chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Influenza like illness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Entire right arm down to fingers very painful.; Right arm pit very painful.; Right side of neck stiff.; Entire body flu like aches; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 15Dec2021 at 14:30 (Lot number: unknown) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ADVIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN; Anatomical location: Right arm), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 14:30, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Entire right arm down to fingers very painful"; AXILLARY PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Right arm pit very painful"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Right side of neck stiff"; INFLUENZA LIKE ILLNESS (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Entire body flu like aches". Therapeutic measures were not taken as a result of pain in extremity, axillary pain, musculoskeletal stiffness and influenza like illness. Additional Information: The patient had no known allergies to past drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Immunisation, Malaise
Clinical narrative: Mild Right arm pain at site of injection; Mild Right arm pain at site of injection, which ran underneath right scapula around  10-11 hrs post injection; Moderate malaise; Headache; Chills around 24-30 hrs post injection; Dose received: 3; This is a spontaneous report from a contactable reporter (physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 17Dec2021 at 12:00 (Lot number: FF8839) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy to antibiotics" (unspecified if ongoing), notes: Known allergies: Quinolones. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Anatomical location: Left arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 26Apr2021, when the patient was 44 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Right arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 05Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2021 at 04:00, outcome "recovered" (an unknown date in Dec2021), described as "Mild Right arm pain at site of injection"; BACK PAIN (non-serious) with onset 18Dec2021 at 04:00, outcome "recovered" (an unknown date in Dec2021), described as "Mild Right arm pain at site of injection, which ran underneath right scapula around  10-11 hrs post injection"; MALAISE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Moderate malaise"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Headache"; CHILLS (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "chills around 24-30 hrs post injection". Therapeutic measures were taken as a result of vaccination site pain, back pain, malaise, headache and chills.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The treatment for the events vaccination site pain, musculoskeletal pain, malaise, headache and chills included PARACETAMOL.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild Right arm pain at site of injection; Mild Right arm pain at site of injection, which ran underneath right scapula around  10-11 hrs post injection; Moderate malaise; Headache; Chills around 24-30 hrs post injection; Dose received: 3; This is a spontaneous report from a contactable reporter (physician). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 17Dec2021 at 12:00 (Lot number: FF8839) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergy to antibiotics" (unspecified if ongoing), notes: Known allergies: Quinolones. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: EL3247, Anatomical location: Left arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 26Apr2021, when the patient was 44 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3247, Anatomical location: Right arm, Administration time: 11:00, Route of administration: Intramuscular), administration date: 05Apr2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 12:00, outcome "unknown", described as "Dose received: 3"; VACCINATION SITE PAIN (non-serious) with onset 18Dec2021 at 04:00, outcome "recovered" (an unknown date in Dec2021), described as "Mild Right arm pain at site of injection"; BACK PAIN (non-serious) with onset 18Dec2021 at 04:00, outcome "recovered" (an unknown date in Dec2021), described as "Mild Right arm pain at site of injection, which ran underneath right scapula around  10-11 hrs post injection"; MALAISE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Moderate malaise"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Headache"; CHILLS (non-serious) with onset 18Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "chills around 24-30 hrs post injection". Therapeutic measures were taken as a result of vaccination site pain, back pain, malaise, headache and chills.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The treatment for the events vaccination site pain, musculoskeletal pain, malaise, headache and chills included PARACETAMOL.
Sex: U
Vaccine: COVID19
Symptoms: Hemiparesis
Clinical narrative: Weakness on the left side of the body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization. The following information was reported: HEMIPARESIS (medically significant), outcome "unknown", described as "Weakness on the left side of the body". Clinical course: It was reported that the patient got the shot in the left side of the body. Weakness on the left side of the body came after the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: experienced a significant increase in the intensity and frequency of migraines; Severe migraine in five days following.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 15:00 (Lot number: ER8731) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic migraine", start date: 01Mar2002 (ongoing), notes: Other medical history: Chronic migraine. Concomitant medication(s) included: SUMATRIPTAN taken for migraine (ongoing). Vaccination history included: Bnt162b2 (Dose:1, vaccine location=Right arm, Administration time=03:00 PM,, Lot Number: EP6955, No events reported), administration date: 25Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 19Apr2021, outcome "recovered" (Apr2021), described as "Severe migraine in five days following."; MIGRAINE (non-serious), outcome "not recovered", described as "experienced a significant increase in the intensity and frequency of migraines". Therapeutic measures were taken as a result of migraine. Additional information: At Pharmacy or Drug Store facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. No Known allergies. The vaccination was followed by a very severe migraine that did not respond to treatment. In the following three weeks the patient experienced a significant increase in the intensity and frequency of migraines, resulting in 5 days off work. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Blister, Herpes zoster, Influenza, Rhinorrhoea, Vaccine breakthrough infection
Clinical narrative: This case involves a patient (demographics unknown) who experienced influenza B (influenza), sniffling (rhinorrhoea), shingles (herpes zoster) and one small blister (blister) after receiving INFLUENZA VACCINE and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX)  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's 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 received a dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious influenza B (influenza), sniffling (rhinorrhoea), shingles (herpes zoster) and one small blister (blister) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have had very mild breakthrough after flu and shingles shots. In both cases I had no symptoms. I was sniffling and thought it was allergy until a nasal swab revealed Influenza B. A routine visit to the dermatologist revealed one small blister which he diagnosed as shingles. All I can say is thank God I got the shots".  It was unknown if the patient experienced any additional symptoms/events.  Relevant laboratory test results included:  On an unknown date, nasopharyngeal swab (culture throat) of the patient was done and revealed Influenza B.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the outcome of events was unknown.  There will be information available on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Pneumonia
Clinical narrative: This case involves adult female patient who experienced double pneumonia after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 serious double pneumonia (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult female patient who had pneumonia after receiving INFLUENZA VACCINE (Unknown manufacturer). The time to onset is unknown. Furthermore, information regarding medical history, past medical treatment(s), vaccination(s), concomitant medications, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: This case involves a patient (unknown demographic) who had down with the flu for three weeks (influenza) 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) 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious down with the flu for three weeks (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  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 was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu every time; Initial information was received on 18-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves adult male patient who experienced got the flu every time (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 got the flu every time (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  It was reported "My dad got the flu shot for 20 years got the flu every time ten years he didn't hasn't got it sense."  At time of reporting, the outcome was unknown for the event.  There will be no information available on the batch number for this case'
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: This case involves a patient (unknown age and gender) who was sick (illness), after receiving INFLUENZA VACCINE.  The patient had no 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 was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The last flu shot I got made me sick. I had to go back to the doctor (Dr.) twice before I got better. It seems when you reach a certain age they double your shot because they THINK you have a weak immune system."  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.  The patient was recovering from the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 20-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown demographics) 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 INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.   It was unknown if there were laboratory data/results available.  It was reported "took the flu shot twice in the past got the flu both times. I will pass."  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was unknown for the event flu.  There would be no information on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Mobility decreased, Nasopharyngitis
Clinical narrative: This case involves an unknown age and unknown gender patient who experienced bad cold for about 7 days it put me in the bed (nasopharyngitis) after receiving INFLUENZA VACCINE.  The patient's medical history, past 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 not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious bad cold for about 7 days it put me in the bed (nasopharyngitis) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Booster ok laid around 2days later go flu shot ended up with bad cold for about 7 days it put me in the bed."  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal, Rash, Urticaria
Clinical narrative: This case involves Adult and unknown gender patient who experienced after getting the shot, feeling bad (feeling abnormal), rash and hives (urticaria) after receiving vaccine INFLUENZA VACCINE. The patient past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (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 after getting the shot, feeling bad (feeling abnormal), rash and hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "had a serious reaction to my flu shot this year. have taken the flu shot for years but three weeks ago after getting the shot at my Dr office, he started feeling bad before he got home. By midnight he was developing a rash. By morning the rash had turned into hives. Went back to Doctor he gave me shot of prednisone and Medical prescription (Rxs) Instructed to go to Emergency room (ER) if the hives continued to spread. It did. At the ER, I received an IV of benadryl and prednisone and more RXs. It was over a week to recover. No more flu shots for me. But that worries me. He don't want to catch the flu". It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  The patient was treated with PREDNISONE for Hives and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  On an unknown date, the patient recovered from all events.
Age: 39.0
Sex: F
Vaccine: FLU4, MNQ, TYP, YF
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patients that have been administered a dose of YF-VAX, with no reported adverse event; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case from an Other health professional via Agency (under the reference 00899280).  This case involves a 39 years old female pregnant patients that have been administered a dose of YELLOW FEVER VACCINE - US [YF-VAX] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  Event occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The information regarding patient's previous pregnancy was unknown.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL); TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) (lot and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.   On 02-Dec-2021, the patient received a dose of suspect YF-VAX (0.5ml, total, lot UJ409AA and expiration date: 22-Oct-2022) via subcutaneous route in the left arm for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (same day latency).  No reported adverse event  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: M
Vaccine: FLU4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: This case is linked to cases US-SA-2021SA422716(CLUSTER).  This case involves a Nine months old male patient who was administered a dose of  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 treatments, vaccinations, concomitant medications and family history were not provided.  On 15-Dec-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number:  UJ709AB and expiry date; 30-Jun-2022) via intramuscular route in the left thigh for prophylactic vaccination.  It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  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: 0.17
Sex: U
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC, RV5
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This case involves a 2 months old patient (unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (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 LIVE REASSORT ORAL 5V (ROTATEQ); DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE (HEPATITIS B VACCIN) [lot and expiration date were not reported] for prophylactic vaccination. On 14-Dec-2021, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Solution for injection in pre-filled syringe, Total, lot 54C23 and expiration date: 30-Jun-2022) via intramuscular route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to Inappropriate age at vaccine administration (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. 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: M
Vaccine: FLUR4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: a 17 years old patient received a dose of Flublok Quadrivalent vaccine/ No AE; Initial information received on 16-Dec-2021 regarding an unsolicited valid non-serious case from an other health professional via Physician.  This case involves a 17 years old male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  No other concomitant vaccines.  On 16-Dec-2021, the patient received a 0.5 ml total dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE strength: standard, frequency: once, lot number: UJ725AA, Expiry date: 30-Jun-2022 via an unknown route in the left deltoid 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 "Calling in regard to a 17 year receiving a dose of FLUBLOK. Caller would like to know if there are any side effects/ safety information available."  Product used: Used, First time product used: Yes, Still using product: No and Was Device Used: Yes.  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.
Sex: M
Vaccine: HIBV
Symptoms: Medication error, Product preparation error
Clinical narrative: This case involves a 14 months old male patient who had HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) powder which not mixed with sodium chloride diluent; mixed with sterile diluent for live virus vaccine (product preparation error). The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) (lot and expiration date not provided) via unknown route in an unknown administration site for prophylactic vaccination. On 13-Dec-2021, the patient received a dose of suspect ACT-HIB (Solution, 0.5 ml, total, once, lot UJ581AA and expiration date: 14-Oct-2022) via intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error due to wrong diluent used (same day latency). It was reported "Nurse reports that they had an ACTHIB administration error, states that ACTHIB powder was not mixed with the sodium chloride diluent that comes in the box, states ACTHIB powder was mixed with sterile diluent for live virus vaccine. Nurse asks if there are any recommendations in this situation and if there could be any harm to the patient. Nurse states that the patient did not require any treatment after receiving ACTHIB; states the parents have not yet been notified, but to their knowledge the patient has not required any treatment" 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: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: the needle didn't lock with the syringe, so during administration, some of the solution left the syringe with no AE; the needle did not lock with the syringe; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a pharmacist via Agency (Reference number-00903456).  This case involves an unknown demographics gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and the needle did not lock with the syringe, so during administration, some of the solution left the syringe (underdose and syringe issue).  The patient past medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7356MA and expiry date: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination.  It was reported "Should another dose be given? Unknown amount of vaccine was administered".  It was actual medication error case due to Vaccine underdose and syringe issue.  At the time of report, no adverse event was reported.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Cough, Diarrhoea, Headache, Hypersomnia
Clinical narrative: This spontaneous case from the regulatory authority was received on 22-Nov-2021 from other non-healthcare professional (consumer) via  (reference number: SEQW21-05566) and concerned a 68-year-old, male patient.  The patient's medical history included rheumatoid arthritis. The patient's concomitant medications included sulfasalazine, metoprolol (metoprolol tartrate) and statin, all for unreported indication.    On 18-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 324423, expiry date 30-Jun-2022.  On 18-Oct-2021, an unknown amount of time after vaccination with Fluad Quadrivalent, the patient experienced extreme nausea, headache, explosive diarrhea, weakness and dry cough. The patient was also sleeping for three days straight. The patient wanted to know if the Fluad Quadrivalent was an MRNA vaccine. The patient stated that this was not the first time he was administered vaccines for 65 years of age and older, but this was first time that he experienced these symptoms.  The outcome of the events was unknown.  The reported did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed extreme nausea, headache, explosive diarrhoea, weakness and dry cough. The patient additionally reported hypersomnia. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.; Sender's Comments: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed extreme nausea, headache, explosive diarrhoea, weakness and dry cough. The patient additionally reported hypersomnia. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Nausea
Clinical narrative: This spontaneous case from the regulatory authority was received on 22-Nov-2021 from other non-healthcare professional (consumer) via  (reference number: SEQW21-05566) and concerned a 68-year-old, male patient.  The patient's medical history included rheumatoid arthritis. The patient's concomitant medications included sulfasalazine, metoprolol (metoprolol tartrate) and statin, all for unreported indication.    On 18-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 324423, expiry date 30-Jun-2022.  On 18-Oct-2021, an unknown amount of time after vaccination with Fluad Quadrivalent, the patient experienced extreme nausea, headache, explosive diarrhea, weakness and dry cough. The patient was also sleeping for three days straight. The patient wanted to know if the Fluad Quadrivalent was an MRNA vaccine. The patient stated that this was not the first time he was administered vaccines for 65 years of age and older, but this was first time that he experienced these symptoms.  The outcome of the events was unknown.  The reported did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed extreme nausea, headache, explosive diarrhoea, weakness and dry cough. The patient additionally reported hypersomnia. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.; Sender's Comments: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient developed extreme nausea, headache, explosive diarrhoea, weakness and dry cough. The patient additionally reported hypersomnia. No alternative aetiology was provided. Based on plausible time relationship, causality is assessed as possibly related.
Age: 64.0
Sex: M
Vaccine: FLUC3
Symptoms: Decreased appetite, Dizziness, Headache
Clinical narrative: Dizziness; Chronic headache; Loss of appetite; This spontaneous case was received on 22-Nov-2021 from Other Non Healthcare Professional via Agency (reference number: SEQW21-05605) and concerned a 65-year-old, male patient.  The patients' medical history and concomitant medication were not reported.  On 15-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular (IM), anatomical location: deltoid; dose: 0.5 ml as reported) for influenza prophylaxis. The batch number reported was 308484 and expiry date was 30-Jun-2022.  On the same day, after vaccination the patient experienced chronic headache, dizziness, and loss of appetite. The patient was taking Excedrin (acetylsalicylic acid, caffeine, paracetamol) as treatment.  At the time of initial reporting the outcome of the events was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 65-year-old male patient experienced chronic headache, dizziness and decreased appetite on the same day after vaccination with Flucelvax Quadrivalent. Causality for the event chronic headache is assessed as not related due to implausible temporal relationship. Based on plausible temporal relationship, causality for the other two events is assessed as possibly related.; Sender's Comments: A 65-year-old male patient experienced chronic headache, dizziness and decreased appetite on the same day after vaccination with Flucelvax Quadrivalent. Causality for the event chronic headache is assessed as not related due to implausible temporal relationship. Based on plausible temporal relationship, causality for the other two events is assessed as possibly related.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Supraventricular tachycardia
Clinical narrative: I have a history of SVT, which occurs on and off throughout the year. About a week after getting my 2nd Moderna shot and again after my booster shot I experienced an unusually high number of SVT episodes that occured daily for almost a month. I normally do not have episodes of this length and frequency.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site pain, Malaise, Myalgia
Clinical narrative: Symptoms began approximately 8 hours after the injection. Injection site pain, fever, chills, vertigo, headache, joint pain, muscle aches. Now 43 hours post injection & still very sick feeling.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccine positive rechallenge, Vertigo
Clinical narrative: Symptoms began approximately 8 hours after the injection. Injection site pain, fever, chills, vertigo, headache, joint pain, muscle aches. Now 43 hours post injection & still very sick feeling.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Postmenopausal haemorrhage
Clinical narrative: Extremely enlarged axillary and mammary glands with postmenopausal bleeding on days 2,3 and 4 following vaccine. Returned to normal by day 6.     Follow up pelvic ultrasound to be done- not yet completed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Influenza virus test negative, Laboratory test normal, Pyrexia
Clinical narrative: saturday 18, woke up very sleepy Sunday 12/19 had fever high as 103.1!  Cough started monday 12/20 Called clinic where i got my shot monday they say they cant help me to go to immediate care, I go to immediate care to test neg for flu, covid and pneumonia only to be told its just a cough. I walked in healthy now so sick.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence
Clinical narrative: saturday 18, woke up very sleepy Sunday 12/19 had fever high as 103.1!  Cough started monday 12/20 Called clinic where i got my shot monday they say they cant help me to go to immediate care, I go to immediate care to test neg for flu, covid and pneumonia only to be told its just a cough. I walked in healthy now so sick.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pain, Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: aches (2nd dose) for a few days/pains (2nd dose) for a few days; sneezing episodes/will sneeze for 5 or 6 times in a row; eyes will water; nose will run; left arm hurt (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches (2nd dose) for a few days/pains (2nd dose) for a few days), SNEEZING (sneezing episodes/will sneeze for 5 or 6 times in a row), LACRIMATION INCREASED (eyes will water), RHINORRHOEA (nose will run) and VACCINATION SITE PAIN (left arm hurt (2nd dose)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A, 041B21A and 045A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Cataract (patient is using eye drops to treat cataract.), Seasonal allergy, Overweight (patient stated that she is in pretty good shape except for being overweight), Depressed mood (sometimes patient gets depressed), Myalgia and Stress (patient gets stressed out occasionally). Concomitant products included FISH OIL, ZINC and VITAMINS NOS for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (aches (2nd dose) for a few days/pains (2nd dose) for a few days), SNEEZING (sneezing episodes/will sneeze for 5 or 6 times in a row), LACRIMATION INCREASED (eyes will water), RHINORRHOEA (nose will run) and VACCINATION SITE PAIN (left arm hurt (2nd dose)). At the time of the report, PAIN (aches (2nd dose) for a few days/pains (2nd dose) for a few days), LACRIMATION INCREASED (eyes will water), RHINORRHOEA (nose will run) and VACCINATION SITE PAIN (left arm hurt (2nd dose)) outcome was unknown and SNEEZING (sneezing episodes/will sneeze for 5 or 6 times in a row) had not resolved.            It was reported that patient had gone to the dentist and teeth were normal. Patient used to take a fluid pill but stopped taking it. Sneezing episodes are not constant but is ongoing Other concomitant medications include eye drops. .No treatment medications were reported.   This case was linked to MOD-2021-420621, MOD-2021-420632 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: body ache; Fever; Cough; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis.   Previously administered products included Covid-19 vaccine (received 2 doses of Covid-19 vaccine on an unknown date). Concurrent medical conditions included cancer.   On an unknown date, the patient received the 1st dose of Shingrix. On 28th September 2021, the patient received COVID-19 VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced general body pain, fever and cough. On an unknown date, the outcome of the general body pain and fever were recovered/resolved and the outcome of the cough was unknown.   It was unknown if the reporter considered the general body pain, fever and cough to be related to Shingrix.  Additional details were provided are as follows: The patient self-reported this case. The patient received a dose of Shingrix in October or November 2021 (exact date was unknown) and less than 3 months after vaccination, had body ache and fever. The patient received a booster of Covid19 vaccine, less than 3 months after vaccination, but she had a cough and was not sure if it was due to Shingrix or if it was COVID related. It was unknown if the reporter considered the general body pain, cough and fever to be related to COVID-19 VACCINE. The reporter consented to contact healthcare professional. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021257814, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021257814:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had first outbreak of shingles, refer case US2021AMR260214). On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine. Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was unknown. The reporter stated that, he/she had the Shingles vaccine and got the shingles terrible. About a year later, after first outbreak, they were there under the skin, not open blisters like before. They had been under the skin and itch like crazy all the time. The reporter stated that it was not fun, and they were not gone. The follow-up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260214:same reporter.