chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MENB
Symptoms: Erythema, Local reaction
Clinical narrative: A large local reaction appeared (erythema); This is a spontaneous report from a contactable physician.  A 22-year-old male patient of an unspecified ethnicity received his TRUMENBA, via an unspecified route of administration on 02Jun2017 at single dose for immunization.  The patient medical history and concomitant medications were not reported. The patient experienced a large local reaction appeared (erythema) on an unspecified date. The outcome of the event was unknown.
Age: 1.25
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site inflammation, Injection site irritation, Vaccination site bruising, Vaccination site erythema
Clinical narrative: Patient's left thigh is red and bruised. Measured 8x10 cm, looks like a reaction to the vaccine. Mother put ice packs and administered Pain relief medication. Irritation and inflammation.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure 6 days after vaccine.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Administrator attempted to give shot and had a problem saying, "Something's wrong."  Gave another shot in same arm (Lot#33CG3). Arm was sore as expected for a day or so, but then did not get better. Arm pain continues currently and is impeding use of right arm and sleep.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anal pruritus, Back pain, Cheilitis, Constipation, Erythema
Clinical narrative: Fever up to 101 for 4 days followed by episodes of sweats for days, headache, extreme pain from low back to tips of toes, painful itch in vaginal area and anal area, hemorrhoids, constipation for inflamed left eye, red, scaly patch on left eyebrow, red scaly patch on outer left ear canal, raw feeling on tip of tongue and inner area of lips. Tiredness.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye inflammation, Fatigue, Glossitis, Haemorrhoids, Headache
Clinical narrative: Fever up to 101 for 4 days followed by episodes of sweats for days, headache, extreme pain from low back to tips of toes, painful itch in vaginal area and anal area, hemorrhoids, constipation for inflamed left eye, red, scaly patch on left eyebrow, red scaly patch on outer left ear canal, raw feeling on tip of tongue and inner area of lips. Tiredness.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hyperhidrosis, Pain in extremity, Proctalgia, Pyrexia, Skin exfoliation
Clinical narrative: Fever up to 101 for 4 days followed by episodes of sweats for days, headache, extreme pain from low back to tips of toes, painful itch in vaginal area and anal area, hemorrhoids, constipation for inflamed left eye, red, scaly patch on left eyebrow, red scaly patch on outer left ear canal, raw feeling on tip of tongue and inner area of lips. Tiredness.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vulvovaginal pain, Vulvovaginal pruritus
Clinical narrative: Fever up to 101 for 4 days followed by episodes of sweats for days, headache, extreme pain from low back to tips of toes, painful itch in vaginal area and anal area, hemorrhoids, constipation for inflamed left eye, red, scaly patch on left eyebrow, red scaly patch on outer left ear canal, raw feeling on tip of tongue and inner area of lips. Tiredness.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Back pain, Body temperature increased, Cheilitis, Erythema, Eyelid exfoliation
Clinical narrative: Fever up to 101 for 4 days followed by episodes of sweats for days, headache, extreme pain from low back to tips of toes, painful itch in vaginal area and anal area, hemorrhoids, constipation for inflamed left eye, red, scaly patch on left eyebrow, red scaly patch on outer left ear canal, raw feeling on tip of tongue and inner area of lips. Tiredness.
Age: 80.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Glossitis, Headache, Pain, Pain in extremity
Clinical narrative: Fever up to 101 for 4 days followed by episodes of sweats for days, headache, extreme pain from low back to tips of toes, painful itch in vaginal area and anal area, hemorrhoids, constipation for inflamed left eye, red, scaly patch on left eyebrow, red scaly patch on outer left ear canal, raw feeling on tip of tongue and inner area of lips. Tiredness.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Antinuclear antibody negative, Full blood count normal, Petechiae, Platelet count normal, Red blood cell sedimentation rate normal
Clinical narrative: Petechial rash.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Urine analysis normal
Clinical narrative: Petechial rash.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JUN-2017 the patient was vaccinated with improperly stored PEDVAXHIB (dosage and route not reported), lot # M032149, expiration date 18-APR-2019 for prophylaxis. There was no adverse effect reported. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit for1 hour. A digital data logger was involved. Previous temperature excursion: 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information was received on 11-JUL-2017 from a representative regarding her friend, a 50 year old male patient who did not want his name provided. The patient told the representative yesterday that after getting ZOSTAVAX (lot#/expiration unknown) injection, .65 ml one time, to prevent shingles on 09-JUL-2017, his arm became "big, red and puffy" (onset 09-JUL-2017). Treatment was provided for adverse event; "he put ice on it". Patient's present status is recovering. Patient was given the vaccine by an unspecified health care professional at an unspecified pharmacy. Concomitant medication included "a statin" (not further details provided). No additional adverse event information was provided. Patient refused to provide contact information. Additional information is not expected.
