chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Feeling hot, Rash
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program [IBCC (Inbound Call Center for HCPs)]. A contactable nurse reported that a 85 year-old female patient received, on 19Jun2017 around 10 am, the first dose of PREVENAR 13 (lot S06823, expiry date May2018, NDC number: 0005197102) intramuscularly, in the right arm, at 0.5 ml, single, for immunization. Relevant medical history included diabetes (ongoing). Concomitant medications included oral atenolol, Tablet, 50 mg, twice daily, from an unspecified date, in Nov2016 (ongoing), for blood pressure; vitamin b complex (Tablet) 1 DF, daily, from an unspecified date, in Jun2014 (ongoing); FLONASE (Nasal spray, solution) 50 mcg, two spray each nostril daily, from an unspecified date, in Jun2014 (ongoing); hydrochlorothiazide / losartan potassium 12.5 mg/50 mg, one tablet daily, from an unspecified date, in Aug2016 (ongoing); metformin hydrochloride 500 mg, daily from an unspecified date, in Apr2017 (ongoing), for diabetes; oral nifedipine Tablet, 600 mg, daily from an unspecified date, in Feb2016 (ongoing), oral simvastatin Tablet, 20 mg, daily from an unspecified date, in Jun2015 (ongoing); oral vitamin D nos, capsule, 50000 one weekly om an unspecified date, in Apr2017 (ongoing); and nystatin cream 100,000 per 0.1 unit cream, from an unspecified date, in Jun2014 (ongoing). On 19Jun2017, about 5 to 10 minutes after receiving the vaccine, the patient's right arm swelled up. No medical treatment provided for adverse event and no hospitalization was required. The patient did not recover from the adverse event at time of this report.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of an unspecified age, gender and race received PREVNAR 13 at single dose on unknown date for immunization. Medical history and concomitant medications were unknown. On unknown date the patient experienced rash for 5 days post vaccination. The outcome of the event was unknown.
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 16-year-old patient of unspecified race/ethnicity and gender received the first dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received 1 dose of TRUMENBA at age 16 and does not come back for 12 months.
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported different events for two patients. This is the 2nd of 2 reports. A female patient of an unspecified age and race/ethnicity received TRUMENBA (NDC# 0005-0100-01), via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a 102 fever on an unspecified date with outcome of unknown.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dermatitis, Dermatitis diaper, Eczema, Enterococcus test positive, Full blood count normal
Clinical narrative: 5 mo old with generalized exanthem about 21 days after vaccine receipt with affected site initially to his face, and progressed over several days to include torso, all extremities, scalp, neck and back. The flexor sites were more exacerbated. The dermatitis was characterized by pruritic fine papules, followed by macules, and scaling. No fever, malaise, and continued usual activity, eating and drinking. He had fever and emesis on day 44 and was treated for scarlet fever, strep was negative. Exanthem continued to evolve with peak at 46 days post vaccine receipt. . Derm consult differential eczema, Id reaction, viral exanthem and less likely psoriasis. Final Dx at follow up most likely viral exanthema vs. new onset eczema.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Macule, Papule, Pyrexia, Rash generalised, Rash pruritic
Clinical narrative: 5 mo old with generalized exanthem about 21 days after vaccine receipt with affected site initially to his face, and progressed over several days to include torso, all extremities, scalp, neck and back. The flexor sites were more exacerbated. The dermatitis was characterized by pruritic fine papules, followed by macules, and scaling. No fever, malaise, and continued usual activity, eating and drinking. He had fever and emesis on day 44 and was treated for scarlet fever, strep was negative. Exanthem continued to evolve with peak at 46 days post vaccine receipt. . Derm consult differential eczema, Id reaction, viral exanthem and less likely psoriasis. Final Dx at follow up most likely viral exanthema vs. new onset eczema.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Scarlet fever, Skin exfoliation, Streptococcus test negative, Viral rash, Vomiting
Clinical narrative: 5 mo old with generalized exanthem about 21 days after vaccine receipt with affected site initially to his face, and progressed over several days to include torso, all extremities, scalp, neck and back. The flexor sites were more exacerbated. The dermatitis was characterized by pruritic fine papules, followed by macules, and scaling. No fever, malaise, and continued usual activity, eating and drinking. He had fever and emesis on day 44 and was treated for scarlet fever, strep was negative. Exanthem continued to evolve with peak at 46 days post vaccine receipt. . Derm consult differential eczema, Id reaction, viral exanthem and less likely psoriasis. Final Dx at follow up most likely viral exanthema vs. new onset eczema.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Activated partial thromboplastin time shortened, Blood urine present, Diarrhoea, Ecchymosis, Haematocrit normal
Clinical narrative: The patient is a healthy 13 mo old female with a history of eczema who received hep A #1, PREVNAR #4, MMR and varicella vaccine on 18 May 2017 and developed HSP with onset day 11. She initially did fine post vaccine but developed 101.8 fever on day 8 and was treated with TYLENOL. She developed EM like targetoid lesions to extremities followed on day 12 by edema ankles, then edema to face, wrist and lesions to face, extremities, trunk and buttocks. Lesions were macular, raised, fixed, blanching, and on thighs mildly pruritic although that is an eczema site. The buttock lesions progressed to ecchymotic and has scattered purpura. She is doing well and improving. She has had three episodes of watery diarrhea 01 and 02 JUN 2017, but otherwise eating OK, at most slightly decreased. She is more clingy but no other more specific evidence of systemic symptoms such as myalgias, arthralgias, nausea, no emesis, no change in urine, no evidence of pain, no increased sleep or fatigue. Family reports no immediate adverse event after receipt suggestive of IgE such as oral/facial/throat or tongue swelling. No local site reaction. Other than noted above, no systemic symptoms. No other illness symptoms. She was treated with BENADRYL and hydrocortisone cream. Dermatology diagnosed Henoch-Schonlein Purpura Vasculitis.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Haemoglobin normal, Henoch-Schonlein purpura, International normalised ratio normal, Lymphocyte percentage increased, Mycoplasma test negative
Clinical narrative: The patient is a healthy 13 mo old female with a history of eczema who received hep A #1, PREVNAR #4, MMR and varicella vaccine on 18 May 2017 and developed HSP with onset day 11. She initially did fine post vaccine but developed 101.8 fever on day 8 and was treated with TYLENOL. She developed EM like targetoid lesions to extremities followed on day 12 by edema ankles, then edema to face, wrist and lesions to face, extremities, trunk and buttocks. Lesions were macular, raised, fixed, blanching, and on thighs mildly pruritic although that is an eczema site. The buttock lesions progressed to ecchymotic and has scattered purpura. She is doing well and improving. She has had three episodes of watery diarrhea 01 and 02 JUN 2017, but otherwise eating OK, at most slightly decreased. She is more clingy but no other more specific evidence of systemic symptoms such as myalgias, arthralgias, nausea, no emesis, no change in urine, no evidence of pain, no increased sleep or fatigue. Family reports no immediate adverse event after receipt suggestive of IgE such as oral/facial/throat or tongue swelling. No local site reaction. Other than noted above, no systemic symptoms. No other illness symptoms. She was treated with BENADRYL and hydrocortisone cream. Dermatology diagnosed Henoch-Schonlein Purpura Vasculitis.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Oedema peripheral, Pallor, Prothrombin time prolonged, Pruritus, Purpura
Clinical narrative: The patient is a healthy 13 mo old female with a history of eczema who received hep A #1, PREVNAR #4, MMR and varicella vaccine on 18 May 2017 and developed HSP with onset day 11. She initially did fine post vaccine but developed 101.8 fever on day 8 and was treated with TYLENOL. She developed EM like targetoid lesions to extremities followed on day 12 by edema ankles, then edema to face, wrist and lesions to face, extremities, trunk and buttocks. Lesions were macular, raised, fixed, blanching, and on thighs mildly pruritic although that is an eczema site. The buttock lesions progressed to ecchymotic and has scattered purpura. She is doing well and improving. She has had three episodes of watery diarrhea 01 and 02 JUN 2017, but otherwise eating OK, at most slightly decreased. She is more clingy but no other more specific evidence of systemic symptoms such as myalgias, arthralgias, nausea, no emesis, no change in urine, no evidence of pain, no increased sleep or fatigue. Family reports no immediate adverse event after receipt suggestive of IgE such as oral/facial/throat or tongue swelling. No local site reaction. Other than noted above, no systemic symptoms. No other illness symptoms. She was treated with BENADRYL and hydrocortisone cream. Dermatology diagnosed Henoch-Schonlein Purpura Vasculitis.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash macular, Skin lesion, Streptococcus test negative, Vasculitis, White blood cell count normal
Clinical narrative: The patient is a healthy 13 mo old female with a history of eczema who received hep A #1, PREVNAR #4, MMR and varicella vaccine on 18 May 2017 and developed HSP with onset day 11. She initially did fine post vaccine but developed 101.8 fever on day 8 and was treated with TYLENOL. She developed EM like targetoid lesions to extremities followed on day 12 by edema ankles, then edema to face, wrist and lesions to face, extremities, trunk and buttocks. Lesions were macular, raised, fixed, blanching, and on thighs mildly pruritic although that is an eczema site. The buttock lesions progressed to ecchymotic and has scattered purpura. She is doing well and improving. She has had three episodes of watery diarrhea 01 and 02 JUN 2017, but otherwise eating OK, at most slightly decreased. She is more clingy but no other more specific evidence of systemic symptoms such as myalgias, arthralgias, nausea, no emesis, no change in urine, no evidence of pain, no increased sleep or fatigue. Family reports no immediate adverse event after receipt suggestive of IgE such as oral/facial/throat or tongue swelling. No local site reaction. Other than noted above, no systemic symptoms. No other illness symptoms. She was treated with BENADRYL and hydrocortisone cream. Dermatology diagnosed Henoch-Schonlein Purpura Vasculitis.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Laboratory test, Petechiae
Clinical narrative: ITP-petechiae, 7 day after receiving vaccine IVIG infusion, large doses of prednisone for 6 months. Weekly lab draws.
Age: 76.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Allergy test
Clinical narrative: Allergy status to serum and vaccine status on 2017-06-23.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-06-23.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Crying, Gastrooesophageal reflux disease, Irritability, Milk allergy, Pyrexia
Clinical narrative: Fever, extremely fussy, cryed constantly of & on & he never did that. Reflux started bad after his vaccines & he now has a dairy allergy he did not have before.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation
Clinical narrative: Cellulitis like redness and inflammation in injection and surrounding areas.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Skin rash and redness large surface area in back of left arm.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Skin rash and redness large surface area in back of left arm.
Age: 10.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site irritation, Injection site pain, Injection site reaction
Clinical narrative: Pt seen at Primary Health 6/24/17. 7cm area of erythema, tenderness, maculopapular rash spreading from red and irritated injection site. Assessment cellulitis. Treated with Clindamycin and F/U with PCP.
Age: 10.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Rash maculo-papular
Clinical narrative: Pt seen at Primary Health 6/24/17. 7cm area of erythema, tenderness, maculopapular rash spreading from red and irritated injection site. Assessment cellulitis. Treated with Clindamycin and F/U with PCP.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, Gait disturbance, Hyperhidrosis, Hypotonia, Immediate post-injection reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unresponsive to stimuli in a 3-year-old female patient who received ENGERIX B adult. On 19th June 2017, the patient received the 3rd dose of ENGERIX B adult 1 ml. On 19th June 2017, immediately after receiving ENGERIX B adult, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant), limping, sweating, injection site pain, overdose and adult product administered to child. On an unknown date, the outcome of the unresponsive to stimuli, limping, sweating, injection site pain, overdose and adult product administered to child were unknown. The reporter considered the unresponsive to stimuli, limping and sweating to be almost certainly related to ENGERIX B adult. It was unknown if the reporter considered the injection site pain to be related to ENGERIX B adult. Additional details were provided as follows: The patient received the adult dose of the ENGERIX B at an age of 3 years, which led to overdose and adult product administered to child. The patient received ENGERIX B adult in the right arm. Within 40 seconds after the onset of limp and unresponsive, the physician was able to arouse the patient and found a heart rate. She was sweaty. The patient went home with mother. Less than a day after receiving ENGERIX B adult, the patient experienced sweating and injection site pain. The patient's mother called health care professional (HCP) and stated that the patient's right arm hurt and was laying around. The healthcare professional did not have details of vaccine batch number.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Overdose, Unresponsive to stimuli
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unresponsive to stimuli in a 3-year-old female patient who received ENGERIX B adult. On 19th June 2017, the patient received the 3rd dose of ENGERIX B adult 1 ml. On 19th June 2017, immediately after receiving ENGERIX B adult, the patient experienced unresponsive to stimuli (serious criteria GSK medically significant), limping, sweating, injection site pain, overdose and adult product administered to child. On an unknown date, the outcome of the unresponsive to stimuli, limping, sweating, injection site pain, overdose and adult product administered to child were unknown. The reporter considered the unresponsive to stimuli, limping and sweating to be almost certainly related to ENGERIX B adult. It was unknown if the reporter considered the injection site pain to be related to ENGERIX B adult. Additional details were provided as follows: The patient received the adult dose of the ENGERIX B at an age of 3 years, which led to overdose and adult product administered to child. The patient received ENGERIX B adult in the right arm. Within 40 seconds after the onset of limp and unresponsive, the physician was able to arouse the patient and found a heart rate. She was sweaty. The patient went home with mother. Less than a day after receiving ENGERIX B adult, the patient experienced sweating and injection site pain. The patient's mother called health care professional (HCP) and stated that the patient's right arm hurt and was laying around. The healthcare professional did not have details of vaccine batch number.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal stiffness, Nodule, Pain, Pruritus
Clinical narrative: Right arm stiffness; pain, warmth, redness, swelling, 3"x2" firm knot, itching. ice pack 20 minutes several times per day & Benadryl.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Right arm stiffness; pain, warmth, redness, swelling, 3"x2" firm knot, itching. ice pack 20 minutes several times per day & Benadryl.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Burning sensation, Injection site swelling, Pruritus
Clinical narrative: Swelling at site larger than fist, delayed itchying and burning (by 1 week) after receiving vaccine. 1st dose of Anthrax series.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, Chills, Lymph node pain, Pain, Pruritus
Clinical narrative: Rash on face started on 6/04/17, spread to chest and back. Itchy.  Feeling achy 1-2 days prior. Felt chilled 1 day before onset of rash.  Sore glands in neck/behind ear.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rubella antibody positive
Clinical narrative: Rash on face started on 6/04/17, spread to chest and back. Itchy.  Feeling achy 1-2 days prior. Felt chilled 1 day before onset of rash.  Sore glands in neck/behind ear.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of VAQTA with lot # M038572 and expiration date on 11-MAR-2018 (strength and dose were not reported) for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 216 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA011485: US-009507513-1706USA011486: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA011490: US-009507513-1706USA011484: US-009507513-1706USA011487:
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Nodule, Pruritus
Clinical narrative: This spontaneous report was received from a physician and refers to a currently 62 year old male patient. The patient did not have any pertinent medical history or drugs reactions/allergies and was not taking any concomitant medications. On 27-SEP-2016, the patient was vaccinated with ZOSTAVAX injection, 19400 plaque-forming units, via subcutaneous route, lot # L046900 with expiration date of 27-FEB-2017 (dose was not reported) as Herpes Zoster prevention. The vaccines were reconstituted with sterile diluent. On an unknown date (reported as a few months after the vaccine), the patient complained of itchy nodules on lower legs and lower back. The patient sought medical attention and was referred to a dermatologist on an unspecified date. The patient received treatment for the adverse events. No laboratory diagnostics studies were performed. The reporting physician saw the patient on 27-MAY-2017, and the condition persisted. The physician declined Varicella Zoster Virus Identification Program but requested a lot check of ZOSTAVAX. There was no product quality complaint involved. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and suspect therapies was not reported. 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 pharmacist referring to unknown multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. On an unknown date, the patients received improperly stored doses of PROQUAD lot # M022400 and lot # M022402 with expiration dates on 01-NOV-2017, for both, (dose and route were not provided) for prophylaxis. It was reported that the vaccines were reconstituted with sterile diluent (MRK INJ) (lot # and expiration date were not provided) which was not involved in a temperature excursion. On an unspecified day, the data logger registered that during 14 hours, 30 minutes the temperature under the vaccines were stored, was -14° Celsius (°C) to -10°C (-10,6°C), there was no prior temperature excursion and no adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA009576.
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3 month old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. Approximately on 09-JUN-2017, the patient was vaccinated with a first dose of ROTATEQ orally (lot # and expiration date were not reported). On 16-JUN-2017, the patient was vaccinated with a second dose of ROTATEQ orally (lot# M044396 with expiration date: 19-JUN-2018). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-JUN-2017, the patient who was intended to receive ZOSTAVAX, was inadvertently vaccinated with one dose of VARIVAX subcutaneously, lot # M042857, expiration date 21-OCT-2018 (dose was not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of Human Papillomavirus GARDASIL 9 (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # N000326 with expiration date on 14-OCT-2019, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 216 hours (dates between 15-FEB-2017 and 31-MAR-2017). For the lot # M034780 with expiration date on 15-APR-2019, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours (dates between 30-JAN-2017 and 30-MAY-2017) or 12 hours (on 15-FEB-2017); but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 1044 hours. This lot # was also exposed to a storage temperature of 47 to 77 degrees Fahrenheit (°F) (9 to 25 degrees Celsius (°C)) for a time frame of 12 hours. Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA002362: US-009507513-1706USA011486.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Body temperature increased, Fatigue, Haemoglobin decreased, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. An 18-year-old female patient received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included cytosis. The and concomitant medications were not reported. On an unspecified date the patient experienced elevated WBC 15.7 thousand (white blood cell count increased), low hemoglobin of 8 on, fever of 102.2, generalized body aches and fatigue. The outcome of the events was unknown. The patient underwent lab tests and procedures which included body temperature: 102.2, haemoglobin: lowof 8, white blood cell count: 15.7 thousand.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: White blood cell count increased
Clinical narrative: This is a spontaneous report from a contactable nurse. An 18-year-old female patient received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included cytosis. The and concomitant medications were not reported. On an unspecified date the patient experienced elevated WBC 15.7 thousand (white blood cell count increased), low hemoglobin of 8 on, fever of 102.2, generalized body aches and fatigue. The outcome of the events was unknown. The patient underwent lab tests and procedures which included body temperature: 102.2, haemoglobin: lowof 8, white blood cell count: 15.7 thousand.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Chills, Fatigue, Full blood count, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. An 18-year-old female patient received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included cytosis. The and concomitant medications were not reported. On an unspecified date the patient experienced elevated WBC 15.7 thousand (white blood cell count increased), low hemoglobin of 8 on, fever of 102.2, generalized body aches and fatigue. The outcome of the events was unknown. The patient underwent lab tests and procedures which included body temperature: 102.2, haemoglobin: lowof 8, white blood cell count: 15.7 thousand.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema multiforme, Full blood count, Metabolic function test
Clinical narrative: Erythema multiforme to (L) arm.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema multiforme, Full blood count, Injection site reaction, Metabolic function test
Clinical narrative: Erythema multiforme to (L) arm.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pain, Rash
Clinical narrative: Patient had a red, itchy, large spot at injection site. Redness started going down, but it's still itchy. Also developed a rash on torso. Doctor not sure, maybe shingles-> gave Acyclovir and topical steroid. Taking ibuprofen for pain.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Presyncope
Clinical narrative: Red, painful, swollen left arm at the injection site. Vasovagal symptoms.
Age: 24.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Cold sweat, Electrocardiogram normal, Pallor, Syncope
Clinical narrative: Patient became white, clammy to touch, fainted briefly, had a pulse of 47 and a BP of 111/45. I called 911 and within 5 minutes they arrived.  She slowly came back. No meds were administered. BPs and HR checked every 5 minutes for 20 minutes. The EMTs did an EKG which was normal. She drank 2 bottles of water and a technician walked her to her car once she was able. Total time was about 30-40 minutes.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Haematochezia
Clinical narrative: BLOOD IN STOOLS FOR ONE DAY.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eyelid oedema
Clinical narrative: Pt returned to clinic with R eyelid swelling.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # M043987 with expiration date on 20-OCT-2018, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 576 hours (dates between 27-MAR-2017 and 30-MAY-2017). For the lot # N003993 (expiration date was not reported), the storage temperature was from 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours and it was also reported that there were multiple previous temperature excursions with a total cumulative time frame of 216 hours (dates between 15-FEB-2017 and 31-MAR-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002362: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA011484: US-009507513-1706USA011486:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of M-M-R II (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # M010426 with expiration date on 01-MAR-2018, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours (dates between 30-JAN-2017 and 30-MAY-2017) or 12 hours (on 15-FEB-2017); but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 1044 hours. This lot # was also exposed to a storage temperature of 47 to 77 degrees Fahrenheit (°F) (9 to 25 degrees Celsius (°C)) for a time frame of 12 hours (on 15-FEB-2017). For the lot # L032181 with expiration date on 25-AUG-2017, the storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (0 to 1 degrees Celsius (°C)) for a time frame of 24 hours; but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 216 hours (dates between 15-FEB-2017 and 31-MAR-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA002362: US-009507513-1706USA011488: US-009507513-1706USA011489: US-009507513-1706USA011484: US-009507513-1706USA011486:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of PROQUAD (strength, dose, route of administration or anatomical location were not reported), for prophylaxis. For the lot # M044575 with expiration date on 04-MAY-2018, the storage temperature was reported as 15 to 46 degrees Fahrenheit (°F) (-9 to 8 degrees Celsius (°C)) for a time frame of 24 hours (dates between 04-MAY-2017 and 01-JUN-2017); but it was reported that there were multiple previous temperature excursions, under that temperature with a total cumulative time frame of 360 hours. This lot # was also exposed to a storage temperature of 6 to 14 degrees Fahrenheit (°F) (-14 to 10 degrees Celsius (°C)) for a time frame of 24 hours (on 25-MAY-2017). Data logger was involved but no adverse effects were reported. This is one of several reports received from the same source. No product quality complaint (PQC) was involved. Additional information has been requested. Sender's Comments: US-009507513-1706USA011485: US-009507513-1706USA011490: US-009507513-1706USA011487: US-009507513-1706USA002362: US-009507513-1706USA011489: US-009507513-1706USA011484: US-009507513-1706USA011486:
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Gastrooesophageal reflux disease, Hypersensitivity, Pain, Pyrexia
Clinical narrative: Fever, body aches, stomach upset, GERD, patient called dr about symptoms but didnt mention vaccine so dr just told them it must be a virus and to take tylenol/advil.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Viral infection
Clinical narrative: Fever, body aches, stomach upset, GERD, patient called dr about symptoms but didnt mention vaccine so dr just told them it must be a virus and to take tylenol/advil.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus, Scab
Clinical narrative: Pt explained that the area surrounding her upper deltoid was itchy and crusty. Upon examination, the arm was also red and slightly swollen in the area in an approximately 6 inch in diameter area.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Viral rash
Clinical narrative: Patient noted rash on trunk, flank and buttocks area approximately 48-72 hours after vaccine was given. No swelliing of injection site. Denies s/s allergic reax or anaphylaxis.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Death, Respiratory arrest
Clinical narrative: Stopped breathing, passed away.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Diverticulitis, Drug hypersensitivity, Pruritus, Rash
Clinical narrative: 05/15/2017 Diverticulitis of colon-given CIPRO and FLAGYL for 11 days. 5/26/2017 given PREVNAR 13 also CIPRO and FLAGYL for another 4 days. 5/28/2017 itching and rash started and continued. 6/7/2017 started on steroids. 6/12/2017-returned for evaluation by PCP.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diet refusal, Haematochezia, Ultrasound scan, Vomiting
Clinical narrative: 6/22/17 mom reported bloody stool with streak of blood x2, vomited x2 yesterday evening, refused to take bottle, seen by Dr. 6/22/17 and sent to Medical Center for U/S and evaluation-transferred to another Medical Center.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Diarrhoea, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: She felt feverish and tired after getting the vaccine (on the same day). The following day (6/21/17) she developed a headache and diarrhea. Also has redness. Induration and soreness at site. Also had 2 pre-syncopal episodes.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Presyncope, Pyrexia
Clinical narrative: She felt feverish and tired after getting the vaccine (on the same day). The following day (6/21/17) she developed a headache and diarrhea. Also has redness. Induration and soreness at site. Also had 2 pre-syncopal episodes.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling pain (L) deltoid injection site. Itching.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Dizziness, Dysstasia, Gait disturbance, Head discomfort
Clinical narrative: Patient complained that the day after the vaccine she woke up feeling dizzy and had trouble standing and walking. Head felt heavy, rested and felt better next day.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Circadian rhythm sleep disorder, Decreased appetite, Fatigue, Irritability, Macule
Clinical narrative: The patient is a healthy 12 mo old female with a history of eczema who received MMR, Varicella, hep A and PREVNAR vaccines and developed 3 episodes of papular dermatitis with some macules, on day 0, day 3 and day 11. Fever, fatigue, irritability, anorexia was present on day 3 and she continues to have disruption of sleep schedule and increased clinginess. The family did vacation travel out of the area during these episodes. Rash and other nonspec skin eruption.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash papular
Clinical narrative: The patient is a healthy 12 mo old female with a history of eczema who received MMR, Varicella, hep A and PREVNAR vaccines and developed 3 episodes of papular dermatitis with some macules, on day 0, day 3 and day 11. Fever, fatigue, irritability, anorexia was present on day 3 and she continues to have disruption of sleep schedule and increased clinginess. The family did vacation travel out of the area during these episodes. Rash and other nonspec skin eruption.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Pain, Skin warm
Clinical narrative: Form provided  by patient at 6-20-17 Nurse visit appointment. She reports swelling around injection site and left upper arm x 1 week. She did not seek medical advice. X-strength Acetaminophen 500 mg for pain and local fever in arm area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Raised rash on back and abdomen - itching. No tx other than OTC BENADRYL. No fever. Mother reports she texted picture of rash to urologist-was told not reaction to BACTRIM.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid was swollen, red, fever, warm to the touch, very painful for 6 days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Somnolence
Clinical narrative: Throbbing headache in occiput, dizziness and drowsiness.  improved wtih sleep.  Resolved on its own within 24 hours.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right leg swollen x 3 days, redness 2.5 x 3.5 cm day 10. No streaking.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Fever, pain down both legs, unable to get up from bed.
Age: 5.0
Sex: F
Vaccine: MMRV, TD
Symptoms: Wrong drug administered
Clinical narrative: Td was given instead of KINRIX. Supervisor and Doctor were notified. Family was notified as well.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Left leg hot to touch, 1.5 x 1 cm redness.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Rash morbilliform
Clinical narrative: Measles-like rash on chest and abdomen. Suffered fever 4 nights prior that was responsive to Tylenol.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Diarrhoea, Irritability
Clinical narrative: Diarrhea and concern for abdominal pain, increased fussiness x several days after oral rotavirus vaccine (+ IM PEDIARIX, PREVNAR, Hib).
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: Patient received a TDaP injection on 6/19/2017 (423pm) on the (L) deltoid patient states she went home 25 minutes later she ended up having seizure and was taken to the ER for evaluation.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Oral mucosal eruption, Rash, Urticaria
Clinical narrative: Rash, huge welt, bumps in mouth.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Arthritis, Back pain, Costochondritis, Discomfort
Clinical narrative: 4 weeks after having been administered the 3rd Gardasil vaccine, my daughter started having unusual severe joint pain, and headaches.  Initially it was causing costochondritis and she was uncomfortable receiving a hug or being touched. This pain & inflammation progressed to her knees, elbows, shoulders, back, spine, and hands. She was miserable with pain and could barely walk up 1 flight of stairs to her bedroom.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling abnormal, Gait disturbance, Headache, Inflammation, Inflammatory marker increased
Clinical narrative: 4 weeks after having been administered the 3rd Gardasil vaccine, my daughter started having unusual severe joint pain, and headaches.  Initially it was causing costochondritis and she was uncomfortable receiving a hug or being touched. This pain & inflammation progressed to her knees, elbows, shoulders, back, spine, and hands. She was miserable with pain and could barely walk up 1 flight of stairs to her bedroom.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Juvenile idiopathic arthritis, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: 4 weeks after having been administered the 3rd Gardasil vaccine, my daughter started having unusual severe joint pain, and headaches.  Initially it was causing costochondritis and she was uncomfortable receiving a hug or being touched. This pain & inflammation progressed to her knees, elbows, shoulders, back, spine, and hands. She was miserable with pain and could barely walk up 1 flight of stairs to her bedroom.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Spinal pain, X-ray abnormal
Clinical narrative: 4 weeks after having been administered the 3rd Gardasil vaccine, my daughter started having unusual severe joint pain, and headaches.  Initially it was causing costochondritis and she was uncomfortable receiving a hug or being touched. This pain & inflammation progressed to her knees, elbows, shoulders, back, spine, and hands. She was miserable with pain and could barely walk up 1 flight of stairs to her bedroom.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Vaccine rced 6/5/17, leg swollen, warm to touch, red, irritated, pt. has no fever but states leg is painful. Local reaction or secondary cellulitis. Close monitoring for...see pt. note.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Vaccine rced 6/5/17, leg swollen, warm to touch, red, irritated, pt. has no fever but states leg is painful. Local reaction or secondary cellulitis. Close monitoring for...see pt. note.
Age: 65.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site erythema, Injection site irritation, Injection site pain, Skin warm
Clinical narrative: After vaccine patient noticed site was irritated, sore, red. Felt a little better next few days but still red. Redness spread over course of a week down patient's arm. Warm to the touch.
Age: 65.0
Sex: U
Vaccine: PNC13, PNC13
Symptoms: Rash, Rash pruritic, Skin warm
Clinical narrative: After vaccine patient noticed site was irritated, sore, red. Felt a little better next few days but still red. Redness spread over course of a week down patient's arm. Warm to the touch.
Age: 79.0
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Joint swelling, Peripheral swelling, Rash
Clinical narrative: Diarrhea, rash on back, swelling in leg(knee and hip) occuring 3 days after immunization.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal
Clinical narrative: 12 mo F presented with multiple bruises, petechia, mild bleeding from gums and red pigmented stool x 1. Admitted for IVIG x 1.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood urea normal, Carbon dioxide normal, Contusion, Faeces discoloured, Gingival bleeding
Clinical narrative: 12 mo F presented with multiple bruises, petechia, mild bleeding from gums and red pigmented stool x 1. Admitted for IVIG x 1.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: 12 mo F presented with multiple bruises, petechia, mild bleeding from gums and red pigmented stool x 1. Admitted for IVIG x 1.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal, White blood cell count normal
Clinical narrative: 12 mo F presented with multiple bruises, petechia, mild bleeding from gums and red pigmented stool x 1. Admitted for IVIG x 1.
Age: 65.0
Sex: M
Vaccine: DTP, PPV
Symptoms: Influenza like illness, Malaise, Nausea, Vomiting
Clinical narrative: Reported by patient 4 days following administration that they had been sick, that they reaction to them and had been ill in bed for 3 day. Patient reports that they never want this type of vaccine again. Nausea Vomiting and Influenza-like illness.