chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: No adverse event, Product preparation error
Clinical narrative: product was reconstituted with 0.7ml of sterile water and administered/no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from an other healthcare professional and physician via call center via Agency (Reference number- 00898208).  This case is linked to case US-SA-2021SA420893(CLUSTER).  This case involves a 2-month-old male patient who received HIB (PRP/T) VACCINE [ActHIB] which was reconstituted with 0.7 ml of sterile water (product preparation error).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  On 14-Dec-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE (lot number: UJ636AAA and expiry date: 26-Feb-2023) via an unknown route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to wrong solution used in drug reconstitution (latency: same day).  It was reported "Caller would like to know if the dose is valid? Caller would also like to know how soon should they repeat the dose?"  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 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: 39.0
Sex: F
Vaccine: TYP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient took Typhim VI/ No AE; Initial and additional information received on 15-Dec-2021 regarding an unsolicited valid non-serious case from a other health care professional via physician.  This case involves a 39 years old female pregnant patient who was exposed to TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported.  The date of Last menstrual period was within weeks, the patient states she had just found this out.  The estimated due date was not reported.  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  The patient previous pregnancy was not reported.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL), YELLOW FEVER VACCINE LIVE (17D-204) (YF-VAX) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO) for prophylactic vaccinations.  On 02-Dec-2021, the patient received a 0.5 ml total dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (frequency: once, strength: standard, lot number: UQA431M and expiry date: 03-Oct-2023) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency: same day).  It was reported "Nurse is looking for information on if there is a registry for pregnant patients that have been administered a dose of YF-VAX, as they state they have had to do that for other vaccines. Caller mentions giving patient Typhim VI during visit."  Product used: Used and Still using product: No.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Blood test abnormal, Feeling hot, Nerve conduction studies normal, Paraesthesia
Clinical narrative: Within 12 hours I started suffering intense tingling sensations down both legs, front and back and into feet. I also feel heat sensation. The tingling has not subsided since and I have suffered these symptoms since with no relief.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: At approximately 11 days post booster vaccination I broke out into itchy hives all over my body and have never had this before. Now 22 days later I still have hives and chronic uticaria all over my body. I am on daily zyrtec. The skin rash and lines on skin show up and then disappear throughout the day in all places including face. I was put on prednisone for 5 days and that did not help at all. Issue persists and was not an issue until after the booster shot. Never had a rash or eczema or hives in my life
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Diplegia, Fall, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: Patient exhibited confusion and had a fever of 100F.   He was unable to put on pajamas and complete nighttime routine of brushing teeth, etc.   Patient sustained a fall, but did not cry out for help -- he was extremely confused.   He stated that he was experiencing extreme muscle weakness and was losing control of his legs.   Once in bed, he asked that we move his right leg onto the bed -- even though the leg was already on the bed;  he had no feeling in that leg.  Patient follows a routine of exercise prescribed by a DPT and normally has excellent muscle control.   This has never happened before, and did not occur with the initial two Pfizer vaccinations.   After a night's rest, symptoms disappeared.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sensory loss
Clinical narrative: Patient exhibited confusion and had a fever of 100F.   He was unable to put on pajamas and complete nighttime routine of brushing teeth, etc.   Patient sustained a fall, but did not cry out for help -- he was extremely confused.   He stated that he was experiencing extreme muscle weakness and was losing control of his legs.   Once in bed, he asked that we move his right leg onto the bed -- even though the leg was already on the bed;  he had no feeling in that leg.  Patient follows a routine of exercise prescribed by a DPT and normally has excellent muscle control.   This has never happened before, and did not occur with the initial two Pfizer vaccinations.   After a night's rest, symptoms disappeared.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Intial reaction was within 2 minutes of shot, with dizziness and sore, itchy throat and difficulty breathing with intense stomach pain. It lasted just under 15 minutes.  The second reaction included a sore, itchy arm, very painful down the arm. Patient had trouble breathing, got fever and chills and nauseated. Dizziness, general fatigue and feeling quick ill. Chest pain was present.  Duration is unknown, as the reaction is ongoing.  Took Tylenol for pain and had no antihistamine that could be safely taken.