Sex: M
Vaccine: HPV4
Symptoms: Squamous cell carcinoma, Therapeutic response unexpected
Clinical narrative: This literature marketed report was received from a physician regarding a male patient in his 70s. Patient was considered immunocompetent on the basis of an absence of immunodeficiency, history of opportunistic infection, autoimmune disease, systemic malignancy, or treatment with immunomodulatory medications. The patient received 3 doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) at 0, 2 and 6 months in 2013 for prophylaxis (dosing details not reported). The vaccines were well tolerated by the patient and had no adverse effects. Prior to vaccination, patient had a mean of 12 new SCCs (87.5% SCC in situ, 6.25% well-differentiated SCC, and 6.25% SCC, keratoacanthoma-type) and 2.25 new BCCs per year. After vaccination, patient 1 developed a mean of 4.44 SCCs (100% SCC in situ) and 0 BCCs per year. This result represents a 62.5% reduction in sees and a 100% reduction in BCCs within the observation time of 16 months before and 16 months after the first dose of the qHPV vaccine (Therapeutic response unexpected). Outcome of the event was unknown. Causality of the event was considered to be related. This is one of 2 reports 1707USA006525 (Same literature link). Additional information has been requested. Sender's Comments: US-009507513-1707USA006525.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # L043213 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 lot # M042853 for prophylaxis. Temperature was reported as 52.6 FR, timeframe: 2 hours 32 minutes. There was no previous temperature excursion. No adverse effects were reported. This case is linked to case 1707USA006520 and 1707USA006521 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # L038669 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M041084, expiration date 04-APR-2018) for prophylaxis (dose and route of administration were not reported). A sterile diluent (manufacturer unknown) was used. The vaccine was stored at 6°F-14°F for 1 hour. There were no previous temperature excursions and the call was because of a digital data logger. No product quality complaint was involved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # M039060 for prophylaxis. Temperature was reported as 52.6 FR, timeframe: 2 hours 32 minutes. There was no previous temperature excursion. No adverse effects were reported. This case is linked with case 1707USA006122 and 1707USA006521. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Nurse practitioner refers to a patient of unknown age. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB lot # M022077 and L048236 for prophylaxis. Temperature was reported as 52.6 FR, timeframe: 2 hours 32 minutes. There was no previous temperature excursion. No adverse effects were reported. This case is linked to case 1707USA006122 and 1707USA006520 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Squamous cell carcinoma, Therapeutic response unexpected
Clinical narrative: This literature marketed report was received from a physician regarding a female patient in her 80s. Patient was considered immunocompetent on the basis of an absence of immunodeficiency, history of opportunistic infection, autoimmune disease, systemic malignancy, or treatment with immunomodulatory medications. The patient received 3 doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (manufacturer unknown) at 0, 2 and 6 months in 2013 for prophylaxis (dosing details not reported). The vaccines were well tolerated by the patient and had no adverse effects. Prior to vaccination, patient 2 had a total of 5.5 new sees (100% SCC in situ) and 0.92 new BCCs per year. After vaccination, the patient developed 1.84 SCCs (100% well-differentiated SCCs) and 0 BCCs per year, representing a 66.5% reduction in sees and a 100% reduction in BCCs during the observation time of 13 months before and 13 months after the first dose of the qHPV vaccine (Therapeutic response unexpected). Outcome of the event was unknown. Causality of the event was considered to be related. This is one of 2 reports 1707USA005911 (Same literature link). Additional information has been requested. Sender's Comments: US-009507513-1707USA005911.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 30-JUN-2017 from a medical assistant who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The medical assistant reported that multiple doses of improperly stored (31 degrees F or lower (29F) for 7 hours 55 minutes) PNEUMOVAX 23 (lot M043424, expires 06-JUN-2018) were administered to multiple unspecified patients on unspecified dates. No previous temperature excursions. No adverse effects reported. No further details available. Additional information is not expected, no additional information is available. This is one of several reports from the same reporter.
Sex: M
Vaccine: PNC
Symptoms: Death
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his/her brother, via Pfizer-sponsored program. A male patient of an unspecified age received his second single dose of PREVNAR, on unspecified date for immunization. Medical history and concomitant medications were not reported. Previously, on an unknown date, the patient received the first dose of the vaccine. The patient died on an unspecified date, 4 months after getting the second pneumonia shot. It was unknown if autopsy was performed. It was reported that patient was up to date on all the pneumonia vaccines available at the time (2009). Reported Cause(s) of Death: patient died 4 months after getting a pneumonia shot.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient called pharmacy 7/19/17, stated that she received a PNEUMOVAX IMZ yesterday in the afternoon, and in the evening she developed a low grade fever, as well as her arm where injection was administered was hot and swollen. Patient stated that she took some ibuprofen over the counter and used an ice pack, however, it did not seem to help much. Advised patient this morning via phone call 07/19/17, to seek medical care. Patient stated she would contact her PCP.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt reports her arm is warm to touch and red.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: Fever, varicella rash, poor appetite, irritability.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Dysphonia, Loss of consciousness, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Approx. 4 hours after the vaccine, the patient woke up from sleeping and had swelling in throat, red eyes, and voice sounded odd. Mom took patient to PCP for follow up and was given a steroid shot in office and passed out. Patient has 102 temperature for 4 days following the shot. Patient was given amoxicillin and another steroid to take at home. Patient still has a sore throat today. PCP strep tested and negative.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Pharyngeal oedema, Streptococcus test negative
Clinical narrative: Approx. 4 hours after the vaccine, the patient woke up from sleeping and had swelling in throat, red eyes, and voice sounded odd. Mom took patient to PCP for follow up and was given a steroid shot in office and passed out. Patient has 102 temperature for 4 days following the shot. Patient was given amoxicillin and another steroid to take at home. Patient still has a sore throat today. PCP strep tested and negative.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia
Clinical narrative: Joint Pain.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: SORENESS IN LEFT DELTOID 35 DAYS AFTER INJECTION.
Age: 19.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Chills, Dyspnoea, Nausea, Vomiting
Clinical narrative: About 1 hour after administration of vaccines, developed rigors, shortness of breath, nausea and vomiting.
Age: 0.17
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Crying, Flatulence, Irritability, Pyrexia
Clinical narrative: Low grade fever, fussiness, gas, crying.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever "104", nausea and vomiting. Treatment - supportive/antipyretics. Duration: 12 hours.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, UNK, HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: On July 17 2017 I took my daughter to medical group for her 1st year well check and her shots..they gave her 3 shots ... Hep A, MMR and they were supposed to give her varicella but they gave her pneumococcal ..which doctor called me around 5 and said it was a mix of varicella and MMR, and doctor said that patient might get a high fever and a seizure. I'm making a report in case she has complications later on due to the injection.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, UNK, HEPA, MMRV, VARCEL
Symptoms: Injection site mass, Injection site vesicles
Clinical narrative: On July 17 2017 I took my daughter to medical group for her 1st year well check and her shots..they gave her 3 shots ... Hep A, MMR and they were supposed to give her varicella but they gave her pneumococcal ..which doctor called me around 5 and said it was a mix of varicella and MMR, and doctor said that patient might get a high fever and a seizure. I'm making a report in case she has complications later on due to the injection.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Drug administered at inappropriate site, Immediate post-injection reaction, Musculoskeletal pain, Pain
Clinical narrative: Shot given too high in arm. Immediate pain (within 5 minutes) Intense Pain lasted approximately 3 days. Strong pain subsided but pain is felt every day. Now it is not constant but certain movements are painful. Pain is in shoulder, radiates to back some and down arm at times. Sleeping on right side is painful and interferes with sleep. I do have full movement of shoulder but certain movements cause fairly strong pain. Other movements pain is milder.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Shot given too high in arm. Immediate pain (within 5 minutes) Intense Pain lasted approximately 3 days. Strong pain subsided but pain is felt every day. Now it is not constant but certain movements are painful. Pain is in shoulder, radiates to back some and down arm at times. Sleeping on right side is painful and interferes with sleep. I do have full movement of shoulder but certain movements cause fairly strong pain. Other movements pain is milder.