chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Somnolence
Clinical narrative: Migrain on day 1 &2 after vaccine; Lightheaded and slight dizziness on day 1; Drowsiness on Day 1 after; This is a spontaneous report from contactable Other Health Professional, the patient.  A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 16Feb2021 at 12:45 (at the age of 53-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was reported as "none." The patient has no allergies. Historical vaccinations include the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 28Jan2021 at 09:00 in the right arm. The vaccine was administered to the patient at a workplace clinic. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "none." The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she experienced a migraine beginning at 3:30 AM on 17Feb2021 (reported as "on Day 1 and 2 after vaccine")  Additionally, she experienced being lightheaded and having slight dizziness and drowsiness beginning at 3:30 AM on 17Feb2021 (reported as "on Day 1"). The patient did not receive any treatment for the events. The clinical outcomes of the events migraine, dizziness and drowsiness were reported as recovered (date not specified). It was also reported that since the vaccination, the patient had not been tested for COVID-19.   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: Lymphadenopathy, Swelling face
Clinical narrative: swollen lymph nodes; facial swelling; This is a spontaneous report from a contactable consumer (patient). This 53-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 18Feb2021 at 14:00 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 immunization. The patient had no medical history. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine, the patient was no diagnosed with COVID-19. Concomitant medications included cetirizine (ZYRTEC) from an unspecified date for an unspecified indication. The patient previously received naproxen from an unspecified date for an unspecified indication and experienced allergy. The patient also had allergies to beeswax, honey, chemical aerosol sprays, and perfumes. On 18Feb2021 at 16:45, approximately three hours after the vaccine, the patient experienced facial swelling and swollen lymph nodes. The events were reported as non-serious. The patient went to the emergency room/department of urgent care as a result of the event and received treatment with high dose diphenhydramine (BENADRYL). The outcome of facial swelling and swollen lymph nodes was recovering. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Severe chills; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). This 84-year-old male patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via an unspecified route of administration on 16Feb2021 at 13:00 (at the age of 84-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient had not received any other vaccines within 4 weeks prior to the vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccine. Concomitant medications included cetirizine hydrochloride (LITTLE), aspirin, tamsulosin, and simvastatin from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN5318) on 26Jan2021 at 12:00 as a single dose in the left arm for COVID-19 immunization. The patient also previously received codeine, gabapentin, and penicillin from unknown dates for unknown indications and experienced allergy. On 17Feb2021 at 04:00 (also reported as 14 hours after the second dose of BNT162B2), the patient experienced severe chills lasting about 10 hours and extreme fatigue which lasted until about 48 hours after the second dose of BNT162B2. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of severe chills and extreme fatigue were recovered. It was also reported that since the vaccine the patient had not been tested for COVID-19.    No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Several episodes of mild transient and migratory urticaric skin hives; This is a spontaneous report from a contactable consumer (patient). This 69-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN9581) via an unspecified route of administration in the left arm on 03Feb2021 at 14:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, no concomitant medications and was not diagnosed with COVID-19 prior to vaccination. The patient previously took ibuprofen from an unknown date for an unknown indication and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported he had several episodes of mild transient and migratory urticaric skin hives starting on 04Feb2021 at 07:00, which he was not certain were related to the vaccine. He reported the first episode occurred 17 hours after vaccination, located over right knee and lower leg and lasted 2 hours. The second episode occurred 36 hours after vaccination located on left forearm and lasted one hour. The third episode occurred 48 hours after vaccination located over right knee and lasted 2 hours. The patient experienced no other symptoms and reported that all resolved spontaneously. The event was reported as non-serious and did not require hospitalization. No treatment was provided for the event. The clinical outcome of several episodes of mild transient and migratory urticaric skin hives was recovered in Feb2021. It was also reported that since vaccination the patient had not been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: orangish brown lesions appeared on several places on my body - left wrist, left inner thigh, middle lower back, middle back. They are slightly raised and not painful to the touch; This is a spontaneous report from a contactable consumer, patient.  