chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In approximately March 2016, the patients were vaccinated with improperly stored (reported as improperly exposed to 32.9 degrees Fahrenheit (F) for 1 hour on 24-MAR-2016) doses of GARDASIL 9 (lot # reported as K011562, expiration date 08-APR-2017, dose and route of administration were not provided). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with doses of oral ROTATEQ lot # L013193, expiration date 20-JAN-2017 (dose, route and site of administration were not reported). The vaccine was improperly stored in temperature 68.2F for 2 hours. No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 7 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-APR-2016, the patient was vaccinated with the first dose of ROTATEQ (orally, expiration date 23-OCT-2017, lot # reported as M004885; dose was not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with doses of LIQUID PEDVAXHIB lot # K008680, expiration date 11-MAR-2017 (dose, route and site of administration were not reported). The vaccine was improperly stored in temperature 68.2F for 2 hours. No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Petechiae, Vomiting
Clinical narrative: Information has been received from a registered nurse referring to a 13 year old female patient. There was no concurrent condition or medical history reported. On 24-MAR-2016 the patient was vaccinated with GARDASIL 9 (lot # L037339, expiration date 09-FEB-2018) (0.5 ml, strength and route unknown). Concomitant medication included an unnamed hepatitis A vaccine. The patient's mother contacted the health department, staring her daughter had diarrhea, was throwing up and had petechiae on both ankles in March 2016. The reporter stated the child had follow up visit scheduled with her primary care doctor on 28-MAR-2016 (today). The outcome of the events was reported as not recovered. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: MENB
Symptoms: Encephalitis, Pharyngitis streptococcal
Clinical narrative: This case was reported by a physician and described the occurrence of meningoencephalitis in a 11-year-old patient who received BEXSERO. The patient's past medical history included asplenia and spherocytosis. Concurrent medical conditions included headache. Concomitant products included FLUVIRIN. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced meningoencephalitis (serious criteria hospitalization and GSK medically significant) and streptococcal pharyngitis. On an unknown date, the outcome of the meningoencephalitis and streptococcal pharyngitis were unknown. It was unknown if the reporter considered the meningoencephalitis and streptococcal pharyngitis to be related to BEXSERO. Additional details were provided as follows: In July 2014, the patient had undergone splenectomy. The patient had headache prior to vaccination with BEXSERO. The patient experienced aseptic meningoencephalitis and Group A strep pharyngitis. The patient was receiving not any penicillin prophylaxis at the time of reporting. Follow up information was received on 6th April 2016: It was concluded that the symptoms experienced by the patient were very unlikely related to BEXSERO and that the patient should receive the 2nd dose of the vaccine.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a adult male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (dose, lot#, expiration date and route of administration were not reported). On an unknown date six weeks after the patient was vaccinated with the first dose of RECOMBIVAX HB, he received his second dose. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (R.N.) refers to a patient of unknown age. On 11-APR-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L026741, Exp: 18-MAY-2017) orally and RECOMBIVAX HB (lot # L044707, Exp: 16-OCT-2018). Both vaccines were stored under 52.5 degrees Fahrenheit for 1 hour 15 minutes. There was no previous temperature excursion. It was called because of a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse (R.N.) refers to a patient of unknown age. On 11-APR-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L026751, Exp: 18-MAY-2017) orally and RECOMBIVAX HB (lot # L044707, Exp: 16-OCT-2018). Both vaccines were stored under 52.5 degrees Fahrenheit for 1 hour 15 minutes. There was no previous temperature excursion. It was called because of a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse (R.N.) refers to a patient of unknown age. On 11-APR-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot # L026741, Exp: 18-MAY-2017) orally and RECOMBIVAX HB (lot # L044707, Exp: 16-OCT-2018). Both vaccines were stored under 52.5 degrees Fahrenheit for 1 hour 15 minutes. There was no previous temperature excursion. It was called because of a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain, Rash erythematous, Rash macular