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 30-JUN-2017 from a medical assistant who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The medical assistant reported that multiple doses of improperly stored (31 degrees F or lower (29F) for 7 hours 55 minutes) VAQTA (lot L017757, expires 08-APR-2018) were administered to multiple unspecified patients on unspecified dates. No previous temperature excursions. No adverse effects reported. No further details available. Additional information is not expected, no additional information is available. This is one of several reports from the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 30-JUN-2017 from a registered nurse who was reporting on an unspecified patient (no age or gender reported). No medical history or concomitant medications were reported. The nurse reported that on 25-JUN-2017, one unspecified patient was administered a dose of improperly stored PROQUAD (lot M041507, expires  09-APR-2018) that was reconstituted with properly stored DILUENT (lot M019892, expires 18-OCT-2018). No adverse effects reported. The vaccine was under a temperature excursion of 6 degrees F. to 14 degrees F. for 230 minutes. There was no previous temperature excursion and this was as a result of data logger. No other information was provided. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a 46 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 06-JUL-2017, the patient was vaccinated expired dose of M-M-R II, (lot # not reported expiration 01-JUL-2017) for prophylaxis. No adverse event reported. No additional information reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old female patient. On 16-SEP-2016 the patient was vaccinated with GARDASIL 9 dose 1 for prophylaxis. The patient received 2nd dose on 25-APR-2017. No other details were provided. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV9, MMR, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, multiple doses of improperly stored vaccines included: PEDVAXHIB lot # M047666, expiration 24-OCT-2019; (dosage and route not reported); GARDASIL 9 lot # M041990, expiration 28-JUN-2019 (dosage and route not reported); ROTATEQ M035456 expiration 01-MAY-2018 (dosage and route not reported); and M-M-R II M035388 expiration 02-AUG-2018 (dosage and route not reported). No adverse events were reported. Temperature was reported as 47 degrees Fahrenheit to 77 degrees Fahrenheit for 18 hours. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Dysmenorrhoea, Exposure during pregnancy, Haemorrhage in pregnancy, Ultrasound antenatal screen
Clinical narrative: This spontaneous prospective pregnancy report was received from a 38 year old female patient, reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies, and was not taking any concomitant medications. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. On 09-JUN-2017 the patient was vaccinated with M-M-R II for prophylaxis (route of administration reported as injections, dose reported as "two injections"; lot number and expiration date were not reported) (maternal exposure during pregnancy). On approximately 30-JUN-2017, reported as "3 weeks after June 9", the patient experienced spotting and cramping. The patient had two outpatient visits to a medical center where she was administered unspecified intravenous medications and an ultrasound on unknown dates and for an unspecified reason (also reported as treatment given for adverse event: yes). No product quality complaint was filed. No prenatal tests or results were reported. Neither the pregnancy outcome nor the fetal outcome were known at the time of the report. The outcome of haemorrhage in pregnancy and dysmenorrhoea were reported as not recovered/not resolved. The outcome of exposure during pregnancy was unknown. The reporter did not assess the causal relationship between M-M-R II and the events haemorrhage in pregnancy and dysmenorrhoea  Upon internal review the event haemorrhage in pregnancy was considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed vocational nurse, and refers to four unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported. It was reported that, on 29-JUN-2017 and on 30-JUN-2017, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M040271 with expiration date 30-APR-2018 (dose and frequency were not reported), for prophylaxis. No adverse effects were reported. The temperature excursion lasted 15 minutes at a temperature frame of 33°F, recorded by a digital data logger. No previous temperature excursions were reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (route, dose number, lot number and dosage were unknown) for prophylaxis.  The vaccines underwent a temperature excursion from  47°F to 77°F during two hours. There was no previous temperature excursion and it was due to a data logger issue.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent (MRK).The patient's concurrent conditions and medical history were not reported. On 12-JUL-2017, the patient was vaccinated with a dose of ZOSTAVAX intramuscular route instead of subcutaneously, for prophylaxis (dose, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received on 30-JUN-2017 from a medical assistant who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The medical assistant reported that multiple doses of improperly stored (31 degrees F or lower (29F) for 7 hours 55 minutes) RECOMBIVAX HB (lot L014876 expires 17-JAN-2018) were administered to multiple unspecified patients on unspecified dates. No previous temperature excursions. No adverse effects reported. No further details available. Additional information is not expected, no additional information is available.  This is one of several reports from the same reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 30-JUN-2017 from a medical assistant who was reporting on multiple unspecified patients. No medical history or concomitant medications were reported. The medical assistant reported that multiple doses of improperly stored (31 degrees F or lower (29F) for 7 hours 55 minutes) GARDASIL 9 (lot L037554, expires 25-DEC-2017, Lot M040412, expires 30-AUG-2019 and lot M041990, expires 28-JUN-2018) were administered to multiple unspecified patients on unspecified dates. No previous temperature excursions. No adverse effects reported. No further details available. Additional information is not expected, no additional information is available. This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JUL-2017, the patient was vaccinated in error with a dose of VARIVAX injection, by subcutaneous route (strength, dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Confusional state, Syncope
Clinical narrative: Confusion syncope.
