chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB) lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 10-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 8-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB, lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 8-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Age: 0.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 1-day-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 20-OCT-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain
Clinical narrative: This spontaneous report was received from a 66-year-old female patient reporting on herself. Her concurrent conditions included macular degeneration. More than 20 years ago, she had an unspecified reaction to sulfa drugs. On an unknown date in November 2017 (also reported as 31-NOV-2017), she received PREVNAR 13 in left arm. Concomitant therapies included vitamins (unspecified). On 04-DEC-2018, the patient was vaccinated with PNEUMOVAX 23, 1 injection, in the left arm (strength, route of administration, lot # and expiration date were not provided) as recommended by her clinician to avoid Pneumococcal disease. On approximately 04-DEC-2018, 5 hours after injection, the patient began to have regular discomfort such as injection site pain, soreness and muscle pain in the bicep of the arm that received the injection. She continued to have pain in the left arm that was not excruciating but made it difficult for her to lift her arm over her head or button her bra from the back. Even at the day of the report (reported as "today") she had pain, but it was joint pain in her left shoulder. The patient said that she moved her arm each day and exercised, but was surprised that she would still have pain 5 weeks after vaccination. The patient received treatment for the events. She sought medical attention: she called the physician. The outcome of the events was reported as not recovered at the time of the report. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-DEC-2018 the patient was vaccinated with PROQUAD lot # N015625 for prophylaxis. Concomitant therapies included sterile diluent. On 31-DEC-2018, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autism spectrum disorder, Crying, Speech disorder developmental
Clinical narrative: Information has been downloaded from regulatory authority (US-1577272925-2011-10148). This spontaneous report was received from a consumer concerning a 2 year old male patient. It was reported that the patient had prior vaccines at an unknown office on 14-DEC-2006, no illness at the time of vaccination was reported. The patient had 2 sisters and a half brother. The patient's concurrent conditions and concomitant medications were not reported. On 06-MAR-2007, the patient was vaccinated with ACTHIB, lot # Z1038, PEDIARIX, lot # AC21B079BA and PREVNAR 7, lot # B08655C, all vaccines per intramuscular route (strength, dose, dosage schedule, anatomical location and expiry date were not provided). Subsequently, on 09-AUG-2007, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) per unknown route (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided) and varicella virus vaccine live (oka) (strength, dose, dosage schedule, route, anatomical location, lot # and expiry date were not provided). Later, on 09-NOV-2007, the patient was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid; hepatitis a vaccine, inactivated and influenza virus vaccine (unspecified), all vaccines per unknown route (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). Also, it was reported that on an unknown date, the patient was vaccinated with poliovirus vaccine inactivated (unspecified) per unknown route (strength, dose, dosage schedule, anatomical location, lot # and expiry date were not provided). All vaccines were indicated for prophylactic vaccination. On an unspecified date in April 2009, the patient experienced autism. On unknown dates, it was reported that the patient never talk until age 2 and cried all day (also reported as was just crying all the time). No adverse events post-vaccination were reported to the treating physician during approximately the first two years of the child. At that time, the development of the child was normal. The outcome of the events was reported as not recovered. The causal relationship between the events and the suspect therapies was not reported. The agency considered autism spectrum disorder, speech disorder developmental and crying to be serious for the following reason: medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Computerised tomogram normal, Decreased appetite, Fatigue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a male patient who received SHINGRIX for prophylaxis. On 17th December 2018, the patient received SHINGRIX. On 18th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, fever, chills and appetite absent. The patient was treated with analgesic, NOS (Pain Medication). On an unknown date, the outcome of the headache, fever, chills and appetite absent were unknown. It was unknown if the reporter considered the headache, fever, chills and appetite absent to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient experienced horrific headache that lasted all week with a fever, chills and could not eat. The patient called the doctor on Friday, 21st December 2018 and went to see the her. They tested the patient for the flu which came back negative. The doctor thought it was some kind of virus going around. The patient was given a pain shot, which helped some. On Saturday, 22nd December 2018, the patient called the doctor again. She told the patient to go to the emergency room (ER). The patient got there and let them know that he had shingles vaccine. They tested the patient for the flu which was still negative and also ran a lot of blood work which also came back negative. They ran two different computerized tomogram (CT) scans. One was a regular one and another with dye which was also negative. They wanted to do a spinal tap and by that time the patient was too tired and said no. The reporter type was selected as other health professional as per specialty entered on source document.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza virus test negative, Pyrexia, Scan with contrast normal, Viral infection
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a male patient who received SHINGRIX for prophylaxis. On 17th December 2018, the patient received SHINGRIX. On 18th December 2018, 1 days after receiving SHINGRIX, the patient experienced headache, fever, chills and appetite absent. The patient was treated with analgesic, NOS (Pain Medication). On an unknown date, the outcome of the headache, fever, chills and appetite absent were unknown. It was unknown if the reporter considered the headache, fever, chills and appetite absent to be related to SHINGRIX. Additional information was provided as follows: The age at vaccination was not reported. The patient experienced horrific headache that lasted all week with a fever, chills and could not eat. The patient called the doctor on Friday, 21st December 2018 and went to see the her. They tested the patient for the flu which came back negative. The doctor thought it was some kind of virus going around. The patient was given a pain shot, which helped some. On Saturday, 22nd December 2018, the patient called the doctor again. She told the patient to go to the emergency room (ER). The patient got there and let them know that he had shingles vaccine. They tested the patient for the flu which was still negative and also ran a lot of blood work which also came back negative. They ran two different computerized tomogram (CT) scans. One was a regular one and another with dye which was also negative. They wanted to do a spinal tap and by that time the patient was too tired and said no. The reporter type was selected as other health professional as per specialty entered on source document.
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of leg pain in a male patient who received SHINGRIX for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced leg pain, muscle soreness and walking difficulty. On an unknown date, the outcome of the leg pain, muscle soreness and walking difficulty were unknown. It was unknown if the reporter considered the leg pain, muscle soreness and walking difficulty to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced leg pain, muscle soreness and found hard to walk more than a mile. For tolerance of 2nd dose, refer case US2018GSK233789.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Nuclear magnetic resonance imaging, Pain in extremity, Somnolence, Spinal disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of weakness in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018GSK233407 for tolerance of 1st dose).  On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On 27th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, sleepiness and leg pain. On an unknown date, the patient experienced spinal disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the weakness, sleepiness, leg pain and spinal disorder were unknown.  It was unknown if the reporter considered the weakness, sleepiness, leg pain and spinal disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did laboratory test X-ray and MRI to eliminate spinal issue. The patient experienced that he was feeling weak, sleepy and very sore legs. after receiving 2nd dose of SHINGRIX.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, X-ray
Clinical narrative: This case was reported by a consumer and described the occurrence of weakness in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (refer case US2018GSK233407 for tolerance of 1st dose).  On 26th December 2018, the patient received the 2nd dose of SHINGRIX. On 27th December 2018, 1 days after receiving SHINGRIX, the patient experienced weakness, sleepiness and leg pain. On an unknown date, the patient experienced spinal disorder. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the weakness, sleepiness, leg pain and spinal disorder were unknown.  It was unknown if the reporter considered the weakness, sleepiness, leg pain and spinal disorder to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did laboratory test X-ray and MRI to eliminate spinal issue. The patient experienced that he was feeling weak, sleepy and very sore legs. after receiving 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse event in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. Day before reporting, the patient had all the listed side effects (adverse event) from SHINGRIX vaccine except upset stomach. The patient asked how long could she expect to experience the effects.
Sex: M
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site tenderness, myalgia, fatigue and headache. The patient was treated with paracetamol (Tylenol) and cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site tenderness, myalgia, fatigue and headache were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site tenderness, myalgia, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no history of adverse reaction to other vaccines. The reporter was an allergist who tried to help a patient determine whether the patient should get the 2nd dose of SHINGRIX. The patient's major problem was large local reaction. The patient had symptoms of erythema, swelling and tenderness at the injection site for 10 days. The reaction started within a few hours and the size of the reaction continued to get larger and larger for 72 hours at which time it was 5 inches in diameter. The patient saw his internist at that point, he was told to take Tylenol and Zyrtec the erythema and swelling remained that 5 inch diameter size for 2 to 3 days and then slowly subsided over approximately 10 days. There was no sequelae. The patient also had symptoms of myalgias, fatigue and head ache for 2 days after the SHINGRIX injection. The patient realized that those symptoms were very common and was not concerned about them. The reporter asked the company if there was any experience with patients who had larger, longer lasting local reactions and subsequent administration of SHINGRIX likely to result in an even larger, longer lasting local reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Local reaction, Myalgia
Clinical narrative: This case was reported by a physician and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site tenderness, myalgia, fatigue and headache. The patient was treated with paracetamol (Tylenol) and cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site tenderness, myalgia, fatigue and headache were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site tenderness, myalgia, fatigue and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no history of adverse reaction to other vaccines. The reporter was an allergist who tried to help a patient determine whether the patient should get the 2nd dose of SHINGRIX. The patient's major problem was large local reaction. The patient had symptoms of erythema, swelling and tenderness at the injection site for 10 days. The reaction started within a few hours and the size of the reaction continued to get larger and larger for 72 hours at which time it was 5 inches in diameter. The patient saw his internist at that point, he was told to take Tylenol and Zyrtec the erythema and swelling remained that 5 inch diameter size for 2 to 3 days and then slowly subsided over approximately 10 days. There was no sequelae. The patient also had symptoms of myalgias, fatigue and head ache for 2 days after the SHINGRIX injection. The patient realized that those symptoms were very common and was not concerned about them. The reporter asked the company if there was any experience with patients who had larger, longer lasting local reactions and subsequent administration of SHINGRIX likely to result in an even larger, longer lasting local reaction.
Age: 7.0
Sex: M
Vaccine: MEN
Symptoms: Blister, Malaise, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of blister in a 7-year-old male patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced blister, sickness and inappropriate age at vaccine administration. On an unknown date, the outcome of the blister and sickness were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the blister and sickness to be related to Meningococcal B vaccine. Additional details were provided as follows: This case was reported by the patient's parent. It was stated that, when the patient was young, about 7 years old, the patient received Meningococcal B vaccine, which led to inappropriate age at vaccine administration. The patient experienced a bad reaction which looked like he had boiled water poured on his arm and back. The patient blistered and felt very sick for days.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included egg allergy. On 28th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, stomach pain and general body pain. On an unknown date, the outcome of the headache, stomach pain and general body pain were not recovered/not resolved. It was unknown if the reporter considered the headache, stomach pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX the patient experienced worst headache, stomachache and body aches from the study and asked how long would the side effects last.  The patient had egg sensitivity allergy and was recommended by her doctor to take the shot anyway and the patient was considering not taking the second shot.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that 2.5 weeks after receiving the vaccine, she had a bad reaction. The patient did not leave any additional details. Outbound call placed to obtain additional information, however, contact was unsuccessful.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 1-month-old male patient who received ENGERIX B pediatric (batch number GX9X5, expiry date 25th February 2021) for prophylaxis. On 16th December 2018, the patient received the 2nd dose of ENGERIX B pediatric. On 25th December 2018, 9 days after receiving ENGERIX B pediatric, the patient experienced generalized rash. On 27th December 2018, the outcome of the generalized rash was recovered/resolved. It was unknown if the reporter considered the generalized rash to be related to ENGERIX B pediatric. Additional details were provided as follows: The healthcare professional reported that the patient was seen in office on 26th December 2018. On 27th December 2018, his parents reported that rash had cleared up. There were no medical interventions/ treatments.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. On 1st November 2018, 14 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with antivirals for systemic use (Antiviral). On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient experienced an outbreak of Herpes Zoster Virus 2 weeks following 1st dose of SHINGRIX. The reporter did not provide the consent to follow up. No lot or expiry details were available. The vaccine was not given at reporter's facility and the reporter did not know where the vaccine was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 23rd January 2021) for prophylaxis. On 16th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient developed fever and the body temperature was recorded as 103 degree F within 24 hours after receiving a dose of SHINGRIX. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date) and SHINGRIX (1st dose received on an unknown date, without any adverse event). On 27th November 2018, the patient received the 2nd dose of SHINGRIX. On 27th November 2018, less than a day after receiving SHINGRIX, the patient experienced chills. On 28th November 2018, the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The reporter stated that in the evening she had chills. She went to bed and the chills were resolved by the next day of vaccination day. The reporter denied any issues with the first dose of SHINGRIX. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Discomfort, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received SHINGRIX (batch number GG2GA, expiry date unknown) for prophylaxis. The patient's past medical history included shingles (developed 5 years ago) and vesicular rash (developed 5 years ago). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 30 days after receiving SHINGRIX, the patient experienced pain, discomfort and contusion. On an unknown date, the outcome of the pain, discomfort and contusion were not recovered/not resolved. It was unknown if the reporter considered the pain, discomfort and contusion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of SHINGRIX vaccine and approximately one month later, the patient began to feel pain and discomfort like internal bruising at the same site where previous shingles outbreak had occurred. There are no external symptoms. The information was provided by consumer during phone conversation. No additional information was available.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Mobility decreased, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An elderly female patient received, on 30Jul2015, at the age of 69 years, PREVNAR 13, Lot. L77777, Expiration date: 01Jan2017) at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain through all the body that caused extreme pain at a level 9 which then impaired walking and even moving the arms much for over 1/2 of a week and was tender in the muscles for even longer. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported for a 75-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that in the allergy section of the application on the medication list the following medication was noted to HCP: PREVNAR 13. Outcome of the event was unknown. Information on lot number, batch number and expiration date has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RVX
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a two-months-old male patient who was vaccinated with a dose of PENTACEL lot C5573AA (ACT-HIB part) via intramuscular route in right thigh on 27-Dec-2018. The patient received ACT HIB from the PENTACEL and not the DTaP/IPV (lot number: C5427BA). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not reported. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; PREVNAR for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation. It is an actual medication error case due to wrong solution used in drug reconstitution and inappropriate reconstitution technique. It was reported that patient received ACT-HIB 0.5ml from the PENTACEL carton and diluted it with sterile water instead of the 0.4 % NaCl. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 28-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old male patient who received vaccine DIPHTHERIA AND TETANUS TOXOIDS instead of ADACEL. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer, number in vaccine series- 6, lot number, expiry date not reported via unknown route in unknown administration site instead of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, lot number, expiry date not reported. It was an actual medication error due to wrong vaccine administered. It was reported that a patient who received Td when they should have received ADACEL. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA000612, same reporter. This case involves a 16 years old female patient who received vaccine FLUBLOK QIV. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 20-Dec-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1818, expiry date 30-Jun-2019 via unknown route in the left deltoid. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that 16y, female, received FLUBLOK QUADRIVALENT. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 27-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA000605, same reporter. This case involves a 21 years old male patient who received vaccines FLUBLOK QIV and FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 20-Dec-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1818, expiry date 30-Jun-2019 via unknown route in the left deltoid. On unknown date in Oct-2018, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE, lot number, expiry date was not provided via unknown route at unknown administration site. It was an actual medication error due to extra dose administered. It was reported that On 20 Dec 2018 a 21y, male received a second flu vaccine of FLUBLOK QUADRIVALENT, He had already received a dose of FLUZONE QUADRIVALENT in Oct 2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Crying, Dyspnoea, Pruritus generalised
Clinical narrative: He was perfectly well prior to vaccination, breathing well with calm heart rate and rhythm and good air entry. When giving the vaccine the child remained calm and didn't even cry. A few minutes later I was summoned back to the room b/c he started crying and complaining of generalized itching, coughing and difficulty breathing. Oxygen was low 90s. I gave him 0.15 mg of epinephrine and after 10 minutes symptoms gradually resolved. After 20 minutes he was left with a residual cough but was otherwise ok. Oxygen 100%. Gave a dose of Benadryl in office and sent orapred for mom to give at home. Mom had epinephrine in the house and reviewed instructions on how to give. Discussed close observation and to call ems if symptoms return. This morning, spoke to mom who stated he was fine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injury associated with device
Clinical narrative: Patient was stuck with wifes used syringe.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Full blood count, Neutropenia
Clinical narrative: Neutropenia.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth, Mobility decreased, Oral herpes
Clinical narrative: Immediately I got a red, feverish patch about 3X3 on the area of the injection. I also began to feel achy and feverish. In 3 days I broke out in fever blisters on both sides of my mouth. My arm began to be sore and difficult to raise. At this point, almost 3 months later it is still difficult for me to raise my arm and I am being treated by a PT for a frozen shoulder. I have never had a reaction to any type of injection. I am so concerned that I will not take the second shot.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Periarthritis, Pyrexia
Clinical narrative: Immediately I got a red, feverish patch about 3X3 on the area of the injection. I also began to feel achy and feverish. In 3 days I broke out in fever blisters on both sides of my mouth. My arm began to be sore and difficult to raise. At this point, almost 3 months later it is still difficult for me to raise my arm and I am being treated by a PT for a frozen shoulder. I have never had a reaction to any type of injection. I am so concerned that I will not take the second shot.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site induration, Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: This is my second dose, first was mid August 2018, and both times I have had very intense debilitating fevers. As I write this I am on Day Two of 101-102 fever, even with Tylenol the fever doesn't break. Dose 1 I had THREE days of high fever, 2 days of low fever=5 days.  I have a hard painful knot at the injection site now, same as Dose 1.  Dose 1 I developed a huge hot rash on arm a week later, went to Urgent CAre and they were clueless, called it cellulitis and put me on 2 weeks of antibiotics. But why? Dose 1 was at hospital, Dose 2 at pharmacy, both very clean and professional. This is very very difficult.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip pruritus, Lip swelling
Clinical narrative: Patient had had hyaluronic acid lip filler to 1/2 of the lip several months prior. Patient states that the lip area that was filled became itchy and swollen.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, referring to a female patient of an unknown age. There was no information about the patient's historical conditions, concomitant therapies, drug reaction or allergies provided. On some unspecified dates, the patient was vaccinated with the first dose and second dose of RECOMBIVAX, strength:10/1.0 microgram/ml, via intramuscular, for prophylaxis (anatomical location, lot # and expiration date were not reported). At the reporting time, the nurse inquired if it is alright to give the patient the third dose of their RECOMBIVAX series if the patient has missed the 6 months dose. The patient did not receive the third dose and did not experience any adverse reaction.