chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; We had 4 patients that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (We had 4 patients that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (We had 4 patients that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (We had 4 patients that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (We had 4 patients that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose.).    Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-654131, US-MODERNATX, INC.-MOD-2022-654136 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654136:same reporter US-MODERNATX, INC.-MOD-2022-654131:same reporter
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose).    No concomitant medications were provided.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654131, US-MODERNATX, INC.-MOD-2022-654129, US-MODERNATX, INC.-MOD-2022-654135 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654131:same reporter US-MODERNATX, INC.-MOD-2022-654129:same reporter US-MODERNATX, INC.-MOD-2022-654135:same reporter
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022; No adverse event; Patient received vaccine after the 30 days beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 21Jun2022, vaccine administered on 17Aug2022).    No concomitant drug was reported.  The vial size was reported as 2.5 ml.  It was reported that Lot AS1414B was moved from the freezer to the refrigerator on 21-Jun-2022.  It was reported that the vial did not undergo temperature excursions.  They had multiple doses administered after the 30 days beyond use date.  None of patients reported experiencing any symptoms after receiving those doses.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654157, US-MODERNATX, INC.-MOD-2022-654164, US-MODERNATX, INC.-MOD-2022-654166, US-MODERNATX, INC.-MOD-2022-654171, US-MODERNATX, INC.-MOD-2022-654167 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654157:Patient 1 (same reporter) US-MODERNATX, INC.-MOD-2022-654164:Patient 3 (same reporter) US-MODERNATX, INC.-MOD-2022-654166:Patient 4 (same reporter) US-MODERNATX, INC.-MOD-2022-654171:Patient 6 (same reporter) US-MODERNATX, INC.-MOD-2022-654167:Patient 5 (same reporter)
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Physician recommended a lower than authorized dose of the Moderna Bivalent booster dose for an immunocompromised patient).    Concomitant product use was not provided by the reporter.  A pharmacist reported about a patient whose physician recommended that the patient receive a lower/a lower than authorized dose of Moderna COVID-19 bivalent booster dose because the patient was immunocompromised.  Treatment information was not provided.   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itching right arm injection site after Bivalent booster; Swelled up right arm injection site within a couple of hours after Bivalent booster/Feels like a large egg on the right arm after Bivalent booster; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching right arm injection site after Bivalent booster) and VACCINATION SITE SWELLING (Swelled up right arm injection site within a couple of hours after Bivalent booster/Feels like a large egg on the right arm after Bivalent booster) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included TOPIRAMATE (TOPAMAX), ALLOPURINOL (ELAVIL [ALLOPURINOL]) and ERENUMAB (AIMOVIG [ERENUMAB]) for Migraine.    On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced VACCINATION SITE SWELLING (Swelled up right arm injection site within a couple of hours after Bivalent booster/Feels like a large egg on the right arm after Bivalent booster). On 29-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (Itching right arm injection site after Bivalent booster). At the time of the report, VACCINATION SITE PRURITUS (Itching right arm injection site after Bivalent booster) and VACCINATION SITE SWELLING (Swelled up right arm injection site within a couple of hours after Bivalent booster/Feels like a large egg on the right arm after Bivalent booster) outcome was unknown.            The formulation of concomitant drug Topamax was reported as Pill.   On 27 Sep 2022 and again she had a reaction on right arm injection site. The patient received all the shots in right arm. The patient states that within a couple of hours after receiving a Bivalent booster, right arm swelled up and it was itching. It felt like a large egg on the right arm. Itching started on 29 Sep 2022 at night. The patient states that she was not visited a doctor regarding any of reactions, not after Bivalent.   No treatment medication was provided by the reporter.   This case was linked to MOD-2021-028783, MOD-2021-042448, MOD-2022-583956, MOD-2022-583961 (Patient Link).
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Sep-2022 at 9:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine, Bivalent was administered greater than 12 hrs after the 1st puncture).    No concomitant information were reported.  The reporter asked for some stability information.  On 29-Sep-2022 at 11 am PT, the vial (size 2.5 mL) was first punctured.  The vial was refrigerated post puncture. The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C = 46 degree to 77 degree F) was reported as refrigerated for 22.5 hours.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Central nervous system lesion, Hypoaesthesia, IIIrd nerve injury
Clinical narrative: lesion on my 3rd nerve; a brain lesion on the base left side of my brain; my right arm and hand are all numb for the last year and a half; The initial case was missing the following minimum criteria: This case has been considered invalid as - Unspecified product. Upon receipt of follow-up information on (28Sep2022), 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). The reporter is the patient.  A patient (no qualifiers provided) 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: IIIRD NERVE INJURY (medically significant), outcome "unknown", described as "lesion on my 3rd nerve"; CENTRAL NERVOUS SYSTEM LESION (non-serious), outcome "recovered with sequelae", described as "a brain lesion on the base left side of my brain"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "my right arm and hand are all numb for the last year and a half".  Additional information: Initially on 04Sep2021, patient stated Pfizer shot gave me a lesion on my 3rd nerve. I'm incapacitated now for over 4 months. Upon FU on 28Sep2022, patient stated I had an immune reaction to the first series of the covid-19 shot. I was diagnosed with a brain lesion on the base left side of my brain. The lesion is gone but where the lesion was a 1 cm hole remains. This controls my motor skills my vision my sense of awareness my mouth and taste. my right arm and hand are all numb for the last year and a half. I've seen five neurologists and they all say it's an immune reaction. Presently seeing a neurologist at (withheld) in (city withheld) who agrees.  Follow-up attempts completed. No further information expected.  Follow-up (28Sep2022): This is a spontaneous follow-up report received from the contactable consumer.  Updated information included: Reporter information (Alternate phone number in slider#1 added and address updated). Patient details (address updated). Event (a brain lesion on the base left side of my brain and my right arm and hand are all numb for the last year and a half added).  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: Agitation, Discomfort
Clinical narrative: 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: AGITATION (hospitalization), DISCOMFORT (hospitalization), outcome "unknown" and all described as "his son was agitated, uncomfortable, he was taken to the hospital". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical information: The patient was agitated, uncomfortable, he was taken to the hospital. The patient got a shot of the Pfizer Covid vaccine but in the clinic they have a big mistake and the reporter was worried about his son.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (29Sep2022): This is a spontaneous follow-up report from a contactable consumer. This consumer reported in response to Non-HCP letter sent via telephonic follow-up activity which included that:    Updated information included: New events added. Hospitalization check box checked.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 31Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes type 2" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: negative testing twice; Negative, notes: negative testing twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications were received in 2 weeks. Anti-viral treatment for COVID-19 with Paxlovid from 16Sep2022 to 20Sep2022. Rebound COVID-19 after negative testing twice and no fever for 3 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: elo140), in right arm, on 17Jan2021 as dose 2, single (Lot number: el3302), in right arm, on 03Sep2021 as dose 3 (booster), single (Lot number: fc3184), in left arm and on 21Apr2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOCETIRIZINE; TOPIRAMATE. Past drug history included: Biaxin, reaction(s): "Known allergies: biaxin", notes: Known allergies: biaxin. The following information was reported: VACCINATION FAILURE(medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Indication=Treatment of COVID-19; (07Sep2022) Negative, notes: Tested negative for covid on day 5; (10Sep2022) Positive, notes: 3 days later tested positive for covid again for another 4 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours; not feeling well; not feeling normal; feeling tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-024693 (Moderna), 149362 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "cipro antibiotics" (unspecified if ongoing), notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine; "kidney-pancreas transplant patient" (unspecified if ongoing), notes: kidney-pancreas transplant patient; "kidney-pancreas transplant patient" (unspecified if ongoing), notes: kidney-pancreas transplant patient. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergy:morphine", notes: Allergies (medications, food and other products) sulfa and cipro antibiotics and morphine. Vaccination history included: BNT162b2 (DOSE 1, -1st dose Pfizer 22Jan2021), administration date: 22Jan2021, for Covid-19 immunization, reaction(s): "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours", "not feeling well", "not feeling well", "feeling tired". The following information was reported: PYREXIA (non-serious), outcome "not recovered", described as "running a low grade with temperatures below 100°F/fever/she experienced all of them with her previous vaccines (Pfizer) and only lasted 48 hours"; MALAISE (non-serious), outcome "not recovered", described as "not feeling well"; FEELING ABNORMAL (non-serious), outcome "not recovered", described as "not feeling normal"; FATIGUE (non-serious), outcome "not recovered", described as "feeling tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, malaise, feeling abnormal, fatigue.  Additional information: Caller received her fall booster on 09Sep two weeks and 2 days ago. Patient is still running a low grade with temperatures below 100 degree F since the day after receiving the Moderna shot -on 10Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201194742 same patient, different vaccine dose/event;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Pain, Somnambulism
Clinical narrative: Still suffering from pain from behind my knees, mostly right knee but both affected. Knees hurt when I sleepwalk or bend.; Initially I was very sick with body aches for 24 hours; Still suffering from pain from behind my knees, mostly right knee but both affected. Knees hurt when I sleepwalk or bend.; Still suffering from pain from behind my knees, mostly right knee but both affected. Knees hurt when I sleepwalk or bend.; 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 (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9702) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Shrimp" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; RAMIPRIL. Past drug history included: Levaquin, reaction(s): "Known allergies: Levaquin". Vaccination history included: Covid-19 vaccine (Dose:4, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose:3, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose:1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 16Sep2022 at 20:00, outcome "recovered" (Sep2022), described as "Initially I was very sick with body aches for 24 hours"; SOMNAMBULISM (non-serious), PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 16Sep2022 at 20:00, outcome "not recovered" and all described as "Still suffering from pain from behind my knees, mostly right knee but both affected. Knees hurt when I sleepwalk or bend.". Therapeutic measures were not taken as a result of somnambulism, illness, pain, arthralgia.  Additional information: No other vaccine given in four week. No covid prior vaccination. No covid tested post vaccination. Other medical history none.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 61 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: (currently under control with diet and without medication).; "Had nonalcoholic fatty liver disease" (unspecified if ongoing), notes: Had nonalcoholic fatty liver disease but recently reversed through diet.; "Gall bladder disease" (unspecified if ongoing), notes: Gall bladder disease; "Gall bladder disease; removed in 2007.", start date: 2007, stop date: 2007, notes: Gall bladder disease; removed in 2007. The patient had no known allergies. Concomitant medication(s) included: AMBIEN, start date: 01Jan2017; ATORVASTATIN, start date: 01Jan2019, stop date: 14Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: pistachio nuts" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN; OMEPRAZOLE; VIT D3; MAGNESIUM. Past drug history included: Isoniazide, reaction(s): "Known allergies: isoniazide". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, COVID-19 VACCINE [Manufacture unknown]), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series complete  , COVID-19 VACCINE [Manufacture unknown]), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 22Sep2022 at 08:00, outcome "recovered", described as "I became nauseated"; LOSS OF CONSCIOUSNESS (medically significant) with onset 22Sep2022 at 08:00, outcome "recovered", described as "blacked out"; COLD SWEAT (non-serious) with onset 22Sep2022 at 08:00, outcome "recovered"; DIZZINESS (non-serious) with onset 22Sep2022 at 08:00, outcome "recovered", described as "dizzy". The events "blacked out", "i became nauseated", "dizzy" and "cold sweat" required physician office visit. Therapeutic measures were taken as a result of loss of consciousness, nausea, dizziness, cold sweat.  Clinical course: Patient became nauseated, dizzy, cold sweat and blacked out and fell to the floor (her husband caught her head before she hit the floor), but remained conscious. Lasted a few minutes. Same thing happened after the 4th shot. Had electrophysiology study after the first black out episode and now after this second episode, patient was having a loop recorder implanted for monitoring. Patient has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had the Pfizer Covid 19 vaccines and still got Covid.; had the Pfizer Covid 19 vaccines and still got Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Batch/Lot number: unknown), on 13Mar2021 as dose 2, single (Lot number: EN6199) and on 15Dec2021 as dose 3 (booster), single (Lot number: EW0191) for covid-19 immunisation. The patient's relevant medical history included: "blood clot" (unspecified if ongoing), notes: at 8:30 she takes a blood thinner because she had a blood clot; "high blood pressure" (unspecified if ongoing), notes: At 9 o'clock she takes her "high blood pressure". The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had the Pfizer Covid 19 vaccines and still got Covid.". 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: Caller stated that she and her husband had the Pfizer Covid 19 vaccines and still got Covid. They were both taking Paxlovid. She started it at 10pm last night and would take it again at 10am this morning time and then again at 10pm tonight. It said in the paper that it was supposed to be taken it every 6 hours or do they doing at 10 to 10 and are doing it from 10 to 10. She takes Synthroid at 6 and at 8:30 a blood thinner because she had a blood clot. At 9 her high blood pressure and then she figured at 10 she could take those pills. Caller stated that she had no concerns about interactions and thought it said 6 hours I was supposed to take them.  Patient not taking them every 6 hours.  Patient received it once in the morning and it is not specifying what time of the day to take it. It just said in the morning and at night. Caller stated that about paxlovid mentioned she and her husband had the Pfizer Covid 19 vaccines and both got Covid. They were taking Paxlovid. She was 68-years-old and her husband is 74-years-old. Never got sick off the shots or nothing. Information confirmed as provided. Clarified that they had both Pfizer Covid 19 vaccine shots and the Pfizer Covid 19 booster.   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: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: had the Pfizer Covid 19 vaccines and still got Covid.; had the Pfizer Covid 19 vaccines and still got Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A 74-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Mar2021 as dose 1, single (Lot number: ER6955), on 07Apr2021 as dose 2, single (Lot number: ER8732) and on 06Dec2021 as dose 3 (booster), single (Lot number: EW0191) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "had the Pfizer Covid 19 vaccines and still got Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Caller states she and her husband had the Pfizer Covid 19 vaccines and still got Covid.  They are both taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain
Clinical narrative: Chest and back pains; Chest and back pains; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 23Sep2022 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), BACK PAIN (non-serious) all with onset 27Sep2022, outcome "not recovered" and all described as "Chest and back pains". The events "chest and back pains" required emergency room visit. It was unknown if therapeutic measures were taken as a result of chest pain, back pain.  Additional information: Other medical history reported as gurds. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypoxia, Pulmonary embolism, Thrombosis
Clinical narrative: Pulmonary Embolus; Significantly hypoxic; fatigue; shortness of breath; blood clots/The clots are old, not acute; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6201) at the age of 77 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing). Patient did not have any known allergies. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number=EL9261, vaccine location: Right arm), administration date: 05Feb2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening), outcome "recovering", described as "Pulmonary Embolus"; HYPOXIA (hospitalization, disability, medically significant, life threatening), outcome "recovering", described as "Significantly hypoxic"; FATIGUE (hospitalization, disability, life threatening), outcome "recovering"; DYSPNOEA (hospitalization, disability, life threatening), outcome "recovering", described as "shortness of breath"; THROMBOSIS (hospitalization, disability, medically significant, life threatening), outcome "recovering", described as "blood clots/The clots are old, not acute". The patient was hospitalized for pulmonary embolism, hypoxia, fatigue, dyspnoea, thrombosis (start date: 22Sep2022, discharge date: 26Sep2022, hospitalization duration: 4 day(s)). The events "pulmonary embolus", "significantly hypoxic", "fatigue", "shortness of breath" and "blood clots/the clots are old, not acute" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, hypoxia, fatigue, dyspnoea, thrombosis.  Clinical Course: The patient did not have covid Prior vaccination. The patient was not tested with covid post vaccination. Patient did not receive any other vaccine in four weeks. The patient had Pulmonary Embolus, bilateral pulmonary embolic disease, albeit relatively small clot burden. Significantly hypoxic. The clots are old, not acute. Recognized a slow decline after receiving Covid Vaccine. Fatigue, shortness of breath for well over a year. Shortness of breath worsened throughout the year and months. Room air oxygen was 70%. No risk factors at all for blood clots, except for Pfizer vaccine. The patient went to emergency room on 22Sep2022. Admitted from PE in both lungs and severe Hypoxia. Flown to a hirer level of care on 24Sep2022. Release to recover at home on 26Sep2022. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. The patient took Heparin, O2, Blood Thinners and Air Lifted as the treatment of the events.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Haematochezia, Inflammatory marker increased, Inflammatory marker test
Clinical narrative: blood clots in the stool/bloody stools; the mother was 28 weeks pregnant when she received her Covid 19 vaccine; increased inflammatory markers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Private).  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 28 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HAEMATOCHEZIA (medically significant), outcome "unknown", described as "blood clots in the stool/bloody stools"; INFLAMMATORY MARKER INCREASED (non-serious), outcome "unknown", described as "increased inflammatory markers"; EXPOSURE DURING PREGNANCY (serious), outcome "unknown", described as "the mother was 28 weeks pregnant when she received her Covid 19 vaccine". The patient underwent the following laboratory tests and procedures: Inflammatory marker test: Increased.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error
Clinical narrative: did not dilute it prior to administration; did not dilute it prior to administration; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  A 30-month-old male patient received BNT162b2 (BNT162B2), on 29Sep2022 at 08:46 as dose 1 (maroon cap), 0.2 ml single (Lot number: FT9142) at the age of 30 months, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ERROR (medically significant) all with onset 29Sep2022 at 08:46 and all described as "did not dilute it prior to administration".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect none. Prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) and Relevant Tests was also none. Reaction / Event as Reported by the Primary Source for Translation: did not dilute it prior to administration. Reporter is a pediatrician that was calling about the Covid-19 Vaccine Maroon Cap and there was an error when administering the vaccine and they did not dilute it prior to administration. Undiluted dose of Pfizer BioNTech Maroon Cap given to 30months old male patient. The Reporter verified the information provided by the transferring agent. The Reporter called the CDC and were calling Pfizer before they notified the patient. Reporter asked, what do they need to do from here, Event occurred today. HCP wants to know the procedure post administration. Reporter is asking if the child would get a second dose and if the child should be revaccinated. The AE(s) did not require a visit to: Emergency Room nor to Physician Office.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Product use issue
Clinical narrative: temperature and general joint aches within 3 hours of vaccines  (I am a Pfizer employee , but this website kept rejecting that box to enter the info); temperature and general joint aches within 3 hours of vaccines  (I am a Pfizer employee , but this website kept rejecting that box to enter the info); Other Vaccine on Same date product: Flu shot; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:15 as dose 5 (booster), single (Lot number: GH9694) at the age of 52 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 22Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "If COVID prior vaccination: Yes" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE :4, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (DOSE :3, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (DOSE :2, Unknown manufacture), for COVID-19 immunization; Covid-19 vaccine (DOSE :1, Unknown manufacture), for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 22Sep2022, outcome "unknown", described as "Other Vaccine on Same date product: Flu shot"; ARTHRALGIA (non-serious), BODY TEMPERATURE ABNORMAL (non-serious) all with onset 22Sep2022 at 15:00, outcome "not recovered" and all described as "temperature and general joint aches within 3 hours of vaccines (I am a Pfizer employee , but this website kept rejecting that box to enter the info)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, body temperature abnormal.  Additional information: Adverse event treatment: Tylenol. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not covid tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Pain
Clinical narrative: Experienced chills and bodyaches throughout the following day with; Experienced chills and bodyaches throughout the following day with; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2022 at 13:00 as dose 1, single (Lot number: GJ6742) at the age of 53 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), PAIN (non-serious) all with onset 29Sep2022 at 12:00, outcome "recovering" and all described as "Experienced chills and bodyaches throughout the following day with". Therapeutic measures were not taken as a result of chills, pain.  Additional information: The patient had COVID prior vaccination and not tested for COVID post vaccination. No known allergies and no other medical history was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fatigue; body aches; a low grade fever; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "a low grade fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown".   Additional information: Caller dose not sees any prior vaccinations (within 4 weeks) in patient's chart. No family medical history and relevant tests was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue; Body aches; A low grade fever; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Lot number: EN6207) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: coviD-19 vaccine (Dose #1: manufacture: unknown , Date: 25Feb2021, Lot: EN6198, NDC: unknown , Expiry: unknown), administration date: 25Feb2021, when the patient was 67-year-old, for Covid-19 immunisation, reaction(s): "Fatigue", "Body aches", "Low grade fever". The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; PYREXIA (non-serious), outcome "unknown", described as "A low grade fever".  Additional information: Caller dose not sees any prior vaccinations (within 4 weeks) in patient's chart. No family medical history and relevant tests was reported.