Age: 12.0
Sex: F
Vaccine: TYP
Symptoms: Loss of consciousness
Clinical narrative: Patient tolerated vaccination well, however, when father was checking out, she passed out in the waiting room.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: The patient experienced a rash at the injection site, a welt the diameter of a grapefruit and very raised that itched and stung like a bee sting.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Anxiety, Asthenia, Hyperhidrosis, Pain
Clinical narrative: During night after the vaccine was given she awoke sweaty and had body aches and in the morning had body aches, weakness, and anxiousness. She took some Ibuprofen and was feeling better after that but still felt weak.
Age: 25.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Fatigue, Night sweats, Pain
Clinical narrative: Had night sweats, chills, and body aches during the night after the vaccine was given. Had fatigue and body aches next morning.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Swelling face
Clinical narrative: With GARDASIL #1, had minimal facial swelling. After GARDASIL #2, about 1 hour after vaccine, developed swelling of face and swelling of both eyes. Swelling decreased the next day but still had some mild periorbital swelling then. No other symptoms.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Musculoskeletal pain, Neck pain
Clinical narrative: He had chills during the evening after the vaccine. The next day he had pain across his shoulders and neck pain.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Anger, Detoxification, Pyrexia, Speech disorder
Clinical narrative: Fever, anger for 2 weeks (until detox bath), speech went backwards instead of improving or even staying the same.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Pruritus
Clinical narrative: L thigh, red, itchy rash 1 - 2 days after DTaP vaccine on 7/12/17. Getting bigger today. + itchy, no pain. Nowhere else. Never before.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Abdominal pain, Asthenia, Blood chloride normal, Blood sodium normal, Chills
Clinical narrative: After the vaccine, patient said that his arm was hurting. The morning after, patient started feeling sick, chills, weak. He texted his mom from school. He reported nausea, severe headache, eye pain such that he didn't want to open his eyes, dizziness severe enough for him to need support to walk, weakness, and fatigue. A little after 2 pm on June 30th, he was evaluated in the ER. The abdominal pain he described as centering around his belly button, and feeling worse when he moved or took a deep breath. They noted there was no rash. They diagnosed ?vaccine reaction?. The ER noted  "Nonspecific central and right lower quadrant mesenteric subcentimeter lymph nodes-presumably reactive and potentially reflecting mesenteric adenitis. Otherwise no acute abnormalities". He was in ER for 4.5 hours and was treated with morphine, ZOFRAN, and TORADOL which gave him enough relief for him to be released. He was released with a Naproxen prescription for pain. His symptoms as of 7/19/17 are eyes have been hurting and burning, plus he has been extremely fatigued. He has an appointment with an ophthalmologist to evaluate in a week.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram pelvis, Dizziness, Eye irritation, Eye pain
Clinical narrative: After the vaccine, patient said that his arm was hurting. The morning after, patient started feeling sick, chills, weak. He texted his mom from school. He reported nausea, severe headache, eye pain such that he didn't want to open his eyes, dizziness severe enough for him to need support to walk, weakness, and fatigue. A little after 2 pm on June 30th, he was evaluated in the ER. The abdominal pain he described as centering around his belly button, and feeling worse when he moved or took a deep breath. They noted there was no rash. They diagnosed ?vaccine reaction?. The ER noted  "Nonspecific central and right lower quadrant mesenteric subcentimeter lymph nodes-presumably reactive and potentially reflecting mesenteric adenitis. Otherwise no acute abnormalities". He was in ER for 4.5 hours and was treated with morphine, ZOFRAN, and TORADOL which gave him enough relief for him to be released. He was released with a Naproxen prescription for pain. His symptoms as of 7/19/17 are eyes have been hurting and burning, plus he has been extremely fatigued. He has an appointment with an ophthalmologist to evaluate in a week.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Headache, Lipase normal, Lymphadenitis, Lymphocyte percentage decreased
