chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, HPV9, TDAP
Symptoms: Dizziness, Fall, Seizure like phenomena
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 # 667203) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient had no (not per person) medical history and concurrent illnesses. Information on the patient's lab data, other medications and prior vaccinations were not reported. On 19-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm for prophylaxis (batch/lot # MO16193, expiration date was not reported). On the same day, the patient was also vaccinated with BOOSTRIX (dose number 1, intramuscularly in the left arm, lot # 2jx5z, manufacturer: GlaxoSmithKline; lot expiration date was not reported) and FLUARIX QUADRIVALENT (dose number 1, intramuscularly in the left arm, lot # mn5cs, manufacturer: GlaxoSmithKline; lot expiration date was not reported) for prophylaxis. On 19-NOV-2016 post vaccination, while sitting the patient felt like she was going to faint. The patient slowly slid out of the seat onto the ground. The patient's parents reported that the patient had seizure-like jerking activity. The patient required emergency room (ER) visit. The outcome of the events 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: FLU4, HPV9, MNQ, TDAP
Symptoms: Rash generalised, 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 # 668423) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. Information on the patient's medical history, concurrent illnesses, other medications, lab data and prior vaccinations were not reported. On 21-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (lot # M023169, route: unknown, site: right arm; lot expiration date was not reported). On the same day, the patient was also vaccinated with MENACTRA (dose number 1, route: unknown, site: left arm, manufacturer: Sanofi Pasteur, lot# U5392AC; lot expiration date was not reported), BOOSTRIX (dose number 1, route: unknown, site: left arm, manufacturer: GlaxoSmithKline, lot# H549F; lot expiration date was not reported) and FLUARIX QUADRIVALENT (dose number 4, route: unknown, site: right arm, manufacturer: GlaxoSmithKline, lot# 9K7E4; lot expiration date was not reported) for prophylaxis. On the same day, 3-4 minutes after vaccination, the patient developed rash (rash generalized) all over his upper body and shakiness (tremor). The outcome of the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Injection site pain, Injection site rash, 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 # 655201) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included gastrooesophageal reflux disease and seasonal allergic rhinitis. The patient's concurrent illness was reported as none. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On 27-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # M004116, lot expiration date 12-OCT-2017 (dose number, dose and frequency were not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which were given on the same day included ADACEL intramuscularly in the left arm, lot# U5235AA; dose, dose number and expiration date not reported) for prophylaxis. On 30-MAY-2016, the patient had rash on the left deltoid which was warm and tender. The patient was started on treatment with sulfamethoxazole, suspension (200mg-40mg/5ml) 15ml orally every 12 hours for 10 days. The outcome of injection site pain, injection site warmth and injection site rash were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena
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 # 669631) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses or medical history. On 13-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # L036301 dose 2, intramuscularly for prophylaxis. Immediately after administration of GARDASIL 9, patient had a post injection reaction with seizure like activityand passed out. The patient was placed on floor with elevated legs and regained consciousness. He responded to name and was seen by pediatrician. The events required an emergency room visit. The outcome of events 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: 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 # 670355). This spontaneous report refers to a 13 year old female patient. The patient's concurrent illnesses and medical history were not reported. On 17-OCT-2016, the patient was vaccinated with GARDASIL 9, lot# M021407, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced syncope post HPV vaccination. Patient's blood pressure was 105/71, pulse was 84 with possible brief loss of consciousness. The outcome of syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Chest pain
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 # 670880) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included fish allergy (rash). Information on the patient's concurrent illnesses, other medications and prior vaccinations was not reported. The patient's lab data was reported as none. On 01-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm (lot # M011117, expiration date: 07-DEC-2017) for prophylaxis. Two months after the vaccination, during follow up visit, it was reported that the patient developed chest pain the same night GARDASIL 9 was administered. The chest pain resolved without any treatment. The patient was evaluated by a pediatrician. The outcome of chest pain was reported as recovered. 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: Hypoaesthesia, Injected limb mobility decreased, Muscular weakness, Paraesthesia, Sensation of foreign body
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 # 670957). This spontaneous report refers to a 15 year old female patient. Information on patient's current illnesses and prior vaccinations was not reported. The patient's medical history included asthma and attention deficit/hyperactivity disorder (ADHD). Patient's other medications included methylphenidate and adavir disks. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M028323, dose 2, route: unknown in the left arm for prophylaxis. On 16-NOV-2016, after administration of GARDASIL 9 (also reported as GARDASIL) in left arm, patient experienced numbness and tingling extending from neck to down the entire arm. Patient's arm felt weak and was difficult to lift. She described a "lump" in her throat. Benadryl and ibuprofen were administered to the patient. The outcome of the events 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.
