chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was inadverently administered/no ae; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case was linked with 2019SA145240.  This case involves a 1 years old female patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT HIB) for Immunisation.  On 23-May-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation: unknown, lot: C5190AA and expiry date: 24-Apr-2019) via intramuscular route in left thigh.  It was an actual medication error due to expired vaccine used (expired dose of daptacel was inadverently administered).  None adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: a 5 year old male patient was inadvertently administered expired dose of Daptacel/ no ae; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a five years old male patient who was inadvertently administered expired a 0.5ml once dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5190AA, Expiration Date: 24-APR-2019 via intramuscular route in the left deltoid on 22-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used. A 5 year old male patient was inadvertently administered expired dose of Daptacel.  None adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Imovax; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 46 years old female patient who was vaccinated with a 1 ml third dose of expired vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (lot N1B903N and Exp. Date 18-Mar-2019) via unknown route in unknown administration site on 23-May-2019. (Lot of syringe, vial: M0101, N1B90)  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Daptacel was given to a 15 month old/No AE; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 months old male patient who received an expired 4th dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 20-May-2019 (expiry date: 16-May-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HAEMOPHILUS INFLUENZA (HAEMOPHILUS INFLUENZA).  It was of actual medication error case due to expired vaccine used.  No adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: UNK
Symptoms: Vaccination complication
Clinical narrative: a Vaccine injury; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.   This case involves a 54 years old female patient who experienced a vaccine injury, while she received vaccine INFLUENZA VACCINE (QUADRIVALENT).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Jan-2017, the patient received a dose of suspect INFLUENZA VACCINE (QUADRIVALENT) produced by unknown manufacturer (lot UT568MA and expiry date 30-Jun-2017) via unknown route in unknown administration site.  The patient developed a non-serious a vaccine injury (vaccination complication) <<Unknown latency>> following the administration of INFLUENZA VACCINE (QUADRIVALENT).  (Other relevant tests included No lab data reported.)  Final diagnosis was a vaccine injury.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for a vaccine injury.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: DTaP-IPV component of Pentacel was administered seperately from Hib component/ No AE; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 months old male patient who was vaccinated with 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: C5324AC and expiry date: 09-May-2019) via intramuscular route in the right thigh on 23-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) on an unknown date.  It was a case of actual medication error due to inappropriate reconstitution technique.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: expired Pentacel dose was administered to a consumer; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 6 months old patient who received an expired dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot number not reported, expiry date: 17-May-2019 via unknown route in unknown administration site on 24-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of vaccine/ No side effects were mentioned.; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 31 months old patient who received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5202AA via intramuscular route in the left deltoid on 24-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.   Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  No side effects were mentioned.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired Daptacel that was given to patient; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.   This case involves a female patient (age not reported) who received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to expired vaccine used.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 0.92
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the DTaP-IPV diluent portion of the Pentacel kit was given by itself in the left vastus laterus, the ActHIB lyophilized portion was not given; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 11 months old female patient who received (second dose) DTaP-IPV diluent portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: ActHIB portion- UJ095AA, Dtap-IPV diluent portion- UJ108AA, Outer carton- UJ095AA, expiry date: 20-Jul-2024) via unknown route in the left vastus laterus, the ActHib lyophilized portion was not given.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE).  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported if any adverse event occurred or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HIBV, MNQ, TD
Symptoms: Product storage error
Clinical narrative: had a temperature excursion. The excursion lasted for 157 hours and 30 minutes. The high temperature was fro 49 degrees Fahrenheit.; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] while INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC], HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]also had the temperature excursions.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to  incorrect product storage temperature excursion lasted for 157 hours and 30 minutes. the high temperature was fro 49 degrees Fahrenheit.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 18 month old got Pentacel and Adacel on the same day; 18 month old got Pentacel and Adacel on the same day; Initial information received on 24-May-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional via phone.  This case is linked to case 2019SA147706 (same reporter).  This case involves a 18 months old male patient who was vaccinated with a 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: C5572AA and expiry date: 13-Oct-2019) in the right thigh and 0.5 ml first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number: U6226AA and expiry date: 21-Apr-2020) in the left thigh on 20-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  No other vaccines given.   It was a case of actual medication error due to inappropriate age at vaccine administration and extra dose administered.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: an opened Ipol vaccine that was opened and exposed to a lowest temperature of 1.7C for 16 minutes and a highest temperature of 9C for 22 minutes/ no AE; Initial information received on 28-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves adult patient (younger than 18/ gender not reported) who was vaccinated with a dose of IPV (VERO) [IPOL] (batch number: P1A242M and expiry date: 26-APr-2020) via intramuscular or subcutaneous route in the arm on an unknown date.  Relevant medical history: Most likely received more Ipol in the past.  Concomitant medications were not reported.   It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Allergy to vaccine
Clinical narrative: Patient is allergic to tetanus; Initial information received on 28-May-2019 regarding an unsolicited valid non-serious case received from a physician via other company.  This case involves an unknown age patient who was allergic to vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARENICLINE (VARENICLINE).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route.  On an unknown date, , The patient developed a non-serious patient is allergic to tetanus (allergy to vaccine) <<Unknown latency>> following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.  No lab test reported.  Final diagnosis was patient is allergic to tetanus.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for patient is allergic to tetanus.  Information on the batch number was requested:
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 55 years old patient of unknown gender. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. On or about 20-AUG-2014, 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 unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of shingles was unknown. The reporter considered shingles 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 an elderly, currently 69 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. In 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 unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 years old male patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. In 2010, 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 unknown date, the patient experienced Herpes Zoster. On an unspecified date, the patient was treated by a healthcare provider for Herpes Zoster. The outcome of Herpes Zoster was unknown. The reporter considered Herpes Zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Post herpetic neuralgia, Rash macular
Clinical narrative: post herpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or around 20-MAY-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. In approximately 2016 (reported as within 2 weeks after receiving vaccine), the patient suffered from an erythematous macular rash noted over her right face with burning pain. Plaintiff was ultimately diagnosed with shingles and later diagnosed with post herpetic neuralgia following chronic pain after the shingles outbreak. As a direct and proximate result of the vaccine, the patient's symptoms had resulted in physical limitations (not present prior to using the vaccine). The outcome of the events was unknown. Causality was assessed as related.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Postherpetic Neuralgia; Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. On an unknown date after receiving the vaccination, the patient suffered an outbreak of a painful blistering rash. As a result of these symptoms, the patient presented to a medical provider and was diagnosed with herpes zoster accompanied by postherpetic neuralgia. The patient had continued to suffer the effects of herpes zoster and postherpetic neuralgia (not recovered). Causality was not reported.   Additional information has been requested.
Age: 0.92
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effect; Administered a dose a week before turning one year old; This spontaneous report was received from a nurse regarding a patient of unknown demographics. The patient's relevant history, concurrent condition and concomitant medications were not reported. On 18-MAY-2019, at the age of 11 months (also reported as one week before turning 1 year old), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, unit, lot#/expiration date and anatomical location: unknown) reconstituted with sterile diluent injection (product administered to patient of inappropriate age). The reporter informed that there were no other adverse effects reported (no adverse event).  There was no product quality complaint associated with this report.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash generalised, Rash papular