Clinical narrative: After the vaccine, patient said that his arm was hurting. The morning after, patient started feeling sick, chills, weak. He texted his mom from school. He reported nausea, severe headache, eye pain such that he didn't want to open his eyes, dizziness severe enough for him to need support to walk, weakness, and fatigue. A little after 2 pm on June 30th, he was evaluated in the ER. The abdominal pain he described as centering around his belly button, and feeling worse when he moved or took a deep breath. They noted there was no rash. They diagnosed ?vaccine reaction?. The ER noted  "Nonspecific central and right lower quadrant mesenteric subcentimeter lymph nodes-presumably reactive and potentially reflecting mesenteric adenitis. Otherwise no acute abnormalities". He was in ER for 4.5 hours and was treated with morphine, ZOFRAN, and TORADOL which gave him enough relief for him to be released. He was released with a Naproxen prescription for pain. His symptoms as of 7/19/17 are eyes have been hurting and burning, plus he has been extremely fatigued. He has an appointment with an ophthalmologist to evaluate in a week.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Malaise, Nausea, Neutrophil percentage increased, Pain in extremity, Walking aid user
Clinical narrative: After the vaccine, patient said that his arm was hurting. The morning after, patient started feeling sick, chills, weak. He texted his mom from school. He reported nausea, severe headache, eye pain such that he didn't want to open his eyes, dizziness severe enough for him to need support to walk, weakness, and fatigue. A little after 2 pm on June 30th, he was evaluated in the ER. The abdominal pain he described as centering around his belly button, and feeling worse when he moved or took a deep breath. They noted there was no rash. They diagnosed ?vaccine reaction?. The ER noted  "Nonspecific central and right lower quadrant mesenteric subcentimeter lymph nodes-presumably reactive and potentially reflecting mesenteric adenitis. Otherwise no acute abnormalities". He was in ER for 4.5 hours and was treated with morphine, ZOFRAN, and TORADOL which gave him enough relief for him to be released. He was released with a Naproxen prescription for pain. His symptoms as of 7/19/17 are eyes have been hurting and burning, plus he has been extremely fatigued. He has an appointment with an ophthalmologist to evaluate in a week.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Altered state of consciousness, Cold sweat, Eye movement disorder, Feeling abnormal, Nausea
Clinical narrative: 15 min S/P BEXSERO and PPD placement, while on toilet pt C/O nausea and feeling like she was going to pass out. Pt pale and eyes started to rolled back in head. Pt alert and oriented x 3. Helped into wheelchair. Pt then reported tingling. Clammy and reported "I just don't feel like I'm here". Noted rash on chest. (HX anxiety rash). This occurred in BR outside clinic office - 911 called and sent to ER for evaluation.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pallor, Paraesthesia, Rash
Clinical narrative: 15 min S/P BEXSERO and PPD placement, while on toilet pt C/O nausea and feeling like she was going to pass out. Pt pale and eyes started to rolled back in head. Pt alert and oriented x 3. Helped into wheelchair. Pt then reported tingling. Clammy and reported "I just don't feel like I'm here". Noted rash on chest. (HX anxiety rash). This occurred in BR outside clinic office - 911 called and sent to ER for evaluation.
Age: 26.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lip swelling
Clinical narrative: Redness, swelling, heat at site, upper lip swelling. Tx: ZYRTEC; ibuprofen; return as needed.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling of left upper arm around injection site, redness. Ice, diphenhydramine.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Injection site erythema, Injection site warmth, Lymphadenopathy, Mobility decreased
Clinical narrative: On 7/6/17 states several hrs after receiving the vaccine her left upper arm became "red, hot and size of a baseball'. Then she developed an enlarged lymph node left axilla which "went to the left breast". Was unable to elevate her arm above head for 2 days-was given antibiotic by a nurse pract.-had a "peach size" lump (L) axilla- as of 7/6/17 symptoms are improving with KEFLEX.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm got red and swelled and was warm. By the time they came in had gone down.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abnormal behaviour, Arthralgia, Asthenia, Diarrhoea, Dizziness
Clinical narrative: Tired. Headache. Muscle ache. Joint pain. Unusual behavior. Nausea. Diarrhea. Fast heartbeat. Dizziness. Weakness. Tired and fatigue for 2 days. Nausea and diarrhea for 7 days. Weakness and unusual behavior for 4 days. Fast heartbeat 2 days. Dizziness 2 days. Headache and muscle and joint 5 to 6 days.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fatigue, Headache, Heart rate increased, Myalgia, Nausea
Clinical narrative: Tired. Headache. Muscle ache. Joint pain. Unusual behavior. Nausea. Diarrhea. Fast heartbeat. Dizziness. Weakness. Tired and fatigue for 2 days. Nausea and diarrhea for 7 days. Weakness and unusual behavior for 4 days. Fast heartbeat 2 days. Dizziness 2 days. Headache and muscle and joint 5 to 6 days.
Age: 44.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Flushing, Paraesthesia oral, Pharyngeal oedema
Clinical narrative: Approximately 45m - 60m, throat swelling, tingling mouth and lips. Went to ER and treated with prednisone, BENADRYL, ZYRTEC and PEPCID. Next day, symptoms came back with flushing and repeated meds.
Age: 13.0
Sex: F
Vaccine: MENB
Symptoms: Local swelling, Tenderness
Clinical narrative: Mother stated daughter's deltoid was more swollen yesterday, today it is small and tender to touch. No other problems noted.
Age: 12.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Seizure
Clinical narrative: Seizure after both HPV vaccines.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt dizzy and with nausea after vaccines x 4.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Patient had red rash running down her arm starting after the injection. Arm was sore first day but afterwards. Vaccination was on 7/8/17, returned to store on 7/10/17. Patient was treated with lotion.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Noticed swelling around and beneath injection site approximately seven hours after receiving the vaccination. Attempted icing the area. Woke up the following morning with redness and warmth with continued swelling of left bicep extending down to elbow. Associated symptoms include mild discomfort at injection site and nausea.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased activity, Hypotonic-hyporesponsive episode, Pallor, Poor feeding infant
Clinical narrative: Within 5 min of vaccines pt was pale, decreased tone, poor feeding. Symptoms started to improve after approximately 10 hours. Event consistent with HHE.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Confusional state, Decreased appetite, Drooling, Fall, Fatigue
Clinical narrative: 3 days following vaccine injections, a mild rash developed on inner thighs and legs. Rash continued at different levels of severity for several days. On July 2, child was unable to walk without falling for much of the evening. Rash was still present. On July 4, the rash progressed to her entire body, appearing more patchy.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Gait inability, Head discomfort, Pyrexia, Rash, Rash generalised
Clinical narrative: 3 days following vaccine injections, a mild rash developed on inner thighs and legs. Rash continued at different levels of severity for several days. On July 2, child was unable to walk without falling for much of the evening. Rash was still present. On July 4, the rash progressed to her entire body, appearing more patchy.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Tremor, Vomiting
Clinical narrative: 3 days following vaccine injections, a mild rash developed on inner thighs and legs. Rash continued at different levels of severity for several days. On July 2, child was unable to walk without falling for much of the evening. Rash was still present. On July 4, the rash progressed to her entire body, appearing more patchy.
Age: 0.42
Sex: M
Vaccine: DTAP, IPV, PNC13, RV5
Symptoms: Appendicectomy, Eating disorder, Intussusception, Laparoscopic surgery, Pain
Clinical narrative: Vomiting-progressively worse, not eating, child seems to be in pain. Ended up in ER-laparoscopic converted to open reduction of Intussusception with appendectomy.
Age: 0.42
Sex: M
Vaccine: DTAP, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Vomiting-progressively worse, not eating, child seems to be in pain. Ended up in ER-laparoscopic converted to open reduction of Intussusception with appendectomy.
