chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Chest pain, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: warm/warm to the touch at injection site; Injection site swelling; feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.   Follow up information was received from consumer on 6th May 2019: Three days after receiving Shingrix, the patient experienced injection site warmth and injection site swelling. The patient had a photograph of the events and asked whome to send it. The VAERS details were updated.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth, Pain in extremity
Clinical narrative: warm/warm to the touch at injection site; Injection site swelling; feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.   Follow up information was received from consumer on 6th May 2019: Three days after receiving Shingrix, the patient experienced injection site warmth and injection site swelling. The patient had a photograph of the events and asked whome to send it. The VAERS details were updated.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: warm/warm to the touch at injection site; Injection site swelling; feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.   Follow up information was received from consumer on 6th May 2019: Three days after receiving Shingrix, the patient experienced injection site warmth and injection site swelling. The patient had a photograph of the events and asked whome to send it. The VAERS details were updated.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: warm/warm to the touch at injection site; Injection site swelling; feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.   Follow up information was received from consumer on 6th May 2019: Three days after receiving Shingrix, the patient experienced injection site warmth and injection site swelling. The patient had a photograph of the events and asked whome to send it. The VAERS details were updated.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: warm/warm to the touch at injection site; Injection site swelling; feeling painful/painful at injection site; Discomfort/ discomfort at injection site; redness/red around the injection; rash/ rash around the injection; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2019, the patient received Shingrix. In May 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort. The patient was treated with NON-DRUG THERAPY (COLD COMPRESS). On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved and the outcome of the injection site warmth, injection site swelling, injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site warmth, injection site swelling, injection site pain and injection site discomfort to be related to Shingrix.  Additional details were provided as follows: The patient experienced a red rash around the injection site that got larger. It was swollen and warm to the touch.  The pharmacist suggested to apply a cold compress to alleviate the swelling. It had gone from discomfort to being painful.  Only limited details were provided.   Follow up information was received from consumer on 6th May 2019: Three days after receiving Shingrix, the patient experienced injection site warmth and injection site swelling. The patient had a photograph of the events and asked whome to send it. The VAERS details were updated.
Sex: M
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Full blood count, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; This spontaneous report was received from a health professional (nurse) refers to a 66 year old male patient with intervertebral disc degeneration, arthralgia, hyperlipidaemia, hypothyroidism and epilepsy. The patient's concomitant medications included ascorbic acid (vitamin C), atorvastatin calcium (LIPITOR), cholecalciferol(Vitamin D3), diclofenac sodium(VOLTAREN), fluoxetine hydrochloride(PROZAC), ibuprofen, lamotrigine(LAMICTAL), levetiracetam(KEPPRA XR), levothyroxine sodium(SYNTHROID), phenobarbital, medical marijuana and ranitidine hydrochloride(ZANTAC), The patient had drug reactions or allergy to propofol. The historical drug included propofol. On 03-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dosage information were unknown, lot # S009945 and expiration date 10-AUG-2020) dose 1 via intramuscular route in his arm for prophylaxis (also reported as the right age to vaccinate). On 04-JUN-2019, the patient experienced redness, swelling, hard and painful at the site of vaccination down his arm (vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling). On an unknown date in June 2019, the patient underwent complete blood test, C reactive protein and blood test and the results were unknown of all the mentioned test. The patient sought for medical attention and visited physician office. It was reported that similar events were experienced by the other patients (1906USA005500 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking. The outcome of vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling were resolving. Causality was not provided. No product quality complaint reported.  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005500: US-009507513-1906USA005260:
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; This spontaneous report was received from a health professional (nurse) refers to a 66 year old male patient with intervertebral disc degeneration, arthralgia, hyperlipidaemia, hypothyroidism and epilepsy. The patient's concomitant medications included ascorbic acid (vitamin C), atorvastatin calcium (LIPITOR), cholecalciferol(Vitamin D3), diclofenac sodium(VOLTAREN), fluoxetine hydrochloride(PROZAC), ibuprofen, lamotrigine(LAMICTAL), levetiracetam(KEPPRA XR), levothyroxine sodium(SYNTHROID), phenobarbital, medical marijuana and ranitidine hydrochloride(ZANTAC), The patient had drug reactions or allergy to propofol. The historical drug included propofol. On 03-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dosage information were unknown, lot # S009945 and expiration date 10-AUG-2020) dose 1 via intramuscular route in his arm for prophylaxis (also reported as the right age to vaccinate). On 04-JUN-2019, the patient experienced redness, swelling, hard and painful at the site of vaccination down his arm (vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling). On an unknown date in June 2019, the patient underwent complete blood test, C reactive protein and blood test and the results were unknown of all the mentioned test. The patient sought for medical attention and visited physician office. It was reported that similar events were experienced by the other patients (1906USA005500 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking. The outcome of vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling were resolving. Causality was not provided. No product quality complaint reported.  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005500: US-009507513-1906USA005260:
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test, C-reactive protein, Full blood count, Injection site erythema, Vaccination site induration
Clinical narrative: Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; This spontaneous report was received from a health professional (nurse) refers to a 66 year old male patient with intervertebral disc degeneration, arthralgia, hyperlipidaemia, hypothyroidism and epilepsy. The patient's concomitant medications included ascorbic acid (vitamin C), atorvastatin calcium (LIPITOR), cholecalciferol(Vitamin D3), diclofenac sodium(VOLTAREN), fluoxetine hydrochloride(PROZAC), ibuprofen, lamotrigine(LAMICTAL), levetiracetam(KEPPRA XR), levothyroxine sodium(SYNTHROID), phenobarbital, medical marijuana and ranitidine hydrochloride(ZANTAC), The patient had drug reactions or allergy to propofol. The historical drug included propofol. On 03-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dosage information were unknown, lot # S009945 and expiration date 10-AUG-2020) dose 1 via intramuscular route in his arm for prophylaxis (also reported as the right age to vaccinate). On 04-JUN-2019, the patient experienced redness, swelling, hard and painful at the site of vaccination down his arm (vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling). On an unknown date in June 2019, the patient underwent complete blood test, C reactive protein and blood test and the results were unknown of all the mentioned test. The patient sought for medical attention and visited physician office. It was reported that similar events were experienced by the other patients (1906USA005500 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking. The outcome of vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling were resolving. Causality was not provided. No product quality complaint reported.  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005500: US-009507513-1906USA005260:
Sex: M
Vaccine: PPV, PPV
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; Arm was red, swollen, hard and painful at the injection site; This spontaneous report was received from a health professional (nurse) refers to a 66 year old male patient with intervertebral disc degeneration, arthralgia, hyperlipidaemia, hypothyroidism and epilepsy. The patient's concomitant medications included ascorbic acid (vitamin C), atorvastatin calcium (LIPITOR), cholecalciferol(Vitamin D3), diclofenac sodium(VOLTAREN), fluoxetine hydrochloride(PROZAC), ibuprofen, lamotrigine(LAMICTAL), levetiracetam(KEPPRA XR), levothyroxine sodium(SYNTHROID), phenobarbital, medical marijuana and ranitidine hydrochloride(ZANTAC), The patient had drug reactions or allergy to propofol. The historical drug included propofol. On 03-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dosage information were unknown, lot # S009945 and expiration date 10-AUG-2020) dose 1 via intramuscular route in his arm for prophylaxis (also reported as the right age to vaccinate). On 04-JUN-2019, the patient experienced redness, swelling, hard and painful at the site of vaccination down his arm (vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling). On an unknown date in June 2019, the patient underwent complete blood test, C reactive protein and blood test and the results were unknown of all the mentioned test. The patient sought for medical attention and visited physician office. It was reported that similar events were experienced by the other patients (1906USA005500 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking. The outcome of vaccination site pain, vaccination site induration, vaccination site erythema and vaccination site swelling were resolving. Causality was not provided. No product quality complaint reported.  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005500: US-009507513-1906USA005260:
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site induration, Local reaction, Malaise, Peripheral swelling