Clinical narrative: rash; nausea; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 25th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced generalized rash, nausea and papular rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved and the outcome of the nausea was recovered/resolved and the outcome of the papular rash was unknown.   The reporter considered the generalized rash, nausea and papular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine few days later and she felt a bit nauseated but that resolved after several days.  A couple of weeks later, she started breaking out on her forearms. It then spread to her legs then to the trunk of her body.   The patient described it as little dots and this dots have gone down a bit on her arms but the dots on her legs and trunk remain raised. The reporter consented to follow up. The patient  agreed to having the letter from Safety sent to her as she hasn't spoken to her physician yet so she wanted to do that before the physician received anything from Safety.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatinine increased, Blood glucose increased, Chest pain, Dyspnoea, Pallor
Clinical narrative: elevated creatinine; elevated blood glucose; chest pain; pale skin; heart palpitations; shortness of breath; This case was reported by a pharmacist via call center representative and described the occurrence of chest pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 22nd May 2019 18:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced creatinine increased and blood glucose increased. On 22nd May 2019 23:00, the patient experienced chest pain, pale skin, palpitation and shortness of breath. The patient was treated with prednisone. In May 2019, the outcome of the creatinine increased and blood glucose increased were recovered/resolved. On an unknown date, the outcome of the chest pain, pale skin, palpitation and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the chest pain, pale skin, palpitation, shortness of breath, creatinine increased and blood glucose increased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. At approximately 11pm of last night, 4 hrs. 30 min after receiving Shingrix, the patient developed shortness of breath, heart palpitations, chest pain and pale skin.  The patient went to the emergency room and found out that the patient's blood glucose levels and creatinine levels were elevated.  The patient was given prednisone and sent home around 4 am morning of this time of reporting.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: elevated creatinine; elevated blood glucose; chest pain; pale skin; heart palpitations; shortness of breath; This case was reported by a pharmacist via call center representative and described the occurrence of chest pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 22nd May 2019 18:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced creatinine increased and blood glucose increased. On 22nd May 2019 23:00, the patient experienced chest pain, pale skin, palpitation and shortness of breath. The patient was treated with prednisone. In May 2019, the outcome of the creatinine increased and blood glucose increased were recovered/resolved. On an unknown date, the outcome of the chest pain, pale skin, palpitation and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the chest pain, pale skin, palpitation, shortness of breath, creatinine increased and blood glucose increased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. At approximately 11pm of last night, 4 hrs. 30 min after receiving Shingrix, the patient developed shortness of breath, heart palpitations, chest pain and pale skin.  The patient went to the emergency room and found out that the patient's blood glucose levels and creatinine levels were elevated.  The patient was given prednisone and sent home around 4 am morning of this time of reporting.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Upper respiratory tract infection
Clinical narrative: shingles on the upper left leg; upper respiratory infection; This case was reported by a physician via call center representative and described the occurrence of shingles in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number F3D7H, expiry date unknown) for prophylaxis.   On 16th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th May 2019, 3 days after receiving Shingrix, the patient experienced shingles and upper respiratory tract infection. On an unknown date, the outcome of the shingles and upper respiratory tract infection were not recovered/not resolved.   It was unknown if the reporter considered the shingles and upper respiratory tract infection to be related to Shingrix.  Additional details were provided as follows: The expiry date for Shingrix was not reported. The patient received Shingrix on right arm.  The patient experienced shingles on the upper left leg and also experienced a upper respiratory infection. The outcome reported for all the adverse events in the structured field is "recovering" instead of "not resolved" (outcome uploaded in Agency).
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza like illness, Injection site erythema, Pain
Clinical narrative: flu-like symptoms; redness on arm and below injection site; soreness; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 16th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, erythema of extremities and pain. On an unknown date, the outcome of the influenza-like symptoms and pain were recovered/resolved and the outcome of the erythema of extremities was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, erythema of extremities and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received dose of Shingrix in an unknown deltoid. The patient experienced redness on their arm and below the injection site which was in the deltoid of the same arm. The patient also experienced soreness and flu-like symptoms which had since resolved.  The redness was currently improving, at the time of reporting. The pharmacist did not have more patient information during time of call.  The reporter was not at the facility during the time of call. This was most likely the first report, according to health care professional. The reporter consented to follow-up.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic, Urticaria
Clinical narrative: The patient presents with rash.  Other comments include: Pt had HPV #2 yesterday around 4:30. At about 6pm, she developed a red itchy rash. Her face became blotchy.  No fever, swollen lips/tongue, no URI sxs. Pt is on D9/10 Amoxil for strep throat. No h/o medication allergies in past.  There has been the acute onset of a rash.  It is pruritic.  It is located on the face, chest and arms .  Comments: rcvd HPV vaccine 5/28/19. Hives started last PM.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Flu like symptoms began about 24 hours after the injection.  General malaise, diarrhea and loss of appetite followed.  My husband was so tired he slept the first day for about 4 hours that afternoon . On the second day he exercised at the gym for 30 mintues and came home feeling  ill with an upset stomach , sour brash/reflux, body aches, several episodes of diarrhea, sweating and fatigue.  He slept  all afternoon and all night as well. Today, he felt well enough to each a light breakfast. The first injection did not produce any symptoms other than local redness and pain at the injection site.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypersomnia, Influenza like illness, Malaise, Pain
Clinical narrative: Flu like symptoms began about 24 hours after the injection.  General malaise, diarrhea and loss of appetite followed.  My husband was so tired he slept the first day for about 4 hours that afternoon . On the second day he exercised at the gym for 30 mintues and came home feeling  ill with an upset stomach , sour brash/reflux, body aches, several episodes of diarrhea, sweating and fatigue.  He slept  all afternoon and all night as well. Today, he felt well enough to each a light breakfast. The first injection did not produce any symptoms other than local redness and pain at the injection site.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Muscle spasms, Pyrexia
Clinical narrative: patient called and said he had a reaction to shingrix shot. fever, joint pain, muscle cramps and dizziness.  he said he will not get the second shot. he also mentioned that he already reported to FDA.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Asthenia, Culture urine, Diarrhoea
Clinical narrative: the evening after vaccines given child had vomited., she had a large explosive stool with bright red blood in it as well. and a large stool the day after. was refusing to eat. mom had to encourage but taking little/vomiting . refusing pacifier and gagging. not cranky. just no energy and moaning. continued to vomit and  was hard to get her to drink. lost weight ,lethargy in office two days later
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diet refusal, Enema administration, Full blood count, Haematochezia, Intussusception
Clinical narrative: the evening after vaccines given child had vomited., she had a large explosive stool with bright red blood in it as well. and a large stool the day after. was refusing to eat. mom had to encourage but taking little/vomiting . refusing pacifier and gagging. not cranky. just no energy and moaning. continued to vomit and  was hard to get her to drink. lost weight ,lethargy in office two days later
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Laboratory test, Lethargy, Moaning, Retching, Ultrasound abdomen abnormal
Clinical narrative: the evening after vaccines given child had vomited., she had a large explosive stool with bright red blood in it as well. and a large stool the day after. was refusing to eat. mom had to encourage but taking little/vomiting . refusing pacifier and gagging. not cranky. just no energy and moaning. continued to vomit and  was hard to get her to drink. lost weight ,lethargy in office two days later
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Urine analysis, Urine ketone body present, Vomiting, Weight decreased, White blood cell count increased
Clinical narrative: the evening after vaccines given child had vomited., she had a large explosive stool with bright red blood in it as well. and a large stool the day after. was refusing to eat. mom had to encourage but taking little/vomiting . refusing pacifier and gagging. not cranky. just no energy and moaning. continued to vomit and  was hard to get her to drink. lost weight ,lethargy in office two days later
Sex: F
Vaccine: UNK
Symptoms: Anxiety, Malaise
Clinical narrative: feeling unwell; feeling like death; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for an unknown indication.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced feeling unwell and impending doom. On an unknown date, the outcome of the feeling unwell and impending doom were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and impending doom to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. On unspecified date in 2019, the patient received the flu shot and was laying on the sofa feeling like death (feeling unwell) and Impending doom. The patient response that the patient would never have the vaccine and keep the vaccine away from the patient. On the day of reporting, the patient was of 70 and mention never had a flu shot, never would and never had flu shot. Though most of the patient's friend had the shot. All of them had filed adverse event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Eye pain, Eye swelling, Inappropriate schedule of product administration
Clinical narrative: eye condition; pain in eye; eye swollen; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of eye disorder in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (estimated date for the 1st shot was over 6 months before the reporting date).   On 9th May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th May 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced eye disorder, eye pain and eye swelling. The patient was treated with ophthalmologicals (Eye Ointment (Ingredients Or Trade Name Unknown)). On an unknown date, the outcome of the eye disorder, eye pain and eye swelling were recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the eye disorder, eye pain and eye swelling to be related to Shingrix.  Additional details were reported as follows: On 9th May 2019, the patient received the 2nd dose of Shingrix, which led to lengthening of the vaccination schedule. A couple of days later, the patient felt as if she had a stye in one of her eyes.   The doctor stated it was not a stye and gave her some ointment to apply.   It was painful and swollen but improved with the use of the ointment however, it is now in the other eye. Two days after vaccination, the patient experienced eye disorder, eye pain and eye swelling. The reporter did not give consent to follow up. The emergency visit required.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Thrombocytopenia
Clinical narrative: This is a serious observational study case initially received on 21-May-2019, concerning a 23-year-old adult, pregnant female subject of body weight 104 lbs, height 59 inches and body mass index (BMI) 21, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy. The subject's pregnancy history included one full term live birth. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period (LMP) date was 04-Nov-2018 and the type of pregnancy was singleton. On an unspecified date, prior to vaccination, the pregnancy status of the subject was collected, and no pregnancy complications were noted. On 08-Jan-2019, the subject started Prenatal vitamins [minerals nos, vitamins nos, dose: one tablet, once daily (qd) via oral route, stop date: ongoing] for healthy pregnancy. On 24-Jan-2019, at gestational age of 11 weeks, the pregnant subject was administered Flu Vaccine Cell Subunit QIV NVD (influenza vaccine, subunit influenza virus vaccine polyvalent, batch number: 252675, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as vaccine exposure during pregnancy) for an unknown indication. On the same day, after vaccination, the subject was diagnosed with thrombocytopenic disorder. The outcome of the event thrombocytopenic disorder was not recovered (reported as ongoing). The subject's estimated date of delivery was reported as 11-Aug-2019.; Reporter's Comments: A 23-year-old pregnant subject experienced thrombocytopenic disorder, on the same day after administration of study vaccine at 11 weeks of gestation (coded to Exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event and no evidence for a biological mechanism that could cause the event, the event was assessed as not related to the study vaccine. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of exposure during pregnancy was assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Arthralgia
Age: 31.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Arthralgia
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Rash
Clinical narrative: SkinRash & ErythemaMultiform
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema multiforme, Pyrexia
Clinical narrative: Arthralgia, Fever & ErythemaMultiform ACETAMINOPHEN 500 MG ONCE
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: FOR 4 DAYS FOLLOW VACCINE. EXPERIENCED SAME SYMPTOMS FOLLOWING FIRST  SHINGRIX INJECTION. Fever & NAUSEA; FLU-LIKE SYMPTOMS
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient received an expired seconnd dose of Menactra in his left deltoid. The patient did not and has not experienced any adverse reactions.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis contact, Vaccination site mass, Vaccination site rash
Clinical narrative: A lump was formed due to vaccine administration, a rash came after in which the doctor concluded that it was a contact dermatitis reaction from administration.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Streptococcus test negative
Clinical narrative: Fine rash developed on chest/arms/hands on 5/29/19;  no fever at the time of rash and no itching, no respiratory symptoms; physician aware, advised to take PO  Benadryl;   pt went to urgent care 5/30/19; had temp of 100.6; was prescribed prednisone pack;
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: nflammation, pain, swelling at the injection site which was the fatty part at the back of my right arm.  Muscle pain, especially my left biceps, which I had from work out strain before the injection but which got worse after.  Feel soreness all over the body: arms, legs, fingers, where my dental crown was done.  Tiredness.  Maybe fever because I was hot when sleeping but I didn?t measure it.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Medical device pain, Myalgia, Pain, Pain in extremity
Clinical narrative: nflammation, pain, swelling at the injection site which was the fatty part at the back of my right arm.  Muscle pain, especially my left biceps, which I had from work out strain before the injection but which got worse after.  Feel soreness all over the body: arms, legs, fingers, where my dental crown was done.  Tiredness.  Maybe fever because I was hot when sleeping but I didn?t measure it.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: body aches, tiredness, joint pain, pain where shot was given, headache, chills, stomach ache
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: body aches, tiredness, joint pain, pain where shot was given, headache, chills, stomach ache
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: fever of 100.5, controlled with Tylenol  headache lasting 2 days, little relief with Tylenol or Advil
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Pt developed shortness of breath and tightness of throat about 7 hours after admin of vaccine. Pt went immediately to ER, was given IM epinephrine, IV steroids, benadryl and pepcid. Pt observed for about 3 hours and sent home. Pt seen for follow up in primary care office on 5/31/19 for persistent sensation of throat tightness and difficulty swallowing. Was given prednisolone 30mg BID for 3 days.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Attention deficit/hyperactivity disorder, Autism spectrum disorder, Crying, Developmental regression, Emotional distress
Clinical narrative: Febrile seizure and regressed into Autism