A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) administered in left arm via an unspecified route of administration on 19Feb2021 at 12:15 PM (at the age of 33 years-old)  as single dose for COVID-19 immunisation.  Medical history included generalised anxiety disorder from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) taken within two weeks of vaccine for an unspecified indication; minerals nos/vitamins nos (PRENATAL VITAMINS) taken within two weeks of vaccine for an unspecified indication.  The patient previously received the first dose of BNT162b2 on 29Jan2021 at 12:15 PM (Lot Number: EL9261; at age of 33-years-old) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported, on 20Feb2021 at 8:00AM, about 18 hours after getting the vaccine, orangish brown lesions appeared on several places on her body - left wrist, left inner thigh, middle lower back, middle back. They are slightly raised and not painful to the touch. No treatment was provided for the events. The patient had not recovered from the events, orangish brown lesions appeared on several places on my body - left wrist, left inner thigh, middle lower back, middle back. They are slightly raised and not painful to the touch.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rash papular
Clinical narrative: Red bumps now in groups of 2-3 on my chest, back, arms, and legs. More accumulation 8 days later.; This is a spontaneous report from a contactable consumer, the patient.   A 65-year-old male patient received the second dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, in the left arm on 12Feb2021 (at the age of 65-years-old) for COVID19-immunization.  The patient medical history included allergies to sulfa (sulfonamide antibiotics), and levofloxacin.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications included: ibuprofen (ADVIL), paracetamol (TYLENOL), multivitamin, turmeric, and krill oil.  The patient previously received the first dose of BNT162b2 on 22Jan2021 (Lot Number: Unknown; at the age of 65-year-old) for COVID-19 immunisation.  The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 13Feb2021, the patient experienced red bumps now in groups of 2-3 on my chest, back, arms, and legs. more accumulation 8 days later. No treatment was received for the adverse event. The patient had not recovered from the event, red bumps now in groups of 2-3 on my chest, back, arms, and legs. more accumulation 8 days later.
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy
Clinical narrative: broken blood vessel; This is a spontaneous report from a sponsored program,  from a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 12Feb2021 as a single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient received her first dose of the vaccine on 12Feb2021 and when it was given to her the healthcare provider said that she had a broken blood vessel, the patient was wondering if she was vaccinated properly. The clinical outcome of the broken blood vessel was unknown.    The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Tooth disorder
Clinical narrative: a root canal done tomorrow.; This is a spontaneous report from a contactable male consumer (the patient) via the  sponsored program.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unspecified date for COVID-19 vaccination. Medical history was not reported. Concomitant medications not were reported. The patient stated that he is supposed to get his second dose on Friday but is having a root canal done tomorrow. Clarified if the root canal was scheduled prior to the first dose and he said they haven't scheduled it yet, they want to schedule for tomorrow, but are waiting to see if it would mess up his second dose of the COVID vaccine. The clinical outcome of dental disorder was unknown.     Information on the lot batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Fatigue, Pain in extremity, Pruritus
Clinical narrative: Slight pain in left arm of injection site/Sore; Tiny pimple-like bumps on entire scalp, very itchy; Tiny pimple-like bumps on entire scalp, very itchy; Fatigue; This is a spontaneous report from a contactable (consumer). This non-pregnant 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 12Feb2021 at 00:45 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included allergies to penicillin and derivatives from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no concomitant medications. The patient previously received the first dose of BNT162B2 (lot number EL9262) in the left arm on 21Jan2021 at 10:15 (at the age of 75-years-old) as a single dose for COVID-19 immunization and experienced slight pain in left arm of injection site/sore. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient reported that on 16Feb2021 at 16:00 she experienced slight pain in left arm of injection site, sore for 24hrs; tiny pimple-like bumps on entire scalp, further reported as very itchy; and fatigue which lasted 24hrs. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of slight pain in left arm of injection site/sore, tiny pimple-like bumps on entire scalp, very itchy, and fatigue were unknown. It was also reported that since vaccination the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat tightness
Clinical narrative: tightness in my throat; rash on my left forearm and left side continuing across my stomach; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 at 09:30 as a single dose for COVID-19 immunization. Medical history was not reported. It was reported that the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") included lisinopril taken for an unspecified indication on an unspecified date and unspecified if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 at 13:00 the patient experienced tightness in my throat and rash on my left forearm and left side continuing across my stomach. The patient reported that she experienced side effects that included tightness in her throat and a rash on her eft forearm and left side continuing across my stomach. She stated that rash was listed under "allergic reaction", so she was not sure whether she should receive the second dose. She asked if we could advise. The patient reported that she did not receive treatment for the adverse events. The clinical outcomes of the events experienced tightness in my throat and rash on my left forearm and left side continuing across my stomach were both not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced slight headache on an unspecified date with outcome of recovered.    Information about Lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Severe chills; waves of chills, shaking; Severe chills; waves of chills, shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; I am feeling so weak; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 14:30 (lot number was unknown as patient card was in the bedroom, he couldn't go, he was feeling so weak so he was not going up to bring that) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in right shoulder on an unspecified date for COVID-19 immunization and experienced little soreness in shoulder. The patient experienced severe chills, waves of chills, shaking; headache; feeling tired; nausea; feeling unwell; injection site pain; was feeling so weak; all on 18Feb2021. Event details: No treatment received. But patient visited hospital on18Feb2021 because he did have severe chills accompanied with headache, feeling tired, some nausea, there was an unwell feeling, little bit of fever was not actual fever but the injection site pain. There were waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 (19Feb2021) after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he did have injection site pain in shoulder but that's not a big deal. The patient stated there are various different variants of this Covid virus, he asked if this vaccine it is been effective against every other. Patient weight was reported as about 178. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293277 similar report from same reporter
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tremor, Vaccination site pain, Weight
Clinical narrative: Severe chills; waves of chills, shaking; Severe chills; waves of chills, shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; I am feeling so weak; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 14:30 (lot number was unknown as patient card was in the bedroom, he couldn't go, he was feeling so weak so he was not going up to bring that) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in right shoulder on an unspecified date for COVID-19 immunization and experienced little soreness in shoulder. The patient experienced severe chills, waves of chills, shaking; headache; feeling tired; nausea; feeling unwell; injection site pain; was feeling so weak; all on 18Feb2021. Event details: No treatment received. But patient visited hospital on18Feb2021 because he did have severe chills accompanied with headache, feeling tired, some nausea, there was an unwell feeling, little bit of fever was not actual fever but the injection site pain. There were waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 (19Feb2021) after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he did have injection site pain in shoulder but that's not a big deal. The patient stated there are various different variants of this Covid virus, he asked if this vaccine it is been effective against every other. Patient weight was reported as about 178. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293277 similar report from same reporter
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Severe chills; waves of chills, shaking; Severe chills; waves of chills, shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; I am feeling so weak; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 14:30 (lot number was unknown as patient card was in the bedroom, he couldn't go, he was feeling so weak so he was not going up to bring that) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in right shoulder on an unspecified date for COVID-19 immunization and experienced little soreness in shoulder. The patient experienced severe chills, waves of chills, shaking; headache; feeling tired; nausea; feeling unwell; injection site pain; was feeling so weak; all on 18Feb2021. Event details: No treatment received. But patient visited hospital on18Feb2021 because he did have severe chills accompanied with headache, feeling tired, some nausea, there was an unwell feeling, little bit of fever was not actual fever but the injection site pain. There were waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 (19Feb2021) after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he did have injection site pain in shoulder but that's not a big deal. The patient stated there are various different variants of this Covid virus, he asked if this vaccine it is been effective against every other. Patient weight was reported as about 178. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293277 similar report from same reporter
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Tremor, Vaccination site pain
Clinical narrative: Severe chills; waves of chills, shaking; Severe chills; waves of chills, shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; I am feeling so weak; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Feb2021 14:30 (lot number was unknown as patient card was in the bedroom, he couldn't go, he was feeling so weak so he was not going up to bring that) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in right shoulder on an unspecified date for COVID-19 immunization and experienced little soreness in shoulder. The patient experienced severe chills, waves of chills, shaking; headache; feeling tired; nausea; feeling unwell; injection site pain; was feeling so weak; all on 18Feb2021. Event details: No treatment received. But patient visited hospital on18Feb2021 because he did have severe chills accompanied with headache, feeling tired, some nausea, there was an unwell feeling, little bit of fever was not actual fever but the injection site pain. There were waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 (19Feb2021) after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he did have injection site pain in shoulder but that's not a big deal. The patient stated there are various different variants of this Covid virus, he asked if this vaccine it is been effective against every other. Patient weight was reported as about 178. The outcome of the events was recovering.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293277 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; positive COVID-19 test; cold; This is a spontaneous report from A contactable consumer reported for himself that a 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 16Jan2021 and second dose on 04Feb2021, both via unspecified route of administration at single dose for COVID-19 immunization. Medical history included he was a smoker. Concomitant medications were not reported. Patient stated that prior to him getting his vaccine his wife tested positive, he tested negative so he went and got the 1st dose on 16Jan2021 and then on 04Feb2021 he got the 2nd dose. With the 1st dose he had hard side effects and then after the 2nd dose he got a cold in Feb2021, but then on 09Feb2021 he tested positive for COVID. He said after he tested positive he had nothing from the actual COVID so he wanted to call and say the vaccine works. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable consumer (patient). This female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date and unspecified time after receiving the first dose, the patient tested positive for COVID-19. The clinical outcome of testing positive for COVID-19 was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot formed in left arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient, not pregnant at time of vaccination, received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198), via an unspecified route of administration, on right Arm on 27Feb2021 0100, SINGLE DOSE for covid-19 immunisation. Medical history included Diabetic, High blood pressure, both from an unknown date. Concomitant medications included glipizide, metformin, fenofibrate. The patient previously took sumatriptan succinate (IMITREX) and experienced drug allergy. After vaccination 6 days later (05Mar2021) a blood clot formed in left arm. Shot was given in right arm. Hospitalization followed and now on blood thinners. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days. The outcome of the event was not recovered. Eliquis was given as treatment for the event. No covid prior vaccination. Not covid tested post vaccination.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: 3 days after 1st shot, I suffered a stroke; This is a spontaneous report from a contactable consumer (patient himself). This 77-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 02Feb2021 at 09:30 AM (at the age of 77-year old) at single dose for COVID-19 immunization. Relevant medical history included type 2 diabetes, kidney disease, heart failure, cutaneous T-cell lymphoma (CTCL) and allergy to lisinopril. Concomitant medications included atorvastatin (LIPITOR), metformin, losartan, potassium and acetylsalicylic acid (ASPIRIN). On 05Feb2021 at 01:30 PM, after 3 days from the first dose of vaccine, the patient experienced a stroke that resulted in hospitalization for 4 days. Treatment included CAT scan, MRI (with unknown results) and intravenous blood thinner. The outcome of the event was recovering. The event was serious due to hospitalization and life threatening illness (immediate risk of death from the event).  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: left calf pain/ significant DVT in left quad; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264, unknown expiration), via an unspecified route of administration in left arm on 18Feb2021 as single dose for COVID-19 immunisation.  Medical history included rheumatoid arthritis and Leiden factor 5. Concomitant medications included etanercept (ENBREL); gabapentin; meloxicam; and vitamin D3.  The patient previously took Keflex and experienced allergies. The patient also received first dose of BNT162B2 (Lot number: GL9261, unknown expiration) in left arm on 28Jan2021 at 01:00PM for COVID-19 immunization. On the night of second dose on 18Feb2021 at 08:00 PM (20:00), the patient experienced left calf pain. Then quad pain started 2 weeks later along with the return of calf pain. The patient was diagnosed on 15Mar2021 with a significant DVT in left quad. The patient did not receive other vaccine in four weeks.  The patient had no COVID prior to vaccination and not tested for COVID post vaccination. The event significant DVT in left quad resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient is currently on blood thinners as treatment.  The patient is recovering from the event.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Pulmonary embolism, Shock
