chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site warmth, Mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis.  On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, immediately after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm and pain in arm. On an unknown date, the patient experienced local swelling and mass. The patient was treated with medication unknown (Cream (Medication Unknown)) and antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the erythema of extremities, skin warm and pain in arm were recovered/resolved and the outcome of the local swelling and mass were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin warm, pain in arm, local swelling and mass to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Right after receiving the vaccine, the patient experienced red hot spot below the injection site covering an area of 6 to 7 inches and also experienced soreness in arm. The patient also noticed a lump on the right arm inside of the elbow, which had decreased in size. At the time of reporting, it had decreased by half inch in size. The patient also developed another lump in between right elbow and shoulder which was the size of the marble and it felt like there was fluid in there, its size varied sometimes and at the time of reporting it was three quarters of an inch to a inch in size. The patient had visited her doctor on 16th October 2018 and had ultrasound done. The patient was given cream along with antibiotic. The patient was advised to use heating pad. The patient recovered from red hot spot within 3 to 4 weeks and from sore arm within a week. The patient visited her vascular doctor on 30th October 2018.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Skin warm, Swelling, Ultrasound scan
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 75-year-old female patient who received SHINGRIX for prophylaxis.  On 11th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 11th September 2018, immediately after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm and pain in arm. On an unknown date, the patient experienced local swelling and mass. The patient was treated with medication unknown (Cream (Medication Unknown)) and antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the erythema of extremities, skin warm and pain in arm were recovered/resolved and the outcome of the local swelling and mass were not recovered/not resolved. It was unknown if the reporter considered the erythema of extremities, skin warm, pain in arm, local swelling and mass to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. Right after receiving the vaccine, the patient experienced red hot spot below the injection site covering an area of 6 to 7 inches and also experienced soreness in arm. The patient also noticed a lump on the right arm inside of the elbow, which had decreased in size. At the time of reporting, it had decreased by half inch in size. The patient also developed another lump in between right elbow and shoulder which was the size of the marble and it felt like there was fluid in there, its size varied sometimes and at the time of reporting it was three quarters of an inch to a inch in size. The patient had visited her doctor on 16th October 2018 and had ultrasound done. The patient was given cream along with antibiotic. The patient was advised to use heating pad. The patient recovered from red hot spot within 3 to 4 weeks and from sore arm within a week. The patient visited her vascular doctor on 30th October 2018.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Feeling abnormal, Fluid retention, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67year-old male patient. The patient's concurrent conditions, medical history, allergies and concomitant therapies were not provided. On 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R012360, expiration date:15-JAN-2020) intramuscularly, for prophylaxis (dose, frequency and concentration were not provided).  On 12-DEC-2018, the patient experienced inflamed muscles in left shoulder, where the vaccines was administered (myositis), caused the patient to have limited range of motion in the left arm; then, the same date, the patient was admitted to the hospital and received unspecified treatment. It was unknown by the reporter if any laboratory tests were carried out. Additionally, the pharmacist requested a lot investigation with expedited response. On an unspecified day in December 2018, the patient was discharged from the hospital fully recovered. The causality between the events and the PNEUMOVAX 23 was not provided.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Injection site inflammation, Joint range of motion decreased, Myositis
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67year-old male patient. The patient's concurrent conditions, medical history, allergies and concomitant therapies were not provided. On 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R012360, expiration date:15-JAN-2020) intramuscularly, for prophylaxis (dose, frequency and concentration were not provided).  On 12-DEC-2018, the patient experienced inflamed muscles in left shoulder, where the vaccines was administered (myositis), caused the patient to have limited range of motion in the left arm; then, the same date, the patient was admitted to the hospital and received unspecified treatment. It was unknown by the reporter if any laboratory tests were carried out. Additionally, the pharmacist requested a lot investigation with expedited response. On an unspecified day in December 2018, the patient was discharged from the hospital fully recovered. The causality between the events and the PNEUMOVAX 23 was not provided.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67year-old male patient. The patient's concurrent conditions, medical history, allergies and concomitant therapies were not provided. On 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R012360, expiration date:15-JAN-2020) intramuscularly, for prophylaxis (dose, frequency and concentration were not provided).  On 12-DEC-2018, the patient experienced inflamed muscles in left shoulder, where the vaccines was administered (myositis), caused the patient to have limited range of motion in the left arm; then, the same date, the patient was admitted to the hospital and received unspecified treatment. It was unknown by the reporter if any laboratory tests were carried out. Additionally, the pharmacist requested a lot investigation with expedited response. On an unspecified day in December 2018, the patient was discharged from the hospital fully recovered. The causality between the events and the PNEUMOVAX 23 was not provided.
