chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effect reported.; The second dose of GARDASIL 9 on 4/19/2019, and the third dose of GARDASIL 9, on 7/11/2019; Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  On 10-FEB-2019, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. On 19-APR-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis. On 11-JUL-2019, the patient received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R009615, expiration date was 07-DEC-2020; strength, dose and route were not reported) for prophylaxis (Inappropriate schedule of product administration). No adverse effect was reported.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site rash, Papule, Rash papular
Clinical narrative: rash had spread down lhe arm past the elbow. The rash has the appearance of "tiny papules (little fine raised bumps)".; lhe patient developed a "rash" at lhe "injection site"; This spontaneous report has been received from a medical assistant referring to a 12 years old female patient. The patient was not pregnant. The patient had administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 15-MAY-2015, rash developed after first dose. Concomitant drug included meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) administered in the left arm on unknown date. The allergies included poison ivy, poison oak and unspecified sunscreen.       On an unknown date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: R032767, expiration date: 31-AUG-2021, dose 1, intramuscular in the right arm) for prophylaxis.         On 18-JUL-2019 the patient developed a rash at the injection site. On 20-JUL-2019 the patient stated the "rash had spread down the arm past the elbow", the rash had the appearance of "tiny papules (little fine raised bumps)" (rash papular). The patient had "refused treatment" from her Physician. The reporter also mentioned the patient had a similar reaction after being administrated the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (unknown lot # and expiration date).      The outcome of injection site rash and rash papular were reported as not recovered. The causality between injection site rash, rash popular and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided. No Product Quality Compliant (PQC) was present.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA014034:same reporter
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash generalised
Clinical narrative: the patient had a rash on her face; the rash progressed to other parts of the patient's body.; This spontaneous report was received from a nurse referring to a 12 years old female patient. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On 18-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R028651 with expiration date 27-JUL-2021; strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in July 2019, the patient's parent called the office and reported that the patient had a rash on her face. On an unspecified date in July 2019(reported as over the weekend), the rash progressed to other parts of the patient's body.On 21-JUL-2019, the patient was improving. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient recieved the first dose of GARDASIL 9 on 06-APR-2016 and received the second on 25-JUL-2019; This spontaneous report has received from a registered nurse referring to a patient of unknown age. The patient's pertinent medical history, concurrent condition and concomitant therapy were not reported.        On 06-APR-2016, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # L007560, expiration date: 15-JUN-2017; strength and route were not reported) dose 1 for prophylaxis. On 25-JUL-2019, the patient vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S011719, expiration date: 04-DEC-2021; strength and route were not reported) dose 2 (inappropriate schedule of vaccine administered). No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 14-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles which lead to hospitalization. On an unspecified date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 will continue to suffer such losses, and damages in the future.   The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about on 27-OCT-2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.    On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, 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 will continue to suffer such losses, and damages in the future.    The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).    Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, pt was inoculated with zoster vaccine live (ZOSTAVAX), as prescribed and/or administered by a pharmacist (lot#, expiration date, dose, and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, pt experienced and 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), pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs 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 reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: PPV
Symptoms: Anaphylactic reaction, Peripheral swelling, Swelling
Clinical narrative: patient had a similar reaction (anaphylactic reaction described as entire arm swelled into her neck) but not as severe; This spontaneous report was received from a office manager, via a company representative, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were unknown by reporter.  On an unknown date in approximately 2018, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with lot number R000772 and expiration date reported as 10-MAR-2020, as prophylaxis (dose, dose number and anatomical injection site were not reported; route of administration was unknown by reporter).         On an unknown date in approximately 2018, the reporter had an anaphylactic reaction described as "her entire arm swelled into her neck" (captured in MARRS # 1908USA002148). On an unspecified date in 2018 (reported as "around the same time"), the patient had a similar reaction but "not as severe" to  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It was unknown by reporter if the patient sought for medical attention, if any treatment was given for the event or if any laboratory diagnostics or studies were performed.  At the time of the report, the outcome of the anaphylactic reaction was unknown by reporter.  Upon internal review, anaphylactic reaction was determined to be medically significant.  This is one of two reports received from the same reporter.  Lot number R000772 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent).; Sender's Comments:  US-009507513-1908USA002148:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: Herpes Zoster; Postherpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the prevention of shingles and routine health maintenance. On an unspecified date, the patient experienced painful blistering rash on the back, then diagnosed with postherpetic neuralgia and herpes zoster. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the events to be disability.   Additional information has been requested.
