chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test negative
Clinical narrative: cold; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date: unknown) via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During the call caller stated, that caller was due for second vaccine. On an unknown date patient experienced common cold. Patient did get tested and it came back negative and then doctor gave patient an antibiotic today and it was last day of antibiotic. Patient stated that, patient was due for second vaccine. The patient lab data and tests included SARS-CoV-2 test: negative. Therapeutic measures were taken with antibiotics. The outcome of cold was unknown.  Information about lot/batch number had been requested.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: running nose; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced running nose on an unspecified date. Reporter reported as, "Can I get my second dose while having running nose". Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate was going up; and was on a resting rate but it was going up; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 06Jun2021 07:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jun2021 the patient experienced heart rate was going up; and was on a resting rate but it was going up. The patient underwent lab tests and procedures which included heart rate: 124 on Jun2021 it was going up to like 124, 131, 124, 128, 133 and I just got scared, heart rate: 131 on Jun2021, heart rate: 124 on Jun2021, heart rate: 128   on Jun2021, heart rate: 133 on Jun2021.The outcome of event was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pharyngeal swelling, Sinusitis, Swollen tongue
Clinical narrative: Her sinuses start draining as well; tongue and throat swelling; tongue and throat swelling; This is a spontaneous report from a contactable pharmacist from a Pfizer sponsored program. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0176; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Deltoid Right on 17May2021 16:00(Age at vaccination 64 years) as 1st dose, 0.3 ml single dose for covid-19 immunisation. Medical history included Pre-diabetic, Hypothyroidism (It is medically induced hypothyroidism), lymphoedema, disabled with back injury , She is allergic to other medications. Concomitant medications included syntroid (LEVOTHYROXINE SODIUM) aminobenzoic acid, ascorbic acid, betaine hydrochloride, bioflavonoids nos, biotin, calcium, calcium pantothenate, choline bitartrate, colecalciferol, copper, cyanocobalamin, folic acid, glutamic acid, hesperidin, inositol, iodine, iron, magnesium, manganese, nicotinamide, potassium, pyridoxine hydrochloride, retinol palmitate, riboflavin, rutoside, thiamine mononitrate, tocopheryl acetate, zinc (MULTIVITAMIN N) cranberry (CRANBERRY) taken for urinary tract infection. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 15 to 20 min after vaccine application the patient experienced tongue and throat swelling, her sinuses start draining as well on an unspecified date. That morning, she had taken an over the counter antihistamine and was thinking that is probably what stopped the reaction. that is her typical response when faced with something she is allergic to. She is allergic to other medications, medication she took was generic Claritin She does not remember the dose or anything else. When she looked at the CDC information on medications to find out, she did not recognize any of the meds and thought she would be safe. The patient underwent lab tests and procedures which included blood test found synthroid increased (Had bloodwork done, before the vaccine and they had just increased her dose of Synthroid over a month ago). Patient had no medications or treatments after the event occurred. The outcome of events tongue and throat swelling was recovered 10 to 15 minutes on 17May2021 . sinuses start draining outcome was unknown.  Patient states that it is okay to contact her later and that her physician does not know about this. She has not contacted them yet but will see in a week or so.
Sex: M
Vaccine: COVID19
Symptoms: Drug tolerance
Clinical narrative: Recently discovered he has immunity to the vaccine; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient recently discovered that he has immunity to the vaccine on an unspecified date and wants to know if there have been other reports about this and what he should do. The outcome of event was unknown.  No further information provided or obtained.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness presenting to the arm where he got the vaccine but it is predominately to the opposite arm; Very minimal itching; This is a spontaneous report from a contactable consumer (parent, reporting for his son). A 14-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175, expiration date: Aug2021) via intramuscularly in left deltoid muscle on 07Jun2021 as 2nd dose single, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 14May2021 as 1st dose, single dose for COVID-19 immunization. Reporter stated, patient had a little bit of redness presenting to the arm where he got the  vaccine but it is predominately to the opposite arm, he does not have any itching or shortness of breath, he does not feel dizzy, he can swallow, there was no other problem except the redness and very minimal itching very minimal but we wanted to know we can give him some Benadryl or do we just leave him alone. The outcome of the events was unknown.   Follow-up attempts are needed. Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I took 2nd Covid shot yesterday and I'm kind of tired; This is a spontaneous report received from a Pfizer-sponsored program. A contactable 69-year-old female consumer (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Jun2021 as single dose for covid-19 immunisation. The patient medical history were not reported. The patient's concomitant medication included Xeljanz 5 mg (tofacitinib citrate). The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient reported that she took 2nd covid shot yesterday and she was kind of tired. The outcome of the event was unknown.    Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Dizziness; Wheezing; Rash on the side- under her armpit on both sides; achy and severe; Nausea; Severe joint pain; Extreme fatigue; Headache; Arm pain; Injection pain on the left arm; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccination, the patient had a reaction after leaving the vaccination site. The patient experienced nausea, severe joint pain, achy and severe, extreme fatigue, headache, rash on the side- under her armpit on both sides, wheezing, dizziness and arm pain or injection pain on the left arm. The patient also mentioned that all symptoms were severe. It started later in the evening which lasted about 6 days. The outcome of all the events was recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash, Vaccination site pain, Wheezing
Clinical narrative: Dizziness; Wheezing; Rash on the side- under her armpit on both sides; achy and severe; Nausea; Severe joint pain; Extreme fatigue; Headache; Arm pain; Injection pain on the left arm; This is a spontaneous report from a contactable pharmacist. A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 14May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccination, the patient had a reaction after leaving the vaccination site. The patient experienced nausea, severe joint pain, achy and severe, extreme fatigue, headache, rash on the side- under her armpit on both sides, wheezing, dizziness and arm pain or injection pain on the left arm. The patient also mentioned that all symptoms were severe. It started later in the evening which lasted about 6 days. The outcome of all the events was recovered.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: can't breathe well; This is a spontaneous report from a Pfizer-sponsored program [COVAX US Support]. A non-contactable male consumer reported for himself.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced Breathing difficult. The patient reported that he already got the shot and noticed that he can't breathe well. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: nausea; Fatigue; headache; fever 100 F; This is a spontaneous report from a contactable consumer (Patient). A 12-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included migraine. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. It was reported that patient did not have fever after first dose of vaccine. On an unknown date, after second dose of vaccine administration, the patient experienced nausea, fatigue, headache and fever 100 Fahrenheit. Events occurred after the use of product. Laboratory tests and procedures included body temperature 100 Fahrenheit on an unknown date. Outcome of the events nausea, fatigue, headache and fever 100 Fahrenheit was reported as unknown at the time of this report.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Malaise
Clinical narrative: having a lot of side effect/This is useless and frustrating; having a lot of side effect/This is useless and frustrating; This is a spontaneous report from a contactable consumer (patient, reported for self).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported; Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation (reason for no lot number: of COVID-19 vaccine: Complainant hung up abruptly/transfer incomplete). The patient medical history and concomitant medications were not reported.   The reporter (patient) stated, "I am having a lot of side effect (Further not clarified hence captured verbatim) from Pfizer vaccine (Confirmed as Pfizer COVID-19 vaccine) and nobody seems to know how to resolve it, I have been given this information by my pharmacist and I am just trying to figure out who I should contact to, communicate my side effect."  When paraphrased the concern, reporter stated, "Yeah, I been having it from 2 months. Yeah, I would like to is there anyway to resolve it." Reporter stated that this is useless and frustrating, nothing help its all useless. Product details and pharmacy details could not be probed as the consumer hung up abruptly. Hence limited information available. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moderate chills; mild to moderate muscle aches; This is a spontaneous report from a Pfizer Colleague from a contactable pharmacist (patient parent). A 15-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported via an unspecified route of administration on 04Jun2021 (at the age of 15-years-old) as single dose for COVID-19 immunization. Patient did not have known drug allergies. Patient did not have any chronic medical conditions. Patient's medical history included the first dose of bnt162b2 vaccine. The patients concomitant medications were not reported. In Jun2021, patient experienced mild arm soreness, mild swelling at injection site, mild to moderate chills, mild to moderate muscle aches, and having a slight temp the day after her vaccine. On 07Jun2021, the patient started experiencing fever, nausea, vomiting, and diarrhea. The clinical outcome of all events was unknown.  Information about batch/lot number has been requested
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: fever; nausea; vomiting; diarrhea; mild arm soreness; mild swelling at injection site; mild to moderate chills; mild to moderate muscle aches; This is a spontaneous report from a Pfizer Colleague from a contactable pharmacist (patient parent). A 15-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported via an unspecified route of administration on 04Jun2021 (at the age of 15-years-old) as single dose for COVID-19 immunization. Patient did not have known drug allergies. Patient did not have any chronic medical conditions. Patient's medical history included the first dose of bnt162b2 vaccine. The patients concomitant medications were not reported. In Jun2021, patient experienced mild arm soreness, mild swelling at injection site, mild to moderate chills, mild to moderate muscle aches, and having a slight temp the day after her vaccine. On 07Jun2021, the patient started experiencing fever, nausea, vomiting, and diarrhea. The clinical outcome of all events was unknown.  Information about batch/lot number has been requested
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: After the excursion, some of the vaccines were given to different consumers/no AE; Initial information was received on 12-May-2021 regarding an unsolicited valid non-serious case from a other health professional (MI Inquiry number: 00598570).  This case is linked to case 2021SA161603(CLUSTER).  It was reported that different patients of unknown age and gender received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) after the excursion on an unknown date for prophylactic vaccination (product storage error).  It was a case of actual medication error due to incorrect product storage.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 0.17
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: The vaccine was reconstituted with "sterile diluent"; sterile water instead of co-packed 0.4% saline with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via physician via (Reference number- 00607391) and transmitted to Sanofi on 19-May-2021.  This case involves a 2 month old male patient who was vaccinated with 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB], which was reconstituted with sterile diluent; sterile water instead of co-packed 0.4% saline (lot UJ357AAA, expiry; 25-Jan-2022) via intramuscular route in left leg for prophylactic vaccination on 18-May-2021 (Product preparation error)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of an actual medication error due to Wrong diluent used (latency same day)  The caller stated that they used the incorrect dilute for ACTHIB and administered it to a patient. The caller would like to know what steps to take now. But the nurse who prepared the vaccine reconstituted it with sterile diluent; sterile water instead of co-packed 0.4% saline. The vaccine will be repeated  No adverse effects reported  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: 5 month old male patient administered expired dose of PENTACEL vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a Physician via other health care professional via Medical Information (MI) (Reference number- 00607806) and transmitted to Sanofi on 19-May-2021.  This case involves a five month old male patient who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 13-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot U6622AB and expiry date: 12-Mar-2021) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that Caller states that a Nurse provided an expired PENTACEL to a patient. Nurse states that on 5/13/2021, another nurse administered a PENTACEL vaccine that was later noted to have expired on 3/12/2021.   At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAP, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received PENTACEL and DAPTACEL this morning, no AE; Initial information was received on 19-May-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional.  This case involves a 15 months old female patient who received 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ504AA) and 0.5 ml first dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5743AA) via intramuscular route in the left thigh for prophylactic vaccination on 19-May-2021 (Extra dose administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to Extra dose administered (latency same day)  At the time of report, no adverse event was reported.  A 15-month-old patient received PENTACEL and DAPTACEL this morning, so patient was duplicated on the DTAP. They were calling to see what they needed to do and what to expect. They were suggested to be on a lookout for any adverse reaction or side effect. They were requesting a response as soon as possible, preferably within 24 hours  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. 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: 0.5
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was inadvertently administered only the DTap-IPV component of the Pentacel without reconstituting with HIB/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (MI) (reference number- 00609599) and transmitted to Sanofi on 20-May-2021.  This case involves a 6 months old male patient who was inadvertently administered 0.5 mL only of DTap-IPV component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [ third dose, batch number: UJ382AAA and expiry date: 10-Jan-2021 via an intramuscular route at thigh (left or right thigh not reported) administration site] as the product was not first mixed with the Hib component (product preparation issue) on 28-Apr-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  Reporter want to know if the DTAP and Polio portion are still valid or if some other protocol needs to be followed at this point. Healthcare professional also asked if there were any special safety issues to look out for if only the DTap-IPV portion of the Pentacel vaccine was administered, without the Hib.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of MENACTRA; Initial information was received on 01-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional (Agency Inquiry number: 00623308).  It was reported that a 57-year old female patient received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6594AB, expiry date: 21-May-2021) on 28-May-2021 via intramuscular route at right arm for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue, Syringe issue
Clinical narrative: the patient miss the first dose of the three dose series; plunger wasn't working right and medication spilled out; Initial information was received on 01-Jun-2021 regarding an unsolicited valid non-serious case from a pharmacist. (GMI Inquiry number: 00623420).  It was reported that a female patient missed the first dose of the three dose series (missed dose) as plunger wasn't working right and medication spilled out (syringe issue) RABIES (HDC) VACCINE [IMOVAX RABIES] (Suspension For Injection) (lot number: T1C661M, expiry date: 17-Jun-2022) on an unknown date via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to Product dose omission issue and syringe issue.  At the time of report, no adverse event reported.  IMOVAX RABIES was dispensed to a customer to take to the doctor's office for administration, the product was not working right, she didn't speak to the doctor's office so the customer said the plunger wasn't working right and medication spilled out, they brought the empty IMOVAX RABIES syringe back and said they called Sanofi and filed a complaint and Sanofi said the pharmacy should call for a replacement. Reporter reports the replacement request is urgent because this caused the patient to miss the first dose of the three dose series, the patient needs to start her series as soon as possible for veterinary school.  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 by the regulatory authority. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave a dose of an expired vaccine which had been expired for about a month with no reported adverse event; Initial information was received on 02-Jun-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Inquiry number: 00624801).  It was reported a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Suspension For Injection) which was expired a month ago was administered to a patient (age and gender not specified) on an unknown date via an unknown route for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 0.33
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month-old child received FLUZONE QUADRIVALENT, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information inbound (reference number- 00625248) and transmitted to Sanofi on 02-Jun-2021.  This case involves a 4 month old (gender not reported) patient who was administered 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination on 02-JUN-2021 (Product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication' and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of this report, no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/3/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information available on the batch number for this case.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: a medical assistant gave an expired dose of Menactra; which expired 08May2021 with no adverse event; Initial information was received on 02-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional.  It was reported that a medical assistant gave an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6575AB, expiry date: 08-May-2021) to a 12 year old female patient on an unknown date via an unknown route for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medication included sodium.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient inadvertently received a dose of ActHIb reconstituted with an MMR diluent (sterile water)/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (reference number- 00626689) and transmitted to Sanofi on 03-Jun-2021.  This case involves a 6-months-old female patient to whom healthcare professional (HCP) administered the dose of 0.5 mL ACT-HIB (PRP/T) VACCINE [ACT-HIB] (frequency: once, strength: standard, batch number: UJ405AAB and expiry date: 08 Oct 2021via intramuscular route at left thigh administration site) after diluting with MMR diluent (sterile water) (product preparation error) on 26 May 2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (INFANRIX); ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  Reporter requested guidance on how to proceed.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: 25 hours after the vaccine, my dad began to feel numbness to the right side of his face and was unable to to move his right eyebrow or blink his right eye. He also was not able to feel some of his tongue and lips and he was not able to speak probably since he couldn?t tighten his lips.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardioversion, Chest pain, Coma, Death
Clinical narrative: My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest.   He was shocked back to life where he lay in a coma.  His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dialysis, Hepatic failure, Laboratory test, Life support, Myocardial infarction
Clinical narrative: My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest.   He was shocked back to life where he lay in a coma.  His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Renal failure, Respiratory failure
Clinical narrative: My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest.   He was shocked back to life where he lay in a coma.  His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest Pain day after 2nd ModernaVax. Returned to clinical site for evaluation...no blood work or ECG performed
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Mobility decreased, Pain
Clinical narrative: not being able to move her arm due to pain; not being able to move her arm due to pain/barely able to lift arm to put her shirt on; This spontaneous report was received from a nurse referring to a 45-year-old female patient with asthma, eczema, haemorrhoids, decreased visual acuity, viral warts, night sweats, obsessive-compulsive disorder (OCD) and irregular menses. Historical drug included azithromycin (reported as "zythromycin"). The patient was allergic to azithromycin (reported as "zythromycin"). Concomitant therapies included acyclovir (ACICLOVIR), aripiprazole (ABILIFY), cetirizine hydrochloride (ZYRTEC), ascorbic acid (VIT C), clomipramine hydrochloride (ANAFRANIL), diazepam, lorazepam and propranolol.     On 11-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength and dose 0.5 milliliter, lot # T025367, expiration date 18-NOV-2022) route reported as injection for preventative (prophylaxis).    It was reported that the patient was still complaining of not being able to move her arm due to pain (onset date 11-MAY-2021). The patient was barely able to lift arm to put her shirt on. It sounded like the pain was still the same and had not decreased since receiving the vaccine (not recovered). Medical attention was sought. No additional adverse event (AE) or product quality complaint (PQC) was reported.   It also reported that the vaccination would not be discontinued. The causality assessment was not provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T025367; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: injection site has become swollen, inflamed; injection site has become swollen; injection site has become swollen, inflamed & sore.; Redness has spread; This case was reported by a consumer via Shingrix GSK Chatbot and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site inflammation, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling, injection site inflammation, injection site pain and erythema of extremities were unknown.   It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient itself. The age at vaccination was not reported. The patient received Shingrix and the injection site was swollen, inflamed and (amp) was sore. The redness was spread and the patient asked if that could be shingles in the injected arm. No further information was provided
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and have had them Three times in different variations./ suspected vaccination failure; had them Three times in different variations.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure 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 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 reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles three times in different variations. 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.
Age: 0.08
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: accidentally administered an extra dose  (Extra Dose); per record, the patient received the first dose /on 08/20/2003, / and third dose on 01/2004. The schedule between 1st and 3rd dose was one month early. (Inappropriate schedule of vaccine).; per record, the patient received the first dose / on 08/20/2003, second dose on 10/08/2003; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 1-month-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis b vaccine (1st dose received on 20th August 2003).   On 7th June 2021, the patient received the 4th dose of Engerix B (intramuscular) .5 ml and Engerix B Pre-Filled Syringe Device. In January 2004, the patient received the 3rd dose of Hepatitis B vaccine. On 8th October 2003, the patient received the 2nd dose of Hepatitis B vaccine. On 8th October 2003, not applicable after receiving Engerix B, Engerix B Pre-Filled Syringe Device and Hepatitis B vaccine and unknown after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. In January 2004, the patient experienced drug dose administration interval too short. On 7th June 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered, drug dose administration interval too long and drug dose administration interval too short 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 provided as follows: The patient accidentally received dose of Engerix B which led extra dose administered.  The patient received 2nd dose of Hepatitis B vaccine, more than recommended interval which led lengthening of vaccinaton schedule. The patient received  3rd dose of Hepatitis B vaccine, less than the recommended interval which led to shortening of vaccination. The reporter consented to follow up via email. This case was linked with case US2021122659 reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122659:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: patient was only injected the adjuvant component; patient was only injected the adjuvant component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. The pharmacist reported that, the patient was only injected the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No adverse event was reported . The reporter consented to follow up. No patient's identifiers provided,no LOT number and expiration and no vaccination date were provided.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF ONE DOSE OF JANSSEN COVID 19 VACCINE AFTER 24  HOURS THE VIAL WAS PUNCTURED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administration of one dose of janssen covid 19 vaccine after 24 hours the vial was punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of one dose of janssen covid 19 vaccine after 24 hours the vial was punctured was not reported. This report was non-serious.