chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Ear pain, Tinnitus
Clinical narrative: she had full severe hearing loss; tinnitus/ ringing in the right ear.; She then experienced some pain overnight that second night after in one ear, the right ear; she started developing a feeling of fullness or pressure in the right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old female patient received BNT162b2 (COMIRNATY), on 04Apr2022 as dose 4 (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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2,  MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER),  MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: EAR DISCOMFORT (non-serious) with onset 05Apr2022, outcome "unknown", described as "she started developing a feeling of fullness or pressure in the right ear"; EAR PAIN (non-serious) with onset 06Apr2022, outcome "unknown", described as "She then experienced some pain overnight that second night after in one ear, the right ear"; DEAFNESS (medically significant) with onset 07Apr2022, outcome "unknown", described as "she had full severe hearing loss"; TINNITUS (non-serious) with onset 07Apr2022, outcome "unknown", described as "tinnitus/ ringing in the right ear.". Clinical course: the patient received second booster dose for patients over 50 on Monday 4Apr2022.  Within the next day (26-27 hours) she started developing a feeling of fullness or pressure in the right ear.  She then experienced some pain overnight that second night after in one ear, the right ear.  When she woke up the next morning she had full severe hearing loss in her right ear and tinnitus/ ringing in the right ear. She read a short course of corticosteroids can be very helpful and is very hopeful can be resolved. Have these side effects been reported?  Will a corticosteroid help decrease inflammation?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiomegaly, Heart rate, Heart rate increased
Clinical narrative: heart is mildly enlarged; my heart rate went to 144 bpm and I went to the ER; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history in-cluded: "two time cancer survivor", start date: 2016 (unspecified if ongoing); "obese" (unspecified if ongoing), notes: obese (251 lbs, 5 T9). The patient's concomitant medications were not reported. Vac-cination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufac-turer), for Covid-19 Immunization; Covid-19 vaccine (1st Booster; Unknown manufacturer, Primary Immunization series complete), for covid-19 Immunization.  The following information was reported: CARDIOMEGALY (medically significant), outcome "unknown", described as "heart is mildly enlarged"; HEART RATE INCREASED (medically significant), outcome "un-known", described as "my heart rate went to 144 bpm and I went to the ER". The events "heart is mild-ly enlarged" and "my heart rate went to 144 bpm and i went to the er" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: 144, notes: 144 bpm; 90. On Monday (04Apr) I received my fourth shot (second booster) at a local (name withheld). Yesterday afternoon, my heart rate went to 144 bpm and I went to the ER. The diagnosis was heart is mildly enlarged. I was given a saline iv and kept until my heart rate was in the 90 Ts.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: got a minor nose bleed.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (COMIRNATY), in Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "stroke" (unspecified if ongoing), notes: she has a history of having 3 strokes and had been taking Eloquis and a baby aspirin which were both last taken on 23Jan2022. Concomitant medication(s) included: ELIQUIS taken for cerebrovascular accident, stop date: 23Jan2022; BABY ASPIRIN taken for cerebrovascular accident, stop date: 23Jan2022. The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "got a minor nose bleed.". Additional information: Caller states she has a history of having 3 strokes and had been taking Eloquis and a baby aspirin which were both last taken on 23Jan2022. Caller states that she received the Pfizer Covid19 vaccine 1st dose in Dec2020 and got a minor nose bleed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: The first Pfizer Covid Vaccine helped her breathing/Pfizer Covid Vaccine booster dose and the same thing happened, her breathing was fine again, better.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202), in right arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: Onset date unknown other than years ago. She has been on inhalers for years and years for COPD.; "Vitamin D deficiency" (unspecified if ongoing), notes: She thinks she had a vitamin D deficiency but that was before all of this. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE. Batch/Lot No. Unknown, Expiry: Unknown, Upper Arm.), administration date: 26Mar2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The first Pfizer Covid Vaccine helped her breathing/Pfizer Covid Vaccine booster dose and the same thing happened, her breathing was fine again, better.".  Additional Information: There was product complaint to report (product is not suspect product) with Description of Product Complaint as patient has been on inhalers for years and years for COPD. After first Pfizer Covid Vaccine noticed whenever went to take Advair inhaler in the morning would start to cough. So patient stopped taking Advair Inhaler. Patient was not using Advair inhaler for like 6 months after getting first Pfizer Covid Vaccine, After about 6 months started having a bit of a problem breathing again. When booster came out she went and got the Pfizer Covid Vaccine booster dose and the same thing happened, her breathing was fine again, better. She tried to get off inhalers numerous times on her own prior to this and never could. Would only last maybe 2-3 days at the most and then have to take the inhaler again. Reporter did not provide any additional inhaler product names regarding been on inhalers for years and years; tried to get off inhalers; only provided Advair inhaler. Description of complaint of the product Advair inhaler, Manufacturer name Glasko Smith Kline with NDC no. 0173-0717-20 for lot K35H with Expiry as 20Aug2022.  Follow-up (07Apr2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included the lot number for the booster dose was 320308D.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: high blood pressure; 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 male patient received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (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 (For Dose: 1, 2 and 3), for Covid 19 immunization, reaction(s): "high blood pressure".  The following information was reported: HYPERTENSION (non-serious) with onset Apr2022, outcome "unknown", described as "high blood pressure". The event "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient received the 4 shots of the Pfizer-BioNTech Covid 19 Vaccine (2 of the primary series and 2 booster shots), and every time he received a shot of the vaccine, he has had a high blood pressure. He has visited his doctor to control this levels and after receiving the second booster shot on 03Apr2022 he had again a high blood pressure. He wanted to know if it was a normal side effect of the vaccine. Patient had a SARS-COV2 test before he received the second booster shot and he stated that he had a concentration of 329 SARS-COV Ig. He wanted to know if this high level of antibodies was due to the vaccine, because his doctor doesn't know how to interpret the results. It was reported as non-serious.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: cold began on 04Apr2022 and is ongoing and a little worse; getting a pretty bad cold; he felt that his nostrils were getting raw; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, AE(s) following prior vaccinations: n/a), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, AE(s) following prior vaccinations: n/a), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, AE(s) following prior vaccinations: n/a), for Covid-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 04Apr2022, outcome "not recovered", described as "getting a pretty bad cold"; NASAL CONGESTION (non-serious) with onset 04Apr2022, outcome "unknown", described as "he felt that his nostrils were getting raw"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "cold began on 04Apr2022 and is ongoing and a little worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasopharyngitis, nasal congestion, condition aggravated.  Additional information: Reporter is asking on behalf of her husband who took a dose of the Pfizer Covid 19 vaccine last 01Apr2022, she further states that her husband started getting a pretty bad cold on 04Apr2022 and that he felt that his nostrils were getting raw. she states that the last shot he took was his 4th dose the vaccine. She also states that he took a home covid 19 test yesterday and that it turned out negative. She is asking if this has been previously reported, if the colds were caused by the vaccines, and if he should start taking antibiotics for the cold. She states the patient's cold began on 04Apr2022 and is ongoing and a little worse and he experienced his nostrils getting raw regarding his symptoms and this began in the evening on 04Apr2022 around 3:00pm to 4:00pm. She states the patient's card for his lot numbers, expiry dates, dates of administration and NDC numbers for his 1st, 2nd, 3rd and 4th doses of the covid vaccines is unavailable at this time and his card is not with him right now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Epistaxis, Factor X deficiency, Prothrombin time
Clinical narrative: severe nose bleeds; Caller states that she was diagnosed with Factor 10 deficiency; bruising; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received BNT162b2 (COMIRNATY), in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: Dec2020, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "minor nose bleed"; Bnt162b2 (2nd dose), when the patient was 67 years old, for COVID-19 immunization. The following information was reported: EPISTAXIS (hospitalization), outcome "unknown", described as "severe nose bleeds"; FACTOR X DEFICIENCY (non-serious), outcome "unknown", described as "Caller states that she was diagnosed with Factor 10 deficiency"; CONTUSION (non-serious), outcome "unknown", described as "bruising". The patient underwent the following laboratory tests and procedures: Prothrombin time: unreadable. Therapeutic measures were taken as a result of epistaxis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Epistaxis, factor x deficiency, contusion cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product 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
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Immunisation, Off label use, Pyrexia
Clinical narrative: Very tired; chills; fever; Received dose 4; Received dose 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FF2589) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 05Apr2022 at 11:00, outcome "unknown" and all described as "Received dose 4"; FATIGUE (non-serious) with onset 06Apr2022 at 05:00, outcome "recovered" (Apr2022), described as "Very tired"; CHILLS (non-serious) with onset 06Apr2022 at 05:00, outcome "recovered" (Apr2022); PYREXIA (non-serious) with onset 06Apr2022 at 05:00, outcome "recovered" (Apr2022), described as "fever". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no known allergies.   Follow-Up: Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Ear pain, Tinnitus, Weight
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 58-year-old female patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 04Apr2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Symptoms of menopause" (unspecified if ongoing); Concomitant medication(s) included: ESTROGEN taken for menopause, cardiac disorder; PROGESTERONE taken for menopause, cardiac disorder. Start date: about 7 years ago or when she was about 51 or 52 years old. Indication as Reported: Symptoms of menopause and possible protection of heart health. Vaccination history included: Bnt162b2 (First dose, administered to her left arm), for Covid-19 immunization, reaction(s): "None"; Bnt162b2 (Second dose, administered to her left arm.), for Covid-19 immunization, reaction(s): "None"; Bnt162b2 (Third dose, administered to her left arm.), for Covid-19 immunization, reaction(s): "None". Regarding dates of doses 1-3 she (patient) explained that their vaccine cards were due to expire on 14Apr2022 which was 9 months from the date of the Third dose/first booster; so that would be approximate timeline of third dose at least. The patient had not received any other vaccine within 4 weeks. Patient no had Family Medical History Relevant to AE(s). The following information was reported: EAR DISCOMFORT (non-serious) with onset 05Apr2022 (onset time by the end of the evening), outcome "not recovered", described as "Fourth dose: Feeling of fullness in right ear, like there is something in the ear"; On 06Apr2022 this worsened, feeling strongly the feeling of fullness in right hear. It sounds very similar to a kind of overreaction of the tissues and inflammation. EAR PAIN (non-serious) with onset 05Apr2022 (onset time was overnight), outcome "unknown", described as "Fourth dose: Pain in right ear"; DEAFNESS (medically significant) with onset time morning of 06Apr2022, outcome "not recovered", described as "Fourth dose: Hearing loss"; TINNITUS (non-serious) with onset time morning of 06Apr2022, outcome "not recovered", described as "Fourth dose: Tinnitus". The patient underwent the following laboratory tests and procedures: Weight: About 131-132. Therapeutic measures were not taken as a result of deafness, tinnitus, ear discomfort, ear pain. Reporter verified that there has been no testing, treatment or medical interventions performed relative to these events, and she has not been seen by any healthcare professional. Report is not related to a study or programme. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Bedridden, Drug ineffective, False negative investigation result
Clinical narrative: I believe i have also been infected twice; I believe i have also been infected twice; liver enzyme elevation; inflammation; became bedridden homme alone for 6 months; very poor sense of smell/taste; very poor sense of smell/taste; 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) with unspecified age and gender received 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE SUSPECTED COVID-19 , outcome "unknown" and all described as "I believe i have also been infected twice"; HEPATIC ENZYME INCREASED outcome "unknown", described as "liver enzyme elevation"; INFLAMMATION outcome "unknown"; BEDRIDDEN outcome "unknown", described as "became bedridden homme alone for 6 months"; ANOSMIA , AGEUSIA outcome "unknown" and all described as "very poor sense of smell/taste". The patient underwent the following laboratory tests and procedures: False negative investigation result: Unknown Result, notes: I was given a test known for false negatives; Hepatic enzyme: elevation, notes: I had liver enzyme elevation; SARS-CoV-2 test: Positive, notes: I believe I have also been infected twice.  Additional information: Customer Verbatim:  I have had initial 2 dose Pfizer vaccines. I had liver enzyme elevation and inflammation post vaccine. Is this a side effect and should I get the booster. I believe I have also been infected twice. I was given a test known for false negatives and was sent home from hospital and became bedridden home alone for 6 months. I continue to have very poor sense of smell/taste. I live in (withheld) now a hotbed if New variant cases. Trying to determine risk. Can you assist with side effect info. I am a  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Inflammation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I believe i have also been infected twice; I believe i have also been infected twice; liver enzyme elevation; inflammation; became bedridden homme alone for 6 months; very poor sense of smell/taste; very poor sense of smell/taste; 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) with unspecified age and gender received 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE SUSPECTED COVID-19 , outcome "unknown" and all described as "I believe i have also been infected twice"; HEPATIC ENZYME INCREASED outcome "unknown", described as "liver enzyme elevation"; INFLAMMATION outcome "unknown"; BEDRIDDEN outcome "unknown", described as "became bedridden homme alone for 6 months"; ANOSMIA , AGEUSIA outcome "unknown" and all described as "very poor sense of smell/taste". The patient underwent the following laboratory tests and procedures: False negative investigation result: Unknown Result, notes: I was given a test known for false negatives; Hepatic enzyme: elevation, notes: I had liver enzyme elevation; SARS-CoV-2 test: Positive, notes: I believe I have also been infected twice.  Additional information: Customer Verbatim:  I have had initial 2 dose Pfizer vaccines. I had liver enzyme elevation and inflammation post vaccine. Is this a side effect and should I get the booster. I believe I have also been infected twice. I was given a test known for false negatives and was sent home from hospital and became bedridden home alone for 6 months. I continue to have very poor sense of smell/taste. I live in (withheld) now a hotbed if New variant cases. Trying to determine risk. Can you assist with side effect info. I am a  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme abnormal, Hepatitis, SARS-CoV-2 test
Clinical narrative: I believe i have also been infected twice; I believe i have also been infected twice; liver enzyme elevation; inflammation; became bedridden homme alone for 6 months; very poor sense of smell/taste; very poor sense of smell/taste; 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) with unspecified age and gender received 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE SUSPECTED COVID-19 , outcome "unknown" and all described as "I believe i have also been infected twice"; HEPATIC ENZYME INCREASED outcome "unknown", described as "liver enzyme elevation"; INFLAMMATION outcome "unknown"; BEDRIDDEN outcome "unknown", described as "became bedridden homme alone for 6 months"; ANOSMIA , AGEUSIA outcome "unknown" and all described as "very poor sense of smell/taste". The patient underwent the following laboratory tests and procedures: False negative investigation result: Unknown Result, notes: I was given a test known for false negatives; Hepatic enzyme: elevation, notes: I had liver enzyme elevation; SARS-CoV-2 test: Positive, notes: I believe I have also been infected twice.  Additional information: Customer Verbatim:  I have had initial 2 dose Pfizer vaccines. I had liver enzyme elevation and inflammation post vaccine. Is this a side effect and should I get the booster. I believe I have also been infected twice. I was given a test known for false negatives and was sent home from hospital and became bedridden home alone for 6 months. I continue to have very poor sense of smell/taste. I live in (withheld) now a hotbed if New variant cases. Trying to determine risk. Can you assist with side effect info. I am a  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Bedridden, Drug ineffective, False negative investigation result
Clinical narrative: liver inflammation post vaccine; I had liver enzyme elevation post vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), outcome "unknown", described as "liver inflammation post vaccine"; HEPATIC ENZYME ABNORMAL (non-serious), outcome "unknown", described as "I had liver enzyme elevation post vaccine". The patient underwent the following laboratory tests and procedures: Hepatic enzyme abnormal: Eleveted, notes: had liver enzyme elevation; SARS-CoV-2 test: false negatives, notes: I was given a test known for false negatives.  Additional information: The patient had initial 2 dose Pfizer vaccines. The had liver enzyme elevation and inflammation post vaccine. Is this a side effect and should get the booster. The patient believe have been infected twice. The patient was given a test known for false negatives and was sent home from hospital and became bedridden home alone for 6 months. The patient continue to had very poor sense of smell/taste. The patent live in name withheld now a hotbed if New variant cases.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased, Inflammation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: liver inflammation post vaccine; I had liver enzyme elevation post vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), outcome "unknown", described as "liver inflammation post vaccine"; HEPATIC ENZYME ABNORMAL (non-serious), outcome "unknown", described as "I had liver enzyme elevation post vaccine". The patient underwent the following laboratory tests and procedures: Hepatic enzyme abnormal: Eleveted, notes: had liver enzyme elevation; SARS-CoV-2 test: false negatives, notes: I was given a test known for false negatives.  Additional information: The patient had initial 2 dose Pfizer vaccines. The had liver enzyme elevation and inflammation post vaccine. Is this a side effect and should get the booster. The patient believe have been infected twice. The patient was given a test known for false negatives and was sent home from hospital and became bedridden home alone for 6 months. The patient continue to had very poor sense of smell/taste. The patent live in name withheld now a hotbed if New variant cases.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme abnormal, Hepatitis, SARS-CoV-2 test
Clinical narrative: liver inflammation post vaccine; I had liver enzyme elevation post vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), 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 and concomitant medications were not reported. The following information was reported: HEPATITIS (medically significant), outcome "unknown", described as "liver inflammation post vaccine"; HEPATIC ENZYME ABNORMAL (non-serious), outcome "unknown", described as "I had liver enzyme elevation post vaccine". The patient underwent the following laboratory tests and procedures: Hepatic enzyme abnormal: Eleveted, notes: had liver enzyme elevation; SARS-CoV-2 test: false negatives, notes: I was given a test known for false negatives.  Additional information: The patient had initial 2 dose Pfizer vaccines. The had liver enzyme elevation and inflammation post vaccine. Is this a side effect and should get the booster. The patient believe have been infected twice. The patient was given a test known for false negatives and was sent home from hospital and became bedridden home alone for 6 months. The patient continue to had very poor sense of smell/taste. The patent live in name withheld now a hotbed if New variant cases.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasopharyngitis, Rhinorrhoea
Clinical narrative: head cold; Runny nose; cough; I was tested positive Thursday 31Mar2022 I started your medicine on Saturday.; I was tested positive Thursday 31Mar2022 I started your medicine on Saturday.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) 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 31Mar2022, outcome "unknown" and all described as "I was tested positive Thursday 31Mar2022 I started your medicine on Saturday."; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "head cold"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Mar2022) Positive. Therapeutic measures were taken as a result of covid-19, nasopharyngitis, rhinorrhoea, cough. The patient reported that today is my last day to take Paxlovid. I was tested positive Thursday 31Mar2022 I started your medicine on Saturday. My only symptoms have been a head cold runny nose and a cough no fever. I had my booster vaccination in October how long do I have to wait to get the fourth booster that is now available. Also do you know how long I will still be tested positive even though I no longer have the virus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: head cold; Runny nose; cough; I was tested positive Thursday 31Mar2022 I started your medicine on Saturday.; I was tested positive Thursday 31Mar2022 I started your medicine on Saturday.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) 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 31Mar2022, outcome "unknown" and all described as "I was tested positive Thursday 31Mar2022 I started your medicine on Saturday."; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "head cold"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Mar2022) Positive. Therapeutic measures were taken as a result of covid-19, nasopharyngitis, rhinorrhoea, cough. The patient reported that today is my last day to take Paxlovid. I was tested positive Thursday 31Mar2022 I started your medicine on Saturday. My only symptoms have been a head cold runny nose and a cough no fever. I had my booster vaccination in October how long do I have to wait to get the fourth booster that is now available. Also do you know how long I will still be tested positive even though I no longer have the virus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Indication: Treatment of COVID-19; Indication: 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 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Feb2021 at 10:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "known allergies Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Oct2021 at 11:00, outcome "unknown" and all described as "Indication: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No Other medications in two weeks. Patient received Treatment with Paxlovid from 06Apr2022.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=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 67-year-old male patient received BNT162b2 (BNT162B2), on 15Sep2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "MRSA" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Atenolol, reaction(s): "Known allergies: Atenolol", notes: Known allergies: Atenolol, Vancomycin; Vancomycin, reaction(s): "Known allergies:Vancomycin", notes: Known allergies: Atenolol, Vancomycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 2 days after the suspect product(s) administration, outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: headache; chills; painful joints; swollen lymph node in left armpit (tennis ball sized); This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 10:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "Weak bladder" (unspecified if ongoing), notes: Weak bladder; "ADHD" (unspecified if ongoing); "Vit D deficiency" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN HCTZ; MONTELUKAST SODIUM; BUPROPION HCL; DEXTROAMPHETAMINE [DEXAMFETAMINE]; ALPRAZOLAM; MYRBETRIQ; ESCITALOPRAM; CETIRIZINE HCL; PROPANOLOL [PROPRANOLOL]; AMPHETAMINE SALTS; VITAMIN D [COLECALCIFEROL]; OMEGA 3 [FISH OIL]; FISH OIL. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 06Apr2022 at 10:30, outcome "recovering"; HEADACHE (non-serious) with onset 06Apr2022 at 10:30, outcome "recovering"; ARTHRALGIA (non-serious) with onset 06Apr2022 at 10:30, outcome "recovering", described as "painful joints"; LYMPHADENOPATHY (non-serious) with onset Apr2022, 40 hrs after the suspect product(s) administration, outcome "recovering", described as "swollen lymph node in left armpit (tennis ball sized)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, chills, arthralgia, lymphadenopathy.  Additional information: Reported that Approx. 24 hrs post vaccination - headache, chills, painful joints approx. 40 hrs post vaccination - swollen lymph node in left armpit (tennis ball sized). Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks: Olmesartan-HCTZ 20-12.5mg tab QD (Once a day); Montelukast Sod 10mg tab QD (Once a day); Bupropion HCl 150mg tab QD (Once a day); Dextroamp-Amphetamin 10mg tab PRN; Alprazolam 0.25mg PRN; Myrbetriq ER 25mg tab QD (Once a day); Escitalopram 20mg tab QD (Once a day); Ceterizine HCL 10mg tab QD (Once a day); Propanolol 10mg tablet PRN up to TID; Amphetamine Salts ER 20mg cap QD (Once a day); Vitamin D 1000 Supplement; Omega 3/ Fish Oil capsule. Prior vaccination, patient was not diagnosed for COVID-19. Post vaccination, patient had tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Immunisation, Malaise
Clinical narrative: Profound fatigue; Nausea; Loss of appetite; Night sweats; Dizziness; Not feeling well; Booster; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 at 15:30 as dose 4 (booster), single (Lot number: J9943) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "GERD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "SADD" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FC3592, Location of injection: Arm Right), administration date: 09Sep2021, when the patient was 76-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Apr2022 at 15:30, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 06Apr2022 at 15:30, outcome "unknown"; DIZZINESS (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering", described as "Loss of appetite"; NAUSEA (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; NIGHT SWEATS (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; MALAISE (non-serious) with onset 06Apr2022 at 19:30, outcome "not recovered", described as "Not feeling well"; FATIGUE (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering", described as "Profound fatigue". Therapeutic measures were not taken as a result of fatigue, nausea, decreased appetite, night sweats, dizziness, malaise.  Additional information: The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had not COVID prior vaccination and was not COVID tested post vaccination. known allergies: Yes. Reported Event: 3 hrs. after receiving dose began experiencing, symptoms lasted until 1pm today at that time they started to subside. Patient reported "it is 5pm 07Apr2022 and I am still not feeling well".  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Off label use
Clinical narrative: Profound fatigue; Nausea; Loss of appetite; Night sweats; Dizziness; Not feeling well; Booster; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 at 15:30 as dose 4 (booster), single (Lot number: J9943) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "A-fib" (unspecified if ongoing); "GERD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "SADD" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FC3592, Location of injection: Arm Right), administration date: 09Sep2021, when the patient was 76-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose:2, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Apr2022 at 15:30, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 06Apr2022 at 15:30, outcome "unknown"; DIZZINESS (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering", described as "Loss of appetite"; NAUSEA (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; NIGHT SWEATS (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering"; MALAISE (non-serious) with onset 06Apr2022 at 19:30, outcome "not recovered", described as "Not feeling well"; FATIGUE (non-serious) with onset 06Apr2022 at 19:30, outcome "recovering", described as "Profound fatigue". Therapeutic measures were not taken as a result of fatigue, nausea, decreased appetite, night sweats, dizziness, malaise.  Additional information: The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient had not COVID prior vaccination and was not COVID tested post vaccination. known allergies: Yes. Reported Event: 3 hrs. after receiving dose began experiencing, symptoms lasted until 1pm today at that time they started to subside. Patient reported "it is 5pm 07Apr2022 and I am still not feeling well".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: always gets "hardness at injection site" on her left arm and it goes away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INDURATION (non-serious), outcome "recovered", described as "always gets "hardness at injection site" on her left arm and it goes away".  Additional Information: Question: Reporter states she just received her Pfizer Covid-19 "second booster shot" last Tuesday 05Apr2022. Reporter states she never had any issues before with the vaccine and is calling to report a potential side effect. Reporter states she always gets "hardness at injection site" on her left arm and it goes away. Last night when she was about to sleep, she turned on her side then her heart starts raising and beating extremely rapidly that lasted a minute and a half. No chest pain and shortness of breath. Reporter states when she rolled over slowly it did dissipate. Reporter states she never had that prior to getting the booster shot. Reporter states she didn't know if it is a reaction or can be related to myocarditis.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.