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pyrexia
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on request by the company from the FDA (HA671698) under the Freedom of Information Act and refers to a 14 year old female. Medical history and concomitant medications were not reported. Current illnesses were reported as none. On 07-NOV-2016 the patient was vaccinated with GARDASIL 9 (lot # M009378, dose 2.0, intramuscular) for the indication of prophylaxis. On 08-NOV-2017 the patient experienced fever and body aches x 2 days. No treatment was needed. The action taken with GARDASIL 9 is not applicable,  and the outcome of the adverse events was reported as recovered. The reporter did not rate the causal relationship. Additional information is not expected as no follow-up can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on a request by the company from the FDA (HA674297) under the Freedom of Information Act and refers to a 14 year old male. Medical history/concurrent conditions included lactose intolerance, and concomitant medications included multivitamin (not further specified). On 15-DEC-2016 the patient was vaccinated with GARDASIL 9 (lot # L307554, dose 1.0, left arm) for the indication of prophylaxis. On 15-DEC-2016, 20 minutes after the shot, the tops of the patient's hands got very red and faded the next morning but the symptoms have come and gone since then. Then shortly after hand rash the hands grew painful and tender, only on the dorsum side of both hands. He also noticed his veins looking very prominent on the tops of his hands since the shot. The next day he had trouble getting out of bed due to pain in both feet that was moderate. His feet were also red and he had been experiencing foot pain and tenderness on the tops and bottoms of his feet. His mother reported both feet were swollen, but no longer are swollen. The outcome of the other adverse events was unknown. The reporter did not rate the causal relationship. Additional information is not expected as no follow-up can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Superficial vein prominence, Tenderness
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on a request by the company from the FDA (HA674297) under the Freedom of Information Act and refers to a 14 year old male. Medical history/concurrent conditions included lactose intolerance, and concomitant medications included multivitamin (not further specified). On 15-DEC-2016 the patient was vaccinated with GARDASIL 9 (lot # L307554, dose 1.0, left arm) for the indication of prophylaxis. On 15-DEC-2016, 20 minutes after the shot, the tops of the patient's hands got very red and faded the next morning but the symptoms have come and gone since then. Then shortly after hand rash the hands grew painful and tender, only on the dorsum side of both hands. He also noticed his veins looking very prominent on the tops of his hands since the shot. The next day he had trouble getting out of bed due to pain in both feet that was moderate. His feet were also red and he had been experiencing foot pain and tenderness on the tops and bottoms of his feet. His mother reported both feet were swollen, but no longer are swollen. The outcome of the other adverse events was unknown. The reporter did not rate the causal relationship. Additional information is not expected as no follow-up can be obtained from the local regulatory authority.
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on request by the company from the FDA under the Freedom of Information Act (FOI) (VAERS ID 674426) and refers to an 11 year old male. Medical history/concurrent conditions included asthma and no known drug allergies. Concurrent medications included CONCERTA. On 19-DEC-2016 the patient was vaccinated with GARDASIL 9 (lot # L040054, dose and route not reported) in the right arm and FLUARIX (GlaxoSmithKline) (lot # C5414, dose and route not reported) in the right arm, BOOSTRIX (GlaxoSmithKline) (lot # 92S2S, dose  and route not reported) in the left arm, and MENVEO (Novartis) (lot # M16013, dose and route not reported) in the left arm (all for the indication of prophylaxis). On 19-DEC-2016 the patient's left arm was red, hot and firm to touch. No fever was reported. He visited the emergency room on 22-DEC-2016. He was noted to have a possible allergic reaction to the vaccines he received in the left arm 3 days ago. He was prescribed cephalexin 500 mg capsules. The outcome of the adverse events was reported as not recovered. Additional information is not expected as no follow-up can be obtained from local health authorities.
