chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: FLU3, MENB
Symptoms: Vaccination complication
Clinical narrative: This is a spontaneous report from two contactable HCP communicated to a sales representative. The two HCP reported same event for 3 non-contactable unknown patients. This case is for the 3rd patient. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at 0.5ml, single on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced reaction to TRUMENBA on an unspecified date with outcome of unknown. The Pfizer sales representative mentioned that in the doctor's opinion the reaction was due to TRUMENBA.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The patient was vaccinated with VARIVAX (Merck) (dose, route and lot number not provided) (dose 1 on an unspecified, dose 2 in February 2008, dose 3 on 24-FEB=2016). Concomitant therapies were not provided. No adverse effect was reported. There was no product quality (PQC) involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Fatigue, Pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable nurse and from a contactable physician. A 20-year-old female patient received first dose of TRUMENBA (Lot# J28923), intramuscular in left deltoid, on 21May2015, at 0.5 ml single. Relevant medical history included borderline factor 7 deficiency that did not require medications or treatments. Concomitant medication included ORTHO CYCLEN, oral, at 1 DF 1x/day, for oral contraception. The patient experienced really red swollen arm, about 4 inches swollen, a lot of pain and fatigue on Jun2015. The patient was treated with ice packs and TYLENOL either 650mg or 1000mg tablets by mouth 3 times a day as needed with good effect and relief. No other treatments were required. The events were assessed as non-serious. The events recovered. Follow-up (16Feb2016): New information received from a contactable physician includes: vaccination details. Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MMRV
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. The patient's pertinent medical history and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports received from the same reporter. Additional information is not expected as no further follow-up is required.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TTOX
Symptoms: Dizziness, Erythema, Fatigue, Headache, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 11-year-old male patient received TRUMENBA (LOT M13066; NDC number 0005-0100-10; Expiry Date 30Sep2016), via an unspecified route of administration on 18Jan2016 at 0.5mL on right shoulder. The patient medical history was not reported. Concomitant medication included MENACTRA on right shoulder, HPV9 on left shoulder, tetanus vaccine, all given on 18Jan2016. On 19Jan2016 the patient experienced fatigue, dizziness, high fever 103.9 F, headache, red shoulder all the way to elbow and severe vomiting-threw up four times. Patient was treated with ZOFRAN given either 19Jan2016 or 20Jan2016 because patient kept throwing up and couldn't keep TYLENOL down. All events recovered on 20Jan2016.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TTOX
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 11-year-old male patient received TRUMENBA (LOT M13066; NDC number 0005-0100-10; Expiry Date 30Sep2016), via an unspecified route of administration on 18Jan2016 at 0.5mL on right shoulder. The patient medical history was not reported. Concomitant medication included MENACTRA on right shoulder, HPV9 on left shoulder, tetanus vaccine, all given on 18Jan2016. On 19Jan2016 the patient experienced fatigue, dizziness, high fever 103.9 F, headache, red shoulder all the way to elbow and severe vomiting-threw up four times. Patient was treated with ZOFRAN given either 19Jan2016 or 20Jan2016 because patient kept throwing up and couldn't keep TYLENOL down. All events recovered on 20Jan2016.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable consumer. A 20-years-old female patient of an unspecified ethnicity received the second dose of TRUMENBA, via an unspecified route of administration on 28Dec2015 at single dose. The patient medical history and concomitant medications were not reported. The patient received the first dose of vaccine in Aug2015. The patient experienced warmth, redness, swelling of the injection site, and the site was tender all on an unspecified date with outcome of unknown.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Headache, Myalgia, Protein urine present, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 8-year-old female patient who received HAVRIX Junior (batch number F3J75, expiry date 18th November 2017). On 11th February 2016, the patient received HAVRIX Junior .5 ml. On 11th February 2016, several hours after receiving HAVRIX Junior, the patient experienced fever. In February 2016, the patient experienced chills, muscle pain and headache. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the fever, chills, muscle pain and headache were unknown. It was unknown if the reporter considered the fever, chills, muscle pain and headache to be related to HAVRIX Junior. Additional details were provided as follows: The patient did not have any other significant medical history that the reporter was aware of. The patient was not receiving any other concomitant medication. On 11th February 2016, within a few hours after vaccination, the patient experienced waxing and waning fevers, which spiked as high as 103.1 degrees F. In February 2016, less than a week after receiving the vaccine, the patient also experienced chills, muscle aches and headache. The patient went to the Emergency Room (ER) within a day or two and she began receiving ibuprofen and TYLENOL. On 17th February 2016, the patient was seen in the urgent care clinic and it was determined that she had 2 plus protein in her urine. The reporter's call was escalated to Medical Information System.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise, Neck pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA in the left arm, a single dose of MCV4 (manufacturer unknown) in the left arm and a single dose of HPV9 (manufacturer unknown) in the right arm, all 06Nov2015. Medical history and concomitant medications were not reported. The patient complained later on 06Nov2015 (Friday) that she had a swelling at the base of her shoulder and she felt sick. Over the weekend on Saturday and Sunday (07Nov2015 and 08Nov2015), the patient had fevers on and off. She took ibuprofen (manufacturer unknown) and she was presented to the office on 07Nov2015 and her shoulder looked red and it was hot to touch, according to the nurse. The patient continued to complain of sharp pain and tenderness from the shoulder to the upper neck. The patient recovered from fevers. The outcome of all over events was unknown. The doctors did not know but they suspect that all these side effects were related to the vaccines. They did not know if it was the combination of the vaccines or a single vaccine. Follow-up (07JAN2016): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pyrexia, Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16-year-old female patient of an unspecified ethnicity received a single dose of TRUMENBA in the left arm, a single dose of MCV4 (manufacturer unknown) in the left arm and a single dose of HPV9 (manufacturer unknown) in the right arm, all 06Nov2015. Medical history and concomitant medications were not reported. The patient complained later on 06Nov2015 (Friday) that she had a swelling at the base of her shoulder and she felt sick. Over the weekend on Saturday and Sunday (07Nov2015 and 08Nov2015), the patient had fevers on and off. She took ibuprofen (manufacturer unknown) and she was presented to the office on 07Nov2015 and her shoulder looked red and it was hot to touch, according to the nurse. The patient continued to complain of sharp pain and tenderness from the shoulder to the upper neck. The patient recovered from fevers. The outcome of all over events was unknown. The doctors did not know but they suspect that all these side effects were related to the vaccines. They did not know if it was the combination of the vaccines or a single vaccine. Follow-up (07JAN2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of MMRII recombinant human albumin (rHA) status (lot# J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Wheezing
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer colleague. A female patient of unspecified age received first dose of TRUMENBA on unknown date, at single dose. Medical history and concomitant medications were not reported. The patient became very short of breath with wheezing about 12-15 hours after vaccination. The patient visited an allergist who felt that while this was a side effect to the vaccine and could reoccur (however did not call it an allergic hypersensitivity reaction). Prior to receiving second dose of TRUMENBA, she was pre-medicated with BENADRYL and provided EPIPEN. The same reaction re-occurred. This time the allergist has recommended to not proceed with further immunizations. He did not feel that skin testing or progressive dilution injections would be beneficial because of the delay in the time of the development of symptoms. Events outcome was unknown. Follow-up (24DEC2015): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Pain in extremity, Wrong drug administered
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A 23-year-old female patient (her daughter) received first dose of TRUMENBA on 04Mar2015 and the second dose on 13May2015 both at 0.5ml single dose intramuscular in the left deltoid. The third dose vaccine was due in Oct2015, but her physician did not carry the TRUMENBA, so administered meningococcal vaccine (ZAXSERO or BEXSERO) intramuscular on left arm at 1 DF single dose on 05Nov2015. Concomitant medications included  NECON for hot flashes and acne but it wasn't helping with her hot flashes and acne and AVIANE. Medical history included ongoing lactose intolerance, ongoing hormone level abnormal, ongoing hot flush and ongoing menstrual disorder. After both doses of vaccine the patient experienced arm sore. She noticed the soreness immediately after getting vaccinations. The soreness lasted almost a week after the TRUMENBA vaccines. The outcome of the event was recovered. Follow-up (31DEC2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer referring to a female consumer. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). On an unknown date, she had gotten two outbreaks of shingles after receiving the "Shingles vaccine" as well. The outcome of shingles was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Crying, Induration, Pain, Swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. A 19-year-old female patient received, on 21Aug2015, the first dose of TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Aug2015, one or two hours after the vaccination, the patient experienced severe pain, induration, swelling and crying. The patient took ALEVE for the pain. Clinical outcome of the events was unknown at time of this report. Follow-up (22JAN2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Pyrexia, Skin warm, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for two brothers. A male patient of unspecified age received the first single dose of TRUMENBA on an unknown date. Medical history and concomitant medications were not provided. After vaccination, on an unknown date, the patient experienced red, warm, swollen arms, vomiting and a high fever. Events outcome was unknown. Follow-up (22JAN2016): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL 9 (Lot # L020015 and expiry: 16-AUG-2017), route, strength and dose were not reported, which was improperly stored at 23 degrees Fahrenheit for 11 hours. The patients experienced no adverse events. There was no prior temperature excursions and nurse called because of data logger. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Disturbance in attention, Fatigue, Influenza virus test negative, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner via a company representative and from a healthcare professional on behalf of physician. A 17-year-old male patient received the first dose of TRUMENBA (lot number J28923, expiry date 30Jun2016) at 0.5 ml single, intramuscular, in left arm, on 09Dec2015 at 02:42 P.M. No other vaccine given along with the vaccine. Medical history included seasonal allergies. Concomitant medication included FLONASE daily (25 days), for 2 years. On 09Dec2015, the patient experienced achiness and extreme fatigue, raised area of redness around the injection site, 4x5 cm red/hot/tender area at vaccination site, that persisted for 48 hours with hot to touch and general lethargy. All these events recovered on 11Dec2015, Additionally it was reported that the patient did not feel on 09Dec2015 after noon but had to go back to school and then presented back at the office the next day. He could not concentrate to stay in school. On 10Dec2015 4x5 cm red/hot/tender area at vaccination site, extreme fatigue, body aches and weakness were noted. Outcome of feeling unwell, impaired concentration and vaccination site tenderness was unknown. On 10Dec2015 the patient had a flu test that resulted negative. The reporter felt that there was a causal relationship between the immunization and the reported side effects. Therapeutic measures included TYLENOL. The patient was not admitted to hospital. Follow-up (10Feb2016): New information from a contactable healthcare professional and nurse on behalf of physician includes: vaccination details, medical history, concomitant drug, additional events with relative details.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Lethargy, Malaise, Pain, Vaccination site pain, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner via a company representative and from a healthcare professional on behalf of physician. A 17-year-old male patient received the first dose of TRUMENBA (lot number J28923, expiry date 30Jun2016) at 0.5 ml single, intramuscular, in left arm, on 09Dec2015 at 02:42 P.M. No other vaccine given along with the vaccine. Medical history included seasonal allergies. Concomitant medication included FLONASE daily (25 days), for 2 years. On 09Dec2015, the patient experienced achiness and extreme fatigue, raised area of redness around the injection site, 4x5 cm red/hot/tender area at vaccination site, that persisted for 48 hours with hot to touch and general lethargy. All these events recovered on 11Dec2015, Additionally it was reported that the patient did not feel on 09Dec2015 after noon but had to go back to school and then presented back at the office the next day. He could not concentrate to stay in school. On 10Dec2015 4x5 cm red/hot/tender area at vaccination site, extreme fatigue, body aches and weakness were noted. Outcome of feeling unwell, impaired concentration and vaccination site tenderness was unknown. On 10Dec2015 the patient had a flu test that resulted negative. The reporter felt that there was a causal relationship between the immunization and the reported side effects. Therapeutic measures included TYLENOL. The patient was not admitted to hospital. Follow-up (10Feb2016): New information from a contactable healthcare professional and nurse on behalf of physician includes: vaccination details, medical history, concomitant drug, additional events with relative details.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Diarrhoea, Injection site pain, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A 18 year-old female patient of unspecified ethnicity received the first dose of TRUMENBA via an unspecified route of administration, on 23Dec2015, at a single dose. Relevant medical history and concomitant medications were not reported. About 8 hours later the vaccination, on Dec2015, the patient experienced arm very sore, and 16 hours later she had chills, she felt a lot of tingling, the brain felt tingly. On unknown date the patient was laying next to her mom and she was nauseous, she had diarrhea, the injection site was sore and fell asleep after 2 hours. The outcome of the events was unknown. Follow-up (04-FEB-2016): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 18 year-old female patient of unspecified ethnicity received the first dose of TRUMENBA via an unspecified route of administration, on 23Dec2015, at a single dose. Relevant medical history and concomitant medications were not reported. About 8 hours later the vaccination, on Dec2015, the patient experienced arm very sore, and 16 hours later she had chills, she felt a lot of tingling, the brain felt tingly. On unknown date the patient was laying next to her mom and she was nauseous, she had diarrhea, the injection site was sore and fell asleep after 2 hours. The outcome of the events was unknown. Follow-up (04-FEB-2016): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MENB
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A male patient of unspecified age and ethnicity received the first dose of TRUMENBA via an unspecified route of administration, on unknown date, at a single dose. Relevant medical history and concomitant medications were not reported. The patient experienced severe pain and limitation of arm movement on unknown date with outcome of unknown. The physician wanted to know if there were patients who have pain from one dose prone to having pain from the whole series.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Headache, Injection site erythema, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. An 18-year-old other ethnic group male patient received the first dose of TRUMENBA, intramuscular at 0.5 ml single in the left arm on 28Dec2015. The patient medical history and concomitant medications were not reported. On 28Dec2015, the patient experienced chills, pain. On 29Dec2015 he developed slight pinkness around the sight, slight fever at 99.8 degrees Fahrenheit, headache. Therapeutic measures were taken as a result of headache included ibuprofen. The outcome of the events was not recovered.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Chills, Headache, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer. An 18-year-old other ethnic group male patient received the first dose of TRUMENBA, intramuscular at 0.5 ml single in the left arm on 28Dec2015. The patient medical history and concomitant medications were not reported. On 28Dec2015, the patient experienced chills, pain. On 29Dec2015 he developed slight pinkness around the sight, slight fever at 99.8 degrees Fahrenheit, headache. Therapeutic measures were taken as a result of headache included ibuprofen. The outcome of the events was not recovered.
Sex: U
Vaccine: MENB
Symptoms: Abdominal pain upper, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from two contactable nurses via a Pfizer sales representative. The nurses reported similar events for 3 patients. This is the first of 3 reports. A patient of unspecified age, gender and ethnicity received the first dose of TRUMENBA (lot M13066) via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced faint redness and swollen at sight, fever at 101 F, stomach pain, vomiting, dizzy, severe headache, severe soreness of arm and she was nauseous. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from two contactable nurses via a Pfizer sales representative. The nurses reported similar events for 3 patients. This is the first of 3 reports. A patient of unspecified age, gender and ethnicity received the first dose of TRUMENBA (lot M13066) via an unspecified route of administration, on unknown date, at single dose. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced faint redness and swollen at sight, fever at 101 F, stomach pain, vomiting, dizzy, severe headache, severe soreness of arm and she was nauseous. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Injection site erythema, Myalgia, Pyrexia, Tuberculin test
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-years-old male patient received TRUMENBA (Lot# M13066, Expiry Date 30Sep2016), intramuscular in the left deltoid at 0.5 ml, single on 28Dec2015 between 2:30 and 3:00 PM. The patient medical history and concomitant medications were not reported. On 29Dec2015 the patient experienced felt fluish and fever with outcome of recovered, muscle aches and large area of redness around the meningococcal group b injection site with outcome of unknown. The patient had no cough or flu symptoms. The patient underwent tuberculin test with MANTOUX (Manufacturer: Sanofi Pasteur, Lot number: C4858BA), intradermal in the left arm at 0.1 ml, single on 28Dec2015. The doctor saw the patient 30Dec2015.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. A 18-year-old female patient received the first dose of TRUMENBA intramuscular, in deltoid, on 28Dec2015, at 0.5 ml, single. The patient medical history was not reported. The patient's concomitant medications were not reported. No other vaccines received on the same date. The patient experienced soreness in the injected arm, hot area around the injection site and a two inch area around the injection site raised, all in Dec2015 (on 28Dec2015 or 29Dec2015). The reporter recommended ice and ibuprofen as needed. The events resolved on 30Dec2015. The reporter considered there was a reasonable possibility that the events were related to the vaccine. No follow-ups attempts are needed. No further information expected.
Age: 24.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pediatrician via a company sales representative. A male patient in his 80s received TRUMENBA (lot# J28923, exp date Jun2016), intramuscularly in right deltoid, on 12Oct2015, at 0.5 ml single. Relevant medical history included ongoing asplenic and spherocytes from 06May2991 and unknown if ongoing. Concomitant medications were none. ON 12Oct2015 the patient experienced high fever, headache and overall myalgia. It was unknown if the patient took any treatment for high fever. The patient recovered from the events on 14Oct2015. The physician believed that the event was related to the vaccine. The reporter considered the event as related to TRUMENBA. Follow-up (29Jan2016): New information received from a contactable physician includes: vaccination site, new events, medical history added, causality assessment.
Sex: M
Vaccine: MENB
Symptoms: Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable physician and nurse via a Company representative. This physician and nurse reported for three patients, this is the 1st of 3 reports received for a male patient. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at 0.5ml single on an unspecified date for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced reaction to TRUMENBA (vaccination complication) on an unspecified date with outcome of unknown. The Pfizer Sales Representative mentioned that in the doctor's opinion the reaction was due to TRUMENBA.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 13 year old female patient. In an unknown date in 2013, the patient received one dose of GARDASIL (dose, frequency, route of administration and indication were not reported). However, the second dose administered, in approximately December 2015 (reported as 2 months ago) was GARDASIL 9 (dose, frequency, route of administration and indication were not reported). No adverse effects reported. Additional information is not expected. The reporter did not wish to be contacted.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A 12-year-old male patient, the doctor's son, received one dose of TRUMENBA (lot M13066, Expiry Date: Sep2016), intramuscular on 17Jan2016 at 0.5 ml single dose for prevention of meningococcal disease. The patient medical history and the patient's concomitant medications were not reported. The patient experienced muscle pain at site, headache and low grade fever on 17Jan2016. The outcome of the events was reported as recovered. The events were assessed as non-serious.
Sex: U
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist intern via Pfizer (company # 2016112624) referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were unspecified. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, dose and route were unknown). Concomitant medication was unspecified. On an unknown date, after receiving PNEUMOVAX 23, the patient developed swelling. The outcome of swelling was unknown. The reporter stated that since the patient had a previous reaction to PNEUMOVAX 23, he want to know if the patient could received PREVNAR 13. The causality of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
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. The patient's pertinent medical history and concurrent conditions were not reported. On 20-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, albumin status HSA, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports received from the same reporter. Additional information is not expected as no further follow-up is required.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with doses of improperly stored of VARIVAX (Merck) (lot # L018002 and expiration date on 19-MAY-2017, dose and route unknown) (Incorrect product storage). The stored temperature was 12 Fahrenheit and time frame was 96 hours. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In February 2016 (reported as starting on or after 14-FEB-2016), the patients were vaccinated with the improperly stored doses of VARIVAX (Merck) (lot # L032391, expiration date 28-AUG-2017; dose and route of administration were not reported). No adverse effects were reported. The vaccines were stored in -14 degrees of Celsius for 12 hours and 45 minutes and in -14 degrees of Celsius for 17 hours on unknown dates. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Abdominal pain upper, Dizziness, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from two contactable nurses via a Pfizer sales representative. The nurse reported similar events for 3 patients. This is the second of 3 reports. A patient of unspecified age, gender and ethnicity received the first dose of TRUMENBA (lot number M13066) via an unspecified route of administration, on unknown date, at single dose for immunization. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced faint redness and swollen at sight, fever at 101 F, stomach pain, vomiting, dizzy, severe headache, severe soreness of arm and she was nauseous. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from two contactable nurses via a Pfizer sales representative. The nurse reported similar events for 3 patients. This is the second of 3 reports. A patient of unspecified age, gender and ethnicity received the first dose of TRUMENBA (lot number M13066) via an unspecified route of administration, on unknown date, at single dose for immunization. Relevant medical history and concomitant medications were not reported. On unknown date the patient experienced faint redness and swollen at sight, fever at 101 F, stomach pain, vomiting, dizzy, severe headache, severe soreness of arm and she was nauseous. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a female nurse of unknown age, referring to herself, via a company representative. The patient had no allergies or drug reactions. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot# and expiration date were not provided). No concomitant therapies were reported. On an unknown date after vaccination, the patient developed shingles. The patient sought unspecified medical attention, but no laboratory diagnostics were performed. The outcome of herpes zoster was reported as recovered on an unknown date. The reporter did not provide a causality assessment between the event and therapy with ZOSTAVAX. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a nurse practitioner, via a company representative, referring to a 14 year old female patient. No medical history, concurrent conditions or drug reactions/allergies were reported. On 15-FEB-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # reported as 013429, expiration date 21-JUL-2017) intramuscularly (strength was not provided) in the right deltoid. This dose was reported as "the third dose", the first two doses were of the original GARDASIL. On an unknown date, she also received the flu vaccine (manufactured by sanofi) and the hepatitis A vaccine (manufactured by GlaxoSmithKline) at different injection sites. On 15-FEB-2016, on the same day of vaccination, the patient experienced syncope and tonic-clonic motions, the patient was observed by a doctor for about 30 minutes and once symptoms resolved, she was sent home from the office. It was also reported that the adverse events improved on therapy, the patient did not receive any treatment and there was not product quality complaint involved. The outcome of syncope and tonic-clonic motions was reported as recovered on 15-FEB-2016. Lot number 013429 is an invalid lot number for GARDASIL 9. The causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Device leakage, Exposure via direct contact, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist who is also the patient of unknown age reporting on herself. On 23-FEB-2016 the patient was preparing ZOSTAVAX vial (lot # L032184; expiry unspecified) (dosing regimen unspecified). No concomitant medications were reported. The pharmacist called to report that after reconstitution the ZOSTAVAX today on 23-FEB-2016 the vial leaked out of the rubber stopper while withdrawing the ZOSTAVAX solution up into the syringe. Product quality complaint filed. The pharmacist indicated that some of the ZOSTAVAX solution dripped onto her hand. Pharmacist declined to participate further in the AE report stating there were no adverse effects as result of the ZOSTAVAX dripping onto her hands. No further AE information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient (also reported as wife of the pharmacist) of unknown age. No concurrent conditions and medical history were reported. On an unknown date (also reported as a while ago) the patent was vaccinated with ZOSTAVAX vial 19400 PFU, (lot number and expiry date was unknown) (dosing regimen and frequency unknown) for an unknown indication from an unspecified doctor. No concomitant medications were reported. On an unknown date (also reported as a while ago) the patient experienced injection site redness and injection site swelling that lasted for a while. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of injection site erythema and injection site swelling is unknown. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an elderly female patient. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route and site of administration, dose, lot number and expiration date were not reported) however it is not documented in her medical record. On an unknown date, the patient developed shingles on her face and complained of pain in her face. The patient sought medical attention via physician visit and was treated with unspecified "antivirals and steroids" and gabapentin. The outcome of herpes zoster and facial pain was unknown. The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Pain, Pruritus
Clinical narrative: This literature marketed report has been received from the authors of a published article, and refers to a 76 year-old male patient. His past medical history was significant for a recent episode of allergic contact dermatitis due to poison ivy, which was managed by his primary care physician with a short seven-day taper of oral methylprednisolone. On an unknown date, within a couple of days of completing the methylprednisolone taper, the patient received (manufacturer unknown) VZV vaccine, which was administered subcutaneously into the left upper extremity (dose, lot # and expiration date were not provided). On an unknown date, the patient presented with a three day history of a vesicular rash localized to the left lateral neck, shoulder, and proximal upper extremity. The rash was not accompanied by pruritus, burning, or pain. Additionally, the patient denied experiencing prodrome symptoms, such as paresthesia, pain, burning, and/or pruritus, prior to developing the cutaneous eruption. Review of systems was unremarkable. On an unknown date, physical exam findings were significant for a confluent, erythematous, vesicular eruption in a dermatomal distribution on the left inferior/lateral neck, left clavicle, left shoulder and proximal upper extremity. These findings were consistent with herpes zoster (aka, shingles). The patient was immediately started on a seven-day course of oral valacyclovir. Since the rash was asymptomatic, no topical anti-inflammatory medications were prescribed. The patient reported improvement in the eruption within 2-3 days of starting oral valacyclovir. The rash remained asymptomatic. Of note, after starting valacyclovir, the patient indicated he experienced mild, intermittent left-sided headaches, which resolved with over-the-counter ibuprofen. Otherwise, his review of systems remained unremarkable. Of note, no samples were collected from the rash to determine if the varicella zoster virus was derived from the vaccine versus a wild-type strain. The outcome of the event was considered to be recovering/resolving. The authors considered the event of herpes zoster to be related to the therapy with Zoster Vaccine Live (manufacturer unknown) as the herpes zoster developed shortly after vaccination. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash vesicular
Clinical narrative: This literature marketed report has been received from the authors of a published article, and refers to a 76 year-old male patient. His past medical history was significant for a recent episode of allergic contact dermatitis due to poison ivy, which was managed by his primary care physician with a short seven-day taper of oral methylprednisolone. On an unknown date, within a couple of days of completing the methylprednisolone taper, the patient received (manufacturer unknown) VZV vaccine, which was administered subcutaneously into the left upper extremity (dose, lot # and expiration date were not provided). On an unknown date, the patient presented with a three day history of a vesicular rash localized to the left lateral neck, shoulder, and proximal upper extremity. The rash was not accompanied by pruritus, burning, or pain. Additionally, the patient denied experiencing prodrome symptoms, such as paresthesia, pain, burning, and/or pruritus, prior to developing the cutaneous eruption. Review of systems was unremarkable. On an unknown date, physical exam findings were significant for a confluent, erythematous, vesicular eruption in a dermatomal distribution on the left inferior/lateral neck, left clavicle, left shoulder and proximal upper extremity. These findings were consistent with herpes zoster (aka, shingles). The patient was immediately started on a seven-day course of oral valacyclovir. Since the rash was asymptomatic, no topical anti-inflammatory medications were prescribed. The patient reported improvement in the eruption within 2-3 days of starting oral valacyclovir. The rash remained asymptomatic. Of note, after starting valacyclovir, the patient indicated he experienced mild, intermittent left-sided headaches, which resolved with over-the-counter ibuprofen. Otherwise, his review of systems remained unremarkable. Of note, no samples were collected from the rash to determine if the varicella zoster virus was derived from the vaccine versus a wild-type strain. The outcome of the event was considered to be recovering/resolving. The authors considered the event of herpes zoster to be related to the therapy with Zoster Vaccine Live (manufacturer unknown) as the herpes zoster developed shortly after vaccination. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # reported as K012303, expiration date 10-MAY-2016) (dosage and strength unknown) (temperature: -10 degree centigrade, time frame: over a two day period with a cumulative of 12 hours (2 cycles)) orally. No adverse effect was reported. This is one of several reports received from the same reporter. Lot number K012303 is an invalid lot number for ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On an unknown date since 12-FEB-2016 the patient was vaccinated with a dose of VAQTA (lot # K018181 with expired date 04-JUN-2017, dose and route were unknown), which was improperly stored. No concomitant therapy was reported. The vaccine was exposed at -16.99 degrees Celsius for 16.5 hours. This temperature excursion was not supported. No adverse effects reported. The reporter stated that there was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse regarding unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with GARDASIL (Lot#K010215 and expiry: 15-MAY-2017; Lot# K008931 and expiry:  04-MAR-2017), route, strength and dose were not reported, which were improperly stored at 23 degrees Fahrenheit for 11 hours. The patients experienced no adverse events. There was no previous temperature excursions and the nurse called because of data logger. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. The patient was vaccinated with the GARDASIL injection (confirmed not GARDASIL 9) on 09-JUN-2014, 19-AUG-2014 and 22-DEC-2014 (inappropriate schedule of drug administration). No adverse symptoms were reported. No further information was provided. Product quality complaint (PQC) was not involved. 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 certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 14-OCT-2015, the patient was vaccinated with an improperly stored dose of M-M-R II recombinant human albumin (rHA) status (lot# J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.