chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; 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 16-APR-2019, the patient was vaccinated with improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAY-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011860: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011861:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; 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 19-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-00950751-1905USA004595: US-00950751-1905USA011854: US-00950751-1905USA011855: US-00950751-1905USA011856: US-00950751-1905USA011858: US-00950751-1905USA011859: US-00950751-1905USA011860: US-00950751-1905USA011861:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; 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 20-MAR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; 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 01-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011860: US-009507513-1905USA011861:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; 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 30-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011861:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of vaccine was administered to the patient; 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 01-MAY-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R024144, expiration date: 23-AUG-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: excruciating pain in the left arm; arm numb; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date unknown) for prophylaxis.   On 8th March 2019, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and numbness of upper extremities. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the numbness of upper extremities was unknown.   It was unknown if the reporter considered the pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were reported as follows: The patient experienced excruciating pain in the left arm and finally subsided at the time of reporting, two months later completely numbness there. The reporter agreed to follow up with GlaxoSmithKline.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 6th May 2019 Monday from the reporting date, the patient received 2nd dose of Shingrix The patient experienced redness and swelling at the injection site. The patient was treated with cold conpress and ibuprofen.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: Tiredness; No energy; cannot stay awake; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced tiredness, loss of energy and somnolence. On an unknown date, the outcome of the tiredness, loss of energy and somnolence were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, loss of energy and somnolence to be related to Shingrix.  Additional details were provided as follows: On 6th May 2019, the patient received the vaccine. On 8th May 2019 at the time of reporting the patient had no energy and could not stay awake. The patient asked how long tiredness lasts.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Gait disturbance, Pyrexia
Clinical narrative: shivering; running a fever; weakness; barely walk; This case was reported by a consumer via call center representative and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2019, the patient received Shingrix. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced shivering, fever, weakness and walking difficulty. On an unknown date, the outcome of the shivering, fever, weakness and walking difficulty were unknown.   It was unknown if the reporter considered the shivering, fever, weakness and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the vaccine and started shivering, running a fever and am so weak that the patient can not barely walk.  The reporter asked how long would the patient feel like this.
Sex: U
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Heart palpitations; This case was reported by a consumer via call center representative and described the occurrence of palpitation in an unspecified number of an adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced palpitation. On an unknown date, the outcome of the palpitation was unknown.   It was unknown if the reporter considered the palpitation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as an adult as per the vaccine indication. The reporter said that the physician told her that he had several patients that experienced heart palpitations after receiving the Shingrix vaccine. This case has been linked with the case US2019089966, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash papular, Rash pruritic, Skin indentation
Clinical narrative: indentation; body rash/pimple like bumps; itching bumps; This case was reported by a consumer via call center representative and described the occurrence of skin indentation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In July 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced skin indentation, papular rash and itchy rash. On an unknown date, the outcome of the skin indentation, papular rash and itchy rash were unknown.   It was unknown if the reporter considered the skin indentation, papular rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash all over the body after receiving 2nd dose of Shingrix. The patient was seen by dermatologist and it was determined that rash was not shingles. The rash were itchy along with pimple like bumps. The patient also experienced identation on her right upper leg just below the buttock.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash pruritic, Skin tightness
Clinical narrative: unusual rash/somewhat painful rash; felt "tight" itchy; stinging; tight"; This case was reported by a nurse via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced rash, itchy rash, stinging and skin tightness. On an unknown date, the outcome of the rash, itchy rash, stinging and skin tightness were unknown.   It was unknown if the reporter considered the rash, itchy rash, stinging and skin tightness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The retired nurse reportied that he experienced all the side effects listed after he got his Shingrix vaccine.  The patient also describes that he developed an unusual rash in less than a week on his back which felt tight itchy and somewhat painful and stinging after a shower.  The patient saw a dermatologist and she didn't knew what it was. The patient was asked for product lot number and expiration date, but did not have that information. He said he would try to obtain that from pharmacy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Product administered at inappropriate site
Clinical narrative: injection site tenderness; Hot; injection site redness; injection site bump/raised circular area; Wrong Route of Administration; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   On 14th May 2019 16:00, the patient received the 1st dose of Shingrix .5 ml. On 14th May 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 14th May 2019 19:00, the patient experienced injection site erythema and injection site swelling. On 15th May 2019, the patient experienced injection site tenderness and injection site warmth. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site tenderness and injection site warmth were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site tenderness and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The dose was given around 4:00 pm and was documented as being given in left deltoid. The medical assistant on the line reporting a patient was given Shingrix incorrectly. The medical assistant that administered it gave it half way down the patient's arm, it was too low which led to vaccine administered at inappropriate site. There was redness and a bump that developed around 7:00 pm the night of the injection and it was growing larger.  That night it was around 1 inch in diameter and the next morning it was around 3 inches.  The night it started, the patient held ice to it and took Advil.  The area was getting hotter and was really tender.  The patient returned the day of reporting and it was very hot with a pretty large red raised circular area.  The outcome reported for all AES in the structured field is RECOVERING/RESOLVING instead of not resolved (outcome uploaded)
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: tingling in both hands; Left arm soreness, left side, site of the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th May 2019, 5 min after receiving Shingrix, the patient experienced injection site pain. On 17th May 2019, the patient experienced tingling of extremity. On an unknown date, the outcome of the injection site pain and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. Almost immediately, after receiving Shingrix, the patient experienced a sore arm, left side, site of the injection. The patient reported that the next morning, 1 day after vaccination, she experienced tingling in both hands. The reporter gave consent to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry eye, Fatigue, Feeling hot, Headache
Clinical narrative: Tired; Body aches; Headache; Fever/feeling hot/ Warm; Shivering/Chills; Dry eyes; Trouble sleeping; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, several hours after receiving Shingrix, the patient experienced general body pain, headache, fever, shivering, eye dryness, difficulty sleeping and pain in arm. On 17th May 2019, the patient experienced tiredness. On an unknown date, the outcome of the general body pain, headache and tiredness were not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved and the outcome of the shivering, eye dryness and difficulty sleeping were unknown.   It was unknown if the reporter considered the general body pain, headache, fever, shivering, eye dryness, difficulty sleeping, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patients arm became sore soon after and lasted all day. On the day of vaccination, at 8:00 pm, the patient began to experience chills, shivering, dry eyes, and body aches. Less than a day after vaccination, the patient expereinced fever, headache and did not sleep well. The patient felt that she had a fever because she was very warm, but she did not take her temperature. The patient also had a bad headache that she described was a 7 or 8 on a scale of 1 to 10. She said that she did not sleep well last night because she woke of three times during the night feeling hot. On the day of reporting the headache was at a 2. On the day of reporting, 1 day after vaccination, she did not have chills, she felt a little achy but not as achy as day of vaccination, and she felt tired. The patient did not have a fever on the day of reporting. The reporter gave permission to contact her physician. This case has been linked to US2019073176 and US2019073187, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Middle insomnia, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Tired; Body aches; Headache; Fever/feeling hot/ Warm; Shivering/Chills; Dry eyes; Trouble sleeping; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, several hours after receiving Shingrix, the patient experienced general body pain, headache, fever, shivering, eye dryness, difficulty sleeping and pain in arm. On 17th May 2019, the patient experienced tiredness. On an unknown date, the outcome of the general body pain, headache and tiredness were not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved and the outcome of the shivering, eye dryness and difficulty sleeping were unknown.   It was unknown if the reporter considered the general body pain, headache, fever, shivering, eye dryness, difficulty sleeping, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patients arm became sore soon after and lasted all day. On the day of vaccination, at 8:00 pm, the patient began to experience chills, shivering, dry eyes, and body aches. Less than a day after vaccination, the patient expereinced fever, headache and did not sleep well. The patient felt that she had a fever because she was very warm, but she did not take her temperature. The patient also had a bad headache that she described was a 7 or 8 on a scale of 1 to 10. She said that she did not sleep well last night because she woke of three times during the night feeling hot. On the day of reporting the headache was at a 2. On the day of reporting, 1 day after vaccination, she did not have chills, she felt a little achy but not as achy as day of vaccination, and she felt tired. The patient did not have a fever on the day of reporting. The reporter gave permission to contact her physician. This case has been linked to US2019073176 and US2019073187, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Tired; Body aches; Headache; Fever/feeling hot/ Warm; Shivering/Chills; Dry eyes; Trouble sleeping; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, several hours after receiving Shingrix, the patient experienced general body pain, headache, fever, shivering, eye dryness, difficulty sleeping and pain in arm. On 17th May 2019, the patient experienced tiredness. On an unknown date, the outcome of the general body pain, headache and tiredness were not recovered/not resolved and the outcome of the fever and pain in arm were recovered/resolved and the outcome of the shivering, eye dryness and difficulty sleeping were unknown.   It was unknown if the reporter considered the general body pain, headache, fever, shivering, eye dryness, difficulty sleeping, pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patients arm became sore soon after and lasted all day. On the day of vaccination, at 8:00 pm, the patient began to experience chills, shivering, dry eyes, and body aches. Less than a day after vaccination, the patient expereinced fever, headache and did not sleep well. The patient felt that she had a fever because she was very warm, but she did not take her temperature. The patient also had a bad headache that she described was a 7 or 8 on a scale of 1 to 10. She said that she did not sleep well last night because she woke of three times during the night feeling hot. On the day of reporting the headache was at a 2. On the day of reporting, 1 day after vaccination, she did not have chills, she felt a little achy but not as achy as day of vaccination, and she felt tired. The patient did not have a fever on the day of reporting. The reporter gave permission to contact her physician. This case has been linked to US2019073176 and US2019073187, reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Malaise
Clinical narrative: headache; upset stomach; malaise; tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2019, the patient received the 1st dose of Shingrix. On 16th May 2019, 5 days after receiving Shingrix, the patient experienced headache, upset stomach, malaise and tiredness. On an unknown date, the outcome of the headache, upset stomach, malaise and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, upset stomach, malaise and tiredness to be related to Shingrix.  Additional details were provided as follows: The outcome of headache, upset stomach, malaise and tiredness was reported as not recovered, however discrepantly reported as recovering in the source document. The reporter did not consent to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Muscle spasms, Stress fracture, Transfusion, White blood cell count decreased
Clinical narrative: Lowering of white blood cell count; Condition aggravated; hairline fracture in left foot; Cramps; This case was reported by a consumer via call center representative and described the occurrence of hairline fracture in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included denosumab (Prolia) for product used for unknown indication.   The patient's past medical history included cold (in December 2018). Concurrent medical conditions included foot fracture (in January 2019, the patient had hairline fracture in right foot) and white blood cell count low (in December 2018).   On 1st February 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2018, the patient started Prolia at an unknown dose and frequency. In July 2018, the dose was changed to an unknown dose and frequency. In February 2019, less than a month after receiving Shingrix, the patient experienced hairline fracture and foot cramps. On an unknown date, the patient experienced white blood cell count low and condition aggravated. The patient was treated with blood transfusion, auxiliary products (Blood Transfusion). On an unknown date, the outcome of the hairline fracture, foot cramps, white blood cell count low and condition aggravated were unknown.   It was unknown if the reporter considered the hairline fracture, foot cramps, white blood cell count low and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The patient started Prolia last year and received one dose in January 2018 and another in July 2018.  In December 2018, she went to her physician for a cold and it was noted that she had a low white blood cell count.  In January 2019, she reported having a hairline fracture in her right foot.  In February, 2019, the patient developed another hairline fracture in her left foot. Both fractures she said were a result of sever cramping in her feet that occurred during the night over a two month period. She has had 30 vials of blood taken since December 2018. The latest vial was taken last Friday, 10th May 2019. Her white blood cell count had continued to decline and now it was at a critically low level. The physician thought the low white blood cell count could be due to Prolia. Consented to follow up. The patient gave permission for her physician to be contacted. The patient stated that she contacted the manufacturer of Prolia to let them know about her low white blood cell levels.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Product administered to patient of inappropriate age
Clinical narrative: redness; itchy; inappropriate age at vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 44-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date unknown) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced erythema of extremities, injection site itching and inappropriate age at vaccine administration. On an unknown date, the outcome of the erythema of extremities and injection site itching were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration was unknown.   It was unknown if the reporter considered the erythema of extremities and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received their first dose of Shingrix a few days ago and developed a red and itchy area in the injection site, and the redness has spread down her arm.  The redness on patients arm was receding a bit on her arm, but the symptoms around the injection site had remained the same since. The provided date of birth of the patient also indicates that the patient was younger than indicated, which led to inappropriate age at vaccine administration The reporter consented to follow up. The lot number was uncertain (wasn't available in documentation). A possible lot number 4257F was provided. The reporter gave Permission for follow-up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hip fracture, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fractured hip in a 72-year-old male patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On 10th April 2019, 343 days after receiving SHINGRIX, the patient experienced fractured hip (serious criteria GSK medically significant). On 22nd April 2019, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the fractured hip and shingles were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the fractured hip and shingles to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife. After 355 days of receiving SHINGRIX, the patient experienced shingles on his back and buttocks. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Lip swelling, Skin discolouration
Clinical narrative: Gasping for Air; Turned Grey; Hives; anaphilactic reaction; Eyelid Angioedema; Lip Swelling; Emesis; This case was reported by a physician via call center representative and described the occurrence of anaphylactic reaction in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 30th September 2012, the patient received Kinrix. On 30th September 2012, less than an hour after receiving Kinrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), eye angioedema (serious criteria GSK medically significant), lip swelling, vomiting, gasping, skin discoloration and hives. On an unknown date, the outcome of the anaphylactic reaction, eye angioedema, lip swelling, vomiting, gasping, skin discoloration and hives were unknown.   It was unknown if the reporter considered the anaphylactic reaction, eye angioedema, lip swelling, vomiting, gasping, skin discoloration and hives to be related to Kinrix.  Additional details were provided as follows: The physician reported that patient had an anaphylactic reaction to Kinrix, when given concomitantly with other vaccines. The events occurred within minutes of administration in September 2012. The physician did not had batch number or expiration date of Kinrix.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria, Vomiting
Clinical narrative: Gasping for Air; Turned Grey; Hives; anaphilactic reaction; Eyelid Angioedema; Lip Swelling; Emesis; This case was reported by a physician via call center representative and described the occurrence of anaphylactic reaction in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 30th September 2012, the patient received Kinrix. On 30th September 2012, less than an hour after receiving Kinrix, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), eye angioedema (serious criteria GSK medically significant), lip swelling, vomiting, gasping, skin discoloration and hives. On an unknown date, the outcome of the anaphylactic reaction, eye angioedema, lip swelling, vomiting, gasping, skin discoloration and hives were unknown.   It was unknown if the reporter considered the anaphylactic reaction, eye angioedema, lip swelling, vomiting, gasping, skin discoloration and hives to be related to Kinrix.  Additional details were provided as follows: The physician reported that patient had an anaphylactic reaction to Kinrix, when given concomitantly with other vaccines. The events occurred within minutes of administration in September 2012. The physician did not had batch number or expiration date of Kinrix.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: vaccinated patients were not immune by HBsAB; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to 2582 adult patients of unknown gender. The patients' concurrent conditions included chronic kidney disease (CKD). The patients' medical history and concomitant medications were not specified.  On unknown dates, the patients was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On unknown dates, the patients' Hepatitis B surface antibody (HBsAB) titer was equal or less than 12 mIU/ml. The outcome of the event was unknown. The reporter considered the event to be related to hepatitis b vaccine (recombinant) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patients' experience.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse effects were reported in the patient; the patient received a dose of MMR II via the intramuscular route; This non-valid spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information concerning the patient's pertinent medical history, concurrent conditions, concomitant medications or allergies provided.  On 04-MAY-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type rHA(lot # R031679, expiration date: 01-NOV-2020, intramuscularly(Inappropriate route of administration))(exact dose was not provided) for prophylaxis. No adverse effects were reported.  This case is non-valid due to lack of patient identifiers.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored doses of PROQUAD was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.     On 19-MAY-2019, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin, rHA) (lot # R008206 and expiration date 19- SEP-2019) (dose and anatomical location of vaccination were not reported) mixed with a properly stored sterile diluent (DILUENT MRK) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion.The call was because of a "data logger".. There were no adverse effects reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1905USA010085: US-009507513-1905USA010082: US-009507513-1905USA010081: US-009507513-1905USA010080: US-009507513-1905USA010084: US-009507513-1905USA010092: US-009507513-1905USA010083:
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: the patient was pregnant when she received a dose of VARIVAX; the patient is not experiencing any adverse effects; This prospective pregnancy report was received from a registered nurse concerning a female patient of unknown age. The patient's concurrent conditions, past medical history, concomitant medications, and drug reactions or allergies were not reported.  On an unspecified date, the patient became pregnant. Information regarding the patient's last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. On 13-MAY-2019, the pregnant patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength and dose not reported), one single injection, subcutaneously, lot # R021377 and expiration date 25-JUL-2020, for prophylaxis.  The patient was not experiencing any adverse effects. The outcome of the pregnancy was unknown.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, No adverse event, Underdose
Clinical narrative: No adverse reaction reported; The patient "pulled away" during vaccine andministration and only partial dose was administered; The patient "pulled away" during vaccine andministration and only partial dose was administered; Some of the vaccine may have gotten on the patient's skin; This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported.    On 13-MAY-2019,  the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), subcutaneously (lot #  R036581, expiration date 17-DEC-2020) (dose not reported)  for prophylaxis.  The vaccine was reconstituted with sterile diluent (lot # S008565, expiration date 09-AUG-2021).      The patient "pulled away" during administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and as a result, only a partial dose was administered. Medical assistant reported that some of the vaccine may have gotten on the patient's skin. No adverse reaction was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA009445:Original Case : 1905USA009408
Sex: F
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse reaction reported; The vaccine went onto the patient's mother's pants; she could not confirm whether this meant some of the vaccine went onto the patient's mother's skin also; This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant therapy were not reported.    On 13-MAY-2019,  the patient's children was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), subcutaneously (lot # R036581, expiration date 17-DEC-2020) (dose not reported)  for prophylaxis.  The vaccine was reconstituted with sterile diluent (lot # S008565, expiration date 09-AUG-2021).      The patient "pulled away" during administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and as a result, the vaccine went onto the patient's mother's pants; medical assistant could not confirm whether this meant some of the vaccine went onto the patient's mother's skin also. No adverse reaction was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA009408:Original Case : 1905USA009408
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Injection site discolouration, Injection site necrosis, Injection site scab, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer to a 67 year old female patient. The patient's concurrent condition included arthropathy. The patient's concomitant therapies included citalopram, omeprazole, and valacyclovir hydrochloride. The patient's medical history was not reported. The patient's historical drugs included codeine. On 23-APR-2019, the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, frequency, and route of administration were not reported; lot # R033342 and expiration date 03-AUG-2020) to prevent pneumonia. On 24-APR-2019 (reported as the next day), the patient was sick to her stomach and experiencing severe arm pain. She had a fever of 103.7. The patient vomited nonstop for 2 days. Her arm was swelled around the injection site, and she had a raised rash. She sought medical attention, hence, went to urgent care where she saw 3 physicians, who gave her cream (unspecified) for the rash and medicine for nausea. She did also see a dermatologist who told her there must have been a bad toxin (product contamination microbial) that got into the vaccine that caused her reaction. She had a large scab on the injection site that was black, the tissue there was dead and was still healing. She said her doctor told her she would have a large scar when it was completely healed. The patient's daughter took pictures of her arm.  The patient reporter she has never had a reaction to a shot before this. The outcome of nausea, injection site necrosis, rash papular, vaccination site swelling, vomiting, pyrexia, pain in extremity, abdominal discomfort and injection site scab was reported as not recovered. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review, the injection site necrosis was determined to be medically significant. Lot number was reported in the source document but the expiration date was not. But, when entering the lot number in the system automatically auto-populated the expiration date.
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain in extremity, Product quality issue, Pyrexia, Rash papular
Clinical narrative: This spontaneous report was received from a consumer to a 67 year old female patient. The patient's concurrent condition included arthropathy. The patient's concomitant therapies included citalopram, omeprazole, and valacyclovir hydrochloride. The patient's medical history was not reported. The patient's historical drugs included codeine. On 23-APR-2019, the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, frequency, and route of administration were not reported; lot # R033342 and expiration date 03-AUG-2020) to prevent pneumonia. On 24-APR-2019 (reported as the next day), the patient was sick to her stomach and experiencing severe arm pain. She had a fever of 103.7. The patient vomited nonstop for 2 days. Her arm was swelled around the injection site, and she had a raised rash. She sought medical attention, hence, went to urgent care where she saw 3 physicians, who gave her cream (unspecified) for the rash and medicine for nausea. She did also see a dermatologist who told her there must have been a bad toxin (product contamination microbial) that got into the vaccine that caused her reaction. She had a large scab on the injection site that was black, the tissue there was dead and was still healing. She said her doctor told her she would have a large scar when it was completely healed. The patient's daughter took pictures of her arm.  The patient reporter she has never had a reaction to a shot before this. The outcome of nausea, injection site necrosis, rash papular, vaccination site swelling, vomiting, pyrexia, pain in extremity, abdominal discomfort and injection site scab was reported as not recovered. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review, the injection site necrosis was determined to be medically significant. Lot number was reported in the source document but the expiration date was not. But, when entering the lot number in the system automatically auto-populated the expiration date.