chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Vaccination site pain
Clinical narrative: Injection site is sore (after second booster); Second booster and the nurse said that it was like a full dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site is sore (after second booster)) and ACCIDENTAL OVERDOSE (Second booster and the nurse said that it was like a full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 017F21A, 038B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Second booster and the nurse said that it was like a full dose). On 06-May-2022, the patient experienced VACCINATION SITE PAIN (Injection site is sore (after second booster)). At the time of the report, VACCINATION SITE PAIN (Injection site is sore (after second booster)) and ACCIDENTAL OVERDOSE (Second booster and the nurse said that it was like a full dose) outcome was unknown.            No concomitant medication were reported.  The patient received second booster on 05-May-2022.  No treatment information were provided.   This case was linked to MOD-2022-560530 (Patient Link).   Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental underdose, Fatigue, Lethargy
Clinical narrative: Exceptionally lethargic; Very tired; Patient received secnd dose as 0.3 ml; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Exceptionally lethargic), FATIGUE (Very tired) and ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concurrent condition included (start date- 1995) high cholesterol (Meds have reduced.  Slightly high). Patient not been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Blood pressure high (Meds have reduced BP but still on high side) since 1990, Gout (Improvement-Taking Allpurinol, 300mg No symptoms) since 1998, Hay fever (Allergy injections result in very minor symptoms) since 1950 and Anxiety (Reduced level of anxiety) since 2008. Concomitant products included AMLODIPINE BESYLATE from 1990 to an unknown date and IRBESARTAN from 2000 to an unknown date for Blood pressure high, ALLOPURINOL from 1998 to an unknown date for Gout, ESCITALOPRAM from 2008 to an unknown date for Tension.   On 04-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 01-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 milliliter. On 01-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml). On 02-Apr-2021 at 8:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Very tired). On 01-May-2022 at 9:00 AM, the patient experienced LETHARGY (Exceptionally lethargic). On 03-Apr-2021, FATIGUE (Very tired) had resolved. On 02-May-2022, LETHARGY (Exceptionally lethargic) had resolved. At the time of the report, ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml) outcome was unknown.            On an unknown date in 2016, the patient concomitantly received allergy injections every three week for extract.  On 03Feb2021 and 24Mar2021, one month prior to Moderna COVID-19 vaccine, the patient received allergy injections on both arms.   Treatment medication were not reported.   This case was linked to MOD-2022-557731, MOD-2022-560592, MOD-2022-557731 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Exceptionally lethargic; Very tired; Patient received secnd dose as 0.3 ml; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Exceptionally lethargic), FATIGUE (Very tired) and ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     Concurrent condition included (start date- 1995) high cholesterol (Meds have reduced.  Slightly high). Patient not been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Blood pressure high (Meds have reduced BP but still on high side) since 1990, Gout (Improvement-Taking Allpurinol, 300mg No symptoms) since 1998, Hay fever (Allergy injections result in very minor symptoms) since 1950 and Anxiety (Reduced level of anxiety) since 2008. Concomitant products included AMLODIPINE BESYLATE from 1990 to an unknown date and IRBESARTAN from 2000 to an unknown date for Blood pressure high, ALLOPURINOL from 1998 to an unknown date for Gout, ESCITALOPRAM from 2008 to an unknown date for Tension.   On 04-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 01-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .3 milliliter. On 01-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml). On 02-Apr-2021 at 8:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Very tired). On 01-May-2022 at 9:00 AM, the patient experienced LETHARGY (Exceptionally lethargic). On 03-Apr-2021, FATIGUE (Very tired) had resolved. On 02-May-2022, LETHARGY (Exceptionally lethargic) had resolved. At the time of the report, ACCIDENTAL UNDERDOSE (Patient received secnd dose as 0.3 ml) outcome was unknown.            On an unknown date in 2016, the patient concomitantly received allergy injections every three week for extract.  On 03Feb2021 and 24Mar2021, one month prior to Moderna COVID-19 vaccine, the patient received allergy injections on both arms.   Treatment medication were not reported.   This case was linked to MOD-2022-557731, MOD-2022-560592, MOD-2022-557731 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period; 5 Expired Doses Administered - date of administration on 26-Jan-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Expired Doses Administered - date of administration on 26-Jan-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Expired Doses Administered - date of administration on 26-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Expired Doses Administered - date of administration on 26-Jan-2022) and PRODUCT STORAGE ERROR (Continuously stored in stable FREEZER environment. Only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Overdose, Product preparation error, Pyrexia
Clinical narrative: they administered 0.2 ml, undiluted second dose of the Pfizer Covid-19 vaccine (orange cap) to 11 year old patients; they administered 0.2 ml, undiluted second dose of the Pfizer Covid-19 vaccine (orange cap) to 11 year old patients; fever; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 11-year-old male patient received BNT162b2 (BNT162B2), as dose 2, 0.2 ml single (Lot number: FL8094, Expiration Date: 05Apr2022) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose, Dose: 1st, Date: 02Mar2022, Anatomical site of injection: Deltoid, Route of Administration: Intramuscular, Batch/Lot number: Misplaced/Discarded), administration date: 02Mar2021, when the patient was 11-year-old, for COVID-19 Immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "they administered 0.2 ml, undiluted second dose of the Pfizer Covid-19 vaccine (orange cap) to 11 year old patients"; PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown".  Additional information: Caller was seeking guidance on what to do and any possible effects that the parents need to look for. They said he was fine but caller wanted to find out if there was anything that the parents need to be watching for. The child is healthy normal.  Follow-up (04May2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported in response to HCP letter sent which included that: Updated information: Reporter's address updated, RMH, Anatomical site of administration, Facility details, and new events added   No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: vaccine administration date=16Nov2021; Covid positive; vaccine administration date=16Nov2021; Covid positive; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergy: Tree nut" (unspecified if ongoing); "Known allergy: shellfish" (unspecified if ongoing); "Known allergy: Latex" (unspecified if ongoing); "Known allergy: Sulfa" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; CITALOPRAM; ASPIRIN [ACETYLSALICYLIC ACID]; BIOTIN; CETIRIZINE; VITAMIN D [COLECALCIFEROL]; FISH OIL. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Lidocaine, reaction(s): "Known allergy: Licocaine". The following information was reported: COVID-19 (medically significant) with onset 02May2022 at 14:00, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "vaccine administration date=16Nov2021; Covid positive". 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.  Additional information: Adverse event: Covid positive and started on Paxlovid for 5 days immediately as described above. 3 days after completing paxlovid started with covid symptoms again retested and is positive again.  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 the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive home Covid test; positive home Covid test; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Mar2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild seasonal asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "Sulfa Rx" (unspecified if ongoing). Concomitant medication(s) received in 2 weeks included: ATORVASTATIN; LOSARTAN; METOPROLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01May2022 at 13:00, outcome "recovering" and all described as "positive home Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Positive; (unspecified date) positive; (unspecified date) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Viral rebound w positive home Covid test (Abbott BinaxNOW) on day 12 following start of Paxlovid, cough, congestion, cold-like sx. Paxlovid treatment was started from 22Apr2022 to 26Apr2022.    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 the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Diagnostic aspiration, Fatigue, Hernia, Pain in extremity, Pancreatic cyst
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for Covid-19 immunisation. The patient's family history included: "Rheumatoid arthritis", start date: 10Oct1998 (ongoing), notes: Mother had RA. The patient's concomitant medications were not reported. The following information was reported: HERNIA (medically significant), outcome "unknown"; PANCREATIC CYST (non-serious), outcome "unknown", described as "cyst in pancreatic duct"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "little tiredness". The patient underwent the following laboratory tests and procedures: Diagnostic aspiration: (13Sep2021) for cyst in pancreatic duct; SARS-CoV-2 test: (10Sep2021) negative; (22Oct2021) negative; (06Feb2022) negative. Therapeutic measures were taken as a result of hernia. Clinical course: Vaccination facility type was other and did not administer at Military Facility. The patient did not receive prior vaccinations (within 4 weeks) and did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient had Laparoscopic hernia surgery on 25Oct2021. After speaking with patient's rheumatologist, patient stopped taking methotrexate the week of his Covid booster shot and the week after. The patient has not had an adverse reaction to any Covid-19 shot other than a sore arm and a little tiredness after the 2nd shot. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 74 years for Covid-19 immunisation. The patient's family history included: "Rheumatoid arthritis", start date: 10Oct1998 (ongoing), notes: Mother had RA. The patient's concomitant medications were not reported. The following information was reported: HERNIA (medically significant), outcome "unknown"; PANCREATIC CYST (non-serious), outcome "unknown", described as "cyst in pancreatic duct"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "little tiredness". The patient underwent the following laboratory tests and procedures: Diagnostic aspiration: (13Sep2021) for cyst in pancreatic duct; SARS-CoV-2 test: (10Sep2021) negative; (22Oct2021) negative; (06Feb2022) negative. Therapeutic measures were taken as a result of hernia. Clinical course: Vaccination facility type was other and did not administer at Military Facility. The patient did not receive prior vaccinations (within 4 weeks) and did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient had Laparoscopic hernia surgery on 25Oct2021. After speaking with patient's rheumatologist, patient stopped taking methotrexate the week of his Covid booster shot and the week after. The patient has not had an adverse reaction to any Covid-19 shot other than a sore arm and a little tiredness after the 2nd shot. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: And her son also has covid but has not yet had a booster./  She stated they all have had the Pfizer Covid vaccine for their vaccinations.; And her son also has covid but has not yet had a booster./  She stated they all have had the Pfizer Covid vaccine for their vaccinations.; 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 male patient received BNT162b2 (BNT162B2), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "And her son also has covid but has not yet had a booster. She stated they all have had the Pfizer Covid vaccine for their vaccinations.".  Clinical course: Question: Does Nurtec (Rimegepant) interact with Paxlovid?Caller states that she takes the Nurtec for migraine and has recently felt the beginning of one coming. She was also put on dexamethasone (unknown manufacturer) for her cough while she is being treated with the Paxlovid for her Covid infection. She also stated that it is cloudy outside and that will also cause her to get migraines. In addition, caller mentioned that she had her 4th Pfizer Covid vaccine booster and recently was diagnosed with Covid. Her brother was also boosted with his 4th booster and recently was diagnosed with Covid. And her son also has Covid but has not yet had a booster. She stated they all have had the Pfizer Covid vaccine for their vaccinations.  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: Paxlovid:Treatment of COVID-19; Paxlovid:Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN, start date: 01Nov2020; LISINOPRIL, start date: 01Nov2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: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 covid-19.   Clinical course: The patient took Paxlolvid as treatment from 26Apr2022 to 01May2022. The patient had cold like systems, head congestion from 03May2022.  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 the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Tinnitus
Clinical narrative: continued as intermittent issue for several months, some time lower tone of ringing; 1st dose 26Aug2021/ 2nd dose 01Dec2021; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 48-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2021 at 11:02 as dose 2, single (Lot number: FF2589) at the age of 48 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Sinusitis", start date: 26May2021 (ongoing), notes: Pertinent details: Endoscopic procedure in November D/T sinus re-alleviant injection; "Rhinosinusitis Chronic" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE] nasal taken for sinusitis, start date: Sep2021 (ongoing); BUDESONIDE nasal taken for sinusitis, start date: Nov2021 (ongoing); BENADRYL oral taken for sinusitis, start date: 2020 (ongoing); CLARITIN [LORATADINE] oral taken for sinusitis, start date: 2020 (ongoing). Vaccination history included: BNT162b2 (Dose Number: 1, Date: 26Aug2021, Time (24 hr): 1104, Site and route of injection: Left deltoid, Route of administration: Intramuscular, Batch/lot number: FD0809), administration date: 26Aug2021, when the patient was 48-year-old, for COVID-19 immunization, reaction(s): "moderate hearing loss", "ear ringing/ringing bilateral ear", "sinus re-current infection", "sinus re-current infection". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Dec2021 at 11:02, outcome "unknown", described as "1st dose 26Aug2021/ 2nd dose 01Dec2021"; TINNITUS (non-serious), outcome "not recovered", described as "continued as intermittent issue for several months, some time lower tone of ringing".  Additional information: Reporter was unsure if the Pfizer product had a causal effect to the adverse event. Vaccine facility type was workplace clinic. Vaccine was not administered at private facility. Prior vaccinations was reported as none. Report ongoing ringing bilateral ears approximately starting 2 hours with 1st vaccine. During ENT procedure ears were evaluated. Patient told ear issue or treatable concerns/ signs they noted for her ringing. Continued as intermittent issue for several months, some time lower tone of ringing that does not cause as much disruption. No specific relevant test for thromboembolic events with thrombocytopenia.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Illness, SARS-CoV-2 test
Clinical narrative: She states she had a metallic taste in her mouth after her 2nd dose of the COVID-19 vaccine; felt a little sick; 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 24Feb2021 as dose 2, single (Lot number: EL3247) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis throughout her body and everything esle is good; 10 years ago; "Cough" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for bronchitis, start date: 27Apr2022, stop date: 01May2022; BENZONATATE, start date: 27Apr2022, stop date: 30Apr2022; PROZAC taken for anxiety; NAPROXEN taken for arthritis. Vaccination history included: BNT162b2 (Dose 1, Lot number: EL9265 , Anatomical Location: Left upper arm.), administration date: 03Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "quite sick", "chills", "tired", "just felt like the flu", "metallic taste in her mouth"; Flu vaccine (Flu Shot many years ago); Shingles. The following information was reported: DYSGEUSIA (non-serious) with onset 24Feb2021, outcome "unknown", described as "She states she had a metallic taste in her mouth after her 2nd dose of the COVID-19 vaccine"; ILLNESS (non-serious) with onset 24Feb2021, outcome "unknown", described as "felt a little sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She stated she slept for 3 days but didn't have a cough felt like the flu. She stated she had a metallic taste in her mouth after her 2nd dose of the COVID-19 vaccine and felt a little sick but not as much and she was fine after her booster dose of the COVID-19 vaccine. Caller stated there were no additional vaccines administered on same date of the Pfizer suspect. She stated on Wednesday she took a COVID test and the test was negative. She stated on Sunday, 01May2022 she tested positive for COVID. Caller stated she took the same test on Wednesday because she had the cough. She took a test herself on Sunday, 01May2022 and she was positive.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Since I received my second dose of the vaccine. I have been getting allergies non stop; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "Since I received my second dose of the vaccine. I have been getting allergies non stop". The event "since i received my second dose of the vaccine. i have been getting allergies non stop" required physician office visit. Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Patient have been to different type of hospitals and doctors and they keep prescribing medicine but nothing helped patient.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Pericarditis, Pleural effusion, Pulmonary embolism
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 72-year-old female patient received BNT162b2 (BNT162B2), on 09Feb2022 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, Single: Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single: Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Single, First Booster dose, unknown manufacturer), for COVID-19 immunization. The following information was reported: PERICARDITIS (hospitalization, medically significant), outcome "unknown"; PULMONARY EMBOLISM (hospitalization, medically significant), outcome "unknown", described as "pulmonary emboli"; ATRIAL FIBRILLATION (hospitalization, medically significant), outcome "unknown", described as "AFib"; PLEURAL EFFUSION (hospitalization), outcome "unknown". The patient was hospitalized for pericarditis, pulmonary embolism, atrial fibrillation, pleural effusion (start date: 14Feb2022, hospitalization duration: 7 day(s)). Therapeutic measures were taken as a result of pericarditis, pulmonary embolism, atrial fibrillation, pleural effusion. Additional information: On 09Feb2022, Patient took a 2nd Pfizer booster. On 14Feb2022, Patient was admitted to the hospital with pericarditis, pulmonary emboli, AFib, and subsequently pleural effusion. Patient was in the hospital for 7 days over a two week period. Patient was with no underlying factors at the time. Her PCP reported her case to the CDC, since it was determined that what she developed was vaccine related. Patient was on multiple meds and was out on work disability and trying to get her life back. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Purulent discharge, Vaccination site mass
Clinical narrative: 1 year later injection site had a bubble that never went away; t started oozing dried dark puss today until the small bubble went away completely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Aug2021 at 12:00 as dose 2, single (Lot number: Fc3181) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Red and green dye" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensative to Elm, elderberry, corn. Rice and milk; "Known allergies: Sensitive to Elm" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk; "Known allergies: elderberry" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk; "Known allergies: corn. Rice" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk; "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Known allergies: milk" (unspecified if ongoing), notes: Known allergies: Red and green dye. Sensitive to Elm, elderberry, corn. Rice and milk. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW0181, Location of injection: Arm Right, Vaccine Administration Time: 05:00 PM, When the 1st shot was given, I felt extremely tired and sleepy. My arm also hurt for days.), administration date: 23Jul2021, when the patient was 43-year-old, for COVID-19 Immunization, reaction(s): "felt extremely tired", "sleepy", "My arm also hurt for days". The following information was reported: VACCINATION SITE MASS (non-serious) with onset 03May2022 at 15:00, outcome "recovered", described as "1 year later injection site had a bubble that never went away"; PURULENT DISCHARGE (non-serious) with onset 03May2022 at 15:00, outcome "recovered", described as "t started oozing dried dark puss today until the small bubble went away completely". Therapeutic measures were not taken as a result of vaccination site mass, purulent discharge.  Additional information- Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was list of other medications Seamoss the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Costochondritis, Inappropriate schedule of product administration
Clinical narrative: Costochondritis; Dose 1: 21Feb2021; Dose 2: 22Feb2022; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 22Feb2022 as dose 2, single (Lot number: unknown), at the age of 28 years, Intramuscular, in the right arm for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: Penicillins and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient did not receive any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Route of administration: Intramuscular; Anatomical site; Left arm), administration date: 21Feb2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset an unknown date in Feb2022, outcome "unknown", described as "Dose 1: 21Feb2021; Dose 2: 22Feb2022"; COSTOCHONDRITIS (non-serious) with onset 26Apr2022 at 12:00, outcome "not recovered". Therapeutic measures were taken as a result of costochondritis.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment for the event costochondritis included non-steroidal anti-inflammatory drugs (NSAID). Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: When the 1st shot was given, I felt extremely tired and sleepy; When the 1st shot was given, I felt extremely tired and sleepy; My arm also hurt for days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2021 at 17:00 as dose 1, single (Lot number: EW0181) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Milk" (unspecified if ongoing); "Known allergies: Rice" (unspecified if ongoing); "Known allergies: Elderberry" (unspecified if ongoing); "Known allergies: Corn" (unspecified if ongoing); "Known allergies: Sensative to Elm" (unspecified if ongoing); "Known allergies: Red and green dye" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: FATIGUE (non-serious), SOMNOLENCE (non-serious), all with latency 8 months 13 days 15 hrs after the suspect product(s) administration, outcome "unknown" and all described as "When the 1st shot was given, I felt extremely tired and sleepy"; PAIN IN EXTREMITY (non-serious), 8 months 13 days 15 hrs after the suspect product(s) administration, outcome "unknown", described as "My arm also hurt for days".  Additional information: Patient did not receive any other vaccine in four weeks. Other medications in two weeks reported as Seamoss. It was reported that 1 year later injection site had a bubble that never went away. It started oozing dried dark puss today until the small bubble went away completely. When the 1st shot was given, the patient felt extremely tired and sleepy. Her arm also hurt for days. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 29Apr2021 as dose 2, single (Lot number: EW0170) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Facility type vaccine: Other. If other vaccine in four weeks: No. Concomitant medication(s) included in two weeks: ATORVASTATIN; PROGESTERONE; ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Covid test result=Positive". If covid prior vaccination: No. If covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab. Covid test name post vaccination=Unknown. Covid test date: 28Dec2021. Covid test result: Positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2021) Positive.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: EP7533), in right arm and on 29Apr2021 as dose 2, single (Lot number: EW0170) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Facility type vaccine: Other. If other vaccine in four weeks: No. Concomitant medication(s) included in two weeks: ATORVASTATIN; PROGESTERONE; ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Covid test result=Positive". If covid prior vaccination: No. If covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab. Covid test name post vaccination=Unknown. Covid test date: 28Dec2021. Covid test result: Positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Dec2021) Positive.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I've noticed a ringing in my ears since I got the vaccine in Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; PROGESTERONE; ESTRADIOL. Vaccination history included: BNT162b2 (prev dose brand unknown=False, prev dose lot number=EP7533, prev dose lot unknown=False, prev dose administration date=08Apr2021, prev dose dose number=1, prev dose vaccine location=Right arm), administration date: 08Apr2021, when the patient was 51-year-old, for Covid-19 Immunization, reaction(s): "covid test result Positive"; bnt162b2 (Dose 2, lot number=EW0170), administration date: 29Apr2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset May2022, outcome "not recovered", described as "I've noticed a ringing in my ears since I got the vaccine in Apr2022". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: There were no other vaccine in four weeks. There were no COVID prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: I've noticed a ringing in my ears since I got the vaccine in Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; PROGESTERONE; ESTRADIOL. Vaccination history included: BNT162b2 (prev dose brand unknown=False, prev dose lot number=EP7533, prev dose lot unknown=False, prev dose administration date=08Apr2021, prev dose dose number=1, prev dose vaccine location=Right arm), administration date: 08Apr2021, when the patient was 51-year-old, for Covid-19 Immunization, reaction(s): "covid test result Positive"; bnt162b2 (Dose 2, lot number=EW0170), administration date: 29Apr2021, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset May2022, outcome "not recovered", described as "I've noticed a ringing in my ears since I got the vaccine in Apr2022". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus.  Additional information: There were no other vaccine in four weeks. There were no COVID prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/tested positive for antigen and PCR; Treatment of COVID-19/tested positive for antigen and PCR; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose  2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/tested positive for antigen and PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for antigen and PCR; Positive, notes: tested positive for antigen and PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: No other medication in 2 weeks. No Known allergies. The patient had disease recurrence developed cough and sore throat and tested positive for antigen and PCR on 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: imbalance issue; 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 12-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 2, single (Lot number: 30145BA) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0191), administration date: Sep2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: BALANCE DISORDER (non-serious) with onset Dec2021, outcome "not recovered", described as "imbalance issue". The event "imbalance issue" required physician office visit.  Additional information: Caregiver for 12 year old daughter vaccinated in September. Caller stated that in December, daughter began having "imbalance" issues after running or strenuous activity. Daughter's HCP did not think there was a connection, but mother was reaching out to find any information available about other cases or to receive medical suggestions. Reporter stated, "she was speaking to her cousin and he suggested I contact Pfizer so my daughter had the vaccine for the corona virus both of them in September and December until now she had an imbalance issue. Now, doctor can't seem to figure out what's wrong with issue, it was perfectly healthy before. So she was sure if you have see patient with this type of situation he has mentioned that some times the pharmaceutical company have medical people that you speak to when you have symptom that could to could not be related to you know something like that that why I am calling I don't know what department it was. Reporter was informed about role of Pfizer drug safety department and Pfizer medical information department.  No follow-up attempts are possible. No further information is expected.