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Intial reaction was within 2 minutes of shot, with dizziness and sore, itchy throat and difficulty breathing with intense stomach pain. It lasted just under 15 minutes.  The second reaction included a sore, itchy arm, very painful down the arm. Patient had trouble breathing, got fever and chills and nauseated. Dizziness, general fatigue and feeling quick ill. Chest pain was present.  Duration is unknown, as the reaction is ongoing.  Took Tylenol for pain and had no antihistamine that could be safely taken.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Intial reaction was within 2 minutes of shot, with dizziness and sore, itchy throat and difficulty breathing with intense stomach pain. It lasted just under 15 minutes.  The second reaction included a sore, itchy arm, very painful down the arm. Patient had trouble breathing, got fever and chills and nauseated. Dizziness, general fatigue and feeling quick ill. Chest pain was present.  Duration is unknown, as the reaction is ongoing.  Took Tylenol for pain and had no antihistamine that could be safely taken.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: Pediatric patients were administered a dose of Fluzone HD with no reported adverse event; Initial information received on 15-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Regulatory Authority number: 00900069.  This case is linked to case US-SA-2021SA422744(CLUSTER).  This case involves a two years old male patient who was administered 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: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Injection site erythema, Pain, Pain in extremity, Skin warm
Clinical narrative: There was some mild redness and swelling after the first shot. (01/2021).  Just mild soreness after the second shot (02/2021);  The third booster  (12/06/2021).  Lots of redness that spread from the injection spot down to her elbow.  It has subsided in the upper arm area, but now extends down her arm to below the elbow area (12/24/2021).  It is red and her arm seems warm.  She complains that her arm hurts.   No one ever asked if she was taking a blood thinner.  All three doses were the Moderna EUA.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling
Clinical narrative: There was some mild redness and swelling after the first shot. (01/2021).  Just mild soreness after the second shot (02/2021);  The third booster  (12/06/2021).  Lots of redness that spread from the injection spot down to her elbow.  It has subsided in the upper arm area, but now extends down her arm to below the elbow area (12/24/2021).  It is red and her arm seems warm.  She complains that her arm hurts.   No one ever asked if she was taking a blood thinner.  All three doses were the Moderna EUA.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Injection site pain, Nausea
Clinical narrative: Started getting chills around 8:00pm. Some nausea and injection site soreness also. Took temp around 9:30 and it was 102. Took temp about 15 min later and temp was up to 106. Took Tylenol and temp was back to normal about 2 hours later.
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: Extreme fatigue, body pain, chills and fever, sweating, headache, swollen lymph nodes in armpits, elbow, and groin that are worse on left side where injection was given
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Extreme fatigue, body pain, chills and fever, sweating, headache, swollen lymph nodes in armpits, elbow, and groin that are worse on left side where injection was given
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Antithrombin III, Chest X-ray, Coagulation factor V level normal
Clinical narrative: I received the flu vaccination at the respective location, on the date and hour listed above. I was with my roommate, friend, and fellow pharmacy student. I had the typical side effects from the vaccine including sore arm, mild fatigue in the couple of following days. Roughly 5-7 days after the vaccination, I began feeling slightly short of breath which would progress to moderate shortness of breath until date of hospitalization. I also, began to have palpitations and heart racing which would not go away. These symptoms went on for roughly 1 week before I sought urgent care which then referred me to the hospital. After a series of tests, imaging, etc. I was found to have multiple, small blood clots (pulmonary embolism) in my right lung. My hypercoagulable workup was negative, as well as US doppler for any evidence of simultaneous DVT. I was treated with LMWH therapy (lovenox) while in the hospital where I was eventually transitioned to apixaban. I was released a few days later. I was on no other medications and had no other concurrent illnesses at time of hospitalization. I was physically active and working on pharmacy rotations until that time. This is the first of two pulmonary embolisms I would be hospitalized for in two consecutive years. With the second occurring almost one year later in October 2018, also coincidentally after receiving the same manufacturer FluArix vaccine in the same two week (following administration) time frame as this first thromboembolic event. This will be in a separate reported entry on VAERS. During the second event, I was anticoagulated on Apixaban 2.5mg daily.