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose decreased, Feeling cold, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on request by the company from the FDA (HA674591) under the Freedom of Information Act and refers to a 17 year old male. It was reported the patient had no medical history, concurrent conditions and concomitant medications. On 22-DEC-2016 the patient was vaccinated with GARDASIL 9 (lot # M031557, dose 1.0 intramuscular in the left arm) for the indication of prophylaxis. On 22-DEC-2016 the patient developed immediate onset of feeling of burning pain, then whole body going cold. He also had a feeling of weakness in body and stiffness. He had normal vital signs and blood sugar was 70. Symptoms started to improve with cold water and eating, but were not fully resolved by the time he left the office. He was neurologically able to move all extremities equally and with adequate strength. The action taken with GARDASIL 9 is not applicable, and the outcome of the adverse events were unknown. The reporter did not rate the causal relationship. Additional information is not expected as no follow-up can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on request by the company from the FDA (HA674591) under the Freedom of Information Act and refers to a 17 year old male. It was reported the patient had no medical history, concurrent conditions and concomitant medications. On 22-DEC-2016 the patient was vaccinated with GARDASIL 9 (lot # M031557, dose 1.0 intramuscular in the left arm) for the indication of prophylaxis. On 22-DEC-2016 the patient developed immediate onset of feeling of burning pain, then whole body going cold. He also had a feeling of weakness in body and stiffness. He had normal vital signs and blood sugar was 70. Symptoms started to improve with cold water and eating, but were not fully resolved by the time he left the office. He was neurologically able to move all extremities equally and with adequate strength. The action taken with GARDASIL 9 is not applicable, and the outcome of the adverse events were unknown. The reporter did not rate the causal relationship. Additional information is not expected as no follow-up can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: 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 referring to a 12 year old female patient.  No medical history and concurrent condition were reported. The prior vaccination included GARDASIL 9 and the patient experienced rash. On 28-DEC-2016 the patient was vaccinated with GARDASIL 9 (lot # M034780, 2 DF, intramuscular in the left arm). On 31-DEC-2016, the patient experienced hives. The outcome of hives was reported as recovered. Additional information is not expected since we cannot follow up with agency.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Rash, 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 referring to a 12 year old female patient.  No medical history and concurrent condition were reported. The prior vaccination included GARDASIL 9 and the patient experienced rash. On 28-DEC-2016 the patient was vaccinated with GARDASIL 9 (lot # M034780, 2 DF, intramuscular in the left arm). On 31-DEC-2016, the patient experienced hives. The outcome of hives was reported as recovered. Additional information is not expected since we cannot follow up with agency.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor, Rash generalised, Rash maculo-papular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency # 677567 (VAERS ID)) under the Freedom of Information Act and refers to a 13 year old male patient. The patient's history drug included albuterol. The patient had no known drug allergies (NKDA) and mild intermittent asthma. She also had prior vaccinations. On 04-JAN-2017, the patient was vaccinated with GARDASIL 9 (lot # M034195, expiration date and route unknown, in the left arm) for prophylaxis. On 04-JAN-2017, the patient experienced whole body maculopapular blanching rash no pruritic rash starting 3 hours after vaccine. On the same day, he also experienced pallor and rash generalised.  The outcome of the events was reported as resolved in 2017. The causal relationship between the event and GARDASIL 9 was not provided. The Agency considered the event was non-serious. Additional information is not expected as no further information could be obtained from the agency.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency # 682617 (VAERS ID)) under the Freedom of Information Act and refers to a 20 year old female patient. The patient's history drug included ORTHO-CYCLEN birth control pills. The patient was allergy to chocolate, she had prior vaccinations. On 14-FEB-2017, the patient was vaccinated with GARDASIL 9 (dose reported as 1 (united not provided)), lot # M037770, expiration date unknown, intramuscularly in the right arm for prophylaxis. On 14-FEB-2017, the patient experienced syncope. The outcome of syncope was reported as resolved in 2017. The causal relationship between the event and GARDASIL 9 was not provided. The Agency considered the event was non-serious. Additional information is not expected as no further information could be obtained from the agency.
