chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Myalgia, Nausea, Pain
Clinical narrative: Some muscle pain at site; Some muscle pain at site; Badly swollen lymph nodes (arm pit/neck) site side only; Couldn't lift arm from shoulder, lymph node under arm felt like size ofbaseball thru 10Apr2021, but could from elbow; Fever - low grade (99-100°F) - 10 days; Chills/Body Aches - even when fever gone till 12Apr2021; Chills/Body Aches - even when fever gone till 12Apr2021; Severe fatigue even after full nights sleep; Lack of hunger forcing myself to eat; Tinnitus - ongoing; Nausea - off & on; from normal allergies causing PND; migraine/sinus issues; migraine/sinus issues; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 63-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8727) via an unspecified route of administration, administered in left arm on 25Mar2021 13:30 (at the age of 63-year-old) as dose 2, single for covid-19 immunization. Medical history included Chronic migraines, osteoarthritis from an unknown date and unknown if ongoing. Patient was allergic to Tylenol. The patient concomitant medications in two weeks were Mineral & Vitamin supplements. The patient received other vaccines within 4 weeks. The patient was not diagnosed with COVID prior to the vaccination. The patient had been not tested for COVID post vaccination. The patient previously took tylenol and experienced allergies. Historical vaccine included BNT162B2 (solution for injection, Lot Number: EN6203) administered in left arm on 04Mar2021 at 09:00 AM (at the age of 63-years-old), as dose 1 single for COVID-19 immunization and experienced Severe muscle pain at site at 48hrs, soreness about 4" below injection site, eased by day 7, Couldn't lift arm from shoulder, but could from elbow, Fever - low grade (99-100 degree f) - 7days, Chills, Body Aches - even when fever gone, Severe fatigue even after full night sleep, Tinnitus - this continued full 3wks. On 25Mar2021 19:00 the patient experienced some muscle pain at site, badly swollen lymph nodes, couldn't lift arm from shoulder, lymph node under arm felt like size of baseball through 10Apr2021, but could from elbow, fever - low grade (99-100 degree f) - 10 days, chills/body aches - even when fever gone till 12apr2021, severe fatigue even after full nights sleep, lack of hunger forcing herself to eat, tinnitus - ongoing, nausea - off & on, from normal allergies causing pnd, migraine/sinus issues. The patient underwent lab tests and procedures which included body temperature (reported as fever): low grade (99-100 degree f) fahrenheit (reported as Fever - low grade (99-100 degree F) - 10 days.) on 25Mar2021. No treatment received for the events. Outcome of the event Fever - low grade (99-100 degree F) - 10 days resolved on 03Apr2021, Chills/Body Aches - even when fever gone till 12Apr2021 resolved on 12Apr2021, outcome of the event Tinnitus ongoing was not resolved, Outcome of rest all events were resolved with sequel. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Somnolence
Clinical narrative: Difficulty breathing; she sleeping up for about hour; bad body aches and pains; This is a spontaneous report from a contactable consumer or other non healthcare professional (parent). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date unknown), via an unspecified route of administration on 06Jul2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On 07Jul2021, the patient experienced little bit difficulty in breathing, sleeping up for about hour, bad body aches and pain. The outcome of the events was unknown. The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: I have a knee pain; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program support.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported I have a knee pain. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: fever; fatigue; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional received via mail.  A 69-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0180, Expiry date: not reported) via an intramuscular route of administration, administered in right arm (upper) on 04Jun2021 at 11:20 as dose 2, single for COVID-19 immunization. Medical history included ongoing stage 3 kidney disease (likely secondary to ileostomy), ongoing arthritis (knees, elbows, shoulders and ankles), ongoing ileostomy from Jan2012 (following surgery to treat small bowel obstruction), urinary tract disorder and pain. Concomitant medications included buprenorphine (BUTRANS), transdermal from unknown date to ongoing at unknown dose and frequency for pain; tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), orally from unknown date to ongoing at unknown dose and frequency for urinary tract; finasteride, orally from unknown date to ongoing at unknown dose and frequency for urinary tract. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EW0182, Expiry date: not reported) via intramuscular route of administration, administered in right arm (upper) on 04May2021 at 11:20 as dose 1, single for COVID-19 immunization and on 17 May2021, the patient experienced joint pain (experienced severe pain in right knee and left shoulder starting 3 days after 1st vaccination. Pain in knee quite intense. Resolved after 5-7 days). On an unspecified date in 2021, the patient experienced fever and fatigue. Patient reported that after second vaccine had no joint issues. Patient experienced fever (100.8 F) and fatigue for 1-2 days. On an unspecified date in 2021, the patient underwent lab tests which included body temperature: 100.8 fahrenheit. The clinical outcome of the events were resolved on an unspecified date in 2021. No follow-up attempts are needed. Information about batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: This case involves a patient of unknown age and gender who experienced event "sick as a dog for three and a half weeks" (illness) after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious event "sick as a dog for three and a half weeks" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Sorry to hear about that I haven't had a flu shot since 1970 got sick as a dog for three and a half weeks never again". Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment for the event. On an unknown date, patient had recovered from the event. There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu: Initial information received on 29-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional via Regulatory Authority.  This case involves patient (unknown age and gender, probably a child) who had flu (influenza) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.   No laboratory data reported.  It was reported "No thank you. I have not had one since I was a child. The same year I got the flu. I have not had the flu many times in my life so I will just boost my immune system up with clean foods, water and supplements to heal my gut."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: I GOT SICK; Initial information received on 30-Oct-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via Global Digital Media.  This case involves a patient (unknown demographic) who had got sick (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history,medical treatment(s), family history, concomitant disease or risk factor.  The patient's past vaccination history involved falling sick last few times that he got the influenza vaccine.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious had got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "pass last few times i got one, i got sick. and i didn't trust the doctors to sneak the vax into regular flu shots in order to propagate biden's illegal mandate. when it was FULLY TESTED FOR LONG TERM EFFECTS, THEN i would consider taking it."  It was unknown if there were lab data/results available.  It was unknown if the patient experienced any additional symptoms/events.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Impaired work ability
Clinical narrative: Guillain Barre; Trouble walking; Felt strange; Initial information was received on 30-Oct-2021 regarding an unsolicited valid social media serious case via a consumer/non-health care professional (under reference number: US-SA-SAC20211103000621).  This case involves an elderly patient (in seventies) with an unknown gender who experienced Guillain barre (Guillain-Barre syndrome), trouble walking (gait disturbance) and felt strange (feeling abnormal) after receiving INFLUENZA VACCINE.  At the time of the event, the patient was an ongoing Insulin dependent diabetic. The patient's, other medical treatments, vaccinations and family history were not provided.  The patient had no other risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site prophylactic vaccination.  On an unknown date the patient developed a serious Guillain barre (Guillain-Barre syndrome) trouble walking (gait disturbance), felt strange (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.   The patient was hospitalized for these events.  The patient reported that he/she had bad reaction to the flu shot. After that he/ she never took another flu shot and never had flu.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  The patient was treated with IMMUNOGLOBULIN G HUMAN (GAMMA GLOBULIN) for Guillain-Barre syndrome for five days by neurologist.  After treatment the patient went home and spent another three weeks recovering and then went back to work.  At time of reporting, the patient was recovering from the events.; Sender's Comments: This case involves an elderly patient (in seventies) with an unknown gender who experienced Guillain-Barre syndrome, gait disturbance and feeling abnormal after receiving INFLUENZA VACCINE. The patient was an ongoing Insulin dependent diabetic. The time to onset is unknown for the events. Relevant lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: it was a horrible, horrible, horrible flu; Initial information received on 31-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Social Media.  This case involves male patient (unknown age) who had non-serious event "it was a horrible, horrible, horrible flu" (influenza), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "it was a horrible, horrible, horrible flu" (influenza) (unknown latency) following the administration of vaccine.  It was reported "My dad never had flu except the one year he had a flu shot.And it was a horrible, horrible, horrible flu, the sickest he'd ever been. so no, I don't think flu shots are necessary or are safe. The ingredients are disgusting, so how can it be beneficial? Impossible."   It was unknown if the patient experienced any additional symptoms/events.  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient (unknown demographics) who experienced urinary tract infection after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical history, medical treatment(s), past 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 (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious urinary tract infection (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Never will. Last time I got a urinary tract infection (U.T.I.)".  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  There will be no information available on the batch number for this case.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pruritus, Pyrexia
Clinical narrative: tiredness; itchiness all over his body; generalized rash; high fever (103.0); injection site redness and soreness; injection site redness; injection site soreness; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via Medical Information (MI) (Reference number- 00835189).  This case is linked to case 2021SA365482(CLUSTER).  This case involves a 3-year-old male patient who experienced tiredness (fatigue), itchiness all over his body (pruritus), generalized rash (rash), a high fever (103.0) (pyrexia) and injection site redness and soreness (vaccination site inflammation) after receiving vaccine IPV (VERO) [IPOL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 19-Aug-2010, the patient received a dose of suspect IPV (VERO) (lot D0674-1 and expiry date: not reported) (Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On 19-Aug-2010, the patient developed a non-serious tiredness, itchiness all over his body (pruritus) (fatigue), generalized rash (rash), high fever (103.0f) (pyrexia), injection site redness and soreness (vaccination site inflammation), injection site redness (vaccination site erythema) and injection site soreness (vaccination site pain) same day following the administration of IPV (VERO).  Relevant laboratory test results included: Pyrexia - On 19-Aug-2010: 103 [103]  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient recovered from the all events.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Rash
Clinical narrative: tiredness; itchiness all over his body; generalized rash; high fever (103.0); injection site redness and soreness; injection site redness; injection site soreness; Initial information received on 29-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/ non-health care professional via Medical Information (MI) (Reference number- 00835189).  This case is linked to case 2021SA365482(CLUSTER).  This case involves a 3-year-old male patient who experienced tiredness (fatigue), itchiness all over his body (pruritus), generalized rash (rash), a high fever (103.0) (pyrexia) and injection site redness and soreness (vaccination site inflammation) after receiving vaccine IPV (VERO) [IPOL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 19-Aug-2010, the patient received a dose of suspect IPV (VERO) (lot D0674-1 and expiry date: not reported) (Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On 19-Aug-2010, the patient developed a non-serious tiredness, itchiness all over his body (pruritus) (fatigue), generalized rash (rash), high fever (103.0f) (pyrexia), injection site redness and soreness (vaccination site inflammation), injection site redness (vaccination site erythema) and injection site soreness (vaccination site pain) same day following the administration of IPV (VERO).  Relevant laboratory test results included: Pyrexia - On 19-Aug-2010: 103 [103]  It was not reported if the patient received a corrective treatment for the events.  On an unknown date, the patient recovered from the all events.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Photophobia, Visual field defect
Clinical narrative: loss of peripheral vision; extreme light sensitivity; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via consumer/non-health care professional via physician via  Medical Information  (Reference number- 00836974) and transmitted to Sanofi on 01-Nov-2021 in a specific country.  This case involves a 36-year-old male patient who experienced loss of peripheral vision (visual field defect) and extreme light sensitivity (photophobia) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past vaccination(s) included INFLUENZA for prophylactic vaccination without any adverse events.  The patient's medical history, medical treatment(s) and family history were not provided. Patient had no other vaccines   On 01-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE produced by Sanofi Pasteur (lot number: UT7384JA and expiry date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 01-Nov-2021, the patient developed a non-serious loss of peripheral vision (visual field defect) and extreme light sensitivity (photophobia) (unknown latency) about 20 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported "Pharmacist who works for Johnson and Johnson heard from her brother-in-law that he experienced a reaction about 20 minutes after receiving FLUZONE QUADRIVALENT about 2 hours ago. Have reactions such as this been reported? The pharmacist state, "he called me and reported loss of peripheral vision and extreme light sensitivity about 20 minutes after receiving the vaccine." She stated that the reaction did not seem to be related to possible syncope and seemed "different". She did not have information about the National Drug Code (NDC), presentation or injection site. She said the reaction was "dissipating" and is not now as bad as was"  No laboratory data was provided.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the patient was recovering from the events.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: patient had administred Pentacel and ACT Hib on same time with no adverse event; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case from an Other Health Professional via Media Information (under reference 00837120).  This case involves a 6-months-old and unknown gender patient who was administered with HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], which was double dose of the HIB vaccine (extra dose administered).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination.  Medical history,medical treatment, vaccination and family history were not provided.   On 01-Nov-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ494AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination.  On 01-Nov-2021, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ522AA and expiry date: not reported) (Frequency: Once) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported that ''a child was administered ACTHIB and PENTACEL on the same date. Are there any side effects that they need to look out for?''  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: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, Product administered to patient of inappropriate age
Clinical narrative: Administered Fluzone High Dose Quadrivalent to a 10 year old pediatric patient with no reported AE; Administered Fluzone High Dose Quadrivalent to a 10 year old pediatric patient with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via a consumer/non-health care professional via Regulatory Agency (Reference number- 00837551) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 10 year old male patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 01-Nov-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry not reported, formulation: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and overdose (latency same day).  It was reported "calling for a colleague in the retail setting who administered Fluzone High Dose Quadrivalent to a 10 year old pediatric patient. Is there any information or data of side effects FLUZONE HIGH DOSE QUADRIVALENT In a pediatric patient? The hospital pharmacist who called is aware of a retail pharmacy which gave a Fluzone High Dose Quadrivalent vaccine to a 10-year old immunocompetent patient today. The pharmacist caller was not given any information of what contributed to the dosing error. "   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.  There will be no information available on the batch number for this case.
Age: 0.33
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: PENTACEL was administered to a patient without reconstituting with the HIB portion of the vaccine with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Agency (Reference number- 00838521) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 4 month old patient (unknown gender) who was received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] without reconstituting with the Haemophilus influenzae type b (HIB) portion of the vaccine (product preparation issue).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day).  It was reported "Call received from Sanofi Sales representative reporting a dose of PENTACEL was administered to a 4 month old without reconstituting with the HIB portion of the vaccine. Caller did not have any other patient or vaccine data available. Caller questioned if additional actions on his part needed to take place, informed caller he can either use the electronic submission for reporting in the future or have the health care professional (HCP) contact us directly so we are able to collect patient and vaccine data."  No other 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.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under the age of 65 receive a dose of the FLUZONE HD QIV with no adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Regulatory Authority (under the reference 00838659).  This case involves Adult patient (unknown gender) who was under the age of 65 receive a dose of the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to Inappropriate age at vaccine administration (same day latency).  It was reported "Pharmacy manager states they had a patient under the age of 65 receive a dose of the FLUZONE HD QIV. The pharmacy manager states that she thinks the patient was between 23-26 years of age but she does not have any additional information handy."  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 Directive 2001/83/EC. 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 would be no information on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Feeling hot, Rash, Rash pruritic
Clinical narrative: Either that evening or the next evening she developed an itchy, rash across her back; her body felt like it was on fire; Initial information was received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 37-year-old female patient who had developed an itchy rash across her back (rash pruritic) and her body felt like it was on fire (feeling hot), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.    On 30-Jan-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious itchy rash across her back (rash pruritic) and her body felt like it was on fire (feeling hot) (Either that evening or the next evening) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "The caller is requesting the ingredients for FLIBLOK of the 2019/2020 flu season. She said that she had a reaction to it. The caller stated that she received Flublock Quad on 1/30/2019. Either that evening or the next evening she developed an itchy, rash across her back and her body felt like it was on fire. Those symptoms resolved in less than a day. The rash was not treated. She does not have a Lot # or exp date for the product. She would like to obtain a flu vaccination this flu season and would like the ingredients."  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the patient was recovered from both the events.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: had two influenza vaccines this season with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via  Medical Information (Reference number- 00839292) and transmitted to Sanofi on 02-Nov-2021 in a specific country.  This case involves a 73-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 02-Nov-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ732AA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to extra dose administered. (latency: same day).  It was reported Pharmacist reports consumer had two influenza vaccines this season.  At time of reporting, 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 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: 41.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of Menactra was given with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (MI) (Reference number- 00839453) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 41-year-old patient (unknown gender) who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 02-Nov-2021, the patient received a 0.25 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6785AA, expiry date: 31-Oct-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "Medical assistant reporting that an expired dose of MENACTRA was given to a patient, the vaccine was given yesterday, 02Nov2021, but had expired on 31Oct2021."  At time of reporting, 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 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: COVID19, FLU4
Symptoms: Malaise
Clinical narrative: didn't feel so good; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/ non health care professional via Global Media Information (under the reference 00839506).   This case involves an unknown age female patient who experienced didn't feel so good (malaise) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and Corona Virus Disease of 2019 Vaccine.  The patient's past medical history included Atrial fibrillation.  The patient's past medical treatment, vaccination and family history were not provided.  At the time of the event, the patient had ongoing Allergic reaction to excipient.   On an unknown date, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious didn't feel so good (malaise) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and Corona Virus Disease of 2019.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, the patient recovered from malaise.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14years old given flublock vaccine with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist via Global Media Information (under the reference 00839602).  This case involves a 14 years old male patient whom given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  On an unknown date, the patient received a dose of suspect FLUBLOK QIV ( oral suspension, once, lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication Inappropriate age at vaccine administration (same day latency).  It was reported "Pharmacist is asking why FLUBLOK is for 18 and over because a friend's child was administered it at 14 years of age? Caller declined to provide the street location of her pharmacy saying it wasn't given at their pharmacy. Pharmacist states she thinks the injection was given yesterday and the child looks 18 but is 14 and her friend's son."  At time of reporting, the outcome was unknown for the reported 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 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.  There would be no information on the batch number for this case.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of FLUZONE HD QIV was administered to a patient with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health care professional via a consumer/non-health care professional via Regulatory Authority (RA) (Reference number- 00839623) and transmitted to Sanofi on 02-Nov-2021.  This case involves a 74 year old female patient who was received a expired dose INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 02-Nov-2021, the patient received a first 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ537AC, expiry: 30-Jun-2021, formulation: prefilled syringe) via unknown route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Caller states an expired dose of FLUZONE HD QIV was administered to a patient. Caller is looking for information in regards to possible adverse effects as well as if they need to revaccinate. A nurse practitioner (NP) administered a dose of FLUZONE QUADRIVALENT HIGH DOSE today that expired on 30Jun2021. The NP plans to administer a dose of in-date vaccine to the patient as soon as possible."  No other 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. 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: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Cerebrovascular accident, Computerised tomogram, Condition aggravated, Deep vein thrombosis
Clinical narrative: CVA, R facial weakness no prior cva or tia. DVT on xarelto.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Facial paresis, Laboratory test
Clinical narrative: CVA, R facial weakness no prior cva or tia. DVT on xarelto.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Headache
Clinical narrative: Back pain, heart pain, bad headaches
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: Hour after vaccine patient had vomited, vomited a 2nd time some time later, also feeling very fatigued. Advised family to continue monitoring symptoms and seek medical care if needed.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Nausea, Pruritus
Clinical narrative: At 5:16pm the patient received 0.2mL of the Pediatric Pfizer vaccine. At 5:20pm the patient lost consciousness. The father grabbed the patient as he was falling to the ground and gently laid him on the ground. The father carried the patient to the cot. The patient reported feeling dizzy and nauseous. The patient denied any pain. The head of the bed was elevated. The patient denied any trouble breathing. At 5:24pm the patient's BP was 90/62 and HR was 110. At 5:24pm the patient vomited. At 5:24pm EMS was called. At 5:29pm the patient reported that he no longer felt dizzy. The patient was asked if he was itchy anywhere and he reported that his back was itchy. The back was assessed and hives were present across his back. The patient's parents reported that the patient has a history of breaking out in hives. The patient reported that his back was itchy before receiving the vaccine. At 5:31pm BP was 102/72 and RR 13. The fire department arrived at 5:35pm and assumed care of the patient. At 5:40pm  BP was 118/77, HR 74, and O2 Sat 95%. At 5:41pm paramedics arrived on site and assumed care of the patient. At 5:43pm the patient was transported by the paramedics to the emergency room.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: At 5:16pm the patient received 0.2mL of the Pediatric Pfizer vaccine. At 5:20pm the patient lost consciousness. The father grabbed the patient as he was falling to the ground and gently laid him on the ground. The father carried the patient to the cot. The patient reported feeling dizzy and nauseous. The patient denied any pain. The head of the bed was elevated. The patient denied any trouble breathing. At 5:24pm the patient's BP was 90/62 and HR was 110. At 5:24pm the patient vomited. At 5:24pm EMS was called. At 5:29pm the patient reported that he no longer felt dizzy. The patient was asked if he was itchy anywhere and he reported that his back was itchy. The back was assessed and hives were present across his back. The patient's parents reported that the patient has a history of breaking out in hives. The patient reported that his back was itchy before receiving the vaccine. At 5:31pm BP was 102/72 and RR 13. The fire department arrived at 5:35pm and assumed care of the patient. At 5:40pm  BP was 118/77, HR 74, and O2 Sat 95%. At 5:41pm paramedics arrived on site and assumed care of the patient. At 5:43pm the patient was transported by the paramedics to the emergency room.
Age: 50.0
Sex: F
Vaccine: COVID19, HEPAB, VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Mild fever Sore arms  Body aches Headaches Congestion  Exhausted
Age: 50.0
Sex: F
Vaccine: COVID19, HEPAB, VARZOS
Symptoms: Respiratory tract congestion
Clinical narrative: Mild fever Sore arms  Body aches Headaches Congestion  Exhausted
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Vital signs measurement
Clinical narrative: High heart rate.  Can feel pulse around entire body while resting
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Heavy menstrual bleeding
Clinical narrative: I am on kyleena for birth control. I have had it for a few years. My periods have almost completely stopped since having this IUD. I experience slight spotting every now and then but haven?t seen actual blood in about half a year or longer.  I got the Covid shot on November 2, 2021 and on November 4, 2021 I started a full heavy bleeding cycle. During this cycle I have experienced severe cramping. One cramp sent me to the floor it was so bad. It is now November 11, 2021 and I am still bleeding. The bleeding has slowed down but still there and I am still experiencing mild cramping today. I have been taking ibuprofen for pain and using a heating pad. I will be scheduling an appointment with my OBGYN in the morning.  I have also experienced more frequent headaches since receiving the shot.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Muscle spasms
Clinical narrative: I started my period earlier than expected and had cramping
Age: 38.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Localized reaction injection site for influenza vaccine developed large red/painful welt approximately 1.5 inch in diameter
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Oedema peripheral
Clinical narrative: I developed a huge baseball size lump under my left underarm. It has gone down but there is still pain and seems to be a bump deep in my underarm. It is taking so long to go away and hurts.