Sex: F
Vaccine: MMRV
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: PROQUAD was given to a pregnant patient; This spontaneous prospective pregnancy report as received from a nurse referring to a currently 37 years old pregnant female patient. The patient had none pertinent medical history and none drug reactions or allergies. Concomitant medication included sterile diluent. The LMP and gestation were unknown except that she was early in the pregnancy based on lab hormone levels.  On unspecified date prior to 01-AUG-2019 vaccine titers were drawn and mumps were low; she was not immune to mumps. Office decided to give measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) because the patient's previous vaccination history was unknown. On 01-AUG-2019, the pregnant patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 ml once; lot number: R030801, expiration date: 22-APR-2020) subcutaneously, for prophylaxis. On that day, serum pregnancy test results initially looked negative so vaccine given then determined results actually were positive for pregnancy. Patient's present status was unknown. No treatment was given for the event. The pregnancy outcome was pending. The patient did not seek medical attention.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; Patient received 3 doses/inadvertently administered additional dose; Patient received one dose each on 6/9/2015 and 7/2/2018; This spontaneous report was received from a licensed practical nurse regarding a 5 years and 2 months old patient. Information on pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 09-JUN-2015, 02-JUL-2018 and 06-AUG-2019, the patient was vaccinated with one dose each of varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route, anatomical location, lot# and expiry date were not reported) for prophylaxis (extra dose administered (06-AUG-2019) and inappropriate schedule of product administration (02-JUL-2018)). No adverse effects were reported (no adverse event).
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects; inadvertently received one dose of PNEUMOVAX 23 but were supposed to receive GARDASIL 9; This spontaneous report was received from a health professional (medical assistant) refers to a 12 year old female patient. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 05-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dosage information, route of administration and anatomical locations were unknown) of lot # S004548, expiration date 12-AUG-2020 for prophylaxis but was supposed to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, lot#, expiration date, dosage information, route of administration and anatomical locations were unknown) (wrong product administered). No adverse effects reported. The reporter described the patient as a health, normal patient, not indicated for the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The outcome of wrong product administered was unknown. No product quality complaint (PQC) reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; administered a dose of PROQUAD that expired on 7/30/2019; This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 02-AUG-2019 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # R002931, expiration date reported as 30-JUL-2019 but upon internal validation established as 29-JUL-2019) (dosing details and route unknown) for prophylaxis. It was reported that the used vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was already expired on 30-JUL-2019 (also reflected as 29-JUL-2019) (expired product administered). No adverse effects reported (no adverse event). Therapy type involved was rha.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose decreased, Presyncope
Clinical narrative: vasovagal reaction; blood sugars dropped; 16 year old patient received an adult dose of VAQTA; This spontaneous report was received from a medical assistant regarding a 16 year old female patient. Information on the patient's pertinent medical history and concomitant therapies were not reported. The patient was reported to be allergic to fish containing products (food allergy). On 05-AUG-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) at a strength of 50 unspecified units with lot # S001832 and expiration date of 12-MAY-2020, intramuscular for prevention of Hepatitis A (antiviral prophylaxis) (product administered to patient of inappropriate age). On the same day (05-AUG-2019), the patient experienced vasovagal reaction (presyncope), and blood sugars dropped (blood glucose decreased) and a candy was given as supplement. Outcome of presyncope and blood glucose decreased was reported as recovered. No product quality compliant (PQC). Causality assessment was not provided by the reporter.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect reported; Six month old patient received PNEUMOVAX 23; This spontaneous report as received from a medical assistant regarding a 6 month old patient. Information on the patient's pertinent medical history, other concurrent conditions, drug allergies or reaction and concomitant medication were not reported. On 06-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse effect reported. No product quality compliant (PQC).
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: HEPLISAV-B given subcutaneously; Initial Report Received on 24-Jun-2019, 27-Jun-2019, and 25-Jul-2019  A pharmacist reported that a 34-year-old female patient was administered with HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization. "HEPLISAV-B (was) given subcutaneously."   Relevant medical history was not provided. The patient previously received 2 doses of the 3 series hepatitis B vaccine. The patient had no known allergies.   Concomitant medications were reported as none.   On 24-Jun-2019, the patient received the first dose of HEPLISAV-B subcutaneously in the left interior arm from a pre-filled syringe (lot # 933094, expiration date 17-Apr-2021, and NDC # 43528-003-05). On this date, the adverse event report was received via voicemail.   On 27-Jun-2019, the pharmacist reported that she was "confused" when giving the injection because she had been giving a lot of subcutaneous vaccines lately. The patient had no adverse reactions at that time and when the pharmacist spoke with the patient on this date, the patient continued to have no adverse reactions to report. No further information was provided.   On 25-Jul-2019, the pharmacist reported that she did not administer a second dose of Heplisav-B yet.   At the time of this report, no adverse events were reported.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of incorrect route of product administration as non-serious. The event of incorrect route of product administration is unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of incorrect route of product administration as non-serious. The event of incorrect route of product administration is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: Immunocompromised Patient Not Responded to Two Doses of Heplisav-B; Initial Report Received on 15-Jul-2019 and 16-Jul-2019  A pharmacist reported that an immunocompromised patient (age, gender, and race unknown) was administered with two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the "immunocompromised patient (has) not responded to two doses of HEPLISAV-B."     Relevant medical history, concomitant medications, and allergies were unknown.   On unknown dates, the patient was administered with two doses of HEPLISAV-B (lot #, expiration date, and NDC # unknown).   On 15-Jul-2019, the pharmacist reported that she had an immunocompromised patient that did not respond to two doses of HEPLISAV-B. No other information was available.    At the time of this report, the outcome of the event of was not reported.     The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B.; Sender's Comments: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B.
Age: 57.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Intranasal hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: inappropriate schedule of vaccine; Shivering; fever; numbness and tingling in left nostril; numbness and tingling in left nostril; This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number C7B9P, expiry date 27th February 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, fever, intranasal numbness, tingling and incomplete course of vaccination. On an unknown date, the outcome of the shivering, fever, intranasal numbness and tingling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering, fever, intranasal numbness and tingling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after receiving 1st dose of Shingrix in the right deltoid, the patient experienced shivering, fever and numbness and tingling in left nostril for 2 weeks. The reporter stated that the patient had delayed getting 2nd dose for fear of having side effects again, which led to incomplete course of vaccination. The batch number reported for Shingrix(C789P) did not exist and was updated to C7B9P, as per sales database. This case has been linked with case US2019140583, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain
Clinical narrative: Chills / could not stop shivering; muscle aches; soreness; This case was reported by a consumer via other manufacturer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a day after receiving Shingrix, the patient experienced chills, muscle pain and pain. On an unknown date, the outcome of the chills, muscle pain and pain were unknown.   It was unknown if the reporter considered the chills, muscle pain and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  During the night patient experienced chills and could not stop shivering. The patient also had muscle aches and soreness.  The patient knew these events were possible after receiving the vaccine, but the reporter reporting it according to policy.  The reporter did not gave permission to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; pain at injection site; flu like symptoms; chills; body aches; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received Shingrix. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the GSK employee for his/her relative. The patient received Shingrix later that same day, the patient experienced pain, swelling, and redness at the injection site. The patient also experienced flu like symptoms described as chills and body aches on the same day. The patient, a relative of field employee gave permission to contact their physician and provided correspondence contact details for the same.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: redness at injection site; swelling at injection site; pain at injection site; flu like symptoms; chills; body aches; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2019, the patient received Shingrix. On 24th July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain, influenza-like symptoms, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the GSK employee for his/her relative. The patient received Shingrix later that same day, the patient experienced pain, swelling, and redness at the injection site. The patient also experienced flu like symptoms described as chills and body aches on the same day. The patient, a relative of field employee gave permission to contact their physician and provided correspondence contact details for the same.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperaesthesia, Influenza like illness, Myalgia
Clinical narrative: Muscle Pain throughout the body; Fatigue; Sensitive to touch; Flu Like Symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number H549S, expiry date 1st October 2021) for prophylaxis.   On 19th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2019, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, fatigue and touch sensitivity increased. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the muscle pain and fatigue were recovering/resolving and the outcome of the touch sensitivity increased was unknown.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, fatigue and touch sensitivity increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the left arm and experienced flu like symptoms which lasted for 2 days. The patient was also experiencing muscle pain throughout the body, fatigue and sensitivity to touch. The muscle pain and fatigue had decreased. No further details were provided.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal transplant failure (was on immunosuppressant therapy until June 2018).   On 18th July 2019, the patient received the 1st dose of Shingrix. On 27th July 2019, 9 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The physician on the line reported that the patient received their dose about a week before the reporting date and at the time of reporting had shingles. The reporter consented to follow up. The caller had no information regarding the vaccine given. It was given at a pharmacy, information for pharmacy was unknown.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pruritus, Urticaria
Clinical narrative: itching; malaise; chills; urticaria on trunk and other extremeties; This case was reported by a physician via call center representative and described the occurrence of pruritus in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ9N5, expiry date 31st July 2020) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced pruritus, malaise, chills and urticaria. The patient was treated with cetirizine hydrochloride (Cetirizine) and naproxen. On an unknown date, the outcome of the pruritus, malaise, chills and urticaria were unknown.   It was unknown if the reporter considered the pruritus, malaise, chills and urticaria to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician 6 hours after injection developed itching, malaise, chills, urticaria on trunk and other extremeties. The physician took Citerazene and Naproxen with some relief. The physician consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) for prophylaxis.   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th July 2019, 63 days after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported patient received 1st dose in the left arm and they called to remind of 2nd dose 2 months later and the patient noted she had shingles.  The patient was treated with Valtrex.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Body temperature increased, Fontanelle bulging, Irritability
Clinical narrative: Overnight after his vaccines, mother noted bulging fontanelle. Also had slight elevated temperature, tmax ~100. Was fussy/irritable. Gave Tylenol around 1 AM. Throughout the next day the fontanelle was less bulging but still present, pulsating in upright position. No seizure activity just irritable. Tolerating formula bottles. Planned to observe given otherwise clinically well.
Age: 1.17
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Crying, Febrile convulsion, Feeling hot, Tremor
Clinical narrative: Caregiver reported patient felt hot and started shaking.  The child shook for about 1 minute and resolved when the mother called the baby's name.   Then the baby started crying.  Dx febrile seizure, first episode.  Referred to pediatric neurology
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Nodule, Skin warm
Clinical narrative: red knot hard and warn to touch
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt informed me today 8-8-19, after vaccination she had a high fever that she couldn't control and was hospitalized for 3 days. The drs told her not to get anymore vaccines.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Depressed level of consciousness, Somnolence
Clinical narrative: At 12:15pm client showed signs of passing out. He was lowered to floor and feet elevated. 12:20 pm  v/s within normal limits O2 was 96%. 911 called. Ammonia inhalants x 1 used. client awake very drowsy but able to say his name and aware of location and able to recognize his brother. Ambulance arrived at 12:40. Client assessed by EMT and able to sit up. Child and family take to ambulance for further  assessment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, fatigue and head ache
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: initial reaction was redness and swelling at injection site very painful on Wednesday. by 1pm Friday noticed itching on left ear. by 2pm visible rash staring all over body.by midnight itching was out of control felt like my skin was crawling.it affected my head feet, palms of hands ,and entire body.  Pt has photos if need further review.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: initial reaction was redness and swelling at injection site very painful on Wednesday. by 1pm Friday noticed itching on left ear. by 2pm visible rash staring all over body.by midnight itching was out of control felt like my skin was crawling.it affected my head feet, palms of hands ,and entire body.  Pt has photos if need further review.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Chills, Feeling cold, Headache
Clinical narrative: muscle aches, sore arm at injection site, severe shivers and profuse sweaty and freezing  during sleep, upset stomach headache stomach pain
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Myalgia
Clinical narrative: muscle aches, sore arm at injection site, severe shivers and profuse sweaty and freezing  during sleep, upset stomach headache stomach pain
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Influenza like illness, Injection site irritation, Injection site swelling
Clinical narrative: Shivering, mild flu-like symptoms, diarrhea with 6 hours, resolved within 12 hours. Swelling and irritation at injection site, still ongoing but improving 72 hours later
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: EXCRUCIATING PAIN THAT GRDUALLY RESOLVED IN 4 DAYS
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Injected limb mobility decreased, Injection site rash, Limb discomfort
Clinical narrative: Right arm became severely swollen, red, warm to touch, difficulty lifting the arm, and developed a raised rash at site of injection.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Right arm became severely swollen, red, warm to touch, difficulty lifting the arm, and developed a raised rash at site of injection.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Patient was given vaccine on 8/6/2019 around 220pm. came in on 8/8/2019 around 1020am saying that night had unbearable pain. Asked if had taken any ibuprofen for pain, patient states no amount would help. states can not move arm and has no range of motion. States no pain on injection but now feels as if the injection has gone into joint- confirmed location gave to patient as was in right upper deltiod muscular area. . Patient has placed call into his PCP to be seen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Night sweats
Clinical narrative: Chills, headache, tired, night sweat 2 nights and 1 day
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Hep A peds and she should have received Hep A adult. this makes it ineffective and patient needs an adult dosing to be complete with series.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: After administering Pediarix in the Right Vastus Lateralis patient immediately had a small isolated cluster of bumps with redness appeared above injection site. Observed for 10 minutes post injection and no sign of progression or improvement. After provider and preceptor evaluation, advised that patient stay in clinic for additional 10 minutes. Another check in on patient and redness had resolved however bumps remained. Provider evaluated again and patient was discharged home with instructions to parents to observe area and to contact our office if worsens
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Client has not experienced any adverse reaction to our knowledge.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Encephalitis viral
Clinical narrative: viral encephalitis
Age: 24.0
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Patient was given Twinrix vaccine and he was already fully vaccinated against Hep A and Hep B. Electronic record was not checked to verfy this prior to giving the vaccine.
