chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Migraine, SARS-CoV-2 test
Clinical narrative: Migraine Friday; Headache started Thursday after shot, persistent headaches daily since vaccination; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 03Nov2021 at 16:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via an unspecified route of administration in the right arm on 07Oct2021 at 16:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 04Nov2021 at 12:00, the patient experienced headache which started after shot. On 05Nov2021, the patient experienced migraine and headaches was persistent daily since vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date in 2021, the patient underwent SARS-COV-2 test (polymerase chain reaction (PCR)) and the result was negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events headache started after shot, migraine and persistent headaches daily since vaccination was not resolved at the time of report.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Loss of personal independence in daily activities, Pain, Paraesthesia
Clinical narrative: Throbbing in the right temple / This is not a headache, but rather pressure/throbbing in the right temple that is uncomfortable; Tingling from the middle of the top of the head, via the right temple, down the right side of the head; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 2587) via an unspecified route of administration in the right arm on 22Sep2021 at 09:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 26Sep2021, a few days after the first shot of the Pfizer vaccine, the patient experienced throbbing in the right temple. Also tingling from the middle of the top of the head, via the right temple, down the right side of the head. The patient reported that this was not a headache, but rather pressure/throbbing in the right temple that was uncomfortable. Since it did not severely impact the patient's daily life, he did not take any steps to treat it. The events persisted until the time of this report (two months later). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 11Nov2021, the patient underwent SARS-CoV-2 test (Polymerase Chain Reaction (PCR)) and the result was negative. The clinical outcome of the events throbbing in the right temple/ not a headache, but rather pressure/throbbing in the right temple that was uncomfortable and tingling from the middle of the top of the head were not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 2587) via an unspecified route of administration in the right arm on 13Oct2021 at 09:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Throbbing in the right temple / This is not a headache, but rather pressure/throbbing in the right temple that is uncomfortable; Tingling from the middle of the top of the head, via the right temple, down the right side of the head; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 2587) via an unspecified route of administration in the right arm on 22Sep2021 at 09:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 26Sep2021, a few days after the first shot of the Pfizer vaccine, the patient experienced throbbing in the right temple. Also tingling from the middle of the top of the head, via the right temple, down the right side of the head. The patient reported that this was not a headache, but rather pressure/throbbing in the right temple that was uncomfortable. Since it did not severely impact the patient's daily life, he did not take any steps to treat it. The events persisted until the time of this report (two months later). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 11Nov2021, the patient underwent SARS-CoV-2 test (Polymerase Chain Reaction (PCR)) and the result was negative. The clinical outcome of the events throbbing in the right temple/ not a headache, but rather pressure/throbbing in the right temple that was uncomfortable and tingling from the middle of the top of the head were not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 2587) via an unspecified route of administration in the right arm on 13Oct2021 at 09:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Condition aggravated, Gout, Magnetic resonance imaging abnormal, Rheumatoid arthritis
Clinical narrative: gout; gout worsened, flare-up on the lest side of the body; Weight loss; Damage in forearm; Ankle swelling; Reduction in muscle mass; trembling in left arm; This case was reported by a consumer via call center representative and described the occurrence of gout in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gout.   On 27th July 2021, the patient received the 1st dose of Shingrix. On 28th July 2021, 1 days after receiving Shingrix, the patient experienced gout, condition aggravated, weight loss, skin injury, ankle swelling, muscle atrophy and tremor limb. On an unknown date, the outcome of the gout and skin injury were not recovered/not resolved and the outcome of the condition aggravated, weight loss, ankle swelling, muscle atrophy and tremor limb were unknown.   It was unknown if the reporter considered the gout, condition aggravated, weight loss, skin injury, ankle swelling, muscle atrophy and tremor limb to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of the Shingrix vaccine when he went in for an appointment regarding his gout flare-up.  The patient reported that the day after receiving the vaccine, his gout worsened and he experienced many side effects including his gout flare-up on the lest side of the body, weight loss, damage in forearm, ankle swelling, reduction in muscle mass, trembling in left arm.. The patient wanted to know the association between receiving Shingrix and experiencing gout and if he should not had the Shingrix vaccine which he had a gout flare up. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Gout, Joint swelling, Muscle atrophy, Skin injury
Clinical narrative: gout; gout worsened, flare-up on the lest side of the body; Weight loss; Damage in forearm; Ankle swelling; Reduction in muscle mass; trembling in left arm; This case was reported by a consumer via call center representative and described the occurrence of gout in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gout.   On 27th July 2021, the patient received the 1st dose of Shingrix. On 28th July 2021, 1 days after receiving Shingrix, the patient experienced gout, condition aggravated, weight loss, skin injury, ankle swelling, muscle atrophy and tremor limb. On an unknown date, the outcome of the gout and skin injury were not recovered/not resolved and the outcome of the condition aggravated, weight loss, ankle swelling, muscle atrophy and tremor limb were unknown.   It was unknown if the reporter considered the gout, condition aggravated, weight loss, skin injury, ankle swelling, muscle atrophy and tremor limb to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of the Shingrix vaccine when he went in for an appointment regarding his gout flare-up.  The patient reported that the day after receiving the vaccine, his gout worsened and he experienced many side effects including his gout flare-up on the lest side of the body, weight loss, damage in forearm, ankle swelling, reduction in muscle mass, trembling in left arm.. The patient wanted to know the association between receiving Shingrix and experiencing gout and if he should not had the Shingrix vaccine which he had a gout flare up. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tremor, Weight decreased
Clinical narrative: gout; gout worsened, flare-up on the lest side of the body; Weight loss; Damage in forearm; Ankle swelling; Reduction in muscle mass; trembling in left arm; This case was reported by a consumer via call center representative and described the occurrence of gout in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included gout.   On 27th July 2021, the patient received the 1st dose of Shingrix. On 28th July 2021, 1 days after receiving Shingrix, the patient experienced gout, condition aggravated, weight loss, skin injury, ankle swelling, muscle atrophy and tremor limb. On an unknown date, the outcome of the gout and skin injury were not recovered/not resolved and the outcome of the condition aggravated, weight loss, ankle swelling, muscle atrophy and tremor limb were unknown.   It was unknown if the reporter considered the gout, condition aggravated, weight loss, skin injury, ankle swelling, muscle atrophy and tremor limb to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received the 1st dose of the Shingrix vaccine when he went in for an appointment regarding his gout flare-up.  The patient reported that the day after receiving the vaccine, his gout worsened and he experienced many side effects including his gout flare-up on the lest side of the body, weight loss, damage in forearm, ankle swelling, reduction in muscle mass, trembling in left arm.. The patient wanted to know the association between receiving Shingrix and experiencing gout and if he should not had the Shingrix vaccine which he had a gout flare up. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Oral discomfort, Paraesthesia oral, Tongue discomfort
Clinical narrative: tingling in mouth lasting >3 days; had lip swelling and burning; had lip swelling and burning; This is a spontaneous report from a contactable healthcare professional. A 69-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 3 vaccination age of 69-year-old intramuscularly administered in the right arm on 01Nov2021 11:30 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnoses with covid-19 prior to vaccination. The patient received the first dose of bnt162b2 (bnt162b2) on 02Mar2021 and second dose bnt162b2 (bnt162b2) on 23Mar2021; all (batch/lot number: unknown) at vaccination age of 68-year-old intramuscularly administered in the right arm for covid-19 immunisation. Concomitant medications included estradiol (ESTROGEN) and colecalciferol (VITAMIN D3 1000), all indication, start and stop date were not reported. The patient previously received prednisone and was allergic to prednisone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Nov2021 12:30, the patient experienced tingling in mouth lasting >3 days, and had lip swelling and burning. It was further reported that the patient has had lip swelling and burning and tingling in mouth lasting >3 days. The patient received diphenhydramine since she is allergic to prednisone. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The healthcare professional assessed the events was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Oral discomfort, Paraesthesia oral
Clinical narrative: tingling in mouth lasting >3 days; had lip swelling and burning; had lip swelling and burning; This is a spontaneous report from a contactable healthcare professional. A 69-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 3 vaccination age of 69-year-old intramuscularly administered in the right arm on 01Nov2021 11:30 (Batch/Lot number was not reported) as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnoses with covid-19 prior to vaccination. The patient received the first dose of bnt162b2 (bnt162b2) on 02Mar2021 and second dose bnt162b2 (bnt162b2) on 23Mar2021; all (batch/lot number: unknown) at vaccination age of 68-year-old intramuscularly administered in the right arm for covid-19 immunisation. Concomitant medications included estradiol (ESTROGEN) and colecalciferol (VITAMIN D3 1000), all indication, start and stop date were not reported. The patient previously received prednisone and was allergic to prednisone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Nov2021 12:30, the patient experienced tingling in mouth lasting >3 days, and had lip swelling and burning. It was further reported that the patient has had lip swelling and burning and tingling in mouth lasting >3 days. The patient received diphenhydramine since she is allergic to prednisone. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The healthcare professional assessed the events was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: Patient states fluctuating high blood pressure after vaccination. Patient stated typical blood pressure did not exceed 130/90 prior to vaccination, but since vaccination has stated that his blood pressure is routinely elevated up to 170's/90's.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation
Clinical narrative: Patient states fluctuating high blood pressure after vaccination. Patient stated typical blood pressure did not exceed 130/90 prior to vaccination, but since vaccination has stated that his blood pressure is routinely elevated up to 170's/90's.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Paraesthesia, Swelling, Urticaria
Clinical narrative: RAISED RED HIVES COVERING TORSO AND LEGS AND UPPER ARMS; TINGLING PRICKLY SKIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 05-NOV-2021, the patient experienced raised red hives covering torso and legs and upper arms. On 05-NOV-2021, the patient experienced tingling prickly skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from raised red hives covering torso and legs and upper arms, and tingling prickly skin on 08-NOV-2021. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Urticaria
Clinical narrative: RAISED RED HIVES COVERING TORSO AND LEGS AND UPPER ARMS; TINGLING PRICKLY SKIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 05-NOV-2021, the patient experienced raised red hives covering torso and legs and upper arms. On 05-NOV-2021, the patient experienced tingling prickly skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from raised red hives covering torso and legs and upper arms, and tingling prickly skin on 08-NOV-2021. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Swelling face
Clinical narrative: FACE SWELLING AT LEFT HALF; NOSE BLEED; DOESN'T FEEL GOOD; SORE ARM; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-NOV-2021, the patient experienced sore arm. On 14-NOV-2021, the patient experienced doesn't feel good. On 16-NOV-2021, the patient experienced face swelling at left half. On 16-NOV-2021, the patient experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 15-NOV-2021, and had not recovered from face swelling at left half, nose bleed, and doesn't feel good. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Malaise, Pain in extremity, Swelling face
Clinical narrative: FACE SWELLING AT LEFT HALF; NOSE BLEED; DOESN'T FEEL GOOD; SORE ARM; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-NOV-2021, the patient experienced sore arm. On 14-NOV-2021, the patient experienced doesn't feel good. On 16-NOV-2021, the patient experienced face swelling at left half. On 16-NOV-2021, the patient experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 15-NOV-2021, and had not recovered from face swelling at left half, nose bleed, and doesn't feel good. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via company representative via social media on 15-NOV-2021 was received on 15-NOV-2021 and concerned a female of unspecified age, race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-NOV-2021, the patient developed suspected covid-19 infection (suspected clinical vaccination failure). The patient reported that "I got my j& j vaccine and then instead of getting boosted at the two month mark, I got the natural booster by catching covid. My husband did too". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000202350. This case, from the same reporter is linked to 20211134046.; Sender's Comments: V0 20211132208-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 59.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Headache, Malaise
Clinical narrative: Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-370140 (Patient Link).
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other AEs or PQC reported; Vaccine administered after temperature excursion; This spontaneous report has been received from a registered Nurse referring to a 7-moths-old infant patient of unknown gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 18-OCT-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at the dose of 2 mL, as prophylaxis (frequency, strength, and route of administration were not provided; lot number T030458 has been verified to be a valid lot number with expiration date on 11-APR-2022).  Administered dose of vaccine experienced temperature excursion of 35 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. No other adverse event was reported. No additional information available.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Rash, Varicella
Clinical narrative: A patient was administered PROQUAC on 09-JUN-2021. On 16-OCT-2021 the patient started to have a rash. The patient was taken to the doctor's office today (18-OCT-2021) and was diagnosed with chickenpox.; This spontaneous report has been received from a physician concerning a 16-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 09-JUN-2021, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) reconstituted with sterile diluent, as prophylaxis (lot number T003714 has been verified to be a valid number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, expiration date 29-JUL-2021) (lot number T003714 is an invalid lot number for sterile diluent) (strength, dose, route of administration, and anatomical location of vaccination were not provided).  On 16-OCT-2021, the patient experienced a rash; she was taken to the physician's office on 18-OCT-2021 (also reported as today) and was diagnosed with chickenpox (varicella post vaccine). The patient received diphenhydramine hydrochloride (BENADRYL) as treatment for the event. No laboratory or diagnostic studies were performed. At the reporting time, the patient had not recovered from varicella post vaccine.  The causality assessment between the suspect vaccine, the sterile diluent and the event was not provided.  As of 19-OCT-2021, an attempt was made to reach the physician to confirm receipt of the  information that was faxed to him. The office administrator confirmed the receipt of the information, but she was unsure if the physician had reviewed it; she placed the physician on the phone and it was discussed the program information, including sample collection and shipping instructions. The physician was not sure if he would be submitting a sample, but he stated that he would review the information further and discuss with the patient's parents. The case number and phone number were provided in case he had additional questions or if he planned to submit a sample for polymerase chain reaction (PCR) testing through the program. No additional information was available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; VARIVAX was administered after improperly stored; This spontaneous report was received from a medical assistance and refers to a 12 month old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant mediation were not reported.  On 08-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot number T027303 with expiration date 12-AUG-2022 for prophylaxis, which was improperly stored at a temperature of 6°F to 14°F (5.8F) for 0 hours, 18 minutes and 0 seconds; and 6°F to 14°F (11.9F) for 1 hour, 0 minutes and 0 seconds; for a cumulative timeframe of 1 hour and 18 minutes. There was no previous temperature excursion. No additional adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occurred; an expired dose of VARlVAX that was administered to a patient; This spontaneous report as received from a customer 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 05-NOV-2021, the patient was vaccinated with 1 expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S019583, expiry date 25-JUN-2021, for prophylaxis (exact dose, route and anatomical location of administration were not reported) (expired product administered). No other adverse event occurred (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported, no further information provided.; a patient received improperly stored vaccine; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 19-OCT-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHa (PROQUAD) 0.5 milliliter, lot # U019287, expiration date 15-DEC-2022 (route and site of administration were not reported) for prophylaxis. The vaccine was stored in temperature 5.7 degrees  Fahrenheit for 6 minutes. There was no previous temperature excursion. It was not reported if the Digital Data Logger was involved. No adverse event was reported.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a lack of effect with his RECOMBIV AX medicationthe vaccine "didn't work" and contracted hepatitis B during "the past few months".; the 1st shot on 01/02/2018, the 2nd shot on 03/09/18, and the 3rd shot on 06/11/18; the 1st shot on 01/02/2018, the 2nd shot on 03/09/18, and the 3rd shot on 06/11/18; This spontaneous report was received from a 55-year-old male patient referring to himself. The patient's did not have pertinent medical history, drug allergies/reactions neither concomitant medications.   On 02-FEB-2018, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), then on 09-MAR-2018 (inappropriate schedule of product administration) and on 11-JUN-2018 (inappropriate schedule of product administration) he was vaccinated with the second and third dose respectively (route reported as injection, dose and anatomical site of vaccination not reported; lot number reported as 4795H) for hepatitis B (HEPB) prevention.  On an unknown date (reported as the past few months), the patient contracted hepatitis B. The patient stated that the vaccine did not work/lack of effect (vaccination failure).  At the reporting time, he had not recovered of vaccination failure.  The causal assessment between the event and therapy with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was considered as related.  Lot number 4795H is an invalid lot number for hepatitis b vaccine (recombinant)(RECOMBIVAX HB). Lot number 4795H does not match any Company product as confirmed by Lot Verification team.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Rash
Clinical narrative: Pain, tenderness at injection site, soreness; Redness at injection site; Swelling at injection site; Bump in arm, 3 bumps beneath the skin; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 20-year-old female patient who received Men B NVS (Bexsero) (batch number ABX987AZ, expiry date 1st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. On 20th July 2021, 6 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain, injection site erythema, injection site swelling and induration. The patient was treated with non-drug therapy (Cold Compress). On 20th July 2021, the outcome of the injection site pain, injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the induration was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The patient received a dose of Bexsero in left arm and post 6 days of vaccination, patient experienced pain, tenderness and redness at injection site.Redness at injection site was resolved. Patient was told to put ice on injection site, no medications were prescribed or recommended. The patient stated that there were 3 bumps beneath the skin.The bumps were still present but had decreased in size.  The patient cancelled appointment for 2nd Bexsero dose. Four weeks later (date unknown), when patient went to get her flu shot in right arm as per pharmacist suggestion. Pharmacist also recommended to contact her health care professional regarding the bumps. Health care professional called GSK and asked if 2nd dose Bexsero was contraindicated. Patient was interested in completing Bexsero series but would not if contraindicated. The health care professional had not seen the patient since July visit and has not seen the bumps. Health care professional also stated she will examine the patient when she comes in for the 2nd dose of Bexsero.
Sex: U
Vaccine: BCG, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: give 5 months old Bexsero; give 5 months old Bexsero; This case was reported by a consumer via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 5-month-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and BCG VACCINE for prophylaxis.   On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and BCG VACCINE. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The reporter asked could Bexsero and BCG vaccines be given at the same day for a 5 months old baby. As follow up could not be possible conservatively captured Bexsero was given to 5 months old baby, which led to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. No contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Mobility decreased, Muscle spasms, Seizure
Clinical narrative: likened to having seizures; muscle spasms, could not get out of bed; no control of body; could not get out of bed; This case was reported by a consumer via other manufacturer and described the occurrence of seizure in a female 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 seizure (serious criteria GSK medically significant), muscle spasm, balance disorder and mobility decreased. On an unknown date, the outcome of the seizure, muscle spasm, balance disorder and mobility decreased were unknown.   It was unknown if the reporter considered the seizure, muscle spasm, balance disorder and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had very severe muscles spasms, that she likened to having seizures, all night long. The patient had no control of her body and could not get out of bed.  The reporter did not have further adverse event information. No additional adverse event reported. No product quality complaint was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had a very mild case even with vaccination\ suspected vaccination failure; mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had chicken pox as a kid. The patient stated he/she was enxpuraged by physician, got the vaccine booster. The patient stated he/she had a very mild case of shingles even with shingles vaccination. Shingles could be quite debilitating. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: every 4 months or 6 months the patient got; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional case details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the case every 4 months or 6 months.  This time the physician gave an oral medicine. No contact details were reported. The case had been linked with US2021AMR233779 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233779:1st outbreak
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Rash
Clinical narrative: shingles; had abdominal pain; abdominal rash; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles, abdominal pain and rash. On an unknown date, the outcome of the shingles, abdominal pain and rash were unknown.   The reporter considered the shingles, abdominal pain and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and got shingles within weeks of vaccination. She had no information to share other than the fact that she did believe it was related to vaccination.  The patient had abdominal pain thought to be associated with a previous condition; no rash at the time.  Then 2-3 weeks later, the patient returned with an abdominal rash consistent with shingles. This case was linked with US2021AMR234702 and US2021AMR234703  reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR234702:same reporter US-GLAXOSMITHKLINE-US2021AMR234703:same reporter US-GLAXOSMITHKLINE-US2021235278:same reporter - initial
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix vaccine and 2 to 3 weeks/ within weeks later developed Shingles. The reporter did not consented to follow up. This case was linked with US2021AMR234679, US2021AMR234702 and US2021235278 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR234702:same reporter US-GLAXOSMITHKLINE-US2021AMR234679:same reporter US-GLAXOSMITHKLINE-US2021235278:same reporter - initial
Sex: U
Vaccine: VARZOS
Symptoms: Hypotension, No adverse event
Clinical narrative: low blood pressure; This case was reported by a consumer via other manufacturer and described the occurrence of low blood pressure in a 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 low blood pressure. On an unknown date, the outcome of the low blood pressure was unknown.   It was unknown if the reporter considered the low blood pressure to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingrix and experienced low blood pressure. No additional adverse event/product complaint case was reported at the time of call. Follow-up would not be possible as no contact details available.
Sex: F
Vaccine: FLU3
Symptoms: Cerebral palsy, Traumatic heart injury
Clinical narrative: cerebral palsy; injured her heart valves; This case was reported by a consumer via other manufacturer and described the occurrence of cerebral palsy in a female patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included flu seasonal tiv dresden pre-filled syringe device (Fluarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix and Fluarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix and Fluarix Pre-Filled Syringe Device, the patient experienced cerebral palsy (serious criteria GSK medically significant) and cardiac valve injury. On an unknown date, the outcome of the cerebral palsy and cardiac valve injury were unknown.   It was unknown if the reporter considered the cerebral palsy and cardiac valve injury to be related to Fluarix and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The age at vaccination was not reported. The caller stated a coworker had a reaction to Fluarix in 2016. The caller stated that the vaccine injured her heart valves and caused cerebral palsy. The caller did not want to provide any patient and additional information. The caller stated the side effects were already reported to the manufacturer. No additional adverse event and no product quality complaint reported. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 2 years ago, should they repeat the dosing; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable. The patient did not receive the 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter asked should they repeat the dosing to get 2 doses again. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot in 2/2020, start the series over; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in February 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable. Till the time of reporting, patient did not received 2nd dose which led to incomplete course of vaccination. The reporter wanted to know should he/she start the series over or just get the 2nd shot. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: vaccinated for shingles / have the shingles/ suspected vaccination failure; shingles; very painful; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2021, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional information was provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles at the time of reporting and stated that it was very painful. The patent guessed he/she was in the 15 percent and the shots were only 85 percent. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.