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: I received the flu vaccination at the respective location, on the date and hour listed above. I was with my roommate, friend, and fellow pharmacy student. I had the typical side effects from the vaccine including sore arm, mild fatigue in the couple of following days. Roughly 5-7 days after the vaccination, I began feeling slightly short of breath which would progress to moderate shortness of breath until date of hospitalization. I also, began to have palpitations and heart racing which would not go away. These symptoms went on for roughly 1 week before I sought urgent care which then referred me to the hospital. After a series of tests, imaging, etc. I was found to have multiple, small blood clots (pulmonary embolism) in my right lung. My hypercoagulable workup was negative, as well as US doppler for any evidence of simultaneous DVT. I was treated with LMWH therapy (lovenox) while in the hospital where I was eventually transitioned to apixaban. I was released a few days later. I was on no other medications and had no other concurrent illnesses at time of hospitalization. I was physically active and working on pharmacy rotations until that time. This is the first of two pulmonary embolisms I would be hospitalized for in two consecutive years. With the second occurring almost one year later in October 2018, also coincidentally after receiving the same manufacturer FluArix vaccine in the same two week (following administration) time frame as this first thromboembolic event. This will be in a separate reported entry on VAERS. During the second event, I was anticoagulated on Apixaban 2.5mg daily.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: International normalised ratio, Metabolic function test, Pain in extremity, Palpitations, Protein C
Clinical narrative: I received the flu vaccination at the respective location, on the date and hour listed above. I was with my roommate, friend, and fellow pharmacy student. I had the typical side effects from the vaccine including sore arm, mild fatigue in the couple of following days. Roughly 5-7 days after the vaccination, I began feeling slightly short of breath which would progress to moderate shortness of breath until date of hospitalization. I also, began to have palpitations and heart racing which would not go away. These symptoms went on for roughly 1 week before I sought urgent care which then referred me to the hospital. After a series of tests, imaging, etc. I was found to have multiple, small blood clots (pulmonary embolism) in my right lung. My hypercoagulable workup was negative, as well as US doppler for any evidence of simultaneous DVT. I was treated with LMWH therapy (lovenox) while in the hospital where I was eventually transitioned to apixaban. I was released a few days later. I was on no other medications and had no other concurrent illnesses at time of hospitalization. I was physically active and working on pharmacy rotations until that time. This is the first of two pulmonary embolisms I would be hospitalized for in two consecutive years. With the second occurring almost one year later in October 2018, also coincidentally after receiving the same manufacturer FluArix vaccine in the same two week (following administration) time frame as this first thromboembolic event. This will be in a separate reported entry on VAERS. During the second event, I was anticoagulated on Apixaban 2.5mg daily.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Protein S normal, Prothrombin time, Prothrombin time normal, Pulmonary embolism, Ultrasound Doppler normal
Clinical narrative: I received the flu vaccination at the respective location, on the date and hour listed above. I was with my roommate, friend, and fellow pharmacy student. I had the typical side effects from the vaccine including sore arm, mild fatigue in the couple of following days. Roughly 5-7 days after the vaccination, I began feeling slightly short of breath which would progress to moderate shortness of breath until date of hospitalization. I also, began to have palpitations and heart racing which would not go away. These symptoms went on for roughly 1 week before I sought urgent care which then referred me to the hospital. After a series of tests, imaging, etc. I was found to have multiple, small blood clots (pulmonary embolism) in my right lung. My hypercoagulable workup was negative, as well as US doppler for any evidence of simultaneous DVT. I was treated with LMWH therapy (lovenox) while in the hospital where I was eventually transitioned to apixaban. I was released a few days later. I was on no other medications and had no other concurrent illnesses at time of hospitalization. I was physically active and working on pharmacy rotations until that time. This is the first of two pulmonary embolisms I would be hospitalized for in two consecutive years. With the second occurring almost one year later in October 2018, also coincidentally after receiving the same manufacturer FluArix vaccine in the same two week (following administration) time frame as this first thromboembolic event. This will be in a separate reported entry on VAERS. During the second event, I was anticoagulated on Apixaban 2.5mg daily.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heavy menstrual bleeding
Clinical narrative: Still very heavily bleeding and trying to figure out what it is worth family doctor
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Chills, Heavy menstrual bleeding, Migraine, Muscle twitching
Clinical narrative: Left Eye twitching chronic since day or vaccine Occasional left lip twitching  this issue continues currently   First week after 2nd dose I had a severe migraine for 7 days, chills and body aches, and a very early menstral cycle with black clotting and heavy flow (I haven?t had a bloody cycle in over 6 years since my ablation, this we the worst cycle with bleeding I?ve experienced - similar to having a miscarriage with pain and bleeding)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Polymenorrhoea
