chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TTOX
Symptoms: Allergic reaction to excipient, Death
Clinical narrative: Initial information received on 30-Apr-2019 regarding an unsolicited valid serious case received from other health professional. This case involves male patient who died after a reaction to horse serum in a tetanus vaccine, while he received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, patient died after a reaction to horse serum in a tetanus vaccine following the administration of TETANUS TOXOID. This event was leading to death. (Other relevant tests included no lab data.) Final diagnosis was (fatal) patient died after a reaction to horse serum in a tetanus vaccine. It was not reported if the patient received a corrective treatment. The outcome is reported as Fatal. It is unknown if an autopsy was done. The cause of death was reported as Allergic reaction to drug excipient. Information on the batch number was requested. Documents held by sender: none. Sender's Comments: This case concerns a male patient of an unknown age who died after a reaction to horse serum in a tetanus vaccine after vaccination with TETANUS TOXOID produced by unknown manufacturer. No conclusion can be made at this point, as no autopsy results are available. This case lacks important data such as past medical history of the patient and of his family, medical circumstances in the previous days and autopsy findings, to assess it.. Reported Cause(s) of Death: reaction to horse serum in a tetanus vaccine.
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: Initial information received on 01-May-2019 regarding an unsolicited valid serious case received from a consumer. This case involves a male patient of unknown age who became paralyzed after receiving vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. In 2014, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (prefilled syringe 0.5 ml) lot U4809AA, exp date: 18-Jun-2014, via unknown route in unknown administration site. On an unknown date, following the vaccination the patient became paralyzed. This event was assessed as medically significant. Note: The reporter asked if Guillain Barre is listed in PI. It was not confirmed that the patient had GBS. (Other relevant tests included no lab data). Final diagnosis was paralysis. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported at the time of reporting. List of documents held by sender: none. Sender's Comments: This case involves a male patient of unknown age who presented with paralysis (unspecified) after vaccination. Time to onset is unknown. More details regarding patient's medical history, previous vaccination history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information, the role of vaccine cannot be assessed.
Age: 57.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: pt had redness, hard, swollen at injection site. 24 hours after injection. still persists on day 4 days after. redness and swelling 10cm x 6cm
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, MNQ, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a Menveo injection in error. patient was to get an MMR injection. No adverse reaction documented.
Age: 0.17
Sex: M
Vaccine: DTAP, RV5
Symptoms: Urticaria
Clinical narrative: Patient broke out with hives all over his left arm, then his face, then they would go away. The next morning he had them on his legs, face, and arms.  This allergic reaction to the RotaTeq, unknown if further issues will develop or if hives will continue to develop. First day clear of hives was 5/5/19.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; The spontaneous report was received from a lawyer and refers to a currently 78-year-old female patient. There was no information about the patient's concomitant therapies or medical history provided. The patient was married.  On 28-JAN-2018, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), subcutaneously for prophylaxis (long-term prevention of shingles and zoster-related conditions) (strength, dose, lot # and expiration date were not reported). On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report as received from an attorney and refers to an elderly, currently 71-year-old patient of an unknown gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not reported) by a healthcare provided for long-term prevention of shingles and zoster-related conditions.  On an unknown date in 2012, the vaccine was administrated by a healthcare provider.  On an unknown date, the patient experienced shingles, which was treated by a registered nurse. The outcome of the event was unknown. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
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 currently 72-year-old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications. On or about 29-APR-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of shingles was not reported. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient had injection-site reaction. The injeciton-site reaction was small, quarter-sized, raised, red and warm to touch; The patient described injection side as sore but not painful; The patient had injection-site reaction. The injeciton-site reaction was small, quarter-sized, raised, red and warm to touch; This spontaneous report has been received from a registered nurse concerning a 16-year-old non-pregnant female patient.  The patient's concurrent condition included allergy to dairy. The patient had no other pertinent medical history, previously drug reactions, or concomitant medications.  On 28-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 of administration and anatomical location were not provided) (lot # 1581027, expiration date: 03-JUN-2021) (indication reported as vaccine).  It was reported that on 01-MAR-2019 (reported as one day after the vaccine administration), the patient experienced an injection site reaction. The injection-site reaction was small, quarter-sized, raised, red and warm to touch; the patient also described injection site as sore but not painful (injection site erythema) (injection site pain) (injection site warmth). On approximately 08-MAR-2019 (reported as: one week later), the patient recovered from all the events. The patient did not received treatment for the events and did not seek medical attention.  