chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Sleep disorder, Vomiting
Clinical narrative: body aches/in pain and freezing under 3 blankets; chills; Nausea; minus vomiting; abdominal tenderness; Overall extremely uncomfortable; in pain and freezing under 3 blankets; preventing sleep; Hours after initial and immediate soreness of arm; prolonged headache about an hour after vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). This consumer reported for a female patient (sister)   A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 21Apr2021 12:45 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC DAIICHI; XOPENEX HFA. Vaccination history included: Bnt162b2 (Dose 1, single, administration time=10:45 PM, vaccine location=Left arm.), administration date: 31Mar2021, for COVID-19 Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "Hours after initial and immediate soreness of arm"; HEADACHE (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "prolonged headache about an hour after vaccine"; PAIN (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "body aches/in pain and freezing under 3 blankets"; CHILLS (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "chills"; SLEEP DISORDER (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "preventing sleep"; NAUSEA (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "Nausea"; ABDOMINAL TENDERNESS (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "abdominal tenderness"; DISCOMFORT (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "Overall extremely uncomfortable"; FEELING COLD (non-serious) with onset 21Apr2021 13:30, outcome "recovering", described as "in pain and freezing under 3 blankets"; VOMITING (non-serious) with onset 21Apr2021 23:30, outcome "recovering", described as "minus vomiting". Therapeutic measures were taken as a result of pain in extremity, headache, pain, chills, sleep disorder, nausea, abdominal tenderness, discomfort, feeling cold, vomiting.  Additional information: Facility type vaccine was reported as other. Adverse events were treated with self-administered tylenol and advil. COVID was not an prior vaccination and not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: he is having severe chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 60-year-old male patient received bnt162b2 (BNT162B2), administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "he is having severe chills". Therapeutic measures were taken as a result of chills.  Additional information: It was stated that consumer called regarding her fiancé and the Pfizer COVID 19 vaccine that he had last night. When ask to report she ask how long it will take and says she just dropped by to check on him. Asks to be transferred directly to ask her question. Stated she just wanted to be sure his side effects are normal. Reports patient was having severe chills, he said it was so bad he felt like calling (withheld). He took some Tylenol and it helped.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Chills, Fatigue, Feeling abnormal, Speech disorder
Clinical narrative: Chills; Extreme exhaustion; Cognitive memory issues/Forgetting how to do a task; Saying words backward; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 16:15 (Lot number: EWO176) at the age of 49 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Chills"; FATIGUE (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Extreme exhaustion"; AMNESIA (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Cognitive memory issues/Forgetting how to do a task"; SPEECH DISORDER (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "Saying words backward"; FEELING ABNORMAL (non-serious) with onset 09May2021 12:00, outcome "recovered" (May2021), described as "brain fog". The events "chills", "extreme exhaustion", "cognitive memory issues/forgetting how to do a task", "saying words backward" and "brain fog" were evaluated at the physician office visit. Therapeutic measures were taken as a result of chills, fatigue, amnesia, speech disorder, feeling abnormal.  Additional information: Patient did not receive any other vaccine in four weeks of vaccination. Other medications in two weeks included prescribed medicines. Facility type vaccine was Pharmacy or Drug Store. AEs resulted in the doctor or other healthcare professional office/clinic visit. AE treatment included consultation. No covid prior vaccination. Patient was not covid tested post vaccination.  No follow-up attempts are required. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Influenza like illness, Malaise
Clinical narrative: feeling sick; flu like symptoms; Initial information was received on 24-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via pharmacy.  This case involves a 61-year-old male patient who had flu like symptoms (influenza like illness) and feeling sick (malaise) after receiving INFLUENZA VACCINE and TREPROSTINIL SODIUM [REMODULIN].  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  It is unknown if the patient had any additional medical history, concomitant disease or risk factor.  Details for the concomitant medication was not reported.  On 28-Sep-2020, the patient started taking REMODULIN (TREPROSTINIL SODIUM) (formulation: unknown; concentration 2.5 mg/ml; lot number and expiry date: not reported) current dose was reported as 0.040 µg/kg continuous via intravenous (IV) route for Pulmonary arterial hypertension.  On an unknown date in Oct-2021, 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 for prophylactic vaccination. It was reported that the patient got his flu vaccine last week.  On 31-OCT-2021 (yesterday) the patient developed non-serious flu like symptoms (influenza like illness) and feeling sick (malaise) (unknown latency) following the administration of INFLUENZA VACCINE and 1 year 1 month 3 days after following the first dose intake of REMODULIN (TREPROSTINIL SODIUM).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  The patient would follow up with his primary care physician.  Action taken with IV Remodulin was not changed due to the events of malaise and influenza like illness.  It was not reported if the patient received a corrective treatment for the events.  At time of this report, the outcome of the event was reported as unknown.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Sneezing
Clinical narrative: Now sneezing like crazy; Initial information received on 30-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer non health care professional (under reference number: US-SA-SAC20211201001432).  This case involves Adult and unknown gender patient who experienced now sneezing like crazy  (sneezing) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations, concomitant medication 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 expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event now sneezing like crazy (sneezing) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was reported as unknown.  There was be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: sick beyond belief; Initial information was received on 02-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional1  This case involves a female patient (age unspecified) who was sick beyond belief (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 30-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was sick beyond belief (illness) (unknown latency) following the administration of INFLUENZA VACCINE. The event was non-serious.  It was reported "I haven't had a flu shot since 1983 and I never got the flu ever again! My daughter got hers 2 days ago and is sick beyond belief! I'll never take another one but, I realize that's not for everyone"  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 a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache, Malaise
Clinical narrative: Headache; Stomach feel like crap; Initial information received on 03-Dec-2021 regarding an unsolicited valid social media non-serious case from a consumer (patient) via Global Digital Media.  This case involves an unknown age and gender patient who experienced headache and his/ her stomach feel like crap (abdominal discomfort), after receiving INFLUENZA VACCINE.  The patient's past medical treatments, vaccinations, concomitant medications and family history were not provided.   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On 02-Dec-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  On 03-Dec-2021, the patient experienced non-serious events headache and stomach feel like crap (abdominal discomfort) one day following the administration of INFLUENZA VACCINE.  It was reported "I got it yesterday and I am really sick today. Could hardly get out of bed today. Headache and stomach. Feel like crap."  It is unknown if the patient experienced any additional symptoms/ events.   It is unknown if there were laboratory data/ results available.   It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome of the events was reported as unknown.  Relatedness of suspect to event: Not reported.  There will be no information on the lot number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Temperature excursion of the product reaches to negative 1.3 Celsius for 4 hours 24 minutes with no adverse event; Initial information received on 23-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via regulatory agency (under the reference 00870840).  This case involves 118 patients (unknown demographics).  This case involves temperature excursion of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] reaches to negative 1.3 celsius for 4 hours 24 minutes (product storage error).  The patients medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect FLUZONE QUADRIVALENT (lot UT7347MA and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of potential medication error due to product storage error temperature too low (same day latency).  No adverse event reported.  It was reported "I have a question about Fluzone. I have a health department which has all new staff from the clerk to the administrator as well as the nurses, and they went to 3 schools and vaccinated a total of 118 school kiddos with flu vaccine that had experienced a TE (unbeknownst to them of course). they noticed when they went to upload their monthly temps that they had a TE, the refrigerator temperature excursion (TE). I know they likely need to revaccinate, but it's breaking my heart to ask them to do it. please advise?"  The causality of the suspect with the event not 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 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.
Sex: M
Vaccine: UNK, UNK
Symptoms: Off label use, Tinnitus
Clinical narrative: Patient had Sanofi rabies vaccine 4-dose series that was a mixed series with Novartis product, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via regulatory agency (Reference number- 00877948) and transmitted to Sanofi on 30-Nov-2021.   This case involves male patient (unknown age) who was vaccinated with RABIES (HDC) VACCINE [INACTIVATED HUMAN RABIES VACCINE] Sanofi rabies vaccine 4-dose series that was a mixed series with Novartis product, RABIES VACCINE INACT (VERO) (RABIES VACCINE (VERO CELL) FOR HUMAN USE) (Off label use)  The patient's medical history, medical treatment(s), concomitant medications and family history were not provided.  Past vaccination included RABIES VACCINE for an unknown indication  On an unknown date in 2013, the patient received a first dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route in unknown administration site for post exposure immunization  On unknown dates in 2013, the patient received a second, third and fourth dose of suspect RABIES VACCINE (VERO CELL) FOR HUMAN USE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for post exposure immunization  It was a case of an actual medication error due to Off label use (latency same day)  No adverse event was reported  It was reported "A medical information pharmacist with the manufacturer for RabAvert (Bavarian Nordic) learned of adverse event (AE) information when speaking with a retired optometrist (patient) yesterday. The patient is recently received a 2-dose series of RabAvert for post-exposure prophylaxis. He discussed with the Bavarian Nordic pharmacist that he is experiencing tinnitus 10 days after receiving RabAvert. Through that conversation, the patient mentioned his history of receipt of other rabies vaccination. When he was a middle school child, he received a rabies vaccine series. Then in 2013, he had an exposure and was given a 4-dose series of human rabies vaccine, as prescribed by an infectious disease physician. For this 4-dose series, he reports that he received one dose that was from a Sanofi product and three doses of Novartis product"  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 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: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient received Daptacel and not Adacel with no adverse event; four week old patient received Daptacel, Ipol, and ActHIB with no adverse event; Initial information received on 30-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Media Information (under reference 00878770).  This case involves a 34 days old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of Adacel (wrong product administered), also received HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] (Product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Merck ROTAVIRUS VACCINE and Pfizer PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) [lot and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On 08-Nov-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (ORAL SOLUTION IN SINGLE-DOSE CONTAINER, Total, lot C5774CA and expiration date: 18-Sep-2022) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received dose of suspect HIB (PRP/T) VACCINE and dose of suspect IPV (VERO) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination  It was a case of an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration (same day latency).  It was reported "A four week old patient received Daptacel and not Adacel, Ipol, and ActHIB and she would like to know how to proceed with the patient."  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.  There will be no information available on the batch number for IPOL and ACT-HIB.
Age: 0.08
Sex: M
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A four week old patient received Daptacel no AE; Initial information regarding an unsolicited valid non-serious case was received from a physician via a consumer/non-health care professional via Medical Information (MI) (Reference number- 00878868) and transmitted to Sanofi on 30-Nov-2021.  This case involves a 4 week old male patient who was received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (product administered to patient of inappropriate age).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  On 08-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot UJ585AAA, expiry not reported) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  It was reported "A four week old patient received Daptacel and not Adacel, Ipol, and ActHIB and she would like to know how to proceed with the patient. She states that e-mail is fine."  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.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: Patient accidentally received a second MENACTRA vaccination with no reported adverse event; Initial information received on 30-Nov-2021 regarding an unsolicited valid non-serious case from an other health professional via Media Information (under reference 00878903).  This case involves a 17 years old female patient who accidentally received a second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (extra dose administered).  The patient had previously received a Menveo vaccine in 2016.   The patient's other medical history, medical treatment(s) and family history were not provided.  The patient received dose of HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL), dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and dose of HEPATITIS A VACCINE INACT (HAVRIX) [Lot and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination as concomitant vaccines..  On 16-Oct-2020, the patient received first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.   On 29-Nov-2021, she also received 0.5 mL second dose of the same vaccine (Total, lot U7191AA and expiration date: 18-Jan-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Extra dose administered (same day latency).  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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: patient received only the liquid DTAP-IPV portion, no AE; Initial information received on 01-Dec-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and nurse via Agency (under reference number 00880090).  This case involves a 2 months old male patient who received only the liquid dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, medical treatment(s) and family history were not provided.  No other vaccines/ concomitants were given to patient.   On 01-Dec-2021, the patient received a 0.5ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number UJ529AA and expiry date 22-Jul-2022, 30-Jun-2022, standard, once) via intramuscular route in the right leg for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (same day latency).  It was reported "Registered Nurse (RN) calling on PENTACEL. Caller states a patient received only the liquid DTAP-IPV portion of the vaccine and would like to know if that is a valid dose? Caller would also like to know if they can still administer the ACTHIB portion separately? Agent directed caller to visit pentacel.com for vaccine preparation guidance."  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: 15.0
Sex: M
Vaccine: DTAPIPVHIB, HPV4, MNQ
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PENTACEL was administered to a 15-year old patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician via Agency (Reference number- 00882537) and transmitted to Sanofi on 02-Dec-2021.  This case involves a 15-year-old male patient was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product administered to patient of inappropriate age)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE CONJ (MENINGOCOCCAL VACCINE CONJ) for prophylactic vaccination.  On 02-Dec-2021, 15-year-old male patient received first 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ473AAA and expiry date: 09-Jul-2022) (Frequency = once) (Strength = standard) (Form: solution) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age).  It was reported "Nurse asks what adverse events they should look out for; asks if the vaccine would be considered valid? Nurse states that the patient was receiving PENTACEL because he has no immunization record, so he was supposed to be getting a catch-up series. Nurse states they thought they could administer PENTACEL so that the patient did not have to receive as many shots. Nurse states after they realized that PENTACEL is not approved for patients his age, they called the patient and his mother at home; states when they called the patient and his mother, no adverse events were reported to them. Nurse states that the patient did not experience any adverse events that required treatment while he was at their office; states the patient also reported no adverse events that required treatment when they contacted the patient at home. No further information provided by the reporter".  This case was an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no 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: FLU4
Symptoms: Expired product administered, Medication error
Clinical narrative: a patient received an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT vaccine/ No AE; Initial information received on 03-Dec-2021 regarding an unsolicited valid non-serious case from a consumer (patient) via phone via regulatory agency number: 00884333.  This case is linked to case 2021SA411813 (husband case).  This case involves a female patient of an unknown age who received an expired dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 14-OCT-2021, the patient received a 0.7 ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number: UJ500AB, expiry date: 30-JUN-2021 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "Patient states that she was told by the facility where she and her husband received their FLUZONE HIGH-DOSE QUADRIVALENT vaccines on 14-OCT-2021 that the product had expired on 30-JUN-2021. Caller wanted to know what was contained in the 2020-2021 FLUZONE HIGH-DOSE QUADRIVALENT vaccine and asked for a strain comparison between 2020 and 2021. Patient states that she does not know how long the vaccine that she received on 14-OCT-2021 will remain in her body and is unsure if she should be revaccinated at this time. Caller states that she will reach out to the facility to determine if they have reported this to Safety first."  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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster, Hypersensitivity, Rash, Rash macular
Clinical narrative: Shingles; Rash/red spots shortly after the vaccine and then got them on his chest; Allergic reaction to an influenza vaccine; This spontaneous case was received on 08-Nov-2021 from other non-health professional (consumer) via Agency (reference number: SEQW21-05187) and concerned a 55-year-old male patient.  The patient's concurrent condition included diabetic and high blood pressure. The patient's concomitant medications included Metformin (metformin hydrochloride), Diltiazem (diltiazem hydrochloride), glimepiride, all for unknown indication, and unspecified blood pressure medication.  On an unspecified date in Oct-2020, the patient was vaccinated with Afluria Tetra (brand name unknown; dose, route of administration, indication and anatomical location: not reported). The batch number was not reported.   On an unspecified date in Oct-2020, an unknown amount of time after vaccination, the patient developed red spots (bumps) on his right arm, the outside and inside of his bicep as well as on the right side of his chest and hands. As reported, the rash subsided after three weeks. The patient sent pictures to doctor and then was advised to take Benadryl (diphenhydramine hydrochloride).   On an unspecified date in 2020, the patient recovered from the event rash.  On an unspecified date, later in the year after, the patient was vaccinated with non-company co-suspect Covid shot (brand name unknown), and the patient looked like something like shingles, as reported.  The outcome of the events 'allergic reaction NOS' and shingles was not reported.  The reported did not provide causality assessment.  Company comment: A 55-year-old male patient developed rash after vaccination with Afluria Tetra. Posteriorly, after receiving non-company co-suspect Covid-19 vaccine, the patient developed something like shingles. Besides, the patient developed an allergic reaction. Time elapsed between vaccination with the suspect product and the onset of the events is unknown. Due to this lack of information regarding chronology, causality for the reported events is unassessable.; Sender's Comments: A 55-year-old male patient developed rash after vaccination with Afluria Tetra. Posteriorly, after receiving non-company co-suspect Covid-19 vaccine, the patient developed something like shingles. Besides, the patient developed an allergic reaction. Time elapsed between vaccination with the suspect product and the onset of the events is unknown. Due to this lack of information regarding chronology, causality for the reported events is unassessable.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Herpes zoster, Injection site rash, Injection site swelling, Neuralgia, Pain
Clinical narrative: Swelling and rash on right arm where shots given started within 24 hours followed by severe symptoms of shingles: nerve pain, on right torso radiating from back to front followed by a rash on torso all within 3 days of receiving the vaccines.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash
Clinical narrative: Swelling and rash on right arm where shots given started within 24 hours followed by severe symptoms of shingles: nerve pain, on right torso radiating from back to front followed by a rash on torso all within 3 days of receiving the vaccines.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Balance disorder, Chills, Erythema, Fatigue
Clinical narrative: Within 15 min lower lip swelled slightly and began to itch. Felt some weakness in left leg. Within 4 hrs. from injection face turned bright red which has happened to me with past anaphylaxis events. I also experienced some racing of my heart. I did have what are considered normal reactions. Fever. Extreme fatigue. Chills. On Sunday the 5th I started having sensations of shaking on the inside. Like all my nerves were out of sorts. I had some balance issues. Stomach pain. Nausea. The shaking nerve feeling has continued on and off with last experience on 12/10/21.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Lip swelling, Muscular weakness, Nausea, Nervousness
Clinical narrative: Within 15 min lower lip swelled slightly and began to itch. Felt some weakness in left leg. Within 4 hrs. from injection face turned bright red which has happened to me with past anaphylaxis events. I also experienced some racing of my heart. I did have what are considered normal reactions. Fever. Extreme fatigue. Chills. On Sunday the 5th I started having sensations of shaking on the inside. Like all my nerves were out of sorts. I had some balance issues. Stomach pain. Nausea. The shaking nerve feeling has continued on and off with last experience on 12/10/21.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Within 15 min lower lip swelled slightly and began to itch. Felt some weakness in left leg. Within 4 hrs. from injection face turned bright red which has happened to me with past anaphylaxis events. I also experienced some racing of my heart. I did have what are considered normal reactions. Fever. Extreme fatigue. Chills. On Sunday the 5th I started having sensations of shaking on the inside. Like all my nerves were out of sorts. I had some balance issues. Stomach pain. Nausea. The shaking nerve feeling has continued on and off with last experience on 12/10/21.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysstasia, Gait inability, Migraine
Clinical narrative: High fever, Uncontrollable Chills, Nausea, Exaggerated muscle and joint pain, severe migraine and physical inability to walk or stand alone.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: High fever, Uncontrollable Chills, Nausea, Exaggerated muscle and joint pain, severe migraine and physical inability to walk or stand alone.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Skin hyperpigmentation
Clinical narrative: Patient developed acute onset of widespread hyperpigmentation on dorsal aspect of bilateral forearms within an hours after vaccination.  No associated pain, edema, or discomfort.  The color change resolved gradually over the course of 3 days and has not recurred.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Hormone level abnormal
Clinical narrative: Significant hormonal fluctuations and complete cessation of otherwise normal periods.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, Urticaria
Clinical narrative: Developed an Erythematous ,papular,  pruritic rash to bilateral ankles and left knee 2.5 days after receiving 2nd COVID vaccine. Had 1 wheel to left shin.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: HEADACHE MUSCLE ACHE JOINT PAIN CHILLS FRBER NAUSEA
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEADACHE MUSCLE ACHE JOINT PAIN CHILLS FRBER NAUSEA
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Inflammation, Musculoskeletal discomfort, Musculoskeletal stiffness
Clinical narrative: I am athletic and play tennis.  Usually it?s just my fingers that get stiff at night in the morning.  After the Moderna booster, more joints got very sensitive.   Would bend knees and then would need assistance to get up. Woke up in the middle of the night as my elbow was stiff and inflamed.  My hypothesis is that Moderna vaccine overstimulated my immune system.  As someone who has an early (no drugs) auto-immune condition (Hashimoto?s), more joints got inflamed.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: After receiving the vaccine at 7:30pm on Monday, I started to get the anticipated chills, fatigue, soreness and light fever at noon on Tuesday which lasted to Wednesday/Thursday evening. In addition to these symptoms I have also gained a sore throat and stuffy nose, and headache which has lasted too today, Sunday.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: After receiving the vaccine at 7:30pm on Monday, I started to get the anticipated chills, fatigue, soreness and light fever at noon on Tuesday which lasted to Wednesday/Thursday evening. In addition to these symptoms I have also gained a sore throat and stuffy nose, and headache which has lasted too today, Sunday.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging abnormal, Mobility decreased, Pain in extremity, Rotator cuff syndrome
Clinical narrative: I feel pain in my arm and by the nighttime I having trouble to raise my arm .
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Condition aggravated, Insomnia, Neck pain, Pain
Clinical narrative: After the 1st vaccination, I experienced pain in my right arm a few hours after receiving the shot.  The dull, but had a pulsating effect.  On the 3rd day after receiving the vaccine, the pain moved to my left shoulder for about a day and then went away.  During this time I also felt fatigued and slept a lot.   After receiving the 2nd vaccination, I didn't experience any pain in my right arm until 3 days later, on September 25th.  At approximately 4:30AM, I woke up because I was having the same pulsating pain in my right arm.  It was more severe this time, and I was unable to sleep.   The next day the pain in my right arm wasn't as severe, but the pain had moved to my left shoulder again.  This time it was much more severe than the first time.  This lasted about 2 days.   During this time the pain in my left shoulder would also move up my neck and down to my hand.  I was unable to sleep very much until the pain eventually went away.  However over the next few weeks, the pain in my left shoulder returned several times and would usually only last a day or for several hours.  I also experienced pain throughout most my joints and am still experiencing pain in my left elbow.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: After the 1st vaccination, I experienced pain in my right arm a few hours after receiving the shot.  The dull, but had a pulsating effect.  On the 3rd day after receiving the vaccine, the pain moved to my left shoulder for about a day and then went away.  During this time I also felt fatigued and slept a lot.   After receiving the 2nd vaccination, I didn't experience any pain in my right arm until 3 days later, on September 25th.  At approximately 4:30AM, I woke up because I was having the same pulsating pain in my right arm.  It was more severe this time, and I was unable to sleep.   The next day the pain in my right arm wasn't as severe, but the pain had moved to my left shoulder again.  This time it was much more severe than the first time.  This lasted about 2 days.   During this time the pain in my left shoulder would also move up my neck and down to my hand.  I was unable to sleep very much until the pain eventually went away.  However over the next few weeks, the pain in my left shoulder returned several times and would usually only last a day or for several hours.  I also experienced pain throughout most my joints and am still experiencing pain in my left elbow.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Loss of personal independence in daily activities, Malaise, Vomiting
Clinical narrative: After 3 hours of administration of the vaccine my son began to throw up for 8 hours straight. He could not keep anything down and I brought him to the ER where they gave him anti anti naesua medication. He missed 2 days of school after that because he still was not able to eat much and was still feeling ill.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: hives on trunk and arms 4 days after vaccine, no other changes in daily life, very itchy and classic hives presentation
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present
Clinical narrative: Significant bright red blood in urine 3 hours after injection.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient too young for vaccine administered.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Loss of consciousness, Seizure
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Patient lost conscious for 4-5 seconds. Mild, Systemic: Seizure-Mild, Additional Details: Dad stated his daughter experienced the same symptoms when she was playing and fell on her back a few years ago. We called 911. EMS personnel checked her out and took her to the local hospital for observation.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash, Swelling face, Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient complains of rash on face, was told to take benadryl and see if resolves. For patient to call us back or doctor if worsening.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache
Clinical narrative: Headache,chills, dizziness, weakness
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient experienced syncopal episode soon after vaccine administered. Patient was helped to the ground. Patient did not experience any loss of consciousness, or seizure, or confusion. Patient does not have history of recent trauma, or seizure history, or diabetes, or CAD, or cerebrovascular accident, or GI bleeding, or infection. No report or observation of wheezing, or trouble breathing, or swelling/hives of face or lips or mouth, or increased sweating. Patient fully recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Lymphadenopathy, Oropharyngeal pain, Pain
Clinical narrative: 101 fever, sore throat, severe body aches, chills, sleeplessness, huge swollen lymph node
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101 fever, sore throat, severe body aches, chills, sleeplessness, huge swollen lymph node
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injury, Joint injury, Paraesthesia, Product administration error
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Mild, Additional Details: patient went to work out 1 hour  before appt
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Ocular discomfort, Palpitations, Rash
Clinical narrative: Site: Swelling at Injection Site-Mild, Additional Details: palipitationsm and increased pressure in eyes, red dots around ankles 50-100 each side
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster given too early.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild