chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Cerebrovascular accident, Injection site mass, Intracranial mass
Clinical narrative: patient got a stroke from her swine flu shot; lump traveled to her brain and burst; injection site developed a golf ball size lump; Initial information was received on 08-Oct-2020 regarding an unsolicited valid serious case from consumer or non-health care professional.  This case involves a female patient (age unspecified) who had stroke (cerebrovascular accident) and injection site developed a golf ball size lump (vaccination site mass) which traveled to her brain and burst (intracranial mass), while she received INFLUENZA VACCINE (MONOVALENT) [swine flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (MONOVALENT) (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had a serious stroke (cerebrovascular accident) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT). This event was assessed as medically significant. On an unknown date, the patient developed a non-serious injection site developed a golf ball size lump (vaccination site mass) which traveled to her brain and burst (intracranial mass), (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT).   Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, the patient had recovered from vaccination site mass (reported as disappeared) and at the time of reporting, the event outcome for stroke and intracranial mass was unknown .   There will be no information available on the batch number for this case.; Sender's Comments: This case involves a female patient (age unspecified) who experienced cerebrovascular accident, vaccination site mass and intracranial mass after vaccination with INFLUENZA VACCINE (MONOVALENT) [swine flu shot]. The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations ruling out other etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Acute cardiac event
Clinical narrative: cardiac event within a few hours post vaccination; Initial information received on 12-Oct-2020 regarding an unsolicited valid serious case from a other health professional (pharmacy director).  This case involves a patient (unknown demographics) who experienced cardiac event within few hours of vaccination (acute cardiac event), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Prefilled Syringe) lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious cardiac event (acute cardiac event) within a few hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for cardiac event.  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented social media case concerns a patient (unknown demographics) who suffered from acute cardiac event after vaccination with FLUZONE QUADRIVALENT. The time to onset was compatible. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed."
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Malaise, Mouth ulceration, Stomatitis, Tenderness
Clinical narrative: tender; other side is inflamed one side of mouth; sound like a "frog"; sick; ulcer on one side on her mouth; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 82 years old female patient who experienced ulcer on one side on her mouth (mouth ulceration), tender (tenderness), inflamed one side of mouth (stomatitis), sound like a "frog" (breath sounds) and was sick (malaise), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot: UJ518AB) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed non-serious ulcer on one side on her mouth (mouth ulceration), tender (tenderness), inflamed one side of mouth (stomatitis), sound like a "frog" (breath sounds) and was sick (malaise) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the tie of reporting.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Event Started on 10/9 to 10/10/20, right arm muscle pain on extension.  No redness, inflamation, or skin discoloration. No pain when arm is rested or not hanging. Reported by patient on 10/19, examined by provider on 10/19/20, right arm soft compartments and strong equal pulses. patient was seen on 10/16/20 by Dr and has follow up appointment on 10/23/20
Age: 62.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient displayed red, swollen arm and stated she was experiencing severe pain for several days.
Age: 94.0
Sex: F
Vaccine: FLUA4
Symptoms: Sepsis
Clinical narrative: Patient received flu vaccine on 9/10/2020. A few hours later, she developed possible seizure like activity and was sent to hospital. There she was diagnosed with sepsis of unclear etiology, improved with broad spectrum antibiotics. Was not sick prior to vaccination, and had tolerated other flu vaccines in previous years. Patient also high risk for aspiration due to advanced dementia and dysphagia, so unclear what precipitated event.  Vaccine was given in patient's home in as part of Program
Age: 15.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 15 and received vaccine indicated for 18 and over.  Patient has not reported any adverse events.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: none
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 8.0
Sex: M
Vaccine: FLUA3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Influenza vaccine but not sure which one.  AEs include swelling, spreading redness up to 7-8in circle, warm to touch, very itchy
Age: 47.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Nausea
Clinical narrative: Patient received pneumococcal and influenza vaccines on 10/12/2020. Patient reported receiving PCV 13 last year without difficulty.  Patient reported she developed red/painful/warm rash on the interior portion of her left arm near the pneumococcal immunization site first noticed the morning after the vaccination (10/13/2020).  She reported no fever, no vomiting, and no skin breakdown or hives but stated  that she was experiencing  intolerable nausea.  She requested and was prescribed  medication to treat the nausea.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: After getting flu shot, the next morning site was very red, swollen and frim, tender to touch, tender to move left arm.  This resolved 4 days after injection. Pt reports Pins-and -needles sensation in left hand and forearm on the ulnar side.  Reports continues numbness and paresthesia of LUE for 2 weeks.  Reports random sensations "pulsing and lightning bolts".
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia, Sensory disturbance
Clinical narrative: After getting flu shot, the next morning site was very red, swollen and frim, tender to touch, tender to move left arm.  This resolved 4 days after injection. Pt reports Pins-and -needles sensation in left hand and forearm on the ulnar side.  Reports continues numbness and paresthesia of LUE for 2 weeks.  Reports random sensations "pulsing and lightning bolts".
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Chills
Clinical narrative: The nurse stated child's mother called and said the child was seen in the ER the night the flu vaccine was administered. She had a temp of 104.8 and chills. She was treated and sent home. ADH nurse tried to contact parent but the phone number could not leave a message.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea
Clinical narrative: Pt had nausea with diarrhea 3 hours after receiving vaccine. Pt states that it lasted about 4 hours then stopped. She called the office the following week to report.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haematoma, Injection site haemorrhage
Clinical narrative: Vaccine was given in Left upper arm.  Slight Bleeding occurred after vaccination and brusing occured after vaccination. (patient states a hematoma)
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 30-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-OCT-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621931, expiration date: 26-JAN-2022 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 28-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621931, expiration date: 26-JAN-2022 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 26-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 26-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis. The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 18-SEP-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis. The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  22-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number R021636 was confirmed to be valid, expiration date 12-MAY-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  23-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number R021636 was confirmed to be valid, expiration date 12-MAY-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  24-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number R021636 was confirmed to be valid, expiration date 12-MAY-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  14-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number S008153 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number S008153 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 16-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number S008153 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: a patient received expired PNEUMOVAX 23; No additional adverse effects reported; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. On 15-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot S026366 was confirmed to be valid, with expiration date 17-SEP-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No additional adverse effect reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: When do burnig pain go away; This case was reported by a consumer via call center representative and described the occurrence of pain burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain burning. On an unknown date, the outcome of the pain burning was not recovered/not resolved.   It was unknown if the reporter considered the pain burning to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccination indication. The patient received Shingrix vaccine and experienced burning pain. The patient said that it had burning for a month and asked when the burning pain would go away. No other information was available.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sickness; Initial information received on 03-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media. This case involves patient (unknown demographics) who experienced sickness (malaise), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sickness (malaise) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for malaise.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: Reporter also had sickness; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient with an unknown demographic who had also sickness (malaise), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE (produced by unknown manufacturer, batch number and expiration date were not provided) via an unknown route at an unknown administration site for prophylactic vaccination respectively.  On an unknown date, the patient developed a non-serious sickness (malaise), unknown latency following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: patient had a red, swollen, and throbbing arm with temporal thermometer temp of 100.7 in arm and just now starting to subside
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Arm pain, diarrhea, nausea, headache, chills, very tired
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain, diarrhea, nausea, headache, chills, very tired
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Injection site erythema, Tremor
Clinical narrative: Chills/shaking Redness at injection site
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain, decreased ROM
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site rash, Pain in extremity
Clinical narrative: Pt was given Shringrix at pharmacy 2 days before visit. Developed rash at site, felt headache and feverish, painful feeling in arm red and hard skin surrounding site of injection. no drainage from site no tongue swelling no dyspnea no past similar rash or reaction to vaccine No known exposure to chemicals, plants or new personal products.  Pt is doing better now
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pt was given Shringrix at pharmacy 2 days before visit. Developed rash at site, felt headache and feverish, painful feeling in arm red and hard skin surrounding site of injection. no drainage from site no tongue swelling no dyspnea no past similar rash or reaction to vaccine No known exposure to chemicals, plants or new personal products.  Pt is doing better now
Age: 15.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is 15 & 11 months years old and was give FluBloK Quad 2020-2021
Age: 15.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 15 & 11 months years old and was give FluBloK Quad 2020-2021
Age: 80.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: after discussing with patient vaccinations due. patient recieved a flucelvax vaccination after which patient stated she already recieved influenza vaccine from physician approx. 2 week prior.  patient was only interesed in receiving vaccine for shingles
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: pain in shoulder. gets worse at night. has lasted over 3 weeks
Age: 41.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Apheresis, Burning sensation, Intervertebral disc protrusion, Magnetic resonance imaging spinal abnormal, Muscular weakness
Clinical narrative: Pt experienced leg pain starting the night that she received both vaccines described as severe muscle aching. 2 days after she received the vaccines her legs started to feel extremely weak, described as if she felt they were going to give out. She also experienced tingling.  These symptoms progressed to her arms on day 3.  On day 7, the weakness got progressively worse as the day went on and there was a burning sensation in her feet and ankles which improved with elevation.  By day 16, symptoms started to improve (pt also received a round of apheresis). Tingling still present.
Age: 41.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Pt experienced leg pain starting the night that she received both vaccines described as severe muscle aching. 2 days after she received the vaccines her legs started to feel extremely weak, described as if she felt they were going to give out. She also experienced tingling.  These symptoms progressed to her arms on day 3.  On day 7, the weakness got progressively worse as the day went on and there was a burning sensation in her feet and ankles which improved with elevation.  By day 16, symptoms started to improve (pt also received a round of apheresis). Tingling still present.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Feeling cold, Loss of consciousness
Clinical narrative: Patient experienced light headed feeling, and brief loss of conscious. Patient was cold and clammy to the touch. Issue resolved within about 20 minutes of rest.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Skin warm
Clinical narrative: red band around the bicep. 3" by 4" red band that wraps around the arm that is hot to the touch. Was advised to seek urgent care if it becomes worse or severe
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: upper arm is warm, erythematous and swollen
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Rash, Streptococcus test negative
Clinical narrative: Rash all over body, started on chest and progressed. No fever. Slight decreased in appetite. ? body aches.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash
Clinical narrative: Fever 102.5 degrees F the night of the shot and the next day.  Treated with Tylenol rapid release, which broke the fever.  Body aches, chills, headache.  Headache still continues.  Rash under bra line to half-way to hips, which is just now mostly gone away.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: On the day of injection my arm was severely sore, that didn?t happen on my first injection. On day 2, my arm was still sore but not as bad. I had a low grade fever (99.8 my normal temp is usually 96.7) with chills and an intense headache. I also felt fatigued. On day 3 the fever, chills and headache continued. By day 4, I was fine.