chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 15 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 17-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 15 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 18-SEP-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 11 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 23-OCT-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 10 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 24-OCT-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 7 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 29-OCT-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 5 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693:
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 13 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 5 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 07-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 9 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 03-DEC-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 1.58
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 19 months old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 05-DEC-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 14 months old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 05-DEC-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 2 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 11-DEC-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In late 2014, the patient developed a painful rash accompanied by persistent pain. In response to these complaints, she presented to a physician. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. ZOSTAVAX and persistent strain of herpes zoster were considered to be disabling. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from the registered nurse regarding a 12 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not provided. On 14-NOV-2018, the patient was vaccinated with improperly stored VARIVAX (product storage error) lot # N031001 and expiration date 03-NOV-2019 (doses, frequencies, routes were not provided) for prophylaxis which were reconstituted with a properly stored sterile diluent (unknown manufacturer) lot # M037021 with expiration date 04-MAY-2019. The vaccine was stored at a temperature of -9 degree Celsius to 8 degree Celsius, time frame of 2 hours and 15 minutes. The vaccine was also stored out of range at -6 degree Celsius for an approximate time of 15 minutes. There was no previous temperature excursion. Digital Data logger was involved. The date of VARIVAX storage error was 22-JUL-2018. No adverse events were reported. The outcome of the event product storage error and no adverse event were unknown. This is one of the several report received from same reporter. Sender's Comments: US-009507513-1807USA011693.
Sex: U
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a consumer and described the occurrence of white blood cell count increased in a patient who received SHINGRIX for prophylaxis. On 26th December 2018, the patient received SHINGRIX. On 2nd January 2019, 7 days after receiving SHINGRIX, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was recovered/resolved. It was unknown if the reporter considered the white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 2nd January 2019, the patient underwent a blood test and wondered if the SHINGRIX vaccine could be the cause for the elevated white blood cell count. The patient's primary care physician referred to a hematologist and wanted to offer a possible explanation because the patient felt perfectly fine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity, Vertigo, Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a 65-year-old female patient who received SHINGRIX for prophylaxis.  On 28th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 21 hrs 45 min after receiving SHINGRIX, the patient experienced abnormal vision. On 29th January 2019, the patient experienced dizziness and pain in arm. On an unknown date, the outcome of the abnormal vision and pain in arm were unknown and the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the abnormal vision, dizziness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: At 4:15 PM, the patient received SHINGRIX. The next day, at around 2 PM, the patient noticed her vision was off while she was driving home. One day after receiving SHINGRIX, by the time she got in her house things were spinning. She shut her eyes and it was better, but when she opened her eyes she started getting dizzy again. Her arm also hurts. The reporter consented to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of myalgia in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 24th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 24th December 2018, several hours after receiving SHINGRIX, the patient experienced myalgia. On an unknown date, the outcome of the myalgia was recovered/resolved. It was unknown if the reporter considered the myalgia to be related to SHINGRIX. Additional details were reported as follows: Nurse reported that the patient received SHINGRIX at about 11:30 AM. That night of vaccination, the patient woke up in the middle of the night with severe myalgia and thought she was coming down with the flu. She did not get the flu and the myalgia resolved after less than 24 hours. The reporter consented to follow up.
Sex: F
Vaccine: FLUC4
Symptoms: Apgar score normal, Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: This is a spontaneous case, initially received from other health professional on 24-Jan-2019, concerning a female neonate patient. The mother was 27-year-old female whose historical drug included SYNTHROID for thyroid. The mother's historical condition included thyroid (from an unspecified date to 31-Aug-2018). The mother had one previous pregnancy with full term live birth. The mother had no history of offspring with major congenital malformations. The mother had no relevant maternal and paternal medical history with major congenital malformations. The mother did not use tobacco, alcohol and illicit drugs during pregnancy. The mother's current condition included low iron (since an unspecified date). The mother's concomitant medications included OB complete one (as reported) for healthy pregnancy and Ferrous sulphate (reported as ferrouSul) for low iron. The mother's last menstrual period (LMP) date was 12-Apr-2018. The type of pregnancy was singleton. On 16-Oct-2018, at gestation age of 25 weeks, the fetus received FLUCELVAX QIVc [batch number: 252232, route of administration: transplacental, dose, anatomical location, and expiry date: not reported] (explicitly coded as foetal exposure during pregnancy) for an unknown indication. On an unspecified date, after vaccination, the mother had preterm labour with not resulting in live birth. 2 months and 26 days after vaccination, the mother vaginally delivered a full-term female neonate at 37.4 weeks gestation. The neonate's birth weight was 2280 grams (explicitly coded as low birth weight), head circumference was 32.5 cm and body length was 42.5 cm. The APGAR scores were 9 (one minute) and 9 (five minutes). The outcome of the event was not reported. The mother's estimated delivery date (EDD) was reported as 29-Jan-2019. This case is linked to 201805975, the corresponding maternal pregnancy report.; Reporter's Comments: A neonate female baby was delivered with low birth weight,  more than two months (2 months and 25 days) after foetal exposure of vaccine (FLUCELVAX QIVc) during pregnancy. Considering the multifactorial aetiology of the event, maternal history of low haemoglobin, thyroid disorder and long temporal relationship between vaccination to event, the company assessed causality as not related to suspect vaccine. The event foetal exposure during pregnancy was assessed as not related to suspect vaccine due to intended (prophylactic) use of the vaccine. The company assessed this case as serious (medically significant).
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Induration
Clinical narrative: Redness, induration, warmth.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal episode.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Joint stiffness
Clinical narrative: Fever (100.6), headache, joint paint and stiffness, fatigue, stomach upset, ringing in my ears. Fever treated with Tylenol-type pain med, bed rest. Fever broke to normal in 24 hours, other symptoms lessened over two days, headache and joint stiffness continues to 2/5/19.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Fever (100.6), headache, joint paint and stiffness, fatigue, stomach upset, ringing in my ears. Fever treated with Tylenol-type pain med, bed rest. Fever broke to normal in 24 hours, other symptoms lessened over two days, headache and joint stiffness continues to 2/5/19.
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Patient receiving RABIES vaccine series after being scratched by a raccoon that jumped into the family's car. After receiving the third dose in the series, patient developed a rash 1 day after the third dose was administered. Rash is described as a vague maculopapular rash to the inner thighs.  No urticaria or papules. Administration of BENADRYL prior to last injection advised.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2019, the patient was vaccinated with improperly stored VARIVAX, lot # R022116, expiration date 02-AUG-2020, subcutaneously, diluted in properly stored sterile diluent for prophylaxis. The vaccine was stored in temperature ranges 15 Fahrenheit degrees to 46 Fahrenheit degrees for 45 minutes. Previous temperature excursion was also reported in ranges 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 8 hours and 5 minutes. The temperature was measured by "data logger". No adverse effects reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1902USA000278; US-009507513-1902USA000279.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2019, the patient was vaccinated with improperly stored VARIVAX, lot # R022116, expiration date 02-AUG-2020, subcutaneously, diluted in properly stored sterile diluent for prophylaxis. The vaccine was stored in temperature ranges 15 Fahrenheit degrees to 46 Fahrenheit degrees for 45 minutes. Previous temperature excursion was also reported in ranges 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 8 hours and 5 minutes. The temperature was measured by "data logger". No adverse effects reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1901USA006124; US-009507513-1902USA000279.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2019, the patient was vaccinated with improperly stored VARIVAX, lot # R022116, expiration date 02-AUG-2020, subcutaneously, diluted in properly stored sterile diluent for prophylaxis. The vaccine was stored in temperature ranges 15 Fahrenheit degrees to 46 Fahrenheit degrees for 45 minutes. Previous temperature excursion was also reported in ranges 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 8 hours and 5 minutes. The temperature was measured by "data logger" No adverse effects reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1901USA006124; US-009507513-1902USA000278.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 17 week and 4 days old infant of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 04-DEC-2018, the patient was vaccinated with the first dose of ROTATEQ, orally, lot # R015439, expiration date 19-APR-2020 for prophylaxis. There was no adverse effect reported. The outcome of product administered to patient of inappropriate age was unknown.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Complex regional pain syndrome, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of reflex sympathetic dystrophy in a 63-year-old male patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. Concomitant products included SHINGRIX. On 30th October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced reflex sympathetic dystrophy and pain. On an unknown date, the outcome of the reflex sympathetic dystrophy and pain were unknown. It was unknown if the reporter considered the reflex sympathetic dystrophy and pain to be related to SHINGRIX. Additional details were reported as follows: On 27th August 2018, the patient received 1st dose of SHINGRIX (batch number: JC92P, expiry date: 22nd November 2020) The physician reported that, the patient diagnosed with reflex sympathetic dystrophy (RSD) had experienced worsening RSD symptoms followed with completion of the SHINGRIX 2 dose series. The call center representative was listed both doses of SHINGRIX due to concern of a cumulative effect and adverse event was reported as Pain-RSD. The reporter consented to follow up. The reported lot number (EH927) for SHINGRIX did not exist and was updated to EH9Z7, according to sales datasheet.
