chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Mobility decreased, SARS-CoV-2 test, Sensory loss
Clinical narrative: left leg lost movement and feeling and then both legs; left leg lost movement and feeling and then both legs; falling down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Abalone" (unspecified if ongoing); "Known allergies: Sulpha drugs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Lot unknown=False, Administration date=Feb2021, Administration time=04:00 AM, Vaccine location=Left arm), administration date: Feb2021, when the patient was 76 years old, for COVID-19 IMMUNIZATION, reaction(s): "Falling down", "Left leg lost movement and feeling and then both legs", "Left leg lost movement and feeling and then both legs". The following information was reported: FALL (medically significant) with onset 2021, outcome "unknown", described as "falling down"; MOBILITY DECREASED (disability), SENSORY LOSS (disability) all with onset 2021, outcome "not recovered" and all described as "left leg lost movement and feeling and then both legs". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2021) Negative. Therapeutic measures were taken as a result of mobility decreased, sensory loss, fall.  Additional information: No other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257251 same patient/drug/event, different doses;
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: terrible joint pain; muscle aches; headaches; naseaua; terrible fatigus; reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8732) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Prev dose lot number=EN6201, Prev dose vaccine location=Left arm), administration date: 10Mar2021, when the patient was 70-year-old, for COVID-19 IMMUNIZATION, reaction(s): "terrible joint pain", "muscle aches", "headaches", "naseaua", "terrible fatigus". The following information was reported: HEADACHE (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "headaches"; MYALGIA (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "muscle aches"; NAUSEA (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "naseaua"; FATIGUE (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "terrible fatigus"; ARTHRALGIA (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "terrible joint pain". The events "terrible joint pain", "muscle aches", "headaches", "naseaua" and "terrible fatigus" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, myalgia, headache, nausea, fatigue.  Additional information: Patient had the same types of reaction for the 2nd dose, but the issues lasted about 6 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258400 same patient/event, diffrent drug dose;
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Paraesthesia, Trigger finger
Clinical narrative: Tingling sensations in lower right arm and hand; The fingers on right hand can suddenly snap shut/ Snap Finger; The pain in my neck began about 17 to 18 minutes after injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6201, Anatomical site of vaccine administration: Left arm), administration date: 10Mar2021, for COVID-19 immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigue"; BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8732, Anatomical site of vaccine administration: Left arm), administration date: 31Mar2021, for COVID-19 immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigue"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot Number: PF2590, Anatomical site of vaccine administration: Left arm), administration date: 21Oct2021, for COVID-19 immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigue". The following information was reported: NECK PAIN (non-serious) with onset 01Jul2022, outcome "not recovered", described as "The pain in my neck began about 17 to 18 minutes after injection"; PARAESTHESIA (non-serious), outcome "not recovered", described as "Tingling sensations in lower right arm and hand"; TRIGGER FINGER (non-serious), outcome "not recovered", described as "The fingers on right hand can suddenly snap shut ". The events "the pain in my neck began about 17 to 18 minutes after injection", "tingling sensations in lower right arm and hand" and "the fingers on right hand can suddenly snap shut " required physician office visit. Therapeutic measures were not taken as a result of neck pain, paraesthesia, trigger finger.  Additional Information: When she went for the second booster, she had reported her previous reactions. The pain in her neck began about 17 to 18 minutes after injection and the reaction was much worse than the prior ones. The fingers on her right hand can suddenly snap shut and she had tingling sensations in her lower right arm and hand. While not as serious as in Jul2022 and Aug2022, she still had difficulties.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258400 same patient/reporter, different dose/event;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right arm  for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258958 same patient, different drug, different event;
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Nervousness
Clinical narrative: awful bitter bitterness in my mouth; It makes me nervous also; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "awful bitter bitterness in my mouth"; NERVOUSNESS (non-serious), outcome "unknown", described as "It makes me nervous also". Additional information: Patient wanted to know why it's bitter, leaves an awful bitter bitterness in the mouth and it's making the patient very nervous.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Hyperhidrosis, SARS-CoV-2 test, Syncope
Clinical narrative: Fainting day after vaccine; Sweating; High blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 59 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 01Jan1987 (ongoing); "Diabetes", start date: 01Jan2017 (ongoing); "Bipolar Disorder", start date: 01Jan2019 (ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, Site and Route of injection: arm, Route of administration: Intramuscular, Batch/Lot number: EL32646), administration date: 14Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, Site and Route of injection: arm, Route of administration: Intramuscular, Batch/Lot number: FL9264), administration date: 05Feb2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, Site and Route of injection: arm, Route of administration: Intramuscular, Batch/Lot number: FE3592), administration date: 27Aug2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 23Jun2022, outcome "recovered", described as "Fainting day after vaccine"; BLOOD GLUCOSE INCREASED (non-serious) with onset 23Jun2022, outcome "recovered", described as "High blood sugar"; HYPERHIDROSIS (non-serious) with onset 23Jun2022, outcome "recovered", described as "Sweating". The events "fainting day after vaccine", "sweating" and "high blood sugar" required emergency room visit. Patient went to ER, kept for observation. The patient underwent the following laboratory tests and procedures: Blood glucose increased: (unspecified date) High; SARS-CoV-2 test: (Jun2021) Positive. Therapeutic measures were not taken as a result of syncope, hyperhidrosis, blood glucose increased.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: still got COVID; still got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "still got COVID". Clinical course: It was a great time saver to get both vaccines at the same time. Patient was a bit skeptical because the last booster did not seem to help; patient still got COVID and was pretty ill. Patient did not know if she would choose to get any future boosters if they were available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: COVID vaccine made me incredibly sick/Sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "COVID vaccine made me incredibly sick/Sick".  Additional information: COVID vaccine made the patient incredibly sick; therefore she was skeptical of any vaccines for COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: had COVID-19 a few weeks ago and it was mild.; had COVID-19 a few weeks ago and it was mild.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID-19 a few weeks ago and it was mild.". Clinical course: Patient used Pfizer for her vaccine and that seems to had worked well. Patient had COVID-19 a few weeks ago and that was mild.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: The shots do not work; very sick with COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "The shots do not work"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "very sick with COVID". Clinical course: The shots do not work. None of them. I had 3 shots; and was still very sick with COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got the worst of the symptoms and post COVID symptoms; got the worst of the symptoms and post COVID symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got the worst of the symptoms and post COVID symptoms".  Clinical course: The patient stated, "I liked it because I really like withheld; but when I got COVID; opposed to my other family who were not vaccinated; I got the worst of the symptoms and post COVID symptoms; they barely got any symptoms." Reporter considered that event as caused by suspect product    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had COVID; Had COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Had COVID".  Clinical course: That I had my COVID shots and subsequently had COVID but a relatively mild case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Massive blood clots right after Pfizer shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (hospitalization, medically significant), outcome "unknown", described as "Massive blood clots right after Pfizer shot". The patient was hospitalized for thrombosis (hospitalization duration: 28 day(s)).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Gait disturbance, Pemphigoid
Clinical narrative: Bullous Pemphigoid; blisters all over her; can not walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 20230717306.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PEMPHIGOID (medically significant), outcome "unknown", described as "Bullous Pemphigoid"; BLISTER (non-serious), outcome "unknown", described as "blisters all over her"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can not walk".  Clinical course: Patient had Pfizer booster, diagnosed with Bullous Pemphigold she has blisters all over her, spending her life savings to get help not covered by her health Ins, cannot walk, using diapers  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot; the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot; the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 2, single (Lot number: EN5318), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: AM, Site and Route of injection: arm, Batch/Lot number: Pfizer, EN5318), administration date: 26Jan2021, for Covid-19 Immunization, reaction(s): "Swelling of legs", "Itchy legs", "Extremities hot feeling of". The following information was reported: PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious), FEELING HOT (non-serious) all with onset Jun2021, outcome "unknown" and all described as "the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot". The event "the right began to swell, itching, hot to touch happened noticeable about 3 months after second shot" required physician office visit.  Additional information: After receiving second vaccination. patient leg more so the right began to swell, itching, hot to touch happened. Noticeable about 3 months after second shot. As patient have taken boosters the legs have become more bigger. Leg swollen on Jun2021, It caused (illegible) to become worse. Prior Vaccinations: None.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Internal haemorrhage, Thrombosis, Visual impairment
Clinical narrative: Blood clots; internal bleeding; impaired vision; hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 22Jun2022 at 07:18 as dose number unknown (booster), single (Lot number: EW113, Expiration Date: 01Mar2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots"; INTERNAL HAEMORRHAGE (medically significant), outcome "unknown", described as "internal bleeding"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "impaired vision"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional information: Patient was not breastfeeding at the time of administration.  SUSPECT PRODUCT is under agreement with BIONTECH.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac function test, Cardiac murmur
Clinical narrative: heart murmur; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC MURMUR (non-serious), outcome "unknown", described as "heart murmur". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter considered the event as caused by suspect product. Patient never had a heart murmur until she had the Covid shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Pemphigoid
Clinical narrative: friend who had Pfizer booster, diagnosed with Bullous Pemphigoid; can not walk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 20230717306.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunisation series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: PEMPHIGOID (medically significant), outcome "unknown", described as "friend who had Pfizer booster, diagnosed with Bullous Pemphigoid"; GAIT INABILITY (medically significant), outcome "unknown", described as "can not walk". Clinical course: 8 months after a friend who had Pfizer booster, diagnosed with Bullous Pemphigoid, she had blisters all over her, spending her life savings to get help not covered by her health Ins, can not walk, using diapers.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: became very sick; Initial information was received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 70 years old female patient who experienced became very sick after being vaccinated influenza vaccine.  The patient's past medical history, 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 vaccine produced by unknown manufacturer (dose, strength, formulation, lot number, route, administration site, expiration date: Unknown) for prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed with became very sick (illness) (unknown latency) following the administration of influenza vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (became very sick).  At time of reporting, the outcome was Unknown for the event became very sick.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: she gave an expired menactra vaccine to a patient with no reported adverse event; Initial information was received on 13-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age male patient who reported that she gave an expired meningococcal a-c-y-w135 (d conj) vaccine [Menactra] to a patient with no reported adverse event.  The patient's past , medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 11-Jul-2023, the patient received a dose of 0.5 ml of expired suspect meningococcal a-c-y-w135 (d conj) vaccine (solution for injection) (Frequency : 1x Once) of standard strength, (lot number not reported, Expiry date: 24-Apr-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency : same day). The information on batch number was requested.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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 the guidelines. 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: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administration of an expired Daptacel with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 15 months old male patient who had administration of an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine CONJ (TET TOX) (ACTHIB) for Immunisation; and Hepatitis A vaccine (Hepatitis A Vaccine) for Immunisation.  On 18-Jul-2023, the patient had administration of a standard expired dose 4 of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml once (lot C5893AA, expiry date- 21-JUN-2023) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller asks if they should administer another dose after the incident.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired QUADRACEL was inadvertently administered to a patient with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 4 years old and unknown gender patient who was inadvertently administered expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Jul-2023, the patient was inadvertently administered standard expired dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection at a dose of 0.5 mL total (lot C5916AA, expiry date- 06-JUL-2023) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Adacel were administered post excursion/max/low temperature reached: 28 f/duration out of labelled range: 41 hours and 30 minutes, with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 17 years old female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered post excursion (max/low temperature reached: 28 f; duration out of labelled range: 41 hours and 30 minutes), with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: 2CA23T1; expiry date: 08-Dec-2024) via unknown route in unknown administration site for Prophylactic vaccination (immunization) post excursion (max/low temperature reached: 28 f; duration out of labelled range: 41 hours and 30 minutes; Human error: No), with no reported adverse event (poor quality product administered) (same day latency).   Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event adacel were administered post excursion/max/low temperature reached: 28 f/duration out of labelled range: 41 hours and 30 minutes, with no reported adverse event.  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 the guidelines. 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.; Sender's Comments:  US-SA-2023SA221635:related inquiry US-SA-2023SA220996:01697707
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Expired product administered, No adverse event
Clinical narrative: nurse called to inform that they have given an expired menquadfi to a patient with no reported adverse event; Initial information was received on 20-Jul-2023 regarding an unsolicited valid non-serious case received from other health professional (Nurse).  This case involves a nurse called to inform that they have given an expired meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] to a 17 years old male patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 20-Jul-2023, the patient received an expired dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (Strength: Standard) at dose of 0.5 ml once (lot number: U6821AA, expiration date: 27-Jun-2023) via intramuscular route in the left deltoid for immunization (immunisation) with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event nurse called to inform that they have given an expired menquadfi to a patient with no reported adverse event.  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 the guidelines. 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: 70.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Asthenia, Diarrhoea, Myalgia, Vomiting
Clinical narrative: Vomiting, diarrhea, three days; muscle and joint pain and weakness still occurring 6 days later.
Age: 54.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Impaired work ability, Injection site rash, Lethargy, Malaise, Rash
Clinical narrative: 7/23 @ 1240- Pt received immunizations at pharmacy 7/24 @ 1800- I received a call from patient that she wasn't feeling well. Felt lethargic & had to miss work. She stated that she had a rash on her left arm at injection site. I spent around 20mins with patient on the phone- Discussed early signs of anaphylaxis (Swollen lips/tongue, difficulty breathing, throat tightness. Patient did not have any of these symptoms. Did not have rash any place else 7/25 @ 0930- Received prescription for Prednisone 20mg- 1 PO TID X 6 days. Called patient to check on her. She did okay through the night but woke up with both eyes swollen and did TeleDoc visit. She came to the pharmacy an hour later. I counseled her- her eyes swelling had gone down significantly and she was able to drive herself.  7/25 @ 1630- I called patient to check on her. She had taken 3 doses of prednisone and said her eyes were almost back to normal. Rash on both arms not spread. She was feeling better and considering going to work the next day
Age: 54.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Swelling of eyelid
Clinical narrative: 7/23 @ 1240- Pt received immunizations at pharmacy 7/24 @ 1800- I received a call from patient that she wasn't feeling well. Felt lethargic & had to miss work. She stated that she had a rash on her left arm at injection site. I spent around 20mins with patient on the phone- Discussed early signs of anaphylaxis (Swollen lips/tongue, difficulty breathing, throat tightness. Patient did not have any of these symptoms. Did not have rash any place else 7/25 @ 0930- Received prescription for Prednisone 20mg- 1 PO TID X 6 days. Called patient to check on her. She did okay through the night but woke up with both eyes swollen and did TeleDoc visit. She came to the pharmacy an hour later. I counseled her- her eyes swelling had gone down significantly and she was able to drive herself.  7/25 @ 1630- I called patient to check on her. She had taken 3 doses of prednisone and said her eyes were almost back to normal. Rash on both arms not spread. She was feeling better and considering going to work the next day
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia
Clinical narrative: PATIENT FELT CHILLS, SYSTEMIC MUSCLE PAIN FOR 48 HOURS BEFORE STARTING TO IMPROVE.  ALSO, TENDERNESS AT THE ADMINISTRATION SITE, BUT NO REDNESS.  PATIENT TOOK BOTH ACETAMINOPHEN AND IBUPROFEN WITH LITTLE RELIEF.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Burning sensation, Dizziness, Fatigue, Headache
Clinical narrative: Patient had sore arm & tiredness, which she said it's typical for when she gets vaccine.  10 days after vaccination, she experience tingling on both arms (left first) and feet.  Later she developed burning sensation as well as overall neuropathic pain and general weakness.  She also complained of dizziness that worsen at night.   Patient spoke to her primary physician who prescribed Prednisone and refer her to neurologist who she sees for headache treatments
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain in extremity, Paraesthesia
Clinical narrative: Patient had sore arm & tiredness, which she said it's typical for when she gets vaccine.  10 days after vaccination, she experience tingling on both arms (left first) and feet.  Later she developed burning sensation as well as overall neuropathic pain and general weakness.  She also complained of dizziness that worsen at night.   Patient spoke to her primary physician who prescribed Prednisone and refer her to neurologist who she sees for headache treatments
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Blood test normal, Fatigue, Muscular weakness, Neuropathy peripheral
Clinical narrative: Patient had sore arm & tiredness, which she said it's typical for when she gets vaccine.  10 days after vaccination, she experience tingling on both arms (left first) and feet.  Later she developed burning sensation as well as overall neuropathic pain and general weakness.  She also complained of dizziness that worsen at night.   Patient spoke to her primary physician who prescribed Prednisone and refer her to neurologist who she sees for headache treatments
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient had sore arm & tiredness, which she said it's typical for when she gets vaccine.  10 days after vaccination, she experience tingling on both arms (left first) and feet.  Later she developed burning sensation as well as overall neuropathic pain and general weakness.  She also complained of dizziness that worsen at night.   Patient spoke to her primary physician who prescribed Prednisone and refer her to neurologist who she sees for headache treatments
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose, Fall, Headache, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Pt was in the room talking with me. He stayed quiet and I asked "are you ok" Pt did not respond and feel to his left side from the bed.  Father of child and myself placed patient on his back on the floor. I called the nurse to help me. The nurse called back up and a nurse went to get Dr.. Dr. came in the room.  Checked patient and did a full assessment due to patient  loosing consciousness.  Pt opened his eyes after a minute. He was able to answer where he was and whom he was. Pt was kept laying on the floor after 5 minutes he was able to stand and sit on a chair. Pt was kept in the office for an hour to monitor any other symptom.  Pt then reported having a headache. Pt was given Tylenol 650 MG PO by RN. Headache resolved within  30 minutes of taking medication.  Pt left at 12:05 walking.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Discharge, Flushing, Skin warm
Clinical narrative: flushed and hot to the touch area drained below shot site
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Patient developed a rash of face, trunk, back and elbows 6 days after receiving vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cognitive disorder, Diarrhoea, Injection site pain, Injection site pruritus
Clinical narrative: In order of occurrence: Itching  Soreness  Rash in shape of Little Dipper at injection site  Mental/cognitive problems (couldn?t text without numerous and repeated errors  Shivering  Diarrhea
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: In order of occurrence: Itching  Soreness  Rash in shape of Little Dipper at injection site  Mental/cognitive problems (couldn?t text without numerous and repeated errors  Shivering  Diarrhea
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given booster dose instead of primary dose for second vaccine
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: given booster dose instead of primary series
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: pt given booster dose instead of primary dose
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given booster dose instead of primary dose
Age: 0.83
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given booster dose instead of primary dose
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Diarrhoea, Vomiting
Clinical narrative: Patient began vomiting approximately 15 minutes after vaccine administration. Later in the evening developed  diarrhea and clammy skin . Patient slept from 7/20/23 at 9pm until 7/21/23 at 2:00 pm. Upon waking symptoms had resolved
Age: 60.0
Sex: M
Vaccine: PPV, PPV, TDAP
Symptoms: Injection site erythema, Pain, Peripheral swelling
Clinical narrative: Pt stated he started to have the right upper arm swollen with pain after Pneumonia shot. Right upper arm: Swelling (warm and erythematous; along biceps to deltoid) and tenderness present.  Visit Diagnoses      Redness and swelling of upper arm    -  Primary   Relevant Medications   amoxicillin 500 MG Oral capsule   naproxen sodium 275 MG Oral tablet   Adverse reaction to pneumococcal vaccine
Age: 60.0
Sex: M
Vaccine: PPV, PPV, TDAP
Symptoms: Immunisation reaction, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt stated he started to have the right upper arm swollen with pain after Pneumonia shot. Right upper arm: Swelling (warm and erythematous; along biceps to deltoid) and tenderness present.  Visit Diagnoses      Redness and swelling of upper arm    -  Primary   Relevant Medications   amoxicillin 500 MG Oral capsule   naproxen sodium 275 MG Oral tablet   Adverse reaction to pneumococcal vaccine
Age: 59.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: big red area on left arm injection site, redness bigger down the arm next day
Age: 59.0
Sex: F
Vaccine: PNC20, UNK
Symptoms: Erythema, Injection site erythema
Clinical narrative: big red area on left arm injection site, redness bigger down the arm next day
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: marked swelling of axilla and lateral chest
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MNQ, TDAP, UNK, VARCEL
Symptoms: Feeling hot, Pallor
Clinical narrative: Patient received vaccines at the Mobile Site. Patient stated after receiving the vaccines that she felt hot. Patient skin pale in color. Patient mother stated patient had not eaten. Patient mother feed patient Jello and a apple. Patient given water to drink.  Patient color return to appropriate color for race. Patient denied feeling hot. Patient Temperature- 98.4, Blood Pressure-100/62, SATO2-98 %, Respirations-16, and Pulse-91. Offered to call emergency services for patient. Patient mother and patient refuse emergency services. Patient monitored for 30 minutes. Patient and patient mother denies any complaints prior to leaving post vaccination area.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent; reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA909A, expiry date 30-APR-2024) for prophylaxis.   On 17-JUL-2023, the patient received Menveo (intramuscular). On 17-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent) and inappropriate dose of vaccine administered (Verbatim: reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The reporter reported that the reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dehydration, Hyperkalaemia, Hypophagia
Clinical narrative: Presented with acute hyperkalemia related to dehydration and poor intake nephro consulted hyperkalemia treated.    Incidental finding of COVID-19 infection and asymptomatic
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, COVID-19, Confusional state
Clinical narrative: Brought in by family due to confusion and ataxic gait; incidental finding of COVID-19 but asymptomatic