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received Hep A vaccine 2 months after 1st dose and he should have received it 6 months after the 1st one. this makes it ineffective and patient needs another dose in October 2019
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Four year old give Tdap instead of DTap.   No complications or side effects noted upon observation in clinic following for 45 minutes.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Cold sweat, Neck pain, Pain
Clinical narrative: Sore upper arm, chills, cold & clammy, upset stomach, achy, very sore neck.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore upper arm, chills, cold & clammy, upset stomach, achy, very sore neck.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper
Clinical narrative: Upper abdominal cramps and pain. Cramps occur every 5-10 minutes and last for 1-2 minutes each.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: Patient given the wrong vaccine. He was supposed to have gotten the MMR. Instead was given the MMR & Varicella Combination.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a Hep A peds vaccine and should have received Hep A adult. Patient needs another dose for this to be effective.
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: Patient was giving to many doses of Hep A and Hep B. ALERT was not checked prior to giving this immunization.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored vaccine was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in July 2019 (reported as between 03-JUL-2019 and 29-JUL-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002393, expiration date 31-JAN-2021 and lot # R035225, expiration date 04-DEC-2020 (dose and route of administration were not reported) for prophylaxis and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date reported as 31-JUL-2020, but upon internal validation established as 30-JUL-2020 and lot # S008577, expiration date reported as 30-SEP-2020, but upon internal validation established as 16-SEP-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of total time in range -14 degrees Celsius to -10 degrees Celsius (-12.8 degrees Celsius) for 12 hours 3 minutes. There were no previous excursions reported. The digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA003249: US-009507513-1908USA003250: US-009507513-1908USA003251: US-009507513-1908USA003252: US-009507513-1908USA003253: US-009507513-1908USA003254: US-009507513-1908USA003255: US-009507513-1908USA003256: US-009507513-1908USA003257: US-009507513-1908USA003258: US-009507513-1908USA003259: US-009507513-1908USA003260: US-009507513-1908USA003261: US-009507513-1908USA003262: US-009507513-1908USA003263: US-009507513-1908USA003264: US-009507513-1908USA003265: US-009507513-1908USA003266: US-009507513-1908USA003267: US-009507513-1908USA003268: US-009507513-1908USA003269:
Sex: M
Vaccine: VARZOS
Symptoms: Bronchial hyperreactivity, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Eosinophilic granulomatosis with polyangiitis
Clinical narrative: Allergic Rhinitis; Reactive Airway Disease; Shortness of Breath; COPD exacerbation; Pneumonia; Churg-Strauss Vasculitis; Peripheral Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age with chronic obstructive pulmonary disease (COPD). No information was provided regarding medical history or concomitant medications. In or around 19-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered allergic rhinitis, reactive airway disease, shortness of breath, COPD exacerbation, pneumonia, Churg-Strauss vasculitis and peripheral neuropathy requiring several hospitalizations and rehab.The outcome of the events was not provided. The reporter considered the events to be related zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of pneumonia, Churg-Strauss vasculitis and peripheral neuropathy were determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pneumonia
Clinical narrative: Allergic Rhinitis; Reactive Airway Disease; Shortness of Breath; COPD exacerbation; Pneumonia; Churg-Strauss Vasculitis; Peripheral Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age with chronic obstructive pulmonary disease (COPD). No information was provided regarding medical history or concomitant medications. In or around 19-DEC-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered allergic rhinitis, reactive airway disease, shortness of breath, COPD exacerbation, pneumonia, Churg-Strauss vasculitis and peripheral neuropathy requiring several hospitalizations and rehab.The outcome of the events was not provided. The reporter considered the events to be related zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of pneumonia, Churg-Strauss vasculitis and peripheral neuropathy were determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Hearing aid user
Clinical narrative: sensorineural hearing loss requiring; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 22-OCT-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), patient suffered sensorineural hearing loss requiring use of hearing aids. As a direct and proximate result of Company's defective zoster vaccine live (ZOSTAVAX), patient's symptoms resulted in physical limitations not present prior to using Company's product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The outcome of the events was unknown.  Upon internal review, the event of deafness neurosensory was considered to be medically significant.