Sex: F
Vaccine: HEPA, HPV9, HEPA, HPV9
Symptoms: Dizziness, Pallor, Vision blurred
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 referring to an 11 year old female patient. On 13-FEB-2017 13:30 the patient was vaccinated with dose 3 of GARDASIL 9 (lot # M024261, exp 30-JUL-2018, intramuscular in the right arm) and dose 1 of HAVRIX (323X9, Intramuscular in left arm). On 13-FEB-2017, the patient became pale, complained of dizziness and blurred vision. Assisted to exam table, the patient was provided cooling measures, and apple juice, last food intake was at 10:00 AM on 13-FEB-2017. Vital signs blood pressure: 120/60, Respirations: 18, Pulse: 72, no respiratory or cardiac distress observed. Doctor was informed, the patient was advised to lay down another 30 minutes. Patient was assessed, no further incident noted. The outcome of vision blurred, pallor and dizziness was reported as recovered. The reporter did not provide the causality. Additional information is not expected since we cannot follow up with agency.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site swelling
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on request by the company from the FDA (HA 683030) under the Freedom of Information Act and refers to a 13 year old male. Medical history, concurrent conditions and concomitant medications were not reported. On 04-FEB-2017 the patient was vaccinated with GARDASIL 9 (lot # M007764, dose 2.0, intramuscular right arm) for the indication of prophylaxis. On an unspecified date the patient developed a swollen right shoulder after vaccination. He was seen in the emergency room. No antibiotic was given. The outcome of swollen right shoulder was reported as recovered. The reporter did not rate the causal relationship. Additional information is not expected as no follow-up can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Swelling
Clinical narrative: Information was received on 10-MAY-2017 from a line listing obtained on request by the company from the FDA (HA 683030) under the Freedom of Information Act and refers to a 13 year old male. Medical history, concurrent conditions and concomitant medications were not reported. On 04-FEB-2017 the patient was vaccinated with GARDASIL 9 (lot # M007764, dose 2.0, intramuscular right arm) for the indication of prophylaxis. On an unspecified date the patient developed a swollen right shoulder after vaccination. He was seen in the emergency room. No antibiotic was given. The outcome of swollen right shoulder was reported as recovered. The reporter did not rate the causal relationship. Additional information is not expected as no follow-up can be obtained from the local regulatory authority.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Blood pressure decreased, Bradycardia, Hyperventilation, Hypotension, Presyncope
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 ID #683874) referring to a 16 year old male patient with no current illness and no history. On 25-FEB-2017, the patient was vaccinated with GARDASIL 9, dose 1, intramuscularly in the left arm (lot #M040213, expiration date unknown). Other suspect therapies included FLUZONE (Sanofi Pasteur) (lot #UI673AD), intramuscularly in the right arm, and MENACTRA (Sanofi Pasteur) (lot #M016095), dose 2, intramuscularly in the left arm. On 25-FEB-2017, the patient experienced near syncope, hypotension and bradycardia. The child was hyperventilating. BP dropped to 79/43 with pulse 44, pulse ox 100%. Treated with rest, monitoring, paper bag rebreathing. Given orange and water. EKG ordered (results not provided). Gradually recovered. Normal vital signs at discharge. Observed for 25 minutes. Sibling also had syncope. The outcome of the events was reported as recovered. Causality was not assessed by the agency. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Blood pressure decreased, Bradycardia, Electrocardiogram, Hyperventilation, Hypotension
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 ID #683874) referring to a 16 year old male patient with no current illness and no history. On 25-FEB-2017, the patient was vaccinated with GARDASIL 9, dose 1, intramuscularly in the left arm (lot #M040213, expiration date unknown). Other suspect therapies included FLUZONE (Sanofi Pasteur) (lot #UI673AD), intramuscularly in the right arm, and MENACTRA (Sanofi Pasteur) (lot #M016095), dose 2, intramuscularly in the left arm. On 25-FEB-2017, the patient experienced near syncope, hypotension and bradycardia. The child was hyperventilating. BP dropped to 79/43 with pulse 44, pulse ox 100%. Treated with rest, monitoring, paper bag rebreathing. Given orange and water. EKG ordered (results not provided). Gradually recovered. Normal vital signs at discharge. Observed for 25 minutes. Sibling also had syncope. The outcome of the events was reported as recovered. Causality was not assessed by the agency. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 16.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Presyncope
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 ID #683874) referring to a 16 year old male patient with no current illness and no history. On 25-FEB-2017, the patient was vaccinated with GARDASIL 9, dose 1, intramuscularly in the left arm (lot #M040213, expiration date unknown). Other suspect therapies included FLUZONE (Sanofi Pasteur) (lot #UI673AD), intramuscularly in the right arm, and MENACTRA (Sanofi Pasteur) (lot #M016095), dose 2, intramuscularly in the left arm. On 25-FEB-2017, the patient experienced near syncope, hypotension and bradycardia. The child was hyperventilating. BP dropped to 79/43 with pulse 44, pulse ox 100%. Treated with rest, monitoring, paper bag rebreathing. Given orange and water. EKG ordered (results not provided). Gradually recovered. Normal vital signs at discharge. Observed for 25 minutes. Sibling also had syncope. The outcome of the events was reported as recovered. Causality was not assessed by the agency. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Abdominal compartment syndrome, Acquired tracheo-oesophageal fistula, Bacterial test negative, Blood bicarbonate normal, Blood lactic acid normal
Clinical narrative: Pt received Hep B at birth with no problems. On 1/5/17 had esophagus repair surgery. Pt had to stay in hospital for follow-up due to leak after surgery. At NICU, 6 month vax was administered. Nurse did not discuss vax with parents. Patient had on the same day - high fever - increased heart rate 205 - went through 14 diarrhea diapers - shivers / shaking - nausea - dehydrated - stopped breathing 20-25 minutes - severe brain injury - damaged intestines, required surgery overnight.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Blood pH decreased, Circulatory collapse, Diarrhoea, Encephalopathy, Endotracheal intubation
Clinical narrative: Pt received Hep B at birth with no problems. On 1/5/17 had esophagus repair surgery. Pt had to stay in hospital for follow-up due to leak after surgery. At NICU, 6 month vax was administered. Nurse did not discuss vax with parents. Patient had on the same day - high fever - increased heart rate 205 - went through 14 diarrhea diapers - shivers / shaking - nausea - dehydrated - stopped breathing 20-25 minutes - severe brain injury - damaged intestines, required surgery overnight.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Intestinal resection, Metabolic acidosis, Nuclear magnetic resonance imaging brain abnormal, PCO2 normal, PO2 decreased
Clinical narrative: Pt received Hep B at birth with no problems. On 1/5/17 had esophagus repair surgery. Pt had to stay in hospital for follow-up due to leak after surgery. At NICU, 6 month vax was administered. Nurse did not discuss vax with parents. Patient had on the same day - high fever - increased heart rate 205 - went through 14 diarrhea diapers - shivers / shaking - nausea - dehydrated - stopped breathing 20-25 minutes - severe brain injury - damaged intestines, required surgery overnight.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Post procedural fistula, Pyrexia, Resuscitation, Rotavirus test negative, Viral test negative
Clinical narrative: Pt received Hep B at birth with no problems. On 1/5/17 had esophagus repair surgery. Pt had to stay in hospital for follow-up due to leak after surgery. At NICU, 6 month vax was administered. Nurse did not discuss vax with parents. Patient had on the same day - high fever - increased heart rate 205 - went through 14 diarrhea diapers - shivers / shaking - nausea - dehydrated - stopped breathing 20-25 minutes - severe brain injury - damaged intestines, required surgery overnight.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Brain injury, Chills, Dehydration, Diarrhoea, Gastrointestinal disorder
Clinical narrative: Pt received Hep B at birth with no problems. On 1/5/17 had esophagus repair surgery. Pt had to stay in hospital for follow-up due to leak after surgery. At NICU, 6 month vax was administered. Nurse did not discuss vax with parents. Patient had on the same day - high fever - increased heart rate 205 - went through 14 diarrhea diapers - shivers / shaking - nausea - dehydrated - stopped breathing 20-25 minutes - severe brain injury - damaged intestines, required surgery overnight.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Gastrointestinal injury, Heart rate increased, Intestinal operation, Nausea, Pyrexia
Clinical narrative: Pt received Hep B at birth with no problems. On 1/5/17 had esophagus repair surgery. Pt had to stay in hospital for follow-up due to leak after surgery. At NICU, 6 month vax was administered. Nurse did not discuss vax with parents. Patient had on the same day - high fever - increased heart rate 205 - went through 14 diarrhea diapers - shivers / shaking - nausea - dehydrated - stopped breathing 20-25 minutes - severe brain injury - damaged intestines, required surgery overnight.
