 16 months that almost killed him was ongoing at the time of report. Causal relationship as per reporter was not reported. Relationship to investigational product according to company: not associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Sender's Comments: A six-year-old female subject had bad reaction (not specified) to flu shot at 16 months that almost killed him. Details regarding nature of reaction, latency from vaccination, medical history of the patient, vaccination history, concomitant medications, immune status of the patient and reporter causality were not reported. Based on limited data available, the sponsor assesses this event as not related to study vaccine or trial procedure.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Intussusception, X-ray abnormal
Clinical narrative: Intussusception.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site inflammation, Injection site swelling, Pain in extremity
Clinical narrative: Arm soreness took Aleve. 09/06/2016 02:45 AM has 7 inflamed reddened swollen spots on left arm where Pneumo and Flu shot were given.  Will take Benadryl when off work and ice down.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Patient mom called 6 days after child received vaccines and stated she had a few itchy red bumps on arm, leg and chin. Also stated she had a fever off and on after vaccines but had since resolved. Advised bumps were likely bug bites since reactions typically occur much faster but if symptoms persisted or worsened she could see a doctor and mom agreed.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Pt developed a large rash from elbow to shoulder at the site of zoster vaccine injection.  Pt went to local urgent care and received Medrol dose pack and Keflex rx.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Loss of consciousness, Syncope, Tremor
Clinical narrative: Pt received FLULAVAL QUAD and GARDASIL vaccines at the same time. Pt fainted briefly (< 1 minute) and had tremors. Pt returned to consciousness after about a minute. Paramedics were call and pt evaluated, not taken to ER.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Infection
Clinical narrative: Patient experienced a Cellulitis infection post injection. Patient was prescribed Cephalexin to treat infection on 9/2/2016 to be taken 3 times a day for 7 days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema and pain at the injection site.
Sex: F
Vaccine: HPV9
Symptoms: Needle issue, Syncope, Tension
Clinical narrative: This spontaneous report concerning an 11 years old female patient was received from a medical assistant via a company representative. The patient's concurrent conditions and medical history were not provided. On 25-AUG-2016 (reported as a week ago), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route, lot and expiration date were not provided). and had a fainting episode (syncope). After that, on an unknown date in 2016, the second dose of GARDASIL 9 was given, but when administered, the patient tensed up (tension) and were unable to pull out the needle (needle issue). It was reported that an unspecified treatment was given for the events of syncope and tension. There were no concomitant medications. The patient recovered from the events of syncope and tension on an unknown date in 2016. The reporter did not assessed a causality between the events of syncope and tension, and the therapy with GARDASIL 9. The reporter did not considered the events of syncope and tension as life threatening. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M007960 with expiration date 15-AUG-2017, therapy type rHA; Lot # M015700 with expiration date 26-SEP-2017, therapy type rHA; dose unknown, subcutaneous). It was reported that the vaccine was improperly stored at -13.5 Celsius degree (C) for 2 hours 9 minutes and at -14.7 C for 56 minutes and then was back in range. There was no previous temperature excursion. Data logger was involved. No adverse symptoms were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Abscess, Cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician received via Pfizer sales representative. A female patient (age 45-50, Unit unknown) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose in the left deltoid on an unspecified date. The patient medical history and concomitant medications were not reported. The patient developed an abscess and cellulitis after 1 week of administration on unknown date. Antibiotic treatment was needed for 1 week. The abscess and cellulitis were resolved after antibiotic treatment.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Headache, Hyperaesthesia, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Stiff neck and head with headache, extreme fatigue.  The next morning, it was fever, stiff neck, back and body.  Sensitive to any touching.  Arm hurt.  On call nurse was contacted and pediatrician notified.    Symptoms resolved in 72 hours.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Blood test, Erythema, Peripheral swelling, Rash
Clinical narrative: HIS ARM WAS SWOLLEN TO THE SIZE OF A GOLF BALL. THERE WAS SEVERE REDNESS, RASHY BUMPS, AND THE ARM LOOKED AS IF IT WAS PRESSURE LIKE THE SWELLING WAS TIGHTENING THE ARM. HE HAD TO BE PRESCRIBED ANTIBIOTICS AND RECOMMENDED TO AN ALLERGY SPECIALIST. HE HAS ALSO HAD TO TAKE BLOOD TEST TWO TIMES BECAUSE OF THIS.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Blood test, Diplopia, Facial pain, Hypermetropia, Immediate post-injection reaction
Clinical narrative: Started having shooting pain in limbs for 1 week immediately after receiving vaccine. 10 days later, sudden double vision with severe migraines, constant eye tearing, severe near sightedness and far sightedness and pain in left side of face. Pain in limbs disappeared after 1 week. Double vision, tearing, near and far sightedness, migraines and face pain persist.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Lacrimation increased, Migraine, Myopia, Neurological examination, Nuclear magnetic resonance imaging
Clinical narrative: Started having shooting pain in limbs for 1 week immediately after receiving vaccine. 10 days later, sudden double vision with severe migraines, constant eye tearing, severe near sightedness and far sightedness and pain in left side of face. Pain in limbs disappeared after 1 week. Double vision, tearing, near and far sightedness, migraines and face pain persist.
Age: 54.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Ophthalmological examination, Pain, Pain in extremity
Clinical narrative: Started having shooting pain in limbs for 1 week immediately after receiving vaccine. 10 days later, sudden double vision with severe migraines, constant eye tearing, severe near sightedness and far sightedness and pain in left side of face. Pain in limbs disappeared after 1 week. Double vision, tearing, near and far sightedness, migraines and face pain persist.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Severe swelling, Redness, itchiness, tenderness and discomfort. Patient was instructed to use benadryl topically, ice pack and take Tylenol is necessary.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Swollen raised area around and below the injection site which is hot to the touch. Area is approximately 2-3 inches by 4-5 inches. Arm is sore, especially when moved. Area is still like this after a week.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram, Discomfort, Gait disturbance, Laboratory test, Lymphadenectomy
Clinical narrative: Child seen in clinic on Aug 3 for 5 yr WCC and received KINRIX via right thigh and MMRV via left thigh. Child was brought to clinic on Aug 5 for c/o right inguinal/femoral lymphadenitis, fevers and discomfort. Child had been c/o the past week of right groin discomfort with some limping. Child placed on AUGMENTIN. Did well for 5 doses and then developed fevers, increase in inguinal lymph node size, returned to clinic for ROCEPHIN. Subsequently did well for a few days again and the redeveloped fevers. Brought to ER where US showed possible necrotic inguinal lymph tissue, CT done, multiple labs and testing to determine cause of issue. Child ended up in the OR with inguinal lymph node dissection and inguinal node removal.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Lymphadenitis, Lymphadenopathy, Musculoskeletal discomfort, Pyrexia, Ultrasound scan abnormal
Clinical narrative: Child seen in clinic on Aug 3 for 5 yr WCC and received KINRIX via right thigh and MMRV via left thigh. Child was brought to clinic on Aug 5 for c/o right inguinal/femoral lymphadenitis, fevers and discomfort. Child had been c/o the past week of right groin discomfort with some limping. Child placed on AUGMENTIN. Did well for 5 doses and then developed fevers, increase in inguinal lymph node size, returned to clinic for ROCEPHIN. Subsequently did well for a few days again and the redeveloped fevers. Brought to ER where US showed possible necrotic inguinal lymph tissue, CT done, multiple labs and testing to determine cause of issue. Child ended up in the OR with inguinal lymph node dissection and inguinal node removal.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Initial unsolicited report received from a Physician on 27 August 2016. This case involves a 18 years old female patient who was vaccinated with a dose of MENACTRA (batch number, expiration date, site of administration was not reported) intramuscularly on 24 August 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 24 August 2016, within 30 minutes following vaccination, patient became ill, patient had developed fever of 102-103 Fahrenheit, severe nausea, vomiting and abdominal pain that comes and goes. Patient was seen in emergency room for three times for these symptoms and on the third time patient was admitted. Lab data included white blood cells was within normal limits. The patient received corrective treatment with IV fluids and medications (unspecified) to ease nausea vomiting. The patient was recovering from events. List of documents held by sender: none. Sender's Comments: Abdominal pain and severe nausea are unlisted with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE but fever of 102-103F and vomiting is listed. Time to onset is compatible with the role of the vaccine. This is poorly documented case. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: White blood cell count normal
Clinical narrative: Initial unsolicited report received from a Physician on 27 August 2016. This case involves a 18 years old female patient who was vaccinated with a dose of MENACTRA (batch number, expiration date, site of administration was not reported) intramuscularly on 24 August 2016. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 24 August 2016, within 30 minutes following vaccination, patient became ill, patient had developed fever of 102-103 Fahrenheit, severe nausea, vomiting and abdominal pain that comes and goes. Patient was seen in emergency room for three times for these symptoms and on the third time patient was admitted. Lab data included white blood cells was within normal limits. The patient received corrective treatment with IV fluids and medications (unspecified) to ease nausea vomiting. The patient was recovering from events. List of documents held by sender: none. Sender's Comments: Abdominal pain and severe nausea are unlisted with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE but fever of 102-103F and vomiting is listed. Time to onset is compatible with the role of the vaccine. This is poorly documented case. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients received an improperly stored doses of RECOMBIVAX HB (dose and route of administration were not provided) (lot numbers: reported as "J00793", expiration date: 05-FEB-2016; J006365, expiration date: 05-DEC-2015; reported as "K010536", expiration date: 27-AUG-2016, J013394, expiration date: 25-AUG-2016; K018180, expiration date: 17-SEP-2016; H015537, expiration date: 09-JUL-2015; J012520, expiration date: 30-JAN-2016; L019298 expiration date: unknown; L029631, expiration date: 14-AUG-2017; reported as "L444694", expiration date: unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. Lot numbers: J00793, L444694, K010536 are invalid lot numbers for hepatitis B vaccine. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally, lot # L038534, expiration date 19-AUG-2017; dose was not reported). No adverse effects were reported. ROTATEQ was not supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 11-MAY-2016, the patients were vaccinated with the improperly stored doses of VARIVAX (lot #, expiration date, dose and route were not reported). No adverse effects were reported. VARIVAX was supported until the labeled expiry. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product name confusion, Wrong drug administered
Clinical narrative: The spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (dose, dose number, route of administration, injection site, lot number and expiration date were not reported). It was stated that the patient received ZOSTAVAX instead of VARIVAX (prescribed dose, dose number, route of administration, injection site, lot number and expiration date were not reported) due to product confusion. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 77 years old male patient. The patient's medical histories included congestive heart failure and cellulitis. The patient had no known drug allergies. Concomitant therapy was not reported. On 23-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (once, dose, lot # and expiration date not reported) subcutaneously in the left deltoid. On an unknown date in 2016, the patient experienced redness and swelling at the injection site. The patient went to an unspecified walk in clinic, where he did not have a fever, and was told he had cellulitis at left deltoid. It was unknown if any treatment was provided by the walk in clinic to the patient. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This solicited report as received from a pharmacist, as part of a marketing research program, refers to an elderly (in his early 90's) male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2011, the patient was vaccinated with 1 dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in 2016, the patient experienced mild case of shingles. The patient recovered/resolved with sequelae from the event on an unknown date, in 2016. Causality assessment was not provided. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent for further contact.