Clinical narrative: Left Eye twitching chronic since day or vaccine Occasional left lip twitching  this issue continues currently   First week after 2nd dose I had a severe migraine for 7 days, chills and body aches, and a very early menstral cycle with black clotting and heavy flow (I haven?t had a bloody cycle in over 6 years since my ablation, this we the worst cycle with bleeding I?ve experienced - similar to having a miscarriage with pain and bleeding)
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Vaccine positive rechallenge
Clinical narrative: Dark brown pee. When drinking lots of water, pee turns clearer, but still has brown color. Not yellow.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over my body
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Gingival swelling, Headache, Lymphadenopathy, Oral pain
Clinical narrative: I had Moderna for both of my Covid vaccine shots; both times had moderate side effects (nausea, aches, chills, 'Covid arm rash') for about 12 hrs. It also affected my menstrual cycle for over 6 months. This, however, is in reference to the Pfizer booster I received. Side effects began 12 hrs. after shot and initially included severe headache, body aches and then swollen lymph node under arm that grew from golf ball size to larger. The weird symptom that I haven't seen listed in the side effects is that one side of my mouth (the side that I received the shot on) is extremely sore, both bottom and top gums/teeth are sore and swollen.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Toothache
Clinical narrative: I had Moderna for both of my Covid vaccine shots; both times had moderate side effects (nausea, aches, chills, 'Covid arm rash') for about 12 hrs. It also affected my menstrual cycle for over 6 months. This, however, is in reference to the Pfizer booster I received. Side effects began 12 hrs. after shot and initially included severe headache, body aches and then swollen lymph node under arm that grew from golf ball size to larger. The weird symptom that I haven't seen listed in the side effects is that one side of my mouth (the side that I received the shot on) is extremely sore, both bottom and top gums/teeth are sore and swollen.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Booster (1/2 dose). Seemed ok next day, but by that night pain in area of kidney. Doesn't feel likey muscle. Thinking maybe kidney. Very painful since (now 4 days). Only on the(my) left side.
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered only the liquid component (DTaP-IPV) component of the Pentacel vaccine with no reported adverse event; Initial information received on 16-Dec-2021 regarding an unsolicited valid  non-serious case received from a physician via Agency number: 00901359.  This case involves a four months old female patient who experienced patient was administered only PREVNAR and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE.  On 16-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number:  UJ551AAA (carton) and expiry date: 05-AUG-2022 via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date,  she also received a dose of the same vaccine  lot number: U6990AB and expiry date: 05-AUG-2022 via unknown route in unknown administration site and a dose of suspect PREVNAR not produced by Sanofi Pasteur lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to inappropriate reconstitution technique (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: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Bell's Palsy. Paralysis to left side of face, lip, and eye-lid on left eye
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, C-reactive protein increased, COVID-19, Chest pain, Cough
Clinical narrative: Pt. presented to the emergency department with shortness of breath, chest pain and cough. He was hypoxic in the 80's on room air and was placed on 02. Bloodwork showed pt had a positive d-dimer and a covid-19 pcr test showed positive for covid. pt had booster dose 9 days ago. pt is currently admitted in hospital
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin D dimer, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Pt. presented to the emergency department with shortness of breath, chest pain and cough. He was hypoxic in the 80's on room air and was placed on 02. Bloodwork showed pt had a positive d-dimer and a covid-19 pcr test showed positive for covid. pt had booster dose 9 days ago. pt is currently admitted in hospital
Sex: M
Vaccine: DTAP, DTAPIPVHIB
Symptoms: Interchange of vaccine products
Clinical narrative: first dose was Pentacel, 2nd dose Daptacel then 3rd dose was Pentacel then 4th dose was Daptacel then came back in and gave another dose Pentacel with no AE; Initial information received on 16-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00901547).  This case involves a four-year-old male patient who had first dose was pentacel, 2nd dose daptacel then 3rd dose was pentacel then 4th dose was daptacel then came back in and gave another dose pentacel of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (interchange of vaccine products).  The patient past medical history, medical treatment, vaccination and family history were not provided.   On 09-Dec-2021, the patient received a fifth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ570AA and expiry date: not reported) via intramuscular route in right leg for prophylactic vaccination and also received first and third dose of same vaccine via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a second and fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to interchange of vaccine products.  It was reported "the office gave a child that is 4 years and 2 months this series of vaccines: first dose was Pentacel, 2nd dose Daptacel then 3rd dose was Pentacel then 4th dose was Daptacel then came back in and gave another dose Pentacel. Is this OK?".  At the time of report no adverse event was reported.
