chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; patient inadvertently received a dose of PEDVAX HIB and PENTACEL; This spontaneous report was received from  a Medical Assistant referring to an unspecified 5-month-old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 30-JUN-2020, the patient inadvertently received a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #S000355 and expiration date 10-OCT-2021 for prophylaxis (strength, frequency and route of administration were not reported) and hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (PENTACEL) (strength, frequency, route of administration lot number, expiration date and indication were not reported). No adverse effects reported.
Sex: U
Vaccine: PPV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; The nurse stated Pneumovax 23 that underwent a temperature excursion was administered; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On 16-JUN-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe at the dose of 0.5 milliliter (ml), lot # S021740 with an expiration date reported and validated as 25-MAR-2021, for prophylaxis (dose number, route of administration and anatomical location were not reported). It was stated by the nurse that the vaccine underwent a temperature excursion (product storage error). No additional adverse events were reported, nor product quality complain involved.   It was reported that a data-logger was involved (captured in Marrs #2007USA002972).  This is one of the several reports received 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-009507513-2007USA002422:01631944 US-009507513-2007USA002972:01631948
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about the patient's (pt) concurrent conditions, medical history or concomitant medication.  In 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently, the pt was treated for shingles. As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had 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 provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown age and gender. There was no information about the patient's (pt) concurrent conditions, medical history or concomitant medication.  In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) prescribed and/or administered by a pharmacist for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently, the pt was treated for shingles. As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had 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 provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.   On 13-FEB-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported for the long-term prevention of shingles (herpes zoster) and/or zoster-related conditions.   On an unspecified date, Subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had 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 reporter considered the event of shingles (herpes zoster) to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine that became too warm. Vaccine was administered on once occasion stated by the nurse; No PQC or additional AE reported; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) injection, for prophylaxis, lot number S032055 with expiration date in 09-NOV-2020 (dose, route of administration, strength and anatomical location were not reported), that became too warm.  On 08-JUN-2020, the hepatitis a vaccine, inactivated (VAQTA) was stored at a temperature of 14.32 degrees Celsius (°C) and on an unknown date in July 2020 at 8.9 (°C) for the time frame cumulative of 2 hours and 18 minutes. There was no previous temperature excursion and the call was because of a data logger.   No additional adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032055; expirationdate: 09-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 1.0
Sex: M
Vaccine: FLUX, PNC, VARCEL
Symptoms: Dermatitis diaper, Diarrhoea, Insomnia, Irritability, Pyrexia
Clinical narrative: Severe diaper rash from diarrhea; Diarrhea; Fever; Generalized sleeping difficulty; Chicken pox rash (5 pox lesions); Crankiness; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US001687).  This spontaneous report was received from an other health professional referring to an one year old male infant. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 31-OCT-2014, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), influenza virus, and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), all at 1 dosage form (strength, route, lot # and expiration date for all vaccines were not reported) for immunization.  On 09-NOV-2014, the patient experienced chicken pox rash (5 pox lesions), crankiness, diarrhea, fever and generalized sleeping difficulty. On 10-NOV-2014, she experienced severe diaper rash from diarrhea. The outcome of the events was not resolved.  The causality between varicella post vaccine and influenza virus was suspected, and the causality between other events and influenza virus was not provided. The causality between all the events and varicella virus vaccine live (Oka/Merck) (VARIVAX) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) was not provided.  All the events were reported to be medically significant.
Age: 1.0
Sex: M
Vaccine: FLUX, PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Severe diaper rash from diarrhea; Diarrhea; Fever; Generalized sleeping difficulty; Chicken pox rash (5 pox lesions); Crankiness; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US001687).  This spontaneous report was received from an other health professional referring to an one year old male infant. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 31-OCT-2014, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), influenza virus, and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), all at 1 dosage form (strength, route, lot # and expiration date for all vaccines were not reported) for immunization.  On 09-NOV-2014, the patient experienced chicken pox rash (5 pox lesions), crankiness, diarrhea, fever and generalized sleeping difficulty. On 10-NOV-2014, she experienced severe diaper rash from diarrhea. The outcome of the events was not resolved.  The causality between varicella post vaccine and influenza virus was suspected, and the causality between other events and influenza virus was not provided. The causality between all the events and varicella virus vaccine live (Oka/Merck) (VARIVAX) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) was not provided.  All the events were reported to be medically significant.
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Blister, Eye disorder
Clinical narrative: skin blister; eye blister; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included umeclidinium bromide, vilanterol trifenatate (Anoro) inhalation powder for product used for unknown indication.   On an unknown date, the patient received Shingrix and Anoro at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix and Anoro, the patient experienced blister and eye disorder. On an unknown date, the outcome of the blister and eye disorder were unknown.   It was unknown if the reporter considered the blister and eye disorder to be related to Shingrix and Anoro.  Additional details were reported as follows: The age at vaccination was not reported. The reporter asked whether skin or eye blister resulted from receiving the shingles vaccine. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Erythema, Myalgia, Pruritus
Clinical narrative: large red area on her arm; itching; joint aching; muscle joint aching; arm felt burned; This case was reported by a consumer via call center representative and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema, pruritus, joint pain, muscle pain and burning sensation. On an unknown date, the outcome of the erythema, pruritus, joint pain, muscle pain and burning sensation were recovered/resolved.   It was unknown if the reporter considered the erythema, pruritus, joint pain, muscle pain and burning sensation to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix in the right arm. The patient experienced a very large red area on her arm with intense itching and then very significant muscle joint aching and her arm felt burned. For tolerance of 2nd dose, refer case US2020123365. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020123365:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itch; This case was reported by a other health professional via interactive digital media and described the occurrence of pruritus in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient experienced itching months after receiving vaccine
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Blood pressure increased, Heart rate increased
Clinical narrative: severe reaction; my BP went to 240/190; heart rate of 120 causing a trip to; This case was reported by a other health professional via interactive digital media and described the occurrence of adverse event in a adult 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 adverse event, increased blood pressure and heart rate increased. The patient was treated with intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the adverse event and heart rate increased were unknown and the outcome of the increased blood pressure was recovered/resolved.   It was unknown if the reporter considered the adverse event, increased blood pressure and heart rate increased 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 captured as adult as per vaccine indication. The patient had severe reaction to the first vaccine. The patient's blood pressure went to 240/190 with heart rate of 120 due to which patient visited emergency rrom. The hospital administered medicines through IV to reduce blood pressure. The patient concerned about whether similar reactions occure with 2nd vaccine.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a physician and described the occurrence of allergic reaction in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included upadacitinib (Rinvoq) unknown for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix and Rinvoq (oral) at an unknown dose and frequency. On 13th February 2020, unknown after receiving Shingrix, the patient experienced allergic reaction. The action taken with Rinvoq was unknown. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received shingrix and Rinvoq and experienced allergic reactions. No other information was reported. The reporter's causality for Rinvoq for event allergic reactions was not provided.  It was unknown if the reporter considered the allergic reaction to be related to Rinvoq .
