chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Muscular weakness, Vision blurred
Clinical narrative: he experienced extreme weakness in his extremeties; he still has blurred vision; the weakness is getting worse and the fatigue; the weakness is getting worse and the fatigue; This is a spontaneous report received from a contactable reporter consumer or other non HCP from medical information team. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3248) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "he experienced extreme weakness in his extremeties"; VISION BLURRED (non-serious), outcome "unknown", described as "he still has blurred vision"; FATIGUE (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "the weakness is getting worse and the fatigue".  Additional information: Patient states that he has already filed a report online regarding the adverse events he experienced. He also mentions that his life got worse after that and was now looking for information on clinical studies being conducted by Pfizer to help prevent or treat the side effects he experienced or was still experiencing from the vaccine. Nine weeks ago, he developed some extreme weakness in extremities, mostly legs and arms. Still have some blurred vision, but the weakness was getting worse and the fatigue. It has been a minute since reporting this originally, and he thinks it was reported. No medical treatment. Seen a ton of doctor's who have no explanation for what was going on. His health problems started after the first dose. The second dose was on 19Feb2021, Lot EN5318, expiration was unknown
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: interchange of vaccine products; Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 78 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 011M20A), in left arm, on 15Mar2021 as dose 2, single (Lot number: 048A21A), in left arm and on 09Sep2022 as dose 4 (booster), single (Lot number: A57143C), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type2 Diabetes" (unspecified if ongoing), notes: Other medical history: Type2 Diabetes; "Penicillan Eurthromycin Januvia" (unspecified if ongoing), notes: Known allergies: Penicillan Eurthromycin Januvia. Concomitant medication(s) included: METFORMIN HCL, start date: 01Jan2021; LOSARTAN, start date: 01Jan2021; FARXIGA, start date: 01Jan2021; KRILL OIL OMEGA 3, start date: 01Jan2021; ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Jan2021; VITAMIN E [VITAMIN E NOS], start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Covid-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment included Paxlovid from 01Oct2022 to 05Oct2022. Known allergies included Penicillan Eurthromycin Januvia. other medication in 2weeks included Metformin HCL, Losartan, Farxiga of brand Astazenec, Krill, Vitamin E, Aspirin.
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3, COVID19-2
Symptoms: Blood pressure measurement, Blood test, Diarrhoea, Electrocardiogram, Off label use
Clinical narrative: Constant deep diarrhea For 3 weeks
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3, COVID19-2
Symptoms: Product use issue, Weight, Weight decreased
Clinical narrative: Constant deep diarrhea For 3 weeks
Age: 74.0
Sex: M
Vaccine: COVID19, FLU3, COVID19-2
Symptoms: Diarrhoea
Clinical narrative: Constant deep diarrhea For 3 weeks
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6199), in left arm and on 31Mar2021 as dose 2, single (Lot number: EN6204) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had no known allergies. The patient took nirmatrelvir; ritonavir (PAXLOVID) for COVID 19 treatment starting from 27Sep2022 to 02Oct2022.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 06Oct2022 began with cold symtoms including head congestion, fatigue and loss of taste and smell/tested positive again for covid on 08Oct2022; tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and on 13Sep2022 at 10:45 as dose 5 (booster), single (Lot number: GH2524) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing).Patient had no known allergies. Concomitant medication(s) included: CHLORTHALIDONE, start date: 06Sep2016; FISH OIL, start date: 01Sep2022; TIMOLOL MALEATE (Gel Forming Solution), start date: 08Sep2021.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Sep2022, outcome "recovered" (01Oct2022) and all described as "tested positive for Covid"; DISEASE RECURRENCE (medically significant) with onset 06Oct2022 at 07:00, outcome "unknown", described as "06Oct2022 began with cold symtoms including head congestion, fatigue and loss of taste and smell/tested positive again for covid on 08Oct2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2022) Positive, notes: tested positive for Covid; (01Oct2022) Negative, notes: tested negative; (08Oct2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course included:I have received both vaccines and all three boosters. All Pfizer. I tested positive for Covid on 26Sep2022. I started Paxlovid on 26Sep2022. My symptoms were body aches, headache, fatigue and mild cough. I began to feel much better on 28Sep2022. I tested negative on 01Oct2022. On 06Oct2022 I began with cold symtoms including head congestion, fatigue and loss of taste and smell. I tested positive again for covid on 08Oct2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6198), on 26Mar2021 as dose 2, single (Lot number: EP6955), on 18Oct2021 as dose 3 (booster), single (Lot number: FF2588) and on 11May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "crohns disease" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: HUMIRA; OMEPRAZOLE; ATORVASTATIN, stop date: 21Sep2022.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) positive, notes: started paxlovid 1st day of positive antigen test which was 1.5 days after symptoms. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 22Sep2022 to 26Sep2022.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes; Did you/the patient previously receive a COVID-19 Vaccine?: Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: FD6955), on 14Apr2021 as dose 2, single (Lot number: EW0153), on 05Dec2021 as dose 3 (booster), single (Lot number: FH8030) and on 05Jul2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "Other medical history Sjogrens Syndrome" (unspecified if ongoing), notes: Other medical history Asthma, Sjogrens Syndrome, Hashimotos Thyroiditis; "Other medical history Asthma" (unspecified if ongoing), notes: Other medical history Asthma, Sjogrens Syndrome, Hashimotos Thyroiditis; "Other medical history Hashimotos Thyroiditis" (unspecified if ongoing), notes: Other medical history Asthma, Sjogrens Syndrome, Hashimotos Thyroiditis. Concomitant medication(s) included: WIXELA INHUB nasal, start date: 01Jul2020, stop date: 27Sep2022; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: 25Nov2016, stop date: 10Oct2022; CEVIMELINE, start date: 25Nov2016, stop date: 10Oct2022; LEVOTHYROXINE, start date: 03Apr2006, stop date: 10Oct2022; PRILOSEC [OMEPRAZOLE], start date: 06Nov2017, stop date: 10Oct2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: after testing negative; (Sep2022) Positive, notes: Treatment of COVID-19; (Oct2022) Positive, notes: rebound 6 days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Reporter stated that COVID 19 Treatment (Paxlovid) was done and treatment start date was 27Sep2022 and stop date was 02Oct2022 for Indication COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took antiviral paxlovid from 29Sep2022 to 04Oct2022 for covid-19 treatment. No other medication in 2weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: headache; feverish; chills; muscle aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 27 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3, SINGLE, Vaccine Administration Time: 05:30 PM, Route of Administration: Intramuscular), administration date: 17Dec2021, when the patient was 26-year-old, for COVID-19 Immunization, reaction(s): "Lethargy", "Headache", "low grade fever", "tiredness"; Bnt162b2 (DOSE 2, SINGLE, Vaccine Administration Time: 06:00 PM), administration date: Jun2021, when the patient was 26 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Vaccine Administration Time: 07:00 PM), administration date: May2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022); FATIGUE (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022); PYREXIA (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022), described as "feverish"; HEADACHE (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022); MYALGIA (non-serious) with onset 09Oct2022, outcome "recovered" (Oct2022), described as "muscle aches". Therapeutic measures were not taken as a result of headache, pyrexia, chills, myalgia, fatigue. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Aspartate aminotransferase, Aspartate aminotransferase increased, Blood test
Clinical narrative: AST and ALT levels were extremely high. 337 and 139 respectively.; AST and ALT levels were extremely high. 337 and 139 respectively.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ6742) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Batch/lot number: EL3247, Anatomical Location: Arm Left, Dose Number: 1), for COVID-19 immunization; Bnt162b2 (Batch/lot number: EL3247, Anatomical Location: Arm Left, Dose Number: 2), for COVID-19 immunization; Bnt162b2 (Batch/lot number: FH8030, Anatomical Location: Arm Left, Dose Number: 3), for COVID-19 immunization; Bnt162b2 (Batch/lot number: FN2908, Anatomical Location: Arm Left, Dose Number: 4), for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The following information was reported: ASPARTATE AMINOTRANSFERASE INCREASED (medically significant), ALANINE AMINOTRANSFERASE INCREASED (medically significant) all with onset Oct2022, outcome "recovering" and all described as "AST and ALT levels were extremely high. 337 and 139 respectively.". The events "ast and alt levels were extremely high. 337 and 139 respectively." required physician office visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (21Apr2022) 14; (Oct2022) 139, notes: extremely high; Aspartate aminotransferase: (21Apr2022) 24; (Oct2022) 337, notes: extremely high; Blood test: (Oct2022) normal. Clinical course: Patient had a normal blood workup done on 06Oct2022 in prep for a physical and her AST and ALT levels were extremely high. 337 and 139 respectively. Prior levels done on 21Apr2022 were 24 and 14 (date of start of reaction/event was also reported as 01Oct2022). Events were reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Lymphadenopathy
Clinical narrative: inflammatory response on her arms; autoimmune response like swelling to lymph nodes; The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting- Medical Information. There is no indication that the consumer experienced an event under Product BNT162B2, BNT162B2 OMI BA.4-5. Upon receipt of follow-up information on (10Oct2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A female patient in her 70's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "unknown", described as "inflammatory response on her arms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "autoimmune response like swelling to lymph nodes".  Additional information: Patient wanted to know if she had an inflammatory response on her arms after getting the COVID-19 vaccine in the past, and she enquired can she get another vaccine in her buttocks. Reporter stated that she would have to have the patient provide verbal consent for her to do the report, which patient had disconnected to talk to her provider and is no longer on the call. Reporter said she had already explained to the patient the inflammatory and autoimmune response like swelling to lymph nodes would resolve in a few weeks and to follow up with her doctor if they hadn't, and patient had the question of getting the injection in her buttocks. Reporter said their triage manual explains that it I intramuscular, but it didn't have anything about alternative injection sites, which she was assuming they would be able to, to provide vaccines to people with physical limitations such as amputees with limb removal or due to their anatomy. Reporter said she doesn't have NDC/LOT/EXP or cap color to provide for the patient's COVID-19 vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Wrong product administered
Clinical narrative: Fever over 100 degrees within 24 hours of administration; Is bivalent: False, Dose number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 08Oct2022 at 14:30 as dose 5 (booster), single (Lot number: CZH9703) at the age of 60 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); unknown manufacturer), for Covid-19 immunization. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 08Oct2022 at 14:30, outcome "unknown", described as "Is bivalent: False, Dose number: 5"; PYREXIA (non-serious) with onset 09Oct2022, outcome "recovering", described as "Fever over 100 degrees within 24 hours of administration". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  \Additional information: The patient did not receive any other vaccines within 4 week prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Nasal congestion, Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: aching; throats really hurts when she swallows; she is congested; Feels bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), single (Lot number: GH9703) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "Feels bad"; PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "aching"; NASAL CONGESTION (non-serious) with onset Oct2022, outcome "unknown", described as "she is congested"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "throats really hurts when she swallows". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that she got the Pfizer COVID-19 Vaccine booster dose last Monday and she feels bad, she had real bad sore throat and she is congested and sort of achy. She said that her throat really hurts when she swallows and she is asking if it is really a side effect of the vaccine and I gave her the number of Pfizer Medical Information department as well. It was reported that she never had flu shot.."  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221531 similar report from same reporter;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: aching; throats really hurts when she swallows; she is congested; Feels bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), single (Lot number: GH9703) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization completed, unknown manufacturer), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset Oct2022, outcome "unknown", described as "Feels bad"; PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "aching"; NASAL CONGESTION (non-serious) with onset Oct2022, outcome "unknown", described as "she is congested"; OROPHARYNGEAL PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "throats really hurts when she swallows". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient mentioned that she got the Pfizer COVID-19 Vaccine booster dose last Monday and she feels bad, she had real bad sore throat and she is congested and sort of achy. She said that her throat really hurts when she swallows and she is asking if it is really a side effect of the vaccine and I gave her the number of Pfizer Medical Information department as well. It was reported that she never had flu shot.."  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201221531 similar report from same reporter;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Nasal congestion, Oropharyngeal pain, Pain, SARS-CoV-2 test
Clinical narrative: I did a COVID test this morning and it did show I have COVID; I did a COVID test this morning and it did show I have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), single (Lot number: GH9703) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "I did a COVID test this morning and it did show I have COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: I did a COVID test this morning and it did show I have COVID but I do not know if those home test I really do not know. Clinical course:Consumer stated, she had taken  Pfizer shot last Monday. She did a Covid test this morning and it did show she has Covid but do not know if those home test really do not know (Further clarifications unknown if patient has Covid). she started getting the sore throat last night, yesterday and so achy today. Yeah that is what she was  wondering can anyone  get the Covid 7 days later after getting the shot"  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201218427 similar report from same reporter;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I did a COVID test this morning and it did show I have COVID; I did a COVID test this morning and it did show I have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose number unknown (booster), single (Lot number: GH9703) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Oct2022, outcome "unknown" and all described as "I did a COVID test this morning and it did show I have COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Positive, notes: I did a COVID test this morning and it did show I have COVID but I do not know if those home test I really do not know. Clinical course:Consumer stated, she had taken  Pfizer shot last Monday. She did a Covid test this morning and it did show she has Covid but do not know if those home test really do not know (Further clarifications unknown if patient has Covid). she started getting the sore throat last night, yesterday and so achy today. Yeah that is what she was  wondering can anyone  get the Covid 7 days later after getting the shot"  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201218427 similar report from same reporter;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever last checked 100.2 normally 94.5; Aches all over chills; Aches all over chills; chest pain; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 at 14:15 as dose 4 (booster), single (Lot number: Gj7277) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypogammaglobulinemia" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "Selective immune deficiency" (unspecified if ongoing); "X-ray IVP dye" (unspecified if ongoing), notes: allergies: X-ray IVP dye. Concomitant medication(s) included: SHINGRIX, on 17Sep2022. Past drug history included: Nickel, reaction(s): "allergy"; Bactrim., reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), CHILLS (non-serious) all with onset 10Oct2022 at 16:00, outcome "not recovered" and all described as "Aches all over chills"; PYREXIA (non-serious) with onset 10Oct2022 at 16:00, outcome "not recovered", described as "Fever last checked 100.2 normally 94.5"; CHEST PAIN (non-serious) with onset 10Oct2022 at 16:00, outcome "not recovered"; HEADACHE (non-serious) with onset 10Oct2022 at 16:00, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, chest pain, headache.  Additional information: Dose received received more than 3. Patient had received other vaccine in four weeks and received other medications in two weeks. Patient not had covid prior vaccination and not had performed covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: nasal congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown), administration date: Jan2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown, second vaccine shot 4 weeks later.), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown), administration date: Sep2021, for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN, Lot number: unknown), administration date: Mar2022, for COVID-19 Immunization. The following information was reported: NASAL CONGESTION (non-serious) with onset 2022, outcome "unknown".  Additional information: Patient and his wife received the first Pfizer vaccine Jan2021 and second vaccine shot 4 weeks later. They received the first Pfizer booster Sep2021 and the second booster Mar2022. They got the new omicron booster 12Sep2022. They were so happy to remain COVID free until 5 days ago. They looked forward to the new vaccine to protect them from the omicron variant. Their symptoms have been nothing more that nasal congestion but wanted to pass on the information about the new booster fail.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200079864 same reporter/drug/AE, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP),. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "nausea", "vomiting". The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered".  Additional information: The patient had the two original vaccinations and one booster for COVID, the last one being Oct2021. The patient experienced nausea and vomiting for all three and really took about three days to recover from each shot. The patient tried the Moderna shot last week and still got sick but not quite as badly.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Nausea, Vomiting
Clinical narrative: I'm wondering if I suffered an allergic reaction; nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation, reaction(s): "nausea", "Vomiting"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation, reaction(s): "nausea", "Vomiting". The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I'm wondering if I suffered an allergic reaction".  Additional information: The patient experienced nausea and vomiting for all three doses and really took about three days to recover from each shot. The patient tried the Moderna shot last week and still got sick but not quite as badly. The patient was wondering whether the patient is suffering from an allergic reaction. The patient did not know anyone else who gets hit from the shots in that way.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: I am just wondering my husband is the kind if he says man, I am tired something is wrong; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Caller stated that in Mar/Apr of 2021 that when she and her husband has gotten Pfizer vaccine what they gotten was the original Pfizer-BioNTech COVID-19 Vaccine), administration date: 2021, for Covid-19 immunization; Bnt162b2 (DOSE 2, Caller stated that in Mar/Apr of 2021 that when she and her husband has gotten Pfizer vaccine what they gotten was the original Pfizer-BioNTech COVID-19 Vaccine), administration date: 2021, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "I am just wondering my husband is the kind if he says man, I am tired something is wrong". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Addition Information: Caller stated I know that Moderna had some problems with pericarditis, I don't believe that Pfizer has the same degree issues with that, but I am just wondering my husband is the kind if he says man, I am tired something is wrong.  When and if they can get a booster if they got original Caller stated that in Mar/Apr of 2021 that when she and her husband has gotten Pfizer vaccine what they gotten was the original Pfizer-BioNTech COVID-19 Vaccine, then in Dec of 2021 that is when she and her husband has gotten a booster (Pfizer) Caller stated that her understanding was that the vaccine (Pfizer-BioNTech COVID-19 Vaccine) that was given to them would be the original formulation. Both her and her husband had 3 doses (primary series and booster, per caller both are in their sixties or older.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: 1802070), in right arm, on 28Oct2021 as dose 2 single (Lot number: Ff2593), in right arm and on 13May2022 as dose 3 (booster), single (Lot number: Fm0173) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (2022) Negative, notes: testing negative for five consecutive days beginning on day 5 or 6 after symptom onset; (10Oct2022) Positive, notes: tested positive again for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was taking other medications/ products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient had no known allergies. After fever, sore throat, headache and overall feeling badly resolved with Paxlovid, cough and congestion continued. After testing negative for five consecutive days beginning on day 5 or 6 after symptom onset, tested positive again for COVID on 10Oct2022. This was a full 15 days after beginning Paxlovid. Adverse event was rebound COVID.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing), notes: High BP; "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid for the adverse events. Patient had no known allergies. Patient did not receive any other medications within 2 weeks to the COVID vaccine  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Apr2021 as dose 1, single (Lot number: EW0171), in right arm, on 23May2021 as dose 2, single (Lot number: EW0185), in right arm and on 10Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Non-alcoholic Fatty Liver Disease (diagnosed Nov2020); manageable", start date: Nov2020 (unspecified if ongoing), notes: Non-alcoholic Fatty Liver Disease (diagnosed Nov2020); manageable. Concomitant medication(s) included: KIRKLAND SIGNATURE ADULT MULTIVITAMIN, start date: Jan2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive, notes: positive at-home tests. Therapeutic measures were taken as a result of vaccination failure, covid-19: paxlovid was given.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive; done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "my bladder is ripped of liver injury" (unspecified if ongoing), notes: my bladder is ripped of liver injury; "my bladder is ripped of liver injury" (unspecified if ongoing), notes: my bladder is ripped of liver injury. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: I was tested positive that night. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient mentioned that she was done taking the Pfizer BioNtech COVID-19 vaccine and booster shot but she was tested positive that night, so she started taking Paxlovid. She had it for two days however she cannot have full dose of it because the pharmacy in they mentioned that it was not available in their area (Further clarifications unknown).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema
Clinical narrative: eczema condition continues on getting worse; eczema condition continues on getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional), Program ID: (005570). The reporter is the patient. A 75-year-old patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient relevant medical history included: "diabetes" (unspecified if ongoing), notes: I am a 75 year old diabetic, "Billiary cirrhosis" (unspecified if ongoing), notes: who also has Primary Billiary cirrhosis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (I just realized that my skin condition started days after receiving my, 1st Covid vaccine., Dose 1) for COVID-19 Immunisation, reaction(s): "realized that my skin condition", Covid-19 vaccine (Dose 2) for COVID-19 Immunisation, Covid-19 vaccine (Dose 3) for COVID-19 Immunisation. The following information was reported: ECZEMA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "eczema condition continues on getting worse".  Additional information: Patient just received my 4th shot and my eczema condition continues on getting worse. As I researched chat rooms looking for some knowledge I found a trend of others who also suffered the same fate.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.