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Medication error
Clinical narrative: patient already received a flu vaccine before administering the second dose with no AE; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (Reference number- 00903066).  This case involves a 83-year-old female patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (extra dose administered).  The patient past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for prophylactic vaccination.  On 08-Oct-2021, the patient received a 0.7 ml first dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and on 18-Nov-2021 the patient received a 0.7 ml second dose of the same vaccine (batch number and expiry date: not reported) (Frequency once) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on same day).  It was reported "patient received 2 doses of FLUZONE HIGH DOSE; states the patient received 2 doses because the nurse did not check to see if the patient already received a flu vaccine before administering the second dose. Medical assistant asks if there could be any effects from this".  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, Product preparation issue
Clinical narrative: the consumer on receiving the liquid DTap-IPV portion and not the Hib  of PENTACEL/no AE; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Agency (Reference number- 00903124).  This case involves a 2-month-old (unknown gender) patient who received the liquid DTAP-IPV portion and not the HiB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product preparation issue).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  It was reported "A Pharmacist also wanting to know if the patient could possibly get another dose of PENTACEL or does Sanofi make a stand alone Hib vaccine."  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: This case involves a 17 years old male patient who received a dose of flublok, with no reported adverse event while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received unknown concomitant medication of Pfizer. On 17-Dec-2021, the patient received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, once with lot UJ723AA via intramuscular route in the right deltoid as prophylactic immunization. On 17-DEC-2021 the patient developed a non-serious "17 yo paitent received a dose of flublok, with no reported adverse event" (off label use) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable. It was not reported if the patient received a corrective treatment for the event (17 yo paitent received a dose of FLUBLOK, with no reported adverse event). At time of reporting, the outcome was Unknown for the event 17 yo paitent received a dose of flublok, with no reported adverse event.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: dose of ADACEL that was administered had expired on 26SEP2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00905803) and transmitted to Sanofi on 20-Dec-2021.  This case involves a 47-year-old male patient who administered dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] expired on 26sep2021 (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On 16-Dec-2021, the patient received 0.5ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5667AA and expiry date: 26-Sep-2021) (Frequency = once) (Strength = standard) via intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was reported "Medical assistant asks if there is any information about efficacy of a vaccine that is administered after expiration".  This case was an actual medication error due to expired vaccine used (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: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: This case involves an unknown demographic patient (unknown age and unknown gender) who received only the liquid portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was administered (product preparation issue).  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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to product preparation issue (latency: same day).  At time of reporting, no adverse event.  There will be no information available on the batch number for this case.  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: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: she is pregnant and just received the FLUZONE QIV; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via Regulatory Authority (Reference number- 00906858).  This case involves a 19-years-old female patient was pregnant and just received after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  Patient was exposed to the vaccine at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 21-Dec-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (frequency: once, strength: standard, lot number and expiry date: not reported) via intramuscular route in the right deltoid for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant after received FLUZONE QUADRIVALENT vaccine.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: administered 2 expired doses of IMOVAX to a patient; Initial information received on 21-Dec-2021 regarding an unsolicited non-valid non-serious case from other health professional.  This case involves a male (unknown age) patient who was vaccinated with the  two expired dose of suspect RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 10-Dec-2021, the patient received a dose of suspect RABIES (HDC) VACCINE (lot T1B492M and expiry date: 07-Dec-2021) (Frequency: Once) via intramuscular route in arm site for prophylactic vaccination.  On 14-Dec-2021, he also received a dose of the same vaccine (lot T1B492M and expiry date: 07-Dec-2021) (Frequency: Once) via intramuscular route in arm site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose decreased, Blood pressure decreased, Dehydration, Dizziness
