chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient have been administered from an expired dose) in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Reporter stated that the vial was initially stored in the refrigerator on 08-Mar-2022 (5 doses) and the dates of administration of the vaccine was 29-Mar-2022 with 1 dose and 31-Mar-2022 with 4 doses and another vial was initially stored in the refrigerator on 30-Mar-2022 (2 doses) and the dates of administration of the vaccine was 05-Apr-2022 with 2 doses. And also sated that the vial did not undergo any temperature excursions and Patient did not experienced any side effects.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Vaccine administration dates were updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Date the vial was initially stored in the refrigerator on 8-Mar-2022 (5 doses) and 30-Mar-2022 (2 doses) Dates of administration of vaccine on 29-Mar-2022 gave 1 dose, 31-Mar-2022  gave 4 doses and 05-Apr-2022 gave 2 doses. The vial did not undergo any temperature excursions. The patient did not experienced any side effects.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up information included-Dates of vaccine Administration updated
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving expired doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving expired doses) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Vial was initially stored in the refrigerator on 31 Aug 2021 and it was reported that the vial did not undergo ay temperature excursion. Treatment medication was not provided by the reporter.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after manufacturer date of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after manufacturer date of expiry) in an 83-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Date the vial was initially stored in the refrigerator was on 08 Mar 2022 (5 doses) was administered on 29 Mar 2022 gave 1 dose and 31 Mar 2022 gave 4 doses.Date the vial was initially stored in the refrigerator was on 30 Mar 2022 (2 doses) and administered on 05 Apr 2022. The vial did not undergo any temperature excursions. It was reported that the patient had no side effects. No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up information received and added dates of vaccine administration.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 79-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on 8-Mar-2022 (5 doses) and 30-Mar-2022 (2 doses) Dates of administration of vaccine on 29-Mar-2022 gave 1 dose, 31-Mar-2022  gave 4 doses and 05-Apr-2022 gave 2 doses. The vial did not undergo any temperature excursions. No concomitant medication were provided No treatment details were provided   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up information included-Dates of vaccine Administration updated
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the patient had been administered from an expired dose. The dose was administered after manufacturer date of expiry. It was reported that the vial didn't undergo any temperature excursions.  The dates of administration of the vaccine were 29-Mar-2022 given 1 dose and 31-Mar-2022 given 4 doses. These 5 doses were given from the vials which were initially stored in the refrigerator on 08-Mar-2022.  The other date of administration of the vaccine was 05-Apr-2022 given 2 doses. These 2 doses were given from the vial was initially stored in the refrigerator on 30-Mar-2022.  It was also reported that the patient had no side effects.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up received contains information about date of administration of vaccine and refrigeration dates. Updated the information in the I-narrative.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 7 patients have been administered from an expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients have been administered from an expired dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The vial Didn't undergo any temperature excursions The vials initially stored in the refrigerator on 08March2022 & The dates of administration of the vaccine - 3/29/22 gave 1 dose and 3/31/22 gave 4 doses. The vials initially stored in the refrigerator on 30March2022 & The dates of administration of the vaccine? 4/5/22 gave 2 doses  No Concomitant Medications were provided by the Reporter      No Treatment Medications were provided by the Reporter   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Live Follow up received contains Significant information of Dates of vaccine  Administration updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna Covid 19 vaccine from a vial that was expired/Been giving expired vaccine by 2 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  It was reported that the two vials were initially stored in the refrigerator on 24-Mar-2022. The vaccine were administered (1 or 2 doses) 02-Apr-2022 and (3 doses of 0.25 mL) on 03-Apr-2022. It was also reported that vial did not undergo any temperature excursions it was kept in freezer up until 24-Mar-2022. Estimated total doses were 5 and all doses administered intramuscularly and were booster doses of 0.25 mL.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow up received included. Suspect vaccine information and event onset date were added. Updated narrative.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm after his first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm after his first vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (sore arm after his first vaccine). At the time of the report, MYALGIA (sore arm after his first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  The patient donated blood and tested for Covid-19 positive vaccine antibodies.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up document received contains no new information.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022; dose administered from vial 33 days after stored in fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial did not undergo any temperature excursions.  It was reported that, analysis of the vials associated with your storage excursion was complete. The vaccine administered on 27-Mar-2022 from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Follow up received: Added suspect administration date, onset date of event expired vaccine use and updated narrative supplement.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus symptoms / developed permanent bilateral tinnitus after vaccine; The initial case was missing the following minimum criteria: Other Info not qualifying for AE reporting. Upon receipt of follow-up information on 04Apr2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 18 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus symptoms / developed permanent bilateral tinnitus after vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertrophic cardiomyopathy, Left ventricular hypertrophy
Clinical narrative: Hypertrophic cardiomyopathy; Left Ventricular Hypertrophy with Dyspnea; Left Ventricular Hypertrophy with Dyspnea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: 33130BA) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EP7534), administration date: 22Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose: 2, Lot Number: ER8737), administration date: 12Apr2021, for COVID-19 Immunization. The following information was reported: HYPERTROPHIC CARDIOMYOPATHY (medically significant), outcome "unknown", described as "Hypertrophic cardiomyopathy"; LEFT VENTRICULAR HYPERTROPHY (non-serious), DYSPNOEA (non-serious), outcome "unknown" and all described as "Left Ventricular Hypertrophy with Dyspnea". The events "hypertrophic cardiomyopathy", "left ventricular hypertrophy with dyspnea" and "left ventricular hypertrophy with dyspnea" were evaluated at the physician office visit. The patient reported that he has been diagnosed with Left Ventricular Hypertrophy with Dyspnea and Hypertrophic cardiomyopathy. His cardiologist cannot find the origin of heart condition.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Mild left arm pain; body aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2021 (Lot number: EM9809) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Allergies. The patient's concomitant medications were not reported. Past drug history included: Advair, reaction(s): "oral ulcers", notes: Known allergies: Advair causes oral ulcers; Advair, reaction(s): "Known allergies: Advair", notes: Known allergies: Advair causes oral ulcers. The following information was reported: PAIN IN EXTREMITY (disability) with onset Feb2021, outcome "unknown", described as "Mild left arm pain"; PAIN (disability) with onset Feb2021, outcome "unknown", described as "body aches"; FATIGUE (disability) with onset Feb2021, outcome "unknown", described as "fatigue".  No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: caught covid; caught covid; 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) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single 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), outcome "unknown" and all described as "caught covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19. Clinical Course: It was reported that patient had triple vaccinated however last week he caught covid and was prescribed with Paxlovid. He is to travel next month and he would like to know if the Paxlovid would have any effect on his natural immunity. Would it lower his natural immunity from the covid infection that he just had (when you get an infection from Covid you body produces natural immunity, would this paxlovid lower that amount of immunity).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid on 26Mar2022.; Diagnosed with Covid on 26Mar2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 19 year-old male patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) at the age of 19 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Asthma diagnosed around 2 months of age. It was chronic; "antidepressant" (unspecified if ongoing). Family history included: "Covid-19" (unspecified if ongoing), notes: His son is at his mother's and his mother has COVID too; "They are quarantining together." (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE taken for antidepressant therapy, stop date: 26Mar2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Mar2022, outcome "unknown" and all described as "Diagnosed with Covid on 26Mar2022.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Mar2022) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: The report was not related to a study or programme. His son wasn't boosted but received the vaccines back in Aug2021. The patient was taking Trazodone for depression. His son had been taking it for about six months. The patient had stopped taking Trazodone on (Saturday) 26Mar2022 because of something they read. Doesn't have NDC, lot, and expiry for the Trazodone to provide. That was the only medicine he was on. Reporter's son was prescribed Paxlovid the antiviral for Covid. The patient started taking Paxlovid (Sunday night) on 27Mar2022. The reporter mentioned that PAXLOVID had been working phenomenally for his son. His son had asthma and that was why they put him on Paxlovid. His son had Covid obviously, but reporter was not sure if it was a side effect from Covid or Paxlovid. Reporter clarified that his son was vaccinated against COVID when he got COVID. The reporter confirmed that his son got the Pfizer shot. His son had a sore on his tongue on 29Mar2022. They are in state didn't and go with Moderna. Doesn't have his son's Covid vaccination card to provide NDC, lot, and expiry for the Covid vaccines he received.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Nasal Swab: Positive; Nasal Swab: Positive; 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 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Aug2021 (Lot number: fc3183) at the age of 62 years as dose 1, single and administered in arm left, administration date 10Sep2021 (Lot number: fe3592) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: BENAZEPRIL; OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL, start date: Apr2021; CORTEF [HYDROCORTISONE ACETATE], start date: Aug2017. Past drug history included: Tacrolimus ointment, reaction(s): "known allergies:Tacrolimus ointment", notes: known allergies Tacrolimus ointment. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "COVID-19 Treatment".It was reported that the patient took anti-viral treatment for COVID-19 from 26Mar2022 to 29Mar2022.Device timestamp: 30Mar2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Loss of personal independence in daily activities
Clinical narrative: arthritis; I can barely dress myself, wash my hair or do any of the everyday things I used to take for granted like bending over to pick up something.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "arthritis"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I can barely dress myself, wash my hair or do any of the everyday things I used to take for granted like bending over to pick up something.".  Additional Information: Patient had been extremely healthy my whole life until I got vaccinated. The first 2 vaccines gave me a mild boast of arthritis, but the booster has made me practically an invalid. I'm 76 so I needed to be careful and heed the covid warnings. Now I am trying to find a solution for arthritis that doesn't say it will give me stroke, heart attack, or death. I can barely dress myself, wash my hair or do any of the everyday things I used to take for granted like bending over to pick up something.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Peripheral swelling, Pyrexia, Rash erythematous
Clinical narrative: I have rash; its not a rash, its swollen up, its kind of reddish; my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up; my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up; it felt like I have a fever but it calm down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2022 (Batch/Lot number: unknown, Expiration Date: 05May2022) at the age of 72 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Medical History (disease /surgical procedure / etc.): Glaucoma; "Allergy" (unspecified if ongoing), notes: I do use an allergy pill and the allergy medication which is antihistamine diph, I can't pronounce it. Concomitant medication(s) included: TIMOLOL [TIMOLOL MALEATE] taken for glaucoma; SEROVIT; GABAPENTIN; CYCLOBENZAPRINE; LOVASTATIN; VITAMIN D NOS; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "I have rash; its not a rash, its swollen up, its kind of reddish"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up"; PYREXIA (non-serious), outcome "unknown", described as "it felt like I have a fever but it calm down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash erythematous, peripheral swelling, pain in extremity, pyrexia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Renal function test, Thyroid function test
Clinical narrative: I have rash; its not a rash, its swollen up, its kind of reddish; my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up; my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up; it felt like I have a fever but it calm down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2022 (Batch/Lot number: unknown, Expiration Date: 05May2022) at the age of 72 years as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "Glaucoma" (unspecified if ongoing), notes: Medical History (disease /surgical procedure / etc.): Glaucoma; "Allergy" (unspecified if ongoing), notes: I do use an allergy pill and the allergy medication which is antihistamine diph, I can't pronounce it. Concomitant medication(s) included: TIMOLOL [TIMOLOL MALEATE] taken for glaucoma; SEROVIT; GABAPENTIN; CYCLOBENZAPRINE; LOVASTATIN; VITAMIN D NOS; VITAMIN D3. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "I have rash; its not a rash, its swollen up, its kind of reddish"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "my arm is swelled up from, its sore, wasn't sore before; its a lot sore then it was before but it bothers me, it felt like I have a fever but it calm down but its still swollen up"; PYREXIA (non-serious), outcome "unknown", described as "it felt like I have a fever but it calm down". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash erythematous, peripheral swelling, pain in extremity, pyrexia.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hepatomegaly, Herpes zoster
Clinical narrative: 89yr old mother (former nurse) and states her mother got "a very bad outbreak of shingles; liver was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 89 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "sinus infection".  The following information was reported: HERPES ZOSTER (non-serious), outcome "not recovered", described as "89yr old mother (former nurse) and states her mother got "a very bad outbreak of shingles"; HEPATOMEGALY (non-serious), outcome "unknown", described as "liver was swollen".  Additional information: Reporter is a consumer who is reporting on behalf of her 89year old mother (former nurse) and stated her mother got "a very bad outbreak of shingles" a "day or 2" after receiving her 3rd dose (booster dose) of Pfizer Covid19vaccine. Reporter states that her mother received the Shingles vaccines several years ago. Reporter states that the shingles have now blistered over and now in area where she broke out, she has severe swelling, and it looks like there could be "liver" involvement (they are waiting on a sonogram). She got the Pfizer COVID 19 first dose and on her second dose, she got sinus infection and when she received third dose about a month ago, she came out with shingles and liver was swollen. Shingles has been about 3-4 weeks since she developed it, which was a couple of days after getting the third vaccine dose. Shingles is in the same area of the liver.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: My friend (60 yrs old) had high blood pressure after the Pfizer Covid19 vaccine."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 60 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "My friend (60 yrs old) had high blood pressure after the Pfizer Covid19 vaccine."". Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vomiting
Clinical narrative: fatigue - 24 hours; vomiting 2 days later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2022 10:15 (Batch/Lot number: unknown) at the age of 77 years as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 14:00), administration date: Oct2021, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 10:00), administration date: Feb2021, when the patient was 75 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Jan2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue - 24 hours"; VOMITING (non-serious), outcome "recovered", described as "vomiting 2 days later". Therapeutic measures were not taken as a result of fatigue, vomiting.  Additional information: Facility type vaccine: Hospital, If other vaccine in four weeks: No. Adverse event fatigue - 24 hours. Vomiting 2 days Later. If covid prior vaccination: No. If covid tested post vaccination: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Off label use, Product use issue
Clinical narrative: Off label use; Drug use in unapproved population; dry cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 24Jun2021 (Lot number: EW0187) at the age of 20 years as dose 1, single and administered in deltoid left, administration date 15Jul2021 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: COUGH (non-serious) with onset 2021, outcome "not recovered", described as "dry cough"; OFF LABEL USE (non-serious) with onset 24Jun2021, outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 24Jun2021, outcome "unknown", described as "Drug use in unapproved population". Therapeutic measures were taken as a result of cough. Additional information: The patient received dose 2 at the age of 21 years. Patient took vitamins daily, so Selenium, Zinc, Vitamin C, Vitamin D, Iron, Calcium (further not clarified). Patient had no prior vaccinations (within 4 weeks). Patient stated that she was breastfeeding at the time of her vaccine (further not clarified). Patient used a cough drop as treatment on the days it got worse and other days, she just cough it out.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200513465 same reporter/drug, different patient/event, baby case
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: chills; feelings of nauseousness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200519167 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 3 (booster), single 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, reaction(s): "No adverse event". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; NAUSEA (non-serious), outcome "unknown", described as "feelings of nauseousness".  Additional Information: I had my 4th Pfizer shot yesterday. Shot #1 - no reaction. Shots #2 & #3, started 8-hours post-shot and included chills and feelings of nauseousness. Reaction after 4th shot was more severe: severe chills started after 8-hours, nauseousness including vomiting, diarrhea, etc. No fever. This lasted about 6-hours then began to subside. I'm a little pooped today due to lack of rest, but all will be O.K. I'm just trying to figure out what occurred!  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200516760 Same Reporter, Different Vaccine Dose
Sex: U
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen decreased
Clinical narrative: At that time my PSA was 0.26 this was 8Oct. As of 01Apr22 my PSA is 0.11. I got my booster on 08Oct. Your Covid vaccine may be responsible; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "prostate cancer", start date: 2009 (unspecified if ongoing), notes: i have been fighting prostate cancer since 2009; "my cancer metastasized to my bones", start date: 2013 (unspecified if ongoing), notes: Anyway in 2013 my cancer metastasized to my bones. Concomitant medication(s) included: LYNPARZA, start date: Dec2021. 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. The following information was reported: PROSTATIC SPECIFIC ANTIGEN DECREASED (non-serious) with onset 01Apr2022, outcome "unknown", described as "At that time my PSA was 0.26 this was 8Oct. As of 01Apr22 my PSA is 0.11. I got my booster on 08Oct. Your Covid vaccine may be responsible". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Patient had to many treatments to count on all fingers. Anyway, in 2013 patient cancer metastasized to bones. Patient cancer was from 11Sep was a first responder. Anyway, cancer was NEVER IN REMISSION. Last Dec, Patient was taking Linprazza and various other drugs. Patient's oncologist took off the linprazza. At that time patient's PSA was 0.26 this was 08Oct. As of 01Apr22 patient's PSA was 0.11. Patient got booster on 8Oct and reported that Covid vaccine may be responsible.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: fully vaccinated and boosted but still had a breakthrough case of COVID where the patient was very ill; fully vaccinated and boosted but still had a breakthrough case of COVID where the patient was very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic Lyme disease, Epstein Barr and babesiosis" (unspecified if ongoing), notes: chronic Lyme disease, Epstein Barr and babesiosis. The patient's concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "fully vaccinated and boosted but still had a breakthrough case of COVID where the patient was very ill". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective, illness. Paxlovid saved the patient. The patient believed it knocked other virus out because he/she had chronic Lyme disease, Epstein Barr and babesiosis. Recently the patient had been pale and tired. The patient was not sure what else the drug treated but felt better than he/she had in years. The feet no longer hurt when he/she walked in the AM and energy had tripled.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Carbohydrate intolerance, Glucose tolerance impaired
Clinical narrative: can no longer tolerate carbs/sugar; can no longer tolerate carbs/sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CARBOHYDRATE INTOLERANCE (non-serious), GLUCOSE TOLERANCE IMPAIRED (non-serious), outcome "unknown" and all described as "can no longer tolerate carbs/sugar". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient could control blood sugar with 2-500 mg tablets of metformin before 3 vaccinations for COVID 19 and could eat most carbs and a small amount of sugar in moderation. After booster dose that changed rapidly and patient was taking 2-1000 mg metformin. Patient was trying hard to make life changes but patient might need to start insulin soon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: she lost her sense of taste; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), outcome "not recovered", described as "she lost her sense of taste". Additional information Reporter verifies that she is talking about the Pfizer Covid Vaccine. Reporter said that she had all the Pfizer covid-19 vaccines, including the booster. She stated that after her first dose, which is 2 years ago, she lost her sense of taste after the first vaccination. Says she has never gotten her sense of taste back.  Asks will her sense of taste ever come back, She wanted to know if this has been reported before, when will it comeback or how long it will last. She added that she already contacted her HCP and said that this is a vaccine related since it only happened after that.  The lot number for bnt162b2 was not provided and will be requested during follow up.