Age: 67.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Muscle oedema, Vaccination complication, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 67year-old male patient. The patient's concurrent conditions, medical history, allergies and concomitant therapies were not provided. On 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # R012360, expiration date:15-JAN-2020) intramuscularly, for prophylaxis (dose, frequency and concentration were not provided).  On 12-DEC-2018, the patient experienced inflamed muscles in left shoulder, where the vaccines was administered (myositis), caused the patient to have limited range of motion in the left arm; then, the same date, the patient was admitted to the hospital and received unspecified treatment. It was unknown by the reporter if any laboratory tests were carried out. Additionally, the pharmacist requested a lot investigation with expedited response. On an unspecified day in December 2018, the patient was discharged from the hospital fully recovered. The causality between the events and the PNEUMOVAX 23 was not provided.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Pain, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had 3 years before the time of reporting). On 7th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th December 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting and chest pain. In December 2018, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was unknown and the outcome of the nausea, vomiting and chest pain were recovered/resolved. It was unknown if the reporter considered the post herpetic neuralgia, nausea, vomiting and chest pain to be related to SHINGRIX. Additional details were reported as follows: In the evening after vaccination, the experienced nausea, vomiting and chest pain. Less than a month after vaccination, the patient had developed nerve pain along his back and side following the same area where the patient had a shingles outbreak. The patient did not have any rash or other sign of active shingles. The patient seen by his physician and diagnosed with post herpetic neuralgia. In December 2018, nausea, vomiting and chest pain were resolved. The contact details of the physician was provided. The reporter had consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest pain, Nausea, Post herpetic neuralgia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a 71-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had 3 years before the time of reporting). On 7th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th December 2018, less than a day after receiving SHINGRIX, the patient experienced nausea, vomiting and chest pain. In December 2018, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was unknown and the outcome of the nausea, vomiting and chest pain were recovered/resolved. It was unknown if the reporter considered the post herpetic neuralgia, nausea, vomiting and chest pain to be related to SHINGRIX. Additional details were reported as follows: In the evening after vaccination, the experienced nausea, vomiting and chest pain. Less than a month after vaccination, the patient had developed nerve pain along his back and side following the same area where the patient had a shingles outbreak. The patient did not have any rash or other sign of active shingles. The patient seen by his physician and diagnosed with post herpetic neuralgia. In December 2018, nausea, vomiting and chest pain were resolved. The contact details of the physician was provided. The reporter had consented to follow up.
Age: 38.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Laboratory test
Clinical narrative: Patient states the day of the injection he had pain in his right upper arm at injection site in the pain continued for 3-4 weeks. Patient states since the pain has improved, and rates pain 1/10. States the pain is worse when palpated or touched. Reports an area of induration and states he thinks the area has increased in width. States he has started an antibiotic and steroids on 12/6/18. Denies drainage, fever, chills, sweats, nausea, vomiting. Does report redness of the area at one point, however states this is no longer present. Patient sent to ER for I&D of right arm lesion. ER notified of testing/cultures the Health Department requires for the injection site.
Age: 38.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Biopsy, Incisional drainage, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Patient states the day of the injection he had pain in his right upper arm at injection site in the pain continued for 3-4 weeks. Patient states since the pain has improved, and rates pain 1/10. States the pain is worse when palpated or touched. Reports an area of induration and states he thinks the area has increased in width. States he has started an antibiotic and steroids on 12/6/18. Denies drainage, fever, chills, sweats, nausea, vomiting. Does report redness of the area at one point, however states this is no longer present. Patient sent to ER for I&D of right arm lesion. ER notified of testing/cultures the Health Department requires for the injection site.
Age: 38.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Skin lesion
Clinical narrative: Patient states the day of the injection he had pain in his right upper arm at injection site in the pain continued for 3-4 weeks. Patient states since the pain has improved, and rates pain 1/10. States the pain is worse when palpated or touched. Reports an area of induration and states he thinks the area has increased in width. States he has started an antibiotic and steroids on 12/6/18. Denies drainage, fever, chills, sweats, nausea, vomiting. Does report redness of the area at one point, however states this is no longer present. Patient sent to ER for I&D of right arm lesion. ER notified of testing/cultures the Health Department requires for the injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, for tolerance refer case US2018230497). On 17th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash were unknown. It was unknown if the reporter considered the headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on an unknown arm. On 17th December 2018 around lunch, the patient received SHINGRIX. On 18th December 2018 in morning, the patient experienced a swollen lymph node under her arm pit, headache, feels like flu, sore arm and a rash on the top of her arm around injection area. The patient got vaccination at pharmacy but did not remember the pharmacist who gave her the shot. The reporter was disappointed that, the GlaxoSmithKline was unable to provide treatment recommendations and ended the call.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Injection site rash, Lymphadenopathy, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, for tolerance refer case US2018230497). On 17th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash were unknown. It was unknown if the reporter considered the headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on an unknown arm. On 17th December 2018 around lunch, the patient received SHINGRIX. On 18th December 2018 in morning, the patient experienced a swollen lymph node under her arm pit, headache, feels like flu, sore arm and a rash on the top of her arm around injection area. The patient got vaccination at pharmacy but did not remember the pharmacist who gave her the shot. The reporter was disappointed that, the GlaxoSmithKline was unable to provide treatment recommendations and ended the call.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 55-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (1st dose received on an unknown date, for tolerance refer case US2018230497). On 17th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a day after receiving SHINGRIX, the patient experienced headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash were unknown. It was unknown if the reporter considered the headache, pain in arm, enlargement of lymph nodes, influenza like illness and injection site rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on an unknown arm. On 17th December 2018 around lunch, the patient received SHINGRIX. On 18th December 2018 in morning, the patient experienced a swollen lymph node under her arm pit, headache, feels like flu, sore arm and a rash on the top of her arm around injection area. The patient got vaccination at pharmacy but did not remember the pharmacist who gave her the shot. The reporter was disappointed that, the GlaxoSmithKline was unable to provide treatment recommendations and ended the call.
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Pyrexia
Clinical narrative: 100.5 fever @2am. 100.9  fever @5am.
Sex: U
Vaccine: PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 29-NOV-2018 the patient received improperly stored dose of PNEUMOVAX 23 (dose and route were unknown; lot # R022754, expiration date 12-JUL-2019)and ROTATEQ (dose, batch/lot number and expiration date were not provided)orally, both for prophylaxis(Product storage error). The administered doses experienced a temperature excursion ranged from 47 Fahrenheit to 77 Fahrenheit for 24 hours. No previous excursions were reported. The temperature excursions were not detected by a data logger. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-DEC-2018, the patient was vaccinated with improperly stored dose of VARIVAX (strength and dose were not reported) (lot # R018931 and expiry date: 02-JUL-2020), via subcutaneous for prophylaxis (product storage error). The vaccine vas reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was stored in between -14 degrees Celsius (C) to -10 C(14 C) for 27 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This report is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1812USA011983: US-009507513-1812USA011984: US-009507513-1812USA011985:
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 21 years old female patient. Information about the patient's concurrent condition, medical history and concomitant therapy was not reported. Approximately on an unknown date in 2011, when the patient was 14 years, 5 months old, she was vaccinated with the first dose of  hepatitis a vaccine, inactivated (manufacturer unknown) (lot#, expiration date, dose and unit were not reported) route default as intramuscular for prophylaxis. On an unspecified date one year later, when the patient was 15 years, 5 months old, she was  vaccinated with the second dose of  hepatitis a vaccine, inactivated (manufacturer unknown) (lot#, expiration date, dose and unit were not reported) route default as intramuscular for prophylaxis. On an unknown date in 2018, reported as recently, the currently 21 years old patient received an adult dose of VAQTA (lot#, expiration date, dose and unit were not reported) route default as intramuscular for prophylaxis, due to international travel. No adverse effect was provided. The outcome of the event was not reported.
Age: 0.0
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a physician) refers to a 5 day old patient. Information about the patient's concurrent conditions, medical history and concomitant therapy was not reported. On 17-DEC-2018, the patient received ROTATEQ (lot # was R005865, expiration date was 22-OCT-2019), dose, unit, frequency and indication were not reported (product administered to patient of inappropriate age). No adverse effects was reported. The outcome of the events was not reported.
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 08-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Age: 1.08
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 13-month-old patient of unknown gender. On 09-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications.  On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 27-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Seizure like phenomena
Clinical narrative: This spontaneous report was received from a consumer via company representative regarding an adult(early 50s) female patient. The patient's concomitant medications and drug reaction/allergies were unknown. The patient's past drug included PREVNAR 13. On 15-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 1 injection in her arm (dose, route, lot# and expiry date were unknown) for prophylaxis. On the same day 5 hours after vaccination, the patient had horrible reaction to vaccine. The patient experienced painful injection site redness(vaccination site pain & vaccination site erythema) and swelling in the upper arm by the top of the shoulder (vaccination site swelling). The patient also developed a fever of 100.6 degrees of fahrenheit (pyrexia) and experienced seizure like symptoms (seizure). The reporter did not know if the patient visited an emergency room because of her symptoms. No further adverse event information was provided. On an unknown date in December 2018 (3 or more days after vaccination), the outcome of seizure, pyrexia, vaccination site erythema, vaccination site pain and vaccination site swelling was reported as recovered. The causality assessment of the events was not provided with PNEUMOVAX 23. No product quality complaint was involved. Upon internal review, seizure was determined to be medically significant.
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Anxiety, Crying, Dyspnoea, Hypoaesthesia, Muscular weakness
Clinical narrative: Information has been downloaded from web (US-CHIRONMA-PHHY2014US170482). Information has been received from an other health professional referring to a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were unknown. On 29-SEP-2014, the patient was vaccinated with GARDASIL (1 dosage form, lot # J015378, expiration date was auto-generated as 09-APR-2016) intramuscularly, M-M-R II (1 dosage form, lot # J005846, expiration date was unknown) subcutaneously, MENVEO (1 dosage form, lot # M14055, expiration date was unknown) intramuscularly, HAVRIX (1 dosage form, lot # 9H9R4, expiration date was unknown) intramuscularly, poliovirus vaccine inactivated (vero)(IPOL) (1 dosage form, lot # J13821, expiration date was unknown) subcutaneously and ADACEL (1 dosage form, lot # U4875AA, expiration date was unknown) intramuscularly, all for immunisation. On 29-SEP-2014, the patient experienced anxiety, crying, decreased strength in hands moving to legs, nausea, numbness in hands moving to legs, throat fullness and trouble breathing. The outcome of all the events was reported as recovered. All the events were considered to be suspected to MENVEO by the reporter. The causality assessments between all the events and other suspect products were not reported by the reporter.   All the events were considered to be medically significant. Sender Comments: Reported events are lsited and based on the reported time-to-onset (10 minutes), possible causal association cannot be excluded, however coadministered vaccines confound causality assessment. Case will be reassessed after more details are available.
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Nausea, Throat tightness
Clinical narrative: Information has been downloaded from web (US-CHIRONMA-PHHY2014US170482). Information has been received from an other health professional referring to a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were unknown. On 29-SEP-2014, the patient was vaccinated with GARDASIL (1 dosage form, lot # J015378, expiration date was auto-generated as 09-APR-2016) intramuscularly, M-M-R II (1 dosage form, lot # J005846, expiration date was unknown) subcutaneously, MENVEO (1 dosage form, lot # M14055, expiration date was unknown) intramuscularly, HAVRIX (1 dosage form, lot # 9H9R4, expiration date was unknown) intramuscularly, poliovirus vaccine inactivated (vero)(IPOL) (1 dosage form, lot # J13821, expiration date was unknown) subcutaneously and ADACEL (1 dosage form, lot # U4875AA, expiration date was unknown) intramuscularly, all for immunisation. On 29-SEP-2014, the patient experienced anxiety, crying, decreased strength in hands moving to legs, nausea, numbness in hands moving to legs, throat fullness and trouble breathing. The outcome of all the events was reported as recovered. All the events were considered to be suspected to MENVEO by the reporter. The causality assessments between all the events and other suspect products were not reported by the reporter.   All the events were considered to be medically significant. Sender Comments: Reported events are lsited and based on the reported time-to-onset (10 minutes), possible causal association cannot be excluded, however coadministered vaccines confound causality assessment. Case will be reassessed after more details are available.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Injection site erythema
Clinical narrative: Around 730 PM I started chilling and teeth chattering, headache and queasiness began. By 9:00 PM temp was 99.9. Took TYLENOL and Ibuprofen throughout the night. Woke with temp 100. Lethargic, no energy. Continued thoughout the day, temp went up to 100.1 and on 12/28/18 my temp was gone. Yahoo. Arm is red at site of shot. Tender but tolerable. Still queasy.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lethargy, Nausea
Clinical narrative: Around 730 PM I started chilling and teeth chattering, headache and queasiness began. By 9:00 PM temp was 99.9. Took TYLENOL and Ibuprofen throughout the night. Woke with temp 100. Lethargic, no energy. Continued thoughout the day, temp went up to 100.1 and on 12/28/18 my temp was gone. Yahoo. Arm is red at site of shot. Tender but tolerable. Still queasy.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle aches, arthritic aches, low fever, fatigue came on 6 hours after the shot and is continuing the next day. I am less than 24 hours after the shot at this point.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Clumsiness, Gait disturbance, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: My daughter received her MMR vaccine on 5/18/2017 and was not sick or symptomatic prior to vaccine. The following day I noticed she was more clumsy than normal. This progressively worsened over the next couple of days where she was stumbling, running into walls and look as if she were intoxicated. A couple of days after the vaccine she broke out in hives and rash all over her body with a fever. There were no new foods to her diet or changes in her environment. Took her to the pediatrician where the denied reaction to the vaccine.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: My daughter received her MMR vaccine on 5/18/2017 and was not sick or symptomatic prior to vaccine. The following day I noticed she was more clumsy than normal. This progressively worsened over the next couple of days where she was stumbling, running into walls and look as if she were intoxicated. A couple of days after the vaccine she broke out in hives and rash all over her body with a fever. There were no new foods to her diet or changes in her environment. Took her to the pediatrician where the denied reaction to the vaccine.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hypoaesthesia oral
Clinical narrative: Chills, fatigue, right side of tongue and mouth numb, Upper lip swelling, BP- 85/56 p 96 day of reaction, BP 150/78 p 73 today.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Electrocardiogram, Electroencephalogram, Gaze palsy, Metabolic function test, Muscle twitching
Clinical narrative: Clonic jerks of the right arm. Focal Seizure, left and right face twitching. Second event of staring and leftward head and eye deviation for 1-2 minutes.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Myoclonus, Nuclear magnetic resonance imaging, Partial seizures, Staring
Clinical narrative: Clonic jerks of the right arm. Focal Seizure, left and right face twitching. Second event of staring and leftward head and eye deviation for 1-2 minutes.
Age: 1.42
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 17-month-old patient of unknown gender. On 06-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011661:
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 09-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 16-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011661:
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R I for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 25-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.