Age: 0.33
Sex: M
Vaccine: HIBV, DTAP
Symptoms: Respiratory arrest, Surgery, Tremor
Clinical narrative: Pt received Hep B at birth with no problems. On 1/5/17 had esophagus repair surgery. Pt had to stay in hospital for follow-up due to leak after surgery. At NICU, 6 month vax was administered. Nurse did not discuss vax with parents. Patient had on the same day - high fever - increased heart rate 205 - went through 14 diarrhea diapers - shivers / shaking - nausea - dehydrated - stopped breathing 20-25 minutes - severe brain injury - damaged intestines, required surgery overnight.
Sex: U
Vaccine: HEPA, MMR, VARCEL, VARCEL, MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 15-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M038859, (expiry date, site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1611USA004113:
Sex: U
Vaccine: HEPA, MMR, VARCEL, VARCEL, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 15-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M038859, (expiry date, site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all available information has been received.; Sender's Comments: US-009507513-1611USA004113:
Sex: U
Vaccine: HEPA, MMR, VARCEL, VARCEL, MMR
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 15-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: HEPA, MMR, VARCEL, VARCEL, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 15-MAR-2017, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Decreased appetite, Erythema, Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: 5/5 - rec'd shot 3pm. 5/5-5/6 overnight - fever 102, stomach and thighs hot arm sore (couldn't lay on it). 5/6 PM- fever returned. Sought medical attention on advice of ins. 5/8 - follow-up w/PCP, no elevated WBC.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm, Vaccination complication
Clinical narrative: 5/5 - rec'd shot 3pm. 5/5-5/6 overnight - fever 102, stomach and thighs hot arm sore (couldn't lay on it). 5/6 PM- fever returned. Sought medical attention on advice of ins. 5/8 - follow-up w/PCP, no elevated WBC.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm, White blood cell count normal
Clinical narrative: 5/5 - rec'd shot 3pm. 5/5-5/6 overnight - fever 102, stomach and thighs hot arm sore (couldn't lay on it). 5/6 PM- fever returned. Sought medical attention on advice of ins. 5/8 - follow-up w/PCP, no elevated WBC.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chest X-ray, Cough, Pyrexia
Clinical narrative: Weakness, continuous high fever for 7 days (103 F), was reduced by Motrin only (ibuprofen), fever reappeared right after medicine stopped acting (after ~8 hours). Accompanied by dry coughing all the time.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Lightheadedness for about an hour on 05/23/2017, donor ate 05/24/2017 which resulted in Nausea and Vomitus X2. Donor did not previously share illness with staff.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Joint swelling, Pain, Pain in extremity
Clinical narrative: This initial spontaneous report was received from a Licenced Practical Nurse who put the 46 year old female patient on the line to provide details. The patient had no pertinent medical history and no drug reactions/allergies. Concomitant medications included hydrochlorothiazide (indication not specified).  On 04-APR-2017, the patient received a dose of RECOMBIVAX HB intramusculalry in her left arm for hepatitis B prevention (lot # N002914; expiration 04-NOV-2019). The patient developed pain all throughout her arm immediately following administration of the vaccine which lasted the rest of that afternoon and into that night. When she woke up on 05-APR-2017, her arm no longer hurt, but the pain had traveled into her left hand. The patient also experienced numbness and tingling in her left hand and reported the entire palm of her left hand was swollen, particulalry the joints between her index and middle fingers. Her hand was so swollen she could not make a fist. She had to tape her index and middle fingers together to kep them from moving around too much and causing pain as anytime she bumped those fingers on anything it would hurt really bad. The patient reported she was unable to use her hand very well as a result of these symptoms. She took ibuprofen but it did not help at all. The pain, numbness and tingling and swelling have "gradually subsided" and these symptoms were now isolated to her left index finger, but she still had difficulty using her left hand.  Causality assessment was not provided. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Peripheral swelling
Clinical narrative: This initial spontaneous report was received from a Licenced Practical Nurse who put the 46 year old female patient on the line to provide details. The patient had no pertinent medical history and no drug reactions/allergies. Concomitant medications included hydrochlorothiazide (indication not specified).  On 04-APR-2017, the patient received a dose of RECOMBIVAX HB intramusculalry in her left arm for hepatitis B prevention (lot # N002914; expiration 04-NOV-2019). The patient developed pain all throughout her arm immediately following administration of the vaccine which lasted the rest of that afternoon and into that night. When she woke up on 05-APR-2017, her arm no longer hurt, but the pain had traveled into her left hand. The patient also experienced numbness and tingling in her left hand and reported the entire palm of her left hand was swollen, particulalry the joints between her index and middle fingers. Her hand was so swollen she could not make a fist. She had to tape her index and middle fingers together to kep them from moving around too much and causing pain as anytime she bumped those fingers on anything it would hurt really bad. The patient reported she was unable to use her hand very well as a result of these symptoms. She took ibuprofen but it did not help at all. The pain, numbness and tingling and swelling have "gradually subsided" and these symptoms were now isolated to her left index finger, but she still had difficulty using her left hand.  Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified adult patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were unknown. On an unknown date in March 2017 (reported as "sometime in March"), the patient received their first dose of VAQTA (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis. On 04-MAY-2017, the patient received their second dose of VAQTA lot# N002921, expiration date 08-APR-2018, (dose, frequency and route were not reported) for prophylaxis (drug use for unapproved schedule).  No adverse events reported. Additional information is not expected because the reporter does not want to be contacted further.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On uspecified dates, the patients were vaccinated with improperly stored injections of PROQUAD lot # M038227 expiration date 06-MAR-2018 (dose and route of administration were not provided) for prophylaxis. In a addition, the vaccines were reconstituted with properly stored STERILE DILUENT. The patients' concomitant therapies were not reported. On an unspecified date, the data logger registered a temperature ranges between 6° Fahrenheit (F) and and 14F during a time frame of 2 hours 15 minutes with no previous excursion. Adverse effects were not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007410.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of an unknown age and gender. The patient's medical history, drug and allergy history and current conditions were not provided. It was reported that on 15-MAY-2017, the patient received an improperly stored dose of GARDASIL 9 lot # M036059 and expiration date of 03-JUN-2019 (dose, route and anatomical location were not reported) for prophylaxis. The patient's concomitant therapies were not provided. The vaccine was stored at a temperature ranges between 32° Fahrenheit (F) to 36°F, during a time frame of 100 hours with no previous temperature excursions. No adverse events were reported.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 09-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA0097942:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 19-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 13-DEC-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II, lot # L049314, expiry date 03-DEC-2017 (dose, route and site of administration were not reported). Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. No adverse effects reported. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 23-MAR-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 09-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter.  Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 19-JAN-2017, the patient was vaccinated with an improperly stored doses of M-M-R II, lot # M015931, expiration date 30-MAR-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments:  US-009507513-1611USA011831: US-009507513-1611USA004113: