chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Administration site nodule, Administration site swelling, Injection site haemorrhage
Clinical narrative: Case number PHHY2016US069336 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 631119) on 17 May 2016. This report refers to a 40 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157703) intramuscularly into left arm on 01 Apr 2016. On the same day directly after vaccination the patient experienced bleeding, instant swelling and a small knot at administration site. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, HPVX, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHHY2016US069764, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 631147) website on 17 May 2016. This report refers to an 11 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported), Hepatitis A (manufacturer unknown and batch number: not reported) and ADACEL (manufacturer unknown, batch number: U4965AA and expiry date: 12 Feb 2017) all three intramuscularly in left arm and HPV vaccine (manufacturer unknown and batch number: not reported) and MENVEO (manufacturer unknown and batch number: not reported) both intramuscularly in right arm on 14 Feb 2015. On 15 Feb 2015 (reported as 2 days after), the patient experienced site reaction of redness, swelling, warmth on left deltoid and site reaction of redness and swelling on right deltoid. The patient was prescribed with BACTRIM (manufacturer unknown) and ice packs. It was reported that, the outcome of the events was unknown. The final outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: M
Vaccine: FLU3
Symptoms: Glycosylated haemoglobin normal, Injection site paraesthesia, Injection site warmth, Paraesthesia
Clinical narrative: Case number PHHY2016US093393 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 633232) on 06 Jul 2016. This report refers to 40 year old male patient. Historical condition included morbid obesity, dyslipidemia, GERD (gastrooesophageal reflux disease), knee pain, snoring, enlarged tonsils. Current conditions included Prediabetes (A1c 5.7) and seasonal allergies but no known drug/food allergies. Concomitant medication included CLARITIN, FLONASE, TUMS. The patient was vaccinated with FLUVIRIN (batch number:158104) intramuscularly into left arm on 12 Apr 2016. On 13 Apr 2016, the patient had noted warmth at site and then experienced tingling sensation at the site. It was reported that tingling sensation in the left armpit was coming and going. No weakness was reported. The outcome of events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality of the events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2016US091570 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 634868) on 20 Jun 2016. This report refers to 62 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516401) intramuscularly into left arm on 04 Nov 2015. On 05 Nov 2015, patient had sore, stiff left arm and neck since administration of the influenza vaccine. The outcome of events was reported as condition unchanged. The causality of events was not reported. The seriousness of events was reported as non seriousness.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2016US106732, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 637905) website on 01 Aug 2016. This report refers to a 61 years old female patient. Past medical history and concomitant medications were not reported. Vaccination history included administration of flu vaccine (manufacturer unknown) as preventative on an unknown date. The patient was vaccinated with FLUVIRIN (batch number: 157003) in left arm on 20 Oct 2015. On 01 Nov 2015, the patient experienced left (L) shoulder pain and limited range of motion. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity, Peripheral swelling, X-ray
Clinical narrative: Case number PHHY2016US107315, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 638693) website on 01 Aug 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) into left arm on 02 Oct 2015. On the same day after vaccination, the patient experienced arm stiff, arm pain and arm swollen. The patient had x-ray and magnetic resonance imaging (MRI) tests with no results. The outcome of events was reported as unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Case number PHHY2016US134564, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS ID: 640081) website on 29 Sep 2016. This report refers to a 51-year-old female patient. Historical condition included malabsorption. Current conditions included thyroid disease, high cholesterol and chronic pain syndrome. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516401) on 26 Oct 2015. After supper (late night meal) on 26 Oct 2015 the patient noticed her arm was sore and hurt when she moved it. This pain and restricted movement had not changed since then. The patient had been to doctors and done their exercises. The patient received a cortisone injection in January 2016. Outcome of the event was condition unchanged. Seriousness of the event was reported as non-serious. Causality was not reported.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Visual impairment
Clinical narrative: After the injection, I became blurry-eyes and sat on my car a while before venturing home. I then called the pharmacist who gave me the shot. She told me to use eye drops, which did help. My vision changed. I had to use triple strength magnifying glasses to read at all.
Age: 72.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dysstasia, Laboratory test, Peripheral swelling, Pyrexia, Vaccination complication
Clinical narrative: After flu and pneumonia vaccine shot, patient got a high temp and swelling of hands along with difficulty standing up. The following day patient went to Dr. and was told he had a reaction to vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65-year-old female patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. It was reported that patient had reactions or allergies for sulfa and  phenazopyridine hydrochloride. On 16-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously for prophylaxis (lot # M035148, expiration date:  25-OCT-2017) (dose was not reported). On 16-DEC-2016, within 3-4 hours of receiving ZOSTAVAX, the patient experienced "red spots", swelling and pain at the injection site which radiated through her whole left arm (confirmed that it was not a rash of any sort). The patient sought medical attention by primary care physician office visit. In approximately December 2016, the patient saw her primary care physician reported that he had never seen a reaction like this. The physician prescribed an unspecified antibiotic for 7-10 days. A lot check was requested sooner than 75 days. Product quality complaint was not involved. The outcome of events was reported as resolved, at the time of the call (in approximately December 2016). The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 65-year-old female patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. It was reported that patient had reactions or allergies for sulfa and  phenazopyridine hydrochloride. On 16-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously for prophylaxis (lot # M035148, expiration date:  25-OCT-2017) (dose was not reported). On 16-DEC-2016, within 3-4 hours of receiving ZOSTAVAX, the patient experienced "red spots", swelling and pain at the injection site which radiated through her whole left arm (confirmed that it was not a rash of any sort). The patient sought medical attention by primary care physician office visit. In approximately December 2016, the patient saw her primary care physician reported that he had never seen a reaction like this. The physician prescribed an unspecified antibiotic for 7-10 days. A lot check was requested sooner than 75 days. Product quality complaint was not involved. The outcome of events was reported as resolved, at the time of the call (in approximately December 2016). The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea, Fatigue, Headache
Clinical narrative: 15 year old received TDaP in office and 5 hours later had fever, 101, myalgia, vomited x 6 mild abdominal discomfort, and some diarrhea. Improved next day with 99 degree F, tired, mild myalgia. Normal exam No treatment.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Lethargy, Nausea, Pain
Clinical narrative: 15 year old received TDaP in office and 5 hours later had fever, 101, myalgia, vomited x 6 mild abdominal discomfort, and some diarrhea. Improved next day with 99 degree F, tired, mild myalgia. Normal exam No treatment.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Speech disorder, Vomiting
Clinical narrative: 15 year old received TDaP in office and 5 hours later had fever, 101, myalgia, vomited x 6 mild abdominal discomfort, and some diarrhea. Improved next day with 99 degree F, tired, mild myalgia. Normal exam No treatment.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Gastroenteritis, Myalgia
Clinical narrative: 15 year old received TDaP in office and 5 hours later had fever, 101, myalgia, vomited x 6 mild abdominal discomfort, and some diarrhea. Improved next day with 99 degree F, tired, mild myalgia. Normal exam No treatment.
Age: 15.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Vaccination complication, Vomiting
Clinical narrative: 15 year old received TDaP in office and 5 hours later had fever, 101, myalgia, vomited x 6 mild abdominal discomfort, and some diarrhea. Improved next day with 99 degree F, tired, mild myalgia. Normal exam No treatment.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Noticed bright red 3 x 3 1/2 inch spot -area of injection. Swollen, hot itchy. Increased in size, went to Urgent Care. It is less red but still itching and a much larger area on my arm, forarm. Getting better, resolving slowly. Icing,  Benadryl.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not provided. On an unknown date, the patient was inadvertently vaccinated with a single dose of PNEUMOVAX 23, lot # M032635, expiration date 05-MAY-2018 (dose, route and site of administration were not reported) instead of PREVNAR 13. No adverse effects were reported. No product quality complaint (PQC) was involved. Follow up information has been received on 03-JAN-2017. Letter attempt to obtain follow up information had been unsuccessful. The letter was returned undelivered. Additional information is not expected as all attempts to contact health care professional were unsuccessful. Sender's Comments: MERCK 1611USA000992:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On 30-DEC-2016,  the patients were vaccinated with doses of an improperly stored GARDASIL 9, with lot # M017983, expiration date 30-MAY-2018 and lot# M024261, expiration date 30-JUL-2018 (route of administration, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007904: US-009507513-1701USA007902: US-009507513-1701USA007903.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX injection, lot # M025865, expiration date 24-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. The administered vaccine was exposed to the temperature between 14 and 46 Fahrenheit degrees for an unspecified time. There was also previous temperature excursion with the temperature of 10.4 Fahrenheit degrees for 1 hour. Data logger was involved. No product quality complaint was.  Additional information has been requested.
Age: 1.58
Sex: U
Vaccine: HEPA, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 19 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with PEDVAXHIB(reported as Hib) lot# reported as UI645AA and expiration date 21-JUL-2017 (dose, route and frequency were not reported) and VAQTA (reported as Hep A) lot# reported as M015290 and expiration date 20-SEP-2017 (dose, route and frequency were not reported) for prophylaxis, when refrigerator was out of range (Incorrect product storage). Lot number UI645AA is an invalid lot number for PEDVAXHIB. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726.
Age: 11.0
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with unidentified Merck hpv vaccine GARDASIL or GARDASIL 9 (dosing details and route of administration unknown) lot# reported as L053214 and expiration date 30-AUG-2017 for prophylaxis when refrigerator was out of range(Incorrect product storage). Lot number L053214 is an invalid lot number for GARDASIL or GARDASIL 9. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
Age: 0.17
Sex: U
Vaccine: HEP, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with RECOMBIVAX HB (reported as Hep B) lot # M011838 and expiration date 09-AUG-2018 (dose, route and frequency were not reported) and PEDVAXHIB (reported as Hib) lot# reported as UI645AA with expiration date 21-JUL-2017 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). Lot number UI645AA is an invalid lot number for PEDVAXHIB. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with PEDVAXHIB (reported as Hib) lot # L051124 and expiration date 14-OCT-2018 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
Age: 5.0
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 5 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with VAQTA (reported as Hep A) lot# M015290 with expiration date 20-SEP-2017 (dose, route and frequency were not reported) and RECOMBIVAX HB (reported as Hep A) lot# L045117 with expiration date 10-JUN-2018 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with PEDVAXHIB (reported as Hib) lot # L051124 with expiration date 14-OCT-2018 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726.
Age: 2.0
Sex: U
Vaccine: HEPA, HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 2 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with VAQTA (reported as Hep A) lot# M015290 with expiration date 20-SEP-2017 (dose, route and frequency were not reported) and PEDVAXHIB (reported as Hib) lot# L051124 with expiration date 14-OCT-2018 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726.
Age: 11.0
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding an 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with unidentified Merck hpv vaccine, GARDASIL or GARDASIL 9 valid lot# L043214 with expiration date 30-AUG-2017 (dosing details and route of administration unknown) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
Age: 10.0
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 10 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with unidentified Merck hpv vaccine, GARDASIL or GARDASIL 9 valid lot# M016193 with expiration date 24-APR-2018 (dosing details and route of administration unknown) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004725: US-009507513-1701USA004726.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 4 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 29-SEP-2016, the patient was vaccinated with PROQUAD (dose, route and frequency were not reported) lot# M015700 with expiration date 26-SEP-2017 for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004726.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician regarding a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 29-SEP-2016, the patient was vaccinated with PEDVAXHIB(reported as Hib) lot# reported as UI645AA with expiration date 21-JUL-2017 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). Lot number UI645AA is an invalid lot number for PEDVAXHIB. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725.
Age: 2.0
Sex: M
Vaccine: FLUX, HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 12-JAN-2017, the patient was vaccinated with a dose of expired VAQTA lot # L036300, expiry date 04-NOV-2016, intramuscularly (anatomical location and dose were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to an unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. On 30-DEC-2016, the patients were vaccinated with an improperly stored VAQTA, with lot # M033611, expiration date 02-MAR-2018 (route of administration, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine  was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007903: US-009507513-1701USA007904: US-009507513-1701USA000848.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist (also reported as a nurse) referring to unspecified patients of unknown age and gender. There was not information regarding pertinent medical history, drug reaction or concomitant therapies. O n 30-DEC-2016, the patients were vaccinated with an improperly stored (RECOMBIVAX HB, with lot # M032649, expiration date 11-NOV-2018 and lot# M034894, expiration date 11-NOV-2018, (route of administration, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range  of the vaccine  was 1.4 Celsius (C) and the time frame was 46 minutes, also she stated that the previous temperature excursion was 9.4 Celsius (C) during 1 hour and 35 minutes, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000848: US-009507513-1701USA007904: US-009507513-1701USA007902:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016134142) on 05 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza virus vaccine) (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date.  Patient's medical history reported that the patient was a former smoker (reported as 0.26 ppd, 8.75 pack-years), never used smokeless tobacco and no alcohol. Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergies to Influenza virus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of the documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Alopecia
Clinical narrative: Initial unsolicited report received from consumer on 05 Jan 2017. This case involves a female patient (age not reported) who was vaccinated with dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, route and site of administration was not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination; the patient had experienced alopecia. Patient was also vaccinated with INFLUENZA VACCINE (FLU SHOT) on unspecified date in last year and experienced alopecia. Laboratory data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Initial unsolicited report received from a Physician on 10 January 2016. This case involves two patient (onset age and gender were not reported) who was vaccinated with an unknown doses of DAPTACEL (batch number, expiry date and dose in series were not reported) in an unknown site on an unknown date. Concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient had developed severe swelling and redness. The patient's emergency room (ER) or doctor visit was not reported. The patients Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Rash
Clinical narrative: Fever: 102 and rash reported.
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Patient reported muscle pain in left arm beginning from shoulder extending to lower arm soon after receiving 3 vaccines (ZOSTAVAX, BOOSTRIX, and PREVNAR) on 12/13/16. Patient received both ZOSTAVAX and BOOSTRIX in left arm on the same day. She reported the arm pain to PCP, but pain did not resolve after taking muscle relaxers and pain killers. Patient was still in continuous pain as of 1/18/17 when patient reported adverse reaction to pharmacy.
Age: 21.0
Sex: F
Vaccine: HPVX, TD, TDAP
Symptoms: Eyelid rash, Feeling hot, Pyrexia, Rash
Clinical narrative: Rash on left hand (top), rash on left eye/eye lid , felt hot/ fever on face ears and neck specially. Treatment: intramuscular Benadryl on 01/19/2017 and MethylPREDNISolone tablets (4mg) & Fexofenadine HCL 180mg tablet (allegra allergy) starting 01/20/2017.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lots # L037554 and M011117 with expiration dates 25-DEC-2017 and 07-DEC-2017 respectively, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of GARDASIL 9 were exposed to a temperature below of 32F and lowest of 31.74F and were out of range for 2 hours and 50 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source. Sender's Comments: US-009507513-1701USA009320.
Age: 0.4
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 02-JAN-2017, the patient was vaccinated with an expired RECOMBIVAX HB, lot number L008660, expiration date 10-NOV-2016, (route and anatomical location were not reported), for prophylaxis. The reporter also stated that the RECOMBIVAX HB did not have any previous temperature excursions. No adverse symptoms were reported. Product quality complain was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, since 15-DEC-2016, the patients were vaccinated with improperly stored doses of VARIVAX  lot # reported as M033214, expiration date: 13-JUL-2018 and lot # M024702, expiration date: 18-MAY-2018 (strength, dose and route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported.     The temperature excursion was between >5 °F - <14°F, for a time frame of 50 minutes and >14 °F - <46°F, for a time frame of 5 hours, the cumulative time frame was 5 hours and 50 minutes. There were no previous temperature excursions. The call was  because of a data logger (reported as log tag in use). This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007889:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On 05-JAN-2017, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml, once, lot # M016233, expiration date: 31-MAR-2018 (strength, route were not reported) for prophylaxis (incorrect product storage). No adverse effects were reported. The temperature was 45 F for a time frame of 15 hours and 30 minutes.  There were no previous temperature excursions. The call was not because of a data logger. Additional information has been requested.
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 9 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 14-NOV-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 52 year old female patient (who was also a company representative) reporting on herself via a company representative. Information about the patient's medical history, concurrent conditions, drug reactions or allergies was not provided. On 11-JAN-2017, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for prevention of shingles. No concomitant therapies were administered. On 11-JAN-2017, the patient experienced injection site redness, swelling and a small bump in the center of injection site. The injection site was slightly warm to the touch. No treatment was given for the events. Laboratory diagnostics tests were not performed.    The outcome of the events was reported as not recovered/not resolved (the patient stated that at the time of the report, the symptoms had not gone away). The causality between the events and ZOSTAVAX was not reported. The patient did not seek medical attention. Product quality complaint was not involved. Additional information  is not expected as there were no contact details provided.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an 53 years old female patient. The patient had no pertinent medical history, drug reaction or allergies and concurrent conditions. On unspecified dates (reported as "in the past"), the patient received unspecified number of doses of M-M-R II injection (lot#, expiration date, dose and route of administration were not reported). On 16-NOV-2016, the patient had the titers drawn which came back as "negative". On 12-DEC-2016, the patient received another dose of M-M-R II injection, subcutaneously, 0.5 ml, lot # M022408, expiration date: 02-MAY-2018, because it was mandatory to have immunity to work the hospital. No concomitant therapies were administered. On 03-JAN-2017, the patient experienced redness, warmth and swelling at the M-M-R II injection site. On 10-JAN-2017, the patient was sent to an unspecified urgent care facility in regards to the reactions. The patient was given clindamycin as a treatment for the reactions while the stay at the urgent care facility. According to information received on 11-JAN-2017 from the patient, the reactions subsided but there was still some swelling. The outcome of injection site redness and injection site warmth was reported as recovered on an unknown date in January 2017. The outcome of injection site swelling was not recovered at the time of the report. The outcome of negative titers was unknown. The causality between the events and M-M-R II was not reported. Upon internal review, the events of injection site redness, injection site warmth and injection site swelling were considered to be medically significant as they did not resolve spontaneously and lasted a couple of days until the treatment with clindamycin was initiated. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (exact dose was not reported, lot # L028286, expiration date: 28-OCT-2016) subcutaneously. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse an refers to 6 patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as M017348, expiration date: 06-APR-2018 (exact dose and route of administration were not reported). There was no adverse effect reported. The administered doses experienced the temperature excursion between 46 degrees Fahrenheit (F) and 77 F for 6 hours. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA009339: US-009507513-1701USA009338: US-009507513-1701USA009337.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from an office manager refers to a 79 year old female patient. The patient's medical history was not provided. Her concurrent conditions included hypertension and sulfa drugs allergy. Concomitant therapies included an unspecified beta blocker. On 16-JAN-2017, over the age of 65 years, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M036728, expiration date 20-MAY-2018, intramuscularly; dose was not reported) for prophylaxis. On 17-JAN-2017, the patient experienced a fever and redness and tenderness at the injection site. The patient sought medical attention via calling the physician's office and the physician prescribed ADVIL and ice. None lab diagnostics studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and PNEUMOVAX 23 was not provided. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA007755.
Age: 0.83
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 10 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 29-NOV-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX with lot number M032649 and expiration date of 11-NOV-2018 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved.  This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA00794148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849: