chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel was administered to a patient after it underwent a temperature excursion of 30 degrees F/ NO AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to 2020SA241287, 2020SA241286, 2020SA241285, 2020SA241284, 2020SA241283, 2020SA241282, 2020SA241280, 2020SA241279, 2020SA241278, 2020SA241277 and 2020SA241248 (same reporter).  This case involves a 58-years-old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5667AA, expiry date-26-Sep-21) after it underwent a temperature excursion of 30 degrees Fahrenheit (product storage error) on 20-Aug-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of an actual medication error due to product storage error temperature too low.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: MNQ, HPV9, MNQ, MNQ, TDAP
Symptoms: Erythema, Headache, Pyrexia
Clinical narrative: Pt accidentally recieved 2 doses of Meningococcal vaccines on 7/17/2020. One on Left deltoid and one on R deltoid. Mom informed of this during visit. PCP and Manager aware. Call to Sanofi Pastuer and spoke w/ worker regarding incident. She says there is no info on adverse reaction available for Menactra. She advised to have doctor use their clinical judgement to decide what to look out for. Manager spoke w/ poison control and DPH who reported no adverse reaction has been reported for Menactra. They advise to monitor for any reaction, watch site for redness, any headache or fever pt should call office to be evaluated.
Age: 12.0
Sex: F
Vaccine: MNQ, HPV9, MNQ, MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt accidentally recieved 2 doses of Meningococcal vaccines on 7/17/2020. One on Left deltoid and one on R deltoid. Mom informed of this during visit. PCP and Manager aware. Call to Sanofi Pastuer and spoke w/ worker regarding incident. She says there is no info on adverse reaction available for Menactra. She advised to have doctor use their clinical judgement to decide what to look out for. Manager spoke w/ poison control and DPH who reported no adverse reaction has been reported for Menactra. They advise to monitor for any reaction, watch site for redness, any headache or fever pt should call office to be evaluated.
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site macule, Injection site swelling, Product administered at inappropriate site, Pruritus, Varicella
Clinical narrative: At the time of administering vaccine LP.N had an attitude when entering the room. She told me the vaccine had to be placed in my stomach, which was off putting to me. She administered the vaccine on the right side of my stomach. 1week later at the site, it began to swell and itch. A couple of days later, small bumps formed in between my fingers. The bumps spread to my back,all over my stomach, and butt...
Age: 22.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Rash
Clinical narrative: At the time of administering vaccine LP.N had an attitude when entering the room. She told me the vaccine had to be placed in my stomach, which was off putting to me. She administered the vaccine on the right side of my stomach. 1week later at the site, it began to swell and itch. A couple of days later, small bumps formed in between my fingers. The bumps spread to my back,all over my stomach, and butt...
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Exposure via eye contact, Exposure via skin contact, Eye irrigation
Clinical narrative: that the left eye burned a little bit; Fluzone Quadrivalent sprayed In the left eye; the syringe was never injected into his arm; the entire contents of the syringe spilled onto his skin, clothes, and in the eye; the plunger was pushed prior to injection; Initial and additional information  received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 56 years old male patient who experienced left eye burned a little bit (eye irritation) after being injected with the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that got sprayed in the left eye (exposure via eye contact) and the patient felt that the syringe was never injected into his arm (underdose). The entire contents of the syringe spilled onto his skin, clothes, and in the eye (exposure via skin contact).It seemed that the plunger was pushed prior to injection (wrong technique in product usage process).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not received any concomitant medications.  On 08-Sep-2020, the patient received 0.5 ml of  suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiration date :30-Jun-2021)via intramuscular route in the left arm as prophylactic vaccination  On 08-Sep-2020, that is on the same day, the patient experienced left eye burned a little bit (eye irritation) , due the actual medication error caused by the application of the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] , that got sprayed in the left eye (exposure via eye contact) and the patient felt that the syringe was never injected into his arm (underdose). The entire contents of the syringe spilled onto his skin, clothes, and in the eye (exposure via skin contact).It seemed that the plunger was pushed prior to injection (wrong technique in product usage process).  The patient washed his eyes in the sink with water and the another staff member gave him a spray bottle to rinse. And the new prefilled syringe was used to deliver the dose.  The outcome was unknown for the event eye irritation and not applicable for other events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Eye irritation
Clinical narrative: that the left eye burned a little bit; Fluzone Quadrivalent sprayed In the left eye; the syringe was never injected into his arm; the entire contents of the syringe spilled onto his skin, clothes, and in the eye; the plunger was pushed prior to injection; Initial and additional information  received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 56 years old male patient who experienced left eye burned a little bit (eye irritation) after being injected with the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that got sprayed in the left eye (exposure via eye contact) and the patient felt that the syringe was never injected into his arm (underdose). The entire contents of the syringe spilled onto his skin, clothes, and in the eye (exposure via skin contact).It seemed that the plunger was pushed prior to injection (wrong technique in product usage process).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not received any concomitant medications.  On 08-Sep-2020, the patient received 0.5 ml of  suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiration date :30-Jun-2021)via intramuscular route in the left arm as prophylactic vaccination  On 08-Sep-2020, that is on the same day, the patient experienced left eye burned a little bit (eye irritation) , due the actual medication error caused by the application of the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] , that got sprayed in the left eye (exposure via eye contact) and the patient felt that the syringe was never injected into his arm (underdose). The entire contents of the syringe spilled onto his skin, clothes, and in the eye (exposure via skin contact).It seemed that the plunger was pushed prior to injection (wrong technique in product usage process).  The patient washed his eyes in the sink with water and the another staff member gave him a spray bottle to rinse. And the new prefilled syringe was used to deliver the dose.  The outcome was unknown for the event eye irritation and not applicable for other events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Exposure via eye contact, Exposure via skin contact, Needle issue, Syringe issue, Underdose
Clinical narrative: that the left eye burned a little bit; Fluzone Quadrivalent sprayed In the left eye; the syringe was never injected into his arm; the entire contents of the syringe spilled onto his skin, clothes, and in the eye; the plunger was pushed prior to injection; Initial and additional information  received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 56 years old male patient who experienced left eye burned a little bit (eye irritation) after being injected with the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] that got sprayed in the left eye (exposure via eye contact) and the patient felt that the syringe was never injected into his arm (underdose). The entire contents of the syringe spilled onto his skin, clothes, and in the eye (exposure via skin contact).It seemed that the plunger was pushed prior to injection (wrong technique in product usage process).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not received any concomitant medications.  On 08-Sep-2020, the patient received 0.5 ml of  suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiration date :30-Jun-2021)via intramuscular route in the left arm as prophylactic vaccination  On 08-Sep-2020, that is on the same day, the patient experienced left eye burned a little bit (eye irritation) , due the actual medication error caused by the application of the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] , that got sprayed in the left eye (exposure via eye contact) and the patient felt that the syringe was never injected into his arm (underdose). The entire contents of the syringe spilled onto his skin, clothes, and in the eye (exposure via skin contact).It seemed that the plunger was pushed prior to injection (wrong technique in product usage process).  The patient washed his eyes in the sink with water and the another staff member gave him a spray bottle to rinse. And the new prefilled syringe was used to deliver the dose.  The outcome was unknown for the event eye irritation and not applicable for other events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Severe pain in the left shoulder and entire left arm for the first 2 days. Could not move the arm. I believe that the injection site was too high. Never had any problems in the past. Perhaps too close to the shoulder joint capsule. Third day to present (11 days later) can move the arm, but with severe pain in the shoulder. Cannot abduct the arm at all. Contacted Pharmacists (three of them) immediately and also contacted my healthcare provider by text only. They gave me some suggestions to alleviate pain. Taking antiinflammatory (Nabumetone 750 mg twice a day), but doesn't help much. Flu shot was Fluzone (65+) HD PF 2020-21 INJ 0.7ml
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: Nausea started a few hours after receiving the vaccine and persisted for the last hour.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Pruritus, Rash
Clinical narrative: Rash in the lower abdominal area, itchy skin all over, sore joints,
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE; patient received the second dose of MMR II 7 months after the first dose; patient received the second dose of MMR II 7 months after the first dose; This spontaneous report was received from an office manager and refers to a 16-month-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date in January 2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 11-AUG-2020, also reported as 7 months after the first dose, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (route of administration, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration, Inappropriate schedule of vaccine administered). No adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster oticus
Clinical narrative: zoster related hearing loss; zoster related hearing loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 13-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at an audiology center for zoster related hearing loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered zoster related hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of deafness was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Ophthalmic herpes zoster