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: Increased blood pressure; This case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included lisinopril.   On 4th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 6th July 2020, 2 days after receiving Shingrix, the patient experienced increased blood pressure. On an unknown date, the outcome of the increased blood pressure was recovering/resolving.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reporting blood pressure elevation of 20 points following vaccination with Shingrix.  The patient also added, his blood pressure appeared to be declining towards normal.  Limited information was available.  Lot and expiration date unavailable. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: redness at the site; soreness at the site; have developed muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced injection site erythema, injection site pain and muscle pain. On an unknown date, the outcome of the injection site erythema, injection site pain and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had the soreness and redness at the site and had a couple of other areas where had developed muscle aches which started a couple of days after the injection and it would be a week since received the injection. The reporter asked how long should the side effects last.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Tiredness; Slight Fever 97.7 to 99.1; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced tiredness and fever. On an unknown date, the outcome of the tiredness and fever were unknown.   It was unknown if the reporter considered the tiredness and fever to be related to Shingrix.  Additional details were reported as follows: The patient received vaccine in left arm and experienced slight fever when his usual temperature went from 97.7 to 99.1 degree ferenheit and tiredness. The reporter stated he wanted to know how long side effects would last. The reporter did not consent to follow up. This case was linked to case US2020121805, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020121805:wife's case , original: HUSBAND´S CASE
Sex: U
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: Elevated liver enzymes; This case was reported by a physician via call center representative and described the occurrence of elevated liver enzymes in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2020, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes 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, the patient received Shingrix vaccine 2 weeks from the date of reporting of adverse event. No other information were provided. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Paraesthesia, Pruritus, Skin swelling
Clinical narrative: Shingles; tender to the touch; Swollen; Itching; Tingling; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 2 months after receiving Shingrix, the patient experienced shingles, scalp tenderness, scalp swelling, itchy scalp and tingling. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the shingles, scalp tenderness, scalp swelling, itchy scalp and tingling were not recovered/not resolved.   It was unknown if the reporter considered the shingles, scalp tenderness, scalp swelling, itchy scalp and tingling to be related to Shingrix.  Additional details were provided as follows: Approximately 2 months after vaccination with 1st dose, the patient had shingles in scalp. The patient desribed it as area in scalp was tender to the touch, swollen, itching and tingling and confirmed to be shingles by health care professional via telephone.  The patient received valcyclovir for 1 week but still had itching and tingling. The reporter consented to followup
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Erythema, Fatigue, Headache
Clinical narrative: tired; fatigued; nauseous; pale; headache; chills; redness and swelling of a quarter size; redness and swelling of a quarter size; felt like going to faint; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This nurse reported events for three patients. This is the first of 3 reports.    An 18-year-old female patient receive the 1st dose of meningococcal group b rlp2086 (TRUMENBA) (lot # CM1497), via an unspecified route of administration at single dose on 16Jun2020 for immunisation. The patient medical history and concomitant medications were not reported. On 16Jun2020, the patient experienced nauseous, pale, headache, chills, redness and swelling of a quarter size and felt like going to faint, tired and fatigued. Therapeutic measures were taken as a result of nauseous, pale, headache, chills, redness and swelling of a quarter size and felt like going to faint included Benadryl. The outcome of the events was recovered on unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Pallor, Swelling
Clinical narrative: tired; fatigued; nauseous; pale; headache; chills; redness and swelling of a quarter size; redness and swelling of a quarter size; felt like going to faint; This is a spontaneous report from contactable nurse via Pfizer Sales Representative. This nurse reported events for three patients. This is the first of 3 reports.    An 18-year-old female patient receive the 1st dose of meningococcal group b rlp2086 (TRUMENBA) (lot # CM1497), via an unspecified route of administration at single dose on 16Jun2020 for immunisation. The patient medical history and concomitant medications were not reported. On 16Jun2020, the patient experienced nauseous, pale, headache, chills, redness and swelling of a quarter size and felt like going to faint, tired and fatigued. Therapeutic measures were taken as a result of nauseous, pale, headache, chills, redness and swelling of a quarter size and felt like going to faint included Benadryl. The outcome of the events was recovered on unknown date.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site pain, Nausea, Pain, Pyrexia
Clinical narrative: Over 24 hour period experienced moderate body aches, low grade fever (99.4 - 100.6), fatigue, and mild nausea.  Self-treated with alternating doses of Motrin and Tylenol. Symptoms resolved by morning of 7/14.   Site of injection was mildly sore as well.   I had also experienced similar body aches, low grade fever and fatigue with the first injection in January 2020 but did not complete a VAER report.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, UNK, UNK
Symptoms: Heart rate increased, Pyrexia, Vomiting projectile
Clinical narrative: 10 hours after shots roughly she vacate feverish had a 101.8 temp. She also had a rapid heartbeat and projectile vomited twice
Age: 40.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered
Clinical narrative: The patient was given 2 doses of the Engerix-B at the same time.
Age: 78.0
Sex: F
Vaccine: HEP
Symptoms: Blood test, Fatigue, Malaise
Clinical narrative: malaise and fatigue
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received improperly stored Proquad; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 21-APR-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (recombinant human albumin) (PROQUAD) lot # S027460 was verified to be a valid lot number, expiration date reported and established as 02-MAR-2021 for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine previously experienced a temperature excursion of 6 to 14 Fahrenheit degrees (also reported as 10.4 Fahrenheit degrees) for 15 minutes. Previous temperature excursion included also 6 to 14 Fahrenheit degrees (also reported as 11.1 Fahrenheit degrees) for 15 minutes. Digital Data Logger was involved.   The patient did not experience any additional adverse events.; Sender's Comments:  US-009507513-2007USA001240: US-009507513-2007USA001308: US-009507513-2007USA001370: US-009507513-2007USA001612: US-009507513-2007USA001240:
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Decreased appetite, Vomiting
Clinical narrative: decreased app, bilious spit up,
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Groin pain, Hyperhidrosis
Clinical narrative: This is the second in the series of shots for Shingles.  The first shot that I got a few months ago caused mild chills and slight fever.  Although I was told by the pharmacy that this shot would cause minimal side effects, I have had mush more severe muscle pains and aches, fever, chills, sweats, and sever tiredness.  I should note that when I got the first shot a few months ago, I have had a complication in my groin where lymph nodes have been highly active and the pain was so bad that I had to get one removed. I went to three different specialists and they could not figure out the source of the problem and I am very concerned. What is disturbing about the side effects from this shot is that my groin pain has just started back up intensely and it is hard not to think that it was caused by something in this vaccine.  What is in this vaccine that is causing this pain? Is there some additive that is contributing to my pain and am I going to have long medical issues because of taking this vaccine?
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This is the second in the series of shots for Shingles.  The first shot that I got a few months ago caused mild chills and slight fever.  Although I was told by the pharmacy that this shot would cause minimal side effects, I have had mush more severe muscle pains and aches, fever, chills, sweats, and sever tiredness.  I should note that when I got the first shot a few months ago, I have had a complication in my groin where lymph nodes have been highly active and the pain was so bad that I had to get one removed. I went to three different specialists and they could not figure out the source of the problem and I am very concerned. What is disturbing about the side effects from this shot is that my groin pain has just started back up intensely and it is hard not to think that it was caused by something in this vaccine.  What is in this vaccine that is causing this pain? Is there some additive that is contributing to my pain and am I going to have long medical issues because of taking this vaccine?
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medication were not provided. In 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX), (lot#, dose and route unknown), as prescribed and/or administered by a a healthcare provider at a clinic for the long-term prevention of shingles and zoster-related conditions. Subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation (date not reported), the pt was treated by a health care provider for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX), the pt 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 events was unknown. Causality was assessed as related.
Age: 21.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Nausea
Clinical narrative: nausea; dose of MMR ll  was administered via the intramuscular route versus fue subcutaneous route; The patient received her first dose of MMR ll; This spontaneous report was received from a pharmacist and refers to a 21-year-old, non-pregnant female patient. She had no known allergies. No information regarding her pertinent medical history, drug reactions or concomitant therapies was provided.  On 08-JUL-2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) intramuscularly, lot # S018594, expiration date: 17-JUN-2021 (exact dose and injection site were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK) intramuscularly, lot # S029574, expiration date: 29-MAY-2022 (exact dose, indication and injection site were not provided). On the same date, she experienced nausea. The patient did not seek medical attention and there were no lab diagnostic studies performed. No treatment was given for the adverse event. The outcome of nausea was unknown.  The relatedness between the event of nausea and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) and sterile diluent (MERCK) was not provided
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Insomnia, Pain, Pyrexia
Clinical narrative: Elevated temperatures; Tiredness; Trouble sleeping; Achiness; Late dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in October 2019, refer case US2020AMR125327).   On 6th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 6th July 2020, less than a day after receiving Shingrix, the patient experienced fever, tiredness, difficulty sleeping, general body pain and drug dose administration interval too long. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, tiredness, difficulty sleeping and general body pain were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, tiredness, difficulty sleeping and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had elevated temperatures, tiredness, trouble sleeping and achiness. The reporter did not had lot number or expiration date information to provide for either dose of Shingrix. This case linked with US2020124819 and US2020AMR125323, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020124819:Wife's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125323:Wife's case 1st dose
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Insomnia, Pain, Pyrexia
Clinical narrative: Elevated temperatures; Tiredness; Trouble sleeping; Achiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, tiredness, difficulty sleeping and general body pain. On an unknown date, the outcome of the fever, tiredness, difficulty sleeping and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, tiredness, difficulty sleeping and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had elevated temperatures, tiredness, trouble sleeping and achiness. The patient did not had any specific details or further information. The reporter did not had lot number or expiration date information to provide for either dose of Shingrix. For tolerances of 2nd dose, refer case US2020AMR125326, reported by same reporter for the same patient. This case linked with US2020124819 and US2020AMR125323, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020124819:Wife's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125323:Wife's case 1st dose US-GLAXOSMITHKLINE-US2020AMR125326:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: arm swelling; arm redness; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities and pain in arm were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient was the caller's daughter.  The patient received Shingrix and developed arm swelling, redness and soreness and better at the time of reporting. The reporter consented to follow up. This case linked with US2020126270 and US2020126273, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126270:same reporter US-GLAXOSMITHKLINE-US2020126273:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient was the caller's daughter.  The age at vaccination was not reported. The patient received Shingrix and flu-like symptoms that lasted for 3 days and better at the time of reporting. The reporter consented to follow up. This case linked with US2020126266 and US2020126273, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126266:same reporter US-GLAXOSMITHKLINE-US2020126273:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included kidney transplant.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient was a friend of the reporter.  The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had a fever for two days. This case linked with US2020126270 and US2020126266, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020126270:same reporter US-GLAXOSMITHKLINE-US2020126266:same reporter
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Sensitive skin
Clinical narrative: Chills, achy, sensitive skin, 99.8 fever.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: rash to full leg
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Peripheral swelling
Clinical narrative: headache, arm swollen, total body ache, flu like symptoms. This occurred about 6 hours after vaccine administered and lasted for 5-6 days.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Approximately 8 hours after receiving the dose, I began feeling tired, achy, feverish, and have the chills.  These symptoms have continued into the next day and I am still currently experiencing these symptoms.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood glucose, Cyanosis, Hypoglycaemia, Lethargy
Clinical narrative: Pt presented to local ED for lethargy and blue lips. Pt evaluation indicated that pt had hypoglycemia and was given apple juice/sweets in the ED. Pt's blood sugar was rechecked and showed significant improvement.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling hot, Flushing, Malaise, Vomiting
Clinical narrative: looking flush and warm; not feeling well; vomited; This spontaneous report has been received from a nurse via a company representative referring to an 18 years old female patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 06-JUL-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 dose; lot #, expiration date, route and dose details were unknown) for prophylaxis.         On 06-JUL-2020, after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient "not feeling well", "looking flush and warm", then vomited. The patient was seen by nurse and no treatment was taken. The patient's symptoms recovered "after 5 to 10 minutes". The nurse also stated the patient did not eat prior to receiving the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).      The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Post herpetic neuralgia
Clinical narrative: None; Received PNEUMOVAX on 29-APR-2016 and then on 14-OCT-2019; This spontaneous report was received from a 62-year-old female patient referring to herself. The patient's historical and concurrent conditions, as well as her concomitant medications were not provided.  On 29-APR-2016, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, anatomical site of vaccination, lot number and expiration date were not reported). On 19-OCT-2017, the patient was vaccinated with zoster live vaccine (ZOSTAVAX) and experienced herpes zoster and post herpetic neuralgia (both captured in 1911USA011081). Then, on 14-OCT-2019, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, anatomical site of vaccination, lot number and expiration date were not reported) (inappropriate schedule of product administration). It was reported that the patient did not experience adverse events with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (reported as none).; Sender's Comments:  US-009507513-1911USA011081:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 31-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 13-APR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.  This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA004416:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse event 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, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received and experinced adverse event.