Clinical narrative: Red, blotchy rash from elbow to shoulder. Extreme soreness.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm swelling, itching.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Diarrhoea, Measles, Pyrexia, Rash macular, Rash papular
Clinical narrative: Fever 101, erythematous macular papular rash on trunk, neck, face, and legs, diarrhea, clear discharge from nose, red enlarged tonsils. most likely attenuated measles. fever lasted 6 days rash lasted 8 days.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Rhinorrhoea, Tonsillar hypertrophy
Clinical narrative: Fever 101, erythematous macular papular rash on trunk, neck, face, and legs, diarrhea, clear discharge from nose, red enlarged tonsils. most likely attenuated measles. fever lasted 6 days rash lasted 8 days.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Measles post vaccine, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Fever 101, erythematous macular papular rash on trunk, neck, face, and legs, diarrhea, clear discharge from nose, red enlarged tonsils. most likely attenuated measles. fever lasted 6 days rash lasted 8 days.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Measles, Pyrexia, Rash
Clinical narrative: Fever 101, erythematous macular papular rash on trunk, neck, face, and legs, diarrhea, clear discharge from nose, red enlarged tonsils. most likely attenuated measles. fever lasted 6 days rash lasted 8 days.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Axillary pain, Blood creatine phosphokinase, CSF cell count, CSF culture, CSF glucose
Clinical narrative: HEADACHE, NAUSEA, VOMITING, PHOTOSENSITVITY AND BILATERAL LEG WEAKNESS, LEFT AXILLARY LYMPHADENOPATHY WITH ASSOCIATED PAIN.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: CSF protein, Full blood count, Gram stain, Headache, Laboratory test
Clinical narrative: HEADACHE, NAUSEA, VOMITING, PHOTOSENSITVITY AND BILATERAL LEG WEAKNESS, LEFT AXILLARY LYMPHADENOPATHY WITH ASSOCIATED PAIN.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Lipase, Lymphadenopathy, Muscular weakness, Nausea, Photosensitivity reaction
Clinical narrative: HEADACHE, NAUSEA, VOMITING, PHOTOSENSITVITY AND BILATERAL LEG WEAKNESS, LEFT AXILLARY LYMPHADENOPATHY WITH ASSOCIATED PAIN.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Urine analysis, Vomiting
Clinical narrative: HEADACHE, NAUSEA, VOMITING, PHOTOSENSITVITY AND BILATERAL LEG WEAKNESS, LEFT AXILLARY LYMPHADENOPATHY WITH ASSOCIATED PAIN.
Age: 1.25
Sex: M
Vaccine: DTAPH
Symptoms: Blister, Crying, Lethargy, Pyrexia, Rash
Clinical narrative: Small red bumps on face and body, warm to touch, lethargic on 4/11/16. By 4/12/16 fever, more bumps, some blistered, lethargic and crying. Made doctor appointment for 1300 on 4/12. Doctor said reaction to shot, Tylenol, Benadryl as needed. Did not appear to be able to commit to answer as to whether it was real or contagious chicken pox or just reaction. Did not appear to be able to answer whether I was at risk as a pregnant woman either.
Age: 1.25
Sex: M
Vaccine: DTAPH
Symptoms: Rash erythematous, Skin warm, Vaccination complication
Clinical narrative: Small red bumps on face and body, warm to touch, lethargic on 4/11/16. By 4/12/16 fever, more bumps, some blistered, lethargic and crying. Made doctor appointment for 1300 on 4/12. Doctor said reaction to shot, Tylenol, Benadryl as needed. Did not appear to be able to commit to answer as to whether it was real or contagious chicken pox or just reaction. Did not appear to be able to answer whether I was at risk as a pregnant woman either.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Eye movement disorder, Febrile convulsion, Pyrexia, Rash morbilliform, Somnolence
Clinical narrative: (Twin had fever/rash morbiliform 24 hours prior). Patient had fever over 102. Less than 3 minute episode of eyes rolling back in head rocking back and forth, then stared into space. Sleepy after then fine. Febrile seizure. 14/5/16.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Staring
Clinical narrative: (Twin had fever/rash morbiliform 24 hours prior). Patient had fever over 102. Less than 3 minute episode of eyes rolling back in head rocking back and forth, then stared into space. Sleepy after then fine. Febrile seizure. 14/5/16.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature, Injection site pain, Malaise, Pain
Clinical narrative: Day after injection-malaise, low temp, arm soreness extending to elbow from inj. site, body aches for 3 days. All symptoms resolved 4 days post administration.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: 3 x 3 rash at site of injection - no heat, slight itchy - recommended to keep covered and contact MD if it continues to spread or gets painful - Followed up on 4/4/16 - rash resolving "patient feels better".
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Bright red gold ball size lump on left arm at injection site developed 24 hrs after injection - no heat from site. Recommended apply ice pack and watch - Followed up on 4/4/16: Lump resolving "going away".
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Blister, Erythema, Exfoliative rash, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself. A 78-year-old male patient received PREVNAR 13 (expiry date 01Feb2017, NDC # 0005-1971-01) intramuscular, in right arm, on 11Sep2015, at 0.5 ml single. Medical history included memory impairment and low density lipoprotein (LDL). Concomitant medications included ongoing omeprazole tablets started years before, 20 mg, 1x/day, for heartburn, ongoing vitamin E started years before, ongoing vitamin D started years before (no use in winter when very little sun), ongoing multivitamins, ongoing glucosamine, started years before, ongoing calcium, started years before, ongoing magnesium, started years before, ongoing zinc, started years before, ongoing vitamin C 1000 mg, started years before, ongoing ginkgo biloba to remember stuff, started years before, ongoing niacin to help with LDL, started 5 years before and ongoing krill oil, started years before. Two weeks after the vaccination, the patient experienced rash with outcome of not recovered, hives with outcome of not recovered, blisters with outcome of not recovered, really tired-weak with outcome of not recovered, redness with outcome of unknown, all on an unspecified date in 2015. The rash became red, turned scaly and blisters appeared. Some have gone away but he has 50-100 of them and they keep coming. He had talked to his doctor to ask what he could do and the HCP did not have a solution. He also had gone to a dermatologist for another reason and had shown the symptoms but did not get a solution either. Events 'rash' and 'really tired-weak' required hospitalization and did not require a treatment. Hives, blisters did not require hospitalization. Follow up (07Apr2016): New information from the same contactable consumer includes: vaccine expiry date and NDC number, route of vaccination, updated vaccination date, concomitant drug details, event 'rash' and 'really tired-weak' updated to serious, events clinical course details. Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself. A 78-year-old male patient received PREVNAR 13 (expiry date 01Feb2017, NDC # 0005-1971-01) intramuscular, in right arm, on 11Sep2015, at 0.5 ml single. Medical history included memory impairment and low density lipoprotein (LDL). Concomitant medications included ongoing omeprazole tablets started years before, 20 mg, 1x/day, for heartburn, ongoing vitamin E started years before, ongoing vitamin D started years before (no use in winter when very little sun), ongoing multivitamins, ongoing glucosamine, started years before, ongoing calcium, started years before, ongoing magnesium, started years before, ongoing zinc, started years before, ongoing vitamin C 1000 mg, started years before, ongoing ginkgo biloba to remember stuff, started years before, ongoing niacin to help with LDL, started 5 years before and ongoing krill oil, started years before. Two weeks after the vaccination, the patient experienced rash with outcome of not recovered, hives with outcome of not recovered, blisters with outcome of not recovered, really tired-weak with outcome of not recovered, redness with outcome of unknown, all on an unspecified date in 2015. The rash became red, turned scaly and blisters appeared. Some have gone away but he has 50-100 of them and they keep coming. He had talked to his doctor to ask what he could do and the HCP did not have a solution. He also had gone to a dermatologist for another reason and had shown the symptoms but did not get a solution either. Events 'rash' and 'really tired-weak' required hospitalization and did not require a treatment. Hives, blisters did not require hospitalization. Follow up (07Apr2016): New information from the same contactable consumer includes: vaccine expiry date and NDC number, route of vaccination, updated vaccination date, concomitant drug details, event 'rash' and 'really tired-weak' updated to serious, events clinical course details. Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Patient got a PNEUMOVAX 23 vaccine in the left arm on 4/2/16. He experienced redness/swelling around injection site. The inflammation improved after a few days.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Fatigue, Nausea, Pain, Skin warm
Clinical narrative: Onset 6-8 hrs after MMR vaccine: dizziness, body aches, N/V, fatigue - ? fever, "felt warm" (did not take temp). Symptoms above lasted 24 hrs. Denied local skin reaction.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Onset 6-8 hrs after MMR vaccine: dizziness, body aches, N/V, fatigue - ? fever, "felt warm" (did not take temp). Symptoms above lasted 24 hrs. Denied local skin reaction.
Age: 53.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Blistered, red rash at sight of injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site pain
Clinical narrative: Pt received shingles vaccine on 4/1/16 in the clinic. That day she developed small blister type rash to both hands and forearms. She also had some soreness around the injection site.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure decreased, Cardiac failure congestive, Chills, Intensive care, Pneumonia
Clinical narrative: 4 to 5 hrs following vaccine injection, patient developed severe chills, B.P. plummeted, temp. spiked to 104 degrees - 105 degrees. Emerg. transport to E.R. Once stabilized was admitted to CCU. Suffered a set back. Treated for septic shock, Congestive Heart Failure, pneumonia, etc. Hospital 13 days - P.T. 9 days.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Septic shock
Clinical narrative: 4 to 5 hrs following vaccine injection, patient developed severe chills, B.P. plummeted, temp. spiked to 104 degrees - 105 degrees. Emerg. transport to E.R. Once stabilized was admitted to CCU. Suffered a set back. Treated for septic shock, Congestive Heart Failure, pneumonia, etc. Hospital 13 days - P.T. 9 days.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Viral titre
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was also a pharmacist and was reporting on herself. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patient was vaccinated with two (also reported as previous) doses of (Oka/Merck) VARIVAX injection (strength, route and site of administration, dose, lot number and expiration date were not reported) as routine vaccination. On an unknown date (reported as recent), the patient had titer testing performed, which was required for employment purposes and showed "borderline immunity" to varicella (exact results of titer testing were not reported). Product quality complaint was not involved. The outcome of "borderline immunity" to varicella and the relatedness between this event and (Oka/Merck) VARIVAX were not reported. Additional information has been requested.
Sex: M
Vaccine: PNC13
Symptoms: Polymyalgia rheumatica
Clinical narrative: This is a spontaneous report from a contactable consumer (Pfizer Colleague). A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unknown date in 2015 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced polymyalgia rheumatic in Jul2015 with outcome of unknown. The patient had had a PREVNAR 13 shot 4-5 days before the polymyalgia rheumatic symptoms occurred.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to four unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, the patients were vaccinated orally with an improperly stored doses of RATATEQ lot # L013192, expiry date 19-JAN-2017 or lot # reported as L035511, expiry date 21-MAY-2017 (dose was not specified). Administered doses of ROTATEQ underwent temperature excursion at 49.6 Fahrenheit degrees for three hours. There was no previous temperature excursion. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: MMR
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: Fever, headache, sore throat 04-02-16 rash late on 4/3/16.
Age: 1.27
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Conjunctivitis, Cough, Diarrhoea, Measles, Pyrexia
Clinical narrative: Measles rash, high fever 104, pink eye, cough, diarrhea, runny nose.
Age: 1.27
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rhinorrhoea
Clinical narrative: Measles rash, high fever 104, pink eye, cough, diarrhea, runny nose.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Pt reports since receiving vaccine area first pruritic, then pruritic rash (no redness/bumps) developed on face, ear, neck and back that spread. No redness nor swelling.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: The morning following the vaccination, the patient stated the injection site itched and a welt developed under the skin. By Monday April 11, 2016, the patient stated the welt was already beginning to disappear and itching had stopped.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Dizziness, Injection site pain, Injection site urticaria
Clinical narrative: Pt reports day after receiving vaccine she had joint pain, dizziness, pain at injection site.  No fever, but did have chills.  Hives on arm at site of injection.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: 10 min after vaccines administered child broke out in hives on the left arm and chest. Itchy. 25mg BENADRYL given.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 31-MAR-2016, the patient was vaccinated with a dose of MMR II (lot # 1032181 and expiry date 25-AUG-2017) and a dose of (Oka-Merck) PROQUAD (lot # 1047307 and expiry date 23-MAY-2017). No adverse events were reported. No further information was available. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored ZOSTAVAX (which had the lot number of L039095, expiration date 08-JAN-2017) (strength, dose and route were not provided). Concomitant medication was not reported. It was stated that the no adverse effects were reported and the temperature excursion was 46 F, for the time frame of 79.5 hours. Additionally, there were no previous temperature excursion and data logger was not involved. Furthermore, no product quality complaint was reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Lymph node pain, Lymphadenopathy, Muscle tightness
Clinical narrative: Tenderness around injection site and "tightness" soreness of the muscles in that whole area - anterior chest wall/supraclavicular area/trapezius to the neck/midline. Extremely swollen and tender lymph node at supraclavicular area.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site reaction, Lymph node pain, Lymphadenopathy, Mucosal dryness
Clinical narrative: Tenderness around injection site and "tightness" soreness of the muscles in that whole area - anterior chest wall/supraclavicular area/trapezius to the neck/midline. Extremely swollen and tender lymph node at supraclavicular area.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle tightness
Clinical narrative: Tenderness around injection site and "tightness" soreness of the muscles in that whole area - anterior chest wall/supraclavicular area/trapezius to the neck/midline. Extremely swollen and tender lymph node at supraclavicular area.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site erythema, Nausea
Clinical narrative: Patient briefly felt dizzy and nauseous after the vaccine and developed a red quarter dollar sized red spot at injection site.
Age: 1.4
Sex: F
Vaccine: DTAP, FLU4, HIBV
Symptoms: Erythema, Pallor, Skin lesion, Urticaria
Clinical narrative: 1 mm blanchable erythematous lesions diffusely scattered on torso, legs, arms and face, sparing the palms and soles. Large wheal of 10 cm in width and 15 cm in length noted on the ant. aspect of the R thigh that during visit is dynamic in intensity of erythema. Benadryl dose of 4 mlo every 6 hrs to 12 hrs.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Chest X-ray abnormal, Chills, Cough, Middle insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration on left arm on 26Jun2015 at 0.5 ml single dose. Medical history included cholesterol, diagnosed years ago and ongoing, asthma diagnosed 10 years ago and ongoing, blood pressure diagnosed in 1994-1995 (her blood pressure issues began because of the reflex sympathetic dystrophy diagnosed in 1994 or 1995) and ongoing, breast cancer diagnosed 20 years ago on right side, cardiac disorder, abdominal discomfort, ongoing calcium deficiency and ongoing gastric disorder. She received for immunization unspecified pneumococcal vaccine in 2005 and in 2010 and unspecified Influenza vaccine on an unknown date and did not have a problem. Concomitant medication included SPIRIVA 18 ug once a day in the morning since 2006 for asthma, FLOVENT at 220 mg since 2006 for asthma, ZETIA 10 mg, 1x/day since 2012 for cholesterol, Aspirin 325 once a day since 1998 for good heart, fish oil 1200 mg since 2014, 2x/day, Vitamin D 1000 mg 2x/day since 2010, famotidine 10 mg, 1x/day since 2014 for stomach; verapamil, 180 mg, 2x/day since 1997 for blood pressure, TUMS 1000 mg, 2x/day since 2000 for calcium deficiency, all ongoing. The patient experienced pneumonia in both lungs on 07Oct2015, coughing, the cough wakes her up during the night and chills, clear mucus on 15Oct2015 all with outcome of not recovered. The patient was hospitalized for pneumonia, cough and sleep disorder from an unspecified date in Oct 2015 (07Oct2015 or 09Oct2015) to 15Oct2015. While in the hospital, she received IV antibiotics, steroids, breathing treatments cough drops and a shot for blood clots. She also had to take insulin because blood sugar went up at least 3 times because of steroids. The patient underwent chest X-ray in Oct2015 which revealed pneumonia in both lungs and a sputum culture on an unknown date which revealed "Type of pneumonia from PREVNAR 13". Chest x-ray in Nov2015 was clear. The patient subsequently received unspecified allergy shots at the doctor's office. Follow-up (04Mar2016): New information from the same contactable consumer includes: lab data, vaccine history and vaccinations received after events onset. Follow-up (06Apr2016): New information from the same contactable consumer includes: onset date of the events and hospitalization dates modified; start date of concomitant medications.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Pneumonia pneumococcal, Secretion discharge, Sleep disorder, Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration on left arm on 26Jun2015 at 0.5 ml single dose. Medical history included cholesterol, diagnosed years ago and ongoing, asthma diagnosed 10 years ago and ongoing, blood pressure diagnosed in 1994-1995 (her blood pressure issues began because of the reflex sympathetic dystrophy diagnosed in 1994 or 1995) and ongoing, breast cancer diagnosed 20 years ago on right side, cardiac disorder, abdominal discomfort, ongoing calcium deficiency and ongoing gastric disorder. She received for immunization unspecified pneumococcal vaccine in 2005 and in 2010 and unspecified Influenza vaccine on an unknown date and did not have a problem. Concomitant medication included SPIRIVA 18 ug once a day in the morning since 2006 for asthma, FLOVENT at 220 mg since 2006 for asthma, ZETIA 10 mg, 1x/day since 2012 for cholesterol, Aspirin 325 once a day since 1998 for good heart, fish oil 1200 mg since 2014, 2x/day, Vitamin D 1000 mg 2x/day since 2010, famotidine 10 mg, 1x/day since 2014 for stomach; verapamil, 180 mg, 2x/day since 1997 for blood pressure, TUMS 1000 mg, 2x/day since 2000 for calcium deficiency, all ongoing. The patient experienced pneumonia in both lungs on 07Oct2015, coughing, the cough wakes her up during the night and chills, clear mucus on 15Oct2015 all with outcome of not recovered. The patient was hospitalized for pneumonia, cough and sleep disorder from an unspecified date in Oct 2015 (07Oct2015 or 09Oct2015) to 15Oct2015. While in the hospital, she received IV antibiotics, steroids, breathing treatments cough drops and a shot for blood clots. She also had to take insulin because blood sugar went up at least 3 times because of steroids. The patient underwent chest X-ray in Oct2015 which revealed pneumonia in both lungs and a sputum culture on an unknown date which revealed "Type of pneumonia from PREVNAR 13". Chest x-ray in Nov2015 was clear. The patient subsequently received unspecified allergy shots at the doctor's office. Follow-up (04Mar2016): New information from the same contactable consumer includes: lab data, vaccine history and vaccinations received after events onset. Follow-up (06Apr2016): New information from the same contactable consumer includes: onset date of the events and hospitalization dates modified; start date of concomitant medications.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. Approximately in 2016 (reported as from 24-MAR-2016 to 01-APR-2016) multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L043213, expiry: 28-AUG-2017 (dosing details and route of administration were not reported). The patients sought medical attention. It was reported that the vaccines were exposed to maximum temperature of 9.9C and minimum temperature of 0.8C during at time frame of 2 hours. No previous temperature excursion was reported. No adverse effect was reported. There were no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. Approximately in 2016 (reported as from 24-MAR-2016 to 01-APR-2016) multiple unspecified patients were vaccinated with improperly stored LIQUID PEDVAXHIB lot # L042257, expiry: 17-AUG-2018 (dosing details and route of administration were not reported). The patients sought medical attention. It was reported that the vaccines were exposed to maximum temperature of 9.9C and minimum temperature of 0.8C during a time frame of 2 hours. No previous temperature excursion was reported. No adverse effect was reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding their medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 30-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # L046506, expiry date: 17-MAY-2017. Nurse reported a temperature excursion for the following products: (Oka-Merck) PROQUAD (lot # L046506, expiry date: 17-MAY-2017) and (Oka/Merck) VARIVAX (Lot # L041207, expiry date: 20-OCT-2017), however only (Oka-Merck) PROQUAD was administered. The vaccine underwent a temperature excursion of -13 degree Celsius for 6 hours. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding their medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (lot # L046506, expiry date: 17-MAY-2017). Nurse reported a temperature excursion for the following products: (Oka-Merck) PROQUAD (lot # L046506, expiry date: 17-MAY-2017) and (Oka/Merck) VARIVAX (Lot # L041207, expiration date: 20-OCT-2017), however only (Oka-Merck) PROQUAD was administered. The vaccine underwent a temperature excursion of -13 degree Celsius for 6 hours. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Lethargy
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of lethargy in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced lethargy, tiredness and injection site pain. On an unknown date, the outcome of the lethargy, tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the lethargy, tiredness and injection site pain to be related to BEXSERO. Additional details were received as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days. After two days the symptoms resolved. Office manager then mentioned that another patient (see case US2016GSK049200) who received BEXSERO and experienced a softball-like swelling at the injection site. Also mentioned about some other patients (see case US2016GSK049201) who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days, then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.
Age: 0.3
Sex: F
Vaccine: RV1
Symptoms: Oral administration complication, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received ROTARIX. On 4th April 2016, the patient received the 2nd dose of ROTARIX (oral). On 4th April 2016, less than a day after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details provided were as follows: After vaccination the patient spitted out the dose. The reporter did not have the lot number and the expiration date. No other adverse event was reported.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 55-year-old male patient who received ENGERIX B adult (batch number 24JP3, expiry date 10th July 2017). On 2nd April 2016, the patient received ENGERIX B adult 1 ml. On 2nd April 2016, less than a day after receiving ENGERIX B adult, the patient experienced fever. The patient was treated with ADVIL. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to ENGERIX B adult. Additional details provided were as follows: The patient had a mild fever and was not recovered till the time of reporting. No further information was provided.
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to BEXSERO. Additional details were received as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days (see case US2016046410). Office manager then mentioned that another patient concerned in this case who received also BEXSERO and experienced a softball-like swelling at the injection site. Also mentioned about some other patients (see case US2016GSK049201) who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days, then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: 4/13/16 has a 6x8 annular local reaction at the injection site of the left deltoid. There is evident erythema, edema and warmth at the site. Pt. to take BENADRYL and ranitidine therapy as prescribed.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Local erythema only 18x19 cm cold compress.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dyskinesia, Muscle spasms, Pyrexia
Clinical narrative: Fever, Involuntary movements in lower extremities and spasming of the whole body.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Injection site pain, Injection site swelling, Mobility decreased, Pain
Clinical narrative: I have a painful swollen arm where injected... which I am used to. However, I woke up yesterday with fever of 100.1, fatigue to the point where I stayed in bed all day and aches everywhere. (Taken straight from the patient's message to us on 04/08/2016).
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: I have a painful swollen arm where injected... which I am used to. However, I woke up yesterday with fever of 100.1, fatigue to the point where I stayed in bed all day and aches everywhere. (Taken straight from the patient's message to us on 04/08/2016).
Age: 41.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Headache, Musculoskeletal stiffness, Photophobia
Clinical narrative: Client awoke 4/11 w/ severe headache and light sensitivity. Took Advil, over course of the day her headache subsided. She did not take her temperature, doesn't know if she had a fever. On 4/12/16 she c/o stiff neck. She did not contact her doctor, she called the health dept. Health Dept. MD called client and advised ER visit within 1 to 2 days.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Pt had severe diarrhea for 2 weeks with abd. discomfort.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Parkinson's disease, Tremor
Clinical narrative: Body tremors:  first in left side shoulder then traveled to right side and whole body. Noticed reaction day after shot around 10am, contacted primary around noon who said if tremors continued, take him to ER. Brought him to the ER by 4pm and stayed to 7pm. ER diagnosed as Parkinson's due to tremors; prescribed carbidopa-levodopa 25, which we administered and by the next day, the tremors subsided.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Initial soreness and redness and swelling at site: site located on left arm near the front of the arm. This continued for several weeks then whole arm and shoulder, and other areas on same side of body became sore, extremely painful, and unable to move properly or without constant pain.
Age: 75.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deafness unilateral
Clinical narrative: Hearing loss in left ear. Has gone through treatment with cortisone injections but not effective.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: PATIENT SAID HER ARM START GETTING RED AND SWOLLEN.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: LUE, head and neck itching progressing to entire upper torso.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Blood test normal, Computerised tomogram normal, Crying, Cyanosis, Dyspnoea
Clinical narrative: She had been in her crib sleeping. Heard a cry from her room around 9 am. Entered her room to find her on her stomach in the crib, wide eyed, convulsing, blue in the face and gasping for air. Removed her from crib and convulsions ceased, still unresponsive, tight muscles, turned darker shade in the face and was still gasping. Shortly after went completely limp, no sign of life. Performed CPR and was able to get her breathing again. Went to the ER where blood tests and CT scan came back clear. Was told she had suffered a Grand Mal seizure. EEG several days later came back normal. Started noticing Myoclonics. Had another Grand Mal April 6 around noon, lasted around a minute. Had 2 more Grand Mals April 7. First around 10 seconds at 5am and the second lasted over 2 min around 6 pm. Drastic increase in Myoclonics after the Grand Mals. Was diagnosed as Epileptic and has since started anti convulsion medication. Myoclonics and possible absence seizures are still recurring.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Electroencephalogram normal, Epilepsy, Generalised tonic-clonic seizure, Hypotonia, Muscle tightness
Clinical narrative: She had been in her crib sleeping. Heard a cry from her room around 9 am. Entered her room to find her on her stomach in the crib, wide eyed, convulsing, blue in the face and gasping for air. Removed her from crib and convulsions ceased, still unresponsive, tight muscles, turned darker shade in the face and was still gasping. Shortly after went completely limp, no sign of life. Performed CPR and was able to get her breathing again. Went to the ER where blood tests and CT scan came back clear. Was told she had suffered a Grand Mal seizure. EEG several days later came back normal. Started noticing Myoclonics. Had another Grand Mal April 6 around noon, lasted around a minute. Had 2 more Grand Mals April 7. First around 10 seconds at 5am and the second lasted over 2 min around 6 pm. Drastic increase in Myoclonics after the Grand Mals. Was diagnosed as Epileptic and has since started anti convulsion medication. Myoclonics and possible absence seizures are still recurring.
Age: 1.08
Sex: F
Vaccine: FLU3, HEPA, MMR, PNC13
Symptoms: Myoclonus, Resuscitation, Seizure, Skin discolouration, Unresponsive to stimuli
Clinical narrative: She had been in her crib sleeping. Heard a cry from her room around 9 am. Entered her room to find her on her stomach in the crib, wide eyed, convulsing, blue in the face and gasping for air. Removed her from crib and convulsions ceased, still unresponsive, tight muscles, turned darker shade in the face and was still gasping. Shortly after went completely limp, no sign of life. Performed CPR and was able to get her breathing again. Went to the ER where blood tests and CT scan came back clear. Was told she had suffered a Grand Mal seizure. EEG several days later came back normal. Started noticing Myoclonics. Had another Grand Mal April 6 around noon, lasted around a minute. Had 2 more Grand Mals April 7. First around 10 seconds at 5am and the second lasted over 2 min around 6 pm. Drastic increase in Myoclonics after the Grand Mals. Was diagnosed as Epileptic and has since started anti convulsion medication. Myoclonics and possible absence seizures are still recurring.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: <6 hrs after vaccination, (B) ankle pain approximately 10 hrs after vaccination, fever to 102 degrees, myalgias, arthralgias, abd. pain, diarrhea; pain at vaccination site. Symptoms largely resolved by 18 hrs after vaccination.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Vaccination site pain
Clinical narrative: <6 hrs after vaccination, (B) ankle pain approximately 10 hrs after vaccination, fever to 102 degrees, myalgias, arthralgias, abd. pain, diarrhea; pain at vaccination site. Symptoms largely resolved by 18 hrs after vaccination.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: Low grade fever of 100 occurred at 3:00 pm on 4/11/16. Child went to sleep fine.  Next morning no fever (4/12/16) however by 3:00 pm low grade fever once again.  Went to bed at 8 pm and woke at 11 pm with a temp of 105.  Administered infant Motrin, temp went to normal after an hour but went back up to 105 in three hours.  Day 3, 4/13/16, temp of 103 sustained throughout the day.  No rash yet.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Tonic clonic movements, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Body stiffened, sl TC movements, unresponsive, urinated in pants, episode lasted about 20 sec.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Leg is red, swollen and itchy. Benedryl recommended.