The causal relationship between the aforementioned adverse events and the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71-year-old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 05-DEC-2008, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a physician for ophthalmic herpes zoster. The outcome of ophthalmic herpes zoster was unknown. The reporter considered ophthalmic herpes zoster to be related to ZOSTAVAX. Upon internal review, the event of ophthalmic herpes zoster was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013268: US-009507513-1904USA013269: US-009507513-1904USA013270: US-009507513-1904USA013272: US-009507513-1904USA013275: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is on of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013270: US-009507513-1904USA013272: US-009507513-1904USA013275: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013265: US-009507513-1904USA013268: US-009507513-1904USA013270: US-009507513-1904USA013272: US-009507513-1904USA013275: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013268: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013272: US-009507513-1904USA013275: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013210: US-009507513-1904USA013270: US-009507513-1904USA013268: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013275: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013269: US-009507513-1904USA013210: US-009507513-1904USA013270: US-009507513-1904USA013268: US-009507513-1904USA013265: US-009507513-1904USA013272: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013268: US-009507513-1904USA013210: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013268: US-009507513-1904USA013276: US-009507513-1904USA013272: US-009507513-1904USA013270: US-009507513-1904USA013275: US-009507513-1904USA013265: US-009507513-1904USA013269: US-009507513-1904USA013210: US-009507513-1904USA000187: US-009507513-1904USA000191:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: The patient was vaccinated with expired M-M-R II on 4/29/2019; This spontaneous report was received from the medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.   On 29-APR-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) (expired vaccine used) lot # N025889, expiration date reported and validated as 18-APR-2019 (formulation, strength, dose, frequency, route of administration, anatomical location and indication were not reported).
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: an unspecified patient developed a rash; Information has been received from a pharmacist referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (route, strength, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. The pharmacist reported it was unknown if the patient was previously vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or the patient's first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On an unknown date, the patient experienced rash.      The outcome of rash was unknown. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever; This case was reported by a nurse via sales rep and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd November 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additiona details were provided as follows For tolerance to 2nd dose, refer case US2019AMR030300.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Dyspnoea, Injection site erythema, Injection site pain
Clinical narrative: redness at injection site; swelling at injection site; fever; nausea; weakness; pain at injection site; difficulty breathing; balance feels off; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received in February 2019, refer linked case US2019075925).   On 25th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day before reporting, the patient received 2nd dose on left arm and experienced fever of 100.3 degrees F, nausea, weakness, pain, swelling and redness at injection site, difficulty breathing and balance feels off. The patient's date of birth was not obtained during the call. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pyrexia, Vaccine positive rechallenge
Clinical narrative: redness at injection site; swelling at injection site; fever; nausea; weakness; pain at injection site; difficulty breathing; balance feels off; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema (1st dose received in February 2019, refer linked case US2019075925).   On 25th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, nausea, weakness, injection site pain, difficulty breathing and balance disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A day before reporting, the patient received 2nd dose on left arm and experienced fever of 100.3 degrees F, nausea, weakness, pain, swelling and redness at injection site, difficulty breathing and balance feels off. The patient's date of birth was not obtained during the call. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site redness; Injection site tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site erythema and injection site tenderness were unknown.   It was unknown if the reporter considered the injection site erythema and injection site tenderness to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received flu vaccines in the past and had experienced redness and tenderness at the injection site after flu vaccines. The reporter consented to follow up. This case has been linked with US2019075908, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Nausea; Chills; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluoxetine hydrochloride (Prozac).   On 24th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced nausea and chills. On an unknown date, the outcome of the nausea and chills were not recovered/not resolved.   It was unknown if the reporter considered the nausea and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On Saturday, the patient started on Prozac. The batch number and expiry date of Shingrix was not reported.  Two days ago, from the date of reporting, the patient received Shingrix and felt nauseous and chilly. The reporter was not sure if Prozac played a part in events. Reviewed side effects and median duration of Shingrix per product information (PI) and reporter mentioned hopefully she would feel better at the day of reporting. Reporter willingly stated she would provide further information; however, reporter inadvertently disconnected.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Influenza like illness, Injection site bruising
Clinical narrative: Inappropriate schedule of vaccine; headache; shivering; flu like symptoms; injection site bruise; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 11th October 2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced headache, shivering, influenza-like symptoms and injection site bruising. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the headache, shivering, influenza-like symptoms and injection site bruising were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, shivering, influenza-like symptoms and injection site bruising to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was going to get her 2nd dose next week, which was more than 6 months after the first dose, which led to lengthening of vaccination schedule. The evening of the first dose she started experiencing headache, shivers and flulike symptoms that continued into the next day before resolving. The patient also had a bruise at the injection site that took almost 2 weeks to resolve. The reporter consented to follow up. This case has been linked to US2019GSK080240, same reporter and same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two months ago, from the date of reporting, the patient received 1st dose on left arm and experienced redness and swelling at injection site. The patient's date of birth was not obtained during the call. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix refer case US2019GSK080183, reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Pyrexia
Clinical narrative: redness at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Two months ago, from the date of reporting, the patient received 1st dose on left arm and experienced redness and swelling at injection site. The patient's date of birth was not obtained during the call. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix refer case US2019GSK080183, reported by same reporter.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Tremor
Clinical narrative: Swelling; Chills; Shaking; Redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included TETANUS TOXOID (TETANUS).   On 22nd April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, chills, tremor and injection site erythema. On 25th April 2019, the outcome of the chills and tremor were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, chills, tremor and injection site erythema to be related to Shingrix.  Additional details were provided as follows: On 16th April 2019, the patient received Tetanus intramuscularly on left arm. The patient received Shingrix on right arm. The patient experienced chills and shaking, along with redness and swelling at the injection site. The chills and shaking lasted for about 2 days. The redness and swelling has continued to spread to 5 inches up and down the injection site, and it was spreading to the side of her arm. No further details were provided. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Neuralgia, Pain, Pain in extremity, Pain of skin
Clinical narrative: Nerve Pain; Dart like pain/ pain throughout body; Pain in leg and arm; pain in breast; pain in scalp; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received Zostavax on an unknown date, prior to Shingrix) and Shingrix (received 1st dose on an unknown date).   On 20th June 2018, the patient received Shingrix (intramuscular) .5 ml. On 20th June 2018, less than a day after receiving Shingrix, the patient experienced nerve pain, prick pain feeling, pain in extremity, breast pain and scalp pain. On an unknown date, the outcome of the nerve pain, prick pain feeling, pain in extremity, breast pain and scalp pain were not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, prick pain feeling, pain in extremity, breast pain and scalp pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she did fine with her first dose but has had a reaction to the 2nd dose of Shingrix. She received the injection in her left deltoid.  The patient reported that she experienced sharp dart-like pains throughout her body.  It was mostly in her legs but had occurred in arms, breast and scalp as well. The patient continued to experience these pains presently. She also stated that she had had the Zostivax shot prior to the Shingrix being released and did not have any reaction to that.  The patient had given permission to contact her physician. There was consent to follow up. There was a discrepancy in outcome of the events. The outcome of events were taken as per narrative.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram normal, Grip strength decreased, Hypoaesthesia, Loss of personal independence in daily activities, Monoplegia
Clinical narrative: This is a spontaneous case initially received from other non-health professional (consumer) on 24-Apr-2019, concerning a 56-year-old, adult male patient. The patient's current condition included hereditary heart disease and abnormal cholesterol. The patient's concomitant medications included unspecified blood thinner and cholesterol medication. On 07-Nov-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: YF44509, anatomical location and expiry date: not reported) for active immunization against influenza. On 21-Nov-2018, 14 days after vaccination, the patient experienced severe shoulder pain and right arm numbness. On the same day, by 2 pm that afternoon, the patient's pain was so intense that he was admitted to the hospital. The patient underwent magnetic resonance imaging (MRI) scans, computerized axial tomography (CAT) scans and X-rays from which they could not find the source of the problem. On 22-Nov-2018, the next morning, the patient was discharged and was told to follow up with his primary care doctor. On an unspecified date, the patient had paralysis in his right arm and could not button shirt, could not pick up a pen with his right hand and could not even make a fist with his right hand. The patient was diagnosed with brachial plexus neuropathy. On an unspecified date in December, the patient went to a neurologist and was prescribed with Gabapentin (200 mg in the morning and afternoon and 300 mg at bedtime). The patient had been going to physical therapy since 30-Jan-2019 once a week for 1 hour. On 06-Feb-2019, the patient had a ganglion nerve block. It was reported that the events were ongoing and was uncertain that it would resolve. The outcome of the events was not recovered. The reporter assessed the case as serious (hospitalization) and considered the causality of the event brachial plexus neuropathy as related to the suspect vaccine.; Reporter's Comments: A 56-year-old male patient experienced symptoms of brachial plexus neuropathy, in right arm 14 days after receipt of AFLURIA QUADRIVALENT vaccine and subsequently patient experienced paralysis of right arm, eventually diagnosed with brachial plexus neuropathy. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event 'paralysis arm' as serious (medically significant).
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Nerve block, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, X-ray normal
Clinical narrative: This is a spontaneous case initially received from other non-health professional (consumer) on 24-Apr-2019, concerning a 56-year-old, adult male patient. The patient's current condition included hereditary heart disease and abnormal cholesterol. The patient's concomitant medications included unspecified blood thinner and cholesterol medication. On 07-Nov-2018, the patient was administered AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, batch number: YF44509, anatomical location and expiry date: not reported) for active immunization against influenza. On 21-Nov-2018, 14 days after vaccination, the patient experienced severe shoulder pain and right arm numbness. On the same day, by 2 pm that afternoon, the patient's pain was so intense that he was admitted to the hospital. The patient underwent magnetic resonance imaging (MRI) scans, computerized axial tomography (CAT) scans and X-rays from which they could not find the source of the problem. On 22-Nov-2018, the next morning, the patient was discharged and was told to follow up with his primary care doctor. On an unspecified date, the patient had paralysis in his right arm and could not button shirt, could not pick up a pen with his right hand and could not even make a fist with his right hand. The patient was diagnosed with brachial plexus neuropathy. On an unspecified date in December, the patient went to a neurologist and was prescribed with Gabapentin (200 mg in the morning and afternoon and 300 mg at bedtime). The patient had been going to physical therapy since 30-Jan-2019 once a week for 1 hour. On 06-Feb-2019, the patient had a ganglion nerve block. It was reported that the events were ongoing and was uncertain that it would resolve. The outcome of the events was not recovered. The reporter assessed the case as serious (hospitalization) and considered the causality of the event brachial plexus neuropathy as related to the suspect vaccine.; Reporter's Comments: A 56-year-old male patient experienced symptoms of brachial plexus neuropathy, in right arm 14 days after receipt of AFLURIA QUADRIVALENT vaccine and subsequently patient experienced paralysis of right arm, eventually diagnosed with brachial plexus neuropathy. Considering the plausible temporal relationship between vaccination and reported events, plausible biological mechanism and lack of any underlying conditions or alternative more plausible causes, the company assessed the events as possibly related to suspect vaccine. The company assessed the event 'paralysis arm' as serious (medically significant).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Injection site pain, Pain, Pyrexia
Clinical narrative: Chills, feverish, body aches, sore injection site- started night of the injection; lasted the whole next day ( I had to stay home from work)
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: Body aches, extremely sore arm/muscle (hurt to elevate), redness and extreme tenderness at and just under injection site, chills, headache for 18 hours (starting 7 hours after vaccine).  Treatment: bed rest, limited activity. Outcome: all but arm redness gone within 24 hours.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Body aches, extremely sore arm/muscle (hurt to elevate), redness and extreme tenderness at and just under injection site, chills, headache for 18 hours (starting 7 hours after vaccine).  Treatment: bed rest, limited activity. Outcome: all but arm redness gone within 24 hours.
Age: 6.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: High fever, swollen red arm from the injection,
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Asthma, Condition aggravated, Fatigue, Injection site discomfort, Injection site pain
Clinical narrative: Spinal pain, soreness and pain at injection site, tiredness, and asthma attack.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Spinal pain
Clinical narrative: Spinal pain, soreness and pain at injection site, tiredness, and asthma attack.
Age: 0.58
Sex: M
Vaccine: FLU4
Symptoms: Serum sickness, Skin test negative, Urticaria
Clinical narrative: Developed diffuse severe urticarial rash 6 days after vaccine. Had skin testing to egg and peanut on 2/20/19 which was normal. Allergist feels it is a serum sickness rash to flu vaccine
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site discolouration, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Fever   Chills Shivering uncontrollably Severe body aches Nauseous  Severe pain at injection site Swelling and discoloration at injection site Still sore at injection site after 10 days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever   Chills Shivering uncontrollably Severe body aches Nauseous  Severe pain at injection site Swelling and discoloration at injection site Still sore at injection site after 10 days
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Body temperature increased, Decreased appetite, Myalgia
Clinical narrative: Shingrix 2nd shot. Started with muscle pain followed by restless night, up set stomach, weakness and 101 +temp. I slept on and off the following day and had no appetite. temp went down by evening (6 or 7 PM) Felt better next day, but still weak. Pain where shot was administered continued for 5 more days. Shot was given in left arm. I have never had any kind of reaction like this before. When my symptoms started my husband suspected the vaccine and found all my complaints matched the possible reaction symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep
Clinical narrative: Shingrix 2nd shot. Started with muscle pain followed by restless night, up set stomach, weakness and 101 +temp. I slept on and off the following day and had no appetite. temp went down by evening (6 or 7 PM) Felt better next day, but still weak. Pain where shot was administered continued for 5 more days. Shot was given in left arm. I have never had any kind of reaction like this before. When my symptoms started my husband suspected the vaccine and found all my complaints matched the possible reaction symptoms.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dry throat, Erythema, Pallor, Skin warm
Clinical narrative: 5/1/19 5:20 PM Pt received his HPV (9) Lot # R028762 Exp 6/21 at around 5 PM 10 minutes later while walking to have his blood drawn (routine) for his check up his cheeks got rosy and then his forehead felt very warm and throat felt dry like crushed mints in his throat After drawing of blood he became very pale (? vasovagal) but responded to liquids + chocolate  was given Zyrtec 10 mg Did well and went home  7.21PM called Mom, pt is doing fine
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling in the injection site, rt arm.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal pain, Oral mucosal discolouration, Pain in extremity, Tongue discolouration
Clinical narrative: Arm pain at injection site on Day 1. Pain in underarm area and front of right shoulder on Day 2. About 10 small white, painless spots and bumps on oral mucosa inside of lips, encircling mouth on Day 3. 1small white patch on top of tongue on Day 4.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eyelid rash, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: shingirx vacccine 4/9/19 at 8 am was feeling fine before that  first day R arm mildly sore  nexy day r arm really hurting red and swollen day after vaccine -rash R side of face under eye/over cheekbone saw pt on 4/11 ( 2 days after vaccine) had erythematous rash with swelling over R maxilla.  no vesicles or pustules  rash on face and swelling / redness on arm resolved on own over about 4-5 days
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Swelling
Clinical narrative: shingirx vacccine 4/9/19 at 8 am was feeling fine before that  first day R arm mildly sore  nexy day r arm really hurting red and swollen day after vaccine -rash R side of face under eye/over cheekbone saw pt on 4/11 ( 2 days after vaccine) had erythematous rash with swelling over R maxilla.  no vesicles or pustules  rash on face and swelling / redness on arm resolved on own over about 4-5 days
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Lethargy, Macule
Clinical narrative: Patient developed fever with chills and feeling very cold around 6 pm the same day of immunization.  During the evening, she developed a red facial rash (erythema) with four macules on the cheeks and chin.  two additional small eruptions were inside of her mouth.  Felt very tired and lethargic for 48 hours after the immunization.  Note:  She was eligible for her six month follow-up second dose  last October 2018.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal eruption, Pyrexia, Rash, Rash erythematous
Clinical narrative: Patient developed fever with chills and feeling very cold around 6 pm the same day of immunization.  During the evening, she developed a red facial rash (erythema) with four macules on the cheeks and chin.  two additional small eruptions were inside of her mouth.  Felt very tired and lethargic for 48 hours after the immunization.  Note:  She was eligible for her six month follow-up second dose  last October 2018.