Clinical narrative: zoster related vision loss; zoster related vision loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for zoster related vision loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered zoster related vision loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of blindness was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  On or about 11-AUG-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by the physician for Herpes zoster. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX)vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of Herpes zoster was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  In 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by the physician for Bell's palsy. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX)vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of Bell's palsy was not provided.  Upon internal review, Bell's palsy was considered to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  In 2009, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by a healthcare provider (HCP) for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome shingles was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by a healthcare provider (HCP) for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome shingles was not provided.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored PROQUAD that was administered; No other adverse event reported; This spontaneous report was received from registered nurse concerning a currently 4-year-old patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (rHA) injection, as prophylaxis (frequency, strength, route of administration, and anatomical location were not reported; lot number S023651 has been verified to be a valid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live with expiration date on 26-JAN-2021).  The administered dose of vaccine experienced temperature excursion between -14 degrees Celsius up to -10 degrees Celsius (-11.84 degrees Celsius) for 45 minutes and of -9 degrees Celsius up to 8 degrees Celsius (-4.12 degrees Celsius) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. No other adverse event reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP calling to report vaccine administered after temperature excursion and before temperature excursion evaluation occured; Information has been received from a medical assistant regarding a 5 years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 26-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, for prophylaxis, (lot number S006830 with expiration date in 02-SEP-2020) (dose, route of administration, strength and anatomical location were not reported) after temperature excursion and before temperature excursion evaluation occurred.  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) was stored at a temperature of 5 degrees Celsius (°C) for the time frame of 12 hours. There was a previous temperature excursion of 8.4 degrees Fahrenheit for the time frame of 60 hours and the call was because of a data logger.
Age: 64.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; administered VAQTA to patient this morning on 09/10/2020 before realizing it was expired; This spontaneous report was received from a pharmacist, referring to a 64 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 10-SEP-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) lot # S018419, expiration date  reported as 12-JUL-2020, for prophylaxis (strength, dose, route and frequency were not reported). No adverse event.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: administration of vaccine after temperature excursion prior to vaccine stability evaluation; This spontaneous report was received from a medical assistant regarding a 4-year-old patient of unspecified gender. The information about the patient's concomitant medications, concurrent conditions, medical history, and drug reactions or allergies was not reported.   On 17-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis; after a temperature excursion prior to vaccine stability evaluation (product storage error) (lot number S006830, expiration date reported as 02-SEP-2020, and upon internal validation stablished as the same) (dose, route of administration and anatomical site were not provided). It was reported that the temperature excursion was of 5 degrees Celsius (C) within a timeframe of 12 hours. There was a previous temperature excursion of 8.4 degrees Fahrenheit during 60 hours on an unspecified date. The call was because of a data logger.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a 12 year old patient, gender not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # S012037 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 17-APR-2021) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 5° Celsius (C) for 12 hours respectively.  A digital data logger was involved, and there was previous temperature excursion of 8.4° Fahrenheit for 60 hours.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Syncope
Clinical narrative: syncope episode; seizure; the patient did not want to get up; This spontaneous report was received from a nurse via a company representative, referring to a 12 year old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.      On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for immunisation (dose, route and site of administration, lot number and expiration date were not reported).          On an unknown date, after the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient suffered syncope episode (syncope) (altought patient's mother stated that the patient had a seizure (seizure) and not a syncope episode).  The doctor and nurse practitioner checked on patient after episode. Patient was taken to a room to lay down, nurse stated that after an hour and a half, and as the patient did not want to get up (ill-defined disorder) the patient's mom requested patient to be sent to emergency room. Nurse stated that patient ambulated to the ambulance and was sent to the emergency room. Patient was kept at the emergency room for an hour, did not receive any treatment and was released.   At the time of reporting, the patient had recovered.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events.  Upon internal review the events of syncope and seizure were determined medically significant.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: a one year old received both the PROQUAD and VARIVAX injection; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 09-SEP-2020, the patient was vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (lot # T009930, expiration date 16-SEP-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T010311, expiration date 24-MAR-2022) (both strength, vaccine dosage detail and route of administration were not reported) for prophylaxis (inappropriate schedule of product administration).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: swelling down to the elbow; injection site redness; This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th March 2020, 8 days after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In the first of March 2020, the patient received the first Shingrix shot in unspecified arm at a pharmacy and presented to her primary care health provider with injection site redness and swelling down to the elbow.  The physician treated with unspecified oral steroids and antibiotics.  The event resolved within 5-7 days from the onset. The Shingrix administered in pharmacy the physician did not had the lot and exp date of the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache; feeling Achy; Fever of 100.4; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received Shingrix (intramuscular). On 10th September 2020, 1 days after receiving Shingrix, the patient experienced headache, pain and fever. On an unknown date, the outcome of the headache, pain and fever were unknown.   It was unknown if the reporter considered the headache, pain and fever to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix on next morning after vaccination patient experinced fever of 100.4 degree F, feeling achy and a headache. The reporter was patients spouse. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel vaccine was given without the Acthib portion/ NO AE; Based on information received on 06-Aug-2020, the report previously considered as non-valid became valid: [no patient identifier updated to identifiable patient].  Initial information was received on 06-Aug-2020 regarding an unsolicited non-valid non-serious case from a Other health care professional.   This case involves six months old female patient who received third dose of 0.5 mL once  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U622AA expiry date 16-Feb-2021) via an intramuscular route in the right vastus lateralis on 04-Aug-2020 (HIB lot UJ179AA) for prophylactic vaccination, which was administered without the ACT-HIB portion (Product preparation issue) (vial).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of an actual medication error due to Inappropriate reconstitution technique.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow up information was received on 06-Aug-2020 regarding an unsolicited valid non-serious case from a nurse.   Validity of the case, patients details, dosage regimen updated, reporter updated (other healthcare professional to nurse) and concomitant medication added.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient was inadvertently administered an expired dose of Adacel, no AE; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 25 year old female patient who was inadvertently administered an expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient was administered no other concomitant vaccines on the same date.   On 31-Aug-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot 6021AA, expiry date: 27-Jul-2020) once via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The reporter stated that she was not aware of any adverse effects that the patient had experienced from the Adacel vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: low grade fever; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves a patient (age and gender not reported) who experienced low grade fever (pyrexia), while he/she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed low grade fever (pyrexia) (few days) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient had not recovered from fever.  There will be no information available on the batch number for this case.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Hypoaesthesia, Injection site discharge, Injection site pain, Neck pain
Clinical narrative: Shoulder pain along left lateral neck, down under scapula 4 days after injection. Two weeks later developed a large tender area, injection weeping a tiny amount. Numbness and tingling along ulnar nerve. 2-3 cm scab-like area now that is slightly itchy. Pain is much better after 4 weeks.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pruritus, Scab, Tenderness
Clinical narrative: Shoulder pain along left lateral neck, down under scapula 4 days after injection. Two weeks later developed a large tender area, injection weeping a tiny amount. Numbness and tingling along ulnar nerve. 2-3 cm scab-like area now that is slightly itchy. Pain is much better after 4 weeks.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Nausea, Pain in extremity, Skin warm
Clinical narrative: Within two hours arm was sore and warm. Painful enough after 10 hours sleep was disturbed. After 17 hours was awakened (3 AM) in a profuse sweat with chills, nausea but no vomit. Symptoms were acute for 2 hours. Resolved significantly by 7 AM. No treatment or OTC taken.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Within two hours arm was sore and warm. Painful enough after 10 hours sleep was disturbed. After 17 hours was awakened (3 AM) in a profuse sweat with chills, nausea but no vomit. Symptoms were acute for 2 hours. Resolved significantly by 7 AM. No treatment or OTC taken.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle fatigue
Clinical narrative: Moderate intermittent muscle fatigue in arms, legs and fingers since the day after the injection.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Fatigue, Pain in extremity, Vision blurred
Clinical narrative: She called back and said she had pain in her arm and burning . She called her doctors and no one called her back. I advised her again to ice the site of injection and she has Benadryl  to take those, she will take her Famotidine dose she was prescribed and to call us back.  She called back later and was feeling better. I advised her to use Epi Pen she was prescribed if her symptoms become anaphylactic.  I called her later before end of my day to follow up on her, she was feeling better just a sore arm. She will take another dose of Benadryl and Famotidine before resting. She mentioned she thinks she has blurry vision or she just was tired.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever started during the night 9/12-9/13/20; took temp in morning of 9/13/20: 100.8; temp stayed there all day 9/13/20; temp dropped to 99.8 on morning of 9/14/20 and stayed there all day; temp dropped to 98.6 morning of 9/15/20.  Rash and swelling at injection site began the morning of 9/14/20.  Was sore when moving arm.  Rash began to itch the evening of 9/14/20.  Rash, swelling and itching continues 9/15/20.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Fever started during the night 9/12-9/13/20; took temp in morning of 9/13/20: 100.8; temp stayed there all day 9/13/20; temp dropped to 99.8 on morning of 9/14/20 and stayed there all day; temp dropped to 98.6 morning of 9/15/20.  Rash and swelling at injection site began the morning of 9/14/20.  Was sore when moving arm.  Rash began to itch the evening of 9/14/20.  Rash, swelling and itching continues 9/15/20.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Thirty five minutes following administration, patient became nauseous, dizzy, headache occipital area of head, and blurred vision. A fever developed at about 7:30pm with chills that lasted until about 4:30am the next morning.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Vision blurred
Clinical narrative: Thirty five minutes following administration, patient became nauseous, dizzy, headache occipital area of head, and blurred vision. A fever developed at about 7:30pm with chills that lasted until about 4:30am the next morning.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse symptoms reported.; the patient received an expired dose of PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 31-AUG-2020, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) expiration date 25-AUG-2020 for prophylaxis (exact dose, vaccine schedule, injection site, route of administration and lot # were not provided). No adverse symptoms were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD administered post temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history and drug reactions/allergies was not provided. Concomitant medication included sterile diluent (manufacturer unknown).   On 21-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (strength and route were not reported; lot # S031881 with expiration date 07-APR-2021) for prophylaxis (product storage error). The administered dose of the vaccine experienced a temperature in the range -9 Celsius degree to 8 Celsius degree (-2.8 Celsius degree) for 5 hours and 2 minutes recorded by a data logger. There was no previous temperature excursion.  This is one of multiple reports sent by the same reporter.; Sender's Comments:  US-009507513-2009USA000677: US-009507513-2009USA001227: US-009507513-2009USA001249: US-009507513-2009USA001303: US-009507513-2009USA001333: US-009507513-2009USA001367: US-009507513-2009USA001381: US-009507513-2009USA001696: US-009507513-2009USA001697: US-009507513-2009USA001715: US-009507513-2009USA001812: US-009507513-2009USA001823: US-009507513-2009USA001827: US-009507513-2009USA001831:
Age: 20.0
Sex: F
Vaccine: MMRV
Symptoms: Antibody test negative, Measles antibody negative, Mumps antibody test negative, Product administered to patient of inappropriate age, Rubella antibody negative
Clinical narrative: The patient bad a negative titer to measles, mumps, rubella and varicella.; The patient bad a negative titer to measles, mumps, rubella and varicella; The patient bad a negative titer to measles, mumps, rubella and varicella; The patient bad a negative titer to measles, mumps, rubella and varicella; a 20 year old female receiving one dose PROQUAD 09/02/2020 in error; This spontaneous report has been received from an office manager, referring to a 20 years old female patient (product administered to patient of inappropriate age). The patient's concomitant medication, pertinent medical history and drug reactions or allergies were not provided.  On 02-SEP-2020, the patient was vaccinated with one dose measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, route, lot number and expiration date were unknown) for prophylaxis.         On the same day, the patient had a negative titer to measles, mumps, rubella and varicella (antibody test negative, rubella antibody negative, mumps antibody test negative and measles antibody negative). The outcome of the events (measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative) was unknown. The causality assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the events (measles antibody negative, antibody test negative, rubella antibody negative and mumps antibody test negative) was not provided.