Clinical narrative: suspected pulmonary embolism; shock; cardiac arrest; This is a spontaneous report from a non-contactable consumer (patient's wife). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 04Mar2021 at 11:45 AM at a single dose for COVID-19 immunization.  Medical history reported as none.  The patient has no known allergies. The patient's concomitant medications were not reported.  The patient experienced a suspected pulmonary embolism on Monday 08Mar2021 at 11:30 AM. Embolism led to shock and cardiac arrest. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received unspecified treatment for the events. The patient died on 08Mar2021 at 11:30 AM.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: suspected pulmonary embolism; shock; cardiac arrest
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: He died around 5 o clock; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 12Mar2021 13:00 at a single dose (lot number was reported as NEEU200, the reporter did not know if its 2 or Z) for COVID-19 immunization. Medical history allergic to Penicillin, has a long list of allergies, neck pain and sleep disorder (sleep aid). Concomitant medications included diphenhydramine hydrochloride (BENADRYL), clopidogrel bisulfate, calcitriol, melatonin (MELATONIN) taken for sleep aid, Phillips Laxative tablet Magnesium (not appropriately paraphrased and clarified, as reported), simvastatin, terazosin hydrochloride, tizanidine hydrochloride (TIZANIDINE HCL) for when he had the pain in neck (he didn't take that hardly ever), vitamin C [ascorbic acid] and Multivitamin one a day. On Friday 12Mar2021, the reporter and the patient went to get the Covid shot. Their appointment was at 12:30 but they were in line long time before they got the shot. They got the shot around 13:00 and then they have to wait 15 minutes before they could leave. They drove up, they were ready to shoot us with the needle and they asked the patient, asked was he allergic to anything and the reporter answered for him and said yes, Penicillin and other long list and then they gave him the shot. They never did go over his allergies. They got home about 13:30, so which would take us about that long to get home. The patient died around 5 o clock and the reporter didn't know if this was connected or not with his death. The patient died on 12Mar2021. It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Sender's Comments: This case of death was provided with minimal details and autopsy results not available. However, drug causality cannot be completely excluded for BNT162B2 injection, only due to plausible chronological relation. Otherwise, information received was so limited to prevent a thorough medical assessment for patient death. The impact of this report on the benefit/risk profile of the Pfizer drugs is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: He died around 5 o clock
Sex: F
Vaccine: FLUR4
Symptoms: Injection site rash, Rash
Clinical narrative: rash at the site of the injection; rash appeared behind her ear/had a rash as well but this year it was worse; Initial information was received on 02-Mar-2021 regarding an unsolicited valid non-serious case was received from an Other Health Care Professional via Agency (Reference number- 00500850) and transmitted to Sanofi on 02-Mar-2021.  This case involves a female patient who experienced rash at the site of the injection (injection site rash) and rash appeared behind her ear/had a rash as well but this year it was worse (rash), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious rash at the site of the injection (injection site rash) and rash appeared behind her ear/had a rash as well but this year it was worse (rash) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data were not reported.  She took an anti-itch medicine Benadryl.  On an unknown date, patient had recovered from the events.  There will be no information available on batch number for this case.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 month-old child was supposed to receive Pentacel vaccine, but received Quadracel instead, no AE; 4 month-old child was received Quadracel, no AE; Initial information received on 05-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a four month old female patient who received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration.  It was also reported that 4 month-old child was supposed to receive Pentacel vaccine, but received Quadracel instead.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Pain, Pruritus, Rash
Clinical narrative: so much pain; burning; very severe generalized rash all over from her head to her toe; itching; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00514936) and transmitted to Sanofi on 11-Mar-2021.  This case involves female patient of unknown age who experienced so much pain (pain), burning (burning sensation), very severe generalized rash all over from her head to her toe (rash) and itching (pruritus), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  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 DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, Physician stated that she was calling about side effects of ADACEL. Physician stated that a patient experienced non-serious so much pain (pain), burning (burning sensation), a very severe generalized rash all over from her head to her toe (rash) and itching (pruritus) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.   Physician also stated that the patient was currently in the hospital and was asking for further details regarding the reports of rash in the ADACEL prescribing information. Also was asking about the severity of the rashes reported and if any rashes led to patients being admitted to the hospital.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient did not recover from all the reported events.  There will be no information available on batch number for this case.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC, RV5
Symptoms: Product preparation issue
Clinical narrative: administered the liquid portion of the DTAP IPV vaccine forgot to mix in the powder (ActHIB) from Pentacel/No AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Agency (Reference number- 00515066) and transmitted to Sanofi on 11-Mar-2021.  This case involves a 6 months old female patient who administered with the liquid portion of the DTAP IPV vaccine forgot to mix in the powder (Act-Hib) from DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 11-Mar-2021, the patient received a third 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ413AA, Expiry date- 09-Oct-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day).  Nurse clarifies that she is calling regarding Pentacel, not Quadracel. She asks how to administer the remaining powdered ActHIB portion of the Pentacel. She asks what diluent should be used. Did the issue occur before or after the mixing of the two components? Before If the issue occurred before the mixing, did the problem concern the powder vial or the diluent vial? Before, they forgot to mix in the powder (ActHIB) into the (Ipol/Daptacel) diluent.  It was not reported if the patient experienced any 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administered expiration date on the diluent and not the powder portion of the ActHib with no adverse event reported; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00515128) and transmitted to Sanofi on 11-Mar-2021.  This case involves a patient (with unknown demographics) who received expired diluent and not the powder portion of the HIB (PRP/T) VACCINE [ACT-HIB] lot number not reported (Diluent expiry date 07-Mar-2021) via unknown route in unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (Latency same day).  A representative from a health department wanting to know if we have information on how to proceed after an expired dose of ActHib was administered due to having a clinic in their area that administered a dose of ActHib that was expired. The caller reported that the clinic used the expiration date on the diluent and not the powder portion of the ActHib; that the ActHib expired on 07Mar2021; that she does not have any information on the event.  It was not reported if the patient experienced any 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Pain, Rash, Skin swelling
Clinical narrative: could not raise his arm and it stung then that feeling moved from his upper arm down to his elbow; looked puffy; had a pain sensation; he got a bad rash on it; Initial information regarding an unsolicited valid non-serious case was received from a consumer/ non-healthcare professional via Agency (Reference number- 00515270) and transmitted to Sanofi on 11-Mar-2021.  This case involves a male patient who could not raise his arm and it stung then that feeling moved from his upper arm down to his elbow (hypokinesia), looked puffy (skin swelling), had a pain sensation (pain), and he got a bad rash on it (rash), after he received vaccine INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [FLUZONE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included OSELTAMIVIR PHOSPHATE (FLUCLE).  On an unknown date, the patient received INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, patient who could not raise his arm and it stung then that feeling moved from his upper arm down to his elbow (hypokinesia), looked puffy (skin swelling), had a pain sensation (pain), and he got a bad rash on it (rash), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.  There will be no information available regarding batch number in this case.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: one year old patient was given ActHIB with expired diluent with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (MI) (Reference number- 00515331) and transmitted to Sanofi on 11-Mar-2021.  This case involves a 1 years old male patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for Immunisation.  On 11-Mar-2021, the patient received a 0.5 mL dose of suspect HIB (PRP/T) VACCINE lot UJ181AAA/U6601AA, expiry date-Diluent- 07-MAR-2021/ Powder-18-MAR-2021 via intramuscular route in the left thigh for prophylactic vaccination.  Additional Description of event Adverse events :HCP reporting one year old patient was given ActHIB with expired diluent.  It was not reported if the patient experienced any 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 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.