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site rash
Clinical narrative: Vaccinations administered 7/13. Mother reports rash began to thighs 7/17 and had spread significantly on 7/18.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given first ROTATEQ vaccine at 17 weeks 4 days.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: Patient was given MENACTRA and TRUMENBA at age 16, developed meningitis like sx. Received 2nd dose of TRUMENBA yesterday (7-18-17) experience same sx-with headache, body ache, nausea and vomiting.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Mouth swelling, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Patient was given MENACTRA and TRUMENBA at age 16, developed meningitis like sx. Received 2nd dose of TRUMENBA yesterday (7-18-17) experience same sx-with headache, body ache, nausea and vomiting.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Vomiting
Clinical narrative: Patient was given MENACTRA and TRUMENBA at age 16, developed meningitis like sx. Received 2nd dose of TRUMENBA yesterday (7-18-17) experience same sx-with headache, body ache, nausea and vomiting.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Patient received ZOSTAVAX 7/14/17. She reported having muscle pain starting 7/14 evening. She also had nausea and vomiting twice 7/15. She did had 1 drink 7/15. Her pain has eased after taking a pain pill.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and mild edema in the (R) thigh, no induration or fluctuance.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness at site vaccine (R) thigh and swelling. Mild tenderness 4x2.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient inadvertently received pediatric Hepatitis A (12mo-18years)(0.5ml), rather that adult Hepatitis A (>19yrs)(1.0ml). Will contact patient to return to clinic for full therapeutic dose of Hep A.
Age: 21.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patient unintentionally received pedi dose of Hepatitis A (0.5 ml) instead of greater than/equal to 19 yrs Hepatitis A (1.0 ml). Will contact pt to come back for full therapeutic dose of Hep A.
Age: 63.0
Sex: M
Vaccine: MMRV, VARZOS
Symptoms: Drug administered to patient of inappropriate age, Immunisation, No adverse event, Wrong drug administered
Clinical narrative: Administered MMRV by accident, should have had Zoster administered instead. Pt is out of age range not indicated for this vaccine. Pt was administered ZOSTAVAX directly after error was caught. No reaction indicated. Pt tolerated well.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash, Pyrexia, Vomiting
Clinical narrative: Infant with rash on both legs. Fever and vomiting within 12 hours of receiving vaccines. T max 102 degrees F.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood pressure immeasurable, Heart rate decreased, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Syncope - pale, unresponsive, blood pressure - unable to obtain, pulse dropped to 40, SpO2 at 100% room air.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Back pain, Hyperhidrosis, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of back pain in a 17-year-old female patient who received BEXSERO (batch number 156801A, expiry date 31st August 2017. Concomitant products included FLUZONE. On 20th September 2016, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 20th September 2016, less than a day after receiving BEXSERO, the patient experienced back pain, pain in arm and sweating. In September 2016, the outcome of the back pain, pain in arm and sweating were recovered/resolved. The reporter considered the back pain, pain in arm and sweating to be possibly related to BEXSERO. Additional details were provided as follows: On 20th September 2017, the patient received FLUZONE as a concomitant medication in right deltoid (batch number: UT5673KA, expiry date: 30th June 2017). The patient received BEXSERO in left deltoid and experienced severe back pain, sweating and arm pain. The events lasted for 24 hours.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site discolouration
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site discoloration in a 2-month-old female patient who received HIBERIX (batch number 4XD9P, expiry date 20th January 2018). Concomitant products included PEDIARIX, PREVNAR and ROTATEQ. On 14th July 2017, the patient received the 1st dose of HIBERIX (intramuscular) .5 ml. On 14th July 2017, immediately after receiving HIBERIX, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved. The reporter considered the injection site discoloration to be probably related to HIBERIX. Additional details were provided as follows: The case was reported by Medical assistants. The patient's birth weight was reported as 6 pound and 7 ounce. On 14th July 2017, the patient received PREVNAR, PEDIATRIX and ROTATEQ concomitantly. On the same day, a black dot appeared at the injection site immediately following vaccination with HIBERIX. It was reported that, several hours later, the black dot did not went away. The batch number reported for HIBERIX (4XDNP) did not exist and was updated to 4XD9P, as per sales database.