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced slight flu symptoms from flu vaccines in the past. The patient was unsure which vaccine she received. The reporter did not provide any further details.
Age: 47.0
Sex: M
Vaccine: ANTH, IPV, MMR, TYP
Symptoms: Diarrhoea, Dizziness
Clinical narrative: Extreme diarrhea, dizziness.
Age: 21.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No outcome, or symptoms.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia
Clinical narrative: I had my second shingles shot on Friday, February 1, 2019 at approximately 11:30 am. I then played bridge about 1:00 pm  and the longer I sat there the more my joints ached, starting at my neck and  shoulder  joints; then I had severe pains in all my joints. It was so debilitating that by 3:34 pm I had to be helped to my car. Upon arriving home I took an Aleve, but the pain lasted throughout the day and kept me awake Saturday night. It had eased up considerably by Sunday but I felt like I'd been beat up! I've only had one other reaction to a shot like that following my second infusion of chemo, followed by a patch. I was told to take an antihistamine three days before the next infusion and I never had that reaction again. My last chemo infusion was March 2018.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, puffy, warm spot around injection, itchy, and painful. Instructed to use antihistamine and anti-inflammatory. Employee admitted to only taking at night and symptoms not resolving. Instructed to take around the clock and symptoms disappeared in 24 hours after following instructions.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Red, puffy, warm spot around injection, itchy, and painful. Instructed to use antihistamine and anti-inflammatory. Employee admitted to only taking at night and symptoms not resolving. Instructed to take around the clock and symptoms disappeared in 24 hours after following instructions.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Swelling and pain at injection site from the beginning, especially when pressure applied: diminished over six days. Low grade fever night and day following injection, treated with Tylenol and didn't return. Redness of upper arm - mostly below the injection site: showed up day after injection and diminished over five days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Palpitations
Clinical narrative: Patient felt palpitations and dizziness 5 minutes after vaccine administered. Symptoms lasted 5 minutes.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen, hot, painful arm. Very significant fatigue.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Peripheral swelling, Rash macular, Swelling
Clinical narrative: Swelling to right arm extending into fingers and into right lateral breast. Tenderness at site with splotchy skin.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported pain and swelling in arm since injection, was seen by physician 2/4/19, he determined it was an allergic reaction to shot and gave Prednisone 20mg on 2/4/19.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Pruritus
Clinical narrative: On 1/22/2019 after a couple of hours of vaccination, patient started to feel itchy and was starting to have difficulty in swallowing. Patient drove herself to the ER for medical attention. Patient said that she was given steroids and diphenhydramine at the ER. She felt relief and was discharged the same day. Patient reported event on 2/4/2019 to Pharmacy.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Epistaxis, Fatigue, Jaundice, Nausea
Clinical narrative: Within an hour of injection he became very weak, achy and nauseous. Within 3 hours he was running a fever. By the next morning he was having severe nose bleeds. In the 4-5 days span he experienced 5-6 very heavy nose bleeds and by day number 4 was mildly jaundice. He had symptoms for 4-5 days. He had unusual fatigue for over a week. He had not been around anyone else sick prior. His brother received vaccine same day and time and had same symptoms but on a much milder level. His brother, age 11 at the time had symptoms for 2 days. He also had nose bleeds but only 2-3 times. No jaundice noticed.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Pain, Pyrexia
Clinical narrative: Within an hour of injection he became very weak, achy and nauseous. Within 3 hours he was running a fever. By the next morning he was having severe nose bleeds. In the 4-5 days span he experienced 5-6 very heavy nose bleeds and by day number 4 was mildly jaundice. He had symptoms for 4-5 days. He had unusual fatigue for over a week. He had not been around anyone else sick prior. His brother received vaccine same day and time and had same symptoms but on a much milder level. His brother, age 11 at the time had symptoms for 2 days. He also had nose bleeds but only 2-3 times. No jaundice noticed.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 16-year-old male patient. His concurrent conditions, past medical history, concomitant medications or drug reactions and allergies were not reported. On 25-JAN-2019, the patient was inadvertently vaccinated with an adult dose of VAQTA (exact dose, route and site of administration were not reported) lot # R018775, expiry date 09-AUG-2019 for prophylaxis. No adverse effects were reported. The outcome of the incorrect dose administered was unknown.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse regarding a 4 year old Child patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 06-AUG-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. Sender's Comments: US-009507513-1807USA011693; US-009507513-1902USA001123; US-009507513-1902USA001140; US-009507513-1902USA001126; US-009507513-1902USA001137; US-009507513-1902USA001119; US-009507513-1902USA001124; US-009507513-1902USA001133; US-009507513-1902USA001132; US-009507513-1902USA001135; US-009507513-1902USA001136; US-009507513-1902USA001125; US-009507513-1902USA001129; US-009507513-1902USA001134; US-009507513-1902USA001139; US-009507513-1902USA001138; US-009507513-1902USA001120; US-009507513-1902USA001127; US-009507513-1902USA001131; US-009507513-1902USA001122; US-009507513-1902USA001121; US-009507513-1902USA001142; US-009507513-1902USA001130; US-009507513-1902USA001141.
Age: 0.5
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: This is a spontaneous report from a contactable physician.  A 6 month old male patient received TRUMENBA (Lot Number: T52805, Expiry date: Aug2019, NDC number: 0005-0100-01) intramuscular in the left thigh at 0.5 ml single dose on 02Jan2019 at 09:00 for immunisation. The patient medical history none. The patient had no concomitant medications. The patient previously took PENTACEL (Sanofi, Lot number: UI969AB) IM in the left thigh on 19Dec2018, ROTATEQ (Merck, Lot number: RQ156Q7), oral on 19Dec2018, FLUZONE (Sanofi, Lot number: UT6315RA), IM in the right thigh on 19Dec2018. On 02Jan2019, the patient inadvertently received a dose of TRUMENBA / was given product by mistake. The reporter queried what safety concerns should be on the lookout for. Reporter clarified the patient was scheduled to receive PREVNAR but he ended up not getting it because he was given the TRUMENBA by mistake. Upon follow-up on 23Jan2019, it was reported that patient experienced fever following vaccine: T 101.1 in office/ 102.3 at home. Patient received MOTRIN orally on 03Jan2019 for fever. Follow-up (02Jan2019): New information obtained from a contactable physician includes: Patient's details, event details, date of adverse event, TRUMENBA Lot number and expiry date, no concomitant and medical history. No follow-up attempts are needed. No further information is expected. Follow-up (23Jan2019): New information received from a contactable physician in response to HCP letter includes: suspect drug detail (dose, route, time of vaccination, anatomical location), past drug medications (PENTACEL, ROTATEQ, FLUZONE), new adverse event (fever).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into the pharmacy on 2/6/19 asking to show the pharmacist her arm. She had a swollen area 2 to 3 inches in diameter that was red and hot to touch where she had been given the vaccine. The patient stated she had been putting an ice pack on it and was asking what else she could do. The pharmacist told her she could take Benadryl and watch it. If it became painful or the area moved, the pharmacist asked the patient to call her doctor. The pharmacist asked the patient if she could call the pharmacy the next day to discuss how it was doing. The pharmacist spoke to the patient on 2/5/19 and patient stated it was no longer warm to touch or as swollen as before. The patient stated she felt fine and it was getting better.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Hyperaesthesia
Clinical narrative: Skin sensitivity; fatigue; joint pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Fever 102F, chills, headache, body aches, nausea, malaise for 2 days; swollen, red, painful, itchy large lump (whole upper arm) at injection site for two weeks, lessening over the two weeks but redness & itch remaining for 2 weeks.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Malaise, Nausea, Pain
Clinical narrative: Fever 102F, chills, headache, body aches, nausea, malaise for 2 days; swollen, red, painful, itchy large lump (whole upper arm) at injection site for two weeks, lessening over the two weeks but redness & itch remaining for 2 weeks.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102F, chills, headache, body aches, nausea, malaise for 2 days; swollen, red, painful, itchy large lump (whole upper arm) at injection site for two weeks, lessening over the two weeks but redness & itch remaining for 2 weeks.
Age: 1.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Crying, Injection site pain, Injection site swelling, Pyrexia, Weight bearing difficulty
Clinical narrative: Vaccines administered into left and right thighs approximately 1:15pm. About 4 hours later, child appeared to develop severe pain in left leg with continuous crying, redness/swelling at injection site, low grade fever, and inability to bear weight through extremity for several hours. Child was given a warm bath, MOTRIN, and cold compresses, followed by TYLENOL after no relief.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient was administered ZOSTAVAX 12/16/2008 then SHINGRIX 10/04/2018 and the second dose on 12/29/2018 - Patinet was diagnosed with shingles on 02/01/2019.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported erythema and itching at the injection site, several days after vaccination. Patient did not take any medications or seek medical care. Symptoms subsided within 24 hours on its own.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, severe burning sensation in my legs, sore arm, severe nausea.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Pain, Pyrexia
Clinical narrative: The evening after the vaccine, the patient developed fever, chills, aches/ pains that lasted through the next day. 2 days after vaccine, pt developed what is described as arthritic pain in her fingers, thumb, neck, waist. Pt reported it to me on 02/04/2019 and says the arthritic pain travels from place to place and hands were worse while I was talking to her. She states that ibuprofen helps with the arthritic pain. Pt spoke to her physician on 02/04/2019 and physician counseled her that the pain is due to the vaccine and should resolve by the end of this week.
Age: 16.0
Sex: F
Vaccine: FLU4, IPV, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Pallor
Clinical narrative: Flu vaccine and polio vaccine given first in left deltoid with client sitting on exam table. Within 10 seconds of administration of both vaccines client stated she felt dizzy. I observed her eyes roll in the back of her head and stood in front of her to lie her down gently on the exam table. Client had pale face and overall appearance. Client woke up shortly, within about 10 seconds. Remaining vaccines were given to client in right deltoid while client remained supine. Client stayed in supine position for 10 minutes then sat up for 10 minutes and drank water. Client regained color in her face and stated that she felt much better. Client's mother in attendance during vaccine administration.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: It was noticed that patient was administered PCV 13 1 year after 1st dose of PCV 13 after the age of 65 instead of the follow up PPSV23.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Injection site erythema, Mobility decreased, Wheezing
Clinical narrative: Chills, cough, wheezing, redness at injection site (about 1 1/2 inches around injection site), couldn't lift arm. Reactions were more severe with the second dose than with the first dose.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Pain, rash.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Rash, Visual impairment
Clinical narrative: Information regarding a case in litigation has been received from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the male patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the ZOSTAVAX (date unknown), the patient suffered a painful zoster rash, followed by vision problems which ultimately resulted in him losing his vision in his right eye. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, loss of vision in his right eye was determined to be medically significant. Vision problems, loss of vision in his right eye, and painful zoster rash were considered to be disabling. Additional information has been requested.