Clinical narrative: Around 4am the morning after I received the vaccine I began experiencing severe muscle and joint pain. I had a fever of about 100F. While standing up to take my temperature and take some Tylenol I began to feel dizzy and fainted. At around 5am I became extremely nauseous and vomited several times. After this I attempted to use the toilet and fainted, falling off the toilet. After I regained consciousness I called for help but was unable to stand up without becoming dizzy or fainting. I attempted to drink some water but was unable to keep anything down. I became dehydrated and both my blood sugar and blood pressure dropped. Around 8am I had thrown up so much that I was dry heaving. Even though there was nothing left for me to throw up I continued to dry heave and was unable to keep any water or medication down. At around 9am my roommate drove me to the student health clinic where I was treated by the doctor with an injection of Zofran and an IV of saline, glucose, and water. I was also given a prescription of Zofran tablets to take home with me. After a few hours I was sent home to rest. I slowly began drinking water but was unable to eat anything except a few saltine crackers later that night. I spent much of the recovery time sleeping and attempting to treat my fever with Tylenol, water, and cold compress. My fever lasted another 24-36hrs and I was unable to complete any daily tasks such as bathing or dressing etc.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Loss of personal independence in daily activities, Myalgia, Nausea
Clinical narrative: Around 4am the morning after I received the vaccine I began experiencing severe muscle and joint pain. I had a fever of about 100F. While standing up to take my temperature and take some Tylenol I began to feel dizzy and fainted. At around 5am I became extremely nauseous and vomited several times. After this I attempted to use the toilet and fainted, falling off the toilet. After I regained consciousness I called for help but was unable to stand up without becoming dizzy or fainting. I attempted to drink some water but was unable to keep anything down. I became dehydrated and both my blood sugar and blood pressure dropped. Around 8am I had thrown up so much that I was dry heaving. Even though there was nothing left for me to throw up I continued to dry heave and was unable to keep any water or medication down. At around 9am my roommate drove me to the student health clinic where I was treated by the doctor with an injection of Zofran and an IV of saline, glucose, and water. I was also given a prescription of Zofran tablets to take home with me. After a few hours I was sent home to rest. I slowly began drinking water but was unable to eat anything except a few saltine crackers later that night. I spent much of the recovery time sleeping and attempting to treat my fever with Tylenol, water, and cold compress. My fever lasted another 24-36hrs and I was unable to complete any daily tasks such as bathing or dressing etc.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Syncope, Vomiting
Clinical narrative: Around 4am the morning after I received the vaccine I began experiencing severe muscle and joint pain. I had a fever of about 100F. While standing up to take my temperature and take some Tylenol I began to feel dizzy and fainted. At around 5am I became extremely nauseous and vomited several times. After this I attempted to use the toilet and fainted, falling off the toilet. After I regained consciousness I called for help but was unable to stand up without becoming dizzy or fainting. I attempted to drink some water but was unable to keep anything down. I became dehydrated and both my blood sugar and blood pressure dropped. Around 8am I had thrown up so much that I was dry heaving. Even though there was nothing left for me to throw up I continued to dry heave and was unable to keep any water or medication down. At around 9am my roommate drove me to the student health clinic where I was treated by the doctor with an injection of Zofran and an IV of saline, glucose, and water. I was also given a prescription of Zofran tablets to take home with me. After a few hours I was sent home to rest. I slowly began drinking water but was unable to eat anything except a few saltine crackers later that night. I spent much of the recovery time sleeping and attempting to treat my fever with Tylenol, water, and cold compress. My fever lasted another 24-36hrs and I was unable to complete any daily tasks such as bathing or dressing etc.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure, Cardiac failure congestive, Cardiac valve disease, Cardiac valve prosthesis user, Carditis
Clinical narrative: November my mom began having  problems with fatigue, shortness of breath and chest pain. She went to ER and had elevated troponins and more cardiac work up revealed valvular heart failure. She required a mechanical valve in December, and then had a stroke and brain bleed. She is in a medical center. She likely had myocarditits causing heart inflammation and heart  valve  failure that caused her to go into congestive heart failure.
Sex: U
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Chest pain, Computerised tomogram thorax, Dyspnoea
Clinical narrative: November my mom began having  problems with fatigue, shortness of breath and chest pain. She went to ER and had elevated troponins and more cardiac work up revealed valvular heart failure. She required a mechanical valve in December, and then had a stroke and brain bleed. She is in a medical center. She likely had myocarditits causing heart inflammation and heart  valve  failure that caused her to go into congestive heart failure.
Sex: U
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Fatigue, Intensive care, Myocarditis, Troponin increased
Clinical narrative: November my mom began having  problems with fatigue, shortness of breath and chest pain. She went to ER and had elevated troponins and more cardiac work up revealed valvular heart failure. She required a mechanical valve in December, and then had a stroke and brain bleed. She is in a medical center. She likely had myocarditits causing heart inflammation and heart  valve  failure that caused her to go into congestive heart failure.
Age: 24.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Chills, Condition aggravated, Fatigue, Headache, Nausea
Clinical narrative: - soreness of arm & tiredness ~6:30pm 12/23/21 -chills ~9:00pm -11pm ish (fell asleep) 12/23/21 ; 11:00 am -11:45 am 12/24/21 -headache & nausea 11:20am 12/24/21 - 5:00am 12/25/21
Age: 24.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity
Clinical narrative: - soreness of arm & tiredness ~6:30pm 12/23/21 -chills ~9:00pm -11pm ish (fell asleep) 12/23/21 ; 11:00 am -11:45 am 12/24/21 -headache & nausea 11:20am 12/24/21 - 5:00am 12/25/21
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Tinnitus
Clinical narrative: constant ringing in the Right Ear, Stabbing pain in the neck Right side
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Angiogram pulmonary abnormal, Anticoagulant therapy, Atelectasis, Computerised tomogram abdomen
Clinical narrative: Pulmonary Embolism  Symptoms: Shortness of breath when climbing stairs.  Pulse Oxygen level 85% prompted visit to Emergency room.  Symptoms thought to be COVID but tests during ER visit showed nagative COVID result but Pulmonary Embolism in both lungs found.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Echocardiogram abnormal, Electrocardiogram ST-T segment abnormal, Hot flush, Hypoaesthesia
Clinical narrative: Pulmonary Embolism  Symptoms: Shortness of breath when climbing stairs.  Pulse Oxygen level 85% prompted visit to Emergency room.  Symptoms thought to be COVID but tests during ER visit showed nagative COVID result but Pulmonary Embolism in both lungs found.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Intensive care, Pulmonary arterial pressure increased, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: Pulmonary Embolism  Symptoms: Shortness of breath when climbing stairs.  Pulse Oxygen level 85% prompted visit to Emergency room.  Symptoms thought to be COVID but tests during ER visit showed nagative COVID result but Pulmonary Embolism in both lungs found.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombectomy, Ultrasound Doppler normal
Clinical narrative: Pulmonary Embolism  Symptoms: Shortness of breath when climbing stairs.  Pulse Oxygen level 85% prompted visit to Emergency room.  Symptoms thought to be COVID but tests during ER visit showed nagative COVID result but Pulmonary Embolism in both lungs found.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Dizziness, Pyrexia
Clinical narrative: Joint soreness, slight fever, light headed, chills at times, and cough