chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 07-OCT-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, she was treated by a healthcare provider at a hospital, for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: adverse reaction or side effect: none; date of vaccination: get every year; This spontaneous report was received from a consumer regarding a currently 68-year old female patient. The patient's concurrent and historical conditions, and concomitant medications could not be identified.  On an unspecified date the patient experienced neuropathy peripheral, vaccination failure and herpes zoster (all captured in MARRS# 1707USA010512).  It was reported that the patient was vaccinated every year with a pneumonia vaccine (manufacturer unknown) (vaccination regimen, lot #, and expiration date were not provided) for prophylaxis (Inappropriate schedule of product administration) with no adverse reaction or side effect (No adverse event). ; Sender's Comments:  US-009507513-1707USA010512:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported.; the patient received an improperly stored doses of VARIVAX on 15-JUL-2020; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 15-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, for prophylaxis (lot number S031495 which has been verified to be valid, expiration date reported as 06-OCT-2021, but upon internal validation established as 07-OCT-2021) (dosage, vaccination scheme, route of administration and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 6 degrees Fahrenheit (F) to 14 F (10.3 F), during a time frame of 46 minutes, as recorded by a digital data logger. There was a previous temperature excursion reported of 47 F to 77 F (52.1 F), during a time frame of 3 hours. No adverse symptoms were reported in the patient.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: a patient received a dose of ROTATEQ at 2 months old and again at 8 months 9 days; No other adverse effects were reported in the patient.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered, as prophylaxis (dosage regimen, vaccination scheme, lot number and expiration date were not reported), at the age of 2 months old.  On an unspecified date, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (ml) orally administered, as prophylaxis (lot number 1684151 which has been verified to be valid, expiration date reported and validated as 23-JUN-2021) (vaccination scheme was not reported), at the age of 8 months and 9 days old (inappropriate schedule of product administration). No other adverse effects were reported in the patient.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: an unspecified patient was administered an expired dose of MMR II; The patient experienced no symptoms; This spontaneous report was received from a nurse, referring to a child patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified date, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (strength, dose, vaccination scheme, anatomical site of injection, route of administration, lot number and expiration date were not reported) as prophylaxis (expired product administered). Also, the use of a sterile diluent (DILUENT MRK) was reported. The patient experienced no symptoms.
Age: 38.0
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported; the patient was inadvertently administered an expired dose ofVAQTA (Lot: S012250, Exp: 07/07/2020) on 07/14/2020; This spontaneous report was received from a medical assistant referring to a 38-year-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 14-JUL-2020, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated(VAQTA) (lot # S012250 with expiration date 07-JUL-2020; dose detail, frequency and route were not reported) for prophylaxis (expired product administered). No adverse symptoms were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S012250; expirationdate: 07-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: shot area became very red; shot area became very red and angry; shot area became very red and angry and felt hot to the touch.; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced injection site erythema, injection site discomfort and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site discomfort and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site discomfort and injection site warmth 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 was captured as adult as per the vaccine indication. About a week after getting Shingrix, the patient received regular allergy shot. About an hour later the shot, the are became very red and angry and felt hot to the touch. The patient was aksing, was this common and if it was caused by allergy shot.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Get sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient got sick evetime after she or he got a flu shot.
Sex: U
Vaccine: VARZOS
Symptoms: Lichenoid keratosis, Rash
Clinical narrative: lichenoid skin rash; This case was reported by a consumer via interactive digital media and described the occurrence of skin rash in a adult patient 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 skin rash. On an unknown date, the outcome of the skin rash was unknown.   It was unknown if the reporter considered the skin rash 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 was captured as adult as per the vaccine indication. After receiving Shingrix, the patient experienced lichenoid skin rash.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Tiredness; sleeping all day; Warm and hot to touch; Swollen; Rash; Itching; Pain in arm; Headache; suspects injection was not administered intramuscularly; Localized reactions; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2020, the patient received the 1st dose of Shingrix. On 9th July 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 10th July 2020, the patient experienced injection site warmth, injection site swelling, rash, pruritus, pain in arm and headache. On 11th July 2020, the patient experienced tiredness and sleepiness. In July 2020, the patient experienced local reaction. The patient was treated with non-drug therapy (Cold Compress). On 12th July 2020, the outcome of the tiredness was resolved with sequelae and the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site swelling, rash, pruritus, pain in arm and local reaction were recovering/resolving and the outcome of the headache was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site warmth, injection site swelling, rash, tiredness, pruritus, pain in arm, headache, local reaction and sleepiness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but patient was over 65 years old. The next morning after receiving vaccine, the patient had a mild headache. Later on, consumer reported developing pain in left arm and then itching. The patient observed her arm in the mirror and noticed a rash 2 x 3 inches in area approximately 1 inch below the injection site. She suspected injection was not administered intramuscularly as indicated in Shingrix prescribing information, which led to intramuscular formulation administered by other route. The patient described area as swollen, both warm and hot to touch and itching increased with each day. On Saturday 11th July 2020, consumer reported extreme tiredness and sleeping all day which was resolved by Sunday morning. Headache resolved at an unspecified time. Localized reactions not resolved but becoming better. The patient's doctor recommended cold compresses. The reporter did not consent to follow up. Consumer declined to provide demographic information and health care professional follow up. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash, Somnolence
Clinical narrative: Tiredness; sleeping all day; Warm and hot to touch; Swollen; Rash; Itching; Pain in arm; Headache; suspects injection was not administered intramuscularly; Localized reactions; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2020, the patient received the 1st dose of Shingrix. On 9th July 2020, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 10th July 2020, the patient experienced injection site warmth, injection site swelling, rash, pruritus, pain in arm and headache. On 11th July 2020, the patient experienced tiredness and sleepiness. In July 2020, the patient experienced local reaction. The patient was treated with non-drug therapy (Cold Compress). On 12th July 2020, the outcome of the tiredness was resolved with sequelae and the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the injection site warmth, injection site swelling, rash, pruritus, pain in arm and local reaction were recovering/resolving and the outcome of the headache was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site warmth, injection site swelling, rash, tiredness, pruritus, pain in arm, headache, local reaction and sleepiness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, but patient was over 65 years old. The next morning after receiving vaccine, the patient had a mild headache. Later on, consumer reported developing pain in left arm and then itching. The patient observed her arm in the mirror and noticed a rash 2 x 3 inches in area approximately 1 inch below the injection site. She suspected injection was not administered intramuscularly as indicated in Shingrix prescribing information, which led to intramuscular formulation administered by other route. The patient described area as swollen, both warm and hot to touch and itching increased with each day. On Saturday 11th July 2020, consumer reported extreme tiredness and sleeping all day which was resolved by Sunday morning. Headache resolved at an unspecified time. Localized reactions not resolved but becoming better. The patient's doctor recommended cold compresses. The reporter did not consent to follow up. Consumer declined to provide demographic information and health care professional follow up. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved in narrative.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Flu-like Symptoms; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 13th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 14th July 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and fatigue. On an unknown date, the outcome of the influenza-like symptoms and fatigue were recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms and fatigue to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient was fatigued and having flu-like symptoms The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: a rash of the arm and legs; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient developed a rash of the arm and legs. No additional information was provided. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pneumonia
Clinical narrative: pneumonia; first dose of the Shingrix vaccine on 01/15/2020; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In May 2020, between 3 and 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant). On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the pneumonia and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pneumonia to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of the Shingrix vaccine and in May 2020, she was admitted to the hospital with pneumonia. The day of reporting was her 6th month mark and she did not receive her second dose yet and also did not know when she would receive it which, led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness in his arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised, white blood cell count decreased and shoulder operation (little usage of left arm due to shoulder surgery).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix six months ago and experienced soreness in his arm the following day after receiving the vaccine.   The soreness resolved after two days. The reporter did not consent to follow up. No follow up was requested.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Pain
Clinical narrative: body ache, slight headache, dry mouth.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Fatigue, Feeling hot, Pain, Pain in extremity
Clinical narrative: Sore arm, diarrhea, body aches, tired, feels warm
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling face
Clinical narrative: Pt reported one sided swelling of the face under her eye/over her cheek and states that it is very itchy.  Pt states that sx began following receipt of 2nd zoster recombinant series.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Patient received MCV4 vaccine and PPD, while checking out of the office patient had a syncope event. 911 was called and patient was taken to the hospital by ambulance.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: sore arm not long after given the vaccine followed by headache, body aches, chills, fever, nausea approximately 12 hours after getting the vaccine
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: sore arm not long after given the vaccine followed by headache, body aches, chills, fever, nausea approximately 12 hours after getting the vaccine
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: No adverse event
Clinical narrative: no AE; pneumonia vaccine and shingles vaccine administered on the same day; This spontaneous report as received from a lawyer refers to a 65-year-old female patient. The patient smoked cigarettes. Her concurrent conditions included pain, hot flush, high cholesterol, and fibromyalgia. The patient's medical history included shingles, pneumonia, varicella type rash, herpes zoster ophthalmicus, post herpetic neuralgia, hypertension, headache, stomach disorder, chickenpox, traumatic brain injury, depression and anxiety. Her concomitant therapies included influenza virus vaccine (unspecified) (manufacturer unknown), sumatriptan (IMITREX), duloxetine hydrochloride (CYMBALTA), estradiol acetate (FEMRING) and tramadol hydrochloride (ULTRAM).  On 28-OCT-2019, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On the same day, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (contraindicated product administered). There was no adverse event reported.  This is one of two cases concerning the same patient (case in litigation, # 1811USA008725).; Sender's Comments:  US-009507513-1811USA008725:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a medial group for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not reported. Causality was related.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not reported. Causality was related.
Age: 1.0
Sex: F
Vaccine: HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash vesicular
Clinical narrative: appetite absent; lethargy; fever; vesiculat rash; Information has been downloaded from Agency(HQ6120719JAN2001).  This spontaneous report was received from a healthcare professional referring to a 12-month-old female patient. The patient's medical history, and concurrent conditions were not disclosed, her concomitant therapies included albuterol (reported as salbutamol).  On 30-NOV-2000, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form, administered via subcutaneous route, lot number 1139K, expiration date not reported but upon internal validation was established as 20-JUL-2002. On that same day she was also vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) 1 dosage form, administered via subcutaneous route, lot number 472-543 (expiration date not provided); haemophilus b conjugate (meningococcal protein conjugate) and hepatitis b (recombinant) vaccine (COMVAX) 1 dosage form, administered intramuscularly, lot number 1173K, expiration date not reported but upon internal validation was established as 06-FEB-2003; poliovirus vaccine inactivated (unspecified) (reported as POLIO VACCINE PASTEUR) 1 dosage form, administered via subcutaneous route, lot number T0161 (expiration date not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 1 dosage form, administered via subcutaneous route, lot number 1169K, expiration date not reported but upon internal validation was established as 26-JUL-2002. All these vaccines were administered as immunization (strengths, dose numbers, frequencies, and anatomical vaccination sites were not reported).  On 01-DEC-2000, the patient experienced fever (pyrexia) and vesicular rash (rash vesicular). On 06-DEC-2000, the patient had appetite absent (decreased appetite) and experienced lethargy.  On an unspecified date in December 2000, the patient had to be hospitalized due to these events.   At the reporting time, the outcomes of the events pyrexia, lethargy, decreased appetite and rash vesicular were unknown.  The causality assessment between the suspect therapies and the aforementioned events was not reported.  This is a new safety report and has been created due to safety report US-009507513-2007USA002568 having been submitted with an incorrect WWID reference HQ6120719JAN2001 that does not refer to an existing case. Case US-009507513-2007USA002568 will be nullified. The correct WWID US-009507513-2007USA007762 is referenced within this safety report and will be kept as the master case file.
Sex: U
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Sleep disorder
Clinical narrative: avoid lifting my arms very high; pain at they gave me the shots / pain is not as sever; avoid lifting my arms very high and they hurt enough to make me wait up in night; make me wait up in night; This case was reported by a other health professional via interactive digital media and described the occurrence of injected limb mobility decreased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, pain in arm and sleep disturbance. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, pain in arm and sleep disturbance were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, received 2nd dose in may 2020 and had pain where dose gave. The reporter stated that, the pain was not as sever but the patient had to avoid lifting arms very high and hurt enough to make the patient wait up in night. The patient asked, would the pain gone away.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and had many of the side effects. The patient was asking how long the side effects lasts.
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Myalgia, Pyrexia, Skin burning sensation
Clinical narrative: very muscle hurt; skin felt like it was on fire; had difficulty moving; fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 18th March 2020, refer case ID: US2020AMR135486).   On 6th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced fever, muscle pain, burning sensation skin and movement disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever and movement disorder were recovered/resolved and the outcome of the muscle pain and burning sensation skin were unknown.   It was unknown if the reporter considered the fever, muscle pain, burning sensation skin and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient experienced 4 days difficulty in moving, very muscle hurt, fever for 24 hours, skin felt like it was on fire. The patient's body temperature was reported as 101-101.5 Degree F. The case has been linked with the cases US2020AMR135104 and US2020AMR135291 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135104:Same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR135486:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Movement disorder, Myalgia, Pyrexia, Skin burning sensation
Clinical narrative: very muscle hurt; skin felt like it was on fire; had difficulty moving; fever; This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever, muscle pain, burning sensation skin and movement disorder. On an unknown date, the outcome of the fever, muscle pain, burning sensation skin and movement disorder were recovered/resolved.   It was unknown if the reporter considered the fever, muscle pain, burning sensation skin and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, the patient experienced difficulty in moving, very muscle hurt, fever, skin felt like it was on fire. For tolerance of 2nd dose, refer case US2020AMR135190. The case has been linked with the cases US2020AMR135104 and US2020AMR135291 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR135104:Same reporter US-GLAXOSMITHKLINE-US2020AMR135291:same reporter US-GLAXOSMITHKLINE-US2020AMR135190:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Product supply issue, Skin burning sensation
Clinical narrative: Skin burning sensations on various parts of their body / right side of head; Received their second 7-8 months later; This case was reported by a consumer via call center representative and described the occurrence of burning sensation skin in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on January 2019).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced burning sensation skin and product supply issue. On an unknown date, the outcome of the burning sensation skin was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the burning sensation skin to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in an unknown arm. The reporter stated that, after vaccination with 2nd dose of Shingrix, the patient had skin burning sensations on various parts of body. The last incident was last week (right side of head) but all has resolved. The reporter stated that, due to availability and insurance, the patient received 2nd dose 7 to 8 months later 1st dose, which led toproduct supply issue. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site rash
Clinical narrative: The patient reported a small lump in the injection area along with redness/ rash down the arm. Area totaled about 5 inches in length down the arm, towards the elbow.  There was no pain and no numbness in the arm or fingers   She started to take 25mg Benadryl  during the day and 50mg at bedtime along with the use of ice.  On 7/16/2020 the patient reported less swelling and redness in at the injection site and the lump was smaller. There were no other reported complications and patient was informed to continue the same treatment for the next 24 hours. On 7/17/2020 the swollen area was significantly smaller than on 7/15/2020 and the redness was about 3 inches down the arm. The patient reported that it was not worsening and no other complications. Advised to continue the same treatment of Benadryl and to contact primary care provider if area worsens or other symptoms arise.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headache, extreme nausea, vomiting
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Swelling , tenderness, and redness of injection site , fever, muscle aches, and tiredness lasting 48 hrs
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling , tenderness, and redness of injection site , fever, muscle aches, and tiredness lasting 48 hrs
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Lip swelling, Rash
Clinical narrative: Patient sent message to her Provider that she had 3 days with joint pain, swelling lips  skin rash after the vaccine administration.
Sex: U
Vaccine: PPV, UNK
Symptoms: Product storage error
Clinical narrative: no adverse event; Administered vaccine after temperature excursion; This spontaneous report was received from a consumer and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 24-JUN-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) underwent the temperature excursion. Previous temperature excursion was detected.   On an unknown date in 2020, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) pre-filled syringe, 0.5 ml, lot number: S021740, expiration date: 25-MAR-2021, for prophylaxis (route of administration was not provided). The digital data logger was involved. No product quality complaint (PQC) was present.  This is one of several report from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA002507: US-009507513-2007USA002422:
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse symptoms reported; the patient did not receive "a full dose" of MMR II.; This spontaneous report has been received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not provided by reporter. The patient's concomitant therapy included sterile diluent.  On 07-JUL-2020, the reporter stated while she was administering a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) (lot # S015427 with 20-MAY-2021; route, strength and dose were unknown) for prophylaxis to the patient, the patient moved and a small amount of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) went into the reporter's eye. The reporter stated that the patient did not receive a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) (underdose). No adverse symptoms reported. AE (adverse event) for the reporter with eye exposure to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin (rHA)) (M-M-R II) documented in case 1633271.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA003124:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered improperly stored VARIVAX; This spontaneous report was received from an medical assistant and refers to a 4-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-JUN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)( VARIVAX) injection lot # S028924, expiration date 16-SEP-2021 (strength, dose and route of administration were not provided) for prophylaxis, which was reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 and 46 (reported also as 29.5 F) degrees Fahrenheit (F) for 67 hours. Data logger was involved. There were no previous excursions reported. No additional adverse effects reported.
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient experienced no symptoms; she accidentailly administered the PROQUAD (lot S012535, expiration 10/20/2020) to the patient because PROQUAD and MMR II both have the same blue cap, the same blue lettering and are both stored in the freezer; she accidentailly administered the PROQUAD (lot S012535, expiration 10/20/2020) to the patient because PROQUAD and MMR II both have the same blue cap, the same blue lettering and are both stored in the freezer; on 7/8/2020 she administered a dose of PROQUAD (lot S012535, expiration 10/20/2020) and a dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 08-JUL-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # S012535, expiration date: 20-OCT-2020, subcutaneously (exact dose and injection site were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) lot # reported as S02131 (upon internal verification lot # was determined to be not valid), expiration date reported as 09-JUL-2021 (exact dose, injection site and route of administration were not provided) both for prophylaxis. The reporter stated, she had intended to administer a dose of varicella virus vaccine live (oka/merck) (VARIVAX) and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), but she accidentally administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) to the patient because measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) both had the same blue cap, the same blue lettering and are both were stored in the freezer. The patient experienced no symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions and concomitant medications. In 2011, the pt was vaccinated by healthcare providers with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; A nurse states that on 07/14/2020 a patient was administered an improperly stored dose of MMRII; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies was not provided.  On 14-JUL-2020, the patient was administered an improperly stored dose (product storage error) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (therapy type: rha), lot number S022754 and expiration date 22-JUL-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided).  The vaccine was stored at a temperature of 52.2 F (Fahrenheit), for a timeframe of 45 minutes, with no previous temperature excursion. The call was due to a digital data logger.  No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2013, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).