Clinical narrative: Fever; chills; body aches; Arm swelling; Injection site hardening; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 15th May 2021) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills, general body pain, injection site swelling and injection site induration. On an unknown date, the outcome of the fever, chills, general body pain, injection site swelling and injection site induration were unknown.   It was unknown if the reporter considered the fever, chills, general body pain, injection site swelling and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The pharmacist reported that the patient received the 1st dose of Shingrix then developed a fever, chills, body aches and localized swelling with hardening of the right arm (4 inch diameter). No additional details were provided.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; chills; body aches; Arm swelling; Injection site hardening; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 15th May 2021) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills, general body pain, injection site swelling and injection site induration. On an unknown date, the outcome of the fever, chills, general body pain, injection site swelling and injection site induration were unknown.   It was unknown if the reporter considered the fever, chills, general body pain, injection site swelling and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The pharmacist reported that the patient received the 1st dose of Shingrix then developed a fever, chills, body aches and localized swelling with hardening of the right arm (4 inch diameter). No additional details were provided.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site induration, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; Arm swelling; Injection site hardening; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date 15th May 2021) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills, general body pain, injection site swelling and injection site induration. On an unknown date, the outcome of the fever, chills, general body pain, injection site swelling and injection site induration were unknown.   It was unknown if the reporter considered the fever, chills, general body pain, injection site swelling and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right arm. The pharmacist reported that the patient received the 1st dose of Shingrix then developed a fever, chills, body aches and localized swelling with hardening of the right arm (4 inch diameter). No additional details were provided.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Hypersensitivity, Swelling of eyelid
Clinical narrative: allergic reaction; swelling of my eyelids; This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   Previously administered products included Neosporin with an associated reaction of swelling face.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced allergic reaction and swelling of eyelid. On an unknown date, the outcome of the allergic reaction and swelling of eyelid were unknown.   It was unknown if the reporter considered the allergic reaction and swelling of eyelid to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The patient had an allergic reaction to influenza vaccine. The patient experienced swelling of eyelids. The patient was tested for allergy with Flublock and the patient could take that. The patient had face swelling after taking neosporin eye drops. The patient asked if he/she could take the shingles vaccine and if neosporin is a component of Shingles vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Fatigue, Hypersomnia, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Mother calls reporting fever starting at 6 pm the evening of the vaccination and has it the next day. Fever- 101 degrees Significant swelling at site of injection and patient is complaining that his arm hurts and he doesn't want it touched, not moving it normally He was tired at 11:30 this morning/never tired then and then slept from 1:30-4:30/never sleeps 3 hrs Tired and lethargic and only wanting to sleep x 2 days No respiratory distress Day 3 after vaccination swelling better and patient less tired/lethargic
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Pyrexia
Clinical narrative: Mother calls reporting fever starting at 6 pm the evening of the vaccination and has it the next day. Fever- 101 degrees Significant swelling at site of injection and patient is complaining that his arm hurts and he doesn't want it touched, not moving it normally He was tired at 11:30 this morning/never tired then and then slept from 1:30-4:30/never sleeps 3 hrs Tired and lethargic and only wanting to sleep x 2 days No respiratory distress Day 3 after vaccination swelling better and patient less tired/lethargic
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site warmth, Myalgia
Clinical narrative: Woke up next morning with severe chills, all over muscle/joint pain and fatigue. The following day she had a huge red welt where injection was given.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Immediate post-injection reaction, Malaise, Nausea, Pallor
Clinical narrative: Immediately after giving vaccine the patient turned gray, pale, and asked to lie down. Patient stated that her stomach hurt and she might vomit.  Laid patient down on the exam table.  Got water and ice pack and had patient rest for 5 minutes.  Stayed in room with patient and mother After 5 minutes patients color returned and she felt she could sit up.  Instantly after sitting up she felt sick again and lost color.  Laid patient down again.  Called for nurse.  Began taking Vitals .  Nurse came in to exam and spoke to patient and gave her apple juice. Nurse stayed in room with patient and mother.  Let patient rest for 10 minutes and then she sat up and stayed for another 5 minutes.  No injury to patient. Provider notified and patient rechecked/monitored. Patient observed and symptoms completely resolved. Flag added to chart that patient should be monitored after any vaccine or blood draw, all reporting completed.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Skin discolouration
Clinical narrative: Immediately after giving vaccine the patient turned gray, pale, and asked to lie down. Patient stated that her stomach hurt and she might vomit.  Laid patient down on the exam table.  Got water and ice pack and had patient rest for 5 minutes.  Stayed in room with patient and mother After 5 minutes patients color returned and she felt she could sit up.  Instantly after sitting up she felt sick again and lost color.  Laid patient down again.  Called for nurse.  Began taking Vitals .  Nurse came in to exam and spoke to patient and gave her apple juice. Nurse stayed in room with patient and mother.  Let patient rest for 10 minutes and then she sat up and stayed for another 5 minutes.  No injury to patient. Provider notified and patient rechecked/monitored. Patient observed and symptoms completely resolved. Flag added to chart that patient should be monitored after any vaccine or blood draw, all reporting completed.
Sex: U
Vaccine: MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; Nurse reported that 1 dose of improperly stored PROQUAD was administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient´s pertinent medical history, concurrent conditions and concomitant therapies were not reported.     On 29-MAY-2019, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S002501 and expiration date 23-JUL-2020) 2 doses each dose 0.5 milliliter, subcutaneous for prophylaxis.  It was not reported if the sterile diluent was properly stored.   There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 18.3 degrees Fahrenheit for 8 hours and 47 minutes. Data logger was involved. There were no previous excursions reported.
Sex: F
Vaccine: VARCEL
Symptoms: General physical health deterioration, Intensive care, Pain, Peripheral swelling
Clinical narrative: clinical deterioration; Arm swelling; extreme pain; This spontaneous report was received from a pharmacist via company (ref# 2019SAO00167) and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or past medical history provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported).    On unspecified dates, she experienced swelling of the arm and extreme pain that led to clinical deterioration, and she was hospitalized in an intensive care unit (ICU).   The outcome of the events was unknown.  The causality assessment was not provided.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Death; Herpes zoster; This spontaneous report was received from a lawyer and patient's spouse regarding a case in litigation referring to male patient who would be 76-year-old. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unknown date in 2013, at  approximately age of 70, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. On an unspecified date, the patient died. The cause of the patient's death is unknown. It is unknown if an autopsy was performed. The outcome of the event herpes zoster was not reported. The reporter considered the death and herpes zoster to be related to zoster vaccine live (ZOSTAVAX).; Reported Cause(s) of Death: Death
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: ocular shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced ocular shingles. On an unspecified date, the patient was treated by a healthcare provider for ocular shingles. The outcome of the event ocular shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Post herpetic neuralgia
Clinical narrative: Herpes zoster ophtalmicus; Shingles; post herpetic neuralgia; This spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On approximately, 14-NOV-2014, at approximately age of 61, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated at a hospital for shingles, herpes zoster ophthalmic and post herpetic neuralgia resulting from his use of zoster vaccine live (ZOSTAVAX). At the time of the report, the outcome of the events was unknown. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).    Upon internal review, herpes zoster ophthalmic was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness, Deafness
Clinical narrative: hearing loss; vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unspecified age. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On 19-JAN-2016 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. Thereafter, on unknown dates he suffered from hearing loss and vision loss as a direct and proximate result of the zoster vaccine live(ZOSTAVAX) vaccine. The patient was caused to suffer serious and dangerous side effects related to the zoster vaccine live(ZOSTAVAX) vaccine and therefore sought compensatory damages as a result of the injuries sustained due to his zoster vaccine live(ZOSTAVAX) use.   Upon internal review, hearing loss and vision loss were determined to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative
Clinical narrative: positive vaccination history with MMRII and negatiev titers for measles; This spontaneous report was received from a pharmacist refers to a 50-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown.  The pharmacist reported that, on unspecified dates, the patient received age appropriate measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination (dose, frequency, route of administration, lot# and expiry unknown) for prophylaxis and had negative titers for measles (measles antibody negative). Concomitant medications included sterile diluent (DILUENT MRK INJ)  The pharmacist reported that on 30-APR-2019, the patient received a booster dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) therapy type: rHA, (dose and frequency unknown) lot# R008685, expiry: 22-MAR-2020.  Outcome of the event was unknown. Causality assessment was not reported. Product quality complaints was not involved.
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, Measles antibody negative
Clinical narrative: the patient received 3 additional doses of M-M-R II; the patient had a negative measles titer; This spontaneous report was received from a physician assistant concerning a 28-year-old female patient. The patient's pertinent medical history and concomitant therapies were reported as none. It was reported that the patient was allergic to unspecified penicillin.     The physician reported the patient received 3 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II (strength, route of administration lot number and expiration date were not reported) on unspecified dates when the patient was growing up and the patient was moving on to be a healthcare provider at age 28 years. The physician assistant stated the patient had measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) titers drawn during a physical for her school that also had a negative measles titer on 01-APR-2019. On an unknown date, the patient received 3 additional doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and then subsequently continues to have a negative measles titer. The patient sought medical attention, she received treatment and had an IGG antibody blood test (results not provided).   The outcome of measles antibody negative was reported as not recovered.  The causality assessment between the event with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: Incorrect route of product administration, Measles antibody negative, Mumps antibody test negative, Product administered to patient of inappropriate age, Rubella antibody negative
Clinical narrative: negative titres with serologic tested for measles, mumps, rubella and varicella; negative titres with serologic tested for measles, mumps, rubella and varicella; negative titres with serologic tested for measles, mumps, rubella and varicella; negative titres with serologic tested for measles, mumps, rubella and varicella; Vaccine adminisred intramuscularly; received one dose of PROQUAD at age 22 years old; This spontaneous report was received from a physician refers to a 22-year-old female patient. The patient's medical history, current conditions and concomitant medications were not reported.  On two separate unspecified dates, the patient was immunized as a child with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot number and expiration date unknown) for measles, mumps, rubella and varicella immunity.  On an unspecified date, the patient was also immunized as a child with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number and expiration date unknown) for measles, mumps, rubella and varicella immunity. On 14-MAY-2019, at 22 years of age the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number and expiration date unknown by reporter) (Product administered to patient of inappropriate age). On an unspecified date, the patient showed negative titers with serologic tested for measles, mumps, rubella and varicella. The vaccines were administered intramuscularly (Incorrect route of product administration). Blood work for measles, mumps, rubella and varicella was done. Outcome of the events were unknown. Causality of events were not reported. No PQC (product quality complaint) was filed.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; Arm was red, swollen, hard and painful at the injection site and down his arm; This spontaneous report was received from a nurse, refers to a 59-year-old male patient with hypertension, arthritis in right knee and who was overweight. The patient had drug reaction or allergies to morphine.  On 07-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and frequency unknown) lot# S009945, expiry: 10-AUG-2020, intramuscular for prophylaxis. Concomitant therapies included aspirin, chlorthalidone (HYGROTON), esomeprazole magnesium (NEXIUM), losartan, multivitamins and naproxen sodium (ALEVE).  The patient mentioned to the reporter that, on 08-JUN-2019 his arm became red (injection site erythema), swollen (injection site swelling), hard (injection site induration) and painful at the injection site (injection site pain) and down his arm (pain in extremity) after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The reporter requested a lot check on the report.  The outcome of injection site swelling, pain in extremity, injection site induration, injection site pain and injection site erythema is unknown. Causality assessment was not reported. Product quality complaints was not involved.  This is one of 3 cases with similar adverse events.; Sender's Comments:  US-009507513-1906USA005194:
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission
Clinical narrative: No adverse reaction was reported; missed their third dose of GARDASIL 9 that was supposed to occur six months after the initial dose; This spontaneous report was received from a consumer referring to her currently 16-year-old son, a male patient. His concurrent conditions, medical history, drug reactions/allergies were not reported. On an unknown date in October 2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). On an unknown date in  December 2018, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). It was reported that the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that was suppose to occur six months after the initial dose (onset date: Approximately April 2019) (product dose omission). No adverse reaction was reported. The outcome of product dose omission was unknown. No product quality complaint (PQC) was involved.  This is one of the two reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect were reported; the patient was administered one dose of PEDVAX HIB (lot, exp unknown) on 4/24/2019, and was administered the booster dose of PEDVAX HIB (lot R021083 exp 6/13/2021) on 5/24/2019; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were unknown. On 24-MAY-2019, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), injection, one dose (strength, frequency, route of administration, lot # and expiry date unspecified)  and on 24-MAY-2019, the patient administered booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), 1 dose of  lot # R021083 with expiry date 13-JUN-2021 (strength, frequency, route of administration unknown) for prophylaxis (inappropriate schedule of product administration). No adverse effects (no adverse event) were reported. The outcomes of events were unknown. No product quality complaint was involved.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission
Clinical narrative: No adverse reaction was reported; missed their third dose of GARDASIL 9 that was supposed to occur six months after the initial dose; This spontaneous report was received from a consumer referring to her currently 18-year-old son, a male patient. His concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date in October 2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). On an unknown date in  December 2018, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, unit, route, anatomical location, lot # and expiration date were not reported). It was reported that the patient missed the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that was suppose to occur six months after the initial dose (onset date: Approximately April 2019) (product dose omission). No adverse reaction was reported. The outcome of product dose omission was unknown. No product quality complaint (PQC) was involved.  This is one of the two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: one improperly stored dose of VARIVAX was administered to one patient on 6/7/2019; no adverse effect; This spontaneous report was received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R018931, expiry date 02-JUL-2020, subcutaneous for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. Temperature time frame -14 degree centigrade to -10 degree centigrade(-13.8 degree centigrade) for 6hours and 38 minutes. -50 degree centigrade to -15 degree centigrade(-14.8 degree centigrade) for 4minutes. Previous temperature excursion -50 degree centigrade to -15 degree centigrade (-14.7 degree centigrade) for 7minutes. -14 degree centigrade to -10 degree centigrade(-13.1 centigrade) for 1 hour and 22 minutes. Data logger was involved.
Age: 39.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Musculoskeletal discomfort
Clinical narrative: injection site soreness; severe pain at injection site; joint discomfort; This spontaneous report was received from a physician via company representative refers to a 39 year old female patient. The patient's concurrent conditions, concurrent conditions and concomitant medications were not reported. On 29-MAY-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, intramuscular for prophylaxis. On 29-MAY-2019, the patient experienced soreness at the injection site. On MAY-2019(reported as over the next few days), the patient developed severe pain at injection as well as joint discomfort. There was no treatment rendered for the event. Lab tests were not performed. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. The patient sought medical attention.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO ADVESRE EFFECT; improperly stored vaccine administered; This spontaneous report was received from a medical assistant refers to a 5-year-old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 15-MAY-2019, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R030801 and expiration date 22-APR-2020) (dose, units and frequency were not reported). The temperature excursion was at -14 c to -10 c (-14.4 degree centigrade (c)) for 15 minutes. The previous temperature excursion was at -9 c to -8 c (-3.2c, -7.6c) for 4 hours and 29 minutes. Data logger was no involved. No adverse